Speakers

2018 Speakers

Click on a speaker’s name for their full bio.  Speaker information will be updated as received.



Justin T. Baker, M.D., Ph.D.
Assistant Professor
Director of Functional Neuroimaging & Bioinformatics
Schizophrenia and Bipolar Disorder Program, Scientific Director, Institute for Technology in Psychiatry
McLean Hospital. Harvard Medical School


Henry Chen, MBA
Principal Offering Manager
IBM Watson for Drug Discovery


Cartier Esham, Ph.D.
Executive Vice President for Emerging Companies
Biotechnology Innovation Companies (BIO)


Baruch Fischhoff, Ph.D.
Howard Heinz University Professor
Department of Engineering and Public Policy
Institute for Politics and Strategy
Carnegie Mellon University


Peter Honig, M.D., M.P.H.
Senior Vice President and Head
Worldwide Safety and Regulatory
Pfizer


Jake LaPorte, Ph.D.
Head of Digital Development
Global Drug Development
Portfolio Strategy & Innovation
Novartis


Shanthi Ganesham, Ph.D.
Head of Oncology
North American Regulatory Affairs
Novartis Pharmaceuticals


Michael Holmes, Ph.D.
Vice President, Research
Sangamo Therapeutics


Ed Margerrison, Ph.D.
Director
Office of Science and Engineering
Federal Drug Administration


Mark B. McClellan, M.D, Ph.D.
Director and Robert J. Margolis, MD Professor of Business
Medicine and Policy, Duke University
Senior Health Policy Advisor
Dell Medical School, The University of Texas at Austin


Mehul Mehta, Ph.D.Mehul Mehta, Ph.D. FDA, CDER
Director
Division of Clinical Pharmacology I Office of Clinical Pharmacology
Federal Drug Administration


MiksinskiSarah Pope Miksinski, Ph.D.
Astra Zeneca


Richard Moscicki, M.D.
Chief Medical Officer
Executive Vice President
Pharmaceutical Research and Manufacturers of America (PhRMA)


Gary Noel, M.D.
Pediatric Infectious Disease
Chair Janssen’s Pediatric Advisory Committee
Drug Development Center of Excellence
Johnson and Johnson


Paul Seo, Ph.D.Paul Seo, Ph.D. FDA, CDER
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA, CDER,OPS


Salomon Stavchansky, Ph.D.Stavchansky
ICD2 Conference Scientific Chair
Professor of Pharmaceutics
UT Austin College of Pharmacy


Robert Temple, M.D. – Appearance Canceled 2/8/18
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-I)
Center for Drug Evaluation and Research
Federal Drug Administration


Henrietta Ukwu, MD, FACP, FRAPS
Senior Vice President
Head of Global Quality & Global Regulatory Affairs
Otsuka Pharmaceutical


Wendy Wilson-Lee, Ph.D.
Acting Branch Chief
Office of New Drug Products
Center for Drug Evaluation and Research
Federal Drug Administration


Celia Witten, M.D., Ph.D. 
Deputy Director
Center for Biologics Evaluation and Research
Food and Drug Administration


Janet Woodcock, M.D.Janet Woodcock, M.D. FDA, CDER
Director
FDA, CDER


Andrew Wright
Vice President
Digital Medicine
Otsuka Pharmaceutical Companies



Moderators


chiociolaArthur A. Ciociola, Ph.D., F.A.C.G.
Vice President, Head of Global Regulatory Affairs
Alcon Research, Ltd.


John EngelJohn M. Engel, Esq.
Founder and Managing Member
EngelNovitt, PLLC


hoibergCharles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc


Kay Holcombe Biotechnology Industry AssociationKay Holcombe
Retired
Former Senior Vice-President Science Policy
Biotechnology Industry Association (BIO)


Pravin Jadhav, Ph.D, MPH, MPharm
Senior Director
Corporate Projects, R&D Innovation
Otsuka Pharmaceutical Development and Commercialization (OPDC)


kaitinKenneth I. Kaitin, Ph.D.
Professor and Director • Tufts Center for the Study of Drug Development
Tufts University


Masciale2016Andrea Masciale
Vice President
Regulatory Policy and Global Analytics
Johnson & Johnson Worldwide Government Affairs & Policy


Mehul Mehta, Ph.D. FDA, CDERMehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
OTS, CDER, FDA


miksinski popeSarah Pope Miksinski, Ph.D.
Astra Zeneca


Nicholas Pelliccione, Ph.D.
Vice President, Regulatory Affairs
Turing Pharmaceuticals


Lisa_ShipleyLisa A. Shipley, Ph.D.
Vice President & Global Head
Pharmacokinetics,
Pharmacodynamics & Drug Metabolism
Merck & Co., Inc.


Gretchen Trout
Head, North America Policy & FDA Liaison
Regulatory Affairs
Novartis Pharmaceuticals Corp.


RinaidiPaula Rinaldi
North American Head of DRA
Novartis Pharmaceuticals


Paul Seo, Ph.D.Paul Seo, Ph.D. FDA, CDER
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA, CDER,OPS


yakatan

Gerald J. Yakatan, Ph.D.
Founder & Chairman
IriSys, Inc.


Texas Pharmacy: The University of Texas at Austin College of Pharmacy