2025 Speakers

Murray Abramson, MD, MPH is a visionary and entrepreneurial professional with extensive experience in clinical operations and drug development. He earned his B.S. in Chemistry with honors and his M.D. from Duke University, followed by a clinical fellowship in infectious disease and a role as Chief Resident in the Department of Medicine at Duke University Medical Center.

Dr. Abramson spent 13 years at Merck, where he held various clinical, operational, and leadership positions, and later joined Biogen as VP of Global Clinical Operations, overseeing strategic planning and execution of clinical trials across all phases and indications. Subsequently, he was SVP, head of clinical innovation at Tempus AI. Murray is currently SVP, head of Clinical Development and Medical Affairs at Precision Biosciences. He also co-hosted a bi-weekly webcast for ALS patients and care providers for Everything ALS.

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

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

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

Andrei Antonescu is the Head of Product at Strategikon, where he leads the development of Clinical Maestro VISION and CORE. With a background in computer science and deep expertise in product management and UX design, Andrei plays a central role in delivering innovative solutions that simplify and optimize clinical business operations. His work focuses on streamlining R&D processes and enhancing financial and operational efficiency for biopharmaceutical sponsors.

Andrei is passionate about customer-led product development, consistently engaging with clinical research professionals to understand their challenges and evolving needs. His strategy-driven approach has helped transform Clinical Maestro into a powerful, intuitive platform that delights users and drives business impact. Through continuous innovation, Andrei ensures that Strategikon remains at the forefront of an industry shaped by complexity and change.

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

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

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

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

Marta Arias-Salgado was appointed Vice President and Global Head of Global Clinical Trial Operations (GCTO) Regions and Regional Operations (RRO) in April 2025. She manages the GCTO RRO leadership team in managing clinical operations, including trial execution and support functions.

Marta began her career at Merck in 1998 and has held various leadership roles, focusing on quality improvement, regulatory inspections, and clinical supply chain management.

Marta received a Bachelor of Science degree in biochemistry and molecular biology from UAM University in Madrid, Spain. She also holds a Master of Science degree in Research & Development from Navarra University.

Andrea Bastek, Ph.D., is VP of Innovation at Florence Healthcare. Her team's mission is to identify the biggest challenges in clinical trial operations and harness technology to solve them. Prior to Florence, Andrea spent 15 years working in clinical trial operations in the cardiac medical device industry. She holds a Ph.D. in Bioengineering from Georgia Tech as well as a BS and MS in Biomedical Engineering from Tulane University.

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

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

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

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Walter is a seasoned Analytics and Data Science professional dedicated to advancing the evolving needs of the modern health industry. With a diverse background spanning multiple domains within healthcare, he brings a deep understanding of how data-driven insights can transform patient outcomes, streamline operations, and drive innovation. Passionate about the life-changing potential of analytics, Walter continues to champion the use of data to create meaningful impact across the health sector.

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

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

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

With over 30 years of international leadership and accountability in the biopharmaceutical industry, Elspeth Carnan is an accomplished global executive, specialized in clinical development, implementing strategy and operational execution of a portfolio of pre-clinical and clinical stage programs, across a variety of therapeutic areas, including, oncology, immunology, and rare disease. In her roles at Alkermes and Regeneron, as SVP and VP of clinical operations, Carnan was accountable for driving global clinical trials, improving efficiency and consistency of performance as well as implementing an improved delivery of risk based strategic monitoring. At Merck KgA/ EMD Serono, Carnan drove the R&D Strategic Sourcing & Vendor management function being accountable for global outsourcing strategy for clinical development, developing and negotiating strategic alliance partnerships, critical issue management and executive governance. While at Amgen (2005 to 2015), Carnan was instrumental in shaping the Amgen clinical monitoring platform; first successfully driving the global implementation of the Functional Service Provider, with 12 providers and across 56 countries. With her wealth of clinical operations experience, she was instrumental in the design and support of the centralized monitoring initiative. During her Amgen tenure, she made a significant impact in shaping Amgen’s approach to innovation. Through her commitment to driving Operational Efficiency and supporting the scoping of the Streamline Clinical Trials initiative, Carnan ensured a focus on transforming the approach to clinical trial execution, most notably in study design and study start up. Her dedication to the establishment of the R&D Global Network framework to enhance end to end process development added value to Amgen’s approach to knowledge sharing. Carnan holds a PhD in Physiology from University Newcastle Medical School and a Bachelor of Science (Physiology) from University of Glasgow. 

Carnan lives in Lexington MA, an ‘empty nester’ as her twins attend the University of Toronto. 

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.

David Carruthers joined AstraZeneca in 2024 and is the Vice President of BioPharmaceuticals and Global Head of Clinical Operations. David leads global operations related to the conduct and delivery of AstraZeneca Biopharmaceuticals Clinical Trials. David is also responsible for data management and insights across the AstraZeneca Clinical Trials portfolio. With a career in the biopharmaceutical industry, David brings a wealth of experience and expertise to his role, leading a global team dedicated to advancing clinical operations and delivering innovative treatments to patients worldwide.

David's leadership is characterized by his commitment to excellence in clinical trial execution and patient-centric approaches. His strategic vision and collaborative mindset drive the development of integrated clinical operations teams that work across disciplines to achieve holistic and impactful outcomes.

Throughout his career, David has been devoted to reimagining clinical trial execution and engaging with clinicians and patients to design and deliver inclusive clinical trials. This commitment to inclusivity and innovation is reflected in AstraZeneca's increasingly complex portfolio of trials, which aim to improve patient outcomes through novel disease endpoints and enable greater engagement with healthcare professionals.

David's commitment to patient care is deeply influenced by his research background, which consistently puts patients first in his work. From study enrollment to post-trial access, he is driven to make it easier and faster for patients to access treatments and improve the clinical trial experience. His dedication to clinical excellence and patient care is a hallmark of his leadership at AstraZeneca.

In addition to his role at AstraZeneca, David has held executive positions at leading biopharmaceutical companies including AbbVie and Allergan, where he has contributed to the advancement of clinical operations and drug development. His extensive experience and strong links to academia and industry make him a respected collaborator in the field.

