Henry "Skip" Francis, M.D. , Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Henry From March 11, 2013 to the present, Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.  In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating the efficient use of scientific methods to evaluate complex data information in order to make regulatory decisions for drug approval and drug safety.

From October of 2007 until March 10, 2013, Dr. Francis was the deputy director of the Office of Surveillance and Epidemiology (OSE) in the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA).  Dr. Francis works with the OSE director to lead 5 divisions of pharmacy and clinical scientists in the detection and study of adverse medical events (AE’s) occurring after the release of new drugs into the American health market, also called the post market period.   Dr. Francis’s specific interest is in the development of data mining techniques to enhance pharmacovigliance capabilities in national medication use and health care databases.

Prior to working in FDA, Dr Francis was a basic and clinical researcher in the National Institute of Allergy and Infectious Diseases in the National Institutes of Health (NIH).  As an AIDS clinical investigator, he worked in several clinical and epidemiologic research projects conducting AIDS and tropical  research projects in the Democratic Republic of the Congo (DRC, formerly known as Zaire) and other projects in the Caribbean and the South Pacific.   In the DRC, Dr. Francis was the Director of the U.S. Public Health Service & Belgian Project SIDA (AIDS research) Research Laboratories in Kinshasa, DRC.

Dr. Francis served as the first Director of the National Institute on Drug Abuse’s (NIDA) Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA).  CAMCODA’s mission was to establish sustainable AIDS specific research projects in coordination with the other NIDA projects investigating drug abuse prevention and treatment.

As a clinician, Dr. Francis was an assistant professor of medicine at the Johns Hopkins University School of Medicine’s Division of Infectious diseases where he served as the Principal Medical Officer of the Broadway Women’s Drug Use Center and as the Ryan White Title III investigator and medical Director of the Baltimore City Department of Health’s Sexually Transmitted Diseases clinics.

He completed his Internal Medicine residency training at the Long Beach Veterans Administration Hospital in Long Beach, California and his infectious diseases specialty training at the Johns Hopkins Hospital Division of Infectious Diseases, Baltimore, Maryland.  He has published over 60 papers and book chapters on U.S. and international public health issues.

Sessions

1:55 PM - 2:25 PM

Applying AI to Augment Regulatory Affairs Knowledge

Technological capabilities in the area of AI are advancing rapidly. Meanwhile, data is being collected from numerous sources, from electronic health records to wearable devices. In addition, the drug development landscape is becoming more transparent as further data is made publicly available. AI can be used to analyze this data and facilitate access to information and insights needed to formulate drug development and regulatory strategies. This presentation will examine opportunities and challenges related to the use of data science and AI to better understand and innovate within the regulatory environment.
  • Henry

    Henry "Skip" Francis, M.D. Director for Data Mining and Informatics Evaluation and Research
    Office of Translational Sciences
    Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

  • Nicholas Drago

    Nicholas Drago Assistant Director of Regulatory Policy & Intelligence Bayer Pharmaceuticals


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