2023 Speakers

Leslie Addy has over 10 years of experience in the biotechnology industry. He is currently Director of Development Operations Innovation and Decentralized Clinical Trials at Amgen where he is driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies and services. Mr Addy spent a majority of his working life in Information Systems and Digital Health and has a proven track record of identifying, testing and bringing new solutions to scale, in close collaboration with internal and external stakeholders. He has a Bachelor’s Degree in Computer Science and Mathematics and an MBA from the University of Southern California (USC).

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.

Marigrace Ambrosia is a Director in PricewaterhouseCoopers’ Pharmaceutical & Life Sciences R&D Advisory Services practice with 10+ years of experience working in clinical R&D, clinical data management, and clinical operations. Ms Ambrosia has focused on clinical trial innovation at the intersection of technology and operations for clinical trials to create and implement fit for purpose solutions tailored to fit specific needs across clinical scientists, operations, data management, and IT. She has significant experience in strategy and deployment of new technologies including, protocol design tools, digital protocol, eCOA, eConsent, telehealth, sensors/wearables, and trial orchestration tools.

Prior to joining PwC, Ms Ambrosia worked at a US AMC, her industry experience includes operational improvement, strategic planning, resource allocation, clinical trial site selection, data management and storage, statistical analysis, regulatory, and project management in neuroscience research.

Dr Brian Anderson is chief digital health physician at MITRE, where he leads research and development efforts across major strategic initiatives in digital health alongside industry and the U. S. government. Dr Anderson is responsible for co-founding the Coalition for Health AI (CHAI), and the VCI™ coalition of more than 1,000 organizations assembled during the COVID-19 pandemic to work towards interoperable and verifiable clinical information; leading MITRE’s development of machine learning techniques to leverage real world health data; and linking genomic and clinical data to provide insight into the efficacy of therapeutics and vaccines. He also leads MITRE’s largest health R&D effort in oncology and personalized medicine. His team helps to architect, implement, and analyze health data and information systems for federal agencies, including HHS, CMS, the FDA, and VA

.Dr Anderson is an internationally recognized author and expert in digital health, and is regularly engaged as a speaker on digital health innovation, health standards development, clinical decision support systems, and interoperability. He has been quoted in leading publications, including CBS News, CNN, Fast Company, Forbes, STAT, and USA Today. Prior to joining MITRE, Dr Anderson led the Informatics and Network Medicine Division at athenahealth, where he launched a new model of clinical decision support leveraging artificial intelligence. He has also served on several national health information technology committees in partnership with the Office of the National Coordinator.

Dr Anderson completed his clinical training at Massachusetts General Hospital and practiced in Greater Lawrence (MA). He completed his BA and MD degrees at Harvard College and Harvard Medical School.

Ardy Arianpour is CEO & Co-Founder of SEQSTER the leading healthcare technology company that puts the patient at the center of all their health data for more efficient clinical trials and improved healthcare outcomes for life science enterprises. With over 20 years of experience driving innovation in life sciences and digital health, Mr Arianpour is a visionary health tech executive. Before founding SEQSTER, he successfully launched numerous clinical and consumer-based genetic tests while serving as CCO of Pathway Genomics. Additionally, he held the position of SVP of Ambry Genetics, which was sold to Konica in 2017 for $1 Billion.

Mr Arianpour played a crucial role in the landmark SCOTUS decision that eliminated gene patents, expanding access to genetic testing. The launch of BRCA testing, in particular, significantly benefited patients and their family members nationwide.

Mr Arianpour received his BS in Biological Sciences from UC Irvine and an MBA from Marshall Goldsmith School of Management. He was a Medical, Marketing, and Media’s (MM&M) Top 40 Healthcare Transformer and San Diego Business Journal 40 under 40. Mr Arianpour is on the Digital Health Advisory Board of UCSD and Faculty for NextMed.Health.

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.

Hila Barak, PhD, joined Gilead in 2021 as the Head of Oncology Clinical Science and Chief of Staff. Dr Barak serves as a key business partner to the Oncology Therapeutic Area Head and is immersed in strategic and operational elements for Gilead’s Oncology, leading and driving large projects, providing insight and access to the organizational strategy and direction.  Furthermore, she is directly responsible for building, managing, and mentoring a high-performance clinical science team to support clinical development programs across the Oncology Therapeutic Areas.

Dr Barak obtained her PhD from the Technion Institute in Israel and completed her post-doctoral fellowship at Washington University School of Medicine in St. Louis, where she performed distinguished research in the field of stem cells and renal development. After joining the pharmaceutical industry, she held a variety of roles in Regulatory Affairs, Global Medical Affairs and Clinical Science in multiple therapeutic areas as well as leadership roles, in leading strategic and operational projects for Clinical Oncology within R&D organization and provided strategic input for future clinical development of products in the pipeline. In her last role, Dr Barak served as the Global Clinical Lead for the MORPHEUS Combination Platform at Roche-Genentech, where she effectively led the overall strategy of more than 40 novel combinations tested across 10 solid tumor indications. In addition, she led several innovation initiatives to bring transformative treatment to patients with unmet medical need, including utilization of Artificial Intelligence tools to explore combination development and patient enrollment.  

Dr Barak is passionate about bringing transformative treatment to patients with cancer. 

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.

Paul Bassett holds a Bachelor’s and a Master’s degree in Analytical Chemistry from Youngstown State University and a BSN degree from Kent State University. Mr Bassett has over 25 years of pharmaceutical drug development and clinical research experience, leading research teams to develop formulations for Zithromax, Caduet, Zyrtec, Zoloft, and anti cancer drugs such as Fludara, Doxorubicin, Daunorubicin, Cisplatin, and Methotrexate.

Currently, Mr Bassett is a Project Lead in Early Development Oncology Operations at Sanofi. His mission has been to create new ways of working through the complexities of operationalizing pre-candidate molecules for FIH studies, through study start-up and conduct processes.

Arnaud Bastien, MD is Vice President, Global Program Lead for Mavacamten and the Global Drug Development Cardiovascular Products Transition Lead at Bristol Myers Squibb.

Dr Bastien is a board-certified internist with 15+ years of industry experience. Dr Bastien has held key leadership positions in clinical drug development positions of multiple compounds at Roivant Sciences, Akros Pharma, Amarin and BMS in Cardiovascular, Metabolic and Immunology.

Dr Bastien received degrees from Columbia University, Universidad Mundial Dominicana, Dominican Republic and completed his post-graduate training in Internal Medicine at UMDNJ-Robert Wood Johnson School of Medicine, Cooper University Hospital.  He also attended Rutgers University School of Business and Management for executive education in Biopharma Innovation. For the past 12 years, Dr Bastien has served as a member of the Board of Trustees at the Coriell Institute for Medical Research.

Liz Beatty is a co-founder and chief strategy officer at Inato, a clinical trials platform which flips the traditional model and allows community sites to participate in the trials that are best aligned with their interests and that of their patients. Ms Beatty is focused on advancing Inato’s corporate strategy, developing partnerships and driving growth in North America. Previously, she headed digital clinical trials at Bristol-Myers Squibb, where she led digital innovation efforts across global clinical operations.

Sanjay Bharwaj is the Global Head of Clinical Technology Strategy & Operations at AbbVie where he leads an organization of technologists who enable AbbVie’s clinical trials data collection, data processing, and deliver submission-ready datasets. Prior to AbbVie, Mr Bharwaj was the Global Head of Clinical Data Management at Allergan. For over more than 2 decades in the Clinical Operations – Clinical Data and Technology domain, he has led global teams at several bio-pharma companies such as Biogen, Novartis, and Merck. He is active in industry conferences and forums focused on clinical data. As chair of the board at the Society for Clinical Data Management, he led the organization through its most challenging times during the COVID-19 pandemic. Mr Bharwaj has authored a number of clinical data related publications.

Tina Bhatia is a Clinical Trial Manager at Insmed, working on clinical trials in rare disease. Ms Bhatia is passionate about bringing therapeutic options to patients that may currently have limited options to manage their ailment. She is pursuing her MS in Clinical Research Administration from George Washington University and has her BA from Rutgers University.

Fun Fact: Ms Bhatia recently visited Argentina with her colleague to help boost patient enrollment in this region of the world for a rare disease trial she is working on. While there, she had the opportunity to visit one of the seven wonders of the world, Iguazu falls. While on the viewing platform, and surrounded by nearly 1.7 miles of this awesome waterfall, she truly understood what it meant to “travel to the end of the world” to help patients!

With 20 years of experience in tech, media, marketing and public relations, Jennifer Bittinger brings a wealth of knowledge, skills and leadership helping brands grow to their highest potential utilizing her experience with digital marketing, demand generation, data reporting and brand development. Ms Bittinger now serves as the President of Narrativa, one of the fastest growing artificial intelligence (AI) companies that specializes in automating transformative content (i.e. articles, whitepapers, reporting and more) for multiple industries, including Media, Marketing, Gaming, Finance and Life Sciences. Throughout her career, she specialized as a multi-faceted VP of Marketing and Branded Content Specialist serving many clients, including Entertainment Tonight, Dr Phil, Cesar Millan, TBS, Hulu, Beliefnet, OWN, San Francisco Giants, Chevron, ExxonMobile, and more.

Mariel Boyd is a Senior Product Manager at Flatiron Health on the Clinical Research team, where she leads the development of Flatiron Clinical Pipe. During her 7 years at Flatiron, Ms Boyd has worked across both Flatiron’s prospective and retrospective research offerings, giving her a unique perspective into the development of Flatiron Clinical Pipe. Prior to joining Flatiron, she spent multiple years conducting clinical research at various prestigious Academic Medical Centers, focused on Oncology. Ms Boyd graduated from Fordham University with a BS in Biology.

Jordan Brayanov, PhD is a Senior Director of Digital Strategy within the Data Sciences Institute at Takeda. In this role, Mr 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, Mr Brayanov served as Vice President of Research at Respiratory Motion — a leader in respiratory volume monitoring. Mr 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. Mr Brayanov holds a PhD in Computational Neuroscience from Harvard University.

Xuemei Cai oversees a clinical group within Worldwide Research, Development & Medical at Pfizer focused on developing and qualifying digital endpoints in clinical trials. Dr Cai also provides medical, scientific, and compliance oversight for the Pfizer Innovation Research Laboratory, an industry-leading, state-of-the-art research facility located in Cambridge, MA providing groundwork that enables the analytical and clinical validation of technology prior or in parallel to deployment in interventional clinical trials.

Dr Cai is a founding member of the Digital Medicine Society. She received her MD from Harvard Medical School. She remains a practicing ICU physician and has taken her passion for multimodal monitoring and improving functional prognostication and measurement tools for patients, families, and providers into the digital medicine space to improve the clinical trial experience for participants and enable new therapies.

Taras is Executive Director, Innovation and Process Improvement within Global Development Operations at Amgen. His team leads efforts to transform how clinical trials are conducted at Amgen, with a focus on cycle time reduction and reducing barriers to participation for patients and investigators. Prior to his current role, Mr Carpiac served in leadership positions at Amgen within Study Operations and Data Management. He holds a BA in History from University of California, Berkeley, and an MBA from Golden Gate University.

Jennifer Levin Carter is a Venture Partner at Sandbox Healthcare and the Blue Venture Fund. Dr Carter currently serves on the Board and/or as a strategic advisor to multiple public and private precision medicine, healthcare services, digital health and life science companies. She is also Founder and CEO of a Precision Medicine company in stealth.

Prior to Sandbox, Dr Carter served as a Managing Director of JLC Precision Health Strategies, LLC and in 2018, she founded TrialzOWN™, Inc., a healthcare company in stealth, and was CEO until its prelaunch acquisition by the Flagship Pioneering company, Integral Health, (now Valo Health), in 2019. Prior to TrialzOWN™, she was the Founder and President of N-of-One®, Inc, serving as acting-CEO from 2008-2012, and Chief Medical Officer from 2012 until its acquisition by Qiagen (Market Cap $8B) in 2019.

Dr Carter holds a BS in Molecular Biophysics and Biochemistry from Yale University, an MD from Harvard Medical School, an MPH from Harvard School of Public Health, and an MBA from the Sloan School at Massachusetts Institute of Technology.

Janice Chang is the Chief Executive Officer at TransCelerate BioPharma Inc. Ms Chang has been involved with the organization since its inception. As CEO, she works closely with the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Ms Chang defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio. She also actively participates in various cross-stakeholder global discussions to help evolve the R&D paradigm.

With a background of 20+ years of experience leading initiatives in large pharma and biotech companies, Ms Chang has experience spanning across regulatory, clinical, and manufacturing.  Janice is passionate in driving meaningful change across our ecosystem and not settling for the status quo.  She believes in reimagining the way we advance innovative medicine and advocates for the power of open collaboration across stakeholder groups.

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.

Victoria L. Chiou, MD, is Head, Clinical Excellence and Innovation, Late Development Oncology at AstraZeneca, where she leads strategic development and implementation of global initiatives at the intersection of clinical cancer research, technology, and innovation. Dr Chiou is an oncology research physician with academic, industry, and regulatory experience in patient-centric drug development. Prior diverse clinical development experiences include GlaxoSmithKline in cell therapy, and MedImmune/AstraZeneca in novel immuno-oncology drug combinations for treatment of multiple cancers. Dr Chiou also served as a medical officer at the US Food and Drug Administration, Office of Hematology and Oncology products.

Dr Chiou completed her BA in human biology and psychology as a Jefferson Scholar at University of Virginia, MD at Medical College of Virginia, internal medicine residency at Wake Forest University, and medical oncology fellowship at National Institutes of Health, National Cancer Institute. Multiple career recognitions include Conquer Cancer Foundation of ASCO Merit Award, ASCO/AACR Methods in Clinical Cancer Research Workshop, and SITC Women in Cancer Immunotherapy Network Leadership Institute.

Disa Lee Choun has 20 years of experience working in digital and innovative solutions especially in the pharmaceutical industry.  She has been actively involved in developing ground-breaking solutions. Ms Lee Choun’s expertise encompasses digital solutions for clinical trials and the exploration of emerging technologies. Currently, she holds a pivotal position in the Digital Transformation Strategy, spearheading data transformation and leveraging advanced insights to optimize clinical trial processes and operations. Her contributions to the industry have garnered recognition, earning her a place among the Top 100 Women in Technology and Financial Times 100 most influential BAME leader. Furthermore, she has showcased her expertise through numerous articles and publications, including her recent co-authorship on the book titled ‘Digital Health and Patient Data: Empowering Patients in the Healthcare Ecosystem’. Her true passion lies in health equity and bridging the gap between science and digital solutions to help and support patients with unmet needs.

