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.

Fixing the paradigm for biopharmaceutical R&D: Where to start?

Abstract: The basic thesis of this paper is that the R&D sector of the new medicines' business is experiencing evolutionary stress. Due to the failure of the regulatory framework and applied sciences to keep pace with advances in discovery, there is a bottleneck in the development phase of R&D. While improved process may help, there are still problems related to the products themselves, such as the need to move from a population-based model of product development, in which one size fits all, to a more targeted approach based on specialty drugs for patient subpopulations. The old paradigm dominated by big pharma and blockbusters must evolve, in order for a new bio-pharmaceutical paradigm to emerge. Despite the challenge that the fates of the pharmaceutical and biotech sectors are currently intertwined, it may be the dark before the dawn that betokens real change.

Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA‐Sponsor Conferences

Abstract: Clinical Pharmacology & Therapeutics (1996) 59, 191–191; doi: 10.1038/sj.clpt.1996.264

US and European regulatory initiatives to improve R&D performance.

Abstract: Both the FDA and the European Medicines Agency recognise that the process of R&D must be changed to improve industry productivity They also realise that industry cannot do it alone and have crafted initiatives to facilitate industry R&D performance Some initiatives have been ongoing since the late 1990s, such as scientific interaction between drug sponsors and regulators Others have emerged more recently in the mid-2000s, such as the FDA’s Critical Path and the European Medicines Agency’s new medicines legislation and the Road Map to 2010 The overarching purpose is to reinvent the process by which drugs are ushered through the clinical phase of development, as well as providing a better feedback loop from bench to bedside

Studies and Inquiries into the FDA Regulatory Process: An Historical Review:

Abstract: THE FOOD AND DRUG Administration (FDA) has been dubbed “the most closely watched federal regulatory agency in existence” ( 1 ), and its regulatory activities “the most thoroughly investigated and studied program of government regulation in history” (2). The many investigations and inquiries have produced what has been described as a “virtual tidal wave of recommendations” (3). The validity of these comments becomes readily apparent even on cursory review. For the purposes of this White Paper, a detailed review and documentation of a substantial portion of this investigatory activity has been undertaken. The first section of this segment of the White Paper draws from a comprehensive two-part summary prepared by Peter Barton Hutt in which he provides an historical review of investigations and reports of FDA regulation over the years 1822-1983. All inquiries, congressional hearings, commissions, studies, and other reports concluded during that period are listed in the appendix to this article. They have been organized into six broad categories according to the nature of the event or concern that triggered the inquiry: drug safety, ethical issues, FDA administration and resources, advisory committees, FDA review process, and competitiveness issues. A summary statement of the recommendations or conclusions of each inquiry is also provided. In the next two sections, the recommendations of the major inquiries undertaken during the periods 1981-1987 and 19881992, respectively, are reviewed in detail. Regulatory and administrative changes that, at least in part, appeared to occur in response to repeated criticisms or recommendations for reform over the years are also reported. Since similar proposals often arose from diverse sources, it is usually impossible to say that a specific inquiry or commission provided the sole impetus for any particular reform. When examined in their entirety, the recommendations reported in the first three sections below project a drumbeat quality with certain issues and themes appearing repeatedly. The last section reflects on the energy and efforts directed to improving the efficiency of drug development and the FDA process, and provides a summary of the

On the possibility of a positive-sum game in the distribution of health care resources.

Abstract: Health care resource distribution is a subject of debate among health policy analysts, economists, and philosophers. In the United States, there is a widening gap between the more-and less-advantaged socioeconomic sub-populations in terms of both health care resource distribution and outcomes. Conventional wisdom suggests that there is a tradeoff, a zero-sum game, between efficiency and fairness in the distribution of health care resources. Promoting fairness in the distribution of health care resources and outcomes is not efficient in terms of maximization of a health outcome production function. On the other side of the coin, improving efficiency comes at the expense of fairness. Such conventional wisdom is supported in part by standard static Paretian welfare analysis. However, in this paper it is shown that in a dynamic setting in which there are efficiency gains in the health production function, fairness in distribution of health care resources can improve simultaneously.