Faculty – Disclosure and Transparency for Clinical Data Summit


René Allard
Public Disclosure Lead, GRÜNENTHAL GMBH

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René Allard, Ph.D., graduated from the University of the Witwatersrand in 1991 and completed reading for his doctorate at the Ruhr-University Bochum 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 and serves on DIA and ISPOR working groups.


Bhanu Bahl, Ph.D.
Director, Clinical and Translational Science Center, HARVARD MEDICAL SCHOOL

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Dr. Bhanu Bahl is a Director for Harvard Clinical and Translational Science Center’s Biomedical Informatics Program at Harvard Medical School. At Harvard Catalyst, she is Director of informatics projects for accelerating research in translational science. Bhanu is a physician with a broad informatics background in clinical research domain within pharmaceuticals and Academia.


Kristen Bolt
Former Project Manager, Data Sharing and Transparency, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD

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Kristen Bolt is a data management expert with over 15 years of experience working with academic researchers, research administrators, and data contributors. As the former Program Manager for the Multi-Regional Clinical Trials Center she participated in and supported the design of a global clinical trial data sharing platform that will facilitate data sharing and transparency. In her previous positions at Harvard University and Harvard Medical School she designed a process and web application for sharing research metadata across multiple research administration stakeholders; thereby easing the organizational burden and accelerating the approval process for investigators. Her experience includes writing university and department policies to evaluate data sensitivity, data collection practices, and data management plans that also comply with state and federal regulations. She is also the Co-Chair of the Emerging Technologies, Ethics and Research subcommittee of the Harvard Clinical and Translational Science Award.

Kristen is a graduate of Harvard University.


Karla Childers
Senior Director, Strategic Projects, JOHNSON & JOHNSON

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Karla Childers joined Johnson & Johnson in October 2013 in the Office of the Chief Medical Officer where her primary responsibility has been leading the support and coordination of Johnson & Johnson’s Clinical Trial Data Transparency Initiative, including the management of the Yale Open Data Access (YODA) Project collaboration. In this role, she has been active in advocacy efforts supporting the implementation of responsible data sharing, including consultations with various health authorities and engagement with relevant stakeholder groups. Ms. Childers is also responsible for the management and conduct of the J&J Bioethics Committee, which serves as a forum to obtain guidance on bioethical questions within J&J.

Before joining J&J, she was an Associate Director in Global Project Management (GPM) in Merck Research Laboratories (MRL) for four years, where she managed cross-functional drug development teams in various therapeutic areas and stages of development. Prior to joining GPM, Ms. Childers was a bench chemist in MRL’s Process Chemistry group where she developed and executed multi-kilogram syntheses of advanced intermediates and active pharmaceutical ingredients (API). She also spent two years supporting outsourcing efforts in Process Chemistry and managed projects and partner relationships with contract research organizations in China, India, Europe and North America.

She received her Bachelor of Arts Degree in Chemistry from Indiana University-Purdue University in Indianapolis and a Master of Science in Jurisprudence (MSJ) with a concentration in Health Law from Seton Hall Law School.


Frantz Derilus
Associate Director, Clinical Trial Transparency, SHIRE

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Frantz Derilus is the Associate Director of Clinical Trials Transparency at Shire Pharmaceuticals. He has been the AD at Shire for two years. Prior to his tenure at Shire, He was the Senior Manager of Clinical Trials Transparency at GlaxoSmithKline for over 10 years. He has an undergraduate degree in Biology and Chemistry along with a Master’s Degree in Ethics. Frantz has over 17 years of experience within the Pharmaceutical Industry and 12 of those years have been directly within the Transparency field.


Khaled El Emam
President, Privacy Analytics, Director, QUINTILESIMS

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Dr. Khaled El Emam is the founder and President of Privacy Analytics and Director of Real World Evidence Solutions at QuintilesIMS. He is also a senior investigator at the Children’s Hospital of Eastern Ontario Research Institute, and previously held the Canada Research Chair in Electronic Health Information from 2005 to 2015. He is an expert in statistical de-identification and re-identification risk measurement. He is one of only a handful of individual experts in North America qualified to anonymize Protected Health Information under the HIPAA Privacy Rule.


