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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

    Dr. Greg Ball’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. He is a co-lead for the ASA Safety Monitoring working group, focusing on safety regulations and cross-disciplinary scientific engagement.

  • 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. Buchanan has been in the pharmaceutical industry working in drug safety for over 30 years. He started his career at Genentech and led the drug safety departments at a number of subsequent companies, Gilead Sciences, Tularik and Nuvelo, before serving as the head of the medical and safety consulting group at BioSoteria. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He has also been teaching the DIA course on Advanced Signal Detection for a number of years and teaches drug safety at the UC Berkeley Extension program on clinical development.

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