Date: Wednesday, October 8, 2025
Time: 11 am ET
Summary
How do we as an industry generate medical evidence that’s not only meaningful in the quest for regulatory approval, but compelling enough to also support timely reimbursement, clinical adoption and access?
We’re convening an expert panel on Wednesday, Oct. 8 at 11 a.m. ET to discuss the role of ‘Integrated Evidence’ approaches to bridge the persistent regulatory and payer gap, and help leading pharmaceutical companies align R&D and commercial objectives.
‘The Pursuit of Certainty: Integrated Evidence and the evolving drug development and reimbursement landscape’ will offer diverse perspectives from leaders in medical affairs, real-world data, HEOR, market access and clinical development on the potential of this approach to meet the needs of multiple stakeholders – regulators, payers, clinicians and patients, and move beyond isolated findings toward a more holistic understanding of therapeutic impact. We’ll also ask our panelists to share obstacles they’ve encountered to adopting these strategies and practical steps you can take to encourage cross-functional collaboration.
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Head of Medical Evidence Generation, Pfizer
Dr. Doyle is an epidemiologist and health services researcher who specializes in studying the risks, benefits, and value of healthcare interventions. He has 25+ years experience in conducting research and leading teams covering specialties such as pharmacoepidemiology, health economics & outcomes research, and real-world evidence. He has applied these disciplines to develop novel models of market access for biopharmaceuticals, including outcomes-based agreements and innovative financing to support value-based healthcare initiatives in pursuit of the “Quadruple Aim”.
Dr. Doyle has published over 200 abstracts and peer-reviewed articles, with special concentration in oncology. He serves as the co-chair of the Health Economic Impact Steering Committee for the Alliance for Regenerative Medicine where he focuses on the value assessment of cell and gene therapy. Dr. Doyle frequently gives presentations and lectures on the above areas of expertise in both commercial and academic settings internationally. Dr. Doyle served on the faculty at Columbia University’s Mailman School of Publish Health since 2005.
Global Head of Patient-Focused Real-World Evidence, Merck Healthcare
Gorana Capkun, PhD, is Vice President and Global Head of Patient-Focused Real-World Evidence at Merck Healthcare KGaA (Merck Group), where she leads patient-centric RWE strategies that feed integrated evidence plans to inform development, access, and outcomes for diverse populations. She brings 20+ years across HEOR, biostatistics, and real-world data science, including leadership roles building RWE and methods capabilities at Novartis Oncology.
Her scholarship and thought leadership span HTA-ready RWE methods and integrated evidence planning, including work on guidance for robust RWE for payer/HTA decision-making (IJTAHC, 2022), an editorial on the value of evidence in product strategy (2024), and a Clinical Pharmacology & Therapeutics article on harnessing RWE within integrated evidence plans (2025). Earlier in her career, she served as Head of HEOR Innovation at Novartis and helped advance comparative-effectiveness and Bayesian methods used in clinical development. She holds a doctorate in applied statistics from EPFL (Swiss Federal Institute of Technology in Lausanne).
Director, Value & Outcomes at Amicus Therapeutics
A seasoned healthcare ecnomics and outcomes research leader, Vera currently serves as Director of Value & Outcomes at Amicus Therapeutics. Prior to her current role, she advanced through key strategic positions at GSK, first as Director, Value Evidence and Outcomes and then as Value Evidence Leader.
Vera earned her PhD from Imperial College London, following which she served as a postdoctoral researcher at the same instituation. Her studies also include an MSc and BSc from Utrecht University.
Her experience spans health economics, market access, clinical outcomes, HTA, epidemiology, and value-based evidence – making her an authoritative and insightful speaker on value-driven strategies in drug development and market access.
Bob Powell is a clinical pharmacologist focused on “getting the dose right” from first-in-human studies through real-world use, especially for patients often under-represented in Phase 3 trials. He has led early-development and dose-selection strategy at Glaxo, Parke-Davis, and Roche, translating preclinical insights into go/no-go decisions and clinical dosing plans. At FDA/CDER’s Pharmacometrics group, he contributed to approval decisions and early-phase sponsor consultations—experience that now informs his precision-dosing research and ongoing collaborations with regulators and industry as an adjunct at UNC Chapel-Hill. His recent publications propose more precise dosing for direct-acting oral anticoagulants, including rivaroxaban and dabigatran, in atrial fibrillation. Bob has authored 100+ peer-reviewed publications.
SVP, Biometrics, Data Science and Access, Certara
As the Senior Vice President, Biometrics, Data Science and Access at Certara, Tiffany oversees global, multi-disciplinary consulting teams that focus on evidence generation and drug development throughout the medical product lifecycle. Prior to joining Certara, she served as the President at Panalgo and General Manager, HEOR and Medical Affairs at Norstella, overseeing all strategy, operations, engagement, product, and analytic support of Panalgo’s Instant Health Data (IHD) platform. Tiffany has 20 years of varied health outcomes research experience, from leading safety analyses for regulators to supporting traditional health economics outcomes research.
Tiffany received her MPH at Boston University School of Public Health and her MBA from Temple University’s Fox School of Business.
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