The First UMBC–Stanford Workshop
on Clinical Trials and Regulatory Science

Event Summary: A one-day workshop organized by the Center for Interdisciplinary Research and Consulting at the University of Maryland, Baltimore County (UMBC), and the Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.

Registration is now closed

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Organizing Committee:
Yi Huang (UMBC)
Nagaraj Neerchal (UMBC)
Bimal Sinha (UMBC)
Tze Lai (Stanford)
Phillip Lavori (Stanford)
Ying Lu (Stanford)
Jie Chen (Novartis)
Joseph Heyse (Merck)

For more information: Please contact Dr. Yi Huang, Department of Mathematics and Statistics, University of Maryland Baltimore County (UMBC), 1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.

For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.




Precision Medicine: Challenges and Opportunities from Regulatory, Clinical and Statistical Perspectives
 
Date: Sept. 19, 2015 (Saturday)
Time: 8:00 am - 6:30 pm
(Lunch and Coffee Breaks in Public Policy Atrium)
Location: UMBC Physics 101 and Public Policy 105
University of Maryland, Baltimore County
1000 Hilltop Circle, Baltimore, MD 21250
Plenary Speakers: Dr. Robert Temple
Deputy Director CDER/FDA
Title: "Enrichment Designs in Precision Medicine"

         and

Dr. Eric Gibson
Global Franchise Head, Novartis Pharmaceuticals Corporation
Title: "Precision Medicine: Matching the Right Treatment at the Right Dose to the Right Patient".

The inaugural 2015 UMBC-Stanford Workshop features an opening introductory remark by Professor Lai of Stanford on "Clinical Trials and Regulatory Science: Recent Development and New Directions" and two plenary lectures by Dr. Robert Temple of the US Food and Drug Administration and Dr. Eric Gibson of Novartis. Following the plenary talks, a floor panel discussion will be held in late morning. The afternoon program will feature parallel invited and contributed sessions. This one-day workshop at UMBC immediately follows the 2015 FDA-Industry workshop in Washington D.C., providing networking opportunities for registered participants who will be served lunch in addition to coffee breaks.


Objectives: This UMBC-Stanford Workshop Series brings together regulators, academic researchers, and industry professionals to explore prominent issues of common concern, particularly those related to laboratory and clinical development and subsequent regulation of biopharmaceutical products.

Target audience: Clinicians, statisticans, regulatory scientists, and other drug development professionals.

Organizing Committee: Yi Huang (UMBC), Nagaraj Neerchal (UMBC), Bimal Sinha (UMBC), Tze Lai (Stanford), Philip Lavori (Stanford), Ying Lu (Stanford), Jie Chen (Novartis), Joseph Heyse (Merck).

For more information: Please contact Dr. Yi Huang, Department of Mathematics and Statistics, University of Maryland Baltimore County (UMBC), 1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.