conference call today at 6pm
3 messages over —, 2010-02-11 – 2010-02-11.
-
Greetings - Believe it would be useful for us to talk briefly today at 6pm. Our meeting with the President remains scheduled for 2pm tomorrow in the WHSR. During the call we will clarify the meeting intent, discuss any concerns, and generally seek to set all of us up for success. Meanwhile, we will have a new version of the draft strategy to you soon. Appreciate all of the very good comments. And, to be clear, we expect the draft strategy will be further adjusted based on consultations. The ongoing MCM review, PCAST study, and talks with industry will be critical to further shape the way forward. We remain early in the process. Thanks, Heidi BRIDGE NUMBER: CONFEREE PASSCODE: -------------- Heidi E. Avery Deputy Assistant to the President for Homeland Security The White House
-
Greetings - Believe it would be useful for us to talk briefly today at 6pm. Our meeting with the President remains scheduled for 2pm tomorrow in the WHSR. During the call we will clarify the meeting intent, discuss any concerns, and generally seek to set all of us up for success. Meanwhile, we will have a new version of the draft strategy to you soon. Appreciate all of the very good comments. And, to be clear, we expect the draft strategy will be further adjusted based on consultations. The ongoing MCM review, PCAST study, and talks with industry will be critical to further shape the way forward. We remain early in the process. Thanks, Heidi BRIDGE NUMBER: CONFEREE PASSCODE: -------------- Heidi E. Avery Deputy Assistant to the President for Homeland Security The White House Draft Strategy for Reinventing the Integrated Public Health Emergency Medical Countermeasures Enterprise The U.S. Government's Integrated Public Health Emergency Medical Countermeasures Enterprise (iPHEMCE) has struggled for almost a decade to develop drugs, diagnostics, and vaccines ("countermeasures") against naturally occurring pandemics and other infectious diseases, and deliberately propagated bioterrorism and other public health threats. Despite significant investment, our National efforts have yielded only a modest number of new countermeasures. We recognize that our current approach is not sustainable over the long term, will not provide us with the comprehensive protection we require against both known and emerging threats, and that recent advances in the biological sciences and pharmaceutical industry create scientific opportunities that must be pursued. (Excellent! To reduce our vulnerability to public health threats and safeguard the health and safety of the American people, we must pursue immediately a-very different approach to novel medical countermeasures development and acquisition. To that end, and as announced during the President's State of the Union address on January 27, 2010, the Obama Administration is launching a transformative initiative. The goal is to develop a national capability for the rapid, reliable, robust, and affordable production of an array of medical countermeasures against public health threats. This document lays out the broad strategy to achieve this goal. 'Commented [a1]: I inserted the word "broad" to alleviate the In creating a transformed iPHEMCE, it is useful to understand the obstacles that have limited its success to date. In pursuing new biodefense countermeasures over the last eight years, the Federal Government has experimented with a variety of "push" and "pull" incentives for the pharmaceutical industry, a critical partner in the development of countermeasures. These incentives, including the creation of a $5.6B Special Reserve Fund for Project BioShield, have not resulted in the desired flow of new and next-generation medical countermeasures because they have not addressed the real problem, which is the barriers that the pharmaceutical industry perceives to return on investment in this area. These barriers include: '* Complex, burdensome, and uncertain path to licensure of countermeasures; Rapid and unpredictable pace of new requirements for novel countermeasures; Small markets and/or low profit margins for the products the USG has indicated it requires: High cost of drug development under any circumstances; High costs associated with scale-up and manufacturing: Limited in-house subject matter expertise: Lack of expertise and experience in negotiating the U.S. Food and Drug Administration (EDA) "animal rule" pathway to product licensure: © Complex policy environment; © Complex funding environment; and © High risk of failure. Afier assessing the high opportunity cost and financial risk of working in the domain of developing countermeasures for bioterror threats, and considering the high transaction costs associated with government contracts, capable large pharmaceutical firms have uniformly elected to focus their ty that this is final and to Stil specifics to be ironed out. afauci 2010-02-11 19:37:00 by the that there are Draft efforts and resources on the development of more commercially viable productselsewhere. The innovative small biotechnology firms that have been attracted to countermeasure development against bioterror and pandemic threats generally do not possess the inherent expertise or capabilities that enable larger firms to complete development and industrialization projects. The result for the U.S. Government has been an inconsistent return on its investments to date. The Administration's initiative is aimed at transforming how investments are made in the countermeasure enterprise and at enhancing performance of the enterprise through highly engaged end-to-end support and management. Greater productivity from such investments will be achieved primarily by reducing or eliminating the barriers that impede progress. By reducing these barriers, the U.S. Government can change the calculus that results in an unacceptable return on investment and thus offer private sector partners a more favorable value proposition. As a complement to Complementing this approach of attacking the barriers, incentives external to the drug development process will also be employed in more creative ways. The new U.S. Government strategy comprises five principles or "pillars" necessary to transform IPHEMCE. The first is the adoption of the multi-use principle as a high priority and governing principle for future investments. The second through fifth pillars are collectively aimed at fundamentally altering the conduct and management of public-private partnerships in the area of countermeasure development against public health threats. These pillars will be pursued in tandem and as an Enterprise-wide initiative. Implementing individualtke pillars alone or in isolation will not effect the comprehensive transformation that is required or ensure greater productivity for our efforts and investment. The principles must be enacted and implemented together as a composite initiative if their full benefit is to be realized. The goal is to markedly increase the return on the U.S. Government' investment in medical countermeasures against public health threats. Achieving this breakthrough will yield a new template for government support of private sector drug development in areas where progress has been impeded by apparent market failures. I. The Multi-Use Principle Orthodox opinion holds that the U.S. Government is the only customer for biodefense and pandemic countermeasures and that viable commercial markets for these products do not exist. This received wisdom has inhibited efforts on the part of government program managers to find and leverage the market forces that will attract private sector partners to invest in projects that address our requirements. For far too long, the U.S. Government has attempted to counter market forces that drive potential private sector partners toward lower-risk investments in other areas. As our track
-
Greetings - Believe it would be useful for us to talk briefly today at 6pm. Our meeting with the President remains scheduled for 2pm tomorrow in the WHSR. During the call we will clarify the meeting intent, discuss any concerns, and generally seek to set all of us up for success. Meanwhile, we will have a new version of the draft strategy to you soon. Appreciate all of the very good comments. And, to be clear, we expect the draft strategy will be further adjusted based on consultations. The ongoing MCM review, PCAST study, and talks with industry will be critical to further shape the way forward. We remain early in the process. Thanks, Heidi BRIDGE NUMBER: CONFEREE PASSCODE: -------------- Heidi E. Avery Deputy Assistant to the President for Homeland Security The White House