Robert Paarlberg, MS
Principal, 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.
Suzanne Carlson, MA
Consultant, ABSD Associates, LLC, United States
Suzanne Carlson MA, MFA is President of ABSD Associates LLC. She is an independent medical writing consultant with 12 years of exclusive specialization in clinical trial disclosure and transparency for pharmaceutical companies throughout the United States. Her expertise encompasses both advisory and operational support, including disclosure program audits, onsite training, process development and improvement, and preparing study results and registration records for clinical trial registries. Suzanne’s prior consulting roles include regulatory writer, global competitive intelligence analyst, continuing medical education program editor, and scientific supervisor for international advisory boards and medical symposia.
Kelly Coulbourne, MS
Director, Clinical Trial Disclosure and Data Transparency, Pfizer Inc, United States
Kelly is the Director of Clinical Trial Disclosure & Data Transparency at Arena Pharmaceuticals where she is responsible for ensuring Arena remains in compliance with global clinical trial registration and results disclosure requirements, redaction of clinical documents, and plain language summary development.
Information Disclosure Administrator, Office of Research Protections, University of Pittsburgh, United States
Patrick holds a BS in Biology from Penn State University. His clinical research work experience includes data monitoring, regulatory affairs and clinical trial disclosure. Patrick contributed to developing the ClinicalTrials.gov reporting program for the NCI-Designated UPMC Hillman Cancer Center. Since April 2017, he has held a newly created position with the University of Pittsburgh, to develop and manage a program of education and compliance monitoring related to ClinicalTrials.gov.
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.
Francine Lane, MBA
Senior Director of Product Management, Citeline, United States
Francine Lane is the VP of Global Transparency at TrialScope and the Chair of the DIA Clinical Trial Disclosure Community. In her day job, Francine is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Francine also dedicates her time building relationships with external stakeholders – including sponsors, investigators, regulators, and transparency and patient advocates – to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Prior to her current role, Francine served as Director of Product Management at TrialScope.
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.
Tabassum "Tab" Y. Hoda
Senior Manager, Clinical Trials Disclosure, Amgen, United States
Tab Hoda is a Senior Manager at Amgen and manages the Clinical Trials Disclosure team. She brings years of industry experience including in data management and as a site coordinator. Tab is a foreign medical graduate with an M.B.B.S degree.
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
Donna R. Cryer, JD
Chief Executive Officer , Global Liver Institute, United States
Donna R. Cryer, JD, has channeled her personal experience as an IBD and liver transplant patient into professional advocacy as president and chief executive officer of the Global Liver Institute, the innovation and collaboration platform for the liver community. For almost a decade Mrs. Cryer led CryerHealth, a healthcare consulting firm she founded, providing strategic counsel to top biopharmaceutical companies, patient advocacy organizations, and emerging technology firms on patient engagement in health information technology, drug discovery, and clinical decision making. She is a frequent speaker on the topic of patient-centeredness and patient engagement in healthcare transformation.
Jennifer Houser, MS
Senior Manager, Medical Writing, Regmarole LLC, United States
Behtash Bahador, MS
Director, Health Literacy, Center for Information and Study on Clinical Research Participation (CISCRP), United States
Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into the process of clinical research, and always keeping the needs of patients, participants and the public at the forefront of his work.
Sudipta Chakraborty, PhD
Plain Language Summaries / Clinical Trial Transparency Manager, PRA Health Sciences, United States
Sudipta Chakraborty is a Plain Language Summary Manager at PRA Health Sciences. After earning her PhD in neuroscience from Vanderbilt University, Sudipta joined the medical writing space with the desire to help the public better understand the complexities of science and medicine. Collectively, Sudipta has over 10 years of biomedical communication, with her current specialization in plain language summaries of clinical study results. This has included supporting the operationalization of plain language summaries for sponsors, as well as advising sponsors on plain language best practices and regulatory requirements. Sudipta has also trained and managed other writers in the areas of plain language summary development and management.
