2024 Speakers

Afia Afzal is the Sr Director, Applied Innovation in the Global Development R&D Data Science organization at Johnson & Johnson Innovative Medicine (JJIM), where she leads a team dedicated to accelerating trial operations through Data Science. In this role, Afia is driving the development and deployment of cutting-edge AI/ML and Digital Health solutions across JJIM’s therapeutic areas. Additionally, her team focuses on developing and embedding productivity efforts and tools to enhance transparency and improve decision-making across the portfolio, ensuring that operations are not only innovative but also efficient.

In her 10 years at Johnson & Johnson, Afia has held multiple strategic roles. As the former Sr Director of External Innovation & Alliance Management, she led efforts to establish key partnerships with biotech companies, academic institutions, and governmental organizations, bringing advanced AI/ML technologies and multi-modal datasets into Johnson drug development pipeline. She played a critical role in driving innovations like early disease detection algorithms and regulatory-grade real-world evidence (RWE) for high-priority projects. In a prior role on the in the R&D Data Science Portfolio Management team, Afia spearheaded high impact use cases across Oncology, Cardiovascular, and Pulmonary Hypertension portfolios, contributing to transformative clinical operations and enhanced patient outcomes.

Afia has 15 years of leadership experience across healthcare, medical device, pharma, and consumer sectors, where she has developed and deployed innovative solutions and technologies. She is driven by a deep passion to improve patient outcomes and provide equitable access to life saving therapies. Afia holds a BS in Biomedical Sciences, a Post Baccalaureate in Public Health, and an MBA from Rutgers University.

Rinol Alaj is Senior Director, Head of Clinical Outcomes Assessment (COA) and Patient Innovation at Regeneron. His professional focus is centered around integrated innovation, design thinking, and clinical operation with 15+ years of experience in the startup and pharma industries. A savvy, results-oriented leader, Mr Alaj has proven success in transforming and building eCOA organizations from the ground up. He received his undergraduate and graduate degrees in computer science from New Jersey Institute of Technology, where he also went on to earn his MBA. Mr Alaj is currently pursuing his Master’s in Public Health – Epidemiology and Biostats program at CUNY Graduate School of Public Health and Health Policy.

Mo has been in the industry for over 24 years, working across multiple roles, from a site CRC to an executive role at multiple pharma sponsors. He has spent the majority of his career working in Clinical Operations and data analytics, working to bring novel solutions forward for patients worldwide. From eSource to VR, to AI led automation and mobile application development. He is based out of NJ and is an active member of ACRP working to elevate the recognition and awareness of drug development and all its stakeholders.

Abigail Alve is the Senior Director, Head of Data Management and Engineering in US Medical Affairs at Genentech. Over 20+ experience working in Pharma (Roche, Novartis, Bayer & Johnson & Johnson) covering phase 1-4 trials. Abigail is passionate about maximizing data utility and the advancement of platforms/technology to further enhance research in generating and disseminating evidence that enables HCPs, pts and payors make the best treatment decisions.

Dr Nadir Ammour brings more than 20 years’ experience in managing global projects in clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, wearables trials, use of electronic health records for research and is now leading efforts at bridging care and research. Dr Ammour was a member of the Executive Committee of the EHR4CR consortium project and led the EHR2EDC consortia. He is presently working on several consortia projects to advance the concept of clinical trials as a treatment option.

David Apfel is the Head of External Innovation, Janssen R&D Data Science. In this role, Mr Apfel and his team focus on identifying and building Data Science partnerships across Discovery & Development and all of Janssen’s therapeutic areas, enabling the application of the world’s best innovation, data, and technology to Janssen R&D’s mission of developing innovative medicines. These partnerships deploy AI/ML, Digital Health, and regulatory-grade RWE to high-impact areas across the Janssen pipeline with applications ranging from discovering new targets, accelerating the development of new molecules, enhanced clinical trial design, patient stratification, external control arms, and clinical operations.

Prior to his current role, Mr Apfel built and led the Janssen R&D Data Science Immunology Portfolio Management team, working to identify and deliver high impact use-cases to advance Janssen’s Immunology portfolio. Under his leadership, the team developed regulatory-grade real-world evidence, accelerated trials utilizing novel datasets and AI/ML patient finding approaches, and developed algorithms based on real-world data and medical image data. Mr Apfel joined Janssen in February 2019 as a member of the Janssen R&D Strategy and Operations team.

Prior to joining Janssen, Mr Apfel worked at The Boston Consulting Group, a management consulting firm, in the healthcare practice as well as the Clinton Health Access Initiative, partnering with the Eswatini Ministry of Health to improve their public health laboratory infrastructure and strengthen access to life-saving diagnostics.

Mr Apfel received his BA in mathematical-economics from Pomona College and an MBA from NYU Stern.

Munther Baara has over 30 years of experience in the pharmaceutical industry. He is currently the VP of Product Strategy and Innovation at EDETEK, providing strategic oversight, innovation, and development of products and technologies. Mr Baara manages the development team and creates product roadmaps, blending vision with data-backed research to ensure long-term competitiveness of product offerings. Mr Baara’s expertise has a strong emphasis and focus on innovation, trends and emerging technologies in support of the paradigm shift in the execution of clinical trials.

Eileen Babcock PA-C, MBA is a Senior Director of Clinical Operations at AstraZeneca Biopharmaceuticals R & D. In this capacity she has engaged in the design and delivery of dozens of clinical trials across multiple therapeutic areas including cardiovascular, respiratory, immunology, infectious disease, oncology and most recently, rare diseases. In previous roles, Ms Babcock has worked in rural health delivery. As a representative of the Pharma industry, her passion is health equity and diversity. She has published on operational effectiveness and partnership models.

Sriman is the head of diagnostics, connected devices, and packaging at Takeda Pharmaceuticals. His prior work experience includes working at GlaxoSmithKline, J&J, and a few other companies. He is a Mechanical Engineer with post-graduation in Packaging, Plastics, and Financial management. He has several global awards to his credit and has presented at conferences on devices and packaging. Sriman is an avid traveler and loves reading.

Shelly Barnes is the UCB Global Innovations Lead . She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Ms Barnes is delivering solutions using novel technologies, transforming from traditional clinical trials to patient preferred clinical trials while maintaining quality, compliance and stakeholder commitments. Ms Barnes actively represents UCB on several industry consortiums including DTRA, CTTI, TransCelerate and IMI.

Kimberly Barnholt has spent over 20 years in the healthcare industry in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.

Innovative Information Technology leader with over 20 years’ experience in Life Sciences, healthcare and retail industries. Proven operations and project manager covering SaaS, cloud infrastructure, AI, network and application teams servicing multiple data centers, cloud operations, strategic technology planning and critical application support. Early adopter with Box GxP, Zoom, and VMware. Avid traveler and lover of dogs!

Cem Behmoaram is based in New York, joined Warburg Pincus in 2011 and focuses on investments in the healthcare sector. Cem is involved in the firm’s investments in Summit Health and CityMD, Quantum Health, Norstella, and ParetoHealth amongst others. Prior to joining Warburg Pincus, Cem worked in the Investment Banking Division of Merrill Lynch. He received a Bachelor of Engineering and a Concentration in Economics from McGill University and an MBA from the Stanford University Graduate School of Business.

Aaron Berger serves as Senior Vice President and Head of Evidence Development Solutions for UBC. He leads a multi-disciplinary team that designs and executes modernized solutions leveraging forward-leaning technology and research designs that deliver fit-for-purpose evidence on the safety and effectiveness of treatments for patients. Mr. Berger joined the UBC team in 2003 and has since served in a range of diverse roles leveraging global capabilities in the execution of peri- and post-marketing product development programs and real-world evidence generation. Mr. Berger previously served as the Head of Peri- and Post Approval Services and the Head of Global Late-Stage Services. He is responsible for the development of real-world data and real-world evidence technology architectures and decentralized research solutions to drive greater insight into the safety profile and value proposition of medicines.

Deirdre Bevard brings over three decades of expertise in the pharmaceutical industry and is known for authentic and transformative leadership. As the Senior Vice President of R&D Strategic Operations at CSL, she oversees a global team focused on portfolio management, clinical operations delivery, integrated business operations, digital strategies, and patient-centered drug development. Ms Bevard’s leadership philosophy emphasizes collaboration, integrity, and innovation, creating inclusive environments where teams thrive and deliver impactful results. Her diverse experience spans key roles at Elligo Health Research, Nektar Therapeutics, and Endo Pharmaceuticals, as well as a CRO and a start-up software company. This broad perspective gives her a diverse perspective and fuels her passion for bridging clinical research and healthcare through partnering with patients, communities, and providers to accelerate medical advancements and enhance health equity. Ms Bevard is committed to making a lasting impact on the industry. She thrives in strategic and collaborative environments, and is frequently sought for her vision, insights, and enterprise connectivity. Beyond her professional achievements, Ms Bevard enjoys family time, good books, a well-crafted cocktail, and a good laugh. Her leadership style reflects her mindset to take her work seriously, but maintain a lighthearted approach about herself, embracing humility.

Dr Brett Bishop is the global leader of the Clinical Operations Center of Expertise at Novo Nordisk. He and his team are responsible for the clinical trial support infrastructure, enabling Novo Nordisk Project Area teams to plan, place, and implement clinical research worldwide. Dr Bishop joined Novo Nordisk in 2017 and has over 30 years of experience in global development operations. Prior to joining Novo Nordisk, he worked for Covance since 1993. Originally from New Zealand, Dr Bishop has been living and working in the USA since 2001. Dr Bishop holds an MSc in Pharmacology from the University of Otago and a PhD from the University of Auckland.

Amanda serves as the primary lead developing and overseeing the operational strategy, planning and evaluation of patient diversity for the Women’s Cancers therapeutic area.  Since joining Merck in 2022, she coordinates collaborations cross-functionally to create clinical trial diversity plans and develops strategies that foster community engagement and outreach.  Amanda oversees strategy implementation and progress, sharing best practices to increase representation of diverse participants in Merck clinical trials.  She also manages the company’s Diversity & Inclusion in Clinical Trials webinar series, bringing rich insight to sites in how to drive diversity in clinical trials. Amanda has more than 20 years in the clinical research field (Rx & OTC) across several therapeutic areas, including oncology, cardiovascular disease, neuroscience, bone metabolism/inflammation and pain management.  Having a heart for philanthropic activities, service projects, and for encouraging youth to pursue the sciences, she is known for helping youth with their science projects and competitions. She is a graduate of Rutgers University in New Brunswick, N.J.

Stacey Bledsoe, RN, MSN joined Gilead Sciences in July 2023 as the new Head of Global Clinical Trial Diversity and Inclusion. Stacey will be responsible for leading the effort to increase the diversity of Gilead’s clinical trials across the portfolio while bolstering Gilead’s stance to understand how treatments affect all the populations. Stacey has over 20 years of experience in the pharmaceutical industry across multiple disciplines including Research & Development, Global Health Outcomes, Medical and Six Sigma.

Prior to joining Gilead Stacey spent over 20 years at Eli Lilly & Co where she had a demonstrated success in Six Sigma methodology, Health Outcomes research, medical information, and the hospital payer environment. She recently led Lilly’s diversity and trials initiatives across the portfolio through partnerships and internal and external collaboration, earning the company a rating of Gold. She has shared her enthusiasm and passion for driving the industry’s path toward more diverse clinical trial access and inclusion by engaging in national boards, speaking at multiple conferences, interviews, and publications. She also created and built the Lilly Global Medical Outreach Program, which used medical professional working at Lilly to provide medical services to underserved communities in countries such as Africa, Greece, and South America.

Stacey’s passion for patients and emphasis on serving the most vulnerable began before she entered the pharmaceutical industry. She held a Registered Nurse role on the Level III Newborn Intensive Care Unit at Riley Hospital for Children. Stacey earned her Bachelor and Master of Science of Science in Nursing from Indiana University. Stacey is driven by a goal to influence and ensure all patients have the same access to clinical research and life changing medications that will ultimately improve their lives. Stacey resides in Indianapolis, Indiana with her husband of 22 years, three daughters with one at her alma mater Indiana University, and Yorkie, Sam.

Amy Bohn has 20 years of experience focused on innovative solutions in Clinical Operations.  Most recently, as a Director in Bayer’s DCT Strategy and Implementation team, Ms Bohn has worked closely with study teams to implement both hybrid and fully remote decentralized clinical trials. With Bayer’s fit-for-purpose model, Ms. Bohn is driven to implement tailored solutions that facilitate remote participation and are user friendly for both trial participants and investigative site partners.

Prior to joining Bayer, Ms Bohn worked for a start-up organization that pioneered remote centralized ratings to address the high failure rate of clinical trials in CNS disorders. Over the course of a decade, she held leadership roles scaling operations from small start-up to global CRO provider. Her specialized experience implementing central ratings, telemedicine, eCOA, and digital platforms is a natural transition to the modern-day decentralized clinical trial.

Ms Bohn is a graduate of Christopher Newport University and resides outside of Philadelphia in Bucks County.

Leida Bowen, as an Associate Director at AbbVie, is primarily tasked with enhancing the company's Clinical Trial Diversity strategy. She collaborates with numerous teams to improve clinical trial processes, ensuring increased participation from diverse physicians and patients. Additionally, she works with external stakeholders to raise clinical research awareness in underrepresented communities. At AbbVie, Leida has been an instrumental figure in diverse roles, including Associate Director in Research and Development and Senior Medical Science Liaison in Dermatology and Gastroenterology. Leida is a graduate of Florida A&M University, where she received her Doctor of Pharmacy (PharmD). During her time at Florida A&M University, Leida conducted malaria research with the Minority Health International Research Training program in Ghana, West Africa. Upon graduation, she completed a post-doctoral fellowship in Pharmacovigilance at Johnson & Johnson. Leida resides in South Florida with her husband two children.

Mary Brantner is Sr. Director, Head of Clinical Program Optimization and Innovation at Insmed Inc. In her role, she identifies opportunities to leverage technology to streamline and optimize conduct of clinical trials. She has 35 years of experience in the Pharmaceutical and Device Industry, having worked at Daiichi Sankyo, Mallinckrodt, and Becton Dickinson before joining Insmed. Her recent roles have been in the Global Development Operations and Process and Systems area. She has overseen Global Development Operations functions that include Clinical Operations, TMF Operations, Process Excellence and Training, Clinical Trial Disclosure and Transparency, Clinical Systems, and Medical Writing. One of her current responsibilities at Insmed is supporting the Insmed Google Cloud partnership as a business owner representing Development Operations on various workstreams.

Jordan Brayanov, PhD is a Head of Digital Strategy within the Data Sciences Institute at Takeda. In this role, Dr Brayanov oversees the strategic development and deployment of Digital Health Solutions and oversees the design and implementation of Decentralized Clinical Trials within clinical programs across the Takeda R&D organization.

Prior to joining Takeda, Dr Brayanov served as Vice President of Research at Respiratory Motion — a leader in respiratory volume monitoring. Dr Brayanov’s experience and research focus are on the design, development, and deployment of patient-centric tools and measurement equipment, advanced data modeling, and data visualization. Dr Brayanov holds a PhD in Computational Neuroscience from Harvard University.

Lauren Briggs is Senior Vice President of Customer Success at ProofPilot. She boasts a robust background in customer success across large and small biopharma and a keen focus on site experience and patient retention strategies. Lauren's background includes nearly 15 years in Customer Success & Operations in clinical trial technology, underscoring her expertise in her role at ProofPilot to engage site staff and patients for sponsors' clinical trials.

Wout Brusselaers is the founder and CEO of Deep 6 AI, a precision research company that empowers healthcare organizations and life sciences companies to de-risk and accelerate clinical research. Wout founded Deep 6 AI in 2016 to improve clinical trial outcomes through AI-driven software that mines electronic medical record (EMR) data to precision match patients to trials. Wout leverages his entrepreneurial experience and deep operational expertise to help address the industry’s patient recruitment and retention challenges. Wout holds a Masters in International Economics from the University College Dublin and a Licentiate degree in Economics from Vrije Universiteit Brussel.

Ramil Burden joined Optum in February 2022 and is CEO of Optum Life Sciences. Ramil joined Optum from GlaxoSmithKline where he worked for 17 years in government affairs, corporate strategy, and as a General Manager in Africa (based in Kenya), Malaysia (based in Kuala Lumpa), and most recently in the UK. Prior to joining GSK Ramil worked in the UK civil service at the Department for Trade and Industry, including roles in the European Commission (based in Brussels) and 2 years in 10 Downing Street as the Prime Minister’s trade and industry adviser. He has a BSc in Maths & German, MSC in Statistics, and MSc in Economics. Ramil lives in Washington DC, with his wife Sarah and their two children. He loves playing sports, reading, snowboarding, and diving.

Peter Caetano is a Senior Director, Global Regulatory Affairs, and Global Regulatory Lead for multiple indications of novel biologicals at Ipsen in Cambridge, MA, US. He had previous regulatory roles at Allergan-AbbVie in the UK, Genzyme-Sanofi in Cambridge, MA, and Procter & Gamble in Cincinnati, Ohio. Peter’s 16-years of regulatory expertise ranges from first in human clinical trials to submissions, with many novel drugs approved thereafter, and post-market compliance. Peter successfully leads interactions with health authorities such as US FDA, EU EMA, Japan PMDA, China NMPA, or Brazil's ANVISA. This in therapeutic areas as diverse as neurology, rare diseases, endocrinology, oncology, rheumatology, or reproductive health. He leads and has led teams performing regulatory activities such as CTAs/INDs, PIP/PSP, parallel advice, BLAs/MAAs, variations, advisory committees, commercial regulatory compliance, inspections, etc. Additionally, he is a trusted regulatory advisor for external innovation and due diligence, quickly devising, challenging, or improving clinical and regulatory development plans in a variety of indications, including those yet without regulatory precedent. Outside of regulatory, he was in pharmaceutical sales and was a professor in a medical school. Dr. Caetano has a solid academic background focused on pharmaceutical development and regulatory. He has a PhD in Pharmaceutics, where at the University of Michigan he collaborated with FDA, USP (United States Pharmacopeia) and Viatris (formerly Mylan, UpJohn), with internships at BMS and Merck. Moreover, Peter completed a PharmD at Ohio State, an MPH at Harvard, an MBA at ESSEC-Mannheim, and postgraduate diplomas at the universities of Oxford, Hertfordshire, and London.

Penny Carlson has 27+ years of experience in the pharmaceutical industry and is currently Head of Global Clinical Development Operations, which includes Clinical Program Leadership, Study Management, Business Operations and Partnership Health and Supplier Management. Prior to this, Penny held various roles of increasing responsibility across several disciplines and multiple therapeutic areas. She started her career working for a small Contract Research Organization supporting NIH sponsored Vaccine and Infectious Disease studies, followed by several years working for large pharma in various data management roles, eventually transitioning to clinical operations in the Oncology therapeutic area, where she stayed for a number of years.

In 2011 Penny joined Takeda (previously Millennium) initially as a Clinical Program Manager and was later responsible for multiple assets in the early development space and was the Clinical Operations Lead for the Gastroenterology Therapeutic Area. For 5+ years, Penny has been an executive leader in the Global Development Organization, leading transformative initiatives for Takeda and focusing on clinical trial delivery, external partnerships and innovative ways of delivering medicines to patients.

Ilan Carmeli brings deep expertise in user-centric machine learning-based software to his leadership at Beaconcure. Leveraging his background in designing innovative products that place customer needs first, Ilan now focuses on creating elegant AI products for statistical clinical analysis. His passion for advancing clinical trials through developing cutting-edge yet intuitive AI solutions aligns closely with Beaconcure's commitment to shaping a responsible and human-centric approach to emerging technology.

