 |
| 2006 |
2006 Publishes first comprehensive estimate of the average cost of developing a new biotechnology product, and pegs it at $1.2 billion. |
|
| 2005 |
Publishes quantitative evidence demonstrating the lack of correlation between drug safety withdrawals and speed of regulatory approval. |
|
| 2004 |
Demonstrates that follow-on
drugs are typically developed contemporaneously
with the first product in the class and offer
therapeutic value. |
|
| 2003 |
Provides first comprehensive assessment of the impact of FDA's new fast track program on total development times. |
|
| 2002 |
Quantifies potential cost savings that could be achieved by improving product success rates and shortening development cycles. |
|
| 2001 |
Updates its ongoing study of the average R&D cost of developing and bringing a new drug to market. It now costs $802 million. |
|
| 2000 |
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. |
|
| 1999 |
Provides first comprehensive analysis and review of FDAMA's pediatric research incentive program. |
|
| 1999 |
Publishes analysis showing impacts of the Prescription Drug User Fee Act of 1992 (PDUFA) on drug development times. |
|
| 1997 |
Completes comprehensive analysis of FDA/sponsor meetings, showing that meetings reduce the time of new drug development. |
|
| 1996-98 |
Provides critical data and public testimony at Congressional hearings that led to the passage of the FDA Modernization Act of 1997 (FDAMA). |
|
| 1995 |
Publishes first comprehensive analysis of biotechnology success rates. |
|
| 1993 |
Develops first international comparison of biotechnology product discovery, development, and marketing rates in the U.S., Europe, and Japan. |
|
| 1991 |
Updates its seminal drug cost study: bringing new drugs to market now costs $231 million. |
|
| 1987 |
Publishes first comprehensive analysis of FDA's practice of requiring post-approval research as a condition of approval. |
|
| 1984 |
Develops first comparison of the rate of drug safety withdrawals in the U.S. and other nations. |
|
| 1982 |
Completes first analysis of availability of drugs for limited populations, paving the way for the Orphan Drug Act of 1983. |
|
| 1982 |
Provides first comprehensive evaluation of R&D effort of the U.S. pharmaceutical industry. |
|
| 1981 |
Demonstrates dramatic decline in effective patent life for new therapeutic compounds. |
|
| 1979 |
Conducts first comprehensive study of the cost to develop a new drug: $54 million. |
|
| 1976 |
Identifies "drug lag" between the U.S. and the U.K. |
|
| 1976 |
Conducts first comprehensive analysis of innovation in the U.S. pharmaceutical industry. |
