Life Sciences Law's Mikhail speaks at Kellogg Biotechnology & HealthCare Conference
Posted: 01-25-2006 :

Chapel Hill, N.C. -- Sheila Mikhail, Managing Member of Life Sciences Law, PLLC, a Chapel Hill, NC-based firm that advises biotechnology and pharmaceutical companies, served as moderator for a panel discussion on Follow-On Biologics at the Kellogg Biotechnology & HealthCare Conference held at Northwestern University, Evanston, IL last week.

The conference, “Healing Through Innovation”, addressed the role of innovation in an healthcare system that is rapidly evolving. This conference, organized and run by students, hoped to create a dialogue about innovation by exploring the political, ethical and financial perspectives of payers, providers, patients and health companies. The panel for which Ms. Mikhail served as moderator, “Biotechnology: Global Outlook for Follow-On Biologics”, addressed several issues regarding follow-on biologics, including what global competitive forces are at play regarding follow-on biologics, and the arguments for and against the approval of follow-on biologics. The panelists included: Daniel S. Robins, Ph.D., Vice President – Product Development, American Pharmaceutical Partners, Inc.; Ronald Park, M.D., Director, Market Development, Genentech Inc.; and Scott MacIntire, District Director, Food & Drug Administration.

Follow-on biologics has become an increasingly debated topic. The imminent patent expiration of many biopharmaceutical products has increased pressure for the development of generic versions of these therapeutic agents. However, there are a number of issues that will make approval of follow-on biologics much more complicated than the approval of generic equivalents of conventional pharmaceuticals. These issues center on the intrinsic complexity of biopharmaceutical agents, which are recombinant proteins in most cases, and the heterogeneity of proteins produced by different manufacturing processes (i.e. differences in host cells, purification and processing, formulation and packaging). Of concern is the increased immunogenicity of recombinant proteins with different formulations, or those manufactured by different processes. Thus, verification of the similarity to or substitutability of follow-on biologics with reference to innovator biopharmaceutical products will require much more than a demonstration of pharmacokinetic similarity, which is sufficient for conventional, small molecule generic agents. Regulatory requirements for the approval of follow-on biologics have not yet been established, but preliminary guidelines from the European Agency for the Evaluation of Medicinal Products (EMEA) state that the complexity of the product, the types of changes in the manufacturing process, and differences in quality, safety and efficacy must be taken into account when evaluating such therapeutics. The panel at Kellogg determined that for most products, results of clinical trials demonstrating safety and efficacy are likely to be required. In addition, the panel concluded that because of the unpredictability of the onset and incidence of immunogenicity, extended post-marketing surveillance is also important and may be required.

Ms. Mikhail has more than fifteen years experience in corporate and securities law and management consulting, representing a number of biotechnology, life sciences and pharmaceutical entities. Ms. Mikhail received an M.B.A. in finance from the University of Chicago, with honors; and a J.D. from Northwestern University, with honors. She is admitted to the bars of Massachusetts, New York and North Carolina.

Ms. Mikhail established and serves as Managing Member of Life Sciences Law, PLLC, a firm based in North Carolina’s Research Triangle that focuses exclusively on the needs of bioinformatics, biotechnology, genomics, medical device and pharmaceutical companies. Staffed with experienced attorneys with broad business backgrounds, the firm represents many large companies including Bayer HealthCare, sanofi-aventis, and Gilead Sciences. In addition to these companies, the firm’s clients include several spin-outs from local universities. For additional information, visit Life Sciences Law’s website at http://www.lifescilaw.com.