David is proud to lead an exceptional global team at AstraZeneca, working together to push the boundaries of science and transform care for patients. His steadfast commitment to patients and clinical excellence continues to drive the development of new medicines and innovative approaches to clinical trials.

Seasoned pharmaceutical professional with 20+ years of experience specializing in healthcare data integration, clinical analytics, and competitive intelligence. Leverages deep pharmaceutical knowledge and advanced analytics capabilities to transform complex data into actionable business insights

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.

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Grégoire Cosendai is a seasoned leader with over 30 years of expertise in the medical devices industry, specializing in neuro, ophthalmology, endocrinology, audiology, and digital health. With a strong background spanning from innovative R&D, clinical validation, regulatory approvals, to market access and commercialization, he has successfully led cross-functional teams from start-up environments to large publicly traded companies.

Currently serving as Category Lead at Ypsomed, Grégoire is passionate about developing life-changing medical technologies. His previous roles include Device Operations Manager at Verily (Google Life Sciences), Vice President Clinical at Second Sight Medical Products, and Director of Business Development at the Alfred Mann Foundation.

Having worked in USA, UK and Switzerland he brings a global perspective to his leadership. Grégoire’s innovative mindset, strategic vision, and dedication to advancing medical solutions make him a valued speaker and expert in medical device development and commercialization.

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

Alex brings over 17 years of experience in the pharmaceutical industry, specializing in clinical technology at tech vendors, CROs, and pharmaceutical companies. His experience spans clinical and operational data, with deep experience in IRT, EDC, eCOA, eTMF, CTMS, SSU and a range of data and analytics platforms. At Jazz, he is responsible for overseeing the Clinical Data Factory and integration strategy as well as other AI and technology initiatives for the Global Clinical Development Operations team. He is focused on pulling in large amounts of data from different sources into an accurate and easily digestible format, collaborating with the Data Management, Clinical Operations, and RBQM teams at Jazz to align with business priorities. Alex is passionate about streamlining data movement and leveraging technology to simplify and accelerate processes across the clinical trial ecosystem.

Michelle Crouthamel, PhD, head of digital science at AbbVie, is an industry thought leader in digital health, with a broad spectrum of R&D experience. She currently leads the digital health strategy as well as develops digital biomarkers and endpoints. In her previous roles, she has led drug discovery, clinical development, project management, and digital-pharma strategy and execution. She is very passionate about transforming the pharmaceutical industry to become truly patient-centric.

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.

Ashley is the Vice President, Product Lead at Advarra. In this role, Ashley collaborates with current partners and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Ashley has over 20 years of expertise in site activation, clinical operations, data management, and clinical strategy.

Melika Davis is SVP and Global Head of Clinical Operations at BeOne Medicines. She is an accomplished and highly experienced drug development professional leading a team of ~1,700 associates around the world who are responsible for the planning and execution of all clinical trial activities at BeOne, including trial and country/site management, compliance, global clinical supply chain, and implementation of innovative technologies. With a robust background of over 30 years in clinical research and quality assurance, Melika has been instrumental in designing and building successful global organizations. She has leveraged her operations expertise to instill efficiency, reduce costs, build a culture of quality, set standards, and satisfy both external/internal customers' needs.

Melika and her teams have brought 30+ products to the worldwide market over the past 15 years, mainly in oncology, vaccines, and anti-infectives. She has managed a portfolio of ~1,500 clinical trials a year. Prior to joining BeOne, Melika held numerous positions at Novartis and Schering-Plough Research Institute, with increasing responsibilities across the R&D organizations in oncology, transplant, anti-infective, respiratory, and vaccine development. Melika has also been active in various clinical development professional associations, holding leadership roles in multiple committees and initiatives. She holds a master’s degree in molecular biology from Texas Woman’s University in Dallas, Texas, and a Licence de Physiologie from the University of Sciences in Nice, France.

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

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

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

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

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

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

Carissa Dukes has a decade of experience in the industry, specializing in epidemiology and real-world evidence. Her expertise in mental health has led her to work on numerous projects aimed at improving the quality of life for individuals with mental health conditions. Through her observational studies, she has provided valuable insights that are shaping the development of innovative and effective treatments. She has led various initiatives to integrate real-world data into clinical research. Her research helps bridge the gap between clinical trials and real-world practice, accelerating clinical adoption. Carissa has played a pivotal role in the implementation of tokenization within her company. She leads a cross-functional working group and panel of experts, providing consultation on tokenization and developing detailed guidance documents that will be critical in standardizing successful implementation throughout the organization. Carissa earned a Master of Public Health in Epidemiology from Indiana University and is currently pursuing her Doctor of Public Health (DrPH) at Johns Hopkins University, where she is focusing on a specialized public health program designed to enhance her expertise in health systems, implementation science, and clinical trials.

Esther Dyson is finishing a decade of work on Wellville, the 10-year, five-community project she founded and funded in 2013. It operates in five small US communities (Clatsop County OR, Muskegon County MI, Lake County CA, North Hartford CT, Spartanburg SC), with advisors who help community members build their own sustainable organizations and weave their own social fabric. She is now getting ready to write her second book, “Don’t rent your (community’s) health from an absentee landlord.” Her first, “Release 2.0: A design for living in the digital age,” was an international best-seller in 1997. With a background in journalism, finance, tech, health (vs. healthcare), Russia, policy and space travel, Dyson’s mission is to help people see what they thought they already knew. Her current focus is to get the public to understand the importance of investing in the United States’ most important asset: its next generation. The best way to reduce healthcare costs, she argues, is to keep people healthy… Her most recent essay was published by The Information at https://www.theinformation.com/articles/dont-fuss-about-training-ais-train-our-kids. ​D​yson is currently on the boards of Avanlee​ Care, Charity Navigator, PressReader, ProofPilot and The Commons Project. ​D​yson holds ​a​ BA in Economics ​from Harvard University and a certificate of completion from the Yuri Gagarin Cosmonaut Training Institute​.

Laura J Esserman, MD, MBA, is Professor of Surgery and Radiology at UCSF, where she is also Director of the multi-disciplinary UCSF Carol Franc Buck Breast Care Center. She is Co-Leader of the Breast Oncology Program for the Comprehensive Cancer Center.

Dr Esserman’s breast cancer work spans a spectrum from basic science to public policy issues and the impact of both on the delivery of clinical care. She has published more than 300 articles in peer-reviewed journals. She led efforts to address harms of screening including over-diagnosis, and proposed tools including the development of molecular diagnostics to help reclassify tumors as IDLE or ultra-low risk.

She leads the I-SPY TRIALS, a ground-breaking national public-private collaboration among 20 cancer research centers, pharma and biotech companies, FDA, and NCI, designed to reduce the time and cost for drug development, find the right drug for the right patient earlier in the disease course when cure is possible.

In addition, Dr Esserman led the creation of the University of California-wide, and now national Athena Breast Health Network, a learning system designed to integrate clinical care and research and follow 150,000 women from screening through treatment and outcomes. This spawned the PCORI funded WISDOM study to determine if personalized screening has higher health care value than the standard of annual screening.

Dr Esserman was included as one of TIME Magazine’s 100 Most Influential People of 2016, was the recipient of the 2016 Stanford Business School Ernest C Arbuckle Award and the 2016 Personalized Medicine World Conference Luminary Award.

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Patrick is Executive Director, Head of Global Clinical Trial Services at Regeneron where he oversees global site management, central monitoring, study feasibility and site selection, as well as study/site start up, eCOA and patient technology initiatives. He joined Regeneron a little over 5 years ago. 

Patrick worked at Pfizer for 25 years before joining Regeneron, mostly in clinical program operations. He also held roles in GCP Quality (level 1) and Analytics. Patrick has extensive international drug development experience, as he helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. He later served as the Head of Japan Development Operations and Development Japan Portfolio &Project Management Groups for 10 years in Pfizer’s Development Japan organization.

Kenneth C. Frazier is the former Chairman and CEO of Merck, following his retirement from more than 30 years with the company, including a decade-long tenure as CEO. Currently, he is chairman of Health Assurance initiatives at the venture capital firm General Catalyst where he advises on investments and partnerships for companies that are well-positioned to help transform the healthcare industry through collaborative and responsible innovation.  

Upon his retirement from Merck, Ken has committed himself to organizations dedicated to leading social change and building greater equity for all people. He is the co-founder and co-chair of OneTen, a coalition of leading organizations committed to upskilling, hiring, and promoting people without four-year degrees into family-sustaining jobs with an emphasis on Black Americans.

Ken’s contributions, especially in the legal, business, and humanitarian fields, have been widely recognized. Under his leadership, Merck delivered innovative life-saving medicines and vaccines as well as long-term and sustainable value to its multiple stakeholders. Ken substantially increased Merck’s investment in research, including early research, while refocusing the organization on the launch and growth of key products that provide far-reaching benefits to society. He also led the formation of philanthropic and humanitarian initiatives that built on Merck’s 130-year legacy.

Ken joined Merck in 1992 and held positions of increasing responsibility, including General Counsel, before becoming President and CEO in 2011. Prior to joining Merck, Ken was a Partner with the Philadelphia law firm of Drinker Biddle & Reath.

Ken serves on the boards of Eikon Therapeutics, Paradigm, and Transcarent, as well as a number of non-profit boards, including Cornerstone Christian Academy in Philadelphia, PA, the Harvard Corporation, Memorial Sloan Kettering Cancer Center, and the National Constitution Center. He also is a member of the American Academy of Arts and Sciences, the American Bar Association, the American Philosophical Society, the College of Physicians of Philadelphia of which he is a Fellow, the Council of the American Law Institute, and the Legal Services Corporation’s Leaders Council, of which he is co-chair. Ken also serves on the ABA Task Force on American Democracy. 

As a strong advocate for social justice and economic inclusion, Ken is the recipient of numerous awards and honors, including the Anti-Defamation League Courage Against Hate Award, the Botwinick Prize in Business Ethics from Columbia Business School, the Legend in Leadership Award from the Yale School of Management, the NAACP Legal Defense and Educational Fund National Equal Justice Award, and the National Minority Quality Forum’s Lifetime Achievement Award. In 2018, Ken received the Harvard Law School Association Award, the highest honor given by the prestigious association, in recognition of his extraordinary service to the legal profession, Harvard Law School, and the public. In that same year, Ken was named one of the World’s Greatest Leaders by Fortune magazine and was also named one of TIME’s 100 Most Influential People; he again was celebrated by TIME on that list in 2021. In 2019, he became the first recipient of the Forbes Lifetime Achievement Award for Healthcare. In 2021, his peers named Ken Chief Executive magazine’s CEO of the Year. Most recently, he received the highly esteemed Fordham-Stein Prize from Fordham Law School, an honor bestowed for work embodying the highest standards of the legal profession, and the Lifetime Achievement Award from the American Lawyer magazine.

Ken received his bachelor’s degree from The Pennsylvania State University and holds a JD from Harvard Law School.

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.

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

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

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.

Tara Gipp leads the patient engagement team within Regeneron’s Global Trial Optimization team. She has a passion for ensuring patient and site burden is reviewed and assessed during clinical study development and is committed to reducing burden and barriers to participation. Patient focus in her career started when developing HIV treatments whilst employed at Pfizer and was further cemented when spending 10 years at Cancer Research UK. At Cancer Research UK, she led initiatives to incorporate patient views into trial design and garner direct on-study feedback to improve patient experience on clinical trials. Her current work includes having a detailed understanding of patient and caregiver needs early in study design, ensuring clinical trial participation is easily accessible to all trial participants, collecting near immediate feedback on-study from sites and participants as well as a priori feedback on study design. Ms Gipp has a Bachelor’s degree in Chemistry from Northwestern University.

Dr. Bernhard Glombitza is a distinguished leader in the healthcare industry, currently serving as Head of Clinical Customer Engagement and Operations for EMEA & LATAM at Bayer. His career journey began with project leadership roles, notably spearheading the global Xarelto project team, which contributed significantly to its market success. In Clinical Operations, he has managed organizations with over 1000 individuals across more than 40 countries, achieving a 25% increase in productivity through strategic organizational restructuring and innovative resource management. Dr. Glombitza is currently leading the implementation of the Dynamic Shared Ownership model (DSO), decentralizing decision-making and optimizing talent allocation to drive impactful results, all while fostering an environment of psychological safety and appreciation.

