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#40: Interdisciplinary Safety Evaluation During Product Development


Instructors

  • Jeremy  Jokinen, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Senior Director, Decision Sciences
    • AbbVie, Inc., United States

    Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel analytical approaches and methodologies to improve patient safety. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, and medical device research. He holds MS and PhD degrees in quantitative psychology from Ohio University.

  • Greg  Ball, PhD

    Greg Ball, PhD

    • Clinical Safety Statistics
    • Merck Research Laboratories, United States

    After graduating from Northwestern University with a bachelor’s in economics, Greg served in the Navy for 4 years and taught high school math and physics for 5 years, before going back to school to get a master’s in applied statistics from Purdue University. Eventually, while working as a statistician, he earned his PhD in Biostatistics from the University of Texas. Greg’s current research on blinded safety monitoring procedures emerged from his early work at academic medical centers and CROs, developed into his college dissertation and continues to be developed in collaboration with statistical and clinical scientists from several pharmaceutical companies.

  • Jacqueline A. Corrigan-Curay, JD, MD

    Jacqueline A. Corrigan-Curay, JD, MD

    • Director, Office of Medical Policy, CDER
    • FDA, United States

    Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the development, coordination, and implementation of medical policy programs and strategic initiatives, including policy development on real world evidence, drug labeling, prescription drug promotion, clinical trial oversight and innovative trial design. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

  • James  Buchanan, PharmD

    James Buchanan, PharmD

    • Drug Safety Consultant
    • Covilance LLC, United States

    Dr. James Buchanan is presently an independent drug safety consultant. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with Amgen, he moved to Nuvelo to establish a drug safety department and act as Chief Safety Officer where he also had responsibility for clinical operations, biostatistics and data management. Dr. Buchanan next served with BioSoteria for 5 years as the head of the medical and safety consulting group, which was subsequently acquired by Dohmen Life Science Services. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service.

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