Ivor Clarke is Chief Innovation Officer and co-founder of SubjectWell, the largest patient marketplace connecting people with chronic health conditions to new care options. Since 2012, SubjectWell has been raising awareness about the benefits of clinical research, registering over 10 million healthcare-motivated patients. Ivor has over 15 years of C-suite experience with a background in online marketing and the creation and operation of enterprise SaaS solutions. Before SubjectWell, Mr Clarke served as President of Brightfire, a digital marketing startup.

Bryan Cobb is a PR Medical Science Director and the Healthcare Delivery Innovation & Collaborations Lead at Genentech, U.S. Medical Affairs. Dr Cobb is focused on bringing novel biomarkers (digital and traditional) as well as innovative healthcare delivery tools into clinical trials and clinical practice with the goal of improving disease identification, patient treatment, and a patient’s overall quality of life.

Dr Cobb obtained a PhD in Medical Genetics at the University of Alabama at Birmingham and completed an American Board of Medical Genetics post-doctoral fellowship at NIH (National Human Genome Research Institute). He is a board-certified diplomate of the American College of Medical Genetics & Genomics.

Dr Cobb has held several roles at Roche, including Lead for the GE Healthcare partnership for Acute Care, Head of Medical Affairs for Roche, Director for Roche’s Molecular Centers of Excellence, and has over 15 years of experience across therapeutic areas (infectious diseases, genetics, neuroscience and oncology). He has published in key scientific journals, is a scientific reviewer for journals such as the Journal of Clinical Microbiology, and has served on several international scientific committees and working groups.

Lisa Coleman is New York University’s (NYU) inaugural Senior VP for Global Inclusion and Strategic Innovation. In this role she with senior leaders, internal stakeholders, external partners, and constituents to advance, promote and build capacity for strategic global inclusion, diversity, equity, belonging and innovation initiatives across NYU globally and this includes New, York, Shanghai and Abu Dhabi, and NYU’s other thirteen sites, and numerous global research and other centers. This is Dr. Coleman’s third inaugural senior leadership role in which she has reported to the President and worked with C-Suite leaders. Prior to NYU, Dr. Coleman served as the first Chief Diversity Officer and Special Assistant to the President at Harvard University for almost a decade where she and her team developed some of the first initiatives focused on the intersections of technology, disability, and access. Prior to NYU and Harvard, she served as an administrator and faculty member, and was later appointed to serve as that institution’s first senior global inclusion & diversity executive.

Lisa Coleman, PhD, has spent 20+ years working with numerous educational, healthcare and governmental systems, and corporate, for-profit, and non-profit organizations. Her early professional and research experiences include working with the Association of American Medical Colleges, Merrill Lynch Inc., as an independent computer and data analytics consultant, and as an international organizational strategic consultant. Dr Coleman’s collaborations with global stakeholders include work on the future of work and education including emerging fields; developing research, harnessing innovation and cultivating global talent across entrepreneurial markets; and cross-sector leadership and knowledge development.

Dr Coleman is the recipient of numerous awards, recognitions, and honors; and she sits on various national and international boards. Dr. Coleman serves as a faculty member and also advises and consults with C-Suite leaders globally. Her research focuses on 1) cross-sector global leadership and partnerships; 2) intersections of cross/transgenerational innovation in health sciences, and technology, art and humanities, and employing data analytics and digitization to leverage diverse cultures globally; and 3) global C-suite, board development and training.

Dr Coleman is an interdisciplinary scholar who earned her doctorate in Social and Cultural Analysis, American Studies from NYU, and three master’s degrees in African and African American Studies; Women’s, Gender, and Sexuality Studies; and also, in Marking/Communication Studies. She has also specifically studied legal theory, and intercultural development. Dr. Coleman’s undergraduate foci were sociology/anthropology and computer science. She loves to travel, is an avid photographer, gardener and cook, and soon to be a pilot.

Rosa Coppolecchia is a board-certified physician of internal medicine with training in preventive medicine with over 18 years of work at Bayer in both the Pharma and Consumer Care divisions. Dr Coppolecchia has a wide range of experience in medical affairs and clinical development and is a leader in the field of cardiology and preventive medicine with expertise in anti-platelets specifically the use of aspirin (ASA) in both primary and secondary cardiovascular event prevention and has co-authored several peer review journal articles.

In her current role, Dr Coppolecchia is a Global Clinical Lead in clinical development for thrombosis and vascular diseases. She is one of the lead strategists for Phase II and Phase III studies to support new indications, approvals, and product launches in the cardiovascular therapeutic area. She oversees traditional large, randomized controlled trials and is leading a Decentralized Trial in the anti-thrombosis category. Dr Coppolecchia is a strong advocate for increasing awareness of cardiovascular disease in women, as well as increasing diversity and inclusion in clinical trials.

Dr Coppolecchia received her Doctor of Osteopathy degree from the University of Medicine and Dentistry School of Osteopathic Medicine in Stratford, NJ and a Master of Public Health from UMDNJ-Robert Wood Johnson School of Medicine and Rutgers The State University in Piscataway, NJ. She is a Fellow in the American College of Physicians and Fellow in the American College of Preventive Medicine.

Prior to her career at Bayer, Dr Coppolecchia worked at Schering Plough Corporation (currently Merck & Co.,Inc.) as the Assistant Corporate Medical Director in the Employee Health Department.

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. Cotter also leads the Advarra Site-Sponsor Consortium, helping to seamlessly connect site and sponsor technology by addressing key data and process inefficiencies across the clinical research ecosystem. Prior to joining Advarra's strategic team, Cotter worked as a Product Manager for Advarra eRegulatory Management System, and as Product Support Specialist on Allegro CTMS, where he worked alongside dozens of small- to mid-sized 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. Amy 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. Amy’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. Amy’s current focus is on clinical trials solutions, which includes eSource; specifically the secondary use of EHR data for clinical research. Amy is Co-Chair of HL7 Clinical Interoperability Council, AMIA’s Scientific Panel Committee, a TransCelerate member and reviewer for many professional journals. Amy 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.

Rodrigo Crispim, PharmD, MBA is lean sigma certified with over 20 years in the pharmaceutical industry. Currently, Mr Crispim manages the Novartis clinical trials’ portfolio from Latin America and Canada. Previously, he held a variety of leadership roles in clinical operations including LaCan ClinOps region head for oncology, global monitoring excellence head and global trial management innovation head. More recently, he held the position of head for trial design technology platform.

Michelle Crouthamel is the Managing Director, Digital Health Strategy and Implementation at Abbvie. She is an industry leader who integrates digital health in pharmaceutical product development and collaborates broadly with academics, tech, consortia, and health authorities to create impact. As the Managing Director of Digital Health Strategy at AbbVie, Michelle leads the efforts of generating novel digital evidence to support assets development and differentiation. Prior to joining AbbVie, Michelle led many successful R&D programs at Merck and GSK. She is a scientific advisor to many tech companies, an inventor with multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health. Michelle has a Doctorate degree from the Fox Business School, Temple University, a Master degree from the Institute of Neuroscience, and a Bachelor degree in Nursing from the National Yang-Ming University, Taiwan.

Jenn Curry is Head of Patient Engagement Capability at Biogen. In this role, Ms Curry is accountable for driving the capabilities that ensure the patient perspective is incorporated in a manner that optimizes the execution of patient-focused drug development and maximizes the degree of impact on participant enrollment and the participant experience in Biogen’s clinical studies. She is heavily engaged with internal leaders and external partners to support the patient engagement strategies leveraged across Biogen’s portfolio.

Ms Curry entered the field of clinical research as a Research Assistant at Massachusetts General Hospital in 2003 and shifted her focus to industry, specifically patient recruitment, in 2006. Prior to joining Biogen in 2019, she spent 9 years at AES/Acurian Inc., advancing from Project Manager to Director of Operational and Strategic Solutions.

Neal Curtis is a Senior Project Manager at Citeline, specializing in patient engagement and recruitment technologies. His passion shows up in his collaboration with sponsors to accelerate trial recruitment and reduce site burden, seamlessly connecting paths between potential participants and clinical trial sites. Mr Curtis holds an MA from the University of Virginia and a BA from Columbia University, graduating summa cum laude.

Fun fact: before joining Citeline, he undertook graduate research in bibliographical analysis and literary forgery.

Sourav Das is an integral part of ZS’s Clinical Development Excellence (CDE) practice and co-leads Clinical planning vertical. Mr Das has overall ~14 years’ experience and has worked across a number of sponsors in clinical planning areas leading a wide array of consulting, tech and analytics work. Mr Das has strong expertise in clinical feasibility and associated processes.

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.

Angela DeLuca is the Vice President, Head of Oncology and Cell Therapy, Clinical Operations at Takeda. Angela is responsible for leading the clinical operations group to drive the clinical development operational strategy and execution of clinical trials.

With over 18 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 Takeda, she was Head of Global Site Management, Clinical Development Operations at AbbVie where she spearheaded the transformation of the clinical development operations enterprise, developing a knowledge center of excellence to create an industry leading clinical development function.

During her years at AbbVie and Abbott, Ms DeLuca held other leadership roles such as Head of Strategy and Operations for Portfolio Program Management serving as a consulting arm to the R&D Leadership team, assessing & executing innovative improvement opportunities across the R&D enterprise. She also served as Head of Innovation where she managed the Japan Design Lab’s team and ensured digital technologies, health technologies, big data and predictive analytics were used to support enhanced clinical trial design and 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 Shobha Dhadda is Senior Vice President of Biostatistics and Clinical Development Operational Functions for Neurology at Eisai and is responsible for leading statistical and operational strategies in clinical research. Dr Dhadda started her career in 1995 as a senior statistician in a pharma company and she focused her career in the design, conduct and analysis of clinical trials, with more than 25 years of experience working in pharmaceutical Industry covering a variety of therapeutic areas including Alzheimer’s. She has led the design of several innovative Bayesian adaptive design trials, group sequential design trials and platform trails. Dr Dhadda joined Eisai as head of statistics and soon also became the head of clinical development operations, which includes end to end functions involved in running a clinical trial, i.e., medical writing, data management, clinical operations, project management, Biostats, statistical programming, Data Science, and outsourcing.

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.

Alex Eastman is the Vice President of Products at OneStudyTeam. Mr Eastman is responsible for the vision, direction, and delivery of StudyTeam products. Prior to OneStudyTeam, Mr Eastman was the VP Product at TriNetx, a real-world data and real-world evidence company, and earlier led a healthcare analytics product at a division of Premier, Inc.

Melissa Easy is the vice-president and GM of Clinical Technologies at IQVIA, responsible for the development and delivery of products to streamline processes across the clinical development lifecycle, for sponsors, sites, and patients in the IQVIA Orchestrated Clinical Trials Platform.

Ms Easy founded DrugDev in 2009, established its reputation as an industry disruptor, and built collaborative relationships to become a trusted partner for many leading pharmaceutical companies. DrugDev grew organically and through acquisition until it was acquired by IQVIA in July 2017.

Chris Economos is VP of Life Science at Eko Health, a digital health company advancing how healthcare professionals detect and monitor heart and lung disease with its portfolio of digital stethoscopes, patient and provider software, and AI-powered analysis. As lead of Eko’s life science business unit, Mr Economos is responsible for partnering with pharma and medical devices companies to support clinical development and commercial strategies with Eko’s AI-enabled digital stethoscope and SENSORA™ platform. Mr Economos is a long-time leader within the digital health space and previously won Dpharm 2017, representing physIQ, Inc.

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.

Ricki Fairley, MBA, is the co-founder and CEO of TOUCH, The Black Breast Cancer Alliance addressing Black Breast Cancer as a unique and special disease state, with the overall goal of reducing the mortality rate for Black women.

Ms Fairley founded and serves as co-host for “The Doctor Is In,” a weekly live breast cancer advocacy web series on the BlackDoctor.org Facebook page that reaches over 3 million viewers. She is a founding member of #BlackDataMatters, in partnership with Citizen, The Center for Health Care Innovation and Morehouse School of Medicine to encourage and elevate the importance of Black Women participating in clinical trial research.

In January 2022, she started the When We Tri(al) Movement to change the game on Black women participating in clinical trials to improve outcomes for Black women with breast cancer with culturally humble and provocative communication that has resulted in thousands of Black women entering clinical trial research. She also actively assists pharmaceutical companies in revamping and designing their clinical trial recruiting materials.

Tony Fantana is Lead, Emerging Technology Strategy – Clinical Design, Delivery & Analytics, 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.

Charles Fisher is a scientist with interests at the intersection of physics, machine learning, and computational biology. Previously, Dr Fisher worked as a machine learning engineer at Leap Motion and a computational biologist at Pfizer. Dr Fisher was a Philippe Meyer Fellow in theoretical physics at École Normale Supérieure in Paris, France, and a postdoctoral scientist in biophysics at Boston University. He holds a PhD in biophysics from Harvard University and a BS in biophysics from the University of Michigan.

Patrick Floody, MBA, is the Head of the Global Clinical Trial Services group at Regeneron where he is responsible for global site management, central monitoring, study feasibility and site selection, study/site start up, eCOA and patient technology initiatives. He has been with Regeneron for just over 3 years.

Mr Floody spent 25 years at Pfizer, with most of his time spent in clinical program operations but also included time in GCP Quality (level 1) and Analytics. He has extensive international experience in drug development and helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, he spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. He was the recipient of Pfizer’s PGRD Achievement Award in 2007.

Mr Floody is a former officer in the U.S. Army and is a veteran of the first Gulf War. He holds a bachelor’s degree in Biology from the University of Rhode Island and a Master of Business Administration from Temple University.

Darcy Forman is the Chief Delivery Officer for Science 37, where she has responsibility and oversight for clinical operations service delivery, including patient engagement, clinical operations, data management, and nursing solutions.

Ms Forman has more than 20 years of experience bridging clinical operational expertise and strategic corporate development initiatives with a passion for innovative and decentralized clinical trial execution. Most recently, she served as the vice president of corporate development at Firma Clinical Research, where she had oversight and leadership responsibility for the identification, development, and execution of corporate development opportunities, including the evaluation of Firma corporate strategies and strategic planning. Ms Forman started her career at Pfizer Pharmaceuticals as a bench scientist before transitioning into a role in Pfizer’s clinical research division. She continued her career with ascending clinical operations and project management positions at various CROs spanning large, mid-size, and niche including i3 Research (now Syneos Health), Health Decisions, Clinipace, and Firma Clinical. During her career, she has fostered her passion for innovation and intelligent operational strategy by bringing metric-driven decision making to each role and organization. Ms Forma holds a BA in chemistry from Lake Forest College.