Beyond Ilan’s contributions at Beaconcure, he actively pays his experience forward by mentoring aspiring entrepreneurs and students in Israel's technology community. He holds a BSc in Information Management Engineering from Ben Gurion University. 

Through Ilan’s diverse background spanning machine learning R&D, product innovation, and mentorship initiatives, he brings a well-rounded, user-focused perspective to AI advancement.

Sandhya Chandrasekaran is a consultant in the R&D Excellence practice area at ZS. With over 5 years of experience, her expertise spans trial feasibility and optimization, clinical data management, and advanced analytics within the R&D tech domain. Sandhya's exceptional analytical skills and strategic acumen have played a pivotal role in delivering cutting-edge digital device data management solutions, driving transformative impact across numerous pharmaceutical clients.

Ms. Sharon Chen, Co-Founder and CEO of Alphalife Sciences Group, stands at the forefront of the convergence between computer science and life sciences, with over 25 years of software product development experience. In her previous roles, Sharon served as the country General Manager at Verily Life Sciences, an Alphabet company, where she pioneered tech solutions that integrated computer science with life sciences. Additionally, as an engineering director at Google, she developed critical technological platforms and received prestigious accolades such as the "Founder's Award" and the "Outstanding Leadership Award" for her exceptional contributions and leadership. Sharon's unparalleled expertise in artificial intelligence, computer science, and life sciences uniquely positions her as a leading figure in the industry. Recognized as one of the "Top 30 Influential Women in Medicine in 2023," her visionary leadership and innovative spirit continue to drive significant advancements at AlphaLife Sciences Group and across the broader life sciences sector.

Scott Chetham Ph.D. is an experienced healthcare entrepreneur who is currently the CEO and co-founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. This multi-faceted strategic and operational role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and Google[x]. Scott has also served as a Venture Partner at Versant Ventures, CTO and Co-founder of Intersection Medical (sold to ImpediMed), and VP Clinical Affairs (ImpediMed). In these latter two roles he was responsible for clinical research strategy and operations.

Greg Christie is a renowned thought leader in human-centered product development and design. As the Chief Product Officer at StudyKIK, he has gained recognition for his contributions to clinical research technology. Mr Christie’s work on the oncology app concept earned StudyKIK the SCOPE Participant Engagement Award, emphasizing his commitment to a collaborative and user-focused approach that prioritizes participant experience in cell and gene therapy trials.

Under Mr Christie’s leadership, StudyKIK was selected as a finalist for the esteemed Prix Galien UK 2023 Award in the ‘Best Digital Health Solution’ category. This distinction celebrates the patient-centric design and transformative impact of StudyKIK’s study companion applications across various therapeutic areas, including immunology and women’s health.

Mr Christie recently received the prestigious 2023 PM360 ELITE 100 Award in the Tech-Know Geek category for his contributions in reshaping the medtech landscape through innovative and patient-centric products.

Guiding StudyKIK’s Product and Design teams, Mr Christie brings a wealth of experience from his previous roles at technology organizations such as Goldstar Events, Evite, and prominent publications including Elle, Woman’s Day, Car and Driver, Road & Track, and Popular Photography. His expertise spans product development, design, branding, and marketing, positioning him as a versatile and influential leader in the field.

Oversees the medical and scientific aspects of the AiCure portfolio. Dr. Christie brought extensive C-suite and clinical experience to AiCure when he first joined as Chief Development Officer, building on his previous experience as Global Head, Development Science and Innovation at Roche, as Vice President, External Research and Early Development at Johnson & Johnson, and CEO of Solaris Therapeutics. Rich received an SB from MIT, and an MD/PhD from Harvard, where he patented and developed novel optical methods for the study of Alzheimer’s disease.

Stuart Cotter is the Vice President of Product Strategy and Innovation at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Prior to joining Advarra's strategic team, Cotter worked as a Product Manager for Longboat and Advarra eRegulatory Management System, where he supported dozens of study teams and research sites to help them overcome their operational hurdles.

Amy Cramer draws on her experience as a cardiac critical care nurse, clinical research coordinator, certified healthcare quality professional and clinical research informaticist. Ms Cramer has worked in a community hospital, an independent academic medical center, and world class academic medical institution. She is currently Johnson & Johnson Innovative Medicine Clinical Innovation Focus Area Leader: Capitalizing on Data Assets. She has been the Director of eSource Implementation for Pfizer, Inc. Ms Cramer’s focus throughout her career has been determining improvements that provide better patient centric care, whether that be developing a visualization for a complex hypoglycemia protocol, developing a transplant quality program or optimizing the use of the electronic health record for clinical research. Ms Cramer’s current focus is on clinical trials solutions, which includes eSource; specifically the secondary use of EHR data for clinical research. Ms Cramer is Co-Chair of HL7 Clinical Interoperability Council, AMIA’s Scientific Panel Committee, a TransCelerate member and reviewer for many professional journals. Ms Cramer received a Master in Management of Clinical Informatics from Duke University School of Medicine and plans to continue her studies in Clinical Research Informatics at the University of Arkansas for Medical Sciences.

Sourav leads clinical design and planning vertical within Drug development practice at ZS. He works across major pharma companies shaping trial design, early planning and feasibility programs

Shoibal Datta is Head, Digital Health Sciences within the Data Sciences Institute at Takeda. His team focuses on the incorporation of digital health technologies within clinical development specializing in decentralization of clinical trials, remote sensing and measurement and the development of digital health products for post-launch use.

Prior to Takeda he was Vice President of PPD Digital where he set the strategy of working with external platform partners and device manufacturers to create compliant, globally scalable approaches to conduct decentralized trials and their integration into conventional clinical research and data management processes. Prior to that, he spent 13 years at Biogen in roles within translational informatics, data sciences and as part of an innovation hub that launched MS PATHS, a learning healthcare system that utilizes technology to capture high quality data as standard of care for over 10,000 MS patients globally supporting RWE and value-based medicine initiatives.

Ashley Davidson is the Vice President, Product Lead at Advarra. In this role, Ashley collaborates with current partners and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Ashley has over 20 years of expertise in site activation, clinical operations, data management, and clinical strategy. For the last 12 years, Ashley has held a variety of senior positions in life sciences technology organizations, both in Product Strategy and Product Management, where she has led GTM and customer adoption strategies, as well as product development and delivery.

Angela DeLuca is the Associate Vice President, Head of Global Study Operations at Amgen. Angela is responsible for leading the Site Management and Data Management organizations ensuring excellence and consistency in clinical trial execution across the portfolio.

With 20 years in the biopharmaceutical industry, Ms DeLuca has extensive oncology experience and has lived and worked in the US and Japan. She has been recognized for her ability to lead the progress of global clinical development excellence through the creation of innovative operational strategies and the early adoption of digital health initiatives, to optimize the R&D landscape to accelerate products to the global market. Before joining Amgen, she was Vice President, Oncology and Cell Therapy Clinical Operations at Takeda.

Ms DeLuca also held leadership positions at both AbbVie and Abbott, where she led the transformation of the clinical development operations, establishing a center of excellence that became an industry benchmark in clinical development. As the Head of Strategy and Operations for Portfolio Program Management, she served as a consulting partner to the R&D Leadership team, identifying and implementing innovative improvements across the R&D organization. In her role as Head of Innovation, she oversaw the Japan Design Lab team, integrating digital technologies, health technologies, big data, and predictive analytics to enhance clinical trial design and support business decision-making.

Ms DeLuca holds an MBA in Innovation from the University of North Carolina Chapel Hill, Kenan Flagler Business School, and a Bachelor’s in Chemistry from The Ohio State University. She is also a certified PMP.

Dr Charmaine Demanuele is an Executive Director in the AI/ML Quantitative and Digital Sciences group within Global Biometrics and Data Management, Pfizer Research & Development. She leads a team of statisticians and data scientists that bring end-to-end clinical trial innovation with digital health technologies, imaging and statistical, AI/ML methodologies. Her group works across Pfizer's portfolio and leverages models such as Bring-Your-Own-Device and Decentralized Clinical Trials to enable efficient, patient-centric trials and faster breakthroughs for patients. Prior to joining Pfizer, Dr Demanuele was a neuroscience research fellow at Harvard Medical School and Massachusetts General Hospital in Boston, US where she used multimodal neuroimaging to investigate sleep and cognition in health and schizophrenia. Her research has been published in high-impact publications and she received several awards including a prestigious Young Investigator Grant from the Brain & Behavior Research Foundation.

Dr Demanuele received her Bachelor's degree in Engineering from the University of Malta, her PhD in Neuroscience from University of Southampton, UK, and completed postdoctoral work in psychiatric neuroimaging at the Bernstein Center for Computational Neuroscience and Central Institute of Mental Health in Germany.

Marisa DeMartino is a Director and Head of Feasibility in Global Clinical Operations at Vertex Pharmaceuticals. Marisa carved a pathway for data-driven operational feasibility in rare disease and leads a team who support end to end aspects of feasibility from strategic planning through protocol and site feasibility. Marisa collaborates with teams in and outside of clinical trial operations to enhance and develop innovative and scalable processes. She believes each feasibility assessment is truly unique and is particularly interested in the application of data analytics to support trial predictability and risk identification.

James Donohue the Senior Digital Health Lead at Genentech US Medical Affairs. James is focused on identifying and delivering sustainable innovative solutions to transform how a Medical Affairs organization functions by continually improving relationships with customers. James has been in the industry for 15 years and has his Bachelor's of Science from The College of New Jersey and his Masters in Health Care Innovation from University of Pennsylvania.

Tom Dougherty is currently the Data Science & AI Innovative Partnership Lead at Novo Nordisk. He is responsible for developing external partnerships to accelerate the development of new assets across the portfolio. Prior to Novo Nordisk, Tom was the Director of RWE Partnerships & Innovation at Pfizer where he launched therapeutic area external data partnerships and novel technologies.

Tom has over 18 years of experience in healthcare with Merck, GE Healthcare, Boston Scientific, and Premier. He received a bachelor’s degree in chemistry and an MBA from Villanova University.

Hazel Doydum is a visionary leader in digital transformation within the pharmaceutical industry. With extensive and broad experience across Information Technology, Reimbursement, Digital Marketing, Marketing & Sales Operations, Learning & Development, and Clinical Operations, she has consistently driven innovation and process efficiency through automation in each of her roles. Currently, Hazel leads a team at GSK focusing on the large-scale integration of digital health technologies and decentralized trial components within the Global Clinical Operations portfolio. An early adopter of technology, Hazel is based in Pennsylvania and finds joy in camping and exploring the outdoors.

Esther Dyson (@edyson on twitter) is the founder of Wellville (Wellville.net), a 10-year (2105-2024) nonprofit project devoted to fostering health and equitable well-being in five small communities around the US.  Ms Dyson works for Wellville full-time as the advisor to Muskegon County, MI.  In her spare time, she is also chair of TheCommonsProject.org, a nonprofit focused on interoperable identity and data access for patients, with appropriate security and privacy infrastructure.

Ms Dyson is also an active investor in health and health care, including 23andMe (former board member),  4D Healthware,  Abridge.ai, Aivo, AvanleeCare (board member). BAMF Health (board member),  Big Health, Bioz, Boundless.ai (sold to Thrive Global), Care.Coach, CareMESH, Cecelia,  Clover Health, Devoted Health, EatMyWay, Element3 Health, Eligible, Enso Relief (sold to Hinge), Epistemic.ai, Ezra.com,  Foresite, Hawthorne Effect, HealthCelerate, HealthTap, Humanest, Humanity, Iaso.ai,  Lipidio,  LuminDx, Medesk, MedicaSafe, meQuilibrium, Mindright.io, Nanowear, NeuroGeneCES, Nobil,  Nuna, Omada Health,  PatientsKnowBest, Pocket Naloxone, Prognos.ai, ProofPilot (board member), Resilient, Samaritan.city, Solera, Startup Health, Supportiv, Syllable.ai, System.com, Tega, Tocagen, Virgo SVS and X-Vax.

Marie Emms has over 25 years of experience in healthcare communications, spanning public relations, medical education and R&D patient engagement. Marie is currently Head of Patient Engagement & Recruitment at BMS responsible for growing, developing and supporting a team to accelerate recruitment and enrollment globally. Prior to her role at BMS, Marie was the Global Head of Investigator & Patient Engagement at Johnson & Johnson.

She specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness and consent through to compliance and adherence. Marie has worked on a wide range of therapeutic areas across neonatal, pediatric, adult and geriatric studies.

Marie’s unique Commercial and Clinical insight, as well as her spirit of partnership, encourages and ensures successful collaboration. Marie defines what it means to be a leader in today’s rapidly changing healthcare industry. She has a genuine and singular passion to improve the lives of patients – a passion that motivates and energizes her colleagues and everyone with whom she interacts.

Emily Epstein, LMSW, is a Clinical Behavioral Health Specialist at the Genetics and Personalized Cancer Prevention Program at Weill Cornell Medicine. There, she provides valuable support to patients and their families as they navigate hereditary cancer syndromes. She has been called an "empathy advisor" due to her commitment to helping healthcare providers and researchers approach their patients with compassion and understanding. Through her experience as a patient with Hereditary Breast and Ovarian Cancer Syndrome due to a BRCA2 mutation, Ms Epstein brings awareness and perspective to panels, advisory boards and support groups. She collaborates and coordinates research to enhance patient-centered testing, coordinated care, support, and research in hereditary cancers. Ms Epstein holds a bachelor’s degree from New York University and a master’s in social work from Fordham University’s Graduate School of Social Services.

Sarah Ernst is a leader in the healthcare and pharmaceutical industries, with a strong focus on clinical innovation and digital transformation. As the Head of Clinical Innovation Strategy and Implementation at Sanofi, Sarah leads a team dedicated to driving advancements in digital biomarkers and innovative clinical solutions. With over five years at Sanofi, she has held key roles where she spearheaded initiatives in clinical development, data analytics, artificial intelligence, and real-world evidence. Prior to Sanofi, Sarah was at PatientsLikeMe and Imprivata, where she focused on business development, strategic partnerships, and market intelligence. Sarah holds a Bachelor's degree from the University of Pennsylvania and a Master's in Engineering Management from Tufts University, bringing a unique blend of scientific expertise and business acumen to her work.

Paul Evans, PhD has worked in the pharmaceutical industry for over 30 years. He is currently President and CEO of Velocity Clinical Research, which owns and operates investigator sites across multiple therapeutic areas in the US and Europe. From a private equity start-up in 2018 Velocity has grown to be the largest SMO (Site Management Organisation) in the world under Dr Evans’s leadership and is focused on solving the delays caused by the inherent inefficiencies of the clinical research process. This was particularly critical during Operation Warp Speed to develop the COVID19 vaccines in which Velocity contributed more patients than any other organization.

He started his career establishing and managing research sites in the UK and was a founder of one of the first European SMOs. Dr Evans joined the CRO sector in 2005 building global site networks that partnered strategically rather than being selected tactically by the CRO and continued to work on innovative patient recruitment campaigns in some of the most challenging environments across all continents. In two of the world’s largest CROs he has led global functions that have included site intelligence, study start-up, feasibility, site contracting, patient recruitment and Investigator payments. Few people have had the opportunity to spend so much of their careers working both on the investigator and sponsor sides of the GCP divide and this breadth of experience gives him a unique insight into the challenges faced by the drug development industry.

Daniel Eversole, PhD, is an Associate Director of Digital Strategy within the Data Sciences Institute at Takeda. In this role, Dr Eversole supports clinical trial teams in the identification and deployment of Digital Health Solutions that improve trial execution and enable the capture of clinical features not available during traditional study visits.

Prior to joining Takeda, Dr Eversole managed multiple product portfolios that delivered digitals tools for translational oncologists to identify novel, clinically robust multi-comic biomarkers that better predict response. Dr Eversole earned his Ph.D. and M.S. in Biomedical Engineering from The University of Texas at Austin and a dual B.S. Optics and Biomedical Engineering from The University of Rochester.

Tony Fantana is Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly and Company. He is passionate about creatively solving high unmet medical need problems by assembling, leading, and developing great teams. At Eli Lilly, he is responsible for executing pilots and proof-of-concept studies, exploring new ideas for clinical designs and models, and prioritizing capabilities for broad scaling. Prior to this role, he founded and led the Global Patient Safety Analytics and Innovation Hub. Dr Fantana spearheaded the push to better monitor health by remote means in clinical trials, for which he received a Lilly Innovation Award.

Dr Fantana trained at Harvard Medical School, where he received a PhD in Neuroscience. He worked as a management consultant, started and led the Movement Lab as an Assistant Professor at Bowling Green State University, served as a visiting scientist and visiting professor at Massachusetts General Hospital and Brown University, and founded and led a medical device company. When not in the office, Dr Fantana can be found cross-country skiing, biking, or hiking with his family, and mentoring the middle school robotics team.

Candice Fitzgerald – MMedSc, BAppSc Global Head Clinical Development & Operations – Regions

Ms Fitzgerald has 20+ year’s experience in clinical operations and medical affairs for various multi-national pharmaceutical and biotech companies (Roche, AstraZeneca, Alexion, Boehringer-Ingelheim) and contract research organisations (CROs). She has held various positions at a Director level in medical affairs / clinical operations managing large teams with responsibilities spanning team leadership, senior management teams, compliance oversight, CRO Functional Service Provider (FSP) model partnerships, cross functional commercial and R&D teams, strategic medical planning, direction, change management and governance.

Ms Fitzgerald moved from Australia to Germany with her 4 boys and husband in 2021. Since this time, she has led and been involved in key Medicine Excellence transformation projects with the aim of reducing Clinical Development cycle times and creating highest value for our patients and clinical trial sites. Ms Fitzgerald holds a Master of Medical Science (Drug Development), University of NSW, Australia and a Bachelor of Applied Science (Health Information Management), University of Sydney, Australia.

Nichole Gallatti is an Associate Director in the Department of Neurology at the University of Pennsylvania. With nearly 20 years of experience as a certified research professional, she has made significant contributions to both pediatric and adult clinical research across various disease areas. For the past decade, Nichole has managed a federally funded regional coordinating center at Penn, overseeing 12 sites in the Philadelphia region. Since 2019, she has also served as an instructor for Clinical Research Fastrack, where she teaches foundational principles of clinical research to aspiring clinical research professionals.

Dr Ben Geelan currently leads the Strategic Operational Intelligence team at Roche, focusing on developing and integrating innovative strategies and solutions to optimise R&D productivity across the organisation. With a diverse background in academic research, software development, and medtech consulting, he has focused on enhancing strategic decision and insight capabilities, ensuring that patient value and perspectives are at the forefront of R&D decision making.

Patrick Gee, Sr, PhD, JLC, is Founder & Chief Executive Hope Dealer, iAdvocate, Inc. Dr Gee graduated from the American University School of Public Affairs in 2012 with a Doctor of Philosophy in Justice, Law & Criminology. Dr Gee is a former Peritoneal/Hemodialysis patient due to suffering from Diabetic Kidney Disease. He has been a Post-Kidney Transplant Recipient since April 2017. Dr Gee is also a retired Major/Chief of Security from the Virginia Department of Corrections; and currently serves as the Founder & CEHD of iAdvocate, Inc., a non-profit Faith-based Health & Wellness organization. He is also an Ordained Minister at Mountain Movers Ministry in Richmond, VA. As a Patient Representative for the Diabetes Kidney Disease-Collaborative Task Force and an advocate for those living with chronic kidney disease and the morbid conditions that contribute to this disease, such as diabetes, cardiovascular disease, hypertension and obesity, Dr Gee uses his personal experiences to teach, coach, mentor and educate others on how best to manage their outcomes. He also ensures that underserved, undervalued and disenfranchised communities of color have a voice in their quality of life and equitable healthcare access. He also serves as Chair of the Kidney Health Initiative's Patient Family Partnership Council and is on ASN's APOL-1 Kidney Disease Steering Committee.