Julia Farides-Mitchell, M.A.
Senior Project Manager, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

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Julia is a Senior Project Manager in CISCRP’s Communicating Trial Results Program, where she oversees the translation of clinical trial results into lay language for several research sponsor portfolios and works to design and implement results sharing programs with research sponsors throughout the industry. Her past experience in CISCRP’s Research Services division gives Julia a unique understanding of the needs of clinical trial participants, and she uses this understanding to inform her approach as she works to design and oversee results sharing programs. She also uses this experience to manage program evaluation activities across the whole Communicating Trial Results portfolio.

Julia holds a Master of Arts Degree in Sociology, with a concentration in Research Methods and Statistics. Prior to joining the CISCRP staff, she worked as a Psychometrist for a Neuropsychology practice.


Sulochana Gawande, Head of Oncology Medical Writing, EISAI

Sulochana Gawande, Ph.D.
Head of Submission Writing and Director of Publications, EISAI

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Sulochana (Sulu) Gawande’s academic background is in clinical cancer research, having done her MS and Ph.D. work in characterization of human leukemia and lymphoma cells. Her career in oncology drug development started at Eli Lilly & Company in 1999. There Sulu gained understanding of oncology publication and submission documents. She established and managed teams of medical writers both in the US and India. Later as a Clinical Research Scientist (Lilly), she successfully partnered with the clinical lead physician to build a program to test a new Lilly compound for the treatment of colorectal cancer.

As a submission management and regulatory lead in Novartis Oncology (2008-2013), Sulu submitted and gained approval of INDs, led many interactions with the FDA and Health Authorities, and guided teams in the preparation of various regulatory documents including the DSUR, IBs, responses to deficiency or clinical hold, etc. Additionally, she supervised large teams of medical writers in India and the U.S., managed the disclosure process for Novartis oncology studies, and contributed to the strategy and review of commercial and regulatory documents.

Since May 2013, Sulu has been the Head of Oncology Medical Writing and an executive reviewer for all oncology publications at Eisai. She has supervised three regulatory submissions and working on the fourth one. Sulu is also leading the ct.gov and EudraCT disclosure team and the data transparency process. With her passion for oncology and her experience in clinical, regulatory, and scientific communications, she continues to improve the quality of submission documents and the disclosure process at Eisai.


Greg Koski, President and Co-Founder, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)

Greg Koski, M.D., Ph.D.
President and CEO, ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)

Associate Professor, MASSACHUSETTS GENERAL HOSPITAL, HARVARD MEDICAL SCHOOL

Senior Scientist, MONGAN INSTITUTE FOR HEALTH POLICY

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Greg Koski, Ph.D., M.D., is President and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES).  He currently serves on the Board of Directors for SAFE-BioPharma Association and is a Senior Scientist at the James Mongan Institute for Health Policy.  Greg is an Associate Professor of Anesthesia, Harvard Medical School and Honorary Anesthetist, Massachusetts General Hospital.  He is an internationally recognized leader in clinical research, advocating a systemic approach to transforming the infrastructure and ecosystem for conducting clinical research globally.

As the first Director of the Office of Human Research Protections at the U.S. Department of Health and Human Services (OHRP), Dr. Koski championed a “culture of conscience” in human research, emphasizing the values and processes of professionalism and quality improvement, moving beyond mere regulatory compliance.  Aware of growing globalization of clinical research, he created the Program of International Activities within the OHRP.

Greg has been influential in many efforts to enhance human subjects research, including the development of accreditation for human research protections programs and certification of physician investigators, including consulting with the World Health Organization (WHO) to coordinate and strengthen global mechanisms for ethical conduct of human research and engaging with the World Medical Association to clarifying the intent and applicability of the Declaration of Helsinki regarding the use of placebos in clinical trials.

