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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Medical Countermeasures (MCM) for a Burn Mass Casualty Incident, September 27-28, 2012

The Food and Drug Administration (FDA) is announcing a public workshop entitled "Medical Countermeasures (MCM) for a Burn Mass Casualty Incident." This workshop will engage stakeholders across the public and private sector in strategic dialogue related to development, evaluation, deployment and monitoring of medical countermeasures to mitigate the adverse health consequences arising from public health emergencies, specifically those involving radiological, nuclear or chemical threats. The focus of this workshop is on management of the burn injury, bringing together cross-disciplinary subject matter experts to - discuss unmet needs; underscore issues related to product development, testing and commercialization; and address opportunities to meet those challenges leveraging coordination and collaboration among strategic networks.

The purpose of this workshop is to - describe medical countermeasure requirements for burn injuries of radiological, nuclear or chemical origin in a ‘scarce resources’ environment; identify gaps in the product landscape so as to articulate a consensus-based needs assessment; discuss testing approaches and regulatory pathways; and to educate workshop attendees on the concept of medical utilization and response integration.

Date, Time and Location

This workshop will be held September 27, 2012 and September 28, 2012, at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Section A)
Silver Spring, MD 20993

Webcast

The webcast will be available at:

Agenda

Time Subject Name of Speaker
Day 1 : September 27, 2012  
8:30am-8:35am Welcome Remarks Michelle McMurry - Heath, MD, PhD, Associate Director for Science, Office of the Center Director (OCD), Center for Devices and Radiological Health (CDRH)
8:35am-8:45am Setting the Stage: How Did We Get Here? Suzanne B. Schwartz, MD, MBA - Office of the Center Director (OCD), Center for Devices and Radiological Health (CDRH)
8:45am-10:10am Plenary Session: A 30,000 Foot View of the PHEMCE Landscape -Operationalizing Preparedness & Response to A Burn Mass Casualty Incident  
8:45am-8:55am FDA’s MCMi Role within PHEMCE Strategic Objectives Alan Liss, MD - Office of Counterterrorism and Emerging Threats (OCET)/Office of the Commissioner (OC)/ FDA
8:55am-9:05am Medical Countermeasure Requirements: Framework, Players, Process Richard I Jaffe, PhD - Division of Medical Countermeasure Strategy and Requirements (MCSR)/ Office of Policy & Planning (OPP)/Assistant Secretary for Preparedness and Response (ASPR)/ DHHS
9:05am-9:15am Federal Support for a National Burn Surge Framework RADM Clare Helminiak, MD, MPH - Office of Preparedness and Emergency Operations (OPEO)/ Assistant Secretary for Preparedness and Response (ASPR)/ DHHS
9:15am-9:25am Strategic National Stockpile (SNS) Overview Susan Gorman PharmD, MS, DABAT, FAACT - Division of Strategic National Stockpile, Office of Public Health Preparedness and Response, Center for Disease Control and Prevention (CDC)
9:25am-9:35am Medical Countermeasures for Thermal Burns: the BARDA Experience Ronald Manning, PhD - Biomedical Advanced Research & Development Authority (BARDA)/ Assistant Secretary for Preparedness and Response (ASPR)/ DHHS
9:35am-9:45am The Role of NIH in Burn Research Scott Somers, PhD- National Institute of General Medical Sciences (NIGMS)/ National Institute of Health (NIH)
9:50am-10:10am Q & A  
10:10am-10:20am Break  
10:20am-12:30pm CHALLENGE I Organization & Delivery of Burn Care in a Mass Casualty Setting  