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science. Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

Yusuf Ghadiali is Executive Director, Head of Clinical Trials Business Operations at Daiichi Sankyo. Mr Ghadiali has over 20 years of clinical operations experience leading and building several capabilities including innovation centers of excellence, process improvement and metrics & analytics capabilities. As Head of Clinical Trial Business Operations (CTBO) at DSI, Mr Ghadiali leads identification and enablement of key capabilities to support and enhance clinical trial delivery in the areas of: Feasibility & Site Identification, Bio-Sample Operations, Investigator/Site Engagement and Relationship Management, and Site Contracts and Budgets Management.

Dr Noah Goodson is a senior leader driving strategy and advisory consulting services at THREAD. He spends his days supporting pharmaceutical, biotech, and medical device companies in the design and execution of clinical trials. A key theme of his work is the integration of Human-Centered Design to galvanize innovative solutions grounded in science and the practical world of user experience. Prior to joining THREAD, Dr Goodson helped early-stage biotech and medical device companies design and execute hybrid and fully decentralized research. He is also well versed in the complex business needs of these organizations and has spent significant time in guiding business development and scientific communication strategies with investors.

Michael rejoined Bain Capital in 2019. He is a Managing Director on the Bain Capital Tech Opportunities team, where he leads the fund's healthcare IT vertical.

Prior to joining the Tech Opportunities team, Mr Grandfield was an investment analyst at Triarii Capital, an investment firm in Boston. Prior to Triarii Capital, Mr Grandfield was an associate in Bain Capital’s North American Private Equity team, where he spent time in the Technology, Media & Telecom Vertical. Prior to joining Bain Capital initially, Mr Grandfield was a consultant with The Boston Consulting Group in the New York office.

Mr Grandfield graduated from the University of Virginia, where he received a BS in Commerce with Distinction.

Gordon Gregory’s 16-year career in the Pharmaceutical industry has spanned a range of roles at ICON Clinical Research and Johnson & Johnson Innovative Medicine. The constant throughline throughout his work in Clinical Trial Operations & Oversight, Clinical Supplies Operations (primarily in Advanced Therapies) and leading the Center for Adaptive Work Design has been a drive to lead innovation in the way that Clinical Trials are operationalized. From participating in the core team that rolled out an entirely new TMF system at J&J IM, to leading the development of new processes, systems and roles to manage the launch of the CAR-T therapy platform, he has constantly thrived in those spaces where keen operational insights meet innovative technologies and ways of working. Most recently, back in his previous role as a Trial Delivery Leader, he is piloting the utilization of the Workflow Hub as a new and adaptive way of collaborating within the complex and matrixed Team of Teams ecosystem to delivering portfolio outcomes.

Gordon earned Bachelor’s Degrees in Music Composition and Biblical Theology and continues to pursue music as a creative outlet, having released two albums of original music.

Based in Hatfield, PA, he is also involved in a variety of DEI initiatives both in and outside of work and enjoys spending time with his partner and their kids in their queer blended family.

Basker brings a wealth of experience in the Digital Health/Biomarker space. He is accountable for the Digital Measures strategy for GSK and ViiV leading teams that are responsible for Endpoint Analysis, Data Analytics and insights from wearables and devices to inform patient outcomes. Prior to GSK, he was the head of Digital Health at Gilead, Senior Director for Digital Health at BMS, and Digital Innovation Sr Manager at Bayer.

In the roles above he developed innovative Digital Health solutions to support the company portfolio, and was responsible for the vision, strategy, and digital health roadmaps with key stakeholders to support patients in clinical trials and commercial healthcare settings. Some of the key accomplishments in his career are the launch of digital therapeutic applications for Multiple Sclerosis and Multiple Myeloma patients. Basker also teaches Digital Innovation courses at UCSD as part of the certificate program for healthcare professionals.

Syed Waseem Haider has over 17 years of experience in AI healthcare and commercial innovation with a track record of leading AI strategy and delivering enterprise AI solutions. Dr Haider currently leads AI and Life Data Sciences at Merck. A believer in promoting AI and Data Science education and literacy, he is an Adjunct Associate Professor at Columbia University’s Data Science Institute. Dr Haider has authored in leading business publications, co-authored articles for international peer-reviewed journals and conferences and has filed patents and inventions. He holds a PhD from the University of Texas at Dallas.

As Vice President of Innovative Health & Advocacy, Staci is charged with creating a new organizational pillar that delivers an integrated, differentiated and superior patient, site, health authority and industry-leading experience for J&J’s clinical trials. She is accountable for a global team that actively seeks to understand all elements of our external stakeholders, critical to the future success and integrate those understandings into a comprehensive innovative strategy for implementation in protocol design, operational execution, and speed to market. Recently, Staci provided overall leadership and direction for the organizations portfolio delivery operations for the following therapeutic areas (TAs): Neuroscience, Cardiovascular & Metabolism, Retinal, Infectious Diseases, and Vaccines. Additionally, she serves as the senior global functional leader for all TAs, including Immunology and Oncology for site feasibility, patient recruitment/retention and diversity in clinical trials.

She came to Johnson & Johnson from Regeneron Pharmaceuticals where Staci led a diverse set of operational groups including clinical drug supply, start-up and compliance. Having held various supply chain related positions with increasing responsibility levels, while at Pharmaceutical Product Development (PPD), a global contract service provider that provides services to the bio-pharmaceutical and device sectors, Staci had global P&L responsibility of the localized supply chain operations encompassing 12 countries. She also led the build-out and opening of distribution centers in Ireland, South Africa, and Brazil. Staci started her career as a protocol specialist at the National Cancer Institute (NCI), which is part of the National Institute of Health in Washington, DC.

Graduating from George Mason University in Virginia, Staci was a six-time NCAA Division I Track & Field All American. She received an Executive MBA from Fordham University.

Active in several professional and community-based organizations, Staci is a founding member of Chief, private network for professional women, the National Coalition of 100 Black Women (NCBW100), and National Black MBA Association. Additionally, she is a member of the Healthcare Businesswomen’s Institute where she is an Executive Circle of Advisors participant, the Drug Information Association and Black Women on Boards.

Staci’s family includes her husband Joe and her three sons Jacob, Jordan, and Justin.

Terttu Haring, MD, is President, Clinical Sites & Patients at Syneos Health. In her role, Dr Haring leads the global clinical operations organization to drive exceptional delivery, quality and data integrity for customers, while ensuring a positive experience for sponsors, sites and patients.

Dr Haring has over 25 years of experience in the clinical development ecosystem, having seen clinical trials from several angles in a research site, large pharma and CRO setting, including as an investigator and a research director; by managing local and regional teams in Netherlands, Europe & Africa; and through overseeing global trial operations and data management activities and pushing digital innovations to clinical operations.

Dr Haring received her MD from Maastricht University in the Netherlands and is based out of the Amsterdam Syneos Health office.

Kristin Herman is the Executive Director of the Clinical Trials Office (CTO) at the Sidney Kimmel Comprehensive Cancer Center at Jefferson. Herman is responsible for the integration and standardization of all operations, policies, regulations, and finances of the CTO and oversight of all research support personnel. Herman serves a key role in expanding SKCCC clinical trial availability across the Delaware Valley. Prior to joining Jefferson in 2022, Herman spent 5 years at Tallahassee Memorial HealthCare (TMH) in Florida as Director of the Office of Research. There she oversaw the TMH IRB, and clinical research administration across all disease areas. She worked to establish an academic research collaboration with Florida State University, culminating in state funding and approval to develop an FSU academic health center on the TMH campus. She also collaborated closely with the University of Florida to advance population and rural health research via the OneFlorida Clinical Research Consortium where she served on the Executive Committee. Previously, Herman spent 14 years at Memorial Sloan Kettering Cancer Center, working as a clinical research coordinator, and then in operations and project management roles. There she gained experience in clinical trial budget and contract negotiation, research privacy and compliance regulations, and other facets of clinical trials administration. She contributed to the launch of the MSK Cancer Alliance initiative in 2013. Herman has an MBA from FSU, and a BA from the University of Rochester.

Jennifer Hillner, Vice President of Strategic Accounts at OneStudyTeam, leads a seasoned sales team and is responsible for the success of the StudyTeam platform across top sponsor partners. Jenn collaborates with all OneStudyTeam departments including product, marketing and customer success to help create the best solution possible to help accelerate clinical research. She strives to take an all encompassing view of the organization and its solutions in order to provide the best possible experience to sponsors and sites. Jenn has been with OneStudyTeam for more than five years and has been instrumental in company growth.

Faith Holmes, MD, brings more than 30 years of experience in direct patient care, and 11 years of medical practice management to her role as Elligo’s Chief Medical Officer. Her unique perspective plays an important part in building the company’s network of Research Ready physician practices and preparing them to conduct research. Dr Holmes’ rich perspective — including experience in family medicine, hospice, and palliative medicine that spans solo practice and single specialty and multispecialty group practices — allows her to build rapport with study managers, site staff, and investigators, and provide medical and scientific knowledge to support future growth. Dr Holmes has served as the Principal Investigator for interventional, diagnostic device, and observational trials in several therapeutic indications in Elligo’s eSolutions model and at the Elligo Clinical Research Center. She earned her BS in chemistry and biology from Trevecca University, her MD from ORU School of Medicine, and is board certified in family medicine and hospice and palliative medicine.

William B. Holmes, Jr. serves as Director of Supplier Diversity at Novartis as a member of the US

Diversity, Equity & Inclusion (DEI) leadership team. He partners with Procurement to embed DEI into procurement processes and business strategies to deliver value for Novartis, while contributing socio-economic impact through engagement with small and/or minority-, women-, veteran-, LGBT-, and disability-owned businesses.

Prior to joining Novartis in November 2021, William held leadership roles for award-winning supplier diversity programs at Merck and GSK. He led the establishment of GSK’s global program, expanding into the UK. While at Merck, William played a pivotal role in building a global supplier diversity program that became the first pure-play pharmaceutical company to join the Billion Dollar Roundtable (BDR) by spending over $1B annually with US diverse suppliers, and reached across other countries such as the UK, Canada, South Africa, Brazil and Australia. William’s earlier experience at Merck included Global Procurement Sourcing Manager roles for both R&D Lab Supplies and IT Services.   William previously served on the Board of Directors for both the Diversity Alliance for Science (DA4S) and Eastern Minority Supplier Development Council (EMSDC). He is a past recipient of the Minority Supplier Development Council UK Corporate Supplier Diversity Excellence Award, the National Minority Supplier Development Council (NMSDC) Corporation of the Year Award, and DA4S Corporation of the Year Award. He recently received the 2024 DA4S Supplier Diversity Leader Award. William is a graduate of Virginia Union University in Richmond, VA. and resides in Pennsylvania with his family.

Matt Holms is the VP of Sales responsible for overseeing Patient Engagement & Recruitment Solutions at Citeline. He has spent 24 years in the Life Science industry, holding various commercial & executive leadership roles, dedicated to driving innovative technology solutions that enhance clinical research across a diverse spectrum of eClinical technology, Patient Recruitment/RWD, and Sponsor organizations. Beyond his professional endeavors, he is passionate about patient access and awareness of clinical research opportunities, having personally experienced life-changing results and benefits as a clinical research study participant.

Peyton Howell is Chief Executive Officer of Parexel and a member of the company’s Board of Directors. She has more than 30 years of pharma services and healthcare industry experience and currently represents the company as Chairperson of the Association of Clinical Research Organizations (ACRO).

Ms Howell served most recently as Chief Operating and Growth Officer responsible for Parexel’s operational delivery, strategy and growth. From 2018 to 2022 she was the company’s Chief Commercial and Strategy Officer, implementing its patient-focused strategy and launching its Biotech business unit. During her tenure, Ms Howell has made a significant impact in growing Parexel’s customer relationships, delivering strong growth in gross new business awards during a period of significant change in the life sciences industry.

Ms Howell’s healthcare industry experience includes senior leadership positions with AmerisourceBergen (now Cencora), a Fortune 20 company, most recently as President for Health Systems and Specialty Care Solutions, a $50 billion business unit. Prior to AmerisourceBergen, she was a founder of Lash Group, growing the company from an early innovator of patient access services to nearly 5,000 employees and serving as President for nearly 10 years following its acquisition by AmerisourceBergen.

Ms Howell serves on the Board of Directors of Tandem Diabetes Care (NASDAQ: TNDM), a medical device manufacturer. She holds a Master of Healthcare Administration from The Ohio State University and a Bachelor of Arts in Health Communications from the University of Illinois. In 2022, Ms Howell was recognized with PharmaVoice’s highest distinction as a Red Jacket honoree, which distinguishes an elite group of leaders viewed as the most inspiring in the life sciences industry.

Eileen Hughes is a Senior Manager in Site Partnerships at CSL Behring, a registered nurse who has worked in research at a clinical site, as a CRA, at a CRO as well as the sponsor. With her experience as a study coordinator and clinical trial educator, she is intimately familiar with challenges faced by our site partners in clinical research. As a site partnership representative, she is working to bring innovative ideas and solutions to facilitate a more streamlined process for study start-up.

Bill Illis is the Global Head of Collaboration and Technology Strategy, in the Global Drug Development, Analytics line function at Novartis and is currently responsible for developing the Analytics Technology strategy, initiating, and overseeing a portfolio of analytics capability development and improvement projects.

Mr Illis has over 25 years of industry experience in R&D spanning subject areas of Cancer Epidemiology, Health Care Cost/Utilization Research; Preclinical Safety, and Clinical Development and Regulatory Affairs, and functional leadership in Data Mgmt, Programming, Statistics, Data Standards, Data Governance, Information Technology and Operations.

Mr Illis has led business and information technology functions at Novartis, and has developed and led transformation projects in data and digital across the pharma R&D landscape. Mr Illis was appointed as workstream lead for the TransCelerate Digital Data Flow initiative in June 2018. Mr Illis holds a Master’s Degree in Public Health (Biostatistics) from the University of Michigan and a Bachelor’s degree in Psychology from Providence College.

A technologist with over 25 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions. Raj is responsible for the overall direction and management of the company and is a Mechanical Engineer with an MBA from Boston University who firmly believes data is the new fuel that will drive human progress.

Dr Melanie Ivarsson has more than 20 years of experience in the life sciences sector at pharmaceutical companies including Eli Lilly, Pfizer, Shire and Takeda, working across all phases of clinical drug development. She is currently Chief Development Officer at Moderna, where she oversees the delivery of all clinical development programs across the company’s portfolio and led clinical trials to develop one of the world’s first Covid-19 vaccines.

Dr Ivarsoon has a PhD in Neurophysiology from the University of Bristol in the UK and an Executive MBA from Sloan School of Management, MIT in the USA. She was awarded an OBE by Her Majesty The Queen in the 2022 New Year’s Honours List for Services to Public Health, and was appointed a Non-Executive Director of UK biotech company LoQus23 in Jan 2022.

Venky Iyer is Director of Data Strategy & Automations within Information Management Group at Pfizer.  He has over three decades of experience in the pharmaceutical sector delivering key enablers for multiple clients to drive business value. Currently, he is actively involved in several AI/ML strategic initiatives partnering with key stakeholders and driving key concepts for enablement.  He holds a master’s degree in Mathematics and has been with Pfizer since 2019.

Sheryl Jacobs is VP, Global Development Operations at Amgen. Ms Jacobs has nearly 30 years of industry experience and joined Amgen in 2008. As VP, Global Development Operations, Ms Jacobs is responsible for clinical operations activities associated with Phase 1-4 clinical studies and she previously served as the Vice President of Global Study Operations where she was responsible for the site and data management aspects of clinical studies.

Prior to joining Amgen, Ms Jacobs served as VP, SOPs, Training & Processes at Pfizer. Ms Jacobs was the Head of Clinical Data Management at Searle and Pharmacia prior to their acquisition by Pfizer. Ms Jacobs’ background includes working in Government through the National Institutes of Health, working for a Japanese Pharmaceutical company, and starting a Data Management department for a Contract Research Organization (CRO).

Throughout her career in the industry, Ms Jacobs has provided support to the successful filing and approval of over 50 life-changing medicines.

Kelsey Jakee, managing consultant with PA Consulting, has an established track record of leading and managing transformation in pharmaceutical R&D. Over the past 14 years, she has advised Top 20 BioPharma and industry consortia on clinical innovation, new service and business model development, R&D technology strategy, digital transformation, improving the patient experience, and leveraging novel data sources across preclinical, clinical, and drug safety. Her mission is to drive high-impact and lasting change in clinical research to help us all live our best lives.

https://www.linkedin.com/in/kelseyjakee/

TBA

Heidi Johnson is an advocate for modern clinical trials that incorporate tailored technology and minimize complexity.  Ms Johnson has spent the last several years at Bayer as a Director of DCT Operations within the DCT Strategy and Implementation group. In this role, she has guided study teams to select and implement fit-for-purpose DCT components into their hybrid or fully remote DCT studies, with a particular focus on operational requirements gathering, technical specification review, instructional material development, and user acceptance testing. Prior to this role, she has spent more than 20 years in global study operations at both sponsor and CRO organizations, including study and site management, learning management, and data management.  She holds degrees from Purdue University and the University of North Carolina at Chapel Hill

Hassan Kadhim is the Business Engagement Leader for Clinical Operations and Development for Vertex Pharmaceuticals. Prior to this role, he was the Global Head of Clinical Trial Business Capabilities & Clinical Innovation at BMS, where his team governed the business technology capabilities strategy within Global Development Operations, and drove changes and innovation towards better outcomes for clinical trial stakeholders. Mr Kadhim is passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Mr Kadhim regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Mr Kadhim actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges.

He has degrees in bioinformatics and pharmaceutical sciences, both from the University of Montreal in Canada.

Christopher Kata is a dynamic networker and connector, known for his ability to build powerful, meaningful, and long-lasting industry relationships. His nearly 20 years of experience span the globe, encompassing clients from diagnostic start-ups to international pharmaceutical companies, CROs, and consultancies. In his career, Christopher has taken on various roles, including Chief Innovation Officer, and has extensive experience in sales and marketing within EDC companies. His deep knowledge of the industry and expertise across all EDC vendors in the market make him a valuable asset. He is actively involved in the sales and positioning of TrialStat’s EDC platform, competing with industry giants like Medidata Rave and Merative. Christopher's proactive, creative, and value-adding agility sets him apart. His unique and broad understanding of today’s evolving EDC market makes him an exceptional resource and thought leader. Don't miss the opportunity to connect with Christopher and gain insights from his extensive experience and industry knowledge.

Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Mr Katta has over 20 years of experience in the pharmaceutical industry. In his current role, he is responsible for building and executing the advanced analytics strategy that covers both Scientific and Business Operations, across Clinical Development Continuum, Geostrategy and Study start-up, Centralized and Risk Based Monitoring, Site Engagement, Business Performance, Precision Medicine, Patient Safety and R&D. In addition, Mr Katta is actively engaged in evaluating the opportunities created by the technology trends like big data, automation, machine learning and AI, digital health etc. and strategically instantiating them at AbbVie to drive organizational transformation. He has an MBA from The University of Chicago Booth School of Business and an MS in Electrical Engineering from University of Texas at Arlington.

