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Hilton London Docklands Riverside Hotel

Sep 19, 2018 8:00 AM - Sep 20, 2018 5:00 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Global Clinical Trials Transparency Conference

Speakers

Merete  Joergensen, MBA, MSc

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.

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.

Rebecca  Williams, PharmD, MPH

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.

Matthias  Zerm, PhD

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.

Francine  Lane, MBA

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.

Olivia  Shopshear, MS

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.

Kelly  Vaillant

Kelly Vaillant

President, Vaillant Consulting, LLC, 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

Lisa Chamberlain James is a Senior Partner and Chief Executive Officer of Trilogy Writing & Consulting. Aside from management activities, she also leads client projects, with extensive experience in a variety of documents and a special interest in drug safety and patient information. After receiving her Ph.D. in Pathology, Lisa began her medical writing career in Cambridge in 2000. Since then, she has been heavily involved in the EMWA on the Education Committee and as a workshop leader, is a visiting lecturer for King’s College London, initiated and chaired the EMWA PV and Communicating with the Public SIGs, is chair of the Geoff Hall Scholarship Committee, section editor for Medical Writing, and a Fellow of the Royal Society of Medicine.

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 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.

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

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.

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  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.

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, MS, MSc

Sini Eskola, MPharm, MS, MSc

Director Regulatory Affairs, EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium

Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. 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 doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.

Anne-Sophie  Henry-Eude, PharmD

Anne-Sophie Henry-Eude, PharmD

Head of Documents Access and Publication Department, European Medicines Agency, Netherlands

Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

Rebecca  Li, PhD

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.

Anabela  Marcal, PharmD

Anabela Marcal, PharmD

EMA Liaison Official to the US FDA, 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, including Head of Committees and Inspections and Head of Clinical Trials. Currently Anabela is the EMA Liaison Official to FDA.

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

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, 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

Vice President, Product Strategy and Innovation, EDETEK, 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.

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