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Institution

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.


Papers
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Journal ArticleDOI
TL;DR: In this paper, the authors argue that the phase of drug development can best be shortened and made more efficient by early, frequent and continuing collegial discussions and joint planning involving industrial and regulatory scientists so that (barring unforeseen problems) the development strategy, application format, and data needs are agreed to in advance.
Abstract: MODERN DRUG DEVELOPMENT has entered a critical phase in its history as the result of a variety of forces impinging on the pharmaceutical industry. These forces include pressures for cost containment, plans for international harmonization of regulatory standards, the impact of user fee legislation, and the urgent demands of patient advocates for new remedies for currently untreatable diseases. All of these factors have created a situation where, for the first time, both the regulators and the regulated must work together to make the process of drug development more efficient, speedier, and less costly, while continuing to protect the public from preventable toxicity and flawed products. As part of the user fee legislation, Commissioner Kessler set ambitious goals for his agency with regard to the elimination of backlog applications and prompt action on new drug applications (NDAs). These quotas can be met by refusing to file NDAs, rejecting them after filing, or encouraging sponsors to withdraw applications, but eventually Congress will contrast such actions with the intent of the legislation the speedier approval of new medicines. While it has been common to look upon the phase of NDA review as that part of drug development primarily under the influence of FDA, this posture is wrong on two counts: on the one hand, the phase is unquestionably affected by the quality of the NDA and the promptness and quality of sponsor response to FDA questions and concerns; on the other hand, that part of the development process before NDA filing is affected significantly not only by the sponsor’s anticipation of FDA demands, but also by the extent and nature of FDAsponsor interaction from before IND filing until NDA filing. The logical consequence of all of the above is that the extremely lengthy and expensive process of drug development can best be shortened and made more efficient by early, frequent, and continuing collegial discussions and joint planning involving industrial and regulatory scientists so that (barring unforeseen problems) the development strategy, application format, and data needs are agreed to in advance. With such an effort, an NDA would become essentially “self-reviewing” and would not suffer from avoidable delays.

2 citations

Journal ArticleDOI
TL;DR: The study findings encourage drug development professionals to validate disease-specific measures and to identify if specific symptoms are caused by lupus and provide a methodology that can be applied to highly heterogenous diseases where low consensus on diagnosis and treatment exists among drug development and health professionals.
Abstract: Due to the extreme heterogeneity of lupus and the lack of consensus among stakeholders, pharmaceutical and biotechnology companies have had limited success in developing treatments for lupus. For this reason, the Lupus Foundation of America (LFA), researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and an advisory committee of 13 international lupus experts collaborated to launch the Addressing Lupus Pillars for Health Advancement (ALPHA) project. To inform the ALPHA project, 17 in-depth interviews among lupus experts and a global survey among lupus drug development and clinical care professionals was conducted to identify, characterize, and prioritize fundamental barriers and validate findings. The global survey received 127 responses from experts across 20 countries. Results of the in-depth interviews and the survey findings were consistent. Top barriers to developing new medical treatments for lupus included the lack of a clear definition of the disease with respondents identifying 30 autoimmune conditions that may be lupus-related; lack of predictive biomarkers; flaws in clinical trial designs; and a lack of reliable outcome measures. The study findings encourage drug development professionals to validate disease-specific measures and to identify if specific symptoms are caused by lupus. This original research also provides a methodology that can be applied to highly heterogenous diseases where low consensus on diagnosis and treatment exists among drug development and health professionals.

2 citations

Journal ArticleDOI
TL;DR: The results show that overall, the 505(b)(2) regulatory pathway results in longer review time than for NMEs despite the intent to simplify and streamline the review process.
Abstract: Background:Annual review statistics released by the Food and Drug Administration (FDA) and a number of studies indicate that the review process improvements introduced under various versions of the...

2 citations

Journal ArticleDOI
TL;DR: It is necessary to select patients suitable for vaginal or laparoscopic mesh placement for intranasal administration based on prior history and once they provide informed consent for surgery.
Abstract: Clinical Pharmacology & Therapeutics (1997) 62, 241–247; doi:

1 citations

Journal ArticleDOI
TL;DR: The results of this Tufts CSDD study provide a detailed representative mapping of the early drug development research pathway and baseline duration metrics summarizing the overall process and distinct process stages for the first time.
Abstract: The translation of basic research knowledge into human testing is widely regarded as an inefficient and lengthy process, yet there is no detailed, quantitative information characterizing this early drug development pathway. The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study to derive a generalizable granular process map of the non-clinical to early clinical drug development pathway and associated duration metrics. Tufts CSDD constituted a working group of seven small and mid-sized pharmaceutical and biotechnology companies to identify pathway milestones and to provide duration metrics. Tufts CSDD then analysed duration data between each process step in the development pathway. Data for Investigational New Drug (IND) submissions are reported overall and stratified by therapeutic area, phase II transition success and modality. Duration metrics (mean and standard deviation [SD]; median and interquartile range [IQR]) are provided for each milestone along the early drug development and regulatory pathways (e.g. time to IND submission). The overall process from First Synthesis — Medicinal Chemistry to First Patient (Subject) First Dose took on average 151.4 weeks (n = 17; SD = 90.0 weeks) and a median duration of 133.0 weeks (IQR = 89.6 weeks) overall. There were no statistically significant differences between stratified data. Key pathway steps, their respective durations and variation across programmes are presented. The results of this Tufts CSDD study provide a detailed representative mapping of the early drug development research pathway and baseline duration metrics summarizing the overall process and distinct process stages. To our knowledge, this is the first time such a mapping has been completed. Observed duration areas with wide variation between key steps in the process suggest acceleration opportunities. Large variation in duration data may be due to differences in molecule size and structure, as well as strategic decisions made by management teams. Best practices from faster companies also indicate that they perform many activities in parallel, moving forward even before certain milestones have been achieved, and they tend to have more frequent and substantive cross dialogue across different functional areas earlier in the process. It is hoped that the results of this study will assist research and development professionals in making more informed management decisions and in identifying opportunities to streamline and improve the non-clinical to early-stage clinical process.

1 citations


Authors
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Performance
Metrics
No. of papers from the Institution in previous years
YearPapers
20219
20208
201914
201815
201710
201611