Dr Mitchell Katz recently joined Kyowa Kirin, Inc. as Senior Vice President, Global Clinical Operations. In this position, he is responsible for leading the strategic and operational framework of Kyowa Kirin’s clinical development programs within the Global Development Organization. He provides leadership and oversight of the clinical operations team in North America, the European Union, and Japan. Dr Katz also ensures operational excellence and continuous improvement of processes in all clinical operations activities.

Dr Katz has over 25 years’ experience in the pharmaceutical and biotechnology industries, including preclinical and clinical research, pharmaceutical operations, and regulatory affairs. Prior to joining Kyowa Kirin, Inc. he served as Vice President, Development Operations at Ferring Pharmaceuticals, Inc. He also served as Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. Dr Katz has experience working in start-up biotechnology companies, including Acorda Therapeutics, InterMune, Connetics, and NABI. He also held management positions at Eisai, Ortho Biotech and Schering-Plough and participated in seven successful NDA submissions in his professional career.

Dr Katz holds a BA in Biology, a PhD in Microbiology, and served as a postdoctoral research fellow at Downstate Medical Center in NY.

With an expertise in applying Design Thinking approach to Product Models, Chandeep Kaur has been consistently delivering impactful, intuitive, and user-oriented solutions across an extensive spectrum of industries, such as healthcare, public sector, retail, finance, and non-profits.

As a seasoned Product Designer, Ms Kaur plays a pivotal role as the bridge between business stakeholders and cross-functional technical teams, ensuring seamless alignment and delivery of tangible business value. What truly sets Ms Kaur apart is her profound understanding of user needs, honed through rigorous user research and empathy-driven design practices. She played a pivotal role in eliciting business requirements for the Clinical Trials website Project, transforming them into actionable prototypes. This enabled rapid ideation and MVP testing, facilitating a seamless transition to a Product Model approach focused on value and incremental delivery. Her user-centric approach not only effectively communicates solutions but also drives user engagement that directly aligns with overarching business goals.

Ms Kaur’s proficiency in design thinking methodologies empowers her to navigate complexity, uncovering valuable insights and opportunities that fuel Product innovation. By championing iterative development and fostering continuous feedback loops, she ensures that solutions evolve in sync with user needs and market dynamics.

Dr Shameer Khader is an Executive Director of Precision Medicine and Computational Biology at Sanofi. He leads a global team dedicated to utilizing trans-disciplinary big data and machine intelligence in drug target discovery, clinical development, and indication positioning. Before joining Sanofi, Dr Khader played a vital role in establishing the Data Science and Artificial Intelligence function at AstraZeneca. He has extensive experience working with leading organizations like Mayo Clinic, Philips Healthcare, Northwell Health, and Mount Sinai Health System, focusing on precision medicine projects.

Dr Khader holds a PhD in computational biology from the National Center for Biological Sciences in India and completed his post-doctoral training in computational genomics and precision medicine at the Mayo Clinic in Rochester, MN. With over 125 peer-reviewed research papers, patents, and conference proceedings, his scholarly contributions have made a significant impact in domains like healthcare data science, bioinformatics, drug discovery, and precision medicine. His groundbreaking work has gained widespread recognition, receiving attention from reputable media outlets such as Forbes, Fast Company and Bloomberg News.

Acknowledged for his exceptional achievements, Dr Khader has received multiple awards and has been recognized as one of the 100 Artificial Intelligence Leaders in Drug Discovery & Healthcare by DKI Global in 2019. Recently, he was honored as one of the Most Influential AI & Analytics Leaders in the United States by AIM in 2023. Dr Khader’s dedication to advancing precision medicine and artificial intelligence has solidified his position as a prominent figure in the precision medicine and drug development communities.

Faisal M. Khan, PhD is the Corporate Vice President for Artificial Intelligence and Analytics at Novo Nordisk. His team focuses on the applications of AI and data science throughout the drug development lifecycle. His interests focus on the intersections of data science, digital health, biostatistics, bioimaging, personalized medicine, and healthcare delivery. His career has encompassed all aspects of healthcare and biomedical analytics, including diagnostics, devices, clinical trials/therapeutics, and payers/insurance. Dr Khan has worked or consulted across academia and industry with both startups and Fortune-50 companies. He has over 100 published papers, abstracts, and patents on the applications of machine learning and artificial intelligence for healthcare and the life sciences.

Sheraz Khan is Director of Data Science at Pfizer. Sheraz lead operational-AI/ML group in AI/ML Quantitative and Digital Sciences. He obtained his PhD in Computational and Applied Mathematics from the Ecole Polytechnique, France, and has major interests in machine learning, Bayesian statistics and information geometry. He has over two decades of experience in developing signal processing and machine learning algorithms for multivariate time series data. Before joining Pfizer in 2022, he was an Assistant Professor at the Harvard University.

Lisa Kiehne is the Senior Vice President for Clinical Operations at The START Center for Cancer Research. By way of background, Ms Kiehne holds a Masters in Healthcare Administration from Trinity University, with a 16 year career in cancer service line leadership and research operations.

Prior to her role at START, Ms Kiehne worked for Houston Methodist and HCA/ Sarah Cannon, leading the cancer service line in strategy, operations, and program-building for comprehensive cancer programs including early-phase research programs, preclinical research programs, and hematological malignancy research programs. Ms Kiehne has led the development and implementation of essential systems, such as an ERP system in the Research Institute and an EMR and CTMS system in the Cancer Center. Additionally, Ms Kiehne spearheaded a significant recruitment and development plan to deepen research infrastructure and expand clinical capabilities towards NCI designation.

She has a proven track record of fostering growth and global partnerships, representing the organization by opening new START sites and building collaborative relationships with pharmaceutical and biotech companies.

Tracy Killingsworth is a Global Project Manager (GPM) for the BATURA Study with Avillion Life Sciences and has been part of the Avillion Team for 5 years. She was the GPM for the Phase III Denali study investigating PT027 in asthma Patients. She has 25+ years of experience in clinical research and 10+ years of experience as Registered Respiratory Therapist. 

Diagnosed in her teens, Sabina Kineen is passionate about educating others how the diagnosis of an inherited, rare disease can impact an entire family and sharing the unique perspective of living as both a patient and a caregiver. Ms Kineen strives to use her own life experiences, including her involvement and participation in clinical trials, to support patients and industry in order to build bridges and encourage health equity and patient engagement.

Katie King is the Associate Director and DU Lead of Patient Centricity & Engagement for Biogen’s Alzheimer’s Disease pipeline. She brings a wide range of experience in neurodegenerative and neuropsychiatric diseases from not only the CRO, vendor, and sponsor perspective, but also from her firsthand knowledge as both a patient and caregiver. Katie advocates for authentic empowerment of patients and firmly believes that the patient voice should be woven throughout every facet of the clinical research tapestry. In addition to her work in patient engagement strategy development, Katie has dedicated a significant portion of her personal and professional time to the creation of disruptive digital innovations and is known for challenging the “mental red tape” often encountered within the industry.

Brett Kleger is a nationally recognized executive leader with deep strengths in sales, marketing, corporate development and product management. He has extensive experience building healthcare technology and services companies and divisions, and bringing new offerings and capabilities to market. He is particularly interested in data-driven digital solutions. Prior to Inspire, Brett was CEO of Datacubed Health, where he transitioned the company during the pandemic from early stage concepts to a major contender in the eCOA and decentralized clinical trial platform categories. Prior to Datacubed, Kleger was Chief Commercial Officer and Chief Operating Officer at DrugDev, where he led the company’s market success to become the leading provider of site facing technologies, resulting in an acquisition by IQVIA. He remained at IQVIA for several years post acquisition to consolidate and lead the commercialization for all of IQVIA’s clinical trial technologies. Brett holds a business degree from the University of Maryland and a juris doctorate from the Villanova School of Law. In 2018, he was named to the PharmaVoice 100 in recognition of his considerable career achievements.

Motivated each day by the opportunity to make a difference in the lives of patients, Christoph Koenen has extensive experience in leading development teams and organizations in all stages of development from first in human to late stage development. As a physician, his compassion for patients drives his interest in innovation in clinical trials. Dr Koenen understands that the greatest benefit of a successful launch will be patients’ access to a novel treatment. Dr Koenen is equally passionate about interacting with regulatory authorities globally as well as ensuring safety and access for patients on a local level.

Dr Koenen is currently heading up Bayer's global Clinical Development and Operations where he oversees the clinical development of the entire portfolio including executing clinical studies globally. He joined Bayer from Otsuka where, as Chief Medical Officer, he oversaw the entire development organization including Clinical Pharmacology and Translational Medicine, Clinical Development and Operations, Drug Safety, Regulatory Affairs and Quality, Data Management and Analytics, Real World and Value Evidence, Technical Operations, Medical Affairs as well as portfolio and asset management.

Before joining Otsuka in 2019, Dr Koenen was Head of Cardiovascular Medicine and Development at Bristol-Meyers Squibb (BMS), helping to develop its next generation of cardiovascular medicines. Prior to his role at BMS, Dr Koenen worked for Novo Nordisk in various medical and development functions in Europe, as well as in the US. Dr Koenen’s medical background has informed his ability to combine scientific innovation with a strategic approach to business development opportunities, regulatory navigation, and global patient access solutions.

Dr Koenen received his medical degree from Ruprecht-Karls University School of Medicine in Heidelberg, Germany, in 1994. He also holds an MBA from Schiller International University, and is board certified in internal medicine and diabetology.

Bari Kowal joined Regeneron in 2015 and became Head of Global Clinical Operations in 2017. Ms Kowal currently serves as Senior Vice President, Development Operations and Portfolio Management and is responsible for clinical trial strategy and execution, along with overseeing our development shared services functions.

Prior to Regeneron, Ms Kowal was previously at Pfizer where she held the positions of Vice President, Business Operations and Analytics, and, prior to that, Vice President, Strategic Alliance and Development Operations Lead. Ms. Kowal also served as Vice President, Clinical Operations, on the clinical research organization side of the industry at a number of biotech organizations in a variety of clinical research roles early in her career. She holds a BS in Biology from the State University of New York at Binghamton and an MS in Neuroscience from New York University.

Mara Kramer has 20 years of extensive experience from Site, Country, Regional and Global Level. Ms Kramer’s experience in the study coordination, site management, regulatory environment and global feasibility matters allows her to include several perspectives and innovative approaches on the process.She considers that Human and artificial intelligence are complement factors of success supporting the objectives and vision of Sanofi.

Ms Kramer holds a BA in Nutrition from Universidad Veracruzana, Mexico. Previous roles include: Deputy Head Global Feasibility and Competitive Intelligence, Global Feasibility Lead, Cluster Regulatory Manager, Site Manager and Study Coordinator.

Randy Krauss is the Head & Executive Director of Metrics, Analytics, and Performance within Global Clinical Trial Operations at Merck. In this role, his group supports the optimization activities of planned studies, as well oversight of the portfolio, studies, and processes.

Prior to joining Merck in 2016, Randy worked in similar roles at other pharmaceutical/biotech companies including Genzyme (Sanofi), Shire & Alexion. At Genzyme, he served in various roles from R&D Portfolio Management to Clinical Operations, where he developed and maintained an enterprise-wide tool to track global development plans to identifying and maintaining KPIs and other metrics to ensure operational success and compliance.

Randy also spent four years at the BU School of Medicine as an Instructor of Biochemistry. Randy received his B.S. from the SUNY Fredonia and his Ph.D. in Microbiology from the University of Alabama at Birmingham. He completed his post-doctoral Fellowship at the University of Massachusetts Medical Center in Worcester.

Sylvie Kruyner serves as Director, DCT Operations within Bayer’s DCT Strategy and Implementation Team. This highly specialized team evolved from a DCT innovation initiative, which was started in 2019. Their primary focus is to support clinical and operational teams to evaluate the implementation of Decentralized Clinical Trial elements and to support with operationalization of these elements. Up until today, Bayer has implemented DCT in multiple global clinical trials, inclusive of hybrid and fully remote designs.

Ms Kruyner joined Bayer in 2014. She has more than 10 years of operational and trial management expertise within CRO and sponsor organizations, holding different roles on both local and global levels in Europe and the US. Next to this, Ms Kruyner has also been involved in creating and providing intra-company trainings, several taskforce initiatives (related to customer-centricity, change management, monitoring, resourcing) and end-user-insight activities. She holds a Masters in Health Care Management and Policy from Ghent University, Belgium. She currently lives in Chicago, US.

Dr Avi Kulkarni is the CEO of ThoughtSphere. Before ThoughtSphere he was President of Sales for Syneos’s $4b+ clinical business, SVP and head of Cognizant’s $b+ life sciences business, and head of Accenture’s global clinical business. Dr Kulkarni has been at the forefront of the drugs and diagnostics industry for three decades, managing clinical trials, launching new diagnostic tests, building cellular medicine capabilities, and publishing extensively in personalized medicine. Dr Kulkarni’s prior roles included: SVP and leader of IQVIA, a CRO, head of Life Sciences R&D at Booz & Co., a management consulting company, and CXO roles at multiple biotechnology start-ups funded by Sand Hill Road venture capital. Dr Kulkarni currently serves on the Board of Directors of Diaceutics. He is a pharmacist who holds a Ph.D. degree in pharmaceutics from Temple University, Pennsylvania, and an MBA from Stanford University, California. He lives in the San Francisco Bay area with his wife and daughter.

As a trained data scientist and biotechnologist, Mr Biswajit specializes in leveraging the transformative power of data to drive scientific discoveries. With over 17 years of dynamic experience in the healthcare industry, Mr Biswajit garnered a sterling reputation as a versatile, hands-on techno-functional leader, with an exemplary proficiency in data science, Clinical data operations, stats and programming, Real World Evidence, RPA and Six Sigma methodologies.

Fueled by his deep understanding of clinical data operations, statistics, and programming, Mr Biswajit also carries a keen interest in data exploration. He leverages top-tier tools like R Shiny and Python to parse through complex data networks, unearthing crucial insights that power decisive clinical advancements.

Mr Biswajit tenure is marked with leading a multitude of projects, successfully translating intricate business needs into inventive strategies that have consistently yielded notable results. His expertise includes overseeing an array of innovative submission and non-submission trials, such as interventional, non-interventional studies, Real-World Evidence (RWE), and health economics and outcome research (HEOR), where he handles everything from concept design to data acquisition and analysis strategies.

At the heart of Mr Biswajit’s prowess lies ground-breaking work in data linkage through tokenization. By binding data from diverse sources, he has been able to generate an encompassing and comprehensive view of patient health journeys, thus accelerating evidence generation.

As a passionate advocate for technology, he dedicated to improving patient outcomes and driving healthcare innovation. Mr Biswajit’s portfolio includes the successful implementation of purpose-fit digital health solutions such as wearables and sensors and leading the charge in adopting electronic clinical outcome assessments (eCOA).

Mr Biswajit brings with a wealth of experience, passion, and a deep commitment to using data science as a catalyst for innovative advancements in healthcare for the patients.

Matteo Lai is the CEO and co-founder of Empatica, an MIT spinoff and pioneer in developing medical wearables and digital biomarkers for remote health monitoring driven by AI.

Through his versatile background and passion for design and healthcare, he has led Empatica in creating medical-grade technology that is driven by human-friendly design. Empatica’s products include the FDA-cleared Empatica Health Monitoring Platform and EmbracePlus wearable, co-developed with NASA and the HHS and used by some of the world’s top research institutions. Empatica’s consumer products include Embrace and EpiMonitor, the world’s first and only FDA-cleared smart watches in neurology to detect epileptic seizures. 

Matteo studied Engineering, trained as an Architect, holds a Double MSc degree in Architecture, and a Masters in Innovation Management. He is a DiMe contributor, and was named by Sifted as one of the top pioneers of the European startup world.

Mary Jo Lamberti, PhD is a Research Associate Professor at Tufts University School of Medicine and the Director of Sponsored Research at Tufts CSDD. She has extensive experience benchmarking drug development operating practices. Her research focuses on a variety of areas including patient recruitment and retention in clinical trials, clinical research workforce issues, outsourcing and partnerships, and investigative site initiation and management. In addition, she has examined the impact of technologies and digital solutions in clinical trials.

Dr Lamberti has been a frequent speaker at global industry conferences and has published extensively. She holds a BA from Wellesley College and a PhD from Boston University.

Christopher Lamplugh is Associate Vice President and Head of Global Data Management and Standards (GDMS) at Merck & Co., Inc.

GDMS provides Clinical Data Management services for ESD and LSD trials, including data standards, eClinical Interactive Response Technology (IRT), Clinical Outcomes Assessment (COA), Pharmacovigilance Case Processing, and other technical business enablement operations.

Over his 20-year career at Merck, Mr Lamplugh has also led the creation, expansion, and operationalization of the company’s Data Management Centers (DMCs). Located strategically in centers around the globe, the Merck DMC network provides world-class Data Management (DM) deliverables and Pharmacovigilance case process requirements for the company. As Head of Global Data Management and Standards, Mr Lamplugh has sponsored several transformative programs positively impacting the Clinical Development ecosystem and accelerating patient benefit.

Prior to his career at Merck, Mr Lamplugh worked for General Electric for 10 years in Sales Management, Sales Force Effectiveness, and Quality. He is a certified Six Sigma Black Belt and is active in many industry initiatives and forums within the pharmaceutical industry. He has a BA from Ursinus College and an MBA from Penn State, with coursework in Health Policy from Jefferson University. Mr Lamplugh resides in Philadelphia with his wife and 4 children and enjoys saltwater fishing in his free time.

Andy Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO). In this role, Mr Lee leads and manages GCTO, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed and quality standards. Mr Lee is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems and processes to conduct Merck clinical trials.

Mr Lee joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Mr Lee led the integration of Sanofi with Genzyme, where he was Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer.

Mr Lee holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc, a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He also serves as a member of the TransCelerate Operating Committee. Mr Lee received his Masters in Bioenergetics and Physiology from Ball State University in Indiana and two undergraduate degrees from Rhodes University in South Africa.

Felix has over 20 years in strategy and innovation building new business offerings, partnerships, investments, products and services, inside and outside healthcare, across geographies, companies and functions.

He was most recently heading the medical development of digital healthcare for Sanofi US, pioneering medical strategy, evidence generation, stakeholder engagement and capability building for digital health solutions that empower self-management in people living with chronic conditions to improve outcomes.

Over the past 9 years his focus has been in pharmaceutical innovation across the lifecycle continuum, and in recent years, digital health, behavior change and of late, the meaningful applications of real-world data and development of organizational capabilities fit for the future of health.

Felix began his career as a pharmacist in the UK, earned his MBA from the Warwick Business School and is a Fellow of the Chartered Institute of Management Accountants.

Dr. Mark Lee was most recently Senior Vice President and Global Head for Personalized Healthcare, Product Development at Genentech/Roche. Prior to joining Genentech, Dr Lee was a member of the founding leadership team and Head of Clinical Development and Medical Affairs at GRAIL, where his team built one of the largest clinical research programs in genomic medicine aimed at early cancer detection. Some of his previous roles include Lead for Oncology Clinical Sciences at Google[x] Life Sciences, Chief Medical Officer at Boreal Genomics, and Vice President of Oncology Development at Genomic Health, where he led the successful development and validation of the Oncotype DX Colon and Prostate Cancer Assays. Dr Lee received a PhD in Biological Chemistry and Molecular Pharmacology from Harvard, and a MD from Stanford University, where he completed his internal medicine residency and medical oncology fellowship.

Joe Lengfellner is a dedicated digital health innovator with a passion for applying technology strategies in clinical research. He strives to enhance the experiences of patients, clinicians, and research teams by implementing cutting-edge solutions that streamline processes, bolster communication, and optimize data management.

