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Global Clinical Trials Transparency Conference


Speakers

  • 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.

  • 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.

  • 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.

  • 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.

  • Francine  Lane, MBA

    Francine Lane, MBA

    • Vice President, Global Transparency
    • TrialScope, 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.

  • 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.

  • Kelly  Vaillant

    Kelly Vaillant

    • President
    • United States

    Partnering with Industry Organizations in a collaborative, transparent, and trust based approach to deliver operational excellence and ensure process optimization utilizing Six Sigma/Lean principles (Green Belt certified).

  • Lisa  Chamberlain-James, PhD

    Lisa Chamberlain-James, PhD

    • Senior Partner
    • Trilogy Writing & Consulting, United Kingdom

    After receiving her PhD in Pathology, Lisa started her career as a medical writer in the pharmaceutical industry at Napp Pharmaceuticals in 2000. In 2011, she joined Trilogy Writing & Consulting, a company specialised in providing medical writing. In addition to company management activities as Senior Partner and CEO, she continues to undertake client projects, writing a wide array of clinical documents and with a special interest in drug safety and patient information. She has experience of both communications and regulatory medical writing, and is also an experienced trainer of medical writers, regularly running and assessing workshops for the European Medical Writers Association (EMWA).

  • Trish  Groves

    Trish Groves

    • Deputy Editor
    • British Medical Journal, United Kingdom

    Dr Trish Groves trained in medicine and psychiatry before joining The BMJ in 1989, where she is Director of Academic Outreach and Advocacy for BMJ, Editor-in-Chief of the online only journal BMJ Open, and Honorary Deputy Editor of The BMJ. She has published widely, particularly as a coauthor of research reporting guidelines including the CONSORT 2010 statement on clinical trials https://scholar.google.com/citations?user=OMJJMOEAAAAJ&hl=en Trish is currently exploring how BMJ might help to build capabilities for health research in low and middle income countries, and is editorial lead of BMJ’s Research to Publication elearning programme for health researchers.

  • 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.

  • Benjamin  Rotz, RPh

    Benjamin Rotz, RPh

    • Senior Advisor Global Medical Strategy and Operations
    • Eli Lilly and Company, United States

  • Thomas  Wicks, MBA

    Thomas Wicks, MBA

    • Chief Strategy Officer
    • Trialscope, United States

    Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling, and submissions management. Thomas has been a been focused on trial transparency since 2007.

  • Lise  Baltzer

    Lise Baltzer

    • Director for Global Publications
    • Novo Nordisk, Denmark

    Lise Baltzer, MBA. 15+ years as a publication professional, currently Director Global Publications at Novo Nordisk HQ in Copenhagen, Denmark. Previously held various positions at Blackwell Publishing both in Copenhagen and Melbourne. GPP3 steering committee member and co-author of the ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3’ guidelines published in Annals of Internal Medicine 2015. Member of OpenPharma group and ISMPP.

  • 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.

  • Heather  Dobbins, PhD

    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.

  • Sini  Eskola, MPharm, MSc

    Sini Eskola, MPharm, MSc

    • Director Regulatory Affairs
    • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

    Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014. She leads regulatory policy and advocacy activities on clinical trials and transparency, pharmacovigilance, regulatory information technology and environmental sustainability aspects. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently Board member of Industrial Pharmacy Section in FIP.

  • 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.

  • 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.

  • Anabela  Marcal, PharmD

    Anabela Marcal, PharmD

    • Head of Committees and Inspections Department
    • European Medicines Agency, Netherlands

    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.

  • Ronald  Boumans

    Ronald Boumans

    • Senior Global Regulatory Consultant
    • EMERGO, Netherlands

    Ronald Boumans is a senior regulatory consultant at Emergo with a special focus on the Medical Devices Regulation implementation. He is an executive board member of the European Association of Authorized Representatives (EAAR) and represents EAAR in the New Eudamed Steering Committee. Ronald is actively involved in four of the seven New Eudamed working groups. Before working for Emergo, Ronald was employed for more than a decade as a senior inspector of medical technology at the Dutch Healthcare Inspectorate, the competent authority for The Netherlands.