Michelle Detry, PhD
Director, Adaptive Trial Execution & Senior Statistical Scientist, Berry Consultants LLC, United States
Michelle Detry, PhD, is the Director of Adaptive Trial Execution and a Senior Statistical Scientist for Berry Consultants. Dr. Detry’s expertise is in the implementation of adaptive clinical trials, including platform trials. As part of her role in implementing Berry Consultant’s trial designs she is a member of numerous statistical analysis committees that conduct the interim analyses. In addition, she has expertise in clinical trial design, reporting for Data Monitoring Committees, and also serves on Data Monitoring Committees.
Michelle Hellstern, BSN
Manager, Clinical Trial Disclosure & Transparency, CSL Behring, United States
Georgina Humphreys, PhD, MSc
Clinical Data Sharing Manager, Wellcome Trust, United Kingdom
Georgina is committed to maximising the benefits from research data and has experience in clinical trials, both in UK academic institutions, and in the field in East Africa. She completed an MSc at the London School of Tropical Medicine and Hygiene and a PhD at University of Glasgow. She then spent 12 months as a postdoctoral researcher in Tanzania, before moving back to the UK and joining the University of Oxford where she worked for 6 years on individual patient data meta analyses. Georgina joined Wellcome in December 2018 and currently leads work on clinical trial transparency and data sharing.
Anthony Keyes, MBA, PMP
Program Administrator, Clinical Research Operations, Johns Hopkins University, United States
Anthony Keyes, MBA, PMP is the Program Manager, Clinical Research Projects at Johns Hopkins University, Institute for Clinical and Translational Research. As a certified Project Management Professional he has successfully completed several several large-scale research projects. He founded and directs the Johns Hopkins ClinicalTrials.gov Program and Co-chairs the national Clinical Trial Registration and Results Reporting Taskforce. Anthony has over 15 years of experience in many aspects of clinical trial coordination and management. He received his MBA in healthcare management from Johns Hopkins University Carey Business School and a Bachelor's in biology from the University of Maryland, College Park.
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.
Patrick McNeilly, PhD
Senior Health Policy Analyst, Office of Special Medical Programs, OC, FDA, United States
Dr. McNeilly is a Senior Health Policy Analyst with the FDA’s Office of Good Clinical Practice. He is involved in a variety of policy issues related to human subject protections and good clinical practice. He joined FDA in May 2011 with FDA’s Center for Drug Evaluation and Research overseeing compliance programs related to IRBs and RDRCs. Prior to working at FDA, he was the Human Protections Administrator for the Agency for Healthcare Research and Quality. He has also served as a Compliance Oversight Coordinator for the HHS/Office for Human Research Protections. He is a registered pharmacist and trained at the Rutgers University, College of Pharmacy and received his doctoral degree in medicinal chemistry from the University of Maryland.
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.
Christopher Pfitzer, MA
Clinical Trial Transparency Strategy Lead, Biogen, United States
Christopher Pfitzer is the Transparency Operations Lead at UCB BioSciences in Raleigh, North Carolina but today he is representing the TransCelerate Clinical Research Access Initiative. Chris earned his Master’s degree from NC State University and a Bachelor’s degree from the University of Alabama at Birmingham. Prior to joining UCB, Chris worked extensively with healthcare and nonprofit organizations supporting policy and communications activities.
Elizabeth Roberts, MSc
Data Policy and Privacy Lead, UCB Inc., United States
Liz is Senior Director and Global Public Policy Lead at UCB where she is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform clinical trial transparency and responsible data sharing. She also leads other public policy priorities with a focus on producing sustainable value for people living with severe diseases. Liz led the TransCelerate Clinical Data Transparency Data Anonymization sub-team and co-leads the PhUSE Data Transparency workstream. She is also the UCB representative on the PhRMA Clinical Trials Data Transparency work group. Prior to her role in Data Transparency, Liz has more than 20 years’ experience working as a biostatistician, and has an MSc in Applied Statistics.