As the Senior Director of Clinical Research Informatics and Technology at Memorial Sloan Kettering Cancer Center (MSK), Mr Lengfellner has spearheaded numerous large-scale research technology initiatives, such as the implementation of MSK's Clinical Trial Management System (CTMS), the development and deployment of eConsent for research, the management of the Electronic Data Capture (EDC) ecosystem, and leading the implementation of Epic for research at MSK.

Mr Lengfellner is deeply interested in streamlining clinical data pipelines from EHR systems to research platforms, aiming to reduce the data management workload on sites and simultaneously enhance data quality while also lowering costs for both sites and sponsors.

A strong advocate for collaboration, he believes in forging partnerships among clinical research sites, technology vendors, and industry sponsors to develop clinical trial technology solutions that benefit all stakeholders and ultimately accelerate the pace of clinical trial execution.

In addition to his role at MSK, Mr Lengfellner leads the Clinical Research Innovation Consortium, a group designed to spearhead innovation within the clinical research industry. Under his leadership, the consortium works to foster collaboration and drive forward-thinking solutions that address the evolving challenges in clinical research. Through his work with the consortium, Mr Lengfellner is committed to shaping the future of clinical research by promoting innovation and excellence across the industry.

Patty Leuchten is Founder/CEO of Diligent Pharma, a tech-enabled service firm focused on quality and compliance. With 30+ years of experience in clinical trials, Patty is a leading authority on global clinical outsourcing, strategic alliances, and driving change in clinical trial execution. At Diligent, Patty is transforming the current approach to identifying/qualifying clinical trial vendors to drive time savings and efficiency while ensuring quality and compliance. Diligent’s platform can shave 100+ days off the vendor qualification process, providing the potential to accelerate clinical trial start-up timelines. Prior to Diligent, Patty founded The Avoca Group, a firm focused on driving improvements in clinical trial execution. Avoca was the first organization in the industry to launch an industry-wide collaborative focused on quality - the Avoca Quality Consortium (AQC). Patty is a frequent speaker and writer on topics surrounding clinical outsourcing, innovation in life sciences, and quality/risk management in clinical trial execution.

Patrick Leung is the Chief Technology Officer at Faro Health, applying large language models and other forms of AI to optimize clinical trial development. Previously, he was co-founder of Earthshot Labs, an NSF-funded deep tech company applying geospatial AI to predict tropical ecosystem growth and carbon financing. Patrick was also CTO of Two Sigma's $4B AUM Private Investments division, where he pioneered the use of AI, data science, and alternative data in private equity and venture investing. Earlier, he spent 11 years at Google in engineering leadership, including work on the Google Duplex conversational AI system. Patrick was a founding employee and SVP Engineering at an early e-commerce platform that IPOed in 1999.

Dr Abby Levine leads product strategy for Evidation’s Consumer platform, focusing on solutions for enterprise partners. Her product initiatives at Evidation include FluSmart, a digital flu monitoring program powered by machine learning. Dr Levine has a background in Anthropology, and holds a BA and MA from Stanford University, and a PhD from UCLA.

Brandon Li is the Co-Founder and Co-CEO of Power, a platform aimed at democratizing access to clinical trials. Brandon’s background is in building technology products and marketplaces which make it easy to navigate traditionally opaque spaces. With Power, Brandon aims to simplify the complex process of finding and connecting with leading medical research.

Brandon's motivation for founding Power came from a personal experience. A close friend faced significant challenges in finding and enrolling in a clinical trial after her cancer relapsed. Her journey highlighted the difficulties patients encounter when seeking treatment options. Inspired by her story, Brandon and his co-founder, Bask, decided to develop a patient-first platform that connects individuals directly with medical researchers, making it easier for patients to find the clinical trials they need.

As the Chief Growth Officer for Evinova, Gill Livock leads value- driven growth initiatives and is responsible for the go-to-market strategy for Evinova’s suite of platform solutions which accelerate innovation for Sponsors, CROs and Partners. Evinova is a separate health tech business within the AstraZeneca group offering digital health solutions that are science based, evidence led and human experience driven. Gill has led and been part of digital transformation initiatives within large pharma, driven commercial partnerships within Fortune 100 companies and designed business opportunities to help secure over $500m worth of funding resulting in a double unicorn valuation. During a career that has spanned sponsor and service companies, Gill has developed expertise in digital growth strategies which leverage technology to bridge the gap between patients, sites and study teams.

Dr Mike Lu is the Head of Clinical Design & Data, Gilead Design & Innovation. Prior to joining Gilead, Dr Lu held multiple oncology product development roles at Genentech: RWD Platform Strategy Leader; Clinical Strategy Leader, and senior clinical scientist where he served as the lead clinical scientist on the Kadcyla global filing team. Additionally, he has held various clinical development roles at Exelixis, BMS, and Novartis in multiple therapeutic areas.

Kate Luu holds a PhD in Biomedical Engineering and Computer Science from the University of Minnesota, Twin Cities. During her doctoral studies, she specialized in utilizing machine learning and deep learning models to interpret motor intentions from peripheral neural signals, showcasing her skill in applying advanced technologies to solve intricate problems.

Currently, as a data scientist at Gilead, Dr Luu leverages her expertise to analyze factors influencing diversity in clinical trial enrollment. Her work helps identify potential sites for enrolling patients from minority groups, ensuring the safety and efficacy of treatments across various racial and ethnic populations.

Prior to joining Novartis, Sean Lynch was VP, Clinical Operations at DCT provider, Curebase. Mr Lynch has previously worked as Senior Director of Clinical Project Management at biotechnology research company, TrialSpark. He also served as Senior Director of Global Sales at clinical research organization (CRO), Syntactx. He worked for nearly seven years at healthcare IT and clinical research company Quintiles (now IQVIA) in Clinical Data Management roles.

Aaron Mackey is the Senior Vice President of AI and Data Science at Lokavant. At Lokavant, he leads innovative data-driven initiatives to enhance Clinical Trial AI-solutions. With a distinguished career spanning academia and industry, Mackey has held tenure-track faculty research positions at the University of Virginia’s Center for Public Health Genomics and the University of Pennsylvania Genomics Institute. His industry experience includes key scientific and leadership roles at GlaxoSmithKline, Hemoshear Therapeutics, Covance/LabCorp, Valo Health, and Roivant Sciences. Most recently, he served as Vice President of Data & AI/ML at Sonata Therapeutics. Aaron Mackey brings a wealth of expertise in genomics, data science, and AI to his role at Lokavant, driving advancements in the application of AI to improve trial outcomes.

With 20 years of experience in managing clinical trials at large Pharma, Biotech and CRO companies, Andrew Mackinnon, Executive GM, Customer Value at Medable, leverages his broad operational expertise to improve how the deployment of modern, digitally enabled clinical trials are utilized. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients.

Katie Madeen is the Director of Digital Health Optimization, focused on the implementation of Digital Health technology and Remote Services within Global Clinical Operations at GSK. With over 12 years in the industry and certified as a Project Management Professional (PMP), she has front-line experience in trial delivery, agile implementation, intimate knowledge of trial technology, and is a Digital Health SME. Ms Madden is a published author in the Digital Health space, as well as a Strategic Owner for the GSK Digital Health Technology Strategy that was a 2022 Reuters award winner for Most Valuable Digital Patient Engagement.

Brandon Maggio is a Director of Digital, Analytics & Performance, within Global Clinical Operations at GSK. Mr Maggio holds degrees in Biotechnology and Biochemical Pharmacology from the University at Buffalo and has dedicated 20 years to the pharmaceutical industry. He leads a diverse group of global innovators responsible for developing Digital Health strategies, implementing technology and innovative trial designs, optimizing processes to standardize new ways of working, and utilizing data to improve performance.

Kathleen Mandziuk, MPH, RN – Vice President of eClinical Development and Delivery is a nurse and epidemiologist with 25+ years of real world research experience in scientific, technology and operational capacity. Ms Mandziuk leads the eClinical Development and Delivery division of ICON and is closely involved in leveraging ICON's real world data assets, specialty services, innovative solutions and clinical technology to transform clinical research and asset development. Her experience spans a variety of leadership roles and she has supported sponsors with strategy, study design and protocol development. Ms Mandziuk is also featured in various articles speaking about how AI/ML, technology and real world evidence (RWE) space continues to evolve in today's research landscape.

Lydia Matombo is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role, she establishes technical and cross functional business needs, aligns with stakeholders, and oversees data integration activities between Merck and Suppliers resulting in the build out, testing, implementation and maintenance of Risk Analysis deliverables such as Key Risk Indicators (KRI)s or Quality Tolerance Limits (QTLs) in support of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) risk based initiative to further the organization’s risk-based quality management (RBQM) approach through advanced analytics.

She ensures that supplier systems are ready and maintained throughout the study life cycle to enable execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics. This enables each Clinical Trial Team to support the effective identification of important study issues that require monitoring, management, and adaptation of study plans.

Ms Matombo collaborates with other functions, Quality Assurance, Ethics and compliance, to ensure that systems and any outlined processes are compliant and Inspection ready.

Ms Matombo has more than 20 Years of clinical database management expertise, leading end to end clinical trial conduct and execution, strategic implementation of quality-by-design data collection systems, building and leading high-performing teams across many therapeutic areas, and is now in the role of Risk Systems Data Integration Lead.

Ms Matombo is committed to creating a diverse and inclusive work environment. She is a member of the GCTO’s Diversity, Equality and Inclusion Ambassadors as well as Merck’s League of Employees of African Descent (LEAD).

Ms Matombo holds a BSN (Honors) from Fairleigh Dickinson University in New Jersey, is a Registered Nurse, and is Project Management Professional (PMP®) certified.

Marland May is the Associate Director of Clinical Trial Diversity & Patient Inclusion at AbbVie. He specializes in supporting territory development and new clinical investigator acquisition strategies. Through his efforts, AbbVie has established a streamlined process for identifying, training, and onboarding new investigators across the globe. Marland has over a decade of experience in the pharmaceutical industry, with leadership roles in global site management, clinical study leadership, and diversity and patient inclusion. He is committed to paving the way for a more equitable healthcare ecosystem for all. Marland first started his career in the mental health field as a clinical therapist and has worked at all levels of education, from elementary to college. He is an advocate for ensuring diverse perspectives are reflected in drug development and promoting inclusivity in clinical research.

Kelly McKee is the Head of Innovative Recruitment at Evinova, AstraZeneca’s digital healthcare company where she is responsible for leading the department to develop and deploy digital and innovative patient recruitment strategies and tactics.  Kelly is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions. Prior to Evinova, she spent over 20 years in clinical operations, digital technology, and patient recruitment at top-tier companies, including Sanofi, Merck, Eli Lilly and Co., Medidata, and Vertex Pharmaceuticals.

Yvonne McLean Florence, MDiv, is a wife, mother and G-mom who was diagnosed with early stage breast cancer and now living with no evidence of disease. She is a breast cancer survivor, the former President/Founder of Sisters R Us Circle of Survivors and an independent patient advocate.

She received a Masters of Divinity from Palmer Theological Seminary formerly Eastern Baptist Seminary in 2010, completed the AACR Scientist and Survivors Program, National Breast Cancer Coalition Project LEAD Program in 2018, the University of Pennsylvania Community Research Scholar Program in 2019; and, in 2023 the MBCRC Advocate Researcher Program and the Alamo Advocate Scholar Program during the San Antonio Breast Cancer Symposium.

Ms McLean Florence has been involved in patient, research and public policy advocacy with an emphasis on clinical trials, community participatory research, diversity, equity and inclusion, quality of care/life for patients and survivorship. As a way to keep the voice of the patient elevated in cancer research, she continues to serve on numerous peer review panels for local and national organizations as a patient advocate, a patient stakeholder, a consumer reviewer and advocate mentor.

She is one ten ambassadors for the National Coalition for Cancer Survivorship (NCCS) 2023-24 Elevate Ambassador Program and a member of their Cancer Policy Advocate Team (CPAT). She is also blessed to represent Delaware County in the Pennsylvania Breast Cancer Coalition’s Traveling Exhibit 67 Counties, 67 Women Affected by Breast Cancer and serve as a County Block Captain for their Driving Out Breast Cancer Campaign.

Dr Christopher McNair is an Associate Professor in the Department of Medical Oncology and serves as the Director of Cancer Informatics and the Enterprise Associate Director for Data Science at the Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Dr McNair provides informatics leadership and oversees the development of technologies and applications for use by the SKCCC research population. These include data capture software, bio-specimen collection tools, research data warehouse and associated applications, catchment area tools, and those to support genomic research. Dr McNair also serves as the co-director for the SKCCC’s precision medicine program which aims to standardize molecular testing across the center, decrease disparities in testing, and increase genomic-driven research studies and state of the art clinical trials at SKCCC.

Dr Shalini Mohan joined Genentech in 2015 in Global Safety Science in which she was responsible for the pharmacovigilance for multiple molecules and supported late stage clinical trials, one of which led to the filing and approval of tocilizumab for giant cell arteritis. Dr Mohan currently leads a team focused on advancing health equity through inclusive research and supporting access to trials and healthcare for underserved populations in the US. She conducted the largest randomized placebo-controlled trial for COVID-19 pneumonia that was successful in enrolling over 80% historically underrepresented patients. This trial has become foundational for Genentech’s mission to be a leader in health equity research. Prior to Genentech Shalini was a Clinical Research Fellow in Oncology and Dermatology and a Postdoctoral Fellow at Stanford University. She has authored more than 25 peer-review publications and received multiple awards including the 2023 Genentech Professional BusinessWomen of California (PBWC) Industry Leader Award.

Donna’s diverse career in healthcare began in nursing and evolved to focus on technologies that support patients in clinical research. With nearly 20 years in the clinical trials space and expertise in patient centricity, improving enrollment success, eCOA, BYOD, and more, Donna is a published author and presents regularly at pharmaceutical industry conferences. In her current leadership role at YPrime, she is the subject matter expert for eCOA, providing strategic direction that drives key partnerships through innovation.

TBA

Peter Morley is a Clinical Sustainability Manager at Novo Nordisk A/S, leading on the decarbonisation of clinical trials globally. He is also a member of the Sustainable Markets Initiative Health Systems Task Force, collaborating with industry and academia to accelerate the decarbonisation of the clinical trials sector through shared frameworks and tools.

With a background spanning more than 25 years in clinical operations, Mr Morley has been with Novo Nordisk since 2001, taking on various roles across the clinical trial process at both local and global levels. His passion for sustainability, combined with a sharp focus on innovation and digitalisation, positions him at the forefront of setting the path for decarbonisation and driving the necessary changes to significantly lower the environmental impact of clinical trials at Novo Nordisk.

Kissondra is the Oncology PRC Lead in the Clinical Center of Excellence at BMS, where she oversees the scientific rigor and quality of all clinical documents within the BMS oncology portfolio. With 10 years of experience in clinical research, she has held roles in Innovation and Digital Health, Study Optimization, and served as the Trial Digitalization and Foundational Portfolio Lead supporting R&D’s core and emerging business goals through the Drug Development’s Innovation Program. She has extensive experience in solution development with both internal and external partners and is passionate about leading cross-functional collaborations to challenge traditional ways of working.

Kissondra held roles at Moffitt Cancer Center, the University of South Florida, and Intezyne, and she has volunteered for over 4,000 hours at healthcare facilities. In addition, she holds an MBA, MS in Biotechnology, and graduate certificate in Intellectual Property.

Prathap Reddy Mukkara is a highly motivated, experienced, delivery and client-focused professional in a multi-billion-dollar pharmaceutical company. Currently, Mukkara is a Sr. Product Owner in the Global Development IT organization at Regeneron managing various applications and needs in support of Regulatory Affairs for Global Development.

Prior to Regeneron, Mukkra worked in various organizations globally, holding several roles that had a significant impact on his career growth. He holds an Engineering Degree in Computer Science.

As Greenphire’s CEO, Jim Murphy leads the strategy for the company, including client satisfaction, business operations, commercial execution and financial performance. He is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Jim has focused his career on building innovative eClinical software companies to address challenges and unmet needs within the global clinical research ecosystem. Prior to joining Greenphire, Jim most recently served as the president and managing director of Almac Clinical Technologies, where he was responsible for strategic, financial and operational leadership. While at Almac, Jim also served as the president and managing director of Almac Pharmaceutical Services – Asia, where he established and managed the Almac Group’s Asia Pacific organizations and business operations across all solution areas. Jim earned a Bachelor of Science in Biochemistry and a Master of Science in Molecular Biology from the University of California at Santa Barbara. Jim resides in the Philadelphia area with his wife and three children. He has a keen interest in travel, cycling and water sports.

Leticia Murray currently serves in the role of Innovation Capability Associate Director of Diversity in Clinical Trials in Novartis Global Clinical Operations. Ms Murray bring more than 20 years of experience in the pharmaceutical industry, during which she has focused on global patient recruitment strategy and improving access for under-represented populations at the vendor and site level. Ms Murray obtained her MBA from Darden School of Business and has since focused her efforts on product development and long-term strategy.

Ahmad Namvargolian co-founded Care Access in 2015 to help sponsors achieve exceptional enrollment outcomes. He supports the day-to-day operations of Care Access while architecting its growth into one of the largest and most trusted global networks of clinical research sites and the leader in decentralized clinical trials.

Now, with over 200 research sites spanning three continents, Care Access conducts hundreds of research studies sponsored by top biopharmaceutical companies across a dozen therapeutic areas including cardiology, dementia, and oncology. In addition to its proven track record of globally top-enrolling sites, Care Access partners with new-to-research communities and establishes high-quality research infrastructure locally to expand access to clinical trials and increase representation.

Prior to co-founding Care Access, Ahmad studied at UC Berkeley and the University of Chicago and conducted research on medical devices, public policy, and systems engineering. His passion and expertise is in delivering sustainable, transformative solutions that improve and advance society.

Barry Nelson has been a resident of Boston for over thirty years and has deep ties to the local community. A retired risk management professional, with credentialing for business continuity and disaster recovery planning, Mr Nelson has a background in technology that extends across multiple industries, including financial services and banking, airlines, and government contracting.

Since 2012, Mr Nelson has served as a patient experience presenter and patient advisor and he regularly participates in patient and family centered conferences, patient experience panels, and other events where he discusses opportunities for improving long-term health care outcomes. Mr Nelson has participated on multiple research initiatives that focus on patient centered outcomes and healthcare improvements at the Brigham and Women’s Center for Patients and Families and the Dana-Farber Cancer Institute. Mr Nelson’s spirit of activism is centered on his Christian faith and he is the co-chair of the “Somebody Prayed For Me, Let Us Pray with You” weekly prayer call.

As a patient volunteer at Brigham and Women’s Hospital Center for Patients and Families, Mr Nelson supports several Patient Family Advisory Councils, Steering Committees, Patient-Centered Outcomes Research Initiatives (PCORI), and other research goals focused on patient care and engagement. Mr Nelson also volunteers at the Dana-Farber Cancer Institute and provides support for marketing, fundraising, and community outreach.

Mr Nelson is a volunteer and board member for common cathedral, a nonprofit faith organization focused on the homeless community, providing weekly worship on the Boston Common, Street Ministry, educational outreach program to youth and their support entities.

Carrie Northcott, PhD is the Head of Digital Sciences, within the Biomeasures, Endpoints and Study Technologies (BEST) group at Pfizer, Inc. She leads a driven and diverse team that is developing, validating, and utilizing digital health technologies (DHTs) and novel digital endpoints (NDEs). These DHTs and NDEs are used to further characterize diseases for patients, health care providers and scientists, as well as demonstrate drug efficacy in clinical trials. Carrie has a diverse scientific background in Pharmacology, Toxicology, and Physiology which provides her unique insight into understanding how these NDEs provide meaningful information to patients, physicians and researchers to better treat and understand diseases.

