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The Tufts Center for the Study of Drug Development conducts research on a broad range of topics in the areas of drug development, regulation, and utilization. Current research projects are grouped as follows:
Assessing the Impact of Outsourcing on Drug Development Performance and Economics
Getz KA, Kaitin KI, Milne CP, Faden L (in progress)
The objective of this study is to quantify the impact of outsourcing on drug development speed, quality, and cost. Through primary research among sponsors companies, we will examine various drug development performance and economic measures to determine the impact and value of outsourcing.
The results of this study will enable companies to determine how to utilize CROs more strategically and effectively.
The Cost of Biopharmaceutical R&D: Is Biotech Different?
DiMasi JA, Grabowski HG (in press)
This study is a first of its kind analysis of the magnitude of R&D costs associated with the discovery and development of new therapeutic biopharmaceuticals (specifically, recombinant proteins and monoclonal antibodies). Compound–specific data on cash outlays, development times, and success in obtaining regulatory marketing approval will be used to estimate the average pre–tax R&D resource cost for biopharmaceuticals up to the point of original marketing approval.
This is a preliminary effort to examine R&D costs for biopharmaceuticals, with comparisons to R&D costs for the development of traditional chemical compounds.
Economics of Follow–on Drug Development
DiMasi JA, Faden L (in progress)
This study will update a previous study on the development histories and entry rates of new drugs in the same therapeutic class defined in terms of pharmacologic mechanism of action or chemical similarity. The timing of development of follow–on drugs in a class relative to the development of the first–in–class drug will be examined, as well as the speed at which first–in–class drugs face competition in the class.
An existing Tufts CSDD database of the development and regulatory histories of drugs in the same therapeutic class is being updated to cover new drugs approved in recent years.
Evaluating the Impact of Organizational Design Dimensions on Company Performance
Getz KA, Kaitin KI, Wenger J, Young B (in progress)
This study will assess how biopharmaceutical company operating models drive revenue and profitability growth and product innovation. Using primary and secondary research, thirty companies will be classified across a range of operating dimensions. Key performance metrics on each company will be analyzed to determine which company operating dimensions measurably impact performance and whether operating dimensions most impacting performance are different for small/mid–sized companies than for large companies.
The results of this study will inform senior executive decision–making, strategic planning, and implementation of highest impact operating strategies and structures.
Fast Track Product Development Under the FDA Modernization Act of 1997 (FDAMA)
Milne CP, Cabanilla L (in progress)
This multi–phase project consists of three components: (a) in the first we are tracking the output of FDA's Fast Track Program, in terms of the number and therapeutic areas of products being developed; (b) in the second we are surveying fast track product sponsors on their experience with implementation of the Act; (c) and lastly we are measuring clinical development and approval times for fast track products. These results have been published and updated periodically [Kaitin, KI, editor. FDA’s fast track program results in 62% approval rate after first 3 years. Tufts Center for the Study of Drug Development Impact Report 2001 Jan/Feb;3(1); Milne C–P Bergman E. Fast track product designation under the Food and Drug Modernization Act: the industry experience. Drug Information Journal 2001;35(1):71–83]; [Kaitin KI, editor. FDA’s fast track initiative cut total drug development time by 3 years. Tufts Center for the Study of Drug Development Impact Report 2003 Nov/Dec;5(6); Kaitin KI, editor. Fast track program firmly established in U.S. drug development landscape. Tufts Center for the Study of Drug Development Impact Report 2006 March/April;8(2)].
This project will provide a comprehensive assessment of the Fast Track Program and its implementation.
The Impact of FDA Initiatives to Improve Drug and Biological Product Development and Approval
Milne CP, Reichert JM, Kaitin KI, Fadan L (in progress)
In April 2004, Tufts CSDD began a five–year research program to evaluate how new FDA initiatives, such as the FDA’s Strategic Action Plan and programs implemented under the current reauthorization of the Prescription Drug User Fee Act (PDUFA III), affect the development process for new therapeutics. Baseline data gathering is already underway on a number of FDA performance measures and policy responses, including risk management, postmarketing commitments, black box warnings, as well as development/review times and first cycle review performance, with further data analyses scheduled to be completed over the next few years. Results have been published periodically [Kaitin KI, editor. FDA requested postmarketing studies in 73% of recent new drug approvals. Tufts Center for the Study of Drug Development Impact Report 2004 Jul/Aug;6(4)]; Kaitin KI, editor. Drug safety withdrawals in the U.S. not linked to speed of FDA approval. Tufts Center for the Study of Drug Development Impact Report 2005 Sep/Oct;7(5)]. A survey of industry responses to PMCs is currently being conducted, with results expected by the 2nd quarter of 2007.