Rozanno Gonzales, M.S., is a clinical trial professional with over 17 years of experience, specializing in innovative technology and vendor oversight within the clinical trial landscape. He is dedicated to integrating and enhancing partnerships and collaborations to innovate purposefully with stakeholders. 

He holds an M.S. in Clinical Research Administration from Walden University (2013) and a B.S. in Biological Sciences from UC Irvine (2002). As Clinical Trial Innovation and Technology Leader at Genentech, Rozanno is at the forefront of industry trends, leading the development of evidence generation initiatives and acting as a trusted thought partner for innovative solutions. His role involves evaluating health technology systems and understanding the changing healthcare environment to enable broader clinical trial participation and bolster the real-world effectiveness of the Genentech portfolio. He actively promotes a culture of innovation and strategic risk-taking, working globally to streamline processes and share best practices. He also identifies and evaluates technology service providers to accelerate and innovate clinical trial execution.

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Scott Gottlieb, MD, is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr Gottlieb is currently a senior fellow at the American Enterprise Institute for Public Policy Research and a partner at the venture capital firm New Enterprise Associates. Under his leadership, the FDA advanced new frameworks for the modern oversight of gene therapies, cell-based medicines, and digital health devices. The agency implemented new reforms to standardize drug reviews and made historic improvements in post-market data collection and the use of real-world evidence. He promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises. The agency’s prolific advances in new policy distinguished his tenure as FDA Commissioner, along with a record-setting number of approvals for novel drugs, medical devices, and generic medicines. Previously, Dr Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and, before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services. He is the author of the New York Times bestselling book “Uncontrolled Spread: Why Covid-19 Crushed Us and How We Can Defeat the Next Pandemic” and is a regular contributor to CNBC and CBS News’ Face the Nation. Dr Gottlieb serves on the board of directors of publicly traded companies Pfizer, Inc., Illumina, Inc., and TempusAI. Dr Gottlieb is an elected member of the National Academy of Medicine and completed medical school and a residency in internal medicine at the Mount Sinai School of Medicine, where he currently serves on the executive committee of the Mount Sinai Health System’s board of directors and co-chairs the board’s education committee. He graduated from Wesleyan University, where he majored in economics, and currently serves on the university’s board of directors. Dr Gottlieb lives in Connecticut with his wife and three daughters.

Victoria Gray was the 1st Sickle Cell Anemia patient in the world to be treated with CRISPR gene editing in 2019. After a lifetime of pain, treatments, and hospitalizations for Sickle Cell Disease, she is now symptom-free, working as a patient advocate and international speaker to spread the word about CRISPR and rare diseases to clinicians, scientists, patients, and students. Mrs Gray is a wife and mother of three children and lives in Forest, Mississippi.

Suvi is the CEO and Co-founder of Monroe Biomedical Research, a leading and rapidly growing clinical trial site network specializing in multi-therapeutic studies. With more than 15 years of experience in the clinical research industry, Suvi has overseen Monroe’s growth into a high-performing organization recognized for its quality-driven patient enrollment and operational excellence.

Under her leadership, Monroe Biomedical Research has earned distinction for its strong commitment to increasing diversity in clinical trial participation. The organization is dedicated to ensuring that research is both representative and inclusive, supporting the development of therapies that are effective across all populations. Suvi is deeply committed to expanding access to clinical trials and advancing a more equitable future in medical research.

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

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

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

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

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

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Martin Hodosi is a Partner at Kearney and drives the North America pharma R&D advisory services, bringing over a decade of consulting experience. He has collaborated with some of the world's largest companies to tackle their most significant challenges in clinical development, operating model, and post-market obligations. His work includes accelerating time-to-market for innovative treatments and improving the cost of bringing new treatments to market.

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

Yi Hong, PhD is a clinical data scientist with a strong foundation in AI-driven operational analytics, trial design and real-world data. Currently Associate Director at Gilead Sciences, he co-leads strategic initiatives to evaluate the impact of the Gilead Trial AI. His work includes developing operational metrics, leveraging real-world data for protocol design, and AI agentic solution to forecast and optimize trial enrollment. Previously, Yi was a Data Scientist at Verana Health, where he built scalable data quality infrastructure for EHR platform. His earlier leadership at Topchoice Medical in China included founding a Center of Operational Excellence, where he led cross-functional teams to implement AI/ML solutions for patient journey mapping, treatment optimization, and predictive modeling. Yi holds a PhD in Engineering from the University of Cambridge and has published in applied physics and nanoelectronics. His interdisciplinary expertise bridges clinical research, health tech innovation, and advanced analytics, making him a key contributor to the future of AI-enabled clinical trials.

Peyton Howell is Chief Executive Officer of Parexel and a member of the company’s Board of Directors. She has more than 30 years of pharma services and healthcare industry experience.

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

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

Peyton serves on the Board of Directors of Tandem Diabetes Care (NASDAQ: TNDM), a medical device manufacturer. She serves on the Board of Directors for the Association of Clinical Research Organizations (ACRO) and was its Chairperson in 2024. She holds a Master of Healthcare Administration from The Ohio State University and a Bachelor of Arts in Health Communications from the University of Illinois. In 2022, Peyton was recognized with PharmaVoice’s highest distinction as a Red Jacket honoree, which distinguishes an elite group of leaders viewed as the most inspiring in the life sciences industry.

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

Jeff Huntsman is the Chief Commercial Officer for PCM Trials and EmVenio Research, overseeing commercial strategy and revenue growth. Mr. Huntsman joined PCM Trials in 2024 with more than 30 years of experience in the Life Sciences space, where he has led global commercial teams selling pharma services solutions across the clinical development and regulatory lifecycle.

Prior to joining PCM Trials, Mr. Huntsman ran a consulting firm providing strategic advice to private equity, venture capital and emerging growth companies. Earlier in his career, he was the Chief Commercial Officer at Sitero, Citeline, ConnectiveRx, and LIQUENT. He has held executive leadership roles at Clarivate, Parexel, Thomson Reuters, and Rogers Communications as well as having served as a Health Care Advisor at Warburg Pincus and Growth Capital Partners.

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.