Flore Nouvel is a Strategy and Operations Senior Manager on the Data Strategy & Solutions team at Vertex Pharmaceuticals. She drives strategy of data solutions supporting Global Clinical Operations, including solutions for patient / HCP / site identification scalable across disease areas. She is an experienced data translator and change management agent working with business partners and technical teams to drive adoption of data / advanced analytics / data science to inform decision making and generate value for the business. She has led various initiatives to pilot and measure the deployment of data solutions informing site selection, patient recruitment and referrals. Flore also worked in economic consulting at Charles River Associates leading and conducting analytics of Real World Data (RWD) to inform competitive / antitrust disputes across healthcare payors and providers. Flore earned a BA in Economics, Statistics, and Computer Science from Swarthmore College and an MBA from MIT Sloan with business analytics and healthcare certificates.

Josh has more than 17 years of experience in software engineering, systems integration, and data science. He has spent the last 12 years in healthcare working to lower costs and improve patient outcomes. During that time, he has served in several senior leadership roles, leading technical strategy and implementation for remote patient monitoring, chronic care management, population health, revenue cycle, and automation initiatives. Josh is a graduate of the Georgia Institute of Technology where he studied Artificial Intelligence and Machine Learning.

Joe O’Rourke serves as the Head of Commercial Development for Walgreens RWE Clinical Trials as the Head of Commercial Development. He brings 20 years of experience in the clinical trials space and has a passion for increasing patient access and diversity to clinical trials. 

Joe’s history involves growing clinical trial companies, recruiting patients, and conducting clinical trials in a leading academic medical center. Prior to Walgreens, Joe served as Vice President of Business Development at WCG Clinical. Over the course of 7 years, he was responsible for the growth of strategic partnerships, clinical trial enabling technologies, growth of endpoint solutions in CNS diseases, as well as the commercial integration of several acquisitions by WCG. 

Prior to WCG, Joe spent 8 years recruiting patients at Acurian (now a part of PPD/Thermo Fisher Scientific) where he spent 4 years in operational delivery in a variety of roles and 4 years in business development. Joe personally delivered and oversaw more than 100 patient recruitment campaigns and helped to accelerate to market blockbuster new medicines in Diabetes and COPD. He also specialized in early digital patient recruitment from 2009-2011. In Joe’s last 4 years there, he was a Business Development leader supporting Acurian’s growth and account management within the large biopharma market segment. 

Joe started his early career as a research assistant at Johns Hopkins, performing metabolic research in wound healing as well as exercise science. Joe has a MBA from Villanova University and a Bachelors in Kinesiology from West Chester University.

Ken Olovich serves as the Executive Director of Sourcing, Procurement, and Finance for the Chorus Division at Eli Lilly. With a background as a pharmacist from Purdue University and an MBA in Finance, he brings over 32 years of experience to his role at Eli Lilly. In addition to his long-standing career at the company, Ken has remained actively involved in various areas of pharmacy practice. He has been married for 33 years and is the proud father of three children: a daughter who is a Doctor of Physical Therapy, a son who holds a master’s degree in Marine Biology, and a daughter currently pursuing a nursing degree. Outside of his professional life, Ken is a dedicated athlete, an avid pickleball player, and continues to actively pitch in a 55+ baseball league.

Dr. Chelsea Osterman is a medical oncologist and medical director with the Tempus TIME program. She completed her residency in internal medicine at the University of Pennsylvania and fellowships in oncology and health services research at the University of North Carolina. Prior to joining Tempus, Dr. Osterman worked as an oncologist in Asheville, NC and in the Real World Evidence division at Flatiron Health. She is currently supporting the TIME trial network where she leads multiple data science and machine learning initiatives aimed at improving access to clinical trials across the United States.

Colleen is Reverba’s authority for all things science. Her long-standing background and understanding of the evolving pharmaceutical landscape is key for Reverba when helping clients develop solutions to address critical challenges and communicate with diverse audiences from HCPs to patients, to payers. During her 20 years in medical communications, she has provided strategic insights and has driven medical content development and execution for diverse client initiatives with a focus on clinical trial engagement activities, insights-generating programs, publications, congress activities, internal and external training programs., among others. Known for her strong scientific insight and in-depth understanding of the global pharmaceutical industry, Colleen has become a trusted advisor to some of the largest pharmaceutical companies worldwide. “What makes MedComms rewarding is having the opportunity to develop and execute innovative strategies that not only support client business needs but also fill important gaps in scientific knowledge for their target audiences.” Prior to her medical communications strategy role, Colleen held senior positions across a spectrum of R&D functions in the Canadian, US, and global pharmaceutical industry in medical affairs, clinical development, regulatory affairs, and clinical operations. In these roles, Colleen honed her skills in fields ranging from drug development strategy and medical scientific communications to trial design and execution across multiple therapeutic areas, including endocrinology, gastroenterology, neurology, respirology, cardiology and oncology.

David Parker has spent the last 30 years working in Clinical Operations positions of increasing responsibility across all phases and many therapeutic areas of research. His experience spans big pharma such as AstraZeneca, mid-size biopharma such as Regeneron and CSL Behring, and small biotech including MacroGenics and Immunocore. Mr Parker’s focus has been equally split between studyParker delivery, capabilities development, and organizational leadership.

Charlie Paterson is a clinical development expert and associate partner at PA Consulting. He has a background in physics and extensive knowledge of lab technology, clinical trials design and execution, and provider operations. Mr Paterson drives the development and adoption of breakthrough technologies with leading organizations across the clinical trials continuum using data-driven approaches.

https://www.linkedin.com/in/charliepatersoninnovates/

As Chief Executive Officer, Jill Pellegrino brings over 15 years of leadership experience in patient recruitment, real-world evidence, and clinical research site operations. Jill is passionate about growing businesses that rely on innovative, data-driven methods to reach patients to provide them with opportunities to participate in research opportunities. Most recently Jill was at CVS Health where she was responsible for establishing and growing the Real World Evidence and Patient Recruitment businesses. At CVS Health, her businesses were successful in placing 35,000 patients into research opportunities in both clinical trials and research settings, drastically increasing diversity participation in research studies. Prior to CVS Health, Jill was General Manager of Accelerated Enrollment Solutions, which was comprised of 2,000 employees across 11 countries and encompassed a patient recruitment offering and clinical research site network of 160 sites. Jill received her bachelor’s degree from LaSalle University in Mathematics and Computer Science.

Heidi is currently a Vendor Program Strategy Director, where she is responsible for driving clinical trial vendor strategies at the program level, with the objective of early vendor partnerships to deliver faster trial start-up.

She’s held various roles across clinical trial operations over a 20-year career and has a vast experience in trial operations and early strategic cross-functional planning.

Karen Peterson is the Founder and Chief Patient Advocate of Karen’s Club, Ms Peterson was inspired to help other patients of color, understand the complex and sometimes skeptical world of clinical trials.  A Stage IV Triple Negative Breast cancer survivor, Ms Peterson is also a founding member of the Patient Community Council at Foundation Medicine, a consultant for Blue Note Therapeutics and a Cancer Research Institute- Immuno Advocate.  Ms Peterson was the featured patient speaker at the Biden Cancer Initiative’s 2019 presentation at ASCO, and the 2020 Inaugural AACR Cancer Disparities Progress Report presented to Congress.  Her inspiring story has been shared with Cure, Essence, Health and People magazines as well as ABC Radio Networks “Perspective” and The Today Show.  Lastly, Ms Peterson successfully completed the exclusive 2021 Robin Hood/Blue Ridge Labs Fellowship Program, where she co-created (with her partner Nava Friedman) the highly anticipated advocacy platform https://www.karensclub.org/

With over 10 years of experience in Life Sciences, predominantly in the R&D area, Sharma Ramanathan supports several pharma clients and internal asset development to optimize clinical trials end to end through advanced analytics & data sciences, data management & governance, real-world evidence, and other advisory & consulting services. Sharma has supported several pre and post-market safety and epidemiology studies and regulatory reporting for big pharma.

Siân Ratcliffe, PhD, is currently SVP, Head of Quantitative Sciences & Development Operations at Biogen, where she leads large global teams accountable for the strategic planning, execution and analysis of clinical trials across all phases of development and therapeutic areas, ie MS/Immunology, Neuromuscular Disorders, Neurodegenerative Disorders and Therapeutics Development (Neurovascular therapies, Psychiatry, and Genetic Neurodevelopmental Disorders). Dr Ratcliffe is also the chair of the Technical Review Committee reviewing all protocols and protocol amendments for R&D.

Prior to Biogen, Dr Ratcliffe spent 20+ years Pfizer, where she held senior leadership and group head roles in Clinical Development & Operations, Medical Writing, Preclinical Safety (Toxicology and Safety Pharmacology), Safety Risk Management and Regulatory Strategy, managing projects throughout development stages from research to post-approval in multiple therapeutic areas (including Oncology, Neurology, Psychiatry, Pain, Rare Disease, Immunology, Internal Medicine and Vaccines). In that time, she directly led 17 NDA submissions, >70 INDs, >50 health authority interactions across multiple therapeutic areas, as well as functional line oversight of ~50+ NDA/sNDA/MAA submissions, including RTOR pathway and vaccine submissions. In addition, Dr Ratcliffe has co-led a number of cross-industry initiatives for TransCelerate and BIO to transform clinical trials and accelerate clinical development.

Dr Ratcliffe has a PhD in Pharmacology from the University of Cambridge (1996). She is a recognized cross-industry expert in CNS clinical trial methodology, abuse potential and suicide risk assessment; she is also the Treasurer and Executive Committee member for International Society for CNS Clinical Trial Methodology and mentors new investigators involved in psychiatry and neurology research.

Mike Rayburn is a TEDx Presenter who teaches innovation, change and peak performance using world-class guitar and humor to create a transformational experience and generate exponential results. He has headlined Carnegie Hall, Las Vegas, and performed more than 5,000 presentations in 20 countries on five continents. Rayburn is a music/internet pioneering entrepreneur, feature artist on Sirius/XM and Artist In Residence at High Point University. His more than 1000 corporate clients include most of the Fortune 100, 500, and the top five, including multiple presentations for Walmart, Exxon, Wells Fargo, Lincoln Financial, UnitedHealth, IBM, Siemens, Verizon, Ford, Nationwide, MetLife, PepsiCo, Chevron, Sony, Allianz, and Liberty Mutual.

Rosemary is the ad interim Head of Global Clinical Operations at Novartis with  responsibility for over 4500 people in more than 60 countries delivering clinical trials. She is a member of the Development Leadership Team (DLT) and Innovation Management Board (IMB) of Novartis. Prior to this ad interim responsibility  Rosemary was Global Head of Novartis Study and Site Operations.

She joined Novartis in 2001 and has a breadth of experience across the drug development continuum having held leadership roles in patient safety, medical, clinical, and global clinical operations, in addition to leading  several organizational transformations. She is passionate about the science and art of drug development.

Rosemary studied medicine at the University of the Witwatersrand in South Africa, followed by a diploma in anesthetics and then practicing medicine in Johannesburg. She remains a member of the South African Medical Association and the College of Medicine of South Africa. Additionally, she has a Graduate Certificate in Pharmacoeconomics and completed the Certificate Course in Medicine and Law at the University of South Africa.

Rosemary joined the pharmaceutical industry in South Africa, before moving to Switzerland with Novartis, and is now located in the USA with her husband and 2 children.

Erin Reynolds is an Associate Director on the Data Science and Analytics team at AbbVie. Throughout her 10 years at AbbVie, Erin has been working with study teams and functional area leaders to find ways to use clinical, operational, and real-world data to transform drug development while improving clinical trial operations and access for both patients and sites. Her recent work has focused primarily on AbbVie’s diversity and patient inclusion efforts to ensure that AbbVie’s strategy has the data and insights needed to inform decisions. Erin earned her Bachelor’s in Biology from Loyola University Chicago and her Master's in Applied Probability & Statistics from Northern Illinois University.

Sara Riordan develops, plans and implements long-term strategies and solutions that leverage clinico-genetic real-world data (RWD) to advance Genome Medical’s vision of enabling a world where everyone’s health is informed by genetics. Sara has served as the Vice President of Clinical and Research Programs at Unified Patient Network, a precision health ecosystem designed to facilitate clinical and research collaboration between health systems, patients and life sciences organizations. She has held previous roles at leading biotechnology and precision oncology diagnostics firms such as Thermo Fisher Scientific, Life Technologies and Oncocyte. Sara served as the 2021 President of the National Society of Genetic Counselors, where she focused on growing a diverse workforce and advocating for equitable access to genetic counselor services. She received her Masters in Genetic Counseling from the University of Arizona and completed a Masters in Human Genetics at the University of California, Los Angeles.

As the head of Innovation and Digital Health, Gaelan Ritter and his team are responsible for creating and developing innovations across BMS. He co-leads the BMS digital innovation pillar for global drug development, which is enabling a spectrum of digital solutions, including several types of digital trial capabilities.

Mr Ritter is an industry leader in the development and infusion of digital innovation solutions to enable optimization of pharma drug development. In past roles Mr Ritter has led and developed strategic partnerships with large academic medical centers and networks. He has also supported trial design and start-up for the BMS oncology and immunology programs. This experience led him to develop industry leading trial design software and processes that create digital protocols and feed downstream systems and processes. He is passionate about not only the ideation and creation, but the development and business change that creates lasting advancement in the industry. Mr Ritter holds an MBA from Temple University along with MS in human physiology and biophysics from Georgetown.

Developing the most trusted ecosystem of partnerships at the intersection of Digital & Health. 

25 years of leading enterprise-wide data and digital cloud transformations yielding clinical and business breakthroughs expertise journey includes CVS Health-Merck-Oracle-Medidata-IQVIA-Medable. Dr. Rizk is a well-known executive and change agent advocate to improve the patient experience powered by data and digital solutions across market leading organizations. Dr Rizk is an advisor to leading AI organizations, including InSilicoTrials. 

As the PharmaVoice™ 100 Award Recipient, Dr Rizk has been acknowledged as a leading influencer in lifeciences to champion change and collaboration that have made an impact in accelerating scientific breakthrough from pipeline to patient. 

Upon speaking with Dr. Rizk she will identify a path to click 'n connect across the circuit to educate - collaborate -innovate with a targeted focus on the mission to accelerate cures. 

Robert Roberson is the Manager of the Enterprise Shared Service Center (eSSC) at Merck, where he has been contributing since 2022. Before joining Merck, Mr Roberson spent 17 years working in the Laboratory Animal Resource field at the University of Pennsylvania and Temple University. He began his career as an animal laboratory technician and, through his strong work ethic, commitment to excellence, and the guidance of his mentors, quickly advanced to the roles of supervisor and, eventually, manager. This progression showcases Mr Roberson’s dedication and capability in his field, leading to his current leadership position at Merck.

Mr Roberson’s journey in the animal laboratory resource field has allowed him to grow as a leader. However, he remains deeply influenced by the strong family structure he grew up with and the life lessons imparted by his father, who always believed in him. These early lessons instilled in Mr Roberson the importance of seizing the moment and never taking anything for granted. Alongside the mentorship he has received throughout his career, the wisdom of his father and the challenges he has faced remind him of the significance of investing in others, particularly those from his own community. Mr Roberson feels a profound obligation to pay it forward.

He finds great satisfaction in mentoring others and sharing the wisdom passed down from his father. His passion for helping others and creating inclusive environments where individuals can be their authentic selves drives his commitment to continuous learning, development, and growth. Mr Roberson aims to use his experiences and knowledge to support and uplift anyone God places in his life, whether for a moment, a season, or a lifetime. He firmly believes that every encounter is meaningful and can significantly impact both his own future and the future of the person he interacts with.

Dr. Holly Robertson is the Head of Advisory Services at Medidata Solutions where she leads a team of subject matter experts, providing guidance to clients and partners in adopting decentralized clinical trial (DCT) strategies and technologies. She obtained her PhD in Pharmacology from the University of Colorado Health Sciences Center in Denver, CO. Dr.Robertson has over 20 years of experience in pre-clinical, translational, and clinical research at leading academic institutions including the McGovern Institute for Brain Research at Massachusetts Institute of Technology (MIT), Duke University, and Duke Clinical Research Institute (DCRI). She also held appointments at the Broad Institute and the Stanley Center for Psychiatric Research. Since 2015, she has led multi-disciplinary teams in developing operational strategies for DCTs including the ADAPTABLE Study, the Industry’s first and largest fully decentralized clinical megatrial with over 15,000 patients enrolled. She is an active member of Clinical Trials Transformation Initiative (CTTI) participating in the Embedding Clinical Trials into Clinical Practice working group, and the European Forum for Good Clinical Practice (EFGCP) eConsent Initiative resulting in several publications and resources for the clinical trial community. Throughout her career, Dr. Robertson has worked collaboratively with sponsors, sites, patients, ethics committees, and technology companies to pioneer successful strategies in changing the clinical trial landscape. She is passionate about developing patient-centered technologies that improve the design and execution of clinical studies, ease patient participation, and accelerate commercial outcomes to improve patient health.

Currently, as the Head of Patient & Site Engagement Capabilities, Tracey leads a team that is responsible for the development the global solutions and processes supporting all aspects patient and site engagement including the use of decentralized technologies in trials. She started her career in consulting working for Coopers & Lybrand / PricewaterhouseCoopers on projects across a broad cross-section of pharmaceutical clients. Prior to her current role at Boehringer she has worked across Medicine leading the business activities for global systems implementations, in IT heading support for Regulatory Submissions Management, and in Biostatistics & Data Science as the Digital Trials team lead. Her career to date has taken her from the UK to US, Germany and back to the US. Typically, she is responsible for strategy development, leadership, project management, process harmonization, innovation, and organizational change management. She has a Bachelor of Science (Hons) in Technology & Business Studies (Production Engineering and Economics) from Strathclyde University, and an MBA Information Management from Robert Gordon University (Scotland, UK). She is Project Management Professional (PMP) and Certified Scrum Master (CSM). 

Steve’s career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Prior to that, he was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010.

Steve also sits on the board of two residential homes for abused children, and started a non-profit company, The One By One Project, with his wife, to help people in need in the Boston area.

As a Principal with the SV Health Investors Growth strategy, A.J. is focused on majority buyouts and growth equity investments across healthcare services, medical device & pharma services, and HCIT verticals. A.J. is responsible for sourcing, evaluating, and structuring new investment opportunities, as well as providing portfolio company oversight. Current and past healthcare Board directorships and portfolio company involvement includes Robling Medical, Packaging Compliance Labs, Hightop Health, Medbio, Velosity, and Hemasource. Prior to joining SV, A.J. was a Principal and co-lead of the Healthcare sector at private equity firm Graham Partners.

Stephen Ruhmel, MPH is the Clinical Strategy Lead for Digital Endpoints at Sanofi. In his role, he is responsible for identifying, creating, validating, and operationalizing both fit-for-purpose and novel digital endpoints in Sanofi’s clinical studies. Prior to this role, Mr Ruhmel was an Associate Director at J&J Innovative Medicine, focused on delivering clinical trial efficiencies and innovation for patients, investigators and the industry at large. He has worked in the pharmaceutical industry for over 15 years in Global Public Health, Global Development, Digital Health, R&D, and IT. With a proven record of improving business performance as a technologist, researcher, and public health advocate, Mr Ruhmel’s career mission is to dramatically improve healthcare for underserved populations globally by leveraging the latest healthcare technology.

