Therapeutics Lab Meeting Summaries

Lab Meeting 54 consisted of three presentations. First, Dr. Alecia Clary, consultant to the Reagan-Udall Foundation for the FDA, announced new data partners and their research questions. Next, the joint ISPE-FDA Foundation Editorial Committee provided an overview of the COVID-19 Real-World Evidence (RWE) Primer which is a new resource with guidance on using and designing RWD studies. Finally, Dr. Emily O’Brien of the Duke Clinical Research Institute discussed objectives and findings from the National Patient-Centered Clinical Research Network’s (PCORnet) HERO Study.

Full July 21 Lab Summary

Lab Meeting 53 featured two presentations on use of real-world data (RWD) from various sources for providing data-driven insights throughout the pandemic and received an update on progress made in the Medication Use Definitions Workgroup. First, we heard from Drs. Henriette Coetzer and Francois Fressin about how CVS captures data from their services and uses them to inform planning such as optimizing distribution of vaccines and providing policy insights to government stakeholders. Next, we heard from Jennifer Stacy of TriNetX who presented an overview of findings from an analysis of data on breakthrough infections. Finally, Dr. Alecia Clary of the FDA Foundation provided an overview of the framework developed by the Medications Definitions Working Group and discussed how this work will be disseminated.

Full June 16 Lab Summary

Lab Meeting 52 included two presentations on how “signals” in real-world data can help assess the safety and effectiveness of COVID-19 vaccines. First, Dr. Chathuri Daluwatte of Sanofi discussed how social media traffic can provide be used to monitor and identify concerns circulating in the public about the safety of COVID-19 vaccines. Second, Dr. Peter Gilbert of the University of Washington provided an overview of work identifying immune correlates of protection (CoP) of mRNA vaccines against COVID-19 variants. Following Dr. Gilbert’s presentation, the group discussed how real-world and observational studies can be designed to include consideration of CoP.

Full May 19 Lab Summary

During the 51st Vaccines and Therapeutics Lab Meeting we heard from several stakeholders about the Test-to-Treat program. First, Dr. Michael Ganio of the Association of Health System Pharmacists described the new Test-to-Treat program which is intended to provide patients a one-stop option for COVID-19 testing, prescription for oral antivirals, and dispensing of these medications. Next, Dr. Julia Skapik of the National Association of Community Health Centers (NACHC) described efforts to bolster the capacity of data infrastructure at community health centers. Finally, TJ Griffin of PharMerica, described the vital role of long-term care (LTC) pharmacies in caring for and vaccinating high-risk populations, such as elderly living in LTC facilities, throughout the pandemic.

Full April 21 Lab Summary

Lab Meeting 50 highlighted the impact and relationship between COVID-19 and mental health. First, Dr. Murali Doraiswamy of the Duke University School of Medicine facilitated a Q&A with Drs. Joshua Gordon, Director of the National Institute of Mental Health (NIMH), Dr. Susan Borja, also of NIMH, and Dr. Patrizia Cavazzoni of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER). Next, we heard from Dr. Scott Kollins of Holmusk about the challenges and opportunities of utilizing Real World Data (RWD) for understanding COVID’s impact on mental health. The third presentation by Reyna Taylor of the National Council for Mental Wellbeing introduced her organization’s efforts to enhance the capacity, coordination, and quality of community-based mental health care to meet increased demand for these services. Finally, Dr. Amar Bhat of the Reagan Udall Foundation for the FDA presented the data visualization of the week which highlights the demand for information on how to maintain mental well-being throughout the COVID-19 pandemic.

Full March 17 Lab Summary

During Lab Meeting 49 we heard three presentations on evaluating COVID-19 vaccine effectiveness (VE). First, Dr. Minal Patel of the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) provided an overview of guidance, tools, and other resources available to help ensure VE studies are appropriately designed to help answer pressing questions. Next, Dr. Jeff Brown and Jennifer Stacey of TriNetX presented on how their aggregated data from health systems across the world are used by partners to gain insights on VE. Finally, Dr. Sara Tartof of Kaiser Permanente’s Division of Research provided a preview of results from a study looking at the effectiveness of Pfizer-BioNTech against Omicron and Delta variants.

Full February 17 Lab Summary

Lab Meeting 48 focused on the importance of capturing sexual orientation and gender identity (SOGI) in real-world data and how it can help inform understanding of sex and gender-related health disparities. First, Dr. Chloe E. Bird of the RAND Corporation discussed how doubling investment in women-focused clinical research would positively impact health outcomes and result in large societal savings. Next, Dr. Jeff Brown of TriNetX, Dr. Sean Cahill of the Fenway Institute, Dr. Ulka Campbell of Aetion, and Dr. Mark Schmidt of Kaiser Permanente had a discussion on what changes can be made in capturing SOGI data to improve our understanding of the impact of these differences on health outcomes.

Full January 20 Lab Summary