Tufts Center for the Study of Drug Development

About: Tufts Center for the Study of Drug Development is a based out in . It is known for research contribution in the topics: Drug development & Clinical trial. The organization has 78 authors who have published 258 publications receiving 16047 citations.

Trends in Drug Development Costs, Times, and Risks:

Abstract: NEW DRUG DEVELOPMENT in the United States has been characterized by long development and regulatory review periods, high costs, and substantial scientific and financial risks. The factors that explain why the development and regulatory review processes are lengthy, costly, and risky are complex and vary in relative importance over time. Gathering reliable data on these processes and analyzing those data should precede and enhance evaluations of the factors that affect new drug development and regulatory review. This section surveys literature on the cost of drug development, the lengths of the development and regulatory review phases, and technical risks in new drug development for new chemical entities (NCEs). New results on clinical cost and clinical trial complexity for recent years are also presented. tures grew at about a 10% compound annual rate since 1979. On the other hand, new drug approvals in the United States have not yet increased at anywhere near such a rate. Without doubt, there is a substantial lag between R&D expenditures and marketing approval. Most of the expenditures at the end of the period shown should be associated with approvals in the future. Even so, it is hard not to at least suspect, and at most conclude, that R&D costs have increased over time. Several studies have averted the problems inherent in associating industry-level R&D expenditures with NCE approvals by estimating the cost of new drug development using detailed disaggregated data. Figure 2 shows comparative preclinical, clinical, and total costs per approved selforiginated NCE from two studies (1,2).*

Therapeutic monoclonal antibodies: trends in development and approval in the US.

Abstract: Monoclonal antibodies have significant potential as therapeutic agents because of their ability to bind to specific antigens. To determine trends in the clinical development and approval processes for therapeutic mAbs, data on 199 mAbs that entered clinical study from 1980 to 2001 were collected and analyzed. Of the 199 mAbs, 75 are in clinical development, two are undergoing Food and Drug Administration (FDA) review, and 11 are FDA approved. Approval success rates for murine, chimeric and humanized mAbs, and clinical and approval phase lengths for mAbs, are presented. In addition, mAbs that are either in phase III, FDA-review, or are FDA approved for antineoplastic or immunological indications are described.

The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation

Abstract: Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the “21st Century Cures” initiative, Congress is reviewi...

The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era

Abstract: This is the fifth in a series of triennial reports by the Tufts Center for the Study of Drug Development (CSDD) examining various aspects of recent new drug approvals in the United States. In 1996, 1997, and 1998 the United States Food and Drug Administration (FDA) approved 122 new drugs, 110 of which met Tufts CSDD’s definition of a new chemical entity (NCE). Of the 110, 38 (35%) received priority review, while 72 (65%) had standard review. The mean length of the clinical phase (investigational new drug application [IND] filing to new drug application [NDA] submission) was 70.3 months (ie, 5.9 years), and the approval phase (NDA submission to approval) was 16.8 months (1.4 years). Both the clinical and approval phases represent decreases from those values for the previous three-year period (19% and 31%, respectively). The decrease in the clinical phase for the 1996 to 1998 NCEs represents the first such decline since the mid-1980s. The mean approval phase for priority NCEs (11.8 months) was 38% shorter than that for standard NCEs (19.5 months). Of the 107 NCEs for which foreign marketing data were available, 49% were first approved for marketing in the United States, while 26% were available in foreign markets one or more years prior to United States approval, with a mean of 5.7 years of prior foreign marketing. The percent of products first available in the United States represents a considerable increase over that number for previous years.

Are payers treating orphan drugs differently

Abstract: Background : Some orphan drugs can cost hundreds of thousands of dollars annually per patient. As a result, payer sensitivity to the cost of orphan drugs is rising, particularly in light of increased numbers of new launches in recent years. In this article, we examine payer coverage in the United States, England and Wales, and the Netherlands of outpatient orphan drugs approved between 1983 and 2012, as well as the 11 most expensive orphan drugs. Methods : We collected data from drug regulatory agencies as well as payers and drug evaluation authorities. Results : We found that orphan drugs have more coverage restrictions than non-orphan drugs in all three jurisdictions. From an economic perspective, the fact that a drug is an orphan product or has a high per-unit price per se should not imply a special kind of evaluation by payers, or necessarily the imposition of more coverage restrictions. Conclusion : Payers should consider the same set of decision criteria that they do with respect to non-orphan drugs: disease severity, availability of treatment alternatives, level of unmet medical need, and costeffectiveness, criteria that justifiably may be taken into account and traded off against one another in prescribing and reimbursement decisions for orphan drugs. Keywords : orphan drugs; reimbursement; pricing (Published: 15 January 2014) Citation: Journal of Market Access & Health Policy 2014, 2 : 23513 - http://dx.doi.org/10.3402/jmahp.v2.23513