Tufts CSDD White Papers
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.
Summary Report from the Spring 2019 Executive Roundtable on COMPANY Response to ICH E6 (R2) (July 2019)
On April 3, the Tufts Center for the Study of Drug Development held a second executive roundtable at the PwC offices in Boston, MA. The roundtable invited senior R&D leaders from biopharmaceutical companies to provide real-case sharing and discuss insights on the ICH E6 R2 regulatory guidelines. The executive roundtable was produced and facilitated by Ken Getz, MBA, Research Associate Professor and Yaritza Peña, Research Analyst.
In October 2015, the Tufts Center for the Study of Drug Development hosted a workshop to explore innovative strategies for biologics manufacturing. The workshop was moderated by Abdullah Baaj, MD, PharmD, Parrish Galliher, MS, and Kenneth I Kaitin, PhD. This Tufts CSDD White Paper reviews the salient issues discussed and conclusions reached at the workshop, and explores the current state and future of biologics manufacturing.
This report examines the impact on development costs and net returns for drug developers if clinical development cycle times are reduced, which has implications for development efficiency, innovation incentives, and earlier access by patients to new therapies. The analysis is conducted in the context of estimated differences in development times between single-source and multi-source outsourced contract manufacturing. The full study has been submitted for peer-reviewed publication
Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development (May 2015)
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.
Public and Private Sector Contributions to the Research & Development of the Most Transformational Drugs of the Last 25 Years (January 2015)
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.
Academic-Industry Partnerships for Biopharmaceutical Research & Development: Advancing Medical Science in the U.S (April 2012)
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).