10:20am-10:30am Short Talk: 9/11 - The New York Presbyterian/Cornell Burn Center Experience: Lessons Learned. Palmer Q. Bessey, MD, MS - New York Presbyterian Hospital/Weill Cornell Burn Center
10:30am-10:40am Short Talk: Special Considerations in Pediatric Mass Casualty Response. Arthur Cooper, MD, MS - Trauma and Pediatric Surgical Services, Harlem Hospital Medical Center and Columbia University
10:40am-10:50am Short Talk: Leveraging the Science of Self - Organizing Networks in Burn Mass Casualty Preparedness: A Working Model for the National Burn Surge Framework. James C. Jeng, MD - Washington Hospital Burn Center
10:50am-12:15pm Challenge 1 Panel Discussion Panel Moderators:
  • Bruce Cairns, MD - University of North Carolina Burn Center
  • Richard Jaffe, PhD - MCSR/OPP/ASPR
Discussants:
  • Palmer Q. Bessey, MD, MS - NY Presbyterian Hospital Burn Center, NYC
  • Colonel Leopoldo C. Cancio, MD - Brook Army Burn Center, Fort Sam Houston, Texas
  • Susan Gorman, PharmD, MS, DABAT, FAACT - CDC, Atlanta, Ga
  • RADM Clare Helminiak, MD, MPH - Deputy Director for Medical Surge OPEO/ASPR, DC
  • James H. Holmes IV, MD - Wake Forest Burn Center, Winston - Salem, NC
  • James C. Jeng, MD - Washington Hospital Burn Center, DC
  • Randy D. Kearns, DHA, MSA, CEM - University of North Carolina School Of Medicine, NC and Southern Burn Disaster Programs, Chapel Hill, NC
  • Gregg Lord, MS, NREMT - P - ECCC/OPEO/ASPR, DC
  • Steven E. Wolf, MD - Parkland Hospital Burn Center, UT Southwestern, Dallas, Texas
  • David Harrington, MD - Rhode Island
12:15pm-12:30pm Q & A  
12:30pm-2:00pm Lunch Break  
2:00pm-2:20pm Keynote Address: “Burns Are Different.” Tina L. Palmieri, MD: 2012 - 2013 ABA President, UC Davis Burn Center, Shriners Hospital for Children Burn Center -Sacramento, CA.
2:20pm-2:30pm Q & A  
2:30pm-4:30pm CHALLENGE II What’s Missing in Burn MCMs: Next Gen Products to Address the Hot Reality and Cold Truths  
2:30pm-3:45pm Challenge 2 Panel Discussion Panel Moderators:
  • James H. Holmes IV, MD - Wake Forest Burn Center, Winston - Salem, NC
  • Narayan Iyer, PhD - BARDA/ASPR, DC
Discussants:
  • Richard Clark, MD - Stony Brook Medical Center, Stony Brook, NY
  • Bill Hickerson, MD - Memphis Firefighters Burn Center, Memphis, Tennessee
  • Maribeth Love, MS - Logistics, BARDA/ASPR, DC
  • Tina L. Palmieri, MD - UC Davis Burn Center, Sacramento, CA
  • LTC David Shoemaker, PhD - US Army Medical Research and Material Command, Fort Detrick, MD
  • Scott Somers, PhD - NIGMS/NIH, Rockville, MD
  • Hung Tseng, PhD - NIAMS/NIH, Rockville, MD
  • Steven E. Wolf, MD - Parkland Hospital Burn Center, UT Southwestern, Dallas, Texas
  • Tom Tarca - Integra Life Sciences, Plainsboro, NJ
  • Michael Halpin _ Genzyme, Cambridge MA
  • Charles Durfor, PhD - Master Reviewer, Plastic and Reconstructive Surgery Branch (PRSB)/Office of Device Evaluation (ODE)/CDRH/FDA
  • Steven Oh, PhD - CMC Reviewer, Office of Cellular, Tissue and Gene Therapy (OCTGT)/CBER/FDA
  • Jacqueline Francis, MD, MPH - Acting Chief Pediatric Medical Officer, CDRH/FDA
3:50pm-4:00pm Short Talk: “Special Considerations for Threat Agents: Chemical Vesicant Burns” Colonel Leopoldo C. Cancio, MD - Brook Army Burn Center, Fort Sam Houston, Texas
4:00pm-4:15pm Panel Discussion Continues  
4:15pm-4:30pm Q & A  
4:30pm-6:00pm Poster Session  
Day 2 : September 28, 2012
8:30am-8:35am Welcome Back Markham Luke, MD, PhD, Clinical Deputy Director, Office of Device Evaluation (ODE)/CDRH/ FDA
8:35am-12:00pm CHALLENGE III Evaluation, Assessment, and Monitoring: FDA Role and Responsibilities  
