MCM monitoring and assessment update

Monitoring and assessing medical countermeasures (MCMs) after they are dispensed or administered in response to a chemical, biological, radiological, or nuclear threat or an emerging infectious disease is vital to protecting public health, particularly in the case of MCMs that may have limited human efficacy data prior to use. FDA is a key partner—with other U.S. government agencies—in developing MCM monitoring and assessment capabilities, such as this new project.

New project: Examining the Ability to Conduct Influenza Antiviral Effectiveness Studies in Sentinel by Improving Confounding Control

This activity is the second project sponsored by the FDA Office of the Chief Scientist (OCS), Office of Counterterrorism and Emerging Threats (OCET) to explore how the Sentinel System may inform study protocols for medical countermeasure safety and effectiveness and to provide a valuable baseline for comparison during a public health emergency. The objective of this methods activity is to determine whether there is evidence of residual confounding in the association between influenza antiviral(s) and influenza complications in observational studies. (March 21, 2019)

Related information

Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats – first project sponsored by FDA/OCET using the Sentinel System (July 18, 2018)
Monitoring and Assessment of Medical Countermeasures as Part of a Public Health Emergency Response – article in special supplement to the American Journal of Public Health, September 2018
MCM Monitoring and Assessment – MCM Issues webpage with additional information and resources
MCM-Related Legal and Policy Presentations, Publications and Q&As, including monitoring and assessment presentations

Advancing development of new TBI treatments

On March 12, 2019, FDA qualified the OsiriX CDE Software Module, from the TBI Endpoints Development Initiative. This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a biomarker test tool type.

A biomarker test is a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker). This qualification provides a tool for more efficient development of devices in a critical area of medicine – traumatic brain injury (TBI) treatment.

Also see: Biomarkers for Brain Injury Monitoring, an MCMi intramural research project

FDA efforts to promote and foster blood pathogen reduction technologies

Ensuring the safety of blood products is one of our highest priorities. This owes not only to the important role that they play in medical care, but also to their unique risks. Blood products can be susceptible to contamination by both existing and emerging pathogens. In cases where the pathogens aren’t readily identified, there’s a risk that many people receiving blood products could be exposed to an emerging pathogen even before the danger is identified.

For these and other reasons, there’s a need for better safety measures to mitigate the potential risks to blood products. The good news is that the technology exists to potentially transform our assurance of safety of these blood products, while potentially reducing their cost.

The FDA Center for Biologics Evaluation and Research (CBER) is working with a variety of different partners to pursue multiple avenues of research to advance pathogen reduction technology. We believe perfecting these approaches is a critical priority.

Read the full statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D.

Events

April 3-5, 2019: Eleventh Annual Sentinel Initiative Public Workshop (Bethesda, MD) - Experts will share recent developments within the Sentinel Initiative, provide training on Sentinel System’s tools and data infrastructure, and promote engagement and collaboration with patients, industry and consumers. Also see the Sentinel System Five-Year Strategy: 2019-2023 (PDF, 1.7 MB)
April 8, 2019: Public workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Infection (Silver Spring, MD and webcast) - to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease. Register by April 4, 2019.
New! April 9-11, 2019: 4th FDA/PQRI Conference on Advancing Product Quality (Rockville, MD) - Hosted by FDA and the Product Quality Research Institute (PQRI), the conference brings together regulatory, industry and academic leaders to discuss critical topics in drug product delivery design, development, and manufacture. Online registration closes April 3, 2019. (fee)
New! April 17, 2019: Public Meeting on the Draft Guidance to Support Compliance with the Intentional Adulteration Rule (College Park, MD and webcast) - To discuss the draft guidance for compliance and implementation of the “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule, which was issued under the FDA Food Safety Modernization Act. Register by April 10, 2019.
April 18, 2019: NIIMBL Global Health Fund Workshop: Replacing Animal-based Release Testing for Vaccines (Washington, DC area) - Hosted by the National Institute for Innovation in Manufacturing Biopharmaceuticals, this workshop will explore the current state of animal-based release testing and discuss alternative approaches. Organizers encourage those with in-depth knowledge of in vitro vaccine potency and toxicity tests to consider attending.
New! May 1, 2019: FY 2019 Generic Drug Regulatory Science Initiatives public workshop (Silver Spring, MD and webcast) - To provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. To attend in-person or via webcast, register by April 1, 2019 by emailing complete contact information for each attendee (including the attendee's name, title, affiliation, address, email, and telephone number) to GDUFARegulatoryScience@fda.hhs.gov. Also submit any requests to make oral presentations as part of your registration email. Submit comments by June 1, 2019.
New! May 14, 2019: Public workshop: BioCompute Objects: Tools for Communicating NGS Data and Analysis (Silver Spring, MD and webcast), co-sponsored by FDA, the George Washington University and the BioCompute Partnership to engage more stakeholders in creating and using BioCompute for NGS and other bioinformatics data analysis communications with the FDA. Specifically, the workshop will have two components: use case examples, and hands on & demonstrations of new tools that leverage BioCompute. A new Precision FDA-BioCompute Challenge will also be launched at the event. Space limited; please register in advance.