Kenneth Kaitin is a Professor of Medicine at Tufts University School of Medicine and Senior Fellow and former Director of the Tufts Center for the Study of Drug Development. He is also an Advisory Professor at Shanghai Medical College at Fudan University in China, and he serves on the faculties of the European Center for Pharmaceutical Medicine at the University of Basel, the American Course on Drug Development and Regulatory Science at the University of California, San Francisco, and the GMDP Academy-Kings College London Medical Affairs in Medicines Development Certification Program. An internationally recognized authority on drug development policy and science, Dr. Kaitin consults, speaks, and writes on global trends in pharmaceutical development, and has provided public testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin served as Editor-in-Chief of Expert Review of Clinical Pharmacology, and as a consultant to the U.S. Department of Defense on bioterror countermeasures. His honors include the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators in 2011; he was named Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians in 2020; and he received the Distinguished Achievement Award from the Sino-American Pharmaceutical Professionals Association (SAPA) in 2021. Dr. Kaitin is a director on the boards of Curis, Inc. (NASDAQ: CRIS), Bio-Tree Systems, Inc., and QCDx LLC. He holds a BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.

Dr. Justine Rochon leads Takeda’s R&D Data and Quantitative Sciences organization, advancing data-driven decision-making across translational, medical and data sciences. A psychologist and biostatistician with more than 20 years of experience in academia and industry, she holds a doctorate from the Medical Faculty of Heidelberg University. Dr. Rochon champions the responsible use of AI in drug development and co-authored the Charter
for Data Science in Pharmaceutical R&D and
the Manifesto for AI-Driven Clinical Trials.
She is a former President of EFSPI (European Federation of Statisticians in
Pharmaceutical Industry), serves on the ASA Biopharmaceutical Section Executive
Board, co-founded the DISRUPT-DS (Data Science) Roundtable, and was named a
2025 Trailblazing Woman in Pharma by Reuters.

Sangeeta Bhattacharya is a senior leader in data analytics with over 25 years of experience in the pharmaceutical industry. Throughout her career, she has led strategic initiatives across all phases of drug development and has contributed to multiple successful regulatory submissions. She is widely recognized for building high-performing global teams and for advancing data engineering and analytics capabilities.

A biostatistician by training, Sangeeta holds a Master’s degree from the University of Texas School of Public Health. She has also completed a certificate in the Implementation of Machine Learning in Business from MIT.

Michelle has 35+ years of clinical research experience in a range of capacities including ​​data management, project management, portfolio management, strategic partnerships, and business leadership. Her experiences creating complete product development plans, designing novel regulatory pathways to approval, writing both strategic and tactical business development plans, and supporting ​​product commercialization objectives and lifecycle management have provided her with a well-grounded perspective on the business of clinical development.

Michelle is a thought leader in the industry with publications in peer-reviewed and industry journals on the topics of study design, safety/efficacy, data interoperability and the application of emerging technologies to ​advanced analytics. She is focused on establishing new approaches and methods in the development of clinical therapies, with a commitment to improve human health. Michelle stands for developing inclusive, innovative, invested teams that bring their very best to the advancement of therapeutics – something that, here at Cytel, we are strongly invested in.

Shu Yang is a Professor of Statistics, Goodnight Early Career Innovator, and University Faculty Scholar at North Carolina State University. She received her Ph.D. in Applied Mathematics and Statistics from Iowa State University and completed her postdoctoral training at the Harvard T.H. Chan School of Public Health. Her research focuses on causal inference, real-world evidence, and data integration, particularly in the context of comparative effectiveness research in health studies. Dr. Yang has served as Principal Investigator on multiple large-scale research grants from the NSF, NIH (R01), and FDA (U01). She has published over 120 peer-reviewed articles and is a recipient of the Committee of Presidents of Statistical Societies (COPSS) Emerging Leader Award and an elected Fellow of the American Statistical Association (ASA).

Telba Irony joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and science of patient input. Telba received the 2014 FDA Excellence in Analytical Science Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting policy decision making, and changing the submission review paradigm. She has a PhD from Berkeley, is a fellow of the American Statistical Association, and elected member of the International Statistical Institute.