Amy Franzen serves as the Senior Vice President of Trials at Tempus, where she leads all internal and external trial recruitment and clinical trial support efforts. Prior to joining Tempus, Ms Franzen spent her career at the intersection of business and technology as a strategic operator at both Nike and Groupon. In addition to her operating roles, she was a management consultant at McKinsey & Company, where she advised clients across multiple industries in growth strategy and operational excellence. Ms Franzen graduated from Cornell University with a BS in Applied Economics and Management.

Christie Fry is Director, Strategic Technology Innovation at AbbVie. Ms Fry has 30 years of experience in clinical research, including patient recruitment, data management and digital health innovation. In her current role, she is responsible for leading strategy, operations and implementation of decentralized clinical trials (DCT). In addition, Ms Fry actively assesses opportunities requiring innovative tactics to improve existing activities and processes within Clinical Development Operations. She is also involved in industry activities, focusing on technology, improving site experience in clinical trials and in the set up of new capabilities to drive patient centricity in drug development.

Chelsea Gallagher is the Director of Innovation and Digital Health at Bristol Myers Squibb, based in Princeton, NJ. Ms Gallagher is a thought leader in the clinical design innovation space and her focus over the past three years has been on developing an approach to automatically and quantitatively evaluate protocol design and predict likely performance and quality outcomes, in order to optimize design for patients, investigators and Sponsors.

With over ten years of experience in analytics across multiple functions, Ms Gallagher has leveraged her expertise in user experience, change management, and different analytical techniques to solve challenging problems at BMS. She recognizes pain points, identifies synergies across functions, and designs solutions that meet current and future business needs while building for seamless stakeholder experience. Prior to her current role, she held a role in Alliance Leadership with Real World Data (RWD) partners, evaluating and influencing data collection diversity and standards and driving internal investment strategy. In a cross-functional analytics role, she developed a robust career development program to invest in top analytics talent, providing analysts a powerful network, opportunities to work on projects outside of their domain expertise and training for comprehensive data scientist skillsets. Ms Gallagher believes that data drives better decisions and leverages her analytics experience to creatively solve problems.

As a thought leader on data strategy, Dr Victoria Gamerman is focused on improving healthcare by connecting the dots among patient-centricity, digital health, and real-world evidence to evolve clinical research through innovation and digital transformation.

As Global Head of Data Governance and Insights, Dr Gamerman is accountable for shaping the data strategy and data governance for Clinical Development and Operations. Previously, Victoria was the Head of Health Informatics and Analytics where she established the strategic priorities based on needs from Medical and Commercial stakeholders. As a team of data scientists, her organization executed use cases to generate evidence from external clinical data and real-world health care data in support of drug development.

Dr Gamerman has formal training with a PhD and MS in Biostatistics from the University of Pennsylvania School of Medicine and MA/BA in Mathematics from Boston University. She is also trained in Scrum/Agile methodologies (Product Owner and Scrum Master) as well as Design Thinking.

Cindy Geoghegan is a patient advocate, advisor and activist with over 30 years of health policy and communications experience, having held senior staff and board positions with several leading cancer non-profit organizations including Susan G. Komen, Y-ME National Breast Cancer Organization and others. She began her advocacy career shortly after her breast cancer diagnosis in 1995. Ms Geoghegan has provided the patient perspective on research teams and projects funded by Stand Up to Cancer, the National Cancer Institute, the American Association for Cancer Research, the American Society of Clinical Oncology, the Patient-Centered Outcomes Research Institute and has served on the steering committee of the Clinical Trials Transformation Initiative (CTTI), the Duke University/FDA joint venture focused on more efficient clinical trials. Ms Geoghegan is currently a member of the Johns Hopkins Kimmel Cancer Center’s External Advisory Board, and on the Founding Members Council for the Digital Medicine Society, where she also serves on its research committee. Ms Geoghegan has co-authored more than a dozen publications with researchers focused on patient preferences and improving patient outcomes.

Pirinka Georgiev is a Clinician within Digital Sciences and Translational Imaging (DSTI) in the Early Clinical Development (ECD) organization at Pfizer. Within her current role, Ms Georgiev focuses on protocol design and develops plans for implementation, validation, and qualification of novel endpoints from digital health technologies into clinical development programs and trials. She works across therapeutic areas where physical activity is objectively measured using wearable sensors, as well as studies supporting the implementation of patient-centric sampling devices. She has also supported innovative efforts including the operationalization of decentralized trials. Prior to joining Pfizer, Ms Georgiev received her degree in Pharmaceutical Science from the University of Michigan College of Pharmacy.

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.

Geoffrey Gill is the Founder and CEO of Verisense Health, Inc., whose mission is to accelerate the adoption of all digital health technologies by building the Verisense Digital Biobank. Mr Gill is also a founder and current leader of the Open Wearables Initiative, a non-profit initiative to foster the creation and use of open-source algorithms and data sets associated with digital health technologies. Prior to Verisense, he was the President of Shimmer Americas where he spearheaded the company’s entry into the clinical trials market. Other experience includes CFO/SVP of Operations at Innerscope Research, Inc., VP of R&D for Bayer Diagnostics Critical Care division and Global Market Manager at Weidmann Electrical Technology. Mr Gill has an AB in Applied Math and Physics from Harvard University and an MS in Management of Technology from the MIT Sloan School of Management.

Kushal Gohil leads Corporate Strategy and Innovation at Parexel. In this role, he is an enterprise-wide strategic partner and thought leader who implements large-scale organizational plans. Since joining Parexel in 2013, Mr Gohil has held roles of increasing responsibility and accountability in sales operations, corporate development, and strategy. His earlier career included positions in brand management, market research, and account management.

Mr Gohil is a graduate of the Executive MBA class of 2020 from the MIT Sloan School of Management. He holds a Bachelor of Pharmacy degree from the University of Pune (India) and is a Registered Pharmacist under the Pharmacy Council of India. Mr Gohil earned masters’ degrees in Drug Development and Marketing from the University of Cincinnati.

Abbey Gohl is a Global Program Leader in Immunology at Janssen Research & Development, LLC. AMs Gohl has over a decade of experience in the Pharmaceutical industry spanning a wide variety of roles. With a Chemical Engineering background, Ms Gohl has roots in process development of monoclonal antibodies, but quickly discovered a passion for complex operational projects that has been the focal point for most of her career. She has been privileged to work on both R&D due diligence and commercial asset integration. She has also designed and stood up complex access solutions for unique patient populations and embedded real-world datasets into organizational processes.  Ms Gohl’s current focus is delivering operational expertise into the strategic planning and execution of global clinical development programs with the goal of bringing impactful treatment options to patients. She is responsible for the timely, fiscally responsible, and high-quality delivery of several pediatric programs with diverse designs, including the company’s first multi-sponsor platform trial.

Kapil Gombar, Director, Clinical Technologies and Innovation at AbbVie is fascinated by the convergence of technology and medicine. It has dramatically changed the drug development lifecycle while enabling a better understanding of the subject population. Mr Gombar feels rather fortunate to have seen and contributed to this transformation through multiple roles spanning over 20 fascinating years and has had the amazing opportunity to implement large scale strategic initiatives from concept through delivery across leading pharma and biotech giants. Mr Gombar now leads the clinical technologies and innovation team at AbbVie which strategizes around new technologies that can enhance and optimize our clinical ecosystem.

With a passion for health communication and behavior change strategies, Mindy Gruba has spent the last 13 years developing and delivering products that support public health initiatives and global clinical research trials. Ms Gruba’s focus has been to leverage market and user research to drive insights integral for patient-centric software and experiences. Prior to joining Moderna, she worked at multiple start-ups that focus on developing content and technologies that improve people’s lives.

Ms Gruba has an MPH from The George Washington University and completed practicums at Peace Corp’s Office of Global Health and HIV, National Institutes of Health R&W Association, and NASA’s Kennedy Space Center.

David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. At Pro-ficiency, Mr Hadden has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach.

Adam Halbridge leads the team driving Clinical Trial Tokenization at ICON. Mr Halbridge provides strategic advice to sponsors on the management of data and technology in the support of commercialization of their assets and business objectives. He is also the co-founder of a Mobile Health Platform.

Jake Harrell is leading Convergence, the data and digital transformation initiative for AbbVie’s R&D organization.

Mr Harrell is a lawyer by training. He joined AbbVie in 2014 and has held numerous positions in AbbVie’s legal and compliance functions, including Director of Internal Investigations and Senior Privacy Counsel. In 2017, he founded a new department in the legal organization – Enterprise Data, Digital Health, & Technology Solutions – where he focused on helping functions across AbbVie use data and technology to advance their objectives. In 2022, one of his internal clients asked him to lead the Convergence initiative . . . so he put his legal career on hold and made the leap to the business!

Before joining AbbVie, Mr Harrell was a commercial litigator focused on disputes in the data and technology sectors. He has tried cases to verdict in federal court, state court, and various arbitration forums.

Mr Harrell has a BA in English/Creative Writing from Northwestern University and a JD from the University of Michigan Law School. He also recently completed the Chief Digital Officer program at Northwestern’s Kellogg School of Management.

Bert Hartog, PhD is currently Senior Director, Clinical Innovation at Janssen R&D Operations, where he leads transformational innovation projects that have the goal to shape the future of clinical trial execution at Janssen and position Janssen as a role model in patient-centered clinical research.

Dr Hartog is a professional in the pharmaceutical industry, with 20+ years’ experience in Clinical Operations, QA, IT and Project Management. He started his career with a Masters in Biomedicine from Utrecht University in the Netherlands, as CRA with Eli Lilly. During this time he completed his PhD in Medicine at Utrecht University. In 1998, he moved to London to start work as head of Medical Quality Assurance with responsibilities for the EMEA region. In this role, he introduced risk self-assessment tools for local clinical operations departments. In 2001 he became IT manager at Lilly’s R&D site in the UK. In this role, he established a PMO and got deeply involved in project management. In 2005 he left the UK to start work at Johnson & Johnson from Belgium; first in corporate IT & compliance where Sarbanes-Oxley was first introduced. In 2008 he returned to his passion in clinical research, as Director Clinical R&D with Janssen, where he led the clinical operations departments in the Benelux and Nordic countries for 4 years. With this experience, he joined a large transformation program at Janssen’s clinical development operations. His responsibilities included the introduction of a new CTMS and a next generation eTMF solution, as well as setting up a new business function to own these technical capabilities. Since summer 2015 he has become part of the Janssen R&D Operations Innovation team.

Kim Hawkins has 30 years of operational experience managing all phases of the drug development process. Kim started her career at Boston Medical Center as a Research Assistant working on pediatric AIDS and Oncology trials. After working in academia, Ms Hawkins moved into industry and held various clinical operations positions at Boston-area biotechnology/pharmaceutical companies including Genzyme, Antigenics, and Novelos Therapeutics where she was the Vice President of Clinical Development. She joined Sanofi 9 years ago and is currently the Global Head of Clinical Project Operations & Dossier Delivery, the team of clinical operations leads responsible for the management of all clinical programs across the portfolio as well as the submission dossiers. She is a graduate of Boston University with a Bachelor’s degree in Human Physiology and a Master’s degree in Public Health.

In addition to her project responsibilities, Ms Hawkins is leading several projects focused around the evolving clinical trial model to build innovation and digital technology into our programs to further optimize clinical research for Sanofi and patients. In this role, she has led the integration of decentralized approaches into trials at Sanofi and is currently the co-lead  for the IMI Trials@Home Project.

Jane Hiatt joined Merck in 1999 and is currently the Executive Director, Site Management and Monitoring, Early Stage Development. Ms Hiatt is responsible for the monitoring organization in the US across a diverse portfolio and the clinical trial execution within the Phase 1 Portfolio. Her background includes over 30 years of drug experience in CRO and large pharma environments, starting in data management followed by progressive roles in clinical trial operations and management. Ms Hiatt is a member of ACRP and SCRS.

Dave Hine spent the first half of his career working in the aerospace/defense industry as part of a software development team. While there, he learned about the process, training, and customer support required to make a software solution successful. Today, he applies that experience and passion to clinical trial financial software at Greenphire. He spends his time consulting with sponsors and CROs on the problems, solutions, and impact of payments in clinical trials and also works directly on Greenphire’s innovation team to help them prioritize, design, and deliver new solutions.

Eric Hoberman is the Head of Digital Clinical Operations Excellence at Biogen Digital Health, leading a team that owns global study management for DHT in company sponsored trials. In a previous role at Biogen, Mr Hoberman led clinical operations on a large-scale digital health research program called MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions).

Prior to joining Biogen, Mr Hoberman provided clinical operations leadership in small biotech, medium and large pharma, and in the clinic as a research nurse. He began working on DCTs over a decade ago with ePRO mobile devices in endocrinology, and his main areas of focus since then have been in oncology and neuroscience.

Mr Hoberman received his MBA in Healthcare Administration from Rivier University and his BA in Philosophy from Saint Anselm College. He also holds an active RN license in the state of New Hampshire.

Kyle Hogan has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, in that time helping deliver over 500 successful trials for CROs and Pharmaceutical companies globally. He is a recognized expert for implementing innovative and patient-centric ePRO/eCOA solutions with an aim to achieve sponsor confidence and study success across all phases of clinical trials.

Having held leadership and executive positions at clinical research organizations, specialty providers, and healthcare entities, Colleen Yoke has more than 25 years of experience in the areas of business development, organizational management, and executive team building. Ms Yoke was a key member of an executive team that built a successful early-phase research site that was later acquired by a major research corporation, and she has contributed to best practice standards for the Association of Clinical Pharmacology Units (ACPU). She holds a bachelor’s degree of science from the University of Tennessee and is a graduate of the Wharton School of Business Executive Leadership course.

Alison (Ali) Holland is Executive GM, Customer Value at Medable and is chartered to work with Medable’s customers to align the design and execution of DCT platform technology and methodologies to achieve the optimized return on investment and outcomes of digitally enabled clinical research for subjects, sites and sponsors.  Ms Holland has over 20 years of experience in a variety of leadership roles, including Six Sigma Black Belt at Covance, and subsequently with LabCorp as Business Head and global General Manager of Customer and Therapeutic Business Units. Having been engaged in over 300 studies across Biotech, Pharma and all geographies, Ms Holland brings unparalleled clinical insight and technical excellence on the matter of operational needs for sites and patients.