  • Anne  Cutting

    Anne Cutting

    • Director, Human Subject Research Governance
    • GSK, United Kingdom

    Anne Cutting has over 30 years’ experience spanning the clinical development process. For the first 12 years within Data Management and Statistics, then as a Business Change Manager leading and managing change initiatives within the R&D organisation. For the past 5 years, working in the Data Transparency space, managing GSK’s clinical document publication in line with GSK’s transparency commitments and external regulations. Anne also lead GSK’s developing lay summaries capability and other areas in support of future regulations. Since June this year, Anne has taken on additional responsibilities in support of GSK’s governance of Human Subject Research.

  • Rikke  Gøbel

    Rikke Gøbel

    • Senior Medical Writer
    • Novo Nordisk, Denmark

    Rikke Gøbel holds a MSc and a PhD. Rikke has 11 years of experience within clinical research from both University and the Pharmaceutical industry, most recent 4 years as Medical Writer within Clinical reporting at Novo Nordisk A/S. Rikke has been largely involved in establishing the process and principles for layperson summary writing at Novo Nordisk A/S.

  • 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.

  • Sarah  Nevitt

    Sarah Nevitt

    • Department of Biostatistics
    • University of Liverpool, United Kingdom

    Sarah Nevitt is a Medical Statistician at the University of Liverpool, United Kingdom. Sarah is the Statistical Editor of the Cochrane Epilepsy Group, works within the Clinical Trials Unit at the University of Liverpool and performs Health Technology Assessment for the National Institute for Health and Care Excellence. Sarah has active research interests in data sharing and data anonymisation. Sarah is a member of the PhUSE Data Transparency Working Group and the EMA Technical Anonymisation Group.

  • Ann  Olling, MS

    Ann Olling, MS

    • Principal Medical Writer
    • Novo Nordisk A/S, Denmark

    Ann Olling, MSc Biochemistry, has more than 20 years’ experience in basic research and clinical development within the therapeutic area of diabetes. In her current role as Principal Medical Writer at Novo Nordisk A/S, Ann operates in cross-functional project teams, preparing and coordinating clinical documents for regulatory submission. Lately, Ann has been a driver in defining and implementing the process of preparing layperson summaries of the company’s clinical trial results.

  • Smita  Shukla

    Smita Shukla

    • Director Clinical Disclosure Reporting
    • GSK, United States

    I have been working for over 30 years with GSK, first 15 years as a Statistician supporting clinical development, then as a Business Change Manager leading and managing change initiatives within the R&D organisation. For the past 5.5 years I have been working in the Data Transparency space, managing GSK’s patient-level data sharing operations since the launch in May 2013 of www.ClinicalStudyDataRequest.com. In June this year I also took up responsibility for GSK Pharmaceutical’s data transparency operations. I have an MSc in Applied Statistics from the University of Kent and a BSc in Mathematics and Statistics from the University of Reading.

  • Munther  Baara, MS

    Munther Baara, MS

    • Head, New Clinical Paradigm
    • Pfizer Inc, United States

    Munther has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of New Clinical Paradigm within the Global Product Development GPD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies.

  • Ben  Goldacre

    Ben Goldacre

    • Senior Clinical Research Fellow, CEBM, Department of Primary Care Health Science
    • University of Oxford, United Kingdom

    Dr Ben Goldacre is a clinician, Senior Clinical Research Fellow at the University of Oxford, and best-selling author. He is co-founder of the AllTrials.net campaign and PI on a range of transparency initiatives including: the FDAAA.trialstracker.net; EU.trialstracker.net; policyaudit.alltrials.net; trialstracker.ebmdatalab.net; “Unreported Clinical Trial Of The Week” in the BMJ; the COMPare-trials.org project; and various academic publications. He is Director of the EBMDataLab.net at the University of Oxford, a multidisciplinary team of engineers, clinicians and academics producing high-impact interactive data-driven informatics tools such as OpenPrescribing.net alongside traditional academic publications.