Year: 2009-10

Company: Gilead Sciences

Liaison(s): Robert Seemayer, Regan Shea

Gilead Sciences Inc. was founded in Foster City, California over 20 years ago and has become a dominant force in the pharmaceutical industry with over 14 marketed products and more than $7 billion in revenues. Gilead’s product portfolio includes treatments for HIV/AIDS, liver disease, cardiovascular disease and respiratory conditions. All of their products are chemically derived small molecules, many of which were obtained through acquisitions. Gilead has extensive experience performing due diligence for small molecule product acquisitions. The team objective was to identify key challenges and risks Gilead is likely to encounter performing due diligence for a biologic product or involving biologic process components. As an approach, mock due diligence analyses were performed and documented for three existing products: Amoxicillin, Insulin and a recombinant MAb (LEB). The analysis relied on public information and interviews with experts. Due diligence is focused on: 1) Development and Manufacturing; 2) Regulatory; 3) Intellectual Property; and 4) Market Competition. Several challenges and risks were identified that result from the unique regulatory requirements for Biologics, the size and complexity of the molecules, and the increased manufacturing controls and facility design measures needed to produce a safe and consistent product and avoid microbial and viral contamination.