Research Patient Advocate, University of North Carolina At Chapel Hill, United States
Ms. Spears is a 20-year breast cancer survivor and cancer research advocate. Ms. Spears has extensive clinical trial advocacy experience serving as an advocate on the Translational Breast Cancer Research Consortium (TBCRC) and the NCI Breast Cancer Steering Committee (BCSC). She is also Associate Group Chair for Advocacy of the Alliance for Clinical Trials in Oncology (NCTN) as well as Chair of the Alliance Patient Advocate Committee. She is a member of NCI Core Correlative Science Committee (CCSC) and an FDA Patient Representative. She is also an advocate research grant reviewer ASCO (YIA). Ms. Spears is currently working as a scientific research manager and patient advocate at UNC Chapel Hill.
Raina Agarwal, MPharm
Senior Manager, Kinapse Ltd, A Syneos Health Company, United States
Michael A. DiMaio, JD
Attorney, Ropes & Gray LLP, United States
Michael DiMaio is an associate in the health care group at Ropes & Gray. He advises health care providers, pharmaceutical and medical device manufacturers, contract research organizations, and other health care organizations regarding a broad range of privacy, regulatory, compliance, and transactional issues.
Julie G. Holtzople
Senior Director Clinical Transparency and Data Sharing , AstraZeneca, United States
Julie Holtzople is the Sr. Director of Clinical Transparency & Data Sharing for AstraZeneca and co-lead of the CREG CTT group. Julie received her Bachelors of Science in Business Administration at Virginia Polytechnic Institute. Julie has been with AstraZeneca for 14 years. Prior to her time in AstraZeneca Julie was a management consultant in health care. Today, Julie if focused on the implementation and delivery of new transparency policies, regulations, tools and the general best practices as they emerge across the industry. As part of her role Julie is actively involved in several industry organizations focused on establishing best practices in Clinical Trial Transparency.
Special Projects, New England Journal of Medicine, United States
Pamela Miller has been with the editorial office of the New England Journal of Medicine for over 20 years, currently serving as Assistant to the Editor. Prior to that she was the General Manager of Margun and GunMar Music and has been a grants administrator at various Boston Hospitals. In her role at the NEJM she manages large projects, including implementing online peer review, overseeing the publication’s 200th Anniversary and digitizing the journal archive. She also implements policy for the editorial office, most recently the ICMJE's requirements around data sharing statements.
Catina O'Leary, PhD
President and Chief Executive Officer, Health Literacy Media, United States
Oladayo Oyelola, PhD
Senior Director and Head Clinical Trial Information Disclosure, Daiichi Sankyo, Inc. , United States
Dr. Oladayo Oyelola is Senior Director and Head, Clinical Trial Information Disclosure at Daiichi Sankyo. He oversees corporate clinical trial transparency/data sharing strategies and compliance activities; coordinates internal disclosure operations’ training, process improvements and trial transparency policy intelligence.He holds a PhD in Clinical Chemistry from Obafemi Awolowo Univ. Ile-Ife, Nigeria, 1990 and received The Rockefeller Foundation Postdoctoral Fellowship, 1991 and National Mentor Role Model Award of Minority Access Inc/Office of Minority Health, NIH, 2001. Dr. Oyelola has over 35 years’ experience in biomedical R&D, and certifications by National Registry of Certified Chemists and American Society for Clinical Pathologists
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.
Diane Lehman Wilson, JD, MA
Regulatory Affairs Manager, University of Michigan Medical School Office of Regulatory Affairs, United States
Diane Lehman Wilson has worked in the Office of Regulatory Affairs at the University of Michigan Medical School for nearly a decade. She covers a range of regulatory matters supporting research faculty including clinical trials disclosure, human subjects protection, and FDA inspections of clinical trials. Her earlier career included legal and educational positions, teaching in contexts ranging from pre-school Science, a decade of teaching middle school human rights, English, and History in Detroit, to Continuing Legal Education in areas related to Medicare and Medicaid. She has presented to national audiences on clinical trial disclosure obligations as well as the Clostridium Difficile risks of antibiotics.
