Marla Jo Brickman, PhD, is the Senior Director/Team Leader for the Clinical Trial Disclosure Group at Pfizer and serves as the global disclosure policy lead for all clinical trial registration and results disclosures, as well as, providing oversight of Pfizer’s implementation of the PhRMA/EFPIA principles. Marla received her PhD and completed her post-doctoral training in Immunology from Duke University, in Durham, NC.

Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk A/S. She is now working as independent Clinical trials transparency expert. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University. Further she has served as Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.

Erik is a Clinical Trial Disclosure Associate for Takeda Global Research & Development Center, Inc, where he is responsible for trial disclosure compliance worldwide. He is an active member with the DIA CTR/RD SIAC working group.

Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.

Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Therapeutics located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions. He is also involved in a wide range of organizational and process-related projects at Merz Therapeutics, such as preparing for the EU-CTR. He is a biologist by training and has >15 years of global experience in the clinical research arena.

Michael Lauer, M.D., is the Deputy Director for Extramural Research at the National Institutes of Health (NIH), where he serves as the principal scientific leader and advisor to the Director of the NIH on all matters relating to the substance, quality, and effectiveness of the NIH extramural research program and administration. From 2007 to 2015 he served as a Division Director at the National Heart, Lung, and Blood Institute (NHLBI), where promoted efforts to leverage big data infrastructure to enable high-efficiency population and clinical research and efforts to adopt a research funding culture that reflected data-driven policy

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

René Allard graduated from the University of the Witwatersrand in 1991 and completed reading for his doctorate at the Ruhr-University Bochum, Graduation College of Biogensis and Mechanism of Complex Cellular Functions, in 1995. Since 2012 René has been Public Disclosure Lead at Grünenthal after serving in various positions in Research and Development in the Pharmaceutical Industry in the past 20 years. Interests include trial designs, outcomes research, genetic biomarkers, data collection methods, and pharmaco-economics.

Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic skills to bridge gaps between scientists, medical providers, payers, governments, and patients. Deborah has vast research experience in translational, clinical, epidemiology, health outcomes, and health delivery fields while working with academia, federal agencies, companies, non-profits, and patient communities. Key patient insights are delivered throughout development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

Julie Holtzople is a seasoned Clinical Trial Transparency professional. She spent 10 years building Clinical Transparency and Data Sharing at AstraZeneca, becoming an expert in Plain Language Summaries, Clinical Document Anonymization and Clinical Data Sharing. She also led the implementation and readiness for EU CTR Transparency requirements. Julie has been an active member of numerous CTT working groups and organizations contributing to CTT standards and best practices. Prior to AstraZeneca, she started her career as a management consultant working at Ernst & Young and then Booz Allen. Julie has recently returned to consulting as an independent. She specializes in Clinical Trial Transparency, process optimization and program delivery.

Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine learning in biomedical research, therapeutic development, and care delivery.

Ana Rodriguez qualified in Pharmacy in 1990 and received her PhD in molecular microbiology in 1995 at Universidad Complutense of Madrid. Since then she has been working in the clinical research field first in the pharmaceutical industry first and since September 2003 at EMA, after joining the Inspection Sector. She became Head of the Clinical and Non-clinical Compliance Service in 2009, being involved in the implementation of the Clinical Trials Regulation (CTR) since its publication as well as in the development of CTIS, providing the business perspective. She moved to the Clinical Trial Workstream in March 2020 with the role of CTIS deputy programme manager and CTIS expert.

Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the Acting Director of ClinicalTrials.gov at the National Library of Medicine (NLM) after having served as the Assistant Director for over a decade. She has also worked in regulatory and policy aspects of prescription drug advertising and promotion at the Food and Drug Administration and as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins Bloomberg School of Public Health.

Rebecca Li, PhD, is the Executive Director of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over 5 years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. She completed a Fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.

Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Health Communication Services at CISCRP. In this role, she oversees a team dedicated to helping sponsor companies provide trial results summaries in plain language to study volunteers. She is passionate about providing education to the public so they can make an informed decision as to whether clinical research is right for them.

Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to help recognize good practices in companies, improve trustworthiness, and incentivize change where needed. Prior to joining NYU, Dr. Miller was based at Duke University and Harvard University. Dr. Miller serves on NYU’s Pharmacy and Therapeutics Committee, Stem Cell Research Oversight board, and J&J-NYU Compassionate-Use Advisory Committee (monitor).

André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse to leverage time. quality and efficiency for content within documents . Over the last fifteen years, she has led improvements in electronic documents, structured content management reuse implementations. Mitzi participates in the TransCelerate Clinical Content & Reuse workstream and ICH M11 Working group. Additionally, Mitzi has PhD in engineering and 15 years of experience in Aerospace.

David Peloquin is a partner at Ropes & Gray LLP where he is a member of the firm’s health care group. He focuses his practice on advising academic medical centers, life sciences companies, and information technology companies on issues related to human subjects and animal research, data privacy (including both U.S. and EU data privacy), and Medicare/Medicaid and other third-party payor reimbursement issues. He frequently writes and speaks on topics related to each of these areas. He also serves as a community member of the Institutional Review Board at Mass General Brigham in Boston. Prior to attending law school, David worked as a project manager for a leading supplier of electronic medical records.

Nancy Sager serves as Director, DIDP, Center for Drug Evaluation and Research (CDER), FDA. Her staff is responsible for reviewing and redacting a large variety of documents including internal memoranda, scientific reviews, and inspection documents to respond to Freedom of Information Act (FOIA) requests submitted by the public, third-party subpoenas and FOIA lawsuits, Congressional inquiries, and requests from federal, state, local, and foreign government officials. Prior to moving to DIDP, she held various positions in CDER including as a review chemist in the Office of Generic Drugs and as Special Assistant to the Director and Associate Director for Quality Implementation Chemistry in the Office of Pharmaceutical Science.

Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and regulatory policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical product development to commercial tech transfer to global supply chain management. She currently leads PhRMA’s global quality and manufacturing, supply chain, and data transparency regulatory advocacy programs.

Ms. Peggy Zorn is the Associate Director of Regulatory Operations, Submissions, and Transparency at MMS, with over 20 years of experience in regulatory affairs, drug safety, scientific information resources and IT. She is responsible for the management and oversight of all regulatory operations and clinical trial transparency services including all electronic publishing/submissions, clinical trial disclosures, clinical document redaction and patient lay summaries. Previously, Ms. Zorn was a Regulatory Submissions Lead and Associate Director of Worldwide Regulatory Affairs at Pfizer. Ms. Zorn holds a MBA and MS, and also earned a Regulatory Affairs Essentials Certificate from the University of California.