Bio:

Dr. Faranak Jamali is a senior medical officer/compliance reviewer in FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI), Division of Enforcement and Post-marketing Safety (DEPS), Compliance Enforcement Branch (CEB). She has been with FDA for over 15 years of experience. In her current role, she is responsible for helping to ensure human subject safety and data integrity in clinical studies as part of FDA’s BIMO program. Previously, she has served FDA as a clinical reviewer in CDER’s Office of New Drugs (OND).

Her background education is in the field of anatomic and clinical pathology, and fellowships in hematopathology, transfusion medicine, and integrative medicine.

She has been one of the authors of a recently published FDA publications, “An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations,” in Therapeutic Innovation and Regulatory Science.

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Dr. Oladayo Oyelola is Senior Director and Global Head, Clinical Trial Information Disclosure at Daiichi Sankyo, Inc. He is responsible for corporate strategies and operations for global clinical trial information disclosure and clinical data sharing compliance activities. He also manages and coordinates internal trial disclosure operations’ training, process improvements and clinical trial transparency regulatory policy intelligence.

He has also served in the same capacity and as Head of the R&D Clinical Medical Writing Platform at Sanofi Pasteur Inc., the Vaccine Division of Sanofi during which he led regulatory medical 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 BS degree in Biochemistry, MS in Applied (Nutrition) Chemistry, and PhD degree in Clinical Chemistry. He received The Rockefeller Foundation Special Postdoctoral Fellowship Award with tenure at the University of Cincinnati and Cardiovascular Research Center 1991 – 1993; and the National Mentor Role Model Award/Citation of the Minority Access Inc. / Office of Minority Health, National Institutes of Health in 2001.

He has over 35 years’ experience in clinical and pharmaceutical R&D activities along with professional certifications of the National Registry of Certified Chemists and the American Society for Clinical Pathologists.

He is a member of the American Association for Clinical Chemists, the American Society for Clinical Pathology, and the Drug Information Association.

Contact Information Oladayo Oyelola, PhD, SC(ASCP) Senior Director and Head, Clinical Trial Information Disclosure Global Regulatory Operations, Information & Compliance Daiichi Sankyo, Inc. 211 Mt. Airy Road Basking Ridge, NJ 07920 USA Direct Line:    +1 (908) 992-6478 Email: ooyelola@dsi.com

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Dr. Oladayo Oyelola is Senior Director and Head, Clinical Trial Information Disclosure at Daiichi Sankyo. He is responsible for corporate strategies and compliance operations on clinical trial transparency/data sharing; and coordinates internal disclosure operations’ training, process improvements and transparency policy intelligence. He held the same position at Sanofi Pasteur – 2005 to 2016.

He holds a PhD degree in Clinical Chemistry, 1990. He received The Rockefeller Foundation Postdoctoral Fellowship, 1991 and National Mentor Role Model Award of Minority Access Inc/Office of Minority Health, NIH, 2001.

He has over 35 years’ experience in clinical and pharmaceutical R&D: Professional certifications of the National Registry of Certified Chemists and the American Society for Clinical Pathologists.

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Dr. Oladayo Oyelola is Senior Director and Head, Clinical Trial Information Disclosure at Daiichi Sankyo. He oversees corporate clinical trial transparency/data sharing strategies and compliance activities; coordinates internal disclosure operations’ training, process improvements and trial transparency policy intelligence.

He holds a PhD in Clinical Chemistry from Obafemi Awolowo Univ. Ile-Ife, Nigeria, 1990 and received The Rockefeller Foundation Postdoctoral Fellowship, 1991 and National Mentor Role Model Award of Minority Access Inc/Office of Minority Health, NIH, 2001.

Dr. Oyelola has over 35 years’ experience in biomedical R&D, and certifications by National Registry of Certified Chemists and American Society for Clinical Pathologists.

Operations activities

Laura Troast has been working in the disclosure and transparency space at Merck & Co., Inc. since 2006. She is a director within their Clinical Data Disclosure & Transparency (CDD&T) group, currently operating as Head of Medical Writing. Laura holds a B.S. in Biochemistry and Molecular Biology from Penn State University and an M.S. in Regulatory Affairs from Northeastern University.