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Global 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

  • Suzanne  Carlson, MA

    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

    Kelly Coulbourne, MS

    • Director, Clinical Trial Disclosure and Data Transparency
    • Arena Pharmaceuticals, 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.

  • Patrick  Fawcett

    Patrick Fawcett

    • 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.

  • Francine  Lane, MBA

    Francine Lane, MBA

    • Vice President, Global Transparency
    • Informa, 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.

  • Robert  Paarlberg, MS

    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.

  • Nancy  Williams

    Nancy Williams

    • Associate Director, RSMO Document Publishing Solutions
    • Janssen Pharmaceuticals, United States

    Nancy Williams is an Associate Director in the Regulatory Submission Management Organization at Janssen Pharmaceutical. She specializes in data transparency and document-level submission publishing activities and has 21 years of experience in the industry. Nancy contributed to development of processes to support data transparency regulations, such as Policy 0070 and PRCI. She is a member of EFPIA Clinical Research Expert Group Data Transparency pillar and is co-leading a transparency sub-team focusing on operational processes for deployment of EU CTR. In her free time, Nancy enjoys gardening, swimming, and spending time with her rescued Manchester Terrier. She received her BS in Information Tech from Villanova and Capella Universities.

  • Merete  Joergensen, MBA, MSc

    Merete Joergensen, MBA, MSc

    • Senior Director, Clinical Transparency
    • 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. Further she is Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.

  • Stephen  Doogan

    Stephen Doogan

    • Chief Product Officer
    • Real Life Sciences, Inc., United States

    Stephen is a founding member of Real Life Sciences, Inc. (RLS), a software as a service company that automates the extraction, integration and analysis of unstructured patient data for life sciences organizations. Stephen brings over a decade of experience in natural language processing and machine learning, including product development and analytics roles in pharmacovigilance, outcomes research and clinical data management. Since 2015, Stephen has overseen the development of RLS' lead product ARARA, which supports EU Policy 0070 and 0043 disclosure requirements through automated redaction and anonymization of clinical study documents.

  • Cathal  Gallagher

    Cathal Gallagher

    • 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.

  • Sarah  Lyons

    Sarah Lyons

    • Head of
    • Privacy Analytics, Canada

  • Niamh Catherine McGuinness

    Niamh Catherine McGuinness

    • Clinical Trial Transparency Anonymization Expert
    • Privacy Analytics, Canada

    Niamh McGuinness is a technical lead with Privacy Analytics’ Clinical Trial Transparency (CTT) business unit, having joined the company in 2016. Her team specializes in statistical anonymization of clinical trial assets - both structured individual patient data and clinical trial documents. Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and proprietary toolsets, contributing to the ultimate goal of protecting patient privacy while also preserving the utility in clinical data.

  • Theresa  Shalaby, MSN, RN

    Theresa Shalaby, MSN, RN

    • Sr. Regulatory Services Manager
    • Certara Synchrogenix, United States

    Ms. Shalaby has 30 years of experience in the clinical research and drug development industry. Throughout those 30 years, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Synchrogenix.

  • Deborah  Collyar

    Deborah 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.

  • Ahmed  Eldfrawy

    Ahmed Eldfrawy

    • Real Life Sciences, United States

  • Rebecca  Li, PhD

    Rebecca Li, PhD

    • 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.

  • An-Wen  Chan, MD, PhD, FRCPC

    An-Wen Chan, MD, PhD, FRCPC

    • Professor, Dept of Medicine and Phelan Senior Scientist, WCRI
    • University of Toronto, Women's College Hospital, Canada

    Dr. Chan is a clinical epidemiologist and skin cancer surgeon at Women’s College Hospital, Toronto. He is the Phelan Senior Scientist at Women’s College Research Institute and Professor of Medicine at University of Toronto. His research focuses on developing ways to improve the quality and transparency of clinical trials, as well as preventing and managing high-risk skin cancer. Dr. Chan leads the international SPIRIT initiative to improve the quality of trial protocols. He helped launch the WHO International Clinical Trials Registry Platform and currently chairs its Advisory Panel. He is also an Institute Advisory Board member for the Canadian Institutes of Health Research.

