From the Executive Director

Dear CSDD Friends:

We are witnessing strong and growing demand for insights on, and demonstrated impact from, solutions that best leverage cross-functional and sponsor-collaborator integration. Driving this demand is the recognition that point-based and within-function practices and solutions have limited effect on overall drug development program timelines, quality, and economics. Integration efficiencies carry across start-up activities, contribute to more rapid and deeper executional alignment and promote more agile practices and response time.

CSDD projects are contributing to our understanding of the value and impact of integration. We recently completed a study looking at the net financial benefit of implementing end-to-end manufacturing and clinical research capabilities. The compelling results of this study will soon be published. Other CSDD studies underway have been assessing cross-functional implementation of patient engagement practices, partnerships with investigative sites, clinical research data optimization strategies, and risk-based quality management practices and their impact on protocol planning, execution, and performance.

Tufts CSDD is now launching several new working group studies: one evaluating centralized recruitment practices; another mapping the adoption of various clinical trial execution models including retail pharmacies, urgent care facilities, home visits, and rural health centers; and a third assessing how sponsor companies are making the transition from legacy high-frequency study monitoring to risk-based monitoring approaches. Our working group studies offer a unique opportunity for sponsors and CROs to participate in collaborative empirical research initiatives. Please contact me at Kenneth.getz@tufts.edu if your organization is interested in participating in any of our upcoming working group studies.

We are now accepting registrations for our award-winning Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. Celebrating its 52nd anniversary, this internationally recognized program provides R&D executives — experienced and new —with a comprehensive overview of the drug development process and strategies and best practices to optimize development performance and efficiency. We have an excellent faculty lined-up for this interactive program offered virtually beginning in late January. Contact Sarah Wrobel (sarah.wrobel@tufts.edu) or visit our website for more information.

As always, we welcome your ideas, input and collaboration. Best wishes,

Kenneth Getz

Executive Director, Tufts CSDD

To access hard-hitting Tufts CSDD charts and tables, visit  https://csdd.tufts.edu/impact-reports.

To access a comprehensive list of published Tufts CSDD manuscripts and articles, visit Articles - Tufts CSDD