Notes from presentations delivered at the second annual M-CERSI Day have been provided below for the convenience of conference participants.
Biomarker as a drug development tool (DDT) and biomarker qualification at CDER, FDA
Amur Notes
Shashi Amur, PhD
Biomarker Qualification Scientific Coordinator
Food and Drug Administration
Innovative Trial Designs: A Triple Win for Patients, Health Care Providers, and Manufacturers
Connor Notes
Jason Connor, PhD
Statistical Scientist
Berry Consultants
Improving Efficiency and Consistency in the FDA Review Process
Cooper Notes
Charles Cooper, MD
Acting Deputy Director, Computational Science Center
Office of Translational Sciences
Center for Drug Evaluation and Research Food and Drug Administration
Research Initiatives in FDA's Office of Generic Drugs
Lionberger Notes
Robert Lionberger, PhD
Chemist, Office of Generic Drugs
Food and Drug Administration
Streamlining Development and Approval Processes for 505(B)(2) NDAs
Sehgal Notes
Sanjay Sehgal, PhD
Managing Director
Aexelar Regulatory Experts, LLC
Driving Biomedical Innovations by Advancing Regulatory Science at FDA
Frank Weichold, MD, PhD
Director of Regulatory Science and Innovation
Food and Drug Administration