Youssef Idelcaid is the Head of the AI Research Center at Gilead Sciences, where he leads enterprise AI strategy and the deployment of transformative technologies across the drug development lifecycle. His career spans multiple industries—including biotech (Genentech), cosmetics (L’Oréal), fashion (Levi’s), and the food industry (Danone)—giving him a unique cross-sector perspective on the power of AI to drive innovation in complex, regulated environments. Youssef holds an engineering degree in applied mathematics and computing from École Polytechnique Universitaire de Lyon. He is passionate about designing systems that combine science, technology, and strategy to improve outcomes for patients and society.

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

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

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

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

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

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Timothy Joy is the Head, Clinical Operations Strategic Solutions at Pfizer. Mr Joy is responsible for leading a global team tasked to identify and develop creative, scalable, technical and process related solutions for unmet global clinical trial needs.

Mr Joy has been at Pfizer since 2001, when he joined Development Informatics. In Development Informatics he was responsible for implementation and support of Pfizer Electronic Data Capture systems. Since joining Global Product Development in 2006 Mr Joy has held multiple positions with increasing responsibility. He represented Pfizer on an Industry council to redesign and implement enhanced versions of Electronic Data Capture, implement clinical and operational data warehouse, and most recently developing Pfizer’s Decentralized Clinical Trial strategy.

Mr Joy has been involved in numerous innovative projects and initiatives to redesign Investigator Site Support, implementation and usage of novel Patient Technologies, and creation of Pfizer’s eSource strategy.

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.

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

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

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

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

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

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

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

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

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

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

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.

Sara Kohnke, PhD, is a Senior Data Scientist at Vertex Pharmaceuticals, where she uses data to support optimized execution of clinical trials. Before joining Vertex, Sara helped scale data science efforts at Boston-based biotech EQRx. Both in her work and personal life, she is passionate about leveraging data to make healthcare more accessible. Sara earned her PhD in Clinical Biochemistry from the University of Cambridge and holds an MS in Neuroscience from University College London.

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.

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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.

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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. 

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

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

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

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

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

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

Vivian Cheng Larsen is a seasoned leader with over 20 years of experience in healthcare, specializing in patient engagement and advancing scientific innovations through clinical trial diversity. As Associate Director at Exelixis, she leads strategies to enhance patient recruitment and retention, ensuring inclusive and equitable clinical research. Vivian has held senior roles at GSK and Takeda, where she championed patient centricity throughout R&D and built global initiatives to embed diverse patient voices into drug development.

A passionate advocate for underserved communities, she has been featured in national media for her work in advancing health equity and mobilizing action around cancer patient needs, including raising awareness for diverse participation in clinical trials and bone marrow donor registries.

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

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

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

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

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

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

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

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.

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

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Heather Manley brings over 12 years of experience in clinical research, specializing in phase II–IV sponsor trials, investigator-initiated studies, and CRO capacities. Her expertise spans site operations, monitoring, data management, and statistical analysis. She has worked extensively in therapeutic areas including migraine, chronic pain, metabolic disorders, cardiovascular disease, and rheumatic conditions.

Heather holds a Master of Science in Psychology with a graduate certificate in Statistics and Research Design. She joined Clinvest over a decade ago, initially supporting CRO activities for investigator-initiated trials. For the past 10+ years, she has served as Site Director, where she leads clinical trial operations, ensures adherence to high-quality standards, and collaborates closely with sponsors, CROs, and key stakeholders to drive trial success from initiation through closeout.

Since Clinvest became part of the Headlands Research network in 2023, Heather has continued to lead the site while contributing to broader network initiatives and strategic committees. Her deep operational knowledge and leadership experience position her as a valuable resource to both Clinvest Headlands and its research partners.

17 years of experience managing site operations across regulatory, source, finance, recruitment, and clinical workflows Oversees regulatory, eSource, eCRF data entry, contracts and budgets, as well as quality Masters in Pharmaceutical Sciences, Outcomes, and Policy Graduate certificate in Pharmaceutical Regulation Eagle Scout and enjoys sharing that experience with his twin sons

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Sarah McKeown-Cannon (she/her) is the Senior Vice President and Head of Clinical Research at Heartbeat, where she is flipping the script on traditional recruitment and retention. Heartbeat isn’t in the business of chasing referrals or measuring success by vanity metrics. Instead, Sarah leads the charge in fixing the “leaky funnel” once and for all—by shifting the focus to patient activation. At Heartbeat Clinical Research, Sarah and her team meet patients where they are, ensuring they aren’t just found but are ready, willing, and empowered to take action. This means moving beyond outdated recruitment tactics and instead designing sustained engagement strategies that transform passive candidates into active participants in their own health journey. Her commitment to health equity is evident in every initiative she leads—ensuring that underrepresented communities aren’t just included in research but are centered in it. As Co-Chair of the Reflections collective, she extends this work even further, driving industry-wide change for more inclusive, patient-first clinical trials. A MM&M 40 Under 40 honoree, Sarah bridges global healthcare intelligence with deep behavioral insights, ensuring every study doesn’t just recruit but activates. Through her bold vision and relentless leadership, she is shaping the future of clinical research—one where patients aren’t just participants but powerful advocates in their own care.

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

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

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

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

Life science healthcare executive with global experience in biotechnology and technology. Meldrum is currently CEO of AdhereTech, a HealthTech company focused on improving medication adherence in clinical trials and real-world settings. Previously, he served as CEO of Reset Pharma, developing psychedelics for mental health disorders, and as Chief Commercial Officer for Otsuka Pharmaceuticals North America, where he delivered revenue growth despite pandemic challenges.

His career includes commercial leadership at Orexo, where he developed the award-winning "Out The Monster" campaign, and 11 years at Novartis Pharma in the US and Switzerland. Before healthcare, Meldrum spent 10 years in technology, building on his Electrical and Electronic degree from Strathclyde University.

Meldrum brings extensive expertise in psychiatry, neuroscience, respiratory, dermatology, and digital health, with demonstrated success across organizations of all sizes. Outside work, he's a certified scotch professional and enthusiastic golfer.

Thérèse Menear is a seasoned and experienced leader within the drug development space, specifically within clinical trial operations and execution. She joined Exelixis in September 2022 and during her tenure has served as Vice President, Clinical Operations and most recently, she has assumed the role of Vice President, Operational Excellence. From November 2006 to September 2022, Thérèse was at GSK where she held many roles of increasing responsibility, to include Vice President, Global Pharma Clinical Delivery in which she led a global team of approximately 300 members across approximately 200 clinical trials. Prior to GSK, Thérèse was a member of the Project Management (PM) team at Covance, a contract research organization, where she eventually led the North American PM Team, a team of 75 seasoned PM professionals. She started her career at Clinical Research Group, an oncology site management organization and over her 5 years with CRG, she helped grow the company from a 4 to 50 person company while serving as a member of the executive leadership team; Thérèse credits this initial experience to the start of her 30+ year career helping to bring new medicines to patients in need. Thérèse holds a BA degree from University of Scranton in International Languages & Business. She resides in Havertown, PA, with her family.

Brian Mitchell holds both bachelor's and master’s degrees in Nutrition and Dietetics from California State University, Northridge. Beginning his career as a Nutrition Counselor, he transitioned into clinical research in 2010 as a Study Coordinator, later gaining experience in a large cardiology clinic. His passion for advancing clinical science led him to join IQVIA in 2015 as a Clinical Research Associate supporting Amgen trials.

Progressing rapidly, Brian moved into project management in 2018 and was hired directly by Amgen in 2019 as a Development Feasibility Manager. He was promoted to Sr. Manager in 2020, leading U.S. feasibility, study start-up, and contracts/budgets. In 2023, he became Director of Development Operations, overseeing U.S. clinical site operations, and in 2025, accepted a stretch assignment as Regional Head of the United States.

With a family rooted in medicine—his father a cardiologist and mother a nurse—Brian brings a uniquely patient- and site-centric perspective to drug development. His cross-functional experience enables him to apply operational insight with strategic leadership, maintaining a strong emphasis on quality and speed in clinical trial execution.

Outside of work, Brian remains engaged with the wellness community, staying current in nutrition, dietetics, and exercise science. Throughout his career, he has made meaningful contributions to Amgen’s pipeline and exemplifies a holistic approach to clinical development.

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Charlotte Moser, MD, PhD, MBA, is Chief Medical Officer for Parexel. In this role Dr. Moser leads the company’s Global Medical Services (GMS) team in providing medical and scientific leadership globally, building on Parexel’s regulatory and therapeutic expertise with a significant focus on innovative drug development strategies and clinical trial design.

Dr Moser is a (radiation) oncologist who has worked as a clinician and researcher for more than 25 years and across both drug (small molecule, biological and targeted agents) and medical device (diagnostics, biomarkers, software) development. Her experience includes serving as head of clinical development at biotechnology and life sciences companies, bringing her clinical expertise to the early development of targeted oncology diagnostics and therapeutics and working closely with global regulators to support the approval of new therapies. She brings a unique combination of strategic clinical development leadership as well as experience as a principal investigator.

Dr Moser most recently served as Senior Vice President, Clinical Development for Celcuity, a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications.

Dr Moser earned an MD from Vrije University Amsterdam. She completed oncology training and earned a PhD in Biostatistics at the University of Leiden in The Netherlands. Dr. Moser also earned an MBA from the MIT Sloan School of Management and a certificate in drug development (Oncology and Cancer Biology) from Harvard Medical School. She is a strong advocate for innovation, driving better safety and efficiency in cancer care and improvement of global access.

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

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

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

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

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

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As CEO, Carlos Orantes provides leadership and strategic direction for site network. With over 30 years of experience within the life sciences industry, his career has included executive leadership, operational management, LEAN Six Sigma process improvement, as well as systems and technology deployment.

Most recently, Mr Orantes served as Executive Director, Site Operations for Accelerated Enrollment Solutions, a business of PPD and ThermoFisher Scientific. There, he led the site operations for the Americas site operations in support of the company’s vast global clinical trial network.

Prior to joining PPD, Mr Orantes served as Chief Executive Officer of Amplify Clinical and Accel Research Sites, where he developed the business strategy to effectively compete in Phase II-III clinical research involving multi-therapeutic trials and specialty vaccines. He also led activities related to both companies’ asset purchase by private equity.

Earlier career positions included 20 years of operational, quality assurance, process improvement and laboratory management roles of increasing responsibility at Covance, now part of LabCorp.

Mr Orantes earned a Master of Business Administration degree from Old Dominion University, and a Bachelor of Science degree in biology from George Washington University. He is a certified Lean Six Sigma Black Belt from Six Sigma Academy.

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Charlie Paterson is a Partner at PA Consulting, where he leads clinical trials transformation with a focus on AI and digital innovation. He works with leading biopharma and biotech organizations to modernize clinical development, embedding data science and automation to improve trial performance, accelerate timelines, and expand access to care.Charlie brings deep expertise in AI-driven clinical operations, digital health strategy, and innovation. He has led the development of an AI-powered platform that analyzes real-time data from over 80,000 global study sites, and has driven digital-first strategies to enhance participant recruitment and improve early stage discovery. His work bridges clinical and R&D functions, helping clients unify fragmented data and unlock new efficiencies across the development lifecycle.

Michael Pearlman is currently a Sr. Manager, Patient Recruitment Services within Labcorp’s Clinical Trial Enablement team. He has a 12-year background in clinical research, exclusively in patient recruitment focused roles. Prior to his first industry role Michael spent 7 years working in Quality Management & Analyst roles in the Market Research industry. Through these past roles Michael developed core competencies in project management, data analysis, and process optimization. With these skillsets the transition to working in clinical research operations was a seamless one. He used his first couple years in the industry learning the ins and outs clinical trial recruitment. Of particular focus was the tremendous challenges sponsors faced in recruiting enough participants. Michael has dedicated his career to developing expertise in all facets of clinical trial recruitment. This includes social media outreach, search/display advertising, database outreach, working with advocacy groups, site-specific recruitment strategies, affiliate networks, and others.

In his role at Labcorp, Michael leverages proprietary real-world patient diagnostic data to build and optimize patient cohorts; to subsequently email about clinical trial opportunities. In his spare time Michael enjoys fishing, hiking, attending sporting events, and the occasional concert.

