SCT/QSPI AND FDA PRESENT

Innovations in the Science and Practice of Clinical Trials

December 9-10, 2014


The Universities at Shady Grove Conference Center, Rockville, Maryland

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Join colleagues from a wide range of clinical research disciplines as we showcase innovation and partnerships to advance the science and practice of clinical trials, with contributions from FDA, industry, academia, and patient groups.

  Clinical trial design and analysis
Small trials for rare diseases and large trials for rare events

Streamlining clinical trial operations
Central IRBs, master clinical trial agreements, and wearable technology for real-time monitoring

Patient partnerships in clinical trials
Patient group engagement and regulatory efforts to include patient preferences in decision-making

Leveraging underutilized information sources in trial planning and analysis
Shared data, administrative claims databases, and product life-cycle safety data synthesis

Confirmed speakers (more TBA): Jesse Berlin (Janssen R&D), Cong Chen (Merck), Alex Dmitrienko (Quintiles), Sharon Hesterlee (Parent Project Muscular Dystrophy), Telba Irony (FDA/CDRH), Bennett Levitan (Janssen R&D), Michelle McMurry-Heath (FDA/CDRH), Theresa Mullin (FDA/CDER), Elektra Papadopoulos (FDA/CDER), Steve Snapinn (Amgen), Veronica Todaro (Parkinson’s Disease Foundation)


Our target audience includes statisticians, clinicians, epidemiologists, drug safety professionals, study management professionals, and medical scientists from the biopharmaceutical industry, government, and academia who are interested in recent developments in improving clinical trials, and patient representatives and advocates who share those interests.






PROGRAM CHAIRPERSONS

Mike Hale, PhD
John Scott, PhD


PROGRAM ORGANIZING COMMITTEE


Patrick Archdeacon, MD 
Janelle K. Charles, PhD 
Dixie Ecklund, PhD 
Martin Ho, MS
Qi Jiang, PhD 
Olga Marchenko, PhD 
Daniel Sargent, PhD 
Dave Stock, PhD 
Pamela Tenaerts, MD, MBA
Marc Walton, MD, PhD 
Yun-Ling Xu, PhD 



 

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