Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion within and outside Parexel. Dr. Grignolo served as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, the Editor-in-Chief of DIA's digital magazine Global Forum, and served for two decades on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing Training Course, which he taught in Japan, China, Korea, Europe, and the US.

As a senior project manager for the Clinical Trials Transformation Initiative (CTTI), Zachary Hallinan manages the development and implementation of CTTI projects in collaboration with team leaders and multi-stakeholder project teams. His portfolio includes Patient Group Engagement, Quality by Design Adoption, Digital Health Trials: Engaging Patients and Sites, and the Patient Engagement Collaborative. Prior to joining CTTI, Mr. Hallinan directed the patient communication and engagement programs at the nonprofit Center for Information and Study on Clinical Research Participation, where for five years he led efforts to help the research enterprise better understand and meet the needs of the participants who make research possible.

Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson. In this role, she has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations transformation, collaborations on ethical science, and technology and R&D policies, including those related to clinical trial transparency and compassionate access. She chairs the R&D Development Pipeline Review Committee for The Janssen Pharmaceutical Companies of Johnson & Johnson, and supports the Medical Devices and Consumer Development Committees. Joanne is also a faculty affiliate of the Division of Medical Ethics, Department of Population Health, New York University School of Medicine.

Dr. Michael Pencina is a Professor of Biostatistics and Bioinformatics at Duke University & Director of Biostatistics at Duke Clinical Research Institute. An internationally recognized expert in risk prediction model development and evaluation, he also designs, conducts and analyzes clinical studies using modern sources of data focusing on novel and efficient designs. He has been an active promoter of open science and co-authored over 250 manuscripts in peer-reviewed journals. He is Deputy Editor for Statistics at JAMA-Cardiology and Associate Editor for Statistics in Medicine.

Deborah A. Zarin, M.D. was the Director of ClinicalTrials.gov between 2005 and 2018. In that capacity, she oversaw the world’s largest clinical trials registry, as well as the development and implementation of the first public database for summary clinical trial results. She also played a major role in the development and implementation of regulations under FDAAA (42 CFR Part 11) and the NIH trial reporting policy. Dr Zarin’s recent research has been on the quality of trial reporting, as well as issues in the design and analysis of clinical trials. Dr. Zarin has recently joined the MRCT Center as Program Director, Advancing the Clinical Trials Enterprise, and Member of Faculty, Harvard Medical School.