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.

Open innovation: the new face of pharmaceutical research and development.

Abstract: For more than 50 years, pharmaceutical research and development has remained a sequential and insular process. Inefficient, risky and increasingly expensive, the paradigm for drug development is in desperate need of change. Open innovation partnerships represent a new research and development model that holds great promise in transforming the drug development process by integrating capabilities and expertise among a diverse collective of internal and external stakeholders.

Global antibody development trends

Abstract: Although monoclonal antibodies (mAbs) have long been staples of biotech research and development (R&D), the study of mAb therapeutics has recently attracted a great deal of attention by the pharmac...

Establishing Return-on-Investment Expectations for Patient-Centric Initiatives.

Abstract: There has been a proliferation of patient-centric initiatives supporting drug development planning and execution during the past 24 to 36 months. Patient centricity seeks to engage patients and the health care community as drug development partners and represents a fundamental departure from a legacy product-centric research and development paradigm. As the clinical research enterprise gains experience, it is critical that it executes patient-centric initiatives well, provides sufficient support, sets realistic expectations and requires reasonable return on investment (ROI). This article offers insights and suggestions for organizations looking to establish ROI expectation and evaluation of their patient-centric initiatives. The article is based on ideas and concepts that have been shared and discussed among stakeholders throughout the clinical research enterprise.

Factors Associated with Multiple FDA Review Cycles and Approval Phase Times

Abstract: We examined the regulatory review histories of 298 approved new drugs and biologics with new drug applications (NDAs) or new biologic license applications (BLAs) submitted to the US Food and Drug Administration (FDA) during fiscal years 1996–2006 for factors that were associated with multiple review cycles and with longer or shorter total approval phase times (sum of FDA action and sponsor response times) for a given number of review cycles. Using logistic regression models, we found that the likelihood of multiple cycle review varied by therapeutic class, product type (odds ratio = 3.1 for BLAs), fast track status (odds ratio = 0.3), limited sponsor regulatory experience (odds ratio = 2.1 for first US approval), and more recent submissions (odds ratio = 1.7 for fiscal year 2000–2003 submissions compared to fiscal year 1996–1999 submissions). We also applied least squares multivariate regression analysis to explain the variation in total approval phase times with a number of drug, sponsor, and regulatory characteristics. After controlling for the number of review cycles and other factors, we found longer average approval phase times for more recent submissions (56% longer for priority rated compounds with multiple cycle reviews and submissions during a later period, P longer for multiple-cycle BLAs approved by CDER versus multiple-cycle CBER approvals, P = .0209), compounds with December submissions (18% longer for compounds with multiple cycle reviews, P = .0069), and compounds with advisory committee meetings (13% longer for compounds with a single review cycle, P = .0344). We found shorter average approval phase times for compounds with a fast track designation (21 % shorter for compounds with multiple cycle reviews, P = .0825) and accelerated approval status (24% lower for compounds with a single review cycle, P = .0010). Statistical models such as those presented here can help improve the precision with which drug developers and regulators predict approval times and assess the effectiveness of regulatory programs designed to speed the drug approval process.

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

Abstract: Survey data were used to examine the effects that various factors may have on the length of the new drug development and approval processes. These factors include the use of formal conferences between the Food and Drug Administration (FDA) and drug manufacturers. Analyses were based on the type, number, and timing of formal FDA-sponsor meetings for new chemical entities (NCEs) approved from 1987 through 1995. The practice of holding formal conferences was widely applied; 91% of the NCEs were the subject of at least one conference during development or regulatory review, and 46% of the NCEs were the subject of at least three conferences. In addition to conferences, a number of other factors conjectured to have an effect on development and approval times were examined as explanatory factors in multiple regression analyses. The regression results for the new drug application (NDA) phase (NDA submission to NDA approval) indicated that pre-NDA meetings and NDA Days were associated with shorter approval times. Other factors that were shown to be associated with shorter approval times are a priority rating by the FDA, treatment IND status, the submission of a computer-assisted NDA (CANDA) simultaneously with the paper application, and inclusion in the user fee program. Regressions on the investigational new drug application (IND) phase (IND filing to NDA submission) showed that pre-IND meetings and end-of-Phase II conferences were associated with shorter clinical development times, while NCEs with treatment INDs and NCEs that were subject to the user fee program were associated with longer clinical development times. These results provide empirical support for the hypothesis that collaboration between the FDA and drug sponsors has generally expedited new drug development and regulatory review.