Peyton Howell is Chief Operating and Growth Officer responsible for Parexel’s operational delivery, strategy and growth. Ms Howell’s focus is on driving collaboration and innovation across the company’s 18,000+ colleagues to deliver more integrated solutions that meet patient needs and drive customer success. She joined Parexel in 2018 and most recently was President, Consulting and Chief Commercial & Strategy Officer leading the company to record new business growth and creation of a patient-focused strategy. She has more than 25 years of leadership experience in the healthcare industry and prior to joining Parexel held several leadership positions with AmerisourceBergen, a Fortune 20 company, most recently as President for Health Systems and Specialty Care Solutions, a $50B business unit. Ms Howell was also President, Global Sourcing and Manufacturer Relations, responsible for leadership of $150B in manufacturer sourcing relationships. In this role, she led the creation of a new sourcing entity in Bern, Switzerland to support global manufacturer relations and a joint venture with Walgreens. She previously served as President, Consulting Services for the company, managing a portfolio of industry-leading pharma services (including acquisitions) focused on market access, reimbursement, patient programs, specialty pharmacy, specialty logistics and product commercialization. Ms Howell 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.

She holds a Masters’ in Healthcare Administration (MHA) from The Ohio State University and a Bachelor of Arts in Speech Communication from The University of Illinois at Urbana-Champaign. In 2020 she was named a Luminary by the Healthcare Businesswomen’s Association (HBA). Ms Howell serves on the Board of Directors of Tandem Diabetes Care (NASDQ: TNDM), a medical device manufacturer, and represents Parexel on the Board of Directors for the Association of Clinical Research Organizations (ACRO).

Michael Ibara is Chief Data Officer at Elligo and has over 20 years of experience in clinical research and development. Throughout his career, Mr Ibara has sought to improve healthcare by bringing together healthcare data and digital technologies. His interests include regulatory and policy implications for digital healthcare, exploring factors needed to allow interoperability of healthcare data for all stakeholders involved, and implications for the use of big data, machine learning, and natural language processing to improve our ability to perform regulated clinical research.

Before Elligo, Mr Ibaral was the Head of Digital Healthcare for the Clinical Data Interchange Standards Consortium. There, he led the FDA eSource project and Healthcare Link efforts with registries, clinical trials, and mobile health to enable use of real-world data from healthcare for regulated research and decision making. Prior to CDISC, Mr Ibara was Head of Business Development Coordination and Innovation and also Head of Pharmacovigilance Innovation at Pfizer, where he worked for 15 years.

Adama Ibrahim is a UK top 100 influential tech leader passionate about diversity and inclusion practices. She is an innovation award winning pharma industry advisory consultant, founder, disruptor, strategy expert, blockchain advocate, technology enabled clinical trials and patient engagement thought leader with over 20 years in the NHS on commission by the DOH and in Industry. Ms Ibrahim has a deep experience of R&D transformation and led strategies and implementation of decentralized digital clinical trials and regulated digital platforms. She is a driver for change through identifying unmet customer needs, digital strategies, implementation and expansion of disruptive digital platform technologies across drug development and commercial lifecycles and customer journeys.

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. Mr Indupuri 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, Mr Indupuri 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. He 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.

Andrea Jackson is a Partner at Northpond Ventures. Ms Jackson joined Northpond in 2020 after 12 years of operating and finance roles in small and large scientific and technology companies. Her work at Northpond focuses on leading the people operations and portfolio management of the investment team.

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 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.

As Head of Global Development Data Science & Digital Health team, Sid Jain is focused on harnessing the power of Data Science and Digital Health technologies to transform drug development. Mr Jain embraces a patient centric approach – aiming to bring lifesaving and -enhancing therapies to the right patients, faster. His team is responsible for enhancing clinical trial operations with industry-leading advanced analytics and best-in-class linked datasets. Mr Jain’s team has also led several first-in-industry innovations, including RCT-RWD registry via tokenization of Janssen COVID-19 studies to enable real-world effectiveness studies and long-term follow up (LTFU) and scaling these registries across therapeutic areas.

Mr Jain has 20 years of leadership experience in healthcare, data and technology serving patients, biopharma, payers, and providers. He is driven by his passion to improve patient outcomes through innovative technologies. His expertise includes use of artificial intelligence and machine learning (AI/ML) models, real-world data (RWD), and decentralized/virtual trials to increase diversity, equity, and inclusion (DEI), advance patient matching, and reduce patient burden across clinical trials. Prior to joining Janssen, Mr Jain was VP of products at ConcertAI where he was responsible for building the next generation Real World Evidence (RWE) platform, eurekaHealth, which accelerated use of RWD and data science for a variety of R&D and commercial use cases at several leading biopharma companies. Prior to that, he was VP of Product Strategy at NantHealth, where he managed and oversaw delivery of a broad portfolio of capabilities, including clinical decision support, combining molecular insights with standard of care treatment guidelines and oncology prior authorization.

Mr Jain holds a Bachelor of Science with a double major in Computer Science and Management Information Systems. In addition, he has completed an Executive Management Program at MIT focused on Management and Leadership.

Sean Jensen currently serves as Director of Site Relationship Management for Merck Research Laboratory’s Global Clinical Trial Organization (MRL-GCTO). His team is responsible for partnering with and supporting key strategic sites across the US to position Merck as partner of choice. Mr Jensen is a hands-on strategic leader with experience in operations, strategy, partnerships, and finance across the biopharmaceutical and healthcare industries. Outside of work he enjoys reading, writing, and adventuring with his wife and two dogs.

Ryan Jones is CEO of Florence Healthcare. Florence advances cures for disease by enabling clinical trial sites to do their best work.

As the site-enablement category leader, Florence was chosen as the system of record for Pfizer’s COVID-19 trials, is an AJC Best Place to Work, a Deloitte Fast 50 winner, an Inc. Top 500 fastest growing company and a DPharm Innovation winner.

Before joining Florence, Mr Jones was president of Pubget (acquired by the Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals and research institutions worldwide. Mr Jones joined Pubget from Microsoft’s SharePoint team, where he helped the web’s largest sites make information understandable and accessible with document management technology.

Mr Jones has an AB from Dartmouth College and an MBA from UC Berkeley, where he was a Price Fellow. In his free time, he is a pretty good pilot and a terrible golfer.

Elan Josielewski is a Senior Principal and head of Operations of Patient Centered Solutions at IQVIA.  Prior to joining IQVIA, Mr Josielewski was the VP of Patient Centered Sciences at ICON; the integration of: Oxford Outcomes, Mapi Patient Centered Sciences, Mapi Language Services and The Mapi Research Trust. Prior to ICON, he was the Executive VP of Corporate Development and Marketing at Mapi Group, as well as, Vice Chairman of the Mapi Research Trust. Mr Josielewski has over 30 years of business leadership in Lifesciences, Engineering and Defense industries. Nearing a quarter century of specific experience across entire Clinical and Post-Approval Drug and device lifecycle; including Phase I – IV to Commercialization CRO services from 10 years at PharmaNet, Central Labs(MDS Central Labs), Clinical and Specimen Logistics (Marken), Cold Chain, EDC, eCOA (CRF Health), eConsent, Clinical Outcomes assessments and Real World Evidence (Mapi).

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.

Stefan Kaspers is a medical doctor and the leader of the Clinical Development Centre of Excellence at Boehringer Ingelheim. Dr Kaspers is a specialist in Paediatric Endocrinology and Diabetes, with extensive experience in pharmaceutical development, medical affairs, and project management. He holds a diploma in Pharmaceutical Medicine from the University of Basel, Switzerland, and has broad experience in healthcare as a researcher and diabetologist working on type 1 diabetes, type 2 diabetes, and cardiovascular disease. Dr Kaspers partners with many colleagues to bring the Medicine Excellence project to life, which is a testament to his commitment to improving healthcare.

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.

Cheryl Kechichian, RN, BS, currently works at the Butler Hospital Memory and Aging program in Providence, RI as a Research Nurse Coordinator. She has spent the last 16 years working as a Clinical Nurse Research Coordinator representing subjects with memory disorders.  She has worked with several different sponsors for several studies and initiated them from startup to closeout.  Some of the trials had up to 45 participants with varying stages of memory loss. The study medication was either in pill form, injectable or given intravenously.

As a coordinator, the job has many moving parts. Many of the responsibilities and roles of this position have changed over the years. Everything from start-up to close out and all the duties in between, inclusive of enrollment, screening, consenting, scheduling, assessments, training, data entry, safety assessments, adverse event reporting, medical records and data gathering, regulatory, source creation, contracts, out-reach and many other duties as needed.

In her previous work history, Ms Kechichian has worked in a variety of settings, inclusive of Hospitals, Rehab facilities, Homecare, Insurance and medicine, Medical Software development and testing and finally, Research in the clinical setting.

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 Shameer 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.

As Chief Strategy Officer, Joseph Kim brings over 23 years of pharmaceutical research expertise and innovation to ProofPilot. Most recently performing Senior Advisor roles at Lilly in Digital Health, Patient Experience Design, and Clinical Innovation.  Mr Kim brings a wide array of industry knowledge, integrating his experience working for multiple Sponsors such as Merck and Takeda (Shire), as well as CROs, and technology vendors. He has a robust combination of experience across all phases of clinical research, and a well-known history of innovation in the industry, recognized as one of the “Top 100 individuals on the 2015 MedicineMakers Power List,” and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.

Adam Kinsey is currently Associate Vice President and Regional Head of North America for Global Clinical Trial Operations (GCTO) at Merck Research Laboratories. Mr Kinsey has over 26 years of clinical research experience, with the last 8.5 years at Merck. He has been a key leader within GCTO, most recently serving as Executive Director, Clinical Sciences & Study Management and Therapeutic Area Section Head for Melanoma, Hepatobiliary Cancers, and Innovative Strategies. Previously, Mr Kinsey was Clinical Research Director in Oncology where he led country operations activities in the United States for Merck’s oncology pipeline. He started his career as a Clinical Research Associate (CRA) and has traversed through various roles in clinical operations of increasing responsibility and scope. Mr Kinsey also has experience across a wide array of therapeutic areas with companies of different sizes and operating models. He holds a bachelor’s degree in biology from Rice University and completed post-baccalaureate coursework at Houston Baptist University as well as coursework towards a Master of Public Health (MPH) degree at the University of Texas School of Public Health in Houston.

Kris Kokomoor provides expertise and guidance in exploring new processes and tools to streamline and enhance data acquisition and management in pharmaceutical research and development. Mr Kokomoor combines over twenty-five years of experience managing high-volume clinical data modalities with a technical (MS Electrical Engineering, BS Mathematics) and business (MBA) background to provide quality solutions and support within Data Acquisition at Pfizer in southeastern Connecticut.

Wendy Komocsar, BS MT(ASCP) SI is currently a Senior Director in the GI Therapeutic Area – Immunology Business Unit at Eli Lilly and Company in Indianapolis, IN. As part of the medical team, Ms Komocsar leads the pediatric clinical development team for an asset being studied in both ulcerative colitis and Crohn’s disease. This effort includes designing and leading clinical trials, achieving alignment with global regulatory agencies and merging scientific thinking and business needs to deliver strategic decisions involving multiple stakeholder and technical disciplines. Prior to this role, Ms Komocsar led the Immunotoxicology group at both Lilly and Pharmacia, evaluating the potential effects of therapeutic drug candidates on immune function in preclinical species. She is a board-certified medical technologist with specialty boards in Immunology and Flow Cytometry.

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.

Dr Lynn Kramer is Chief Clinical Officer, ADBH (Alzheimer’s Disease & Brain Health) at Eisai and a member of the Eisai Company Ltd. Executive Committee. Dr Kramer oversees the product creation cycle including clinical introduction, and regulatory approval of innovative projects in the neuroscience and general medicine area globally. He recently received the 2022 Epilepsy Foundation Lifetime Accelerator Award.

In 2007, Dr Kramer started as the Executive Vice President of Global Clinical Research at Eisai and was promoted to the additional role of Chief Operating Officer of Eisai Medical Research. He was named Chief Clinical Officer and a member of the Executive Committee, Eisai Company, Ltd. in 2012. In addition to those roles Dr Kramer was named Chief Medical Officer of the Neuroscience Business Group in April 2016.

Before joining Eisai, Dr Kramer oversaw clinical development, pharmacovigilance, drug safety and medical affairs for PAR Pharmaceutical, Inc. Earlier in his career he held senior positions in drug development at Purdue Pharmaceuticals and was Vice President Clinical Research and Head of the Therapeutic Area Strategy Team at Novartis, and Vice President Clinical Research at the R.W. Johnson Pharmaceutical Research Institute.

Dr Kramer received his MD from Hahnemann Medical College. He has been Co-PI on several NIH grants: Clinical and Epidemiologic Studies of Human Epilepsies, Pharmacologic Prophylaxis of Post-Traumatic Epilepsy, and had a Master Agreement Evaluation of Investigational Antiepileptic Drugs prior to his move into industry. He also holds a BA degree from Lycoming College.

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.

Sarah Krüg is the founder of the Health Collaboratory, a global innovation hub that paves the path for participatory co-design and collaboration in healthcare, with a focus on amplifying the voice of the patient and care/support partner in the design, development and continuous improvement of healthcare innovations. The Health Collaboratory has launched various innovations such as Prescription to Learn®, a Health GPS, and the Patient Shark Tank®, among others. Through the Patient Shark Tank ®, over 19,000 patients and care/support partners across disease states have evaluated innovations across the globe, including technology, education, research, and policy. 

Ms Krüg is the CEO of CANCER101, a patient advocacy organization whose mission is to help patients and care/support partners navigate the cancer journey and partner with their healthcare team to make informed decisions. She is also the Acting Executive Director and Past President of the Society for Participatory Medicine, a patient: clinician member driven organization, whose mission is to enable collaborative partnerships between patients and healthcare professionals. She serves on the board of the National Organization for Rare Disorders.  Ms Krüg is also the author of “A Roadmap to Wellness”.

She previously held the position of Global Education Director as well as Patient Advocacy Lead at Pfizer. She also established the Global Investigator Initiated Research Program at Pfizer.  Prior to joining Pfizer, Ms Krüg spearheaded the development of the Disease Management Clinical Pathways and conducted clinical research at Memorial Sloan- Kettering Cancer Center. 

Nuwan Kurukulasuriya, MS, PhD, is Global Vice President and Therapeutic Area Head, Medical Affairs at Alexion, AstraZeneca Rare Disease. He is determined to make a positive difference by bringing life saving innovative therapies to patients in urgent need and has dedicated 20-years in the pharmaceutical & biotechnology industry, at the intersection of R&D and commercial, across multiple therapeutic areas including Rare Disease, Oncology, Immunology, Hematology and Neuroscience. He has vast end-to-end clinical development and life cycle management experience, across Johnson & Johnson, Merck, Biogen, Shire, MorphoSys and AstraZeneca.

