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Appendix A: Workshop Agenda
Pages 83-98

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From page 83... ... released its Public Health Emergency Medical Countermeasures Enterprise Review, which made numerous recommendations to transform the public health emergency countermeasures enterprise to increase its speed, agility, capacity, and success rate, including the promotion of regulatory innovation and investment in regulatory science at FDA. To promote regulatory innovation and investment in regulatory science at FDA, FDA has established an MCM initiative. Read the entire page →
From page 84... ... Regulatory science for MCM development and evaluation is essential for FDA to establish clear regulatory pathways for product approval based on the most advanced scientific foundations available and realize the promise of new technologies for flexible, rapidly scalable development and manufacturing of vaccines and other MCMs. This workshop will (1) Read the entire page →
From page 85... ... Enterprise Activities and Needs for MCM Regulatory Science GeoRGe KoRch Acting Principal Deputy Assistant Secretary for Preparedness and Response Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services 8:35 a.m. Overview of the MCM Initiative: Challenges and Opportunities Luciana BoRio Acting Director, Office of Counterterrorism & Emerging Threats Senior Advisor for Medicine and Public Health, Office of the Chief Scientist Office of the Commissioner, Food and Drug Administration SESSION I: ENTERPRISE AND STAKEHOLDER PERSPECTIVES ON NEEDS TO ADVANCE MEDICAL COUNTERMEASURE REGULATORY SCIENCE Session Objectives: • rovide a broad overview of current efforts under way at FDA and P within HHS and DoD to support the research, development, evalua tion, and production of MCMs. Read the entire page →
From page 86... ... • dentify challenges to and information needs for MCM I regulatory science programs. caRoLyn WiLson Associate Director for Research Center for Biologics Evaluation and Research Food and Drug Administration susan mccune Deputy Director, Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration muRRay maLin Center for Devices and Radiological Health Food and Drug Administration 9:50 a.m. Read the entire page →
From page 87... ... ) Department of Defense michaeL KuRiLLa Director, Office of BioDefense Research Affairs Associate Director for BioDefense Product Development National Institute of Allergy and Infectious Disease National Institutes of Heath RichaRd hatchett Chief Medical Officer and Deputy Director Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services may chu Director, Laboratory Science Policy & Practice Program Office Centers for Disease Control RicK Lyons Director, Infectious Disease Research Center Chief Scientific Officer, Infectious Disease SuperCluster Colorado State University eRic Rose CEO and Chair, Board of Directors SIGA Technologies, Inc. Read the entire page →
From page 88... ... LUNCH SESSION II: CUTTING-EDGE EFFORTS TO ADVANCE MEDICAL COUNTERMEASURE REGULATORY SCIENCE Session Objectives: • eview novel scientific methodologies used by academia and indus R try to discover and develop next generation vaccines, biologics, drugs, and devices. • dentify major gaps in currently available tools to predict and evalu I ate product safety, efficacy, and quality. Read the entire page →
From page 89... ... Discussion with Invited Discussants and Workshop Attendees dRusiLLa BuRns Chief, Laboratory of Respiratory and Special Pathogens Center for Biological Evaluation and Research Judy heWitt Chief, Biodefense Research Resources Section Office of Biodefense Research Affairs DMID/NIAID/NIH ViKRam PateL Office of Testing and Research Office of Pharmaceutical Sciences, CDER Read the entire page →
From page 90... ... Panel Discussion: Post Deployment Surveillance and Side Effects; Toxicology Markers Toxicology Markers RoBeRt house President DynPort Vaccine Company LLC Post Deployment Surveillance and Side Effects Kenneth mandL Faculty, Children's Hospital Informatics Program Harvard-MIT Division of Health Sciences and Technology 2:50 p.m. Discussion with Invited Discussants and Workshop Attendees maRietta anthony Predictive Safety Testing Consortium Critical Path Institute RichaRd FoRshee Associate Director for Research Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research henRy FRancis Center for Drug Evaluation and Research Food and Drug Administration RoBeRt c. Read the entire page →
From page 91... ... Panel Discussion: Statistical Techniques Statistical Techniques stePhen RuBeRG Distinguished Research Fellow & Scientific Leader, Advanced Analytics Eli Lilly & Co. Read the entire page →
From page 92... ... ADJOURN March 30, 2011 Venable Conference Center E11200 Capitol Room 575 7th Street, N.W. Washington, DC 20004 SESSION II, CONT'D: CUTTING-EDGE EFFORTS TO ADVANCE MEDICAL COUNTERMEASURE REGULATORY SCIENCE Session Objectives: • eview novel scientific methodologies used by academia and indus R try to discover and develop next generation vaccines, biologics, drugs, and devices. Read the entire page →
From page 93... ... Panel Discussion: Antimicrobials, Vaccines, and Vaccine Adjuvants Antimicrobials KeVin Judice CEO & Chief Scientific Officer Achaogen Vaccines aLan maGiLL Director, Division of Experimental Therapeutics Walter Reed Army Institute of Research Adjuvants deBBie dRane Senior VP R&D CSL Biotherapies 9:00 a.m. Discussion with Invited Discussants and Workshop Attendees ed cox Center for Drug Evaluation and Research Food and Drug Administration Read the entire page →
From page 94... ... Panel Objectives and Introduction GiGi KWiK GRonVaLL, panel chair Senior Associate, Center for Biosecurity UPMC 9:50 a.m. Panel Discussion: Synthetic Biology, Computational Biology, and Platform Technologies Synthetic Biology John GLass Senior Scientist J Read the entire page →
From page 95... ... BREAK SESSION III: MEDICAL COUNTERMEASURE REGULATORY SCIENCE NEEDS FOR AT-RISK POPULATIONS Session Objectives: • dentify needs that are specific or unique to at-risk populations (e.g., I pediatric populations) that should be considered in developing a regu latory science agenda for MCM development. Read the entire page →
From page 96... ... Discussion with Attendees PRaVin JadhaV Center for Drug Evaluation and Research Food and Drug Administration nancy messonnieR Centers for Disease Control Read the entire page →
From page 97... ... • ropose key opportunities to develop a research agenda P and roadmap for the MCM regulatory science initiative. PhyLLis aRthuR Director, Health & Regulatory Affairs Biotechnology Industry Organization GaiL casseLL, Drug Forum Co-Chair Visiting Professor, Department of Social Medicine, Harvard Medical School Vice President, TB Drug Discovery, Infectious Disease Research Institute, Seattle Read the entire page →
From page 98... ... Closing Remarks Jean hu-PRimmeR Senior Advisor for Regulatory Policy Acting Director, MCMi Regulatory Science Office of the Chief Scientist Office of the Commissioner, Food and Drug Administration Read the entire page →

From page 83...

... released its Public Health Emergency Medical Countermeasures Enterprise Review, which made numerous recommendations to transform the public health emergency countermeasures enterprise to increase its speed, agility, capacity, and success rate, including the promotion of regulatory innovation and investment in regulatory science at FDA. To promote regulatory innovation and investment in regulatory science at FDA, FDA has established an MCM initiative.

Appendix A: Workshop Agenda Pages 83-98

Appendix A: Workshop Agenda
Pages 83-98