Lisa LaVange, PhD, is Professor Emerita and former Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. As a faculty member, she directed the Collaborative Studies Coordinating Center and served as principal investigator of coordinating center grants focused on public health research. She taught courses in clinical trials, regulatory statistics, and statistical consulting and leadership. From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in FDA’s Center for Drug Evaluation and Research. Prior to her government and academic experience, she spent many years in the private sector, both non-profit research and the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President. She was the 2007 President of the Eastern North American Region of the International Biometric Society (IBS – ENAR) and former member of the IBS Executive Board. In 2020, she received the Drug Information Association (DIA) Inspire Award for Outstanding Contribution to Health in the Americas Region. In 2023, she received the International Council on Harmonisation (ICH) Award for Outstanding Contribution to ICH Harmonisation for Better Health.

Estelle Russek-Cohen, PhD, is a retired tenured professor and former Director of the Biometrics Program at the University of Maryland, College Park collaborating with faculty  on diverse research efforts including randomized trials, laboratory studies, and observational research. During this time, Dr. Russek-Cohen also served on grant review panels for the National Science Foundation (NSF) and the National Institutes of Health (NIH).
Following her retirement from academia in 2004, she joined the U.S. Food and Drug Administration (FDA), where Dr. Russek-Cohen held senior roles across three centers. From 2005 to 2010, she served as Team Leader in the Division of Biostatistics (Diagnostic Devices Branch) at the Center for Devices and Radiological Health (CDRH). She then moved to the Center for Biologics Evaluation and Research (CBER), serving as Deputy Division Director (2010–2011), Acting Division Director, and then as Permanent Division Director until retiring again in 2016. From 2017 to 2020, she returned to FDA part-time as a Senior Advisor in the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER), focusing on science and policy related to safety, rare disease initiatives, and complex innovative designs.
Throughout her FDA career, she has contributed to numerous significant guidance documents, including those on adaptive designs, safety reporting, and the use of natural history studies in rare diseases. She views precision medicine from both a drug/biologic and device perspective.
Currently, she reviews global public health projects for the Bill & Melinda Gates Foundation, including vaccine and diagnostic related projects for low- and middle-income countries and applications of artificial intelligence in clinical decision-making. She also consults on companion diagnostics.
A Fellow of the American Statistical Association, Dr. Russek-Cohen has served on editorial boards for several leading statistical journals and the Therapeutic Innovation & Regulatory Science (TIRS) journal and has been a frequent reviewer for a wide range of scientific publications.

Andrew Thomson is the owner and lead consultant of Regnitio, a consultancy firm he founded in 2025 after an 18-year career as a regulator. He helps medicines developers solve challenging problems at the interface of methodology and regulation. He trained as a statistician and joined the UK regulator as a statistical assessor in 2007. After rising to senior assessor, he moved over to the post-licensing side as Head of Epidemiology, and in 2014 he moved on again to the European Medicines Agency, working in many functions but always with a statistical focus. Key responsibilities included being the Regulatory Chair for ICH E11A and ICH E6 Annex 2, as well as the main scientific secretariat for EMA’s Methodology Working Party where he was involved extensively in methodological guidance development. He has been involved in the assessment of many hundreds of development programmes, including Scientific Advice, Marketing Authorisation, PIPs, and Orphan Significant Benefit decisions.

Stuart brings 30 years of experience in rare disease advocacy, including leadership roles at Sanofi Genzyme and Bioverativ Therapeutics, where he championed patient-centered approaches for precommercial and established therapies. His work is grounded in a commitment to transparency, partnership, and elevating the voices of those most impacted by rare conditions.

In addition to his professional contributions, Stuart was Cofounder and Director of the Sanfilippo Research Foundation—a nonprofit dedicated to advancing research for Sanfilippo Syndrome or MPS III, the ultra-rare disorder that affected his son, Benjamin. He remains actively involved in non-governmental organizations, and industry and government initiatives, ensuring that lived experience and advocacy remain at the heart of progress in rare disease care.

Sofie’s unique blend of business expertise in healthcare combined with a PhD in Biotechnology Sciences from Ghent University sets her apart as a marketer who can bridge the gap between science and business. She is also known for her distinct leadership style, emphasizing the importance of positive culture and empowerment. Sofie believes in transforming vision into reality and fostering innovation to achieve outstanding results – something that, as our Vice President, Global Head of Marketing, she’s passionate about delivering together with our leadership team here at Cytel.

Sofie has over 18 years of experience in the life sciences industry, navigating diverse domains such as Research & Development (R&D), Contract Research Organization (CRO), and Specialty and Central Lab businesses. Most recently, Sofie served as the Chief Growth Officer and General Manager at Cerba Research for their Belgium Business Unit. Her background spans various critical areas, including marketing and communication, branding, business transformation, and M&A integrations.