Dr Kurukulasuriya’s repertoire of interdisciplinary skills has culminated in several drugs achieving global blockbuster status. His unwavering focus on value creation is realized through cross-sector collaborations with key opinion leaders and extended stakeholders who span the highly complex health care ecosystem.

He is expert in applying an integrated Medical, Marketing, Market Access or “3M” lens to accelerating drug development and commercialization. Towards this end, he has gained a reputation as both a leader in the Real World Evidence (RWE) space and a champion for digital transformation. His aspirations include deploying artificial intelligence, machine learning and predictive analytics to generate insights that have the power to reimagine healthcare and the medicines of the future.

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, Mr Lai 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, and Embrace2, the only FDA-cleared wrist-worn wearable that detects seizures in people with epilepsy.

Mr Lai 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.

Shayna Lambert, Head of Strategy and Business Transformation, Global Clinical Operations (GCO) at Janssen R&D, has been in the pharmaceutical industry for 19 years, with various roles.  In her current role, Ms Lambert is responsible for leading a robust ‘Future Ready’ strategy and global business transformation tactical plan for GCO, considering the evolutions in the execution of clinical trials. Prior to her current role, she led Janssen’s Digital Health CoE where she has shaped the organization to be set up to meet the increasing demands and ever-evolving digital landscape.

Jason Lanier holds a BS and MS in Marine Biology from UNCW, as well as a Project Management Professional certification.  After somewhat accidentally finding a career in clinical research operations, 17 years later, Mr Lanier now returns to his passion for the environment in his latest assignment as a Director within Janssen Clinical Innovation’s Environmental Sustainability Focus Area.  In this rotational growth assignment, he is leveraging his years of clinical operations expertise to help measure the environmental impact of Janssen’s global clinical trial development program and to identify science-based targets for improvement throughout Janssen and across industry collaborations.

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.

David Leventhal, MBA, is the Senior Director, Data Sharing & Disclosure Lead at Pfizer, Inc. He oversees the expansion and implementation of Pfizer’s Clinical Trial Data Sharing Policy and serves as a single point of leadership for enterprise-wide sharing of sponsored clinical trial data. He is also a representative to stakeholders within and outside of Pfizer as it relates to data sharing. As such, he partners with leaders in the clinical research community. Importantly, Mr Leventhal manages centralized data sharing governance at Pfizer as they continue to demonstrate their commitment to transparency and data sharing. He has been with Pfizer for 27 years, and in that time has served in a variety of R&D and innovation functions.

Gregory Levin is the Associate Director for Statistical Science and Policy in the Office of Biostatistics in the FDA’s Center for Drug Evaluation and Research. Dr Levin received a PhD in biostatistics from the University of Washington in 2012. Dr Levin has experience supporting drug review across a wide range of therapeutic areas and has represented CDER on several policy and guidance working groups, including efforts related to adaptive design, master protocols, benefit-risk, and the evaluation of effectiveness.

Dr Gen Li is the President and Founder of Phesi Inc., a global provider of patient-centric data analytics that deliver smarter trials and faster cures. Dr Li has extensive experience in clinical development, having previously worked at Pfizer and Pharmacia, where he significantly contributed to the Centre for Medicines Research (CMR) International database for pharmaceutical R&D performance. His work inspired him to create Phesi - ensuring the insights held from historical data, or data collected from failed clinical trials were not lost. Under Dr Li’s leadership, Phesi has supported a number of landmark trials including Keytruda with its integrated solutions that accelerate drug development and commercialization. Phesi continues to disrupt the industry with its Trial Accelerator™ platform using artificial intelligence and global real-world patient data to generate Digital Patient Profiles, Digital Twins and Digital Trial Arms. Phesi delivers actionable insights for trial design, planning and execution, enabling pharma and biopharma companies to optimize protocol design, improve enrollment and reduce patient and investigator site burden and cycle times

Craig Lipset leads at the forefront of innovation in clinical research and medicine development. Mr Lipset is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. He was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Mr Lipset designed and launched multiple industry firsts — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants. He currently serves on the Board of Directors for the Decentralized Trials & Research Alliance (Co-Chair), Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. He is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.

Mr Lipset has received the red jacket ‘hall of fame’ recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who’s Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.

Brian Loew created Inspire in 2005 with the goal of accelerating medical progress through engaged patients and caregivers in safe, trusted online social networks. Over the past 17 years, Mr Loew has grown the company to be the leading online community for health with more than 10 million visitors annually who join Inspire to discuss a range of health conditions. He has built a network of dozens of nonprofit partners including the American Lung Association who rely on Inspire for safe, moderated spaces where their members can receive trusted information and support. Mr Loew is a frequent speaker and writer on the topics of patient-centricity, the role of data in healthcare, health-focused social networks and digital medicine. He sits on the boards of the Robert Packard Center for ALS Research at Johns Hopkins, and New Jersey Goals of Care, and was a “Red Jacket” recipient from PharmaVOICE magazine for his contributions to the industry. Mr Loew is a graduate of George Washington University.

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.

Jamie Macdonald is Chief Executive Officer of Parexel. Mr Macdonald has more than 25 years of experience in leading global biopharmaceutical services companies. Prior to joining Parexel, he served as Chief Executive Officer of INC Research, now known as Syneos Health, from January 2013 through September 2016, where he led the company through a successful Initial Public Offering in 2014. Mr Macdonald also served as INC’s Chief Operating Officer from July 2011 through December 2012, and previously held several leadership positions in the biopharmaceutical services industry, including Senior Vice President and Head of Global Project Management at Quintiles, now known as IQVIA. Prior to this, he held various senior operational and finance roles at Quintiles. He has previously served on the Board of Directors for the Association of Clinical Research Organizations (ACRO) and as its Chairman in 2015. Mr Macdonald’s recent experience also includes serving as Chairman of the Board for Certara, a drug development consultancy with solutions spanning discovery, preclinical and clinical drug development, from 2017 to 2018.

Mr Macdonald began his career in the pharmaceutical industry with Syntex Corporation (acquired by Roche Holdings, Inc.). A native of Scotland, he holds a BA in Economics from Heriot-Watt University in Edinburgh, Scotland and is a qualified Chartered Management Accountant (ACMA).

Matt W. Maddox is Associate Vice President in IDS at Eli Lilly and Company. In his role, Mr Maddox is responsible for leveraging innovative technology to transform and run clinical development of Lilly’s late-stage drug portfolio. Key areas of focus include Automation, Advanced Analytics, User Experience and Service Management.

Mr Maddox has deep expertise in Global IT Management, Clinical Development, Advanced Analytics, Sales and Marketing Enablement as well as Mobile Solution Delivery. His passion to transform the pharmaceutical industry through technology as well as his people first approach to leadership provide his foundation to drive innovation.

Mr Maddox earned his undergraduate degree in Business from Indiana University. Mr Maddox lives in Indianapolis with his wife and 4 children and is passionate about being outdoors, travel and red wine.

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.

Paul Mancinelli, PhD, is the Chief Technology Officer of WCG where he leads technology overall, including infrastructure, software engineering, and application development across the organization to support WCG’s strategy and enhance productivity, efficiency, and synergy throughout the enterprise.

Dr Mancinelli previously served as Cigna’s Chief Data and Analytics Engineering Officer where he was responsible for Cigna’s enterprise authoritative data assets as well as the advanced analytics ecosystem and reporting solutions. Under his leadership, the Data & Analytics Engineering team was a catalyst for the use of Big Data, Machine Learning and Open Source technologies in support of Cigna’s Personalization and Affordability strategies.

Ingrid A. Mayer, MD, MSCI is the Breast Cancer Global Clinical Strategy Head at AstraZeneca Late Development Oncology. After 20 years in academia and clinical practice as a breast cancer medical oncologist, her current role is to pioneer and expand novel translational global research and innovative clinical trial development in breast cancer that accelerates the approval of established and novel drugs in the key areas of excellence at AstraZeneca, tumor resistance/ targeted therapies, DNA damage response, antibody-drug conjugates, and immuno-oncology. Before joining AZ, Dr Mayer was a Professor of Medicine and Ingram Professor of Cancer Research at Vanderbilt University Medical Center with a successful track record of phase I, II and III clinical trials and has chaired, co-chaired or been a member of many national and international health services cancer leadership committees in the US, such as ECOG-ACRIN Breast Core Committee, National Comprehensive Cancer Network (NCCN) Breast Cancer Panel of Experts, Translational Breast Cancer Research Consortium (TBCRC) amongst many others. Her translational research focused on identifying targetable pathways and mechanisms of treatment resistance in breast cancer, which have been recognized and funded by the NCI (K23 and SPORE in Breast Cancer), SU2C/ AACR, Susan G. Komen Foundation and the Breast Cancer Research Foundation and published in more than 130 peer-reviewed journals.

Jess Mays is Vice President of Life Sciences at 20/20 Onsite, responsible for the growth of our clinical research division – from sales and marketing to account management and operations. In 20/20 Onsite’s life sciences work, there is potential to not only bring a much-needed mobility to providing eye care for clinical assessments, but also to provide our deep insights on patient experience and care that create the standard we operate by daily. She is thrilled to be leading this charge. Ms Mays has been in customer success for over a decade, working for high-growth companies like HubSpot. She has a track record in leading and scaling teams and developing innovative programs, and her passion for start-ups has allowed her to see success and failure at every stage of business. She holds a BS degree from the University of Mary Washington in Business Administration.

Jean McCoy, EVP, Partnerships for Reverba and accelerates the company’s growth by ensuring they are dependable partners who are consistently bringing value to their clients. Her knowledge of what this requires is based on more than 25 years of leadership in biopharmaceutical marketing and commercialization. She is an outspoken authority on patient engagement who frequently gives keynote addresses about our pioneering work in both the commercial and clinical arenas.

Rita McGrath is a best-selling author, a sought-after advisor and speaker, and a longtime professor at Columbia Business School. Dr McGrath is one of the world’s top experts on strategy and innovation and is consistently ranked among the top 10 management thinkers in the world, including the #1 award for strategy by Thinkers50. Dr McGrath’s recent book on strategic inflection points is Seeing Around Corners: How to Spot Inflection Points in Business Before They Happen (Houghton Mifflin Harcourt, 2019). She is the author of four other books, including the best-selling The End of Competitive Advantage (Harvard Business Review Press, 2013).

Since the onset of the pandemic, she has created workshops, strategy sessions and keynotes, applying her tools and frameworks to strategy under high levels of uncertainty to specific issues organizations are facing. As Rui Barbas, the Chief Strategy Officer for Nestle USA said, “You were incredibly insightful and, despite the virtual setting, there was lots of engagement and comments from leaders sharing eye-opening observations and building on your examples throughout. You delivered the inspiration and illustration desired and it was exactly the right focus and challenge for this team. Appreciate your time throughout the process to align on content and delivery. The future-focus theme was the perfect close to our leadership summit.”

Dr McGrath’s work is focused on creating unique insights. She has also founded Valize a companion company dedicated to turning those insights into actionable capability. You can find out more about Valize at www.valize.com

Dr McGrath received her PhD from the Wharton School (University of Pennsylvania) and has degrees with honors from Barnard College and the Columbia School of International and Public Affairs. She is active on all the main social media platforms, such as Twitter @rgmcgrath. For more information, visit RitaMcGrath.com.

Kelly McKee serves as VP of DCTs and Patient Registries at Medidata. Ms McKee is responsible for creating new solutions to engage clinical trial patients pre-trial, in-trial, and post-trial, as well as developing patient communications for decentralized and hybrid clinical trials. She is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions. Prior to Medidata, she spent over 20 years in clinical operations and patient recruitment at top-tier pharmaceutical companies, including Sanofi, Merck, Eli Lilly and Co., and Vertex Pharmaceuticals.

Sarah McKeown-Cannon (she/her/hers) is an expert in Clinical Trial Experience (CTE), providing innovative patient recruitment and engagement solutions that enrich study experiences and deliver measurable results. In 2016, after gaining experience at Langland’s UK headquarters, Ms McKeown-Cannon opened Langland’s New York office. She now leads the development of global clinical trial programs across a wide range of therapy areas, from oncology and cardiovascular to rare disease and beyond.

Ms McKeown-Cannon is driven by her commitment to making a difference in people’s lives, by understanding all the dimensions that make us human and translating that into meaningful engagement. Her work inspires clients to think further, always pushing the boundaries of what’s possible in clinical trial design, challenging the status quo to accelerate clinical development timelines and ensure global diversity.

Ms McKeown-Cannon’s expertise and passion for improving the lives of others can be seen through her dedication to elevating the voice of those underrepresented within clinical trials, telling meaningful stories on the impact of inclusive clinical trial design. Her recent speaking engagements at the Summit for Clinical Operations Executives (SCOPE), SXSW and Patients as Partners highlight her passion for sharing new and innovative ways to make a difference to patients globally.

Hope Meely is the Chief Clinical Officer at Slope, the industry-leading provider of a clinical trial execution platform for highly complex, sample-intensive clinical trials. Ms Meely has spent the entirety of her 25-year clinical research career supporting several sponsors and CROs in leading clinical operations teams in the execution of their clinical trial programs. Most recently, Ms Meely spent 3 years in a growing biotech leading operations for a robust early phase oncology pipeline. She is passionate about making clinical trial operations easier for research sites, sponsors, and other collaborators.

Matt Michelson is a co-founder and the CEO of Readout AI. An expert in AI and machine-learning, Dr Michelson has been in the field for nearly a decade, both as a venture-backed founder and executive, and as a researcher, publishing more than 35 peer-reviewed articles in scientific conferences and journals. He has been involved in two start-up exits: first as CEO of Evid Science, which was sold to Genesis Research, and later as President of Genesis AI, when Genesis Research itself was sold to GHO Capital. Dr Michelson holds an MS and PhD in Computer Science from the University of Southern California, and a BS in Computer Science from Johns Hopkins University.

As Vice President of eCOA at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Mr Mikulaschek has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

Daniel Millar leads Strategic Business Transformation in Statistics & Decision Sciences at J&J Innovative Medicine R&D and is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Mr Millar is a founding leader and champion for multi-stakeholder engagement in the Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms, “EU PEARL.” Mr Millar was also a co-lead of the Clinical Trials Transformation Initiative (CTTI) project on Master Protocols together with leaders from FDA, academic research hospitals and patient advocacy. Daniel has served on and led DIA program committees for multi-stakeholder workshops focused on Complex Innovative Designs and Master Protocols. An important aspect of his focus has been generating a global discussion and knowledge exchange on innovative methods in clinical trial designs, including regulators in US, Brazil, Canada, Europe, UK, China and Japan, and bringing focus to the benefits of innovative designs for patients.

Mr Millar obtained an MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling.

Shannon Miller competed in TWO Olympic Games, earning 7 Olympic medals! (2 gold, 2 silver, 3 bronze). She is the only female athlete to be inducted into the US Olympic Hall of Fame – Twice! (Individual (2006) and Team (2008))

Shannon is the first US gymnast to win 2 World All-Around Titles. Her tally of five medals (2 silver, 3 bronze) at the 1992 Olympics was the most medals won by a US athlete in any sport. At the ’96 Games, she led the “Magnificent Seven” to the US Women’s first ever Team Gold and for the first time for any American gymnast, she captured Gold on the Balance Beam.

After retiring from Olympic competition, Shannon received her undergraduate degrees in marketing and entrepreneurship from the University of Houston and her law degree from Boston College.

Shannon remains a part of the gymnastics and Olympic communities as an analyst and commentator. In 2010, Shannon launched her company devoted to helping women make their health a priority. She continues to travel the country as a highly sought-after motivational speaker on topics ranging from The Gold Medal Mindset to cancer and survivorship and to the importance of health and fitness.

In January of 2011, Shannon was diagnosed with a rare form of ovarian cancer. She had the baseball sized tumor removed successfully and followed up with an aggressive chemotherapy regimen. Shannon is currently cancer-free and continues to be a strong advocate for early detection, awareness, research and survivorship.

For more than 20 years, Lisa Moneymaker has been a leader in the pharma, biotech, and medical device industries. Ms Moneymaker’s leadership has delivered complex systems solutions in support of excellence in clinical trial execution.Prior to joining Saama, Ms Moneymaker was SVP of Clinical Operations Technology at Medidata Solutions. In this position, she helped to advance the role of internal sponsor and CRO technology in support of Decentralized Clinical Trials, as the industry responded to the pressures of an increasingly remote world.Ms Moneymaker began her career at Accenture and continued as an independent consultant, gaining exposure to information systems across the pharma space. Much of her career was in support of Amgen, developing systems within its global development organization, which gained her exposure and recognition as a subject matter expert within pharma information systems. A graduate of University of Southern California, she holds a BS in Biomedical Biochemical Engineering.

Scott Morris is VP and General Manager for Clinical Trial Solutions of Optum Life Sciences. Mr Morris has significant experience in healthcare and technology across life sciences, research, and provider market segments and is uniquely qualified to understand the challenges and lead the delivery of support offerings to accelerate and diversify clinical trials participation and streamline processes to help bring new therapies to market for the patients who need them. Most recently, he served as Vice President – Health Sciences at Change Healthcare, prior to its acquisition by Optum. He has also held various leadership roles at IQVIA (formerly Quintiles) plus related ventures, Oracle Health Sciences and Premier, Inc. and has demonstrated success in developing and growing new business offerings and partnerships in the context of larger organizations.

Mr Morris received his Bachelor of Science in Marketing from the Wilbur O. and Ann Powers College of Business at Clemson University with additional emphasis in Computer Science and Math. He also completed an Executive Leadership Program at the Kenan-Flagler Business School at UNC-Chapel Hill.

Mr Morris continues to serve Clemson University as a member of its Board of Visitors, has served on a global non-profit board, and is involved in various industry groups, including DIA. He is active in his community and other service opportunities while enjoying his family, outdoor activities, collegiate events, and live music.

Jane Myles has focused on improving clinical trials and patient experience for more than 25 years. Her passion is driving innovation into the trial design and execution to get medicines to patients faster. Ms Myles switched from molecule focus to portfolio focus about 13 years ago, first focused on patient recruitment, then patient voice and input, then patient facing technology and its adoption. She can merge them all together in her current role as Chairperson for Curebase’s Strategic Advisory Board, building DCT technology and services to drive access and inclusion to trials.

Ms Myles is also a Program Director for the Decentralized Trials & Research Alliance (DTRA). She worked at Roche / Genentech for 17 years in many roles, including operational program manager for hematology ultimately working on driving patient-facing technology into global trials. In prior lives, she held various roles in DCT optimization at LabCorp and ran global trials at Lilly and Sanofi. She’s a Canuck who loves San Francisco and the ocean.

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Mr Nambisan was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Mr Nambisan holds an MS in Management and Engineering from MIT, an MA in Neuroscience from Boston University, and a BA in Cognitive Neuroscience from UC Berkeley.

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.

Josh O’Rourke has more than 19 years of experience in software engineering, systems integration, and data science. Mr O’Rourke 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. Mr O’Rourke is a graduate of the Georgia Institute of Technology where he studied Artificial Intelligence and Machine Learning.

While Lucinda Orsini holds a professional medical degree, she has spent most of her ~20-year career in health economics and outcomes research. Dr Orsinis has worked in the pharmaceutical industry at Bristol-Myers Squibb and subsidiaries in Global HEOR focused on oncology and immunotherapy leading and publishing on patient reported outcomes, health economic modeling and real-world evidence studies – both prospective and retrospective in many different tumor types. Dr Orsini also worked on the team that launched nivolumab, one of the first marketed immuno-oncology treatments. After BMS, she led HEOR efforts at Parexel – a full-service contract research group, managing a team of ~30 modeling, biostatistics, and RWE scientists supporting HTA efforts for clients in the pharmaceutical space. Currently, Dr Orsini is Vice President for Value and Outcomes Research at COMPASS Pathways – a mental healthcare company dedicated to delivering evidence-based innovative treatment to people with serious mental illnesses. She is responsible for all the health economic and outcomes research efforts for the company.

Doug Palmer is devoted to innovating and translating novel immunotherapies to treat metastatic cancer. In his two decades at the NCI with Steve Rosenberg and Nick Restifo, Dr Palmer’s work helped to uncover the mechanisms of immune maturation, T cell-host interactions, cancer targeting, and T cell exhaustion. Dr Palmer was fortunate to translate this work into the clinic where he led one of the first CRISPR gene editing clinical trials in the US in neoantigen-specific TIL. Currently, as the Executive Director of Immuno-Oncology at AstraZeneca, Dr Palmer leads efforts to improve the clinical line of sight, drive back translation, and enhance data access and centricity.

With an eminent career spanning over two decades in the pharmaceutical industry, Rajesh Patel has been a driving force in the realm of Clinical Data Management (CDM) and Clinical Operations (ClinOPs). His expertise and leadership in these areas have been honed through significant roles at esteemed big and small pharmaceutical companies as well as Functional Service Provider (FSP) organizations. Demonstrating a keen understanding of drug development processes, Mr Patel has successfully led end-to-end CDM efforts, delivering high quality study outcomes while fostering strong partnership and adhering to regulatory standards.

As a visionary leader, Mr Patel has played a pivotal role in transforming CDM and ClinOps through pragmatic integration of innovative technologies and the establishment of global teams, global standards and processes and reporting for data management and relevant stakeholder groups. His expertise extends beyond the traditional boundaries with published research paper, patents showcasing his contributions in scientific knowledge. Throughout his career, Mr Patel has been lauded for his commitment to excellence, championing a collaborative work environment and inspiring others within the pharmaceutical drug development research community. His dedication to advancing the field and enhancing site and patient experiences continues in his current role as an implementation lead within the Technology and Innovation group at Gilead.

Maria Perkinson brings more than 20 years of experience delivering strategic transformation solutions. Ms Perkinson has led many large-scale global initiatives within the pharmaceutical industry. She has extensive experience applying process improvement, innovation, and change management methodologies to maximize the value of an integrated digitalization strategy and solution. Coupled with her ability to bridge disparate organizations and drive unified strategies and disciplines, Ms Perkinson brings critical value as digitalization and innovation continue to play an increasingly vital role in the pharmaceutical industry.

Jane Perlmutter, PhD, is a long-term survivor of multiple cancers and an active advocate. While her advocacy is largely rooted in her own experiences, it is also informed by her formal training in cognitive psychology and experimental methods (PhD), computer and information science (MS) and business (MBA), as well as her career experiences which included many years in academia, not-for-profit R&D, corporate senior management, and independent consulting.

During her early advocacy Dr Perlmutter was a peer counselor and board member for Y-ME, as well as a grant reviewer for ACS, DOD and PCORI. More recently she focuses much of her advocacy on clinical trials, ensuring that the patient voice is considered in selection of research questions and that trial protocols are sensitive to patient issues. She is especially interested in innovative trial designs that can speed new treatments to patients who need them. Dr Perlmutter serves on the steering committees and is lead advocate on the I-SPY2 and TAPUR trials, two groundbreaking Master Protocol trials. She has been an advocate on NCI’s Breast Steering Committee and CALGB’s Breast and Health Outcomes Committees and is currently on NCI’s Cancer Imaging Steering Committee and NCTN’s DSMB and Cancer Control Executive Committee.

Dr Perlmutter has also been involved in health advocacy beyond cancer and works with many government and not-for-profit groups. She is past-chair of the Patient Centered Outcomes Research Institute’s (PCORI) Patient Engagement Advisory Panel and a member of their Clinical Trials Advisory Committee. She is especially passionate about developing the next generation of advocates and fostering collaboration between advocates and researchers. She has developed and delivered training for many advocacy groups and been a long-term faculty member of the ASCO/AACR Methods in Clinical Research Workshop. In 2023, Dr Perlmutter was honored with AACR’s 2023 Distinguished Public Service Award for Exceptional Leadership in Cancer Advocacy as well as ASCO’s 2023 Patient Advocate Award.

Gus Perna, the visionary leader of ‘Operation Warp Speed,’ shares the principles of leadership, teamwork, strategic planning, secure operations, and supply chain mastery that helped his team orchestrate the largest, safest, and most rapid vaccine deployment effort in global history.

Before he was named to co-lead the U.S. government’s COVID-19 response in 2020 with Operation Warp Speed, General Gus Perna served as head of the U.S. Army Materiel Command where he managed redistribution of critical munitions to the Pacific and fixed the Army’s housing crisis. As Commander of the Philadelphia Defense Supply Center, he was responsible for the fighting force’s global supply chain.

One of the military’s most skilled and most senior logisticians, General Perna worked to build manufacturing capacity and the end-to-end supply chain needed to get vaccines distributed “at warp speed.” Leveraging public-private partnerships, he accelerated the operation beyond what anyone thought possible—all while the vaccines were still in development.

General Perna retired from the U.S. Army in August of 2021 after 38 years of distinguished service in which he was awarded the Defense Distinguished Service Medal, Distinguished Service Medal with three Oak Leaf Clusters, Defense Superior Service Medal with Oak Leaf Cluster, Legion of Merit, and Bronze Star Medal with Oak Leaf Cluster. In 2021, the association of Business Executives for National Security honored him with the Eisenhower Award.

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/

Angela Radcliffe is a clinical research expert and data ethics evangelist with over two decades of experience driving transformation and organizational agility at the intersection of health, tech, and data. Ms Radcliffe’s work has impacted >100 global clinical research efforts across almost every therapeutic area. As an author and speaker, Ms Radcliffe uses her personal journey to demonstrate how inclusive research can impact the root causes of our most challenging social issues. She is committed to AI for good, giving data ownership back to humans, the pursuit of more authentic patient engagement, the promotion of health and data literacy for all, and normalizing clinical research as a care option.

Sridevi Rajeeve is an Assistant attending physician with the Memorial Sloan-Kettering Cancer Center in New York specializing in Multiple Myeloma and Cellular Therapeutics. Dr Rajeeve completed her Internal Medicine residency training and Hematology-Oncology fellowship training at the Icahn School of Medicine at Mount Sinai in New York.

Dr Rajeeve’s clinical and research interests span across plasma cell dyscrasias (Multiple Myeloma, Precursor states – monoclonal gammopathy of undetermined significance (MGUS)/smoldering multiple myeloma(SMM), Amyloidosis) and lymphoid malignancies, cellular therapeutics, clinical trials, digital health technologies and care delivery transformation. She is a grant funded researcher who aims to thoughtfully design clinical trials and make cancer care more accessible to people. She has been involved with patient education groups making educational videos to simplify complex cancer-related topics to patients and caregivers.

Dr Rajeeve is a bibliophile, adores open-air theater performances, travel and an active lifestyle.

Amanda Rangel is Senior Vice President of Business Development at 83bar. Ms Rangel is an experienced entrepreneur, business development and operations executive with a 20-year history of success in the clinical research industry.  Ms Rangel started as a clinical research coordinator and spent a decade in a variety of roles across multiple site settings (academic, single site and global site networks). She then went on to hold leadership roles for DCT and Diversity and Inclusion service providers. Ms Rangel has dedicated her career to making clinical trial access better for patients in a way that is sustainable and friendly for sites.

Prasanna Rao is a distinguished AI practitioner and industry thought leader with over 30 years of experience in information technology and advanced analytics. Currently serving as the Senior Director, Global Head of AI/ML for Clinical Data Sciences at Pfizer, Mr Rao brings extensive expertise in healthcare and life sciences, spanning more than a decade. Previously as a Watson Solution Architect at IBM, he played a key role in implementing AI systems for various clients. With a strong focus on driving innovation and fostering AI adoption, he collaborates with stakeholders, including vendors, SMEs, developers, and data scientists. He has presented at prominent industry conferences such as SCDM, DIA, DPHARM, SCOPE, and Tufts University CSDD, establishing a reputation as a leading authority in leveraging disruptive technologies for clinical development in the pharma industry.

Siân Ratcliffe, PhD, is currently VP, Head of Global Clinical Operations and interim Head of Analytics & Data Sciences 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, Siân 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.

Susan Reilly Salgado, PhD, is a consultant and speaker whose work focuses on how organizations can leverage a strong and healthy organizational culture to achieve outstanding results. Her proprietary model of culture explains how organizations can build infrastructure to support their desired culture, to retain the ‘soul’ of the company.

During her 15 years as an executive and partner in Danny Meyer’s Union Square Hospitality Group (USHG), Dr Salgado created and implemented the company’s leadership development programs, which were a fundamental component of the company’s success in growing its culture throughout significant growth, including the creation and scaling of the Shake Shack brand. In 2010, she opened a consultancy under the USHG umbrella to help organizations across industries do the same, and in 2017, Susan spun the consultancy off and continues to consult and speak in the areas of organizational culture, leadership, and customer experience.

Dr Salgado has shared concepts and best practices with companies across more than 20 different industries, from hospitality, to luxury retail, to hospitals, to financial services, and beyond [including companies such as Delta Airlines, Hyatt Hotels, Merrill Lynch, CLEAR, Assa Abloy Security Systems, Chanel, Ford Motor Company, Pure Insurance, H-E-B, Cedars Sinai Hospital System, Novartis, BJs Restaurants, Condé Nast, Coca Cola, NFP, and Share Our Strength/No Kid Hungry]. Her goal is to help teams understand how effective leadership leads to a positive and uplifting culture that drives performance.

