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Sheraton Philadelphia Downtown Hotel

2024 年 10 月 24 日 7:00 上午 - 2024 年 10 月 25 日 7:00 下午

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Early Bird Rates Expire






David  Martin, MD, MPH

David Martin, MD, MPH

Vice President, Global Head RWE, Moderna, United States

David Martin leads Global RWE for Moderna. Previously he completed 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology in the Center for Biologics. Subsequently, he established the Real World Evidence group in the Office of Medical Policy to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act. He initiated key RWE pathfinding efforts with external stakeholders including RCT Duplicate and the open-source FDA MyStudies mobile application. He holds an MD and MPH from Johns Hopkins and is board certified in occupational & environmental medicine as well as clinical informatics.

Jaclyn  Bosco, PhD, MPH, FISPE

Jaclyn Bosco, PhD, MPH, FISPE

Vice President and Global Head of Epidemiology, IQVIA, United States

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

John  Concato, MD, MPH, MS

John Concato, MD, MPH, MS

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States

Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

Diane  Gubernot, DrPH, MPH

Diane Gubernot, DrPH, MPH

Epidemiologist, US FDA, United States

Dr. Diane Gubernot is a Health Scientist in the Office of Biostatistics and Pharmacovigilance at the Center for Biologics Evaluation and Research (CBER) of the USFDA. She conducts regulatory reviews of RWE/RWD submitted in biologic product applications and performs research to help support RWE policy development as well as other public health initiatives. Dr. Gubernot has been with the FDA for more than 30 years and has worked as an Investigator in the Office of Regulatory Affairs, a Team Lead Epidemiologist in the Office of the Commissioner, and a regulatory product reviewer at CBER.

Rachele  Hendricks-Sturrup, DrSc, MA, MSc

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within the fields of health policy, business, and health innovation.

Camille  Jackson

Camille Jackson

Director, Regulatory Policy; Legal and Regulatory, Flatiron Health , United States

Camille Jackson is the Director and Head of Regulatory Policy at Flatiron Health, bringing nearly 20 years of experience within policy and program management across various corners of the life sciences sector. Earlier in her career, Camille held roles at Clarivate, Sanofi, PhRMA, The World Bank, NIH, The George Washington University, and the American Academy of Child and Adolescent Psychiatry.

Charles  Lee, MBA, MS

Charles Lee, MBA, MS

Executive Regulatory Science Director, AstraZeneca, United States

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader over a 10 year period at Astrazeneca and Roche where he led cross-functional project teams for programs in the early development phase (Ph0 to Ph2b). Previous to that, Charles spent 10 years in Global Regulatory affairs where he held leadership roles on programs across several therapeutic areas in different stages of development. Charles holds BS in Biology from The Johns Hopkins University, MS from University of Virginia, MBA from Columbia Business School

Alexander  Liede, PhD, MSc

Alexander Liede, PhD, MSc

Senior Director, Global Epidemiology, Abbvie, Ireland

Alex is a Senior Director and Head of Evidence & Partnerships in Global Epidemiology at AbbVie based in Dublin, Ireland. Alex has 20 years of experience in the biopharma industry and leads a team of epidemiologists focused on real-world evidence solutions and innovative approaches using real-world data in support of safety strategy and cross-functional initiatives in drug development. Before joining AbbVie in 2019, Alex worked at Amgen in the Center for Observational Research, as a research scientist at Cedars-Sinai Medical Center in Los Angeles, and as a genetic counsellor with Cancer Care Ontario and Women's College Hospital in Toronto, Canada.

Sarah  Martin, PhD, MS

Sarah Martin, PhD, MS

Senior Director - Global Regulatory Policy (Oncology), Eli Lilly & Co., United States

Sarah currently serves as senior director of global regulatory policy for oncology at Eli Lilly. She previously served as senior director of science and regulatory advocacy for the Pharmaceutical Research and Manufacturers of America (PhRMA) where she led their regulatory advocacy efforts on key issues including real-world evidence. Sarah worked for the American Association for Cancer Research (AACR) where she led their efforts to modernize the regulatory process and engage in the development and implementation of programmatic and policy initiatives with the US FDA Oncology Center of Excellence.

Brittany  McKelvey, PhD

Brittany McKelvey, PhD

Director, Regualtory Affairs, Friends of Cancer Research, United States

Keri  Monda, PhD, MS

Keri Monda, PhD, MS

Executive Director, Center for Observational Research, Amgen, United States

Keri Monda, PhD, is an Executive Director of Observational Research and Head of the Data & Analytics Center within the Center for Observational Research (CfOR) at Amgen. In her role, she leads a team of epidemiologists and data scientists responsible for generating real-world evidence in support of programs from research and early development through launch and end of patent expiry, and oversees a large, integrated real-world data and analytics ecosystem. Prior to her time at Amgen, Keri was a genetic epidemiologists on faculty in the Department of Epidemiology at the University of North Carolina, Chapel Hill.