Manuel Cossio is Head of AI Solutions, Real-World Evidence, Value, and Access at Cytel. Manuel is an AI engineer with over a decade of experience in healthcare AI research and development. He currently leads the creation of generative AI solutions aimed at optimizing clinical trials, focusing on hierarchical multi-agent systems with multistage data governance and human-in-the-loop dynamic behavior control.

Manuel has an extensive research background with publications in computer vision, natural language processing, and genetic data analysis. He is a registered Key Opinion Leader at the Digital Medicine Society, a member of the ISPOR Community of Interest in AI, a Generative AI evaluator for the EU Commission, and an AI researcher at UB-UPC- Barcelona Supercomputing Center.

He holds an M.Sc. in Translational Medicine from Universitat de Barcelona, a Master of Engineering in AI from Universitat Politècnica de Catalunya, and a M.Sc. in Neuroscience from Universitat Autònoma de Barcelona.

Li Wang is a recognized leader in artificial intelligence, data science, and statistical innovation, with more than 20 years of experience across the pharmaceutical industry, particularly in driving drug development and enterprise-scale digital and AI transformation in R&D. Throughout his career, he has led the development and application of innovative methodologies including adaptive trial designs, Bayesian frameworks, synthetic controls, digital twins, machine learning, and generative AI to improve clinical development decision-making and accelerate the delivery of medicines to patients.

Li is an active contributor to the broader biopharmaceutical and statistical communities through leadership roles with organizations including the Drug Information Association (DIA), the Society for Clinical Trials (SCT), the International Chinese Statistical Association (ICSA), and the American Statistical Association. He served on the Board of Directors of ICSA and BBSW and serves as an advisor for several AI start-up companies. He is co-leading AI/ML working group for ASA BIOP section. He holds a Ph.D. in Statistics from Virginia Tech and a B.S. in Applied Mathematics from Peking University. He is currently pursuing a EMBA from Kellogg School of Management, Northwestern University, expected in 2027.

Arnaub Chatterjee is President and GM of Life Sciences at Datavant. In his capacity, he oversees Datavant’s platform to improve the liquidity, discovery, security and access of data to power clinical and commercial applications in biopharma. Additionally, Arnaub is passionate about teaching and is a member of the faculty in the Department of Health Care Policy at Harvard Medical School. Prior to Datavant, Arnaub served as Chief Product and Solutions Officer at TriNetX, a health technology platform focused on improving clinical trial design and patient recruitment. Previously, he worked in various leadership capacities in data science and technology at Medidata Solutions, McKinsey & Company, Merck and the Obama Administration. Arnaub is a member of the Board of Directors of MJH Life Sciences, the largest privately-held medical media company in the United States; BioSpring, a life sciences growth equity firm; and the Alliance for Artificial Intelligence in Healthcare (AAIH). His work has been published in multiple peer-reviewed journals such as the Harvard Business Review and Nature and he has presented at conferences ranging from South by Southwest to the American College of Cardiology. He holds masters degrees in health administration (MHA) and public administration (MPA) from Cornell University and a BS in Molecular Biology from the University of Michigan.

Kevin Trimm is Chief Product Officer at Cytel. Kevin is a versatile leader with 20 years of experience at the intersection of data science technology and drug development. As our Chief Product Officer, he is responsible for Cytel’s software product strategy, development, and commercialization. Under Kevin’s leadership, Cytel is delivering a comprehensive and transformative software-as-a-service (SaaS) clinical trial design platform. The platform includes over 30 years of proprietary innovation, coupled with open-source technology and artificial intelligence.

Before Cytel, Kevin was Vice President of Product Management at Certara, leading multiple transformational software implementation projects in top-tier pharmaceutical companies. He developed and launched Certara’s first cloud-native SaaS offering and was also responsible for developing the strategic rationale for key technology acquisitions contributing to the success of Certara’s initial public offering.

Kevin is a PhD candidate at McGill University in the Department of Experimental Medicine where he is performing pharmaco-epidemiological. He holds an undergraduate degree from the University of Waterloo.

Abie brings more than 30 years of experience in pharma, biotechnology, and clinical research organizations around the world to his role at Cytel. He is recognized for helping sponsors optimize development programs through innovative clinical trial design, statistical strategy, and operational excellence.

