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Mar 02, 2021 10:30 AM - Mar 02, 2021 11:30 AM

Online

DIA DIRECT: Principles Into Practice: Improving Trial Conduct and Regulation

New clincal trial guidelines are being developed for a more efficient regulatory environment and improved patient care in response to COVID-19. Register now to learn more.

Presenters

Jeffrey  Sherman

Jeffrey Sherman

Chief Medical Officer and Executive Vice President, Horizon Therapeutics, United States

Jeffrey W. Sherman, MD, FACP, is CMO and EVP at Horizon Therapeutics. Jeff has more than 30 years of biopharmaceutical industry experience at IDM Pharma, Takeda Global Research and Development, NeoPharm, Searle/Pharmacia, and Squibb/Bristol-Myers Squibb. He, a Past Chairperson of the Board of Directors of DIA, has served as DIA Annual Meeting Chair, received the DIA Outstanding Service Award, and served as DIA liaison to the FDA Clinical Trial Transformation Initiative (CTTI) Steering Committee, as well is an inaugural DIA Fellow. Jeff is also a member of the Global Genes Medical and Scientific Advisory Board and serves on the Board of Advisors of the Center for Information and Study on Clinical Research Participation (CISCRP).

Martin  Landray, PhD, FRCP

Martin Landray, PhD, FRCP

Chief Executive, Protas, United Kingdom

Martin is Co-chief investigator of the RECOVERY trial, the world’s largest randomised trial of potential treatments for COVID-19. He is Interim Director of Oxford's Big Data Institute and leads the clinical trials program for Health Data Research UK.His research focuses on the use of digital technology and quality-by-design principles for large randomized trials, particularly of treatments for cardiovascular and kidney disease.He continues to practise clinical medicine as an Honorary Consultant Physician at Oxford University Hospitals NHS Foundation Trust.

Ann  Meeker-O'Connell, MS

Ann Meeker-O'Connell, MS

Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC, FDA, United States

Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner. In this role, she leads an organization that coordinates and supports the development of clinical trial and human subject protection -related policy across the agency. Ms. Meeker-O’Connell has more than 20 years of experience in biomedical research and development in government, academic, and industry settings, including prior FDA service as the Acting Director of the Division of Good Clinical Practice Compliance in CDER. Ann earned her MS in Pharmacology, and was an NIH Integrated Toxicology Fellow, at Duke University.

Pamela  Tenaerts, MD, MBA

Pamela Tenaerts, MD, MBA

Chief Scientific Officer , Medable, United States

Dr. Pamela Tenaerts, currently serving as Medable's Chief Scientific Officer, is a respected advocate for clinical trial innovation. At Duke University, she previously led the Clinical Trials Transformation Initiative, improving efficiency and the quality of trials. With over three decades in conducting and researching clinical trials, her focus on patient engagement and evidence-based approaches has been notable. A board member at MedStar Research Institute, and an active member of the Drug Forum of the National Academies of Science, she holds an MD from the Catholic University of Leuven and an MBA from the University of South Florida.

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