Today, he leads ACRES public interest efforts to build a shared, open global system for clinical research to benefit all stakeholders by aligning ethical principles with good business, scientific and medical practices while accelerating the development of medicines.


Debra Mayo, PharmD, MHA
Vice President, Global Scientific Communications, TEVA

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Debra holds a Bachelor of Science degree in Pharmacy from Temple University and a Master of Science degree, with a concentration in Health Care Administration and Health Care Education, from Saint Joseph’s University in Philadelphia. She completed her Pharm D at the University of Florida.

In her current role as Vice – President of Global Scientific Communications at Teva, Debra leads the medical communications and knowledge management groups. She oversees the strategic planning and execution of the Scientific Communications Plans and guides the management of a Global Knowledge Management System. Last year the scope of internal and external communications was expanded in the Sci Comm group to bridge identified information gaps through the use of digital communication channels. Patient centric activities, managed through Medical Affairs became a profound responsibility also.  Debra has held a variety of other roles in Medical Affairs over the years, including a very well-rounded experience working for a medical communication agency.


Pranab K. Mitra, Ph.D.
Associate Principal Scientist (Biostatistician), MERCK

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Pranab K. Mitra is currently working as a lead clinical trial biostatistician for several studies/programs in Merck. He has an extensive experience of more than 10 years in the pharmaceutical industry. In this role, he is responsible for study design, data analysis, CDISC submission, regulatory response, and primary publications. In addition, he gets involved in clinical trial data sharing (regulatory or academia) process. He is involved with several working group initiatives in Merck. He is a member of American Statistical Association.

Pranab holds Ph.D. in Statistics. Prior to Merck, he worked in Bristol-Myers Squibb.


Oladayo Oyelola, Ph.D.
Director, Clinical Trial Information Disclosure, DAIICHI SANKYO

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Dr. Oladayo Oyelola is Director of Clinical Trial Information Disclosure at Daiichi-Sankyo, Inc. He coordinates and is accountable for corporate strategy and operations of global clinical trial information disclosure and data sharing activities including internal training, process improvements and clinical trial transparency regulatory policy intelligence. He has also served in the same capacity at Sanofi Pasteur Inc., the Vaccine Division of Sanofi and as Head of the Clinical Medical Writing Group, leading regulatory writing activities on clinical projects and clinical study teams for novel vaccine and pharmaceutical products for the US, EU and other international regulatory submissions and marketing approvals.

Dr. Oyelola holds a B.S. in Biochemistry, M.S. in Applied (Nutrition) Chemistry, and Ph.D. in Clinical Chemistry along with professional certifications of the National Registry of Certified Chemists and the American Society for Clinical Pathologists.

He is a recipient of The Rockefeller Foundation Special Postdoctoral Fellowship Award and the National Mentor Role Model Award/Citation of the Minority Access Inc/Office of Minority Health, National Institutes of Health.

He has over 30 years’ experience in clinical and pharmaceutical research and development activities, including years of college undergraduate and graduate teaching and biomedical research. He is a member of the American Association for Clinical Chemists, the American Society for Clinical Pathology, and the Drug Information Association.


Liz Roberts
Senior Director, Global Lead Transparency and Data Sharing, UCB

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Liz is Senior Director, Global Lead, Transparency and Data Sharing at UCB. She relocated from the U.K. to the U.S. in 2009 and is currently based in Maryland. She is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform transparency and responsible data sharing. In addition, she is responsible for aligning best practices that will enable current and future global disclosure requirements including Global Clinical Trial Registration & Results Disclosure, Clinical Data Sharing, Lay Summaries, and other Transparency-related activities. Liz represents UCB on the TransCelerate workstream for Clinical Data Transparency and is also involved with sharing data for secondary research via ClinicalStudyDataRequest.com (CSDR). Prior to this role in Transparency, Liz had more than 20 years’ experience working as a statistician in the pharmaceutical industry and has an M.Sc. in Applied Statistics.


