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Reading Room Production — page 431

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From: "Fauci, Anthony (NIH/NIAID) [E]" </O=NIH/OU=NIHEXCHANGE/CN=NIAID/CN=AFAUCI> To: "Korch, George (OS)" @hhs.gov> Cc: "Kurilla, Michael (NIH/NIAID) [E]" @niaid.nih.gov>, "Conrad, Patricia (NIH/NIAID) [E]" @niaid.nih.gov>, "Folkers, Greg (NIH/NIAID) [E]" @niaid.nih.gov>, "Fauci, Anthony (NIH/NIAID) [E]" <AFAUCI@niaid.nih.gov> Subject: RE: Reminder about inputs for the potential White House Briefing on Sustainable Systems approach to MCM's Date: Mon, 18 Jan 2010 08:26:02 -0500 Importance: Normal Attachments: NIH_-_R_and_D_for_Health_threats_-_1-pager_-_FINAL.docx George: I am attaching our 1-pager as requested. Please let me know if you have any questons. Thanks, Tony -----Original Message----- From: Korch, George (OS) Sent: Monday, January 18, 2010 7:52 AM To: Fauci, Anthony (NIH/NIAID) [E]; Robinson, Robin (OS) Subject: Reminder about inputs for the potential White House Briefing on Sustainable Systems approach to MCM's Gentlemen: I will be assembling the information received on how to augment and improve the medical countermeasure enterprise from each of the partners to present to Heidi Avery and others on the NSC staff sometime tomorrow. Thanks in advance for sending your inputs to me so that I can craft a document to redistribute to all concerned. V/r, George

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RE: Reminder about inputs for the potential White House Briefing on Sustainable Systems — email 431
Reminder about inputs for the potential White House Briefing on Sustainable Systems approach to MCM's Gentlemen: I will be assembling the information received on how to augment and improve the medical countermeasure enterprise from each of the partners to present to Heidi Avery and others on the NSC staff sometime tomorrow. Thanks in advance for sending your inputs to me so that I can craft a document to redistribute to all concerned. V/r, George A Research and Development (R & D) Strategy for Future Health Threats - The NIH Approach - 2010 GOAL: The nation must be prepared to protect its citizens and preserve national security with safe and effective medical interventions that can prevent, diagnose, and treat existing biological threats as well as respond rapidly and effectively to newly emerging threats that are either naturally occurring or deliberately propagated. TRADITIONAL STRATEGY: While the traditional medical countermeasure development approach is a sound and appropriate strategy for mitigation of known biological threats, time and resources limit the ability of this "one bug - one drug - one vaccine" approach to achieve a rapid and effective response to all possible threats. As a result NIH has been transitioning to a new paradigm with three "broad spectrum" strategies (products, platforms, and technology) that will underpin a more flexible and responsive medical countermeasure capability. FUTURE STRATEGY: Broad Spectrum Products: Existing anti-infective products possess narrow activity across the wide range of potential pathogens. a) Vaccines. Using Influenza as an example, vaccines are exquisitely targeted such that a new influenza vaccine is required annually. Cross protective vaccine concepts offer the potential for a universal influenza vaccine such that annual vaccinations would be eliminated and pandemic protection would already be pre-existing. b) Drugs. Given the virtually limitless number of organisms that can constitute public health threats, it is essential to pursue the broad spectrum approach towards therapeutics. In addition to a small number of drugs replacing a medicine cabinet of pathogen specific drugs, drug resistance would be less likely to develop. Truly broad spectrum products offer the potential not only to address the vast, existing infectious disease spectrum, but allow for effective countermeasures for emerging diseases that could not even be predicted. Broad Spectrum Platforms: The concept of new platforms pertains most readily to vaccines. Standardized recombinant DNA technologies must be made available for immediate application in the context of emerging infectious diseases. Standardized methods offer the potential to significantly reduce the complexity, time, and cost required to bring medical countermeasures to general use. Platforms can be expanded to other aspects of the overall product development process such as diagnostic screening. Multiplexed platform diagnostics systems offer the capability to test for a wide array of potential pathogens, while at the same time, offering a simple and straightforward path for introduction of new tests as novel pathogens evolve or emerge. Broad Spectrum Technology: Technological enhancements offer greater capabilities in storage, dispersal, and utilization of countermeasures. NIH has focused on temperature stabilization and alternative delivery for vaccines as ancillary technologies with potential applicability to existing as well as future vaccines. Temperature stabilization allows for room temperature stockpiling which reduces storage and shipment costs as well as extending the shelf life of the vaccine. The potential to improve the vaccination effectiveness in the 3rd world where cold chain capability can be limited is enormous. Taken together, this new R & D strategy will position us well to address existing health threats as well as the challenge of new and emerging threats. afternoon for everyone's edits. ') [E]; Folkers, Greg (NIH/NIAID) [E]; Fauci, Anthony e Briefing on Sustainable Systems approach to MCM's iefing on Sustainable Systems approach to MCM's 2010-01-18 email 431–433