Her work has been profiled in numerous publications, including The New York Times, Wall Street Journal, Fast Company, and Business Insider. She was a co-founder of the NYC Chapter of Conscious Capitalism, has recorded a TEDx talk, has been a contributor to Inc. magazine, and was named one of Fast Company’s 100 Most Creative People in Business. For more information, please visit www.SusanSalgado.com.

Jason Reynolds is the Chief Revenue Officer at Florence Healthcare™. Mr Reynolds has spent his 30+ year career in the life sciences industry, leading organizations that help the biopharmaceutical industry deliver more value to their end customers. His background includes prior positions at Definitive Healthcare, Intralinks, and Phase Forward. Mr Reynolds currently serves on the Board of Directors of Cisiv, a global software and services company dedicated to non interventional research, registries, and expanded access programs. At Florence, he is responsible for global sales, with a focus on connecting clinical trial sites with sponsors and CROs to streamline clinical research workflows.

Ash Rishi is founder and CEO of COUCH Health, a global creative health engagement agency that serves to make health research inclusive. Its focus covers a range of solutions, including patient insights and engagement through to recruitment and retention within health research. Mr Rishi has over 15 years of experience in the industry, navigating the diverse needs of big pharma through to smaller biotech companies. With experience that covers the full medicine lifecycle, from pre-clinical to lifecycle management, his passions lay in working to make research more inclusive and has founded Demand Diversity a non-profit in 2023.

Dr. Isaac R Rodriguez-Chavez is a scientific and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, Vaccinology, and rare diseases. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research, and post-marketing studies. Currently, he is an independent consultant for clinical research and digital medicine. Past positions over the last 30 years include being a Senior Vice President for Scientific & Clinical Affairs, leading strategies and operations for Decentralized Clinical Trials (DCTs) and Digital Medicine at ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development, modernizing clinical research through DCTs enabled by Digital Health Technologies (DHTs); CEO/Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs, NIH; Senior Clinical Scientist, Schering Plough Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He is a board member of BlueCloud by HealthCarePoint, Reveles Clinical Research, Digital Medical Society (DiMe), and the Hypertrophic Cardiomyopathy Association (HCMA). He is a Rare Disease Health Equity Council member for Global Genes, global content Editor for Regulatory Science at the DIA Global Forum Magazine, Co-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering industry standards on DCTs and DHTs. He is a former Leadership Council Board member of the Decentralized Trials & Research Alliance (DTRA), and a former Co-Chair of DTRA’s Regulatory Council. He is a former Co-Chair of the DiMe’s Research Committee, driving digital medicine globally. He is also an active member of sixteen professional associations, published over 60 scientific and technical articles, and has been an invited speaker in over 100 global conferences. He has a PhD in Virology and Immunology; an MS in Microbiology; an MHS in Clinical Research; and a BS in Biology.  He has 5 years of post-doctoral specialty training in Infectious Diseases, Viral Immunology, Viral Oncology linked to Clinical Research.

With more than forty years’ experience supporting the planning and execution of clinical trials in all phases of drug development, Mr Roessner provides guidance and oversight to help Parexel’s clients incorporate innovative study designs into drug development in a way that development is more streamlined, faster, and more focused on objectives.

Steve Rosenberg’s career in life science and healthcare spans more than 40 years. Mr Rosenberg has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. Mr Rosenberg was 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. Mr Rosenberg joined uMotif’s board in 2022.

Krista Russell is a clinical researcher and digital health scientist, eager to bring digital capabilities to solve complex challenges. She is passionate about improving health outcomes for patients through the adoption of the right technology solutions.

Ms Russell is Head of the Digital Health Solutions team at Takeda. Her team is partnering with teams to take on fundamental challenges to further Takeda’s vision of streamlining Digital, Data and Technology in clinical trials. Prior to Takeda, Krista developed, validated, and managed business and clinical technology tools.

Ms Russell’s passion for technology began with her career in the United States Navy. Her career passion for the use of high-quality, safe technology for patient care began while working with Veterans at high risk for suicide. She has worked extensively with patients and sites to implement and validate new technology solutions over the past two decades. She is a certified clinical research coordinator and clinical project manager, having spent over a decade conducting and managing hundreds of clinical trials before transitioning to sponsor work. Ms Russell holds a BS in Health Information Management from Saint Louis University and an MS in Health Informatics from Liberty University.

Dr Marsha Samson joined the FDA from CDC where she served as a Career Epidemiology Field Officer (CEFO) assigned to the DC Health Department to strengthen state, tribal, local, and territorial epidemiology capacity for public health preparedness and response. D. Samson earned her BS in biomathematics from Florida State University, her MPH/MSHSA from Barry University, her PhD in Epidemiology from the University of South Carolina, and completed her postdoctoral training at Georgetown University in cancer biology. Now, Dr Samson manages key CDER initiatives related to the use of AI/ML in the development of drugs and obtained her Regulatory Affairs Certification (RAC) in drugs and devices. Dr Samson is committed to fostering equal opportunities for accessing secure and efficient medications, as well as enhancing public health in general.

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.

Patrick Schorderet has over two decades of experience in consulting, global companies, startups and academia. Dr Schorderet has a proven track record of delivering innovation across the entire pharma value chain. He brings a unique profile at the interface of science, technology, and business, to support holistic and people-centric transformation towards a more connected world.

Meri Kay Scott is responsible for leading the Digital Health Research and Development – Clinical Operations team at Eli Lilly and Company.

Digital Health R&D allows Dr Scott to connect her more than 25 years of global clinical development experience with technology and passion for patients and sites by leading execution of Digital Health Technologies in clinical studies and engaging in Lilly’s Digital Health focus on science-driven patient engagement. This includes the development of digital biomarkers/digital measures for innovative and optimized clinical trials, and provides timely diagnoses, smarter interventions, better adherence and improved health outcomes for patients who require our medications.

Within her 20+ years at Lilly, Dr Scott has had a breadth of technical, managerial and leadership roles in clinical drug/trial development, clinical project management and global clinical operations across therapeutic areas, much with a focus on diabetes, from early drug development to the market. Most recently, her experience is being leveraged in Lilly’s technical space.

Additional career highlights include academia at Purdue University and similar clinical work at Amgen. She earned her bachelor’s degree in Pharmacy at South Dakota State University with her Masters and PhD in Clinical Pharmacy from Purdue University, specializing in nephrology and diabetes.

Mark Scullion is the CEO of Atlas Clinical Research, a therapeutically driven clinical research site network built on centralized process excellence and integrated technology.   Before Atlas, Mark was most recently the Global Head of Trial Monitoring for Novartis AG, and also spent more than 15 years in leadership roles at Syneos Health and IQVIA, where he developed novel approaches to clinical trial design and execution.

Craig Serra is the Head of Commercial Solutions and Partnerships for Flatiron’s Clinical Research business unit, where he is accountable for sales, business development, partnerships, and related activities for the clinical research team. Mr Serra was previously the Global Head, Strategy and Innovation for Data Operations at Novartis and has held senior leadership roles at IQVIA and Pfizer, as well as served in a multi-faceted executive role at a niche CRO (DSP Clinical). He is a recognized industry leader and was named Pharmaceutical Executive’s “2020 Emerging Pharma Leaders” and PharmaVOICE “100 Most Inspiring People” for both 2017 and 2020. Mr Serra earned a BA in Psychology from Rutgers University, an MBA in Management and an MS in Information Systems from Fordham University, and an MS in Pharmacology and Toxicology from Michigan State University.

Judy Sewards currently serves as the Vice President, Head of Clinical Trial Experience and Participant Recruitment at Pfizer.  In this role, Ms Sewards leads a team responsible for designing and delivering new communications and services that provide ease and convenience for more than 6,000 clinical trial sites around the globe and over 100,000 participants who graciously join Pfizer’s trials every year to help advance potential medical breakthroughs. She also stewards the company’s equity commitment to diversity in clinical trials and is launching novel enrolment strategies to help address access barriers and accelerate clinical development, focusing on new ways that engage participants within each investigator’s practice, institution, and community.

Ms Sewards was formerly Vice President, Digital Innovation in Pfizer’s Strategy & Commercial Operations organization, where she set and activated new digital and big data strategies to help the enterprise meet business and customer needs in the future health landscape. Prior to that, she held a number of leadership positions within Pfizer’s commercial organization, including Team Leader for the U.S. Celebrex and Flector Patch businesses, Head of the Primary Care Marketing Innovation Incubator, and Consumer Lead for the iconic Viagra brand.

Before joining Pfizer, Ms Sewards led insights, brand strategy and advertising at Merrill Lynch Global Wealth Management. Her other diverse experience ranges from tech start-up to brand advertising and management consulting.  Ms Sewards received her bachelor’s degree from Smith College, where she also served as a member of the Board of Trustees.

Elmutaz Shaikho is a registered pharmacist, 9x certified AWS technologist, and bioinformatics scientist, holding an MBA. With a deep interest in the intersection of data, technology, and pharmaceuticals, Dr Shaikho began his career as a pharmacist in 2002. Over the last 5 years, he has leveraged computational science, cloud technology, and ML/AI to not only enhance patient care but also drive innovation in the pharmaceutical industry. These efforts have aimed at reducing the gap in patient unmet needs and accelerating time to value through cutting-edge technologies. Recognizing that advances in science are crucial for understanding diseases and developing drugs, Dr Shaikho also champions data, technology, and ML/AI as the transformational forces of successful organization.

Dr Michael Sherman is executive vice president chief medical officer of Point32Health, providing clinical medical leadership to enhance quality of care and outcomes for health care consumers. He is responsible for clinical innovation, quality and accreditation, medical policy, and the Harvard Pilgrim Health Care Institute, which includes the Department of Population Medicine at Harvard Medical School. Dr Sherman was previously chief medical officer and senior vice president for health services at Harvard Pilgrim Health Care, which he joined in 2011 and which merged with Tufts Health Plan in 2021. A pioneer in developing innovative, outcomes-based reimbursement models that engage providers and pharmaceutical and diagnostics companies, he is credited with cementing Harvard Pilgrim’s position as a leader among insurers in crafting agreements that tie drug payments to performance.

Dr Sherman is responsible for overseeing the Harvard Pilgrim Health Care Institute, which encompasses the Department of Population Medicine at Harvard Medical School—the nation’s only appointing medical school department based in a health plan. He is also a faculty member of the department and previously practiced as a cardiac anesthesiologist. He holds board appointments with several nonprofits, including the Institute for Clinical and Economic Review, the Personalized Medicine Coalition, the Harvard Business School Healthcare Initiative, the Network for Excellence in Health Innovation and serves on the Rare Disease Advisory Council for the Commonwealth of Massachusetts.

His previous roles include corporate medical director for physician strategies at Humana, vice president for network and consumer solutions at UnitedHealth Group’s subsidiary Ingenix (now part of Optum), and chief business development officer for United’s Medicare Part D business.  He holds an MD from Yale University, an MBA from Harvard Business School, and master’s and bachelor’s degrees from the University of Pennsylvania.

As a Senior Consultant at ZS, Tricia Siddharth is a dynamic contributor to the Research and Development Excellence team. Ms Siddharth’s expertise spans real-world data generation, clinical trial operations, and a comprehensive understanding of the spectrum from early clinical development to early commercialization. With a strategic focus on leveraging real-world data, Ms Siddharth employs AI/ML to develop predictive and modeling tools that enhance the efficiency of clinical development processes. This approach not only drives optimal clinical trial outcomes but also enriches the understanding of the value that commercialized drugs offer patients in both oncology and non-oncology indications.

Maureen Silverman is the Director of Monitoring Strategy and Oversight at Regeneron. Maureen and her team are responsible for providing monitoring strategy support for Regeneron-led studies that includes implementation of Risk Based Monitoring and oversee execution of Regeneron’s Oversight Monitoring program.

Maureen has been in the industry for 20+ years and worked for various pharmaceutical companies in Clinical Operations roles, overseeing study management and operational execution of early to late phase programs in CNS, Cardiovascular, Infectious disease and Immuno-oncology therapeutic indications.

Grail Sipes, JD serves as Assistant Director for Biomedical Regulatory Policy at the White House Office of Science and Technology Policy (OSTP), where her portfolio includes clinical trial infrastructure, related preparedness issues, and other matters related to the development and marketing of medical products.  For ten years prior to her work at OSTP, Ms Sipes worked in a variety of roles at the FDA, most recently serving as Deputy Director for Regulatory Policy in FDA’s Center for Drug Evaluation and Research (CDER). Prior to that, she was a lawyer in private practice and a partner at Covington & Burling LLP. At FDA, Ms Sipes worked on a wide range of matters involving drugs and other FDA-regulated products, including reproductive health, drug pricing and access, drug shortages, digital health, and First Amendment challenges to regulation. At FDA and at OSTP, Ms Sipes role has been to develop effective public health strategies and policies in light of evolving science, differing stakeholder viewpoints, and various regulatory challenges.

Nick Slack has spent his entire career in leadership positions at organizations that bring meaningful innovation and transformation to the clinical trials industry. In his current role at Warburg Pincus, Mr Slack sits at the cross-section of the investment community, operating companies, and biopharmaceutical companies to align interests around new approaches to solve persistent challenges in healthcare. Mr Slack was most recently President of WCG Clinical, a leading provider of solutions that measurably improve the quality and efficiency of clinical research. During his 10-years at WCG, the Company supported 90% of the new therapies approved by the FDA, acquired 31 companies to streamline the process of clinical research, and transformed the process of IRB oversight of clinical trials. Prior to joining WCG, Mr Slack was an expert advisor to biopharmaceutical companies, research institutions, and contract research organizations – serving in roles as a management consultant, an accreditor of research programs (AAHRPP), and an operational leader at Schulman Associates IRB (Advarra).

Sarah Small is interested in exploring opportunities that promote Patient Focused Drug Development. Ms Small is passionate about deploying patient centric solutions to advance drug discovery to bring new medicines to patients. She has experience in the Biotech and Pharmaceutical Industry with a breadth of knowledge in measuring what is clinically meaningful to patients, deploying digital health solutions, and ensuring through the use of patient centric solutions we can reduce the burden of clinical trials while improving quality of data. As an Associate Director of Patient Centricity at Moderna, her goal is to develop benchmarks through data visualization to identify metrics across the entire Moderna Portfolio globally while deploying patient centric solutions (DCTs) to better support engagement in Moderna’s clinical trials. She also serves the Clinical Development Transformation Enabler (CDO-TE) Lead for the Patient and Site experience team. The CDO-TE is an emerging leader’s peer led change management group responsible for implementing innovative work streams across the organization through advocacy, training, and coaching. Ms Small is the External Engagements Lead for Women in Science Driving Moderna (WISDM) ERG and has previously served as the Chapter Co-Lead for Biogen’s Women’s Innovation Network.

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 in accessing and engaging communities of color so they can make informed decisions about clinical trial participation. 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.

Jennifer Sozio has 25 years of Clinical Operations experience, the past 15 of which have been at Syneos Health. Ms Sozio started her career as a Clinical Research Associate (CRA) moving into Project Management leading global project delivery teams where she honed her project and people management skills. Prior to assuming her current role, she led the North America Clinical Monitoring Lead organization. She has been leading the North America FSP 360 Clinical Operations team at Syneos Health since October of 2019 responsible for the teams that support customers across a wide range of models and therapeutic areas. Ms Sozio serves as one of the Syneos Health Asian ERG executive sponsors, an advocate and ally for Syneos Health Employee Resource Groups and the McKinsey leadership programs with her team celebrating 7 graduates over 2020-2022 and 12 team members enrolled in 2023 cohorts. Ms Sozio is a 2023 HBA Luminary and holds a Biology degree from the University of Pittsburgh as well as a Masters Degree in Anthropology.

Ms Sozio is passionate about building cohesive and collaborative teams that are empowered to deliver project work for customers ultimately accelerating the ability to bring medicines to patients.

Bryan Spielman is Chief Growth Officer at Advarra and is responsible for driving Advarra’s corporate strategy, mergers and acquisitions, strategic partnerships, and corporate marketing. Mr Spielman brings over 25 years of business development and corporate strategy experience from leading technology companies including those with a focus on life sciences.

Prior to Advarra, Mr Spielman served as SVP of Corporate Development and Strategy for Internet Brands’ Health Division, which includes WebMD and Henry Schein One. Mr Spielman also previously served as executive vice president of strategy and corporate development at Medidata, where he was responsible for defining and evolving the company’s corporate strategy and building impactful relationships with customers, partners, and key industry stakeholders. Mr Spielman also helped catalyze important new areas of growth, including Medidata’s focus on deep data and analytics. Earlier in his career, Mr Spielman held leadership roles in investment banking at Centerview Partners, UBS Investment Bank, and Bear Stearns. 

Mr Spielman is a member of Datavant’s Advisory Board, the Board of the Galien Foundation, and the Partnership Fund for NYC’s Healthcare Advisory Board. Mr Spielman also actively mentors technology start-ups through NYU’s Entrepreneurial Center. 

Mr Spielman holds an MBA from New York University Stern School of Business and a BA from the University of Pennsylvania.

Summer Starling, DrPH, MPH, manages the development and implementation of CTTI projects. Along with her colleagues, she is accelerating progress towards the Transforming Trials 2030 Vision.

Dr Starling has more than 15 years’ experience in public health. She joins CTTI from within the Duke University School of Medicine, where she led mixed methods research studies with clinical investigators at Duke to understand and improve patient experiences in clinical research. Earlier in her career, she was a senior scientist and a Ford Foundation Doctoral Fellow with the Public Health Institute in Oakland, CA, conducting research on adolescent health and decision-making. She has also worked as a consultant for Johnson & Johnson and other healthcare companies, where she led client-centered research programs and organizational change campaigns. 

Dr Starling received a Doctor of Public Health (DrPH) from the University of California, Berkeley, and a Masters in Public Health (MPH) in sociomedical sciences from Columbia University.

Alan Switzer joined Fortrea in 2013 and holds the role of Director, IT Client Delivery.  In this capacity Mr Switzer leads the modernization of clinical trial systems through the delivery of the Fortrea Xcellerate Risk Based Quality Management suite of products that leverages statistical analytics to improve access to clinical data and enable faster and more accurate decision making throughout the trial. Prior to Fortrea he was the Global Director of Data Centers and Applications for ICON Clinical Research where he led the delivery of a virtual server architecture to increase reliability and scalability of the IT infrastructure. In his early career, he spent several years with Unisys as a Solutions Architect where he served clients in the Pharmaceutical, Energy and Telecommunications industries to define and implement IT strategies with a focus on process and controls. Mr Switzer earned his undergraduate degree in Electrical Engineering from Boston University, and his MBA from The Wharton School.

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.

Katherine (Kathy) Taylor is Head of Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role she leads the implementation, delivery, and all aspects of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) continuous improvement initiative to further the organization’s risk-based quality management (RBQM) through advanced analytics.

As the head of REAIM, Ms Taylor champions cross-functional engagement and alignment on the AIM strategy and execution of AIM activities in clinical trials. This includes development of central monitoring plans (CMPs) and clinical data specifications aligned with critical data, process, and risk assessments. She ensures execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics to support identification of important study issues that require monitoring, management, and adaptation of study plans.

Ms Taylor has 25 years of experience managing the quality of clinical trial conduct and execution, strategic implementation of quality-by-design principles, building high-performing teams, database management expertise and leading all aspects of GCP health authority inspections. She is a sought-out industry speaker for optimizing inspection readiness and the exacting risk-based quality management methodologies.

Ms Taylor is committed to creating a more diverse and inclusive work environment. She is a member of the inaugural GCTO Diversity & Inclusion Council as well as Merck’s League of Employees of African Descent (LEAD), serving on the Group Mentoring Project Team

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 thirteen years of experience in clinical development, technology planning & business-technology alignment. He is responsible for eCOA operations, wearables, and sensors,  piloting new technology initiatives and digital partner for patient engagement in his current role. Before this position, he had worked at Deloitte, Cognizant & GlaxoSmithKline at various levels.

Bernadette Tosti is the Chief Product Officer at ProofPilot. Ms Tosti was previously Vice President, Patient Experience at Science 37 where she led all patient access and engagement activities including feasibility, provider network, and patient outreach. Prior to her role at Science 37, Ms Tosti was the Executive Director of Clinical Trials at Quest Diagnostics, where she built patient and provider outreach and data and technology solutions to support the life sciences industry. Earlier in her career, Ms Tosti held a variety of clinical development technology, patient engagement and sales positions with increasing responsibility at IQVIA, inVentiv, and Veritas Medicine. She holds a bachelor’s degree in English from Boston College.

Mark Travers joined GCTO 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, Mark 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.

Edward Triebell is the Executive Director, Product Development of Digital Health, at MRN and is responsible for the launch of new products and services in the digital health and data centric operating environment of clinical trials. His career has focused on the forefront of disruptive innovations in the telecommunications, semiconductor, SaaS/PaaS software platforms, mobile/cellular data networks and the healthcare industry for over 30 years. His career started in designing engineering and then migrated into significant roles in project engineering, program management, global sales, product marketing, and strategic business development for enterprises focused on digital technology innovation. Within the healthcare industry, Mr Triebell has been involved with strategic programs that included the creation of a private satellite-based telemedicine platform for the Mayo Clinic network of hospitals to accomplish remote diagnosis and surgical treatments with high resolution imaging/videos, RFID solutions for patient tracking within Emergency Departments as well as audited tracking of patient biological samples, outsourcing radiological contouring services for cancer treatments using a joint-venture with a leading cancer hospital in China, and pivoting an Internet of Things (IoT) software platform into a leading ePRO (electronic Patient-Reported Outcomes) platform. Mr Triebell’s educational background includes a Bachelor of Science degree and Master’s degree coursework in Electrical Engineering, graduate coursework for his Master’s degree in Business Administration and completion of an Executive Management program at the Aresty Institute of Executive Education at the Wharton School, University of Pennsylvania.

Micky Tripathi is the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services, where he leads the formulation of the federal health IT strategy and coordinates federal health IT policies, standards, programs, and investments. Dr Tripathi has over 20 years of experience across the health IT landscape. He most recently served as Chief Alliance Officer for Arcadia, a healthcare data and software company focused on population health management and value-based care, the project manager of the Argonaut Project, an industry collaboration to accelerate the adoption of FHIR, and a board member of HL7, the Sequoia Project, the CommonWell Health Alliance, and the CARIN Alliance.

Dr Tripathi served as the President and Chief Executive Officer of the Massachusetts eHealth Collaborative (MAeHC), a non-profit health IT advisory and clinical data analytics company. He was also the founding President and CEO of the Indiana Health Information Exchange, a statewide HIE partnered with the Regenstrief Institute, an Executive Advisor to investment firm LRVHealth, and a Fellow at the Berkman-Klein Center for Internet and Society at Harvard University.

Dr Tripati holds a PhD in political science from the Massachusetts Institute of Technology, a Masters of Public Policy from Harvard University, and an AB in political science from Vassar College. Prior to receiving his PhD, he was a Presidential Management Fellow and a senior operations research analyst in the Office of the Secretary of Defense in Washington, DC, for which he received the Secretary of Defense Meritorious Civilian Service Medal.

Dr Chirag Trivedi is currently the Global Head, Clinical Study Units (CSU) Early Operational Strategy at Sanofi. Previously, Dr Trivedi was the Director and Head of the Clinical Study Unit India and SouthEast Asia Cluster at Sanofi, overseeing clinical studies in India, Singapore, Malaysia, Thailand, Indonesia, Philippines, Bangladesh, Sri Lanka and Vietnam. He has been with Sanofi since 2006 and has handled various roles and responsibilities over the years.  Prior to Sanofi, Dr Trivedi worked in a CRO and prior to that, in a Central Lab.

From April 2017 to March 2021, Dr Trivedi was the President of Indian Society for Clinical Research (ISCR) for a total of two terms. As a Society, ISCR brings together all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.

Dr Trivedi is experienced in the fields of Clinical Research, Clinical Quality Assurance, Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development and holds a PhD in Pharmacology.

Donna Usiskin is Chief Strategy Officer at New Enterprise Ventures, serving start-ups to Fortune 500 companies. Her proven 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, Marketing, and Business Development. Plus, over ten years of Venture Capital experience in the HCIT and Pharma IT market. 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 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, Marketing, and Strategy and led initiatives to raise funds or identify potential acquisition targets for early and growth stage IT companies serving the healthcare market. Most recently, serving as VP of Corporate Development at MMIT (Norstella).

Ms Usiskin 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.

Ms Usiskin holds a BA in psychology from Rutgers University.

Taylor Uttley is the Head of Strategy and Operations for the corporate data science team at Vertex Pharmaceuticals, where she has worked for almost 14 years. Ms Uttley 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, Ms Uttley 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. Ms Uttley also leads the industry’s only MBA AI program across Vertex which is focused on grooming next generation AI savvy leaders across business units.

Eddie Valaitis is Director, Pharma and Life Sciences, R&D Analytics & AI at PwC. In his role, Dr Valaitis has developed and leads a large team of data scientists and management consultants who design and implement transformational programs for embedding cloud-based analytics, AI and automation into business processes to accelerate drug development at leading pharma companies. The solutions developed by Dr Valaitis’ team have allowed pharma companies to drive business strategy, maximize the value and utilization of data and analytics assets, increase satisfaction of workforce via intuitive user experiences, and lower costs and improve quality of outputs via automation.Dr Valaitis has a PhD in Mathematical Statistics from Yale University and has over 15 years experience in the Pharma & Life Sciences industry.

Steve Walker has spent more than 25 years helping to operationalize clinical trials at mid-sized and large sponsor companies.  He continues to focus on ways to make the planning, setup, execution and participation in clinical trials less of a burden for participants, sites and researchers.

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.

John Wilbanks is the Former Head of Data at Biogen Digital Health, leading a team that builds products and services making clinical study data findable, accessible, interoperable, and reusable inside the company. Mr Wilbanks was formerly chief commons officer at Sage Bionetworks, where he led efforts in data governance for cloud science and informed consent for phone and wearable driven clinical research. He also serves as a Senior Fellow at the Milken Institute’s FasterCures program.

Previously, Mr Wilbanks worked as a legislative aide to Congressman Fortney “Pete” Stark, served as the first assistant director at the Berkman Center for Internet & Society, founded and led to acquisition the bioinformatics company Incellico, Inc., and was vice president of science at Creative Commons. He also served as a senior fellow at the Ewing Marion Kauffman Foundation, on the National Advisory Board for PubMed Central at the National Institutes of Health, and as a senior advisor for big data to the National Coordination Office at the National Science Foundation. In February 2013, in response to a We the People petition that was co-led by Wilbanks and signed by 65,000 people, the U.S. government announced a plan to open up taxpayer-funded research data and make it available for free. Wilbanks graduated with a BA in philosophy from Tulane University.

Shae Wilkins is a clinical software entrepreneur with a track record of building and growing successful technology companies in the eClinical market. As CEO, Mr Wilkins 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.

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.

With an extensive background in Clinical Trials and Research, Thad Wolfram joined EmVenio Research as part of an acquisition of Matrix Clinical Trials from Matrix Medical Network. As President, he is focused on the growth of decentralized trial capabilities and increased clinical trial diversity inclusion, improving the health and lives of patients. Before joining EmVenio, he was Executive Director, Corporate Strategy and Development at PPD, leading several initiatives focused on disruption and the future of clinical trials. Mr Wolfram also held various senior leadership positions in consulting centered on science and research at EY and PA Consulting Group. He earned his MBA at Rensselaer Polytechnic Institute – The Lally School of Management in Innovation and Strategic Management, an MS at Michigan State University in Industrial Microbiology / Medical Microbiology, and a degree in Microbiology and Molecular Genetics from Michigan State University.

Anna Yang, PharmD, is a Clinical Innovation and Technology Leader at Genentech’s US Medical Affairs Innovation Hub. In this role, Ms Yang collaborates with study teams to spearhead decentralized clinical trial (DCT) initiatives and drives innovation across the company’s portfolio. She contributes to the Decentralized Trials and Research Alliance, specifically focusing on DCT Key Performance Indicators/Metrics. She holds a PharmD degree from Rutgers Ernest Mario School of Pharmacy and has completed a postdoctoral fellowship within Genentech’s BioOncology Medical Science Liaisons team.

Nicole Zahradka, PhD, is the Senior Clinical Research Program Manager at Current Health, now part of Best Buy Health. Dr Zahradka designs and implements studies to measure the clinical, financial and operational impact of virtual care. She received her PhD in Biomechanics and Movement Science from the University of Delaware and has a background in Mechanical Engineering. Her previous research at Johns Hopkins University focused on wearables, data science, and clinical care. Dr Zahradka has expertise in leading clinical research studies that utilize digital technology to remotely monitor patients and deliver interventions across the care continuum.