Role at ICON:

I formed the immunoassay group at Prevalere Life Sciences (ICON’s bioanalytical laboratory in Whitesboro, NY) which I have overseen since 2002. The department is responsible for the analysis of biological therapeutics. We strive to add value to our clients’ projects by providing expertise and advice on the complex scientific and regulatory issues related to the analysis of biotherapeutics.

Background:

Prior to joining Prevalere in April 2002, I was senior vice president of Development Sciences at Genentech, Inc., where for almost 20 years, I held both scientific and management positions. