From time to time, Tufts CSDD produces authoritative White Papers to highlight current thinking on critical drug development issues. White Papers present findings and insights from Tufts Center analyses, as well as detailed reviews of roundtable discussions and forums hosted by CSDD.
This report details six primary areas across scientific, operating and manufacturing divisions including new approaches to validating drug targets; integrating real world data into the R&D process; flexible and adaptive clinical trials; and green manufacturing techniques driving efficiency while reducing carbon footprint.
In the current study (January 2015), Tufts CSDD authors examine a diverse array of evidentiary materials for 19 individual drugs, 6 drug classes and 1 drug combination, identified as the most transformative drugs in health care over the last 25 years, to better understand the respective contributions of the public and private sectors. The results of the analysis show that drug discovery and development is a complex ecosystem with a wide range of novel collaboration archetypes, involving industry-academic partnerships, venture capital, disease foundations, as well as public-private, pre-competitive consortia, so that learning is from many disciplines and the result of multiple feedback loops.
Tufts CSDD convened a working group of 20 pharmaceutical and biotechnology companies, and contract research organizations (CROs) to assess current and anticipated use of social and digital media communities in clinical research; to identify challenges, receptivity and concerns about usage; and to develop a comprehensive set of management principles and policies designed to optimize the value and minimize risk posed by social and digital media use in clinical research.
A New Tool for Predicting Marketing Approval of Oncology Drugs (December 2013)
Tufts CSDD and Janssen Research & Development (JRD) collaborated on a pilot study to develop and test a model capable of predicting the likelihood of marketing approval for oncology NMEs and NBEs. The study assessed the predictive power of select new compound characteristics.
Tufts CSDD hosted and facilitated a Senior Leadership roundtable on February 13, 2013 in Boston to discuss the adoption and impact of adaptive design clinical trials. Forty senior executives from a variety of cross-functional areas participated including clinical research and development, biostatistics, project management, and clinical operations. In addition, perspectives from the Food and Drug Administration and European Medicines Agency were represented.
A new study by the Tufts University Center for the Study of Drug Development explores the breadth and nature of partnerships between biopharmaceutical companies and academic medical centers (AMCs).