The findings of this project will provide a measuring stick by which to assess the impact of these FDA programs, in preparation for the public and congressional debates that will emerge as PDUFA reauthorization approaches in 2007.
The Impact of Incentive and Partnering Programs in the Development of Medicines for Neglected Diseases
Milne CP, Young B, Kaitin KI (in progress)
This project, initiated as a paper commissioned by the Institute for Global Health for the World Health Organization, will assess the role of orphan drug legislation in Europe, Japan, and the U.S. for incentivizing the R&D of drugs and biological products to address diseases such as AIDS, tuberculosis, and malaria that especially afflict developing countries. The findings from the commissioned paper were presented at an international conference sponsored by the OECD in Lisbon, Portugal in October 2002. In October 2004, the Tufts Center held a public policy forum in New York City, entitled Medicines for Neglected Diseases: Creating a Policy and R&D Agenda, intended to foster a dialogue among the private and public sectors, the media, patient groups, and other stakeholders regarding ways to address this worldwide public health concern. The focus of this project has expanded from an examination of incentive programs to help thwart the global spread of infectious diseases and to stimulate R&D of bioterror countermeasures, as discussed in a recent publication [Milne C–P. Racing the globalization of infectious diseases: lessons from the tortoise and the hare. New England Journal of International and Comparative Law Fall 2004;11(1):1–36], to include an investigation of the efforts to increase innovation for the R&D of medicines for the most urgent public health diseases in less developed countries and emerging economies under a PhRMA grant.
This project will contribute to efforts by the international public health community to address the problem of neglected diseases and the threat of bioterror.
Mapping the Investigative Site Landscape
Getz KA, Kaitin KI, Faden L (in progress)
This study will provide a detailed picture of the investigative site landscape. The primary areas of focus in this study are the demographics of clinical study staff, the changing geographic locations where sites are located, average investigative site capacity, years of experience and turnover rates, and sponsor usage of site types by phase, therapeutic area, and geographic region.
The results of this project will enhance industry and government sponsor decision–making, as well as study conduct strategies and practices. Additionally, trends and descriptive statistics will provide much needed input into policies designed to strengthen the national clinical research enterprise.
Measuring the Affects of Protocol Complexity on Study Conduct Success
Getz KA, Wenger J (in progress)
This study takes an in–depth look at the impact of rising protocol complexity on study initiation, patient enrollment and retention, and study close–out activities. Secondary data on protocol design changes during the past decade, combined with primary data provided by participating sponsor companies, will be utilized.
The results of this study will inform sponsor company efforts to simplify protocol designs in order to optimize investigative site performance.
The Role of Office of Orphan Product Development Grants in the R&D of Treatments for Rare Disorders
Milne CP, Wegner J, Cairns CP (in progress)
This project, conducted in collaboration with FDA, surveys recipients of grants from the agency’s Office of Orphan Product Development to collect information on the characteristics and output of grant projects, as well as the experience and opinions of grant recipients. Survey results from over 70 grant projects covering a ten–year period are currently being analyzed. Initial results from this project were presented at the Drug Information Association (DIA) Annual Meeting in Washington, D.C. in June 2004. Follow–up data have been collected and will be presented at the 2006 DIA Annual Meeting, with publication of the findings in 2007.
This project will help to evaluate the utility of orphan product grants and the role they play in furthering drug and biologics R&D for rare disorders.
Trends in the Development of Line Extensions in the Pharmaceutical Industry
DiMasi JA, Paquette C, Faden L (in progress)
This study will examine the historical record on new drug approvals for line extensions to new molecular entities, such as new formulations and new combinations, approved in the United States. The data will be examined to elucidate trends in the rate and timing of approvals of new product versions during a drug's lifecycle.
A new Tufts CSDD database of non–new molecular entity new drug application approvals has been developed and maintained so that lifecycle drug development trends can be examined now and in future analyses.
Tufts CSDD's R&D Managaement Report –– Based on Tufts CSDD's Tenth Annual Senior Executive R&D Roundtable: Key Issues in Pharmaceutical R&D Strategy and Management
(November 2, 2006, Boston: Ritz Carlton Hotel [renamed Taj Boston hotel, Jan 2007]) Kaitin KI (editor)
Top pharmaceutical and biotechnology industry executives came together at Tufts CSDD's Annual R&D Roundtable to discuss key issues in bringing drugs to market quickly and efficiently. Tufts CSDD's Annual R&D Roundtables are unique in their approach to discussion and problem–solving. The topic for the November 2, 2006 meeting was "Coping with the Challenges and Pitfalls of Becoming a Clinical Organization: Survival Tips for Biotech Companies." The Tufts CSDD R&D Managaement Report series summarizes the main discussion points of the meeting.
For further information on our 2007 meeting, see our web page: http://csdd.tufts.edu/NewsEvents/Events.asp?eventid=23.
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