Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...

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3/15/13% R & D Efficiency Declining (Inflation Adjusted) Diagnosing the decline in pharmaceutical R&D efficiency Jack W. Scannell, Alex Blanckley, Helen Boldon & Brian Warrington Nature Reviews Drug Discovery 11, 191-200 (March 2012) Key Elements of Drug Development Medical Will the drug work How well In what indications Discovery Chemistry Can we manufacture it Safely With consistent quality Pharmacology / Toxicology How does it work What are the toxic effects in the body 6%
3/15/13% Transition probabilities 1993-2002 DiMasi and Grabowski (2007a) NDAs are Filed Electronically and Can Consist of as Many as 15 Different Sections: • Index • Summary • Chemistry, Manufacturing, and Control (CMC) • Samples, Methods Validation Package, and Labeling • Nonclinical Pharmacology and Toxicology • Human Pharmacokinetics and Bioavailability • Microbiology (for anti-microbial drugs only) • Clinical Data • Safety Update Report (typically submitted 120 days after the NDA's submission) • Statistical • Case Report Tabulations and Case Report Forms • Patent Information and Patent Certification • Other Information FDA Pain Points in Drug Development • Bureaucratic & slow • Not creative • Risk averse especially to innovative technologies 7%
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Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...