Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
346
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
252AB
CHAIR
:
Rebecca D. Kush, PhD (SCHNON), President and CEO, CDISC, United States
Rebecca Daniels Kush, Ph.D. is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC). Dr. Kush has worked for the NIH, academia, a global CRO and pharmaceutical companies in the U.S. and Japan. Dr. Kush earned a Ph.D. in Physiology and Pharmacology from t
SPEAKER
(S):
David C. Jordan, PhD,MSc (SPKNON), Leader, Data Standards Project, TransCelerate Biopharma Inc., United States
David Jordan (MS,PhD statistics - U.Kentucky) has 35+ years in pharma. Since retiring from Abbott in 2012 as DVP, Statistics and Data Mgmt, Dr. Jordan is engaged in biopharma industry consulting, such as with AbbVie, and is leading the data standards development project for TransCelerate Biopharma.
Brian Harvey, MD (SPKNON), Vice President, US Regulatory Strategy, Pfizer Inc, United States
Brian Harvey, MD, PhD is VP US Regulatory, Pfizer, led US Reg Policy at Sanofi. At US FDA (1995–07), CDRHCBERCDER) incl. as Dir of Division of Gastroenterology Products. 2000-01, American Political Science Association (APSA) Congressional Fellow, worked on health & scientific issues at US Senate
Ron Fitzmartin, PhD,MBA (SPKAGY), Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER, FDA, United States
Ron Fitzmartin is Sr Advisor, Office of Planning and Informatics, CDER, FDA. Ron held positions at Decision Analytics, Daiichi Sankyo, & Purdue Pharma. Degrees: PhD in statistics; Univ of Maryland, MBA; Univ of New Haven; and MS / BS - So. Conn. State Univ. DIA President, 2007-09.
Description
The Coalition for Accelerating Standards and Therapies (CFAST) was formed by the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) "to accelerate clinical research and medical product development by creating and maintaining data standard, tools and methods for conducting research in therapeutic areas that are important to public health." CFAST was officially launched in October 2012. This session will focus on CFAST activities, specifically the development of data standards and the implementation of these standards to accelerate the development and review of new therapies and to enhance the information that can be obtained from streamlining the sharing, aggregation and analysis of clinical research data. CFAST is working with FDA, TransCelerate, the Innovative Medicines Initiative (IMI), ACRES, other partners and countless volunteers in this endeavor.