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):
Time | Activity |
---|---|
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):
Time | Activity |
---|---|
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 |