8:35am-8:45am Bridging Burn MCM Product Development and Regulatory Approval/Clearance: What are the Regulatory Challenges, the Opportunities and Considerations? CAPT Carmen Maher RN, USPHS, Office of Counterterrorism and Emerging Threats (OCET)/Office of the Commissioner (OC)/ FDA
8:45am-9:30am Panel Discussion Panel Moderator:
  • CAPT Carmen Maher RN, USPHS, Office of Counterterrorism and Emerging Threats (OCET)/Office of the Commissioner (OC)/ FDA
Discussants:
  • Rosemary Roberts, MD - CDER, MCM Center Lead
  • Cynthia Kelley - CBER, MCM Center Lead
  • CDR Nikhil Thakur MS - CDRH, MCM Center Policy Specialist
  • Debra Lewis, OD, MBA - Office of Orphan Products Development/ Office of the Commissioner (OC)/FDA
  • David Krause, PhD - Branch Chief, Plastic and Reconstructive Surgery (PRSB)/ ODE/CDRH/FDA
  • LTC David Shoemaker, PhD - US Army Medical Research and Material Command (USAMMRC)
9:30am-9:40am Q & A  
9:40am-9:55am The PreMarket Journey - Views from 3 Vantage Points Discussants:
  • Judith O’Grady, RN, MSN, RAC, Integra Life Sciences.
  • Bill Hickerson, MD, Memphis Firefighter’s Burn Center.
  • Charles Durfor, PhD, Master Reviewer, Plastic and Reconstructive Surgery Branch/ODE/CDRH/FDA
9:55am-11:20am Study Considerations for Evaluating Safety & Effectiveness Panel Discussion Panel Moderators:
  • Binita Ashar, MD, FACS, MBA - Medical Officer, Clinical Reviewer, Plastic and Reconstructive Surgery Branch (PRSB)/ODE/CDRH/FDA
  • Steven E. Wolf, MD - Parkland Hospital Burn Center, UT Southwestern, Dallas, Texas
Discussants:
  • Charles Durfor, PhD - Master Reviewer ODE/CDRH/FDA
  • Mitch Frost, MD - Clinical Reviewer, Office of Blood Research and Review (OBRR)/CBER/FDA
  • Bill Hickerson, MD - Memphis Firefighters Burn Center
  • Nisha Jain, MD -Branch Chief, OBRR/CBER/FDA
  • James Jeng, MD - Washington Hospital Burn Center
  • Agnes Lim, MD - Medical Officer, Clinical Reviewer, Office of Cellular, Tissue and Gene Therapy (OCTGT)/CBER/FDA
  • Judith O’Grady RN - Integra Life Sciences
  • David Bostwick, MD - CDER Reviewer, Anti - infective Drug Products, specializing in skin and skin - related issues
  • Suzanne Schwartz, MD, MBA - Medical Officer, Clinical Reviewer, PRSB/ODE/CDRH/FDA
  • CDR Nikhil Thakur MS - CDRH, MCM Center Policy Specialist
  • CDER Clinical Reviewer - Dermatologic Products, TBD
11:20am-11:30am Q & A  
11:30am-11:45am Assessment in Real - Time and Post - Incident Surveillance and Monitoring  
11:30am-11:45am “ United States Critical Illness and Injury Trials Group: Lessons Learned” J Perren Cobb, MD Massachusetts General Hospital Critical Care Center, Harvard Medical School, Boston, MA
11:45am-11:59am WRAP - UP: Synthesizing Workshop Discussions - Learnings; Highlights/Takeaways; & Setting a Roadmap for Future Direction. Session I, II and III Moderators
12:00pm Closing Remarks Suzanne Schwartz, MD, MBA - OCD/CDRH/FDA

Registration to Attend the Workshop

Online registration is closed as of September 21, 2012.

CALL FOR POSTERS - This workshop will include a poster session. Please indicate if you wish to present an abstract during the poster session by email to Suzanne Schwartz MD, MBA (Suzanne.Schwartz@fda.hhs.gov). Abstracts should be submitted by email no later than 5:00 PM on August 31, 2012. No commercial promotional material will be permitted to be presented or distributed at the public workshop.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Ms. Cindy Garris, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5861; email: Cynthia.Garris@fda.hhs.gov.

Contact Us

For questions regarding workshop content and abstract submission, please contact:

Suzanne Schwartz MD, MBA
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Phone: (301)796-6970
email: Suzanne.Schwartz@fda.hhs.gov

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