  • Jolie  Dobre, MS

    Jolie Dobre, MS

    • Product Manager for PRS Modernization
    • ICF, United States

    Jolie Dobre is UX Researcher and Designer who has led user engagement, research, and design activities for government and private sector clients. Jolie’s areas of expertise include contextual inquiry, remote user testing, heuristic evaluation, human-centered design, analytics and accessibility. She has supported legacy systems modernization efforts for multiple agencies including the VA, TTB, and BSEE. She has published original research in journals and conference proceedings related to her work on clinical care team collaboration and electronic Health record use. Jolie combines her background in front-end web development and graphic design to inform her work, creating effective designs that balance technical, business, and user needs.

  • Scott  Feiner

    Scott Feiner

    • Senior Project Manager, Disclosure
    • AbbVie, United States

    Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization for public disclosure. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.

  • Anna  Fine, PharmD, MS

    Anna Fine, PharmD, MS

    • Assistant Director for ClinicalTrials.gov
    • National Institutes of Health (NIH), United States

    Dr. Anna Fine joined the National Library of Medicine as assistant director at ClinicalTrials.gov program in 2018. Prior to her appointment, she worked over a decade at the Food and Drug Administration (FDA) in various leadership roles. She served as Chief of Pharmacy Services at Hanscom AFB in MA & received her PharmD from Northeastern Univ. She also holds an M.S. in Psychopharmacology and completed a Pharmacy Practice Residency in Drug Information at Stanford Hospital.

  • George  Allan, PhD

    George Allan, PhD

    • Associate Director, Regulatory Document Lead
    • Janssen Research & Development, United States

    I am responsible for the preparation of clinical trial documents for publication, overseeing anonymization of private participant information and redaction of confidential commercial information. I have been in the data transparency space for more than 5 years, with previous experience as a medical writer in the neurosciences and a drug discovery scientist in reproductive health. I have worked in the pharmaceutical industry for over 25 years.

  • Stacey  Arnold, PhD

    Stacey Arnold, PhD

    • Results Team Subject Matter Expert
    • National Institutes of Health (NIH), United States

    Dr. Stacey Arnold is a Subject Matter Expert for the Results Quality Control Team, ClinicalTrials.gov, at the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health in Bethesda, MD. She first joined ClinicalTrials.gov in 2011 as a Results Reviewer. In her current role, she participates in the development of educational materials and trainings intended to facilitate the successful completion of results submissions. Prior to joining ClinicalTrials.gov, she received her PhD in Biological Chemistry from the University of Michigan, Ann Arbor, and conducted post-doctoral research at the Institute of Genetic Medicine at Johns Hopkins in Baltimore.

  • Wendy  Harman

    Wendy Harman

    • UX Lead for Modernization
    • ClinicalTrials.gov, United States

  • Ghassan  Karam, MSc

    Ghassan Karam, MSc

    • Manager International Clinical Trials Registry Platform (ICTRP)
    • World Health Organization (WHO), Switzerland

  • Ruediger  Pankow, DrSc

    Ruediger Pankow, DrSc

    • Principal Consultant, Regulatory Affairs
    • Parexel International, Germany

    Ruediger Pankow is currently Principal Consultant Regulatory Affairs at Parexel, where he has 14 years CRO experience in global management of clinical trial applications and regulatory consulting with specific expertise on the EU Clinical Trials Regulation. Representing ACRO for the EU Scientific and Regulatory Committee he has been continuously involved since 2016 in various European Medicines Agency (EMA) stakeholder activities for the EU Clinical Trial Information System (CTIS) development, since 2019 as sponsor product owner for the EMA CTIS delivery model and as CTIS expert for EMA CTIS training modules validation.

  • Dyan  Bryson, MBA

    Dyan Bryson, MBA

    • Patient Engagement Strategist/Patient Advocate
    • Inspired Health Strategies, United States

    Dyan Bryson is a patient engagement strategist and has forged the way for the patient engagement space since 2007. After spending 20+ years in traditional sales, sales leadership and marketing at Merck and Ciba-Geigy (now Novartis) Dyan has spent the last 15 years laser focused on patient engagement, patient advocacy, patient-centricity. Dyan makes the life sciences industry talk of being patient centered very real. When inspired by a project she did for a large pharma client Dyan realized the industry was missing the opportunity to include patients/patient insights in drug and device development from pre-IND through commercialization. She has developed and executed projects that have produced behavior change, improved adherence rates.