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Siân is currently SVP, Head of Quantitative Sciences & Development Operations (QSDO) at Biogen, where she leads a global team accountable for the strategic planning, execution and analysis of clinical trials across all phases of development and therapeutic areas, ie MS/Immunology, Rare Disease (Neuromuscular Disorders, Genetic Neurodevelopmental Disorders) and Neuroscience (Alzheimer’s Disease, Movement Disorders, Psychiatry). Siân and her team are driving numerous innovation projects to transform clinical trials and accelerate clinical development. Prior to Biogen, Siân spent 20+ years Pfizer, where she held senior leadership and group head roles in Clinical Operations, Medical Writing, Clinical Development, 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, Women’s Health and Vaccines). In addition, Siân has co-led a number of cross-industry initiatives for TransCelerate, BIO, ICH and public-private partnerships to advance clinical trial innovation approaches, precision medicine drug development and translational sciences. Siân has a PhD in Pharmacology from the University of Cambridge where she also held post-doctoral research and academic posts. Siân also serves on the Executive Committee as Treasurer for the International Society for CNS Clinical Trials Methodology (ISCTM), co-leads the ISCTM CNS Clinical Trial Diversity Working Group and mentors new investigators involved in psychiatry and neurology research.

Valerie Reynaert is the Head of Global Clinical Operations at Immunocore, a position she has held since April 2023. With over 20 years of experience in clinical development and operations, Valerie has established herself as a leader in the field of Vaccines and Pharmaceuticals development across Europe and the US. Her extensive career includes various leadership roles where she has driven significant advancements in clinical research and development. Valerie holds a Master's degree in Medical and Social Sciences from the Catholic University of Leuven, Belgium. Her academic background, combined with her professional expertise, has equipped her with a deep understanding of the complexities and challenges in clinical operations. Residing in the Philadelphia area, Valerie continues to contribute to the field with her innovative approach and dedication to improving global health outcomes. At Immunocore, she is committed to radically improving outcomes for patients with cancer, infectious diseases, and autoimmune diseases by pioneering and delivering transformative immunomodulating medicines.

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

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.

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Laura Russell is a visionary leader in the life sciences and technology sectors, with expertise in product development and operational excellence. As SVP, Head of Data and AI Product Development at Advarra, she defines and oversees the company’s business transformation through the responsibly guided integration of AI, delivering advanced analytics solutions and novel applications of AI across Advarra’s portfolio of services and technologies.

Previously, Laura held transformative leadership roles at Verily and 23andMe, where she launched impactful products and built scalable operational frameworks. Holding a Master of Science in Clinical and Translational Research from Georgetown University, Laura combines deep industry knowledge with a commitment to advancing healthcare through data-driven and AI-powered solutions.

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

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

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

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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.

Gina Schweizer is Vice President, Head of Strategy, Operations and Analysis & Reporting at Genmab.eporting at Genmab. She oversees integrated functions including Medical Writing, Programming, and Development Operations Strategy & Execution, with a focus on driving excellence across clinical development, having a leadership role or contributing to more than 20 original and supplemental health authority submissions leading to drug approvals in her career. With 25 years of experience at Merck, Janssen, and Genmab, Gina brings deep expertise in Regulatory Affairs Operations, Medical Writing, Trial Disclosure & Transparency, clinical trial processes, and global submission planning and execution. Since joining Genmab in 2018, she has built and scaled a global Medica Writing and Clinical Trial Disclosure & Transparency organization and played a key leadership role in the approvals of TIVDAK and EPKINLY. Gina is enthusiastic about leading high-performing, purpose-driven teams and fostering a culture rooted in accountability, inclusion, and innovation. Her strategic mindset and operational leadership are guided by the mantra, “Anything is possible,” which inspires her approach to transforming complex challenges into scalable solutions.

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

Charlie Semenchuk is the Head of Business & Technology Capabilities for Global Clinical Development Operations at Jazz Pharmaceuticals. He currently oversees a number of functions within GCDO covering technology, data innovation, analytics, and various business functions such as TMF Operations and Learning & Development. Charlie has spent over 20 years working in the pharmaceutical development space, specializing in the intersection of science and technology. With experience at sites, technology service providers, industry consortiums such as TransCelerate, and sponsor companies both big and mid-sized; he has a wealth of knowledge and experience from all sides of pharmaceutical development with a passion for the advancement of innovative medicines.

Rucha Shah has been living with a rare disorder. Her commitment lays in advocating for accessible healthcare and improving health outcomes for the broader patient community, especially the next generation of patients. Currently, Ms Shah leads a patient advocacy group for patients and caregivers at the Children’s Hospital of Philadelphia and the Hospital of University of Pennsylvania. She also collaborates with various national organizations and pharmaceutical companies on bringing forth initiatives which make meaningful connections within the disease community, improve the quality of life for patients and to increase awareness within the larger community.

Ms Shah attained her Master of Science degree in Clinical Research Organization and Management from the Drexel University School of Medicine in Philadelphia, PA. She further completed certificate coursework in Advancing Health Equity from ECOG-ACRIN Cancer Research Group and Research Advocacy Network as well as certificate coursework in Artificial Intelligence in Pharma and Biotech from the Massachusetts Institute of Technology. Professionally, Ms Shah works as a clinical research project manager within the oncology space. She strives to apply the "lessons learned" from her patient advocacy experiences to her professional work by building the trials to be more patient centric and accessible.

Recent Works: Woolford T, Andemariam B, Blaylark R, Colasanti R, Shah N, Jonassaint C, Trimnell C, Sheth S, Davis J, Gallagher E, Zaidi AU, John H, Shah R. Setting Industry Standards for Patient Engagement, Partnership and Care: The Patient Vision Project. Poster and Oral presentation at NORD. October 16, 2023. Washington DC, USA.

Jennifer Sheller joined Merck in 2017 as an Associate Vice President, Clinical Operations. She is currently the Global Head of Monitoring Excellence, Site Development/Engagement and Trail Diversity. She also serves as an R&D integration lead for biotech acquisitions. Ms Sheller’s background includes a bachelor’s degree in Molecular Biology, a Master’s of Public Health in epidemiology and graduate coursework in QA/RA and Project Management. She began her career as a CRA and has worked in various roles with increasing responsibility including global program and therapeutic area leadership, functional leadership (trial operations, data management, clinical supplies) as well as serving on the front line for FDA sponsor inspections. Ms Sheller has over 24 years of experience in pharma, biotech and CRO companies in R&D and Medical Affairs

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

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

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

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

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

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Azia Tariq is a Senior Manager in Clinical Trial Analytics & Visualization at Genmab. At Genmab, she is leading the efforts for GenSignal and other applications by providing digital solutions to support clinical development programs in the efficient and timely review and analysis of clinical and operational data. She has previously worked in various roles in analytics, programming, and clinical development at BMS, AbbVie, GSK, Merck, and Mount Sinai Hospital. She holds an MPH in Epidemiology from New York University and is a certified PMP.

