AGENDA - February th, 2014 Meeting 5: Antimicrobial Resistance and Countermeasures

Transcription

1 AGENDA - February th, 2014 Meeting 5: Antimicrobial Resistance and Countermeasures This meeting will explore: Key issues of antimicrobial resistance and the antimicrobial pipeline. DOD needs and goals in this area. The antimicrobial program and RFI that DoD is developing. Technical challenges and opportunities in antimicrobial drug development. Supporting technologies and approaches (such as combination therapies, repurposing licensed drugs and diagnostics) for combating antimicrobial resistance. Areas where DOD may leverage or catalyze the efforts of other stakeholders. Wednesday, February 12 th, 2014 Lecture Room, National Academy of Sciences Building (Note: Day 2 is in different building) 2101 Constitution Ave., N.W.; Washington, DC OPEN SESSION, LECTURE ROOM Session 1: Introduction and Overviews 8:30 am Welcome and Introductions Melinda Moore Role of the Committee Marilee Shelton-Davenport Thoughts from DOD Franca Jones 8:50 am Meeting Overview Stan Cohen India Hook-Barnard 9:00 am 20 min overview of problem and pipeline Opening presentation -- Key issues, Approaches, and Stakeholders in Antimicrobial Resistance (AMR) Research and Development Scope of the problem Overview of Antimicrobial Pipeline o Who are key players (NIAID, BARDA, DOD, CDC, industry) o Cost and Timeline o What are key challenges technical, regulatory, economic, etc Speaker: Nicole Mahoney Senior Officer, Antibiotics and Innovation, The Pew Charitable Trusts 1, 5/21/2015

2 20 min BARDA overview time >20min for Overview of BARDA efforts in this area Requirements Rick Jaffe, Ph.D., MT (ASCP) Director, Division of Medical Countermeasure Strategy and Requirements, ASPR, HHS AM Program Joe Larsen, Ph.D. Chief, Broad Spectrum Antimicrobials Program Discussion with Speakers Moderator: Doug Weibel Session 2: DOD Antimicrobial Program Plans: Goals, Status, Strategy 10:00 am Break 10:15 am 45 min total DOD/JPEO Program Overview- Status, Strategy, and Goals for the Program: DOD specific concerns, issues? What is the long term vision the capability that DOD wants to build? How does this fit with other programs NIAID, BARDA, CDC, etc RFI/ RFP Lines of Inquiry, Timeline, and Selection Criteria Speakers: LTC Eric Midboe, Joint Product Manager, BioDefense Therapeutics Ms. Malissa Smith Assistant Product Manager,BioDefense Therapeutics Dr. George Christopher, Chief Medical Officer Dr. Kimberly Wallace, Chief Scientific Officer 11:00 am Discussion of Goals and Strategy Moderator: John Hardham 11:30 am Lunch Session 3: Lines of Inquiry 12:00 pm Overview of the afternoon session Stan Cohen Each speaker will discuss: Why does the Line of Inquiry matter?- i.e., why is this topic important for Antimicrobial development? What is the current status for this topic? i.e., where are we in the development pipeline for this area in particular? What are the S&T Challenges and potential new approaches that may be important for the DoD program to consider?

3 Session 3a: Focus on Antimicrobial Medical Counter Measures (MCM) 12:15 pm Speakers have 15 min Panelists, have 3-5 min for initial comments time for Q/A and Panel Line of Inquiry 1: Bacterial Targets Platforms for Antibiotic Discovery Speaker : Kim Lewis Northeastern University Intracellular Pathogens Speaker: Steve Projan, Sr VP R&D, MedImmune Line of Inquiry 2: Host targets Speaker : Alan Cross, University of Maryland School of Medicine Panel Discussion Moderator: Stan Cohen How can the DOD AMR Program maximize impact with the funds and timeline available? What are others (e.g., BARDA, NIAID, industry) doing that can be leveraged or catalyzed by CBDP? Speakers plus Panelist: Lynn Silver Consultant, Formerly Merck 2:00 pm Break Session 3b: Enabling Science and Technology 2:15 pm Speakers have 15 min time for Q/A and Panel Line of Inquiry 3: Diagnostics Next Generation Susceptibility Testing and the Need for Speed Speaker: Wm. Michael Dunne Wash University School of Medicine and biomerieux Line of Inquiry 4: Strategic Approaches to Combat AMR Combination therapies (cocktails, selective pressure, transient resistance) Speaker : Gerry Wright, McMaster University, Hamilton, Ontario Repurposing Speaker : Hao Wan, Merck Frosst Center for Therapeutic Research, Canada Monoclonal antibody approach Speaker : LTC Dan Wattendorf, DARPA/ Defense Science Office

4 4:00 pm Break Panel Discussion Moderator: Tom Slezak How can the DOD AMR Program maximize impact with the funds and timeline available? What approaches for treatment might be pursued to combat resistance or increase the effectiveness or lifetime of MCM? What enabling technologies or diagnostics might improve effectiveness of the AMR program? What are others doing that can be leveraged? Speakers plus Panelist: Michael Dunne Durata Therapeutics 4:15 pm Summary and Key Take-Aways Ideas from committee, broader 5:00 pm Adjourn-End of Antimicrobial Resistance and Countermeasures Presentations and Information-Gathering Thursday, February 13 th, 2014 Keck Center of the National Academies (NOTE: Change in Building) 500 Fifth St., N.W.; Washington, DC CLOSED SESSION: COMMITTEE AND STAFF ONLY, ROOM 106 9:00 am Discussion of Upcoming Meeting Topics (ideas from list and new ideas from sponsor and committee) Pathways to Licensure (May 28-29, 2014) Other Potential Topics OPEN SESSION, ROOM 106 Session 4: Meeting Recap 10:00 am Roundtable Discussion of Meeting Sponsor Thoughts Meeting Insights from Committee Members 11:30am 11:45am Summary of Meeting Insights Lunch NOT OPEN TO THE PUBLIC, ROOM TO BE PROVIDED 12:30pm 2:45pm Discussion Adjourn

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