Drug Policy and Strategy Analyses to Inform R&D and Strategic Planning Decisions
Identifies “drug lag”: delayed drug availability in the U.S. compared with the U.K.
Conducts first comprehensive study of the cost to develop a new drug: $54 million.
Demonstrates dramatic decline in effective patent life for new therapeutic compounds.
Completes first analysis of availability of drugs for limited populations, paving the way for the Orphan Drug Act of 1983
Develops first comparison of the rate of drug safety withdrawals in the U.S. and abroad.
Publishes first comprehensive analysis of the FDA’s practice of requiring post-approval research as a condition of approval.
Updates its seminal drug cost study: it now costs $231 million to develop a new drug.
Develops first international comparison of biotechnology product discovery, development, and marketing rates in the U.S., Europe, and Japan.
Publishes first comprehensive analysis of biotechnology success rates.
Provides data and public testimony at Congressional hearings that led to passage of the FDA Modernization Act of 1997(FDAMA).
Completes comprehensive analysis of FDA/sponsor meetings, showing that meetings reduce the time of new drug development.
Publishes analysis showing impact of the Prescription Drug User Fee Act of 1992 (PDUFA) on drug development times.
Provides first comprehensive analysis and review of FDAMA’s pediatric research incentive program.
Publishes first comparative analysis of new drug and biopharmaceutical approval times under the Centralized Procedure of the European Medicines Evaluation Agency (EMEA) and the U.S. FDA.
Updates its ongoing analysis of average cost of pharmaceutical R&D. It now costs $802 million to develop a new drug and bring it to market.
Provides first assessment of the impact of the FDA’s new fast track program on total development times.
Completes analysis on the economics of follow-on drug development and incremental innovation.
Provides quantitative evidence demonstrating the lack of correlation between drug safety withdrawals and speed of regulatory approval.
Publishes first comprehensive estimate of the average cost of developing a new biotechnology product, and pegs it at $1.2 billion.
Publishes extensive analyses on oncology drug R&D. Overall approval success rate is 8%.
Publishes quantitative analysis demonstrating that U.S. drug plans, in covering 88% of drugs in six specific therapeutic areas are non-compliant with Medicare regulations.
Updates its ongoing analysis of new drug clinical success rates. Overall clinical success rates have fallen to 16%.
Documents integration of orphan drug development into drug company portfolios, representing 25% of all new approvals, and a doubling of designations in past decade.
Provides first analysis documenting lack of clinically useful diagnostics and how it is hindering growth in personalized medicines.
Provides first analysis documenting the dramatic rise in protocol complexity.
Updates its ongoing analysis of average cost of pharmaceutical R&D: it now takes $2.6 billion to develop a new drug.
Publishes first comprehensive analysis of vaccine development trends.
First to document the rapid growth of pharmaceutical benefit managers Exclusion Lists, and the challenges these pose to drug developers.
First to demonstrate that drugs utilizing FDA’s 505(b)(2) regulatory pathway, which is supposed to speed the review process, take, on average, five months longer to approve than new molecular entity approvals.