Reading Room Production — page 454

Manufacturing Capacity Big pharma did not express a concern about a lack of manufacturing capacity per se, but did indicate that rapid turn-around of production to a new product was difficult due to the regulatory approval of products that are site / locality specific. Merck said that it actually has excess capacity in some localities. The biotechnology sector said that they would love to have a manufacturing capacity issue. Merck indicated that overall, it would be happy to provide advice to the USG regarding manufacturing facility designs, etc. It was also understood that new facilities would have greater value if they were on U.S. soil. Small biotechnology Issues The disadvantage of the biodefense or public health emergency countermeasure market is that investors have no ability now to predict cost, return on investment, or timeline to return. Thus the biotechnology firms are looking for multiple ways to reduce the hurdles, with some examples pertaining to access to government and academia partners mentioned above. The SBIR program that would provide funding for small companies requires that the company not be more than 50% investor owned. It was suggested that this is set to change in legislation, but that the legislation is being held up waiting for health care legislation to proceed. At a programming level, lots of money was spent early on for very mature products to achieve approval, but there is less of an investment in early stage platform technologies to move them into position for scale-up and maturation. Many of the disruptive technologies come from the more risk-accepting smaller biotechnology companies, and there is not enough investment in the funds to realize gains faster. There needs to be more transparency on which scientists or investigators within the DoD and NIH programs are working on specific intramural programs to create a chance for more partnering with industry. Platform Technologies Dr. Tony Fauci asked about whether big pharma anticipates, or is pursuing any role in advancing platform technologies which would be transformative in the ability to realize dual marketing potential for products related both to public health emergency needs and to more commercially viable products. It would be preferable to share risk with big pharmaceutical companies in developing these platforms. Dr. George Korch also asked about prospects for host-based therapeutic targets for infectious agents vs. strictly pathogen based targets. Merck acknowledged the interest in host-based technologies,