Reading Room Production — page 451

ble Summary of meeting with VP's of pharmaceutical and biotechnology companies 29 January 2010 Eisenhower Executive Office Building Dr. Zeke Emanuel opened the meeting with a problem definition statement that we as a nation need medical countermeasures for public health emergency events ranging from biodefense to emerging infectious diseases, but after years of investment, we still have not been successful in meeting these needs. He indicated that to a certain degree, there is a sense that the big pharmaceutical companies have opted out of assisting in this endeavor, and while there are smaller, biotechnology companies attempting to fill the gap, they lack the experience to complete the task. Ms. Heidi Avery added that this was not to single out big pharma, but that the USG recognizes that it may not have created the best conditions for being a good partner as well. She pointed out that the industry itself has recently struggled with producing approved medical products for more highly valued commercial products. The bottom line is that the President is seriously committed to this problem and this was highlighted in his State of the Union message. This meeting was being held therefore to start a dialogue with industrial partners (big pharma and the biotechnology sector) to gain their perspectives on what government actions can we take to lower the barrier to entry and to increase the attractiveness of partnership, because without big pharma specifically, the whole thing will not work. We need to hear their ideas. Merck started by reminding folks that they had in fact bid on the contract award for the cell culture derived smallpox vaccine, but had not been successful. Merck then indicated that there are three areas of concern that must be addressed to attract companies like theirs to the program: 1. Need to assure an adequate market 2. Need to make the regulatory path much more viable 3. Need to reduce legal liabilities (e.g. tort claims) Markets On the issue of adequate markets, this allows both big pharma and the biotechnology companies to gauge issues on such things as return on investment, infrastructure and operations costs, etc. Even if the market is destined just to be standard replacement of a strategic stockpile, that constitutes a defined market need. NKT Therapeutics, representing the biotechnology sector indicated that ability to define an adequate market is a key variable for their ability as a small company to secure investment funding. (Note: I interpret the relative order of these three items to actually be in a sort of priority order for big pharma).