Faculty – 3rd Disclosure and Transparency for Clinical Data Summit


Behtash Bahador
Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION AND STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

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Behtash Bahador is a Senior Manager at the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). With a background in health communication, Behtash leads quality and compliance assurance on programs that communicate clinical trial results in plain language for patients and the public. He works directly with a wide range of industry sponsors on global implementation and aligning best practices in health communication with regulatory and industry guidelines.


Jo Anne Blyskal
Head of Global Regulatory Medical Writing and Data Disclosure, TEVA PHARMACETICALS


Mary Brantner
Senior Director, Head of Global Development Operations Process and Systems, MALLINCKRODT PHARMACEUTICALS


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.


Deborah Collyar
President, PATIENT ADVOCATES IN RESEARCH (PAIR)

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Deborah Collyar has applied a wealth of leadership skills from her successful IT business career to help create patient-centered medical research and healthcare, after her first cancer diagnosis at the age of 32. She founded Patient Advocates In Research (PAIR) in 1996, “where research meets reality.” Her work encompasses many diseases, programs, and policies at grassroots, national, and international levels.

In collaboration with the U.S. National Cancer Institute (NCI) and academic institutions, she helped create the SPORE program to translate scientific discoveries into patient tools, and trained hundreds of community members through the Patient Advocate Research Team (PART) Program. Deborah now helps all clinical trial sponsors and groups establish patient engagement programs that inform protocol development through recruitment and retention, and to create public study result summaries. Deb is a DIA Patient Fellow, a Komen Advocate in Science, and serves on several boards, including Experimental Therapeutics committees, the ASCO TAPUR Data Safety and Monitoring Board, the Society for Immunotherapy in Cancer, and the Institute of Clinical and Economic Review (ICER). She is also a member of the Patient Leadership Team on 2 DCIS PCORI grants. She and her husband have survived 3 cancers, and they work with multiple communities and patients.


Kelly DiGian, Ph.D., MBA
Director, Data Transparency and Disclosure, TEVA PHARAMCEUTICALS


Julia Farides-Mitchell, M.A.
Senior Manager, Account and Project Management, 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.


Joyce Hauze, CCRA, ACRP-PM
Associate Director, Clinical Trial Disclosure and Transparency, MALLINCKRODT PHARMACEUTICALS


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.


Catina O’Leary
President and CEO, HEALTH LITERACY MEDIA (HLM)


Bob Stewart
Board Member and Chief Technology Officer, THE ALLIANCE FOR CLINICAL RESEARCH EXCELLENCE AND SAFETY (ACRES)


Asba Tasneem, Ph.D.
Informatics Portfolio Leader, Data Sharing Lead at DCRI, DUKE CLINICAL RESEARCH INSTITUTE

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Dr. Tasneem is a Clinical Research Informatics Leader at Duke Clinical Research Institute where she manages DCRI’s data sharing program, Supporting Open Access for Research (SOAR). Under this program, DCRI has collaborations with Bristol-Myers Squibb, SAS, and American Heart Association (AHA). Dr. Tasneem joined DCRI in 2010 to develop an Aggregate Analysis Dataset of ClinicalTrials.gov (AACT Database). One of her manuscripts about this project was showcased at the American Medical Informatics Association Spring Summit, calling it “one of the top 25 papers in the field of clinical research informatics.” From 2014 to 2018, Dr. Tasneem worked at the Office of Research Informatics, Duke University School of Medicine, where she managed a 22-site clinical data research network with patient population of 50 million.

Prior to joining Duke, Dr. Tasneem was a Bioinformatics Scientist at the National Library of Medicine (NLM/NIH) where she developed conserved domain models for identified superfamilies using genome sequence analysis and structure-sequence comparisons. Her experience in private sector includes working at Strategy& as a Biomedical Informatics subject matter expert. Her academic research included tracking large-scale evolutionary trends in Ligand Gated Ion Channels and discovering nicotinic acetylcholine receptors homologs in bacteria.


Christopher Trudeau, J.D.
Associate Professor and Regulatory Knowledge and Support Group Leader, UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES’ TRANSLATIONAL RESEARCH INSTITUTE

Associate Professor of Law, UNIVERSITY OF ARKANSAS, LITTLE ROCK, WILLIAM H. BOWEN SCHOOL OF LAW

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Christopher R. Trudeau, JD, leads the Regulatory Knowledge & Support function for the University of Arkansas for Medical Sciences’ Translational Research Institute. He is also an Associate Professor at the University of Arkansas Little Rock, Bowen School of Law.

Professor Trudeau is an internationally recognized expert on clear legal communication, informed consent, and health literacy. He is the first lawyer to be appointed to the National Academies of Science, Engineering, and Medicine’s Roundtable on Health Literacy and the FDA’s Risk Communication Advisory Committee. He frequently speaks on clearly communicating about clinical trials, on the impact of GDPR and the Revised Common Rule on consent practices, and on integrating health literacy best practices throughout clinical trials.