Throughout his career, Abie has developed deep expertise in biostatistics, adaptive and advanced trial designs, regulatory strategy, and the execution of complex global clinical programs. He has advised development teams across a broad range of therapeutic areas, including immunology, oncology, neuroscience, endocrinology, and rare diseases. He has also served on independent Data Monitoring Committees and supported regulatory interactions with health authorities.

Before joining Cytel, Abie held senior leadership positions at Premier Research, UCB BioPharma, Quintiles (now IQVIA), and Eli Lilly, where he led global biometrics and statistical sciences organizations and supported pivotal development programs across all phases of clinical research. 

Abie is an active leader in the statistical community, where he has served as an At-Large Advisor to the Executive Steering Committee of the American Statistical Association’s Biopharmaceutical Section (BIOP), as well as a designated BIOP mentor to emerging statisticians and data scientists. He holds a PhD and MSc in Biostatistics from the University of Southampton, a Mini-MBA in BioPharma Innovation from Rutgers Business School, and a BSc in Mathematics with Statistics from the University of Lagos.

With a strong passion for education, Dr Pizzi co-led the development of ISPOR ’s first Health Economics and Outcomes Research Competency Framework, which outlines the core knowledge and skills essential to the HEOR profession.

Dr Pizzi brings more than 25 years of academic and research expertise to ISPOR. She has led multidisciplinary teams of methodologists, statisticians, and clinicians in designing and conducting cost and outcomes analyses for both pharmacologic therapies and non-pharmacologic interventions. Much of her work has focused on improving the quality of and access to treatments for older adults in underrepresented communities for diseases of aging such as dementia, diabetes, chronic vision diseases, and vaccine-preventable illness.

Her achievements include leading health economic analyses for numerous multicenter clinical trials, testifying before the US House of Representatives Committee on Ways and Means on Medicare spending, authoring a textbook on economic evaluation, and publishing more than 100 peer-reviewed manuscripts and 120 research presentations.

Dr. Dooti Roy is Executive Director of Global Biostatistics and Data Sciences at Boehringer Ingelheim and serves as Head of Innovation for Clinical Data Science and Methodology (CDSM) as well as U.S. Head of CDSM. She leads innovation in statistics, statistical programming, and data science, helping accelerate high-quality drug development through scientific and technological advancement. Known for her passion for mentoring and capability building, she focuses on developing future scientific leaders and driving data-driven decision making. Dr. Roy is also an Adjunct Professor at the University of Connecticut and contributes to multiple cross-industry collaborations advancing clinical research and healthcare innovation.

As University Professor, Dr. Tchetgen Tchetgen holds joint primary appointments in the Department of Statistics and Data Science at The Wharton School and in the Department of Biostatistics, Epidemiology and Informatics at the Perelman School of Medicine. He received his BS in Applied Mathematics from Yale University in 1999 and his PhD in Statistics from Harvard University in 2006. After serving on the faculty of the Harvard School of Public Health for ten years, he joined The Wharton School in 2018 as the Luddy Family President’s Distinguished Professor and Professor of Statistics and Data Science.
Dr. Tchetgen Tchetgen is a world leader in the field of causal inference. In recognition of his ground-breaking research, he was a co-recipient of the 2022 Rousseeuw Prize awarded to Causal Inference for pioneering research on causal inference with real-world applications in medicine and public health. He is co-director of the Center for Causal Inference at Penn.

Rod retired in 2022 after 35 years at Pfizer.  During his tenure, he held a number of senior positions, including Senior Vice President and Head of Worldwide Research, Site Director of Pfizer’s largest global R&D facility in Groton, CT, and Chief Development Officer and Executive Vice President. He led the clinical development of Pfizer’s pipeline of innovative medicines and vaccines, including the mRNA vaccine ComirnatyTM and the antiviral PaxlovidTM for COVID-19. He was a member of Pfizer’s executive leadership team.

Rod represented Pfizer on the board of directors for ViiV Healthcare, a global specialist HIV company established by GlaxoSmithKline and Pfizer to deliver advances in treatment and care for people living with HIV.  He also chaired the board of TransCelerate, a non-profit biopharmaceutical industry collaborative formed to identify and solve common drug development challenges.

Rod was trained in organic chemistry at Imperial College, London and Columbia University in New York.  He is the co-inventor of darifenacin, brand named Enablex™.

He was appointed Companion of The Order of St Michael and St George (CMG) by Queen Elizabeth II in 2022 for his outstanding service to public health during the COVID-19 pandemic.