Appendix H
Open Meeting Agenda

COMMITTEE ON DOD’S MALARIA VACCINE RESEARCH—A PROGRAM REVIEW

January 23–25, 2006

Courtyard by Marriott

8506 Fenton St.

Silver Spring, MD 20910

Tel 301-589-4899

Meeting Room

AGENDA

Meeting Objectives

  • Obtain perspectives from DoD on the malaria threat to the force

  • Review DoD’s P. falciparum malaria vaccine research program

  • Review nonmilitary malaria vaccine efforts

  • Develop initial findings and recommendations regarding DoD’s Program



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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Appendix H Open Meeting Agenda COMMITTEE ON DOD’S MALARIA VACCINE RESEARCH—A PROGRAM REVIEW January 23–25, 2006 Courtyard by Marriott 8506 Fenton St. Silver Spring, MD 20910 Tel 301-589-4899 Meeting Room AGENDA Meeting Objectives Obtain perspectives from DoD on the malaria threat to the force Review DoD’s P. falciparum malaria vaccine research program Review nonmilitary malaria vaccine efforts Develop initial findings and recommendations regarding DoD’s Program

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Monday, January 23, 2006 Closed Session 8:00 Bias and Conflict Discussion Susanne Stoiber Executive Director, Institute of Medicine Open Session 9:00 MIDRP Welcome COL David Vaughn, MC Director, Military Infectious Disease Research Program Fort Detrick, Maryland 9:15 Chairman’s Remarks and Introductions 9:30 MIDRP and Malaria Program Overview and Review of Committee Charge COL David Vaughn 10:30 Break 11:00 Overview Malaria Vaccine Development Dr. Filip Dubovsky Scientific Director, Malaria Vaccine Initiative 12:00 Lunch 1:00–5:15 Program Review—Protein-based vaccine strategy 1:00 Objectives and Strategy COL Gray Heppner 1:30 Progress towards an RTS,S-Based Vaccine by Year 2010: New Adjuvants, Antigens, and Vectors Status of RTS,S/AS02A COL Gray Heppner Adjuvant AS01B: RTS,S/AS02A vs. RTS,S/AS01B COL Kent Kester GMP Pf Antigens MSP-1, AMA-1, and LSA-1 Dr. Evelina Angov Adenovirus 35 with circumsporozoite protein Dr. Ann Stewart

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program 2:50 Break 3:00 Clinical Trials of an RTS,S-Based Vaccine COL Gray Heppner 3:30 Future Vaccines Antigen Discovery COL Chris Ockenhouse Vivax COL Chris Ockenhouse Attenuated Knock-out COL Gray Heppner 4:00 Building the RTS,S-Based Vaccine One Allele or Two? COL Chris Ockenhouse The role of molecular analyses Making Development Earlier COL Chris Ockenhouse The potential microarrays Assays of Immune Response Dr. Ann Stewart From robust to validated 4: 30 Barriers from Proof of Concept to Licensure COL Gray Heppner Funding Industrial Partners Licensure Trials 5:00 Discussion 6:30–8:30 Committee Dinner at Redrock Canyon Restaurant, Silver Spring, Maryland

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Tuesday, January 24, 2006 Open Session 8:00–12:30 Program Review—DNA-based vaccine strategy 8:00 Objective, Background & Rationale CAPT Tom Richie 8:30 Program History CAPT Tom Richie 8:50 Functional Elements & Activities Overview CAPT Tom Richie Discovery Research Dr. Denise Doolan Target Antigens Immune Mechanism 9:50 Break (30 minutes) Preclinical Research Dr. Denise Doolan Preclinical Development Dr. Denise Doolan Regulatory Affairs Ms. Gail Levine Clinical Trials LCDR David Regis 11:05 Clinical Development Plan CAPT Tom Richie 11:30 Barriers to Progress CAPT Tom Richie 12:00 Attenuated Sporozoite Vaccine CAPT Tom Richie 12:30 Lunch Closed Executive Session 1:30 Discussion of the DoD program including review of questions posed by the sponsor about the Vaccine Program 5:30–5:45 Chairman’s time 6:30–8:30 Dinner at hotel, local restaurant of choice OR evening working session

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Wednesday, January 25, 2006 Closed Executive Session* 8:00–12:00 Structured discussion of the DoD malaria vaccine research program Clarify gaps or missing information Finish discussions regarding key program questions Develop initial findings and recommendations Establish second meeting date to review report draft. * An open portion of this meeting was posted from 9:00–9:45 and will be honored if needed.