A schedule of events for the second annual M-CERSI Day is provided below for your convenience.

M-CERSI Day is a one-day conference scheduled for Thursday, September 5, 2013, at the University of Maryland School of Pharmacy. Although morning sessions are open to the public, the afternoon agenda only offers closed-door sessions that are open only to researchers from the University of Maryland and the FDA, members of the M-CERSI Advisory Panel, and members of the M-CERSI Industrial Consortia.

Morning Agenda (Open Sessions):

8:30-9:00 a.m. Registration and Light Breakfast
9:00-9:15 a.m. Welcome and Introduction
James Polli, PhD
Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
University of Maryland School of Pharmacy

William Bentley, PhD
Robert E. Fischell Distinguished Professor and Chair
Fischell Department of Bioengineering
University of Maryland, College Park

Frank Weichold, MD, PhD
Director of Regulatory Science and Innovation
Food and Drug Administration

Natalie D. Eddington, PhD, FAA PS, FCP
Dean and Professor
University of Maryland School of Pharmacy
9:15-9:40 a.m. Innovative Trial Designs: A Triple Win for Patients, Health Care Providers, and Manufacturers
Jason Connor, PhD
Statistical Scientist
Berry Consultants
9:40-10:05 a.m. Improving Consistency through Product Review Modernization
Charles Cooper, MD*
Medical Officer, Office of Translational Sciences
Food and Drug Administration
10:05-10:30 a.m. Biomarker As A Drug Development Tool and Biomarker Qualification at FDA/CDER
Shashi Amur, PhD*
Biomarker Qualification Scientific Coordinator
Food and Drug Administration
10:30-11:00 a.m. Break
11:00-11:25 a.m. Streamlining the Development and Approval Processes for 505(B)(2) NDA Applications
Sanjay Sehgal, PhD
Managing Director
Aexelar Regulatory Experts, LLC
11:25-11:50 a.m. Research Initiatives in FDA Office of Generic Drugs
Robert Lionberger, PhD*
Chemist, Office of Generic Drugs
Food and Drug Administration
11:50-1:00 p.m. Lunch and Poster Session

*Indicates speaker was invited to deliver a presentation at M-CERSI Day.

Afternoon Agenda (Closed Sessions):

1:00-2:30 p.m. Project 1 Meeting: Improving Pre-Clinical Assessments of Safety and Efficacy
Location: Pharmacy Hall, Room N208
1:00-2:30 p.m. Project 2 Meeting: Ensuring Readiness
Location: Pharmacy Hall, Room S410
1:00-2:30 p.m. Project 3 Meeting: Harnessing Diverse Data
Location: Pharmacy Hall, Room N310
1:00-2:30 p.m. Project 4 Meeting: Minority Health
Location: Pharmacy Hall, S103
2:30-3:30 p.m. Feedback and Wrap-Up
Feedback collected from M-CERSI Advisory Panel and Industrial Consortia Members
Location: Pharmacy Hall, Room N203