Previously, Mr Ruhmel developed and launched a SXSW-award-winning crowdfunding platform, CaringCrowd, which has raised over $4 million across 600+ nonprofit-led public health projects. Globally, he has contributed to projects throughout Africa, including a six-month secondment with Aga Khan University in Nairobi, Kenya, where he led a mixed methods cross-sectional study to evaluate a five-year nursing and midwifery program across Kenya, Uganda, and Tanzania.

Mr Ruhmel received a bachelor’s degree in Information Sciences and Technology from Penn State and a Master of Public Health from Rutgers.

Dennis Salotti is an accomplished executive with two decades of experience in clinical research. Currently serving as the Executive Director & Head of Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, he oversees strategic initiatives within sourcing that foster innovation in clinical trial management. His leadership has been instrumental in driving efficiency and quality in outsourcing practices, ensuring external relationships and solutions drive value for the business.

Prior to his role at Jazz Pharmaceuticals, Mr Salotti held several senior positions at notable organizations including serving as Chief Operating Officer for The Avoca Group, where he spearheaded operational strategies, contributing to the company's growth and success. His tenure saw significant advancements in various areas of quality and compliance, including innovative approaches to vendor qualification processes, and the creation of the Diligent Pharma platform.

Mr Salotti’s commitment to advancing clinical research extends beyond his corporate roles. He serves as Adjunct Faculty at Drexel University College of Medicine, where he shares his expertise with future industry professionals. With a Master of Business Administration from NJIT and a Master of Science in Clinical Research Organization Management from Drexel University, Mr Salotti combines academic rigor with practical experience to drive innovation and excellence in the pharmaceutical industry. Throughout his career, Mr Salotti has demonstrated exceptional leadership and strategic vision, earning him recognition such as Drexel University's 40 under 40 award and the Professor's Excellence Award from New Jersey Institute of Technology

Eben Scanlon is Chief Commercial Officer at OneStudyTeam. His 20-year career has spanned from research in computational protein folding to clinical data management. Currently, as leader of OneStudyTeam’s recruitment strategy and customer operations, he is focused on partnering with sponsors and CROs to optimize patient recruitment outcomes.

Doug Schantz is Senior Vice President at Asklepios BioPharm, a gene therapy company. In his current role, Mr Schantz has responsibility for Program Leadership, Study Management, Data Management, and Medical Writing.

Prior to joining Asklepios BioPharm, Mr Schantz was Vice President, Clinical Operations at Alexion Pharmaceuticals and was accountable for project delivery of Alexion’s portfolio and led a group responsible for program leadership and study management across all phases of drug development and in all of Alexion’s therapy areas, which include hematology, metabolic diseases, neuroscience and nephrology.

Prior to joining Alexion, Mr Schantz was an Executive Director in Development Operations at AstraZeneca, heading up US Site Management and Monitoring. In this role, Mr Schantz led the transformation to an in-house monitoring group in 2017 and is the proud recipient of the Society for Clinical Research Sites Eagle Award for best sponsor in 2018. Additional contributions and roles included leading late-phase, full-service outsourcing (SCOUT), development and implementation of the late-phase sourcing strategy and implementation of risk-based quality management for the AstraZeneca enterprise.

Additional experience included working at Pfizer for 17 years and Eli Lilly and Company for 8 years, having held a wide variety of positions in clinical research, including clinical development, project management, portfolio management and data management.

Mr Schantz was trained as a paramedic at the University of Medicine and Dentistry of NJ and holds a BA in Public Administration from Kean University. Mr Schantz volunteers as a guest lecturer in the graduate program in Clinical Research Administration at Eastern Michigan University, serves on the Leadership Council for the Society for Clinical Research Sites, facilitates the Linking Leaders Clinical Operations Roundtable and participates on the Disruptive Pharma (DPharm) program committee and DPharm Idol competition. Mr Schantz is the president and volunteer coach for the Saline Area Soccer Association and earned the distinction of Michigan State Youth Soccer’s Volunteer of the Year in 2022.

Tara Schultz is a highly accomplished Digital Transformation specialist with expertise in Agile methodology, business case development, and product roadmap creation. She is recognized as a trusted advisor and thought leader in the field, advocating for the agile culture and its potential to revolutionize business operations and drive innovation. Ms Schultz’s collaborative approach and ability to align stakeholders have consistently led to successful outcomes and the achievement of organizational goals.

As an experienced coach, Ms Schultz plays a pivotal role in guiding and mentoring developers, scrum masters, and product owners within an agile framework. Her leadership skills inspire and empower teams, resulting in improved productivity, enhanced collaboration, and the successful delivery of complex projects. During her four-year tenure as Associate Director IT Project Manager at Bristol Myers Squibb, Ms Schultz has made significant contributions by leading agile transformations in Drug Development IT. Productivity of the team and optimizing processes, leveraging her strategic mindset and ability to navigate complex environments.

In summary, Ms Schultz is a Digital Transformation thought leader with a wealth of experience in AGILE methodology, business case development, and product roadmap creation. Her expertise, coupled with her ability to champion agile culture and philosophy, has made her a trusted partner for organizations seeking to drive innovation and achieve their digital transformation goals. Ms Schultz’s technical expertise, leadership skills, and passion for driving change make her an asset to any organization, consistently improving operational efficiency, enhancing customer experiences, and fostering sustainable growth.

Mark Scullion is the CEO of Atlas Clinical Research, a therapeutically driven clinical research site network built on centralized process excellence and integrated technology. Mr Scullion has spent more than 17 years in the clinical research industry. Before Atlas, Mr Scullion was most recently the Global Head of Trial Monitoring for Novartis AG, and also previously held leadership roles at Syneos Health and IQVIA, where he developed novel approaches to clinical trial design and execution. At Novartis Mr Scullion led a group of clinical professionals delivering over 300 clinical studies in partnership with 14,000 investigative sites across the world.

Siddharth Shah has 21 years of experience in the life sciences industry with passion to enable affordable and faster access to righteous care for patients globally using disruptive innovation. Currently he works for BeiGene as an Executive Director, Global Head – Product Management in the data science and digital innovation group.

Sujata Shah, a seasoned professional with over 30 years of experience in medical writing and clinical operations is known for her innovative approach and expertise in leveraging cutting-edge technologies. As a Senior Director at Moderna, she has been instrumental in envisioning and building the infrastructure for the Medical Writing Delivery and Excellence division. Her leadership has driven the adoption of generative AI and other emerging technologies to enhance performance, streamline processes, and boost productivity within her teams. Sujata's career is marked by a strong commitment to innovation and excellence. She has consistently championed the use of technology to transform traditional practices, ensuring that her teams stay ahead in a rapidly evolving industry. Her role at Moderna includes overseeing centralized systems for resource management, vendor oversight, and the integration of new technologies, which has significantly improved the efficiency and quality of medical writing services. With a background that spans leadership roles at Synchrogenix (Certara), Worldwide Clinical Trials, and UCB Pharma, Sujata has a proven track record of building and optimizing organizational processes. Her ability to inspire and retain high-performing teams, combined with her deep understanding of the clinical and regulatory landscape, has made her a key player in the industry. Sujata holds an MBA in Healthcare Management and a BS in Biology, further solidifying her foundation in both the technical and managerial aspects of her field. Her passion for innovation and her expertise in generative AI continue to drive her success in shaping the future of medical writing.

Ali Shamoun is a highly motivated, experienced, delivery and client-focused executive in a multi-billion dollar pharmaceutical company. Currently, he is a leader in the Global Development IT organization at Regeneron. He leads Architecture, Compliance, Regional/Global Services, and Vendor Governance in support of Global Development.

Aakarsh Shard has been driving change and transformation across Shipping, Logistics, Pharma, Manufacturing and Medical Device industries for almost two decades. Mr Shard holds a degree in Mechanical Engineering and an MBA in Human Resources and multiple change management accreditations. He is currently heading a Centre of Excellence for change management at Novo Nordisk and firmly believes that an organization's ability to change/adapt/transform while taking care of people is its biggest competitive edge. Mr Shard lives in Copenhagen and is fascinated by and would love to connect on human psychology, bringing strategies to life and organizational culture.

Nicole Sheetz serves as Sr. Director of Design & Innovation, an organization within Clinical Operations. She has 24 years of experience including clinical program and trial design, decentralized clinical trials, digital health, data sciences, project management, and scientific communication. Nicole holds a PharmD from the University of North Carolina where she developed her passion for clinical research. She spent time at GSK, Lilly and Medidata leading clinical development programs, transformative initiatives, and strategic consulting design engagements. Nicole enjoys working on projects that have a big impact, and her primary focus is clinical design optimization with an eye towards making clinical research accessible for all people.

Addison (Addie) Shelley is a product manager at Flatiron Health who works on Flatiron’s EHR to EDC product, Clinical Pipe. Addie has a background in software engineering and has worked on various products in the clinical research space both as an engineer and product manager. Addie received her undergraduate degree from the University of Pennsylvania in Computer Science.

Noble Shore has been leading efforts to develop and integrate innovative technologies in clinical research for nearly 20 years. Noble has led groundbreaking projects including (a) one of the first RBM/EDC integrations on the market which was used in the H1N1 pandemic response in 2009, (b) an automation engine for CDISC SDTM transformations used on over 200 studies since 2012, and (c) launch of the unified Advantage eClinical technology platform for clinical research which was used to qualify Remdesivir as the first available treatment for COVID-19 in 2020 and which has been used on over 1,100 studies to date. Noble holds an MS in Software Engineering from the University of Maryland and a BS in Computer Science from Carnegie Mellon University.

Zack Sigal is a Partner and leads Pharma Tech investing for LLR Partners, a private equity firm based in Philadelphia. Mr Sigal’s relevant investments include Suvoda, RealTime and VPL. Prior to joining LLR in 2011, Mr Sigal worked as an investment banker for Bank of America Merrill Lynch.

Nick Slack, MBE, is the Chairman and CEO of The START Center for Cancer Research, bringing nearly two decades of leadership experience to the clinical research industry. He is a transformative healthcare executive with a proven track record of driving growth and innovation, all while focusing on the mission, vision, and values an organization delivers to the broader research community.

Most recently, Mr Slack served as an Executive in Residence at Warburg Pincus. During this time, he was a member of Warburg's Healthcare Team, where he worked on life sciences and pharma services strategy. In this role, he supported Warburg's portfolio companies as an advisor, contributing his extensive knowledge and experience to enhance their strategic initiatives and operational efficiencies.

Before joining Warburg Pincus, Mr Slack was the President of WCG Clinical. During his decade-long tenure, Mr Slack was responsible for developing and growing WCG’s relationships with the industry’s leading sponsors, CROs, and hospital systems. Mr Slack worked with partner-clients to design and implement solutions that accelerate the activation of clinical trials, eliminate the duplication of efforts in research, and promote the highest standards of safety for research subjects.

Throughout his career, Mr Slack has provided guidance to more than 150 sponsors, CROs, and sites. He was previously the director of consulting services for HRP Consulting Group and the Associate Director of Accreditation for AAHRPP. A trained ethicist, Mr Slack earned a master’s degree in bioethics from the University of Pennsylvania.

Dr Del Smith is passionate about health equity through inclusive research. Dr Smith is the co-founder and CEO of Acclinate, a trusted digital health company specializing empower communities to take actions for better health. Dr Smith has 20+ years of leadership experience in healthcare, IT, higher education, and government. His research has appeared in leading publications such as the Journal of Equity, Diversity, and Inclusion and the Journal of Business Research. Dr Smith earned his PhD in Management from the University of Alabama.

Brian Smith joined Science 37 in April 2021 and is the Senior Vice President, Metasite Operations, responsible for clinical operations service delivery, including clinical operations, data management, and nursing solutions. Prior to Science 37, Brian served as the Vice President of Data Management at ERT. Previously, Brian served as VP of Project Operations at iCardiac Technologies. He started his career at Wyeth as a Research Scientist doing vaccine research and testing. Brian earned his BS in Biotechnology at the Rochester Institute of Technology.

TBA

Mrs. Spaziani has over 25 years of experience within the clinical research industry on both the sponsor and CRO side. Starting as a Clinical Research Associate, Mrs. Spaziani was rapidly promoted to regional and global clinical management positions. Mrs. Spaziani has extensive and diverse experience with study feasibility and study start-up through study closure and archival including protocol and CRF development, site selection, Investigator Meeting management, clinical study site monitoring, vendor management, and collaborating on clinical study reports and IND Updates. Mrs. Spaziani has supported global clinical study management by utilizing data to accurately forecast recruitment projections, select quality enrolling sites, and meet planned recruitment commitments. She has spent the last 15 years focused on study start-up.

Brad Stefanovic is a seasoned Life Sciences professional with over 17 years of experience in Clinical Trial management, clinical technology, vendor management, business operations, development, and strategy. Previously, he was the Head of Clinical Operations (VP) at Ocugen, a biotech company specializing in gene and cell therapies. He also served as VP of Clinical Operations at Aura Biosciences, focusing on Virus Like particles for Ocular Oncology and Solid Tumor treatments. At TissueTech Inc., he was Senior Director of Clinical Operations, leading programs in Injectable Biologics, Orthopedic, Pain Management, and Sports Medicine. Brad's multifaceted career spans consulting, academia, non-profits, and commercial ventures. He has a proven track record in managing international clinical programs and leading large teams. In 2022, he was named Alumni of the year at the University of the Sunshine Coast for his leadership in Biotechnology.

Dr Andrew Stelzer is a business development expert in the biotechnology and pharmaceutical industries. Most recently, he supported NewCo formation and translational efforts at The Salk Institute for Biological Studies. Prior to Salk, Dr Stelzer developed the partnering strategy for InSphero, a Swiss biotechnology company spun out of ETH Zurich, and co-founded Nymirum, a private venture backed biotechnology company, spun out of the University of Michigan. He holds a Ph.D. in Biophysics and Chemical Biology from the University of Michigan and a B.S. in Chemistry from the University of Toledo.

Ambassador “Sully” Sullenberger has been dedicated to the pursuit of safety his entire adult life. He recently served as the U.S. Ambassador and Representative to the International Civil Aviation Organization (ICAO) and is a sought-after speaker, safety expert, author and pilot.

Sullenberger considers it one of the greatest honors of his life having been asked by President Biden to be the U.S. Ambassador to the International Civil Aviation Organization, a United Nations Specialized Agency, in Montréal, Québec, Canada. He was nominated by the President and confirmed by the U.S. Senate in 2021. He served in the post in 2022. During his tenure he reasserted effective U.S. leadership at ICAO, tackling the aviation crises involving Belarus, Russia, a Middle East airspace dispute and climate change.

Upon reentering private life, he has resumed his profession as a keynote speaker to audiences around the world and continues his advocacy for safety in global air travel.

Sullenberger has a long history of service. He is a graduate of the United States Air Force Academy, and served as a fighter pilot in the United States Air Force. He advanced to become a flight leader and a training officer, attaining the rank of captain. During his active duty, he was stationed in North America and Europe. After serving in the Air Force, in February 1980 he became an airline pilot with Pacific Southwest Airlines, later acquired by US Airways, until his retirement from commercial flying in March 2010. He still flies privately.

Sullenberger was an active and ardent safety advocate throughout his four-decade-long career. He was selected to perform accident investigation duties for the United States Air Force, and served as an Air Line Pilots Association (ALPA) representative during a National Transportation Safety Board accident investigation. Additionally, Sullenberger served as a Local Air Safety Chairman for ALPA, and was a member of one of their national technical committees, where he contributed to the creation of a Federal Aviation Administration Advisory Circular. He was also instrumental in developing and implementing the Crew Resource Management course used by US Airways, and he taught the course to hundreds of other airline crewmembers.

After logging more than 20,000 hours of flight time Sullenberger became internationally renowned on January 15, 2009 when he, as Captain, and his First Officer Jeff Skiles safely guided US Airways Flight 1549 to an emergency water landing in New York City’s frigid Hudson River, during what has been called the “Miracle on the Hudson.” The Airbus A320’s two engines had lost thrust following a bird strike. In terms of total combined years of flying since they had become pilots, Sullenberger and Skiles had 75 years’ experience at that time. And in terms of total years of just airline flying experience, they had a combined 50 years, so they were an extraordinarily experienced crew.

Sullenberger, Skiles and their crew received international acclaim for their actions that day, including the passage of a Congressional resolution recognizing their bravery. Sullenberger was ranked second in TIME's "Top 100 Most Influential Heroes and Icons of 2009” and was awarded the French Legion of Honour.

Sullenberger is the #1 New York Times best-selling author of Highest Duty: My Search for What Really Matters and also wrote Making a Difference: Stories of Vision and Courage from America's Leaders. Clint Eastwood directed the major motion picture about Sullenberger’s life, titled SULLY, based on Highest Duty. Tom Hanks starred in the lead role; Aaron Eckhart and Laura Linney co-starred. The film was released to critical acclaim in September 2016 and garnered four Broadcast Film Critics nominations and one Academy Award nomination. Highest Duty was republished that year as SULLY: My Search for What Really Matters.

Sullenberger has been an international lecturer and keynote speaker at educational institutions, corporations and non-profit organizations about the importance of aviation and patient safety, high performance systems improvement, leadership, crisis management, lifelong preparation, and living a life of integrity. He presented at the World Economic Forum in Davos in 2011, as well as the Swiss Economic Forum that same year. From 2009 to 2013, he served as co-chairman of EAA Young Eagles—a program that inspires and educates youth about aviation. In more recent years, he has also been outspoken in defending our democracy.

Born and raised in Denison, Texas, Sullenberger pursued his childhood love of aviation by learning to fly at age 16, while still in high school, and later at the United States Air Force Academy. At his graduation from the Academy in 1973, he received the Outstanding Cadet in Airmanship Award. In addition to his bachelor’s degree in psychology, he also has two master's degrees, one in industrial psychology from Purdue University and one in public administration from the University of Northern Colorado. He also has an honorary Doctorate of Letters from Purdue University.

As Director, Product Management, Digital Health, Lauren works to integrate Digital Health Solutions into BMS's Clinical Research portfolio.  Previously at BMS, Lauren was a Business Partnering and Strategy lead for Clinical Technologies, Digital Health and Innovation.  Prior to BMS, Lauren led and built Strategic Partnerships programs at Trialbee and AiCure; and worked in Project Management at Epic.  Lauren's professional focus is dedicated to leveraging technology to gain powerful patient-centered insights that lead to improved access to higher quality healthcare.  Lauren resides in New York, New York and studied Ecology and Evolutionary Biology as a pre-medicine student at Tulane University in New Orleans.

Katherine (Kathy) Taylor is recently appointed as Head, GCTO enterprise Shared Services Center (eSSC ) and will champion Merck's work in fostering a diverse, highly skilled clinical trial operations talent pool.  The eSSC recently celebrated its two-year anniversary, a key milestone of progress in our mission to deliver high-quality clinical trial support services with a skills-first, agile hiring approach.  Building upon the successful foundation, the eSSC will now expand services to the full GCTO organization. The eSSC is one of the major contributors to OneTen candidates enterprise wide. They play a significant role in helping us shape and cultivate the workforce of the future.

Katherine brings more than 28 years of experience managing the quality of clinical trial conduct and execution. Since 2021, she has served as the Head of the Risk Evaluation & Adaptive Integrated Monitoring (REAIM) organization. In this role, Katherine led the implementation, delivery, and all aspects of Adaptive Integrated Monitoring (AIM). Prior to that, she was Director, Clinical Quality Operations (CQO) Lead, in the oncology therapeutic area, proactively embedding quality into our clinical trials. Katherine joined our company in 2016 as Associate Director, GCP Inspection Lead, within Quality & Continuous Improvement (QCI).

