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 of themes from the
2021 Executive Roundtable Examining
Experiences Implementing and
Accommodating the ICH E6 (R2) Guidance
On May 2021, the Tufts Center for the Study of Drug Development — in collaboration with, and with funding from, CluePoints and PwC — hosted a virtual roundtable comprised of R&D senior executives from pharmaceutical and biotechnology companies, contract research organizations (CROs) and a representative from the Food and Drug Administration. In total, 60 people participated in a virtual, facilitated discussion.
On December 4, 2019, the Tufts Center for the Study of Drug Development (Tufts CSDD), with support by a grant from Pfizer, Inc., facilitated a first-of-its-kind Senior Leadership Roundtable in New York City to discuss the current state of the drug development workforce as it enters the digital era. Sixty executives from pharmaceutical and biotechnology companies, technology-solutions companies, professional trade organizations, and academia participated in the roundtable. Participant functional expertise included clinical, clinical operations, data management, regulatory affairs, human resources, digital technology, and R&D strategy. Experts discussed the current state and preparedness of the drug development workforce, challenges and opportunities presented by the digital transformation era, new and emerging critical skills and competencies required, changes in talent recruitment and retention practices, and the reshaping of corporate mindsets and cultures to become digitally proficient organizations. This White Paper, which provides key findings from the roundtable, is intended to inform and stimulate discussion as the various components of the drug development pipeline lead the vanguard in the Fourth Industrial Revolution.
ASSESSING THE FINANCIAL IMPACT OF TRANSLATIONAL PHARMACEUTICS - A PLATFORM FOR ACCELERATING PRODUCT DEVELOPMENT
Pharmaceutical R&D activity continues to grow significantly year-on-year with increasing numbers of molecules in development. Despite increases in spending, the industry struggles with poor R&D productivity, citing lengthy drug development times, increasing costs, and high rates of molecule attrition. Tufts CSDD examined an innovative approach to accelerating drug development, Translational Pharmaceutics®, and quantified the savings to drug developers from applying the approach across the industry portfolio of investigational drugs. Translational Pharmaceutics integrates real-time manufacturing and clinical testing to make drug products available for clinical trials more quickly and flexibly than is the case for traditional drug development. Translational Pharmaceutics projects were compared to industry benchmarks, and the financial benefits were quantified on reduced industry R&D costs and increased returns from earlier sales. Data were obtained for different types of Translational Pharmaceutics projects and topline results included mean total benefits ranging from $102.6 million to $290.1 million and mean timeline savings of >12 months. Access a copy of this White Paper Report.
ALPHA PROJECT UNITES GLOBAL LUPUS COMMUNITY ON BARRIERS TO RESEARCH, DRUG DEVELOPMENT, CARE, AND ACCESS
The study, “Global Consensus Building and Prioritization of Fundamental Lupus Challenges: The ALPHA Project,” brought together experts across 20 countries to provide the first-ever global consensus on key issues in lupus, which until they are addressed, will continue to be major barriers in the field. The ALPHA Project has identified fundamental knowledge gaps preventing advancements in lupus research, clinical care, and access and provides a framework to establish a roadmap for academia, federal agencies, industry, and all other lupus stakeholders to follow moving forward. The next phase of the ALPHA Project will be to organize an international stakeholder meeting with the Global Advisory Committee and other lupus stakeholders to be held in Washington, D.C. in January 2020, to implement specific solutions to address each barrier identified through this research. Access a copy of this White Paper Report.
On April 3, 2019, 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
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
In the current study (January 2015), Tufts CSDD authors examine a diverse array of evidentiary materials for 19 individual drugs, six drug classes and one 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 the risk posed by social and digital media use in clinical research.
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.
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).