  • Nicole  Hinton

    Nicole Hinton

    • Director, Clinical Trial Transparency
    • Ultragenyx Pharmaceutical, United States

    Nicole has over 22 years of experience in the pharmaceutical industry and has been involved with Clinical Trial Disclosure and Transparency since 2013. She is currently the Director of Clinical Trial Transparency at Ultragenyx Pharmaceuticals and oversees clinical trial registration and results disclosure, plain language summary development and redaction of clinical documents.

  • Tabassum "Tab" Y. Hoda

    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.

  • Jennifer  Miller, PhD

    Jennifer Miller, PhD

    • Founder
    • Bioethics International, 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).

  • Jenny  Petersen

    Jenny Petersen

    • Director, Clinical Trial Disclosure and Transparency
    • Alnylam Pharmaceuticals, United States

    Jenny found her niche in Clinical Trial Transparency in 2007. A former wildlife biologist, Jenny transitioned to scientific publishing before entering the industry sector in the regulatory space in the early 2000s. She spent 10 years in Basel Switzerland, much of that time leading the Trial Disclosure activities at Hoffmann La-Roche, moving back to the US in 2015 to continue her career. Jenny is the Director of Clinical Trial Disclosure and Transparency at Alnylam Pharmaceuticals.

  • Christina  Robinson, MA

    Christina Robinson, MA

    • Product Manager for ClinicalTrials.gov Modernization
    • National Institutes of Health (NIH), National Library of Medicine, United States

    Christina Robinson currently leads the team modernizing the ClinicalTrials.gov website at the National Center for Biotechnology Information within the National Library of Medicine, National Institutes of Health in Bethesda, MD. She is a contractor with ICF and joined ClinicalTrials.gov in 2020. Prior to joining ClinicalTrials.gov, she spent 15 years in pediatric clinical research, first supporting research documentation and later leading web-based research communications.

  • Jeppe G.  Manuel, MLIS

    Jeppe G. Manuel, MLIS

    • Principal R&D Data Privacy Specialist
    • Novo Nordisk, Denmark

    Jeppe G. Manuel works as the Principal R&D Data privacy Specialist in Novo Nordisk A/S and is responsible for driving and aligning Novo Nordisk’s privacy by design/default efforts across the global R&D organisation. Hereunder, support managers & employees in Clinical Drug Development on implementing data privacy and ensuring the clinical processes and systems are aligned with personal data protection regulations. Furthermore, as the R&D subject matter expert on Personal Data Protection, Jeppe supports communication, training, and knowledge sharing activities across the R&D organisation and advise the Novo Nordisk on issues related to Data Privacy.

  • Catina  O'Leary, PhD

    Catina O'Leary, PhD

    • President and Chief Executive Officer
    • Health Literacy Media (HLM), United States

    Catina O’Leary, PhD, LMSW, is President & CEO of Health Literacy Media (HLM), a nonprofit health communications company located in Saint Louis, Missouri and working around the world. HLM provides training for health care providers in clear verbal and written health communication; plain language writing; health education and marketing documents to increase accessibility to community members; health literate clinical trial materials and summaries; and deep engagement with communities on their selected health topics. Before joining HLM, O’Leary served on the faculty at Washington University School of Medicine. O’Leary currently serves as a member of the National Academy of Sciences, Engineering and Medicine Roundtable on Health Literacy.

  • David  Peloquin, JD

    David Peloquin, JD

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

    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.

  • Ting  Pun, PhD

    Ting Pun, PhD

    • Volunteer Stanford Healthcare Patient Partner
    • Iconquerms, United States

    Ting is a caregiver of his wife with a rare neurological problem under the umbrella of Multiple Sclerosis. He has been involved with PCORI since 2012 where patients are engaged in its funded research project as partners. After serving in the PCORI Patient Engagement Advisory Panel, Ting became interested in all aspects of Patient Engagement in the healthcare system. Katherine Capperella introduced him to how Pharmaceutical Company is engaging patients in the drug development process. Clinical Trial Disclosure is becoming more important as the inclusion of diverse population for trial participant becomes a major initiative in the Clinical Trial Space.