Research Papers:
FDA's Approvable and Related NDA/BLA ActionsWhite Papers:
Strategy from Science: Evidence-based Scientific Management Principles for Life Science R& D
Introduction to Data Montoring Committees
Selected Publications:
Optimizing Clinical Protocol Development to Enhance Research Productivity NGP
Procedure-related Benchmarks to Inform and Streamline Study Design NGP
Build or Buy Critical eClinical Applications NGP
Smart Clinical Research Protocols JCRBP
The Extensible Clinical Protocol: Setting Up Trials for Successful Execution NGP
Entry Order as a Consideration for Innovation Strategies NRDD
Disappointing Article; Not Disappointing Biotech (Letter) BMJ
Macro Trends in Pharmaceutical Innovation NRDD
Condensed version of above article Discovery Med
The Fast Track Effect NRDD
What Ails the FDA (Letter) NEJM
Trends in Antihyperglycemic Prescribing Diabetes Care
Other publications by Dr. Cohen
Free Tools :
Calculator for inflation adjustment of US prescription sales data
PGS In the News: Pharmacy Times - 12/06 Internal Medicine World Report - 11/06 Nature Reviews Drug Disc. - 10/06 Pharmaceutical Executive - 6/06 Knight Ridder - 4/06 PGS Press Release - 4/06 Indianapolis Star - 3/06 Cincinnati Business Courier - 2/06
Pharma's Cutting Edge - The PGS blog by Dr. Fred Cohen