May 19, 2017 | FDA Medical Countermeasures Initiative Update
Learn about FDA's medical countermeasure (MCM)-related research, and discover how you can collaborate with FDA. Sessions of interest to MCM stakeholders include:
- Use of an FDA Real-time Mobile Communication Platform System during Medical Countermeasure Events: RAPID - Henry "Skip" Francis, MD, Director for Data Mining and Informatics Evaluation and Research, FDA Center for Drug Evaluation and Research (CDER)
- Development of Total and Neutralizing Anti-Ebola Virus Antibody Assays for Deployment in West Africa to Evaluate Clinical Trials of MCMs, including Vaccines and Immunotherapies - Geraldo Kaplan, PhD, Principal Investigator, Center for Biologics Evaluation and Research (CBER)
- Development of Mouse Models to Assess Efficacy and Potency of Zika Virus - Daniela Verthelyi, MD, PhD, Lab Chief, CDER
- FDA-ARGOS Microbial Reference Genomes for Regulatory use: Zika and Ebola - Heike Sichtig, PhD, SME, Principal Investigator, Center for Devices and Radiological Health (CDRH) - more about FDA-ARGOS
- Nanomaterial-Based In Vitro Diagnostics for Pathogens - Indira Hewlett, PhD, Laboratory Chief, CBER
- 2017 FDA Science Forum agenda
- Register to attend in-person (non-FDA attendees)
- More information, including webinar registration links
- MCM regulatory science: FDA intramural and extramural research
Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov
- June 6-7, 2017: Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies: A Stand Alone Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division - FDA Acting Assistant Commissioner for Counterterrorism Policy RADM Carmen T. Maher, MA, BSN, RN, RAC will be the keynote speaker - register by June 1, 2017
- NEW! June 14-15, 2017: NIAID workshop - Pharmacokinetics-
Pharmacodynamics (PKPD) for Development of Therapeutics against Bacterial Pathogens (Bethesda, MD) - register by May 21, 2017
- NEW! June 18-22, 2017: Drug Information Association (DIA) 2017 (Chicago, IL) - FDA Acting Assistant Commissioner for Counterterrorism Policy RADM Carmen T. Maher, MA, BSN, RN, RAC will present on international collaboration in times of public health crisis (fee)
- NEW! June 20-21, 2017: Combating Antimicrobial Resistance: A One Health Approach to a Global Threat—A Workshop (Washington, DC and webcast), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
- NEW! June 21-22, 2017: The Need to Accelerate Therapeutic Development — Must Randomized Controlled Trials Give Way? (New York, NY and webcast) Hosted by the NYU School of Medicine and the New York Academy of Sciences - FDA speakers include Dr. Janet Woodcock and Dr. Luciana Borio (free; registration required to attend in person)
- NEW! June 26-29, 2017: Third annual Biodefense World Summit (Alexandria, VA), hosted by the Knowledge Foundation - includes a keynote presentation: Rapid Surveillance of the Ebola Genome Sequence with Microarray Technology by Robert Duncan, PhD, FDA/CBER (agenda) (fee)
- NEW! July 10, 2017: Public workshop - Sentinel Training at FDA (Silver Spring, MD and webcast) - Early registration is recommended. - Also see FDA's Sentinel Initiative
In case you missed it
- FDA welcomes Dr. Scott Gottlieb as the 23rd Commissioner of the U.S. Food and Drug Administration. Also see Dr. Gottlieb's first remarks to FDA staff (May 11, 2017)
- From CDC - CDC updates guidance on interpretation of Zika testing results for pregnant women - Recommendations focus on women who live in or frequently travel to areas with a CDC Zika travel notice - also see Health Alert Network: Prolonged IgM Antibody Response in People Infected with Zika Virus: Implications for Interpreting Serologic Testing Results for Pregnant Women (May 5, 2017)
- HHS seeks applications from qualified individuals for consideration for membership on the National Preparedness and Response Science Board (NPRSB). Apply by June 7, 2017.
- HHS is also soliciting nominations of individuals who are interested in being considered for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria as a non-voting liaison representative member from an organization and/or interest group. Submit nominations by 5:00 p.m. ET, June 30, 2017.
- CDC is accepting applications for its Laboratory Leadership Service (LLS) fellowship program. The LLS program prepares early-career laboratory scientists to become future public health laboratory leaders. Through on-the-job service at CDC and other public health laboratories, fellows acquire and apply skills in laboratory quality management, the science of biosafety, and leadership. Apply by July 17, 2017.
- CDC is also accepting applications for public health responders to join its Epidemic Intelligence Service (EIS). Apply by June 30, 2017.
- The National Academies of Sciences, Engineering, and Medicine convened a committee to identify global health priorities in light of current and emerging global health threats and challenges. In the resulting report, Global Health and the Future Role of the United States, the committee provides recommendations to the U.S. government and other stakeholders for increasing responsiveness, coordination, and efficiency in addressing these threats and challenges by establishing priorities and mobilizing resources. (May 15, 2017)