Katherine is deeply committed to creating a more diverse, equitable and inclusive work environment. She is a member of the inaugural GCTO Diversity, Equity & Inclusion Council and has been a member of the League of Employees of African Descent (LEAD) since 2017, having served as Pennsylvania Chapter Career Chair and on the Mentoring Project Team. Kathy holds a master’s degree in business administration from Eastern University and a bachelor’s degree in natural science/biology from Indiana University of Pennsylvania.

Anthony K. Taylor, DHSc, MSPharm, is an experienced leader, executive, former clinical research scientist and U.S. Army medic with comprehensive industry knowledge and a proven record for delivering results within large, mid-size, and small pharmaceutical organizations. Dr Taylor is Project Management Professional (PMP®) Certified and has a solid background in leading global clinical programs and teams. He has been in the pharma industry for almost 20 years and has held positions of increasing responsibility. When he is not leading large cross-functional initiatives, Dr Taylor enjoys spending time with his family and playing tennis in the U.S. Tennis Association (USTA). He is recently married, has two children, and lives in the Chicago-area with his family.

Jaydev Thakkar, Chief Operating Officer of Biofourmis currently leads global operations across various business functions, including Customer Success, Sales and Marketing Operations, Clinical Research Operations and Supply Chain. Mr Thakkar has over 25 years of experience in leadership roles at organizations that include fortune 100 companies and rapidly growing start-ups. Prior to Biofourmis, Mr Thakkar was instrumental in founding a Digital Health and Innovation group at world’s leading biotech, Amgen, where he served for 14 years. During this time, Mr Thakkar led its “beyond the therapy” digital innovation strategy to maximize product value and clinical outcomes across the patient journey—from clinical development through product launch and post-marketing. At Amgen, Mr Thakkar also led information technology operations for the company’s large portfolio of global clinical trials—including some of the largest ever in the industry, with more than 27,000 participants across 50 countries and more than 1,000 sites. Before Amgen, Mr Thakkar was a telecommunications, technology and finance consultant who co-founded a technology startup and also managed his family’s manufacturing business in India.

Aman Thukral is the head of Digital Operations and Clinical Systems at AbbVie. He has over sixteen years of experience in clinical development, technology planning & business-technology alignment. Mr Thukral is responsible for Clinical Data Repository, eCOA operations, wearables, and sensors and for piloting new technology initiatives. Before this position, he worked at various levels at Deloitte, Cognizant & GlaxoSmithKline.

Mario Torchia gained 15 years of experience in the tech industry, working in multinational companies such as Dassault Systèmes and Siemens. Most recently he led the Sales Strategy as Delmia Geo Leader for South Europe at Dassault Systèmes, actively supporting customers in their business transformation journey.  Previously, he spent four years in Sao Paulo, managing the Brazilian branch of Hyla Soft, a global IT company that provides technology solutions to improve productivity and efficiency within Manufacturing Engineering, Manufacturing Operations and Sales and Operations Planning processes.  Holding a degree in Computer Engineering, Torchia is passionate about technology, innovation, arts, and water sports. He is currently the Chief Operating Officer (COO) at InSilicoTrials, having previously led the sales and marketing team. Torchia leverages his extensive experience with large and medium-sized companies, strategic market vision, and skills in helping startups expand in international markets.

Mark Travers joined Merck in March 2015 as Executive Director, Head of Monitoring Excellence with a remit of building the ME Group, improving all aspects of site monitoring within Merck, re- valorizing the CRA position and making Merck partner of choice with our Investigator sites and suppliers. Dr Travers implemented Risk Based Monitoring and SMART. In May 2015, he became interim Head for the NA Region with overall responsibility for delivering MRLs clinical trials in both Canada and the US. In June 2017, Dr Travers was promoted to the position of VP, Head of GCTO Regions. In this position, he is responsible for over 3,200 colleagues in 4 regions and 48 countries managing and monitoring all of MRL s clinical studies.

Donna Usiskin is Chief Strategy Officer at New Enterprise Ventures (NEV), serving start-ups to Fortune 500 companies. Her proven expertise, leadership abilities and enviable track record of ascertaining value propositions and designing go-to-market initiatives translate into accelerated sales and investment cycles.

Ms Usiskin has over 25 years of operational experience in IT Sales, Business Development and Marketing. Plus, over ten years of Venture Capital experience in the HCIT and Pharma IT market. As VP of Business Development for the firm, she led both the Sales and Marketing and Healthcare IT Executive Forums for the VC portfolio. Donna worked with Portico (McKesson), Health Market Science (LexisNexis), Octagon (Accenture), Cadient (Cognizant), and iContracts (RLDatix) investments.

Passionate about how information technology can impact care and patient outcomes, she concentrates on the convergence of HCIT and Pharma IT. Before NEV, Donna held executive positions in Sales, Strategy and Growth while leading initiatives to raise funds for early and growth stage IT companies serving the healthcare market. Ms Usiskin identified successful acquisition target while serving as VP of Corporate Development at MMIT (Norstella).

Ms Usiskin holds a BA in psychology from Rutgers University and currently serves on the Dean’s Advisory Council for Rutgers University – School of Arts and Sciences and as a Mentor to the Rutgers Business School – Center for Women in Business. She formerly held Advisory seats at IHT2, NJTC, and NJEN, plus mentors numerous start-ups and incubators in the region.

Taylor Uttley is the Head of Strategy and Operations for the corporate data science team at Vertex Pharmaceuticals, where she has worked for over 15 years. She has held several roles of increasing responsibility in trial operations at Vertex. Ms Uttley has applied innovative strategies as an operations program lead to multiple rare disease programs, where her teams have achieved industry leading speed in execution.

In her current role, she leverages her deep expertise in development execution to identify opportunities to deploy machine learning and AI for business efficiencies and decisions in clinical trials, commercial and other areas. She also leads the industry's only MBA AI program across Vertex which is focused on grooming next generation AI savvy leaders across business units.

Laszlo Vasko’s career of leading technology enabled innovation in drug development spans over twenty five years, having worked at Wyeth, AstraZeneca, and now Johnson & Johnson Innovative Medicines. Throughout his career, Mr Vasko seized opportunities to engage drug development leaders to accelerate the delivery of new medicines with technology capabilities to get the right data, to the right person, at the right time in order to improve clinical trial design, digitalize advanced therapy development, and streamline information flows. Mr Vasko’s current responsibilities, as Product Group Leader, Therapeutic Area Enabling Innovation, are enabling advanced therapies such as CAR-T, innovation in workflow and decision enablement, as well as continuing to pioneer Research in Clinical Care – ways to leverage healthcare platforms for clinical trial execution.

Mr Vasko earned Master’s degrees in both Clinical Research Operations Management and Information Science from Drexel and Penn State respectively.

Mr Vasko’s offices are in Cambridge MA and outside of work he’s active in the aviation community as a private pilot.

Chris Venezia is the Chief Executive Officer (CEO) of ProofPilot. Chris has nearly 20 years of strong leadership experience, with a track record of success in product commercialization, patient recruitment, marketing, and sales. Prior to ProofPilot, Chris was the Chief Commercial Officer (CCO) at Citeline. Chris excels in addressing the pain points of the life sciences industry and bringing technology-driven solutions to the market. Chris’ expertise helps to disrupt the clinical trial industry to improve the experience and research outcomes for all key stakeholders in the space.

Andrew Vigario has held a variety of positions in clinical research over the last 16 years and is currently a Clinical Country & Site Lead with Biogen. Having previously held positions as a Study Coordinator, CRA, and Clinical Lead with a large CRO, Mr Vigario leverages those experiences to seek out ways to enhance the site relationship with the sponsor in his current role. In his talk at DPHARM, he will discuss some recent innovative work at Biogen that is looking to explore ways in which digital biomarkers can help with pre-screening for Alzheimer's disease clinical trials.

TBA

As the SVP Commercial of Beaconcure, Sean is responsible for overseeing all commercial activities within the organization, including Sales, Marketing, and Customer Success. With almost 20 years in business development, including 9 years dedicated to life sciences, Sean brings a wealth of experience to drive growth and customer satisfaction across the Beaconcure organization. Sean has supported organizations of all sizes, from start-ups such as Medable to industry leaders IBM and PPD, a Thermo Fisher company.

Sean has demonstrated a passion for business development and honed his skills in building lasting client and industry relationships. When he’s not advocating for Beaconcure’s solution to transform the clinical trial data validation process, you can find him spending time with his wife and son, on a yoga mat, or rolling around on the floor wrestling his Bernedoodle Eva.

Sean has a Bachelor of Science degree in Biology from the University of North Carolina at Wilmington.

Henry Wei, MD, is Executive Director, Development Innovation at Regeneron, aimed at accelerating clinical research. Dr Wei previously worked at Google, the White House, Aetna, and McKinsey. Dr Wei has co-authored several patents on applied artificial intelligence in healthcare and on real-world data, outcomes and drug safety. He earned his MD at Cornell, his graduate and undergraduate degrees at Harvard University, and did additional informatics training at Stanford and Harvard.

Dr Wei is an adjunct faculty member at Weill-Cornell Medicine in Health Policy and Research. He currently leads TransCelerate’s pragmatic trials workstream within the Real-World Data initiative.

Brian Weiss is the founder and CEO of Carebox (https://careboxhealth.com). The Carebox Connect platform connects patients and physicians seeking treatment options with clinical trials and is used by leading pharma companies (including AstraZeneca, Bristol Myers Squibb, and Eli Lilly), academic medical centers (including UCLA Health, Penn Cancer, and Moffit Cancer Center), and patient/physician groups (including Stand Up To Cancer, Leukemia and Lymphoma Society of America, and American Society of Gene & Cell Therapy). Mr Weiss is passionate about empowering patients as the best way to accelerate new treatments and more broadly advance healthcare. Prior to founding Carebox in 2014, he consulted for HL7 on healthcare data standards. He previously led large software development/product organizations in the CRM and healthcare markets to world-class levels of execution. Mr Weiss holds a master’s degree in software engineering from Columbia University in New York, and lives in Israel with his wife and four children.

Dr Westergaard's role at Evernorth combines her passion for connecting people to cutting edge research with designing solutions that connect data from Evernorth businesses such as Express Scripts and Accredo Specialty Pharmacy. With 7 years of clinical trial experience and 20+ years of pharmacy experience, Dr Westergaard uses her unique insight in knowing the perspectives of patients, payers, and network partners to create innovative solutions that improve patient care and generate revenue.

Sam Whitaker is the CEO and Founder of Mural Health, a Philadelphia-based technology company dedicated to making it easy to be a participant in clinical trials. Prior to Mural Health, Sam founded Greenphire, a provider of clinical payment and communication tools. This experience, combined with a desire to create a participant-first solution was the impetus for Mural Health. Mural Health’s technology platform, Mural Link, is patient-first and primarily designed to benefit the study participant and their caregivers, but also improves site operations and drives strategic value to study sponsors.

Shae Wilkins is a clinical software entrepreneur with a track record of building and growing successful technology companies in the eClinical market. As CEO, Shae is combining his 22+ years of entrepreneurial leadership experience with his software and healthcare expertise to introduce a revolutionary new platform that will significantly simplify the process of conducting clinical trials.

Colby Wilkinson is a Principal Data Scientist at Vertex Pharmaceuticals, where he's been part of the Data Strategy & Solutions team since 2020. He previously held various Data Science roles in the National Defense, Legal, and Health Economics fields. Mr Wilkinson earned a dual degree in Quantitative Economics and Community Health from Tufts University and a master’s degree in Biostatistics from Harvard T.H. Chan School of Public Health. He currently resides in Boston with his wife and dog, Rue.

Jason Williams is a clinical systems manager with a demonstrated history in clinical trials. Mr Williams has over 10 years of experience working in team management, requirements analysis, Electronic Data Capture (EDC), Electronic Clinical Outcome Assessment (eCOA), Good Clinical Practice (GCP), and with a strong expertise in Interactive Response Technology (IRT/IWRS). Currently serving as Clinical Tools and Technologies, Senior Manager at Takeda, Mr Williams is tasked with IRT vendor oversight, IRT SOP and work instruction creation, standards alignment, and is a subject matter expert for IRT design and implementation (including integrations). Mr Williams especially enjoys expanding his knowledge on new technologies in the ever-evolving landscape of IRT and eClinical.

Alethea Wilson is a Director at Merck Research Laboratories in the Global Clinical Trial Operations, Risk Evaluation and Adaptive Integrated Monitoring organization. With over 20 years’ experience in the pharmaceutical industry, Mrs Wilson has primarily focused in Clinical Quality Management and Quality Assurance Auditing. Currently, Mrs. Wilson is a Risk and Analytics Lead where she is able to foster her commitment to ensuring the output of consistent, accurate and high-quality data from clinical trials.

Prior to Mrs. Wilson joining Merck, her career has spanned both small and large pharma including varying roles with Organon, Hoffman La Roche, Eisai Inc., and Wyeth Pharmaceuticals where she provided strategic direction and execution oversight for clinical trial risk identification, development of mitigation strategies, and inspection readiness and preparation activities.

Mrs Wilson received her undergraduate degree in Biology from Old Dominion University and holds a graduate degree in Pharmaceutical and Medical Device Law from Seton Hall University.

Rob Wilson is Currently VP Commercial Strategy at VivoSense.  He is a Digital Health expert with extensive experience in wearable sensor hardware and software technology, algorithm and digital endpoint development and the clinical and regulatory environment. Mr Wilson is a former Senior VP Business Development and Corporate Strategy for ActiGraph. He led ActiGraph's strategy and business development and created a leading hardware and software wearable ecosystem for the clinical trial market. He has extensive consulting and investment banking expertise. Mr Wilson is the former Head of Healthcare Corporate Finance and director of healthcare venture fund relationships at both First Union and RBC Capital Markets for the Royal Bank of Canada.

Gayle Wittenberg is VP and Head of Neuroscience Data Science and Digital Health at Janssen R&D, focused on embedding data science and digital health to add value to the pipeline end-to-end across the Neuroscience portfolio. She and her team leverage molecular data, deep phenotyping, digital health and real-world data to enable decision-making and solution development for Neuroscience compounds from target identification to product launch.

Dr Wittenberg has over 15 years of experience across the pharmaceutical and diagnostics industries, driving data science research into products. Dr Wittenberg joined Janssen Neuroscience in 2011 as Director, Integrative Solutions and Informatics. She founded and was Head of Translational Research and Precision Medicine, Research IT in 2016. She created and led the Intelligent Automation team in Pharm IT in 2019, before moving back to the NS TA as Senior Director, Neuroscience Data Science. Prior to Janssen, Dr Wittenberg was Head of Personalized Healthcare, at Siemens. She earned her doctorate linking Computational and Experimental Neuroscience at Princeton University in 2003.

Susanne Witzke is heading up the Clinical Operations Office, part of the Clinical Operations Center of Expertise at Novo Nordisk A/S. The team is driving process optimization initiatives, facilitating alignment across the clinical organization as well as enabling communication and efficient way of working within the global clinical organization.

Ms Witzke joined Novo Nordisk in 2015 and has 25 years of experience from various clinical operations roles in global pharma companies. Prior to joining Novo Nordisk, she has worked for Janssen-Cilag and Merck.

Ms Witzke is from Denmark and holds a MSc in Pharmacy.

Greg Woo is a Product Manager, CRF Data Acquisition and Ingestion in Informatics at Roche.  He has over 20 years of experience in R&D Engineering & Informatics (Roche and Amgen).  At Roche/Genentech, Greg has worked on a number of technology platforms including Biosample Management, Protocol Digitalization, Data Warehouses, and Digital Health Data Systems.

Xuefang is a digital strategy lead at Takeda Pharmaceuticals. Xuefang has 10 years of experience working in pharma companies across medical device development and digital health sciences.

Jeremy Wyatt is the CEO of ActiGraph, a leading global provider of wearable digital health technology (DHT) solutions for clinical research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective on the challenges and opportunities of deploying wearable technologies to capture accurate and meaningful patient-centric digital measures. He is considered an industry thought leader and expert in the clinical biosensor space and is a frequent representative and contributor at clinical drug development commercial events, scientific consortiums, and FDA/EMA regulatory meetings. He has an undergraduate degree in electrical engineering from the University of Florida and an MBA from the University of West Florida. Jeremy is a member and contributor to the Digital Medicine (DiMe) Society and participates in various digital biomarker efforts with the Clinical Trial Transformation Initiative (CTTI).

Lily Xu is a Senior Principal Data Scientist in the corporate data science team at Vertex Pharmaceuticals. She has a wealth of experience building cutting-edge data science solutions for clinical operations and commercial strategy across multiple disease areas. With a passion for collaborating with cross-functional teams, Dr Xu has spearheaded projects on predictive patient modeling, large-scale claims analytics, GenAI for clinical documentation, data-driven protocol design, and centralized site intelligence applications.

Before Vertex, Dr Xu was a Research Scientist at Philips Research North America, where she leveraged genomic sequencing and data science to manage healthcare-acquired infections. Dr Xu holds a PhD in Biological Engineering from MIT and the Broad Institute and a Bachelor’s degree in Bioengineering from UC Berkeley.

Zdenek Zencak is the Global Clinical Operations Development Unit Head for Cardiovascular, Renal and Metabolism and currently acting as Head of Program Strategy and Planning in Novartis Global Clinical Operations. In this role, he leads a team that oversees the planning and execution of Novartis global clinical trials across various therapeutic areas. Dr Zencak has more than 20 years of experience in the pharmaceutical industry, with a strong background in Development. He joined Novartis in 2006 and has held various roles in the Novartis Development organization since then. Dr Zencak has a PhD in Chemistry from the University of Basel. He lives and works in Switzerland.

Sarah was diagnosed with Young Onset Parkinson’s Disease 5 years ago and finds her purpose inspiring others in the Parkinson’s community to continue to live their best life with a strong hope for a medical breakthrough.

For nearly 30 years she worked in the biopharma industry focused on Prostate Cancer, Lysosomal Storage Disorders (Gaucher Disease, Fabry Disease, MPS 1, Pompe Disease) and with Neuromuscular Specialists treating Spinal Muscular Atrophy.

Since her diagnosis Ms Zenner-Dolan has volunteered as an Ambassador for the Davis Phinney Foundation, a member of the Endpoints Working Group at Critical Path Institute, as a boxing coach at Rock Steady Boxing, and has participated in three clinical research trials.

Martine Zimmermann joined Ipsen in January 2023 as Senior Vice President and Head of Regulatory & Quality Affairs, based in Boulogne (France) and since January 2024, SVP, Head of Global Regulatory Affairs. Previously she was Senior Vice President and Head of Regulatory & Quality Affairs at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion Pharmaceuticals, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board of Inventiva Pharma, and previously in the Board of Caelum Biosciences (now part of AstraZeneca). Martine has been a champion of diversity, equality, inclusion and belonging, having been recognized by the Healthcare Businesswoman’s Association as a Luminary in 2020, and efforts by serving as an executive sponsor for Alexion’s flagship Women In Leadership (WIL) employee resource group. She received her PharmD from the University Louis Pasteur in Strasbourg, France.

Dr Zozus is a professor at the University of Texas Health Science Center at San Antonio’s Joe R. and Teresa Lozano Long School of Medicine. She has dedicated her career to advancing methods for data quality assessment and control in health care and health-related research including collection and management of data for clinical studies, and assessment and use of EHR data in clinical studies. In addition to leading clinical research informatics at UT Health San Antonio her research pursues advancing the design, conduct and reporting of clinical studies through interoperability, automation, decision support and data mining. She is the PI of the AnCilliary Studies to Evaluate Real-World Data Quality (ACE-RWD Program) assessing data from EHR interoperability such as data obtained using the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) standards for use in clinical studies.