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Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Speakers

  • Marla Jo  Brickman, PhD

    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.

  • Merete  Joergensen, MBA, MSc

    Merete Joergensen, MBA, MSc

    • Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
    • Novo Nordisk A/S, 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.

  • Erik  Lakes, MS, MSc

    Erik Lakes, MS, MSc

    • Director, Clinical Study Disclosure
    • PRA Health Sciences, 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.

  • Melanie  North, PhD

    Melanie North, PhD

    • Consultant
    • Melanie North Consulting, United States

  • Robert  Paarlberg, MS, MSc

    Robert Paarlberg, MS, MSc

    • Principal
    • Paarlberg & Associates LLC, United States

    Robert Paarlberg is the 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 created and directed global regulatory policy and intelligence functions at UCB and Pharmacia (Upjohn). Bob is past Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 35 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs.

  • Patricia A. Teden, MBA

    Patricia A. Teden, MBA

    • President and Principal
    • Teden Consulting LLC, United States

  • Matthias  Zerm, PhD

    Matthias Zerm, PhD

    • Lead Expert, Clinical Trial Disclosure and R&D Processes
    • Merz Pharmaceuticals GmbH, Germany

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

  • Issis J Kelly Pumarol, MD

    Issis J Kelly Pumarol, MD

    • Research Subject Advocate
    • Wake Forest Baptist Health, United States

  • Michael S. Lauer, MD, FACC

    Michael S. Lauer, MD, FACC

    • Deputy Director for Extramural Research
    • National Institutes of Health, United States

    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  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    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, PhD

    René Allard, PhD

    • Contractor
    • Self Employed, Germany

    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 E. Collyar

    Deborah E. Collyar

    • President
    • Patient Advocates In Research (PAIR), United States

    Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs, and delivers innovative ways to gather input from thousands of patients. Her work encompasses many diseases, programs and policies at grassroots, national and international levels and emphasizes patient issues throughout development, clinical trials, and health literate communication with providers and patients. She is a speaker, blogger, author, team member, trainer, and faculty at professional workshops.

  • Henry  Drysdale

    Henry Drysdale

    • Honorary Clinical Research Fellow
    • University of Oxford, United Kingdom

  • Anne-Sophie  Henry-Eude, PharmD

    Anne-Sophie Henry-Eude, PharmD

    • Head of Documents Access and Publication Service
    • European Medicines Agency, Netherlands

    Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans in the HIV field. In 2013 she became Head of the new Access to Documents Service and with the implementation of the policy on Clinical Data Publication, she is now Head of Documents Access & Publication at EMA.

  • Julie G. Holtzople

    Julie G. Holtzople

    • Clinical Trial Transparency Operations Director
    • AstraZeneca, United States

    Prior to joining AstraZeneca’s Clinical Trial Transparency Office, Julie worked as a Management Consultant and IT Program Delivery Manager. Today Julie is focused on the end to end implementation of new policies, regulations, tools and the general best practices as they emerge in Clinical Trial Transparency. Julie has been particularly focused on the global implementation of the Data and Document Anonymization, as well as Lay Summaries over the past 3 years.

  • Sean  Khozin, MD, MPH

    Sean Khozin, MD, MPH

    • Associate Director (Acting), Oncology Center of Excellence
    • FDA, United States

    Dr. Khozin is a thoracic oncologist, acting associate director at FDA’s Oncology Center of Excellence, and founding director of Information Exchange and Data Transformation (INFORMED), a data science incubator focused on innovations that enhance FDA’s mission of promotion and protection of the public health. The research portfolio of INFORMED includes investigations into real world data for clinical evidence generation, biosensors and the internet of things, machine learning and artificial intelligence, and blockchain for secure exchange of health data at scale. Previously, Dr. Khozin was in private practice in NYC and an entrepreneur specializing in building health information technology systems.

  • Ana  Rodriguez Sanchez Beato , PhD

    Ana Rodriguez Sanchez Beato , PhD

    • Head of Clinical and Non-Clinical Compliance
    • European Medicines Agency, Netherlands

    Dr Ana Rodriguez qualified in Pharmacy in 1990 and received her PhD in molecular microbiology in 1995 at Universidad Complutense of Madrid. In September 2009 she was appointed Head of the Clinical and Non-clinical Compliance Service as part of the new reorganisation of the European Medicines Agency.

  • Rebecca  Williams, PharmD, MPH

    Rebecca Williams, PharmD, MPH

    • Acting Director, ClinicalTrials.gov, NCBI
    • National Library of Medicine, NIH, United States

    Rebecca Williams, PharmD, MPH, is Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Assistant Director for over a decade. She is responsible for technical, scientific, policy, regulatory and outreach activities related to the operation of ClinicalTrials.gov, an international registry and results database of clinical research. Her research interests relate to improving the quality of reporting of clinical research. Her prior experience was in the area of prescription drug advertising and promotion at FDA and then as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins University.

  • April  Clyburne-Sherin

    April Clyburne-Sherin

    • AllTrials USA Campaign Manager
    • Sense About Science USA, United States

  • Rebecca  Li, PhD

    Rebecca Li, PhD

    • Senior Advisor, MRCT Center; Executive Director
    • Vivli Center for Global Clinical Research Data, 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.

  • Jill  McNair, MBA

    Jill McNair, MBA

    • Senior Director, Health Communication Services
    • CISCRP, United States

    Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement 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  Miller, PhD

    Jennifer Miller, PhD

    • Assistant Professor
    • Yale School of Medicine, United States

    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).

  • Andre  Molgat, PhD

    Andre Molgat, PhD

    • Head of Operations, Public Release of Clinical Information
    • Health Canada, Canada

    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.

  • Milena  Vakrilova

    Milena Vakrilova

    • Regulatory Intelligence Manager
    • Novartis Pharmaceuticals Corporation, Switzerland

  • Mitzi  Allred, PhD

    Mitzi Allred, PhD

    • Director Clinical Operations; Head, Clinical Content Standards
    • Merck Sharpe & Dohme, Co., Inc., United States

    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 Common Protocol work stream. Additionally, Mitzi has PhD in engineering and 15 years of experience in Aerospace.

  •   Panel Discussion

    Panel Discussion

    • All Session Speakers, United States

  • David  Peloquin, JD

    David Peloquin, JD

    • Senior Advisor, MRCT Center; Associate, Health care Group
    • Ropes & Gray LLP, United States

    David Peloquin practices law 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 Partners Healthcare in Boston. d health data privacy. Prior to attending law school, David worked as a project manager for a leading supplier of electronic medical records.

  • Nancy B. Sager, MBA

    Nancy B. Sager, MBA

    • Director, Division of Information Disclosure Policy, ORP, CDER
    • FDA, United States

  • Denise  Qyqja

    Denise Qyqja

    • Sr. Manager CTD & Patient Engagement
    • Transperfect, United States

  • Ramona L Rorig

    Ramona L Rorig

    • Associate Director Clinical Trial Disclosure
    • Astellas Pharma Global Development, United States

  • Olivia  Shopshear, MS

    Olivia Shopshear, MS

    • Senior Director, Science and Regulatory Advocacy
    • Pharmaceutical Research and Manufacturers of America (PhRMA), United States

    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 advocacy programs.

  • Margaret  Zorn, MBA, MS

    Margaret Zorn, MBA, MS

    • Senior Information Scientist
    • Instem, United States

    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.

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Short Course 1

Disclosures 101


Short Course 2

Preparing Documents for Disclosure and Public Sharing 


DIA's Clinical Trial Content Toolkit

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