Showing papers by "Tufts Center for the Study of Drug Development published in 2001"

Risks in new drug development: approval success rates for investigational drugs.

Abstract: Clinical Pharmacology & Therapeutics (2001) 69, 297–307; doi: 10.1067/mcp.2001.115446

New drug development in the United States from 1963 to 1999.

Abstract: Clinical Pharmacology & Therapeutics (2001) 69, 286–296; doi: 10.1067/mcp.2001.115132

Monoclonal antibodies in the clinic.

Abstract: Despite initial teething problems, the number of clinically effective monoclonal antibodies is growing.

Emerging Role of Pharmacoeconomics in the Research and Development Decision-Making Process

Abstract: Objectives: This study examines the organisational structure of pharmacoeconomics departments in major pharmaceutical and biotechnology companies, the impediments to optimal use of pharmacoeconomic evaluations by companies and the integration of pharmacoeconomic analysis with research and development decision making.

Fast track product designation under the food and drug administration modernization ACT: The industry experience

Abstract: With the passage of the Food and Drug Administration Modernization Act (FDAMA), existing programs for expedited development and approval for treatments of serious or life-threatening diseases were codified and consolidated under the administrative rubric of fast track product designation. The four basic programs available with fast track designation have been categorized by FDA as consisting of meetings, written correspondence, review programs, and dispute resolution. Despite some early skepticism by industry, and even FDA, that the benefits of designation were not readily apparent since the individual programs are generally available without designation, there are indications that fast track designation will be the improvement Congress intended. Unlike the individual expedited development and approval programs, which affect only part of the drug development timeline, fast track designation has the potential to facilitate the entire process. Industry requests for fast track designation have dwarfed pre-FDAMA industry participation. Yet, the best predictor of the future success or failure of fast track designation is how well it is working now. In order to evaluate this, the authors surveyed the biotechnology and pharmaceutical sponsors of 32 fast track designated products identified from public information sources and present their findings in this paper.

Clinical development of therapeutic medicines: a biopharmaceutical versus pharmaceutical product comparison

Abstract: The clinical development of therapeutic medicines is a time-consuming and resource intensive process. The published literature documents the length of clinical phases, but there are few published reports on the number of clinical studies and the number of human subjects involved in the development of therapeutic medicines. In this Tufts Center for the Study of Drug Development investigation, clinical study data for 12 new biopharmaceutical products approved in 1994 through 2000 were analyzed and compared to the results of published clinical studji data for new molecular entities (NMEs) and new active substances (NASs) approved during the same time period. We found that, on average, development of the biopharniaceuticals involved significantly fewer studies per application compared with the studies of NASs (11.8 studies vs. 37 studies) and also fewer subjects per application compared with the studies of either NMEs or NASs (1014 subjects vs. 5697 subjects for NMEs approved in 1998, 4980 subjects for NMEs approved in 1999, or 4478 subjects for NASs). A possible reason for this finding is that many of the biopharniaceuticals included in the analysis were treatments for diseases that affect a potentially small number of subjects. that is, rare, serious, or life-threatening diseases.

The effects of the prescription drug user fee act and the food and drug administration modernization act on the development and approval of therapeutic medicines

Abstract: The Prescription Drug User Fee Act of 1992 and the Food and Drug Administration Modernization Act of 1997 include provisions that were intended to increase the efficiency of the processes required for the clinical development and regulatory review of therapeutic medicines. The expected effects of the legislative acts were decreases in the time required for clinical development and product approval. Results from the analysis of the clinical (Investigational New Drug filing date to Biologic License Application [BLA]/New Drug Application [NDA] submission date) and approval (BLA/NDA submission date to approval date) phases for 54 applications for new biopharmaceutical products submitted to the Food and Drug Administration during fiscal years 1981 through 1998 indicate that while clinical phases consistently increased, the rate of increase slowed substantially for fiscal years 1997 through 1998. The approval phase for fiscal years 1997 through 1998, however, proved to be the shortest of any lime period examined. Taken together, the data from fiscal years 1997 through 1998 show the first decrease in the mean total length of time required for clinical development and approval of biopharmaceuticals. Similar analyses of data for 384 applications for new chemical entities indicate that mean clinical and approval phase lengths were shorter for fiscal years 1997 through 1998 than for any other time period included in the study. The results of this study suggest that the regulatory reforms associated with enactment of PDUFA and FDAMA have had a marked effect on the development and approval of therapeutic medicines.

Pharmacy benefit managers and medicare beneficiary access to prescription drugs

Abstract: Despite the fact that prescription drugs are an increasingly important component of modern health care, especially for the elderly and disabled populations suffering from chronic conditions, 35% of Medicare beneficiaries lack any form of prescription drug insurance. Congress is currently debating six major proposals to extend insurance protection to outpatient prescription drugs under Medicare. Five of these proposals suggest the use of pharmacy benefit managers (PBMs) to improve the cost-effectiveness of the prescription drug benefit. A Tufts Center for the Study of Drug Development (Tufts CSDD) survey of eight leading PBMs shows that during the last five years PBMs have increased their enrollment of Medicare beneficiaries considerably. PBMs currently facilitate moderate to full access to pharmaceuticals for approximately 20% of Medicare beneficiaries. Seven of the eight PBMs surveyed are also developing disease management programs targeted specifically at the Medicare population. However regarding the feasibility of a universal prescription drug benefit, a number of issues concerning how to structure government contracts with PBMs and how to meet certain political challenges to PBM mediation remain unresolved.