Welcome to your November issue of The Pipeline from Precision for Medicine. In this offer we offer timely insights on the fallout from Brexit, a new white paper on managing regulatory risk, important advances in diagnostics, an insightful translational webinar, and more. We hope you’ll find this information valuable as you conquer the complexity inherent to R&D innovation.
The Pipeline features timely insights from our experts in the lab, clinical trials, and data science, designed to help innovative researchers unwind complexity. It is published by Precision for Medicine.
November 2021 Contributors
Maham Ansari, MS, RAC Director, IVD Regulatory & Quality Consulting
Chris Ingram, BSc (Hons), Head of Regulatory Consultancy (Europe)
Darren Davis, PhD SVP Lab Services
Megan Liles, Vice President, Operating Strategy, Precision for Medicine
Today’s global economy offers worldwide opportunities to market medical devices and diagnostics, often with the help of third-party distributors. Yet there are market, legal, and regulatory differences of which manufacturers must be aware. Marham Ansari, Director, IVD Regulatory & Quality Consulting at Precision, outlines key steps and considerations for manufacturers interested in using third-party vendors.
The Brexit landscape issued in 4 key changes in the UK's clinical trial regulatory environment. Two are already in place; two start January 1, 2022. Precision’s Head of Regulatory Consultancy (Europe), Chris Ingram, BSc (Hons), explains the changes and how to address them in this 6-minute read.
With diagnostic tests gaining increased prominence due to their role in both precision medicine and the COVID-19 pandemic, it’s important to stay on top of new regulatory considerations—and advancements in next generation sequencing that will fuel biomarker-driven research and development.
Tumor biopsies and advanced multiplex immunofluorescence enable quantification of immune cell subsets including their precise placement within the tumor microenvironment—yet getting samples can put patients at risk. ApoStream® is unique in its approach to rare cell enrichment. Originally presented by Darren Davis, PhD, Senior Vice President, Lab Services, Precision for Medicine at the 2021 Immuno-Oncology Summit.
Historic Misconceptions and Untapped Opportunities: Why Satellites are the Next Rising Stars in Clinical Research
Created in collaboration with Roswell Park Comprehensive Cancer Center, this article outlines the potential of satellite and affiliate sites to foster broader and more agile enrollment initiatives, increase penetration into close-knit or rare markets, and transform patient experiences to give sponsors an advantage in an increasingly competitive clinical trial recruitment environment.
Precision has launched a new biospecimen collection center, providing clinical- and research-grade leukopaks—mobilized or non-mobilized from healthy and diseased donors, including oncology donors. Invaluable for researchers, these can provide up to 100x more cells from the same donor than PBMCs, bolstering studies that require assay-to-assay consistency.
Upcoming Webinar: Defeating Data Silos with a Translational Hub
Join us for a 30-minute webinar, December 8, 12pm ET, where we’ll share how centralizing biomarker and clinical data in a translational hub alleviates the painfully manual data searching and preparation that is typically required for on-study analyses. Learn more and save your spot here.