Frank Rockhold, Ph.D.
Professor of Biostatistics, DUKE CLINICAL RESEARCH INSTITUTE

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Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute and Managing Partner of HunterRockhold, Inc., (www.hunterrockhold.com). His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he recently retired as Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has also held faculty appointments at six different universities. Frank served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials. He is a past member of the PCORI Clinical Trials Advisory Panel and is on the board of the Frontier Science and Technology Research Foundation.

Frank holds a B.A. in Statistics from The University of Connecticut, a ScM in Biostatistics from The Johns Hopkins University, and a Ph.D. in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is a Fellow of both the American Statistical Association and the Society for Clinical Trials and an Accredited Professional Statistician, PStat®. He is widely published in major scientific journals across a wide variety of research topics.


Nathaniel Root, MSA
Associate Director, Clinical Disclosure and Transparency, IONIS PHARMACEUTICALS, INC.

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Nate received his Bachelor of Science in Biochemistry from the University of Michigan and a Master of Science Administration in research from Central Michigan University. He performed research at the University of Michigan and then merged into medical writing at MMS Holdings, a CRO after graduation. While at MMS Holdings, Nate fell into clinical disclosure and helped to develop and grow the disclosure department. After MMS, Nate spent a brief time in study management for the Alliance of Clinical Trials in Oncology before landing back in the disclosure world at Takeda. Nate has now been with Takeda for two years leading the disclosure department and helping with data transparency and lay summaries.


Trevor Standish
Business Analyst, SYNCHROGENIX

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Trevor Standish is the Product Manager at Synchrogenix. He manages all software applications that utilize its unique Artificial Intelligence platform which include Regulatory, Medical Writing and Transparency & Disclosure services. As it relates to EMA Policy 0070, Trevor manages the redaction solution which combines process, AI, and automation to enhance the delivery and experience for Synchrogenix clients. His vast expertise lies in defining and managing the delivery of innovative and scalable technology solutions. He has successfully launched numerous technology platforms with global implementations across multiple clients. His background spans multiple industries, and most recently he has helped create technologies within life sciences that enable Synchrogenix to be industry leaders across its Regulatory services portfolio.


Laura Troast
Director, Clinical Data Disclosure and Transparency, MERCK

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Laura Troast is Director of Clinical Trial Registration and Results Disclosure in the Clinical Data Disclosure and Transparency department at Merck & Co., Inc. Over the past ten years, Laura has overseen activities surrounding the registration and disclosure of results for Merck studies on ClinicalTrials.gov, EudraCT and ENCePP. Her concentration is in leveraging data integrity technical solutions in balance with the Microsoft Office suite of applications. She holds a B.S. in Biochemistry & Molecular Biology from Penn State University and an M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University.


Steven B. Whittaker
Senior Consultant, Executive Director, THE AVOCA QUALITY CONSORTIUM

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Steven Whittaker currently serves as Executive Director, Avoca Quality Consortium and as a senior consultant for The Avoca Group. He also is an independent consultant for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. Whittaker has served for sixteen consecutive years on the Advisory Board for the annual Partnerships in Clinical Trial program, chairing the board for two years. In addition, he regularly moderates quarterly Clinical Research Consortium forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across several top-tier pharmaceutical and biotech organizations.

Whittaker retired from Eli Lilly and Company where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform.


Thomas Wicks
Chief Strategy Officer, TRIALSCOPE

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Thomas is responsible for the product strategy of PharmaCM, TrialScope’s Clinical Trial Transparency Solution, which was acquired from Deloitte. He has more than 19 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 and has been a been on the PharmaCM team since 2007.

Prior to its acquisition of PharmaCM by TrialScope, Thomas served as the General Manager of PharmaCM at Deloitte and the Director of PharmaCM Product Management at Intrasphere Technologies before that. Before to joining Intrasphere, Thomas worked in leadership, client-facing positions for Revelwood Inc. and Shepherd Systems, focused on performance management solutions.


Jack Yeager
CEO, SYLOGENT

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Jack Yeager is the founder and CEO of Sylogent, a Philadelphia-based software products development company. He focuses on business information automation and enjoys sailing in his spare time.