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Roger Berlin, MD

Roger Berlin, MD is a pharmaceutical strategy consultant at 1.618 Consulting, LLC, and was also involved in numerous FDA advisory committee meetings as a presenter and team lead.

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Mitchell G. Kaye, MD

Mitchell Kaye is Medical Director and Principal Investigator of Clinical Research for the Minnesota Lung Center.

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Eric Brass, MD, PhD, Board Chair

Eric Brass is Director of the Center for Clinical Pharmacology at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA.

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Gregory Burkhart, MD

Gregory Burkhart is a regulatory consultant who was a former team leader and epidemiologist at the FDA. Dr. Burkhart has significant FDA and industry experience in both pre-marketing and post-marketing drug development.

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Bruce Burlington, MD

Bruce Burlington is an infectious disease internist and currently serves as the industry representative on the FDA’s Drug Safety and Risk Management Advisory Committee.

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Louis R. Cantilena, Jr., MD, PhD

Louis R. Cantilena, Jr. is Professor of Medicine and Director of the Division of Clinical Pharmacology and Medical Toxicology for the Uniformed Services University of the Health Sciences in Bethesda, Maryland.

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Heidi M. Jolson, MD, MPH

Heidi M. Jolson is an independent consultant to the pharmaceutical industry, specializing in clinical drug development and regulatory strategy.

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Paul Waymack, MD, ScD

Paul Waymack is a regulatory consultant, and previously worked as an FDA Medical reviewer and special consulting reviewer, responsible for assessing new drug applications and investigational drug applications.

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Janet Wittes, PhD

Janet Wittes is the President of Statistics Collaborative, Inc., which provides statistical collaboration for clinical trials and epidemiology to industry, government and non-profit researchers.

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