Speakers
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials , Merete-J Consulting CVR: 34920818, Denmark
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. She is now working as a senior specialist for the area of clinical disclosure. 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 is Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.
Erik Lakes, MS, MSc
Senior Director and Head, Data Disclosure & Transparency, Beigene, United States
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.
Patricia Teden, MBA
President and Principal, Teden Consulting LLC, United States
Sarah A. White, MPH
Executive Director, MRCT Center, United States
Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions. Ms. White has over 20 years of experience in human subjects’ research. She is an expert in QA/QI processes related to the conduct of clinical research protocols, and is the co-chair of the national Clinical Trials Registration Taskforce, a large consortium of academic medical centers and universities that identify best practices and develop tools associated with clinical trials registration and results reporting that affect US academic health centers.
Marla Jo Brickman, PhD
Senior Director - Clinical Data Transparency/Compassionate Access Lead, Pfizer Inc, United States
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.
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
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.
Nicholas C. Ide, MS
Chief Architect, ClinicalTrials.gov, National Library of Medicine, National Institutes of Health (NIH), United States
Mr. Ide is a contractor with the U.S. National Library of Medicine and has been the Technical Lead and Chief Architect of ClinicalTrials.gov since the project's inception in 1999. He has an M.S. in computer science from the University of Maryland.
Rebecca Li, PhD
Executive Director, Center for Global Clinical Research Data, Vivli , United States
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.
Ira Shoulson, MD
Professor of Neurology, Pharmacology & Human Science; Director, PRSM, Georgetown University, United States
Thomas Wicks, MBA
Head of Transparency Operations, Citeline, United States
Thomas Wicks is the Head of Data and Partnerships at Citeline, where he is responsible for the organization’s data governance and interoperability as well as tracking regulatory requirements and clinical data sharing trends that shape the company’s clinical transparency solutions and services. He has over 25 years of experience with compliance management solutions, specializing in applications for life sciences with a focus on clinical trial disclosure and transparency since 2007.
Deborah A. Zarin, DrMed, MD
Faculty, Harvard Medical Center; Program Director, MRCT Center, United States
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.
Heather Dobbins, PhD
ClinicalTrials.gov Lead Results Analyst, NCBI/NLM, National Institutes of Health (NIH), United States
Dr. Heather Dobbins holds a Staff Scientist position in the National Center for Biotechnology Information (NCBI) at the National Library of Medicine, where she serves as the Lead Results Analyst for ClinicalTrials.gov. In this capacity she oversees the submission, quality review process and investigator assistance services for the ClinicalTrials.gov Basic Results Database. Dr. Dobbins earned a B.S. in Physics, a B.S. in Biology and a Ph.D. in Neuroscience. She held a dual appointment as a Postdoctoral Research Associate and Howard Hughes Medical Institute Teaching and Learning Fellow in the Physics Education Research Group at the University of Maryland. She has been a member of the ClinicalTrials.gov Results Team since 2009.
Noemie Manent, PharmD
TDA-CTT Operations Workstream Lead, European Medicines Agency, Netherlands
Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.
Debra JH Mathews, PhD, MA
Assistant Director for Science Programs; Associate Professor, Pediatrics, Berman Institute of Bioethics, United States
Pooja Phogat, PhD
Co-founder and Co-CEO, Krystelis Ltd., India
Pooja Phogat brings a unique breadth of operational experience, global leadership, and technical expertise establishing Kinapse as a global market leader in Clinical Trial Disclosure. Currently, Pooja is leading Development Operations group, where she is responsible for Clinical Trial Disclosure and Medical Writing services. She has over 18 years of experience in the Life Sciences Industry with 13 years in disclosure. Pooja’s career started in pharmaceutical industry as a Ph.D in Microbiology and thereafter moving to industry. Pooja is recognized externally as a global thought leader in disclosure with a comprehensive knowledge of disclosure regulations such as FDAAA, Final Rule EU-CTR, Health Canada PRCI and others).
Rebecca Williams, PharmD, MPH
Senior Clinical Trials Subject Matter Expert, Essex, Part of Emmes Group, United States
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.
Timothy Coetzee, PhD
Chief Advocacy Services and Research Officer, National Multiple Sclerosis Society, United States
Nina Hill, PhD
VP, Science Policy & Advocacy, Global Policy & International Public Affairs, Pfizer Inc., United States
Benjamin Rotz, RPh
Senior Advisor Global Medical Strategy and Operations, Eli Lilly and Company, United States
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