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.
Matthias Zerm, PhD
Lead Expert, Clinical Trial Disclosure and R&D Processes, Germany
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.
Director, Data Protection & IP, EFPIA, Belgium
Brendan Barnes joined EFPIA in 2002 to work on the alignment of national laws in new member states during the enlargement of 2004. Subsequently, he has been involved in EFPIA’s work on multilateral trade and intellectual property issues, including the EU’s legislation on product diversion and compulsory licensing and on issues relating to access to medicines. More recently, he has been involved in the development of new business models in the areas of neglected disease and infection and is now mainly focused on data governance issues. He previously worked in the pharmaceutical industry for 11 years, in a range of roles including Finance, Strategic Planning and Public Affairs,
Till Bruckner, PhD
Founder, TranspariMED, United Kingdom
Till Bruckner is the founder of TranspariMED, a UK-based initiative that works to end evidence distortion in medicine worldwide. TranspariMED has driven improvements in the posting of clinical trial summary results by combining research with coalition building, advocacy and media outreach, with a particular focus on non-profit trial sponsors. Notably, TranspariMED has been a central participant in the UK House of Commons enquiry into unreported clinical trials and its aftermath. Prior to setting up TranspariMED, Till Bruckner worked for the AllTrials campaign and Transparency International.
Niem-Tzu Rebecca Chen, MEd, MS
Human Subjects Protection Senior Analyst, Rutgers, The State University of New Jersey, United States
TAG Member & Transparency Lead, d-wise, United Kingdom
Cathal is a Senior Life Sciences Consultant with d-Wise. He provides product leadership for d-Wise's market-leading data de-identification solution, Blur. He collaborates with customers on product improvements and provides industry thought leadership through papers, presentations, webinars, and blogs. He is also the stream chair at Phuse for Trends and Technologies and is part of an industry-wide working group for data anonymisation. His expertise includes Data Transparency, reusable code, SDTM & ADaM Templates, Clinical Data Integration and Base SAS.
Rebecca Williams, PharmD, MPH
Senior Clinical Trials Subject Matter Expert, Essex, A Veridix AI Company, United States
Rebecca Williams, PharmD, MPH, is the former Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Deputy Director for over a decade. She was 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.
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.
Lucy Mosquera, MSc
Senior Director, Data Science, Replica Analytics, Canada
Lucy Mosquera has a background in biology and mathematics, having done her studies at Queen's University in Kingston and the University of British Columbia. In the past she has provided data management support to clinical trials and observational studies at Kingston General Hospital. She also worked on clinical trial data sharing methods based on homomorphic encryption and secret sharing protocols with various companies. At Replica Analytics, Lucy is responsible for integrating her subject area expertise in health data into innovative methods for synthetic data generation and the assessment of that data, as well as overseeing our analytics program.
Olivia Shopshear, MS
Senior Director, US Regulatory Policy Lead, Biogen, 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 regulatory advocacy programs.
, MMS Holdings, United States
Anne K. Walsh, JD
Director, Hyman, Phelps & McNamara, PC, United States
With more than 27 years of experience in private practice and government, Ms. Walsh helps pharmaceutical and medical device companies comply with, and defend against, FDA regulation. She regularly counsels clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls. She has specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and has investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General.
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).
Nirpal Virdee, MSc
Head, Transparency & Disclosure, Certara, United Kingdom
Nirpal Singh Virdee is the Director of Client Services, Technology at Synchrogenix, a Certara company. Nirpal is accountable for business development, client management and consulting for their technology enabled services. Nirpal provides industry insight, market trends and service line alignment when Synchrogenix look to invest, plan and implement new technologies. This includes the adoption of open APIs, real time data, and machine learning within our regulatory services. Nirpal comes with over 21 years of Life Sciences experience. He has an MSc from Brunel University in London. He is considered an industry thought leader, having globally presented at conferences. He has sat on industry advisory panels and publishes articles and Podcasts
Have an account?