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.

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Liz Thompson is a Global Development Leader and R&D Excellence Execution Lead at Roche Products Ltd, with over 30 years of experience in drug development. At Roche, she spearheads the Study Design and Protocol Optimization initiative, leading to significant cost and time savings. Thompson has been instrumental in developing numerous new medicines, including treatments for rheumatoid arthritis and COVID-19. Her career includes leadership roles in biostatistics and clinical development at Roche, GlaxoSmithKline, and AstraZeneca.

Mark Travers, Ph.D., MBA is Vice President, Global Clinical Trial Operations (GCTO) Regions and Regional Operations (RRO).

Mark has over 30 years’ experience in the Pharmaceutical and Device industry with increasing responsibility at country, region and global level focusing on both People management and clinical trial operations for several companies and industry initiatives.

Mark earned a B.Sc. (hons) in Biochemistry from the University of Strathclyde in Glasgow (Scotland), Ph.D. in Bioengineering again from the University of Strathclyde and an MBA from the University of Sussex in Brighton (UK).

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

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

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

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

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

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

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As the CEO of ProofPilot, Chris Venezia has a track record of success with more than 18 years of strong leadership in product commercialization, patient recruitment, marketing, and sales. Chris joined ProofPilot as the CEO in 2022 after serving as the Chief Commercial Officer at Citeline Connect. Chris excels in addressing the pain points of the life sciences industry and bringing technology-driven solutions to the market. His expertise will help disrupt the clinical trial industry to improve the experience and research outcomes for all key stakeholders in the space.

Andrew Vigario is a Senior Clinical Country & Site Lead (CCSL) within the Quantitative Sciences & Development Operations organization at Biogen. In his current role, Andrew leads a team of CCSLs in the US primarily responsible for driving engagement and enhancing the clinical investigative site experience in their partnerships with Biogen. Additionally, Andrew is also primarily responsible for leading both country and site identification strategies for Biogen's Alzheimer's disease portfolio of trials. During his time at Biogen, he has actively led numerous workstreams and initiatives to streamline clinical trial operations and oversight processes, particularly when it comes to executing timely and efficient country and site identification, aiding in the discovery of IT solutions, and driving efficiency. Andrew has worked in the clinical research arena for 17 years. Prior to his role at Biogen, Andrew has held multiple positions at both IQVIA and Syneos Health, including that of Clinical Lead and Clinical Research Associate. Andrew has also had prior experience working as a Study Coordinator at an academic site. Andrew holds a BA in Psychology from Rutgers University and an MA in Clinical Psychology from Teachers College - Columbia University.

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

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

Brian Weiss is the founder and CEO of Carebox (https://careboxhealth.com). The Carebox Connect platform connects patients and physicians seeking treatment options with clinical trials and is used by leading pharma companies, academic medical centers, and over 40 patient/physician groups. Brian is passionate about empowering patients as the best way to accelerate new treatments and more broadly advance healthcare. Prior to founding Carebox in 2014, he consulted for HL7 on healthcare data standards and led large software development/product organizations in publicly traded CRM and healthcare software vendors. Brian holds a master’s degree in software engineering from Columbia University in New York.

Sam Whitaker is the CEO and Co-Founder of Mural Health, a Philadelphia-based technology company dedicated to making it easier to participate in clinical trials. Sam founded Mural Health not long after his friend, Harley, tragically passed away from ALS. After witnessing the barriers his friend faced to participate in a clinical trial - coupled with his 15 years of experience in clinical trial technology - Sam set out to create a modern, participant-centric solution that was missing in the industry. With kindness and compassion at its core, Sam and the Mural Health team created Mural Link, the industry’s first holistic participant management platform that makes clinical trial participation easier–for patients and caregivers alike–while delivering smoother operations for sites, strategic value for sponsors, and better recruitment and retention.

Previously, Sam founded Greenphire, a clinical trial participant payments company. Building on that experience, he launched Mural Health with the vision of removing barriers to trial participation, fostering more diverse research populations, and ultimately improving clinical research outcomes.

Axel serves as VP, Portfolio & Program Management at Moderna Therapeutics. His global responsibilities include Portfolio & Program Management and Development Systems & Data Strategy. His prior roles and responsibilities include VP, R&D Strategy & Planning at Bristol Myers Squibb (2020-2023), SVP/COO RD, Strategy and Business Operations at Merck Healthcare KGaA/EMD Serono (2014-2019), VP, Strategy and Project Management at Boehringer Ingelheim Biopharmaceuticals (2009-2013), and EVP/COO at Fresenius Biotech GmbH and President of Fresenius Biotech North America Inc. (2002-2009). Prior he served as a management consultant at A.T. Kearney and as a resident physician in Germany and Colombia. He holds an MD/PhD from the University of Heidelberg and the German Cancer Research Center as well as an MPH from the John Hopkins School of Public Health.

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With over 14 years of experience in biopharmaceuticals and healthcare software, I am the co-founder and Chief Operating Officer of IgniteData, a company pioneering the automation of clinical trial data collection. At the forefront of our innovation is Archer, a virtual research assistant that seamlessly integrates electronic health records (EHR) with electronic data capture (EDC) systems, eliminating duplication, reducing errors, and accelerating study timelines. I have co-authored multiple peer-reviewed publications exploring the value and complexities of using real-world data in clinical research and am a frequent public speaker, advocating for the transformation of clinical trials through data-driven technologies. My work is grounded in a passion for improving patient outcomes, driving operational efficiency, and fostering collaboration between sponsors, healthcare providers, and technology partners. Through IgniteData, our mission is to make clinical trials more efficient, accessible, and reliable, ensuring that the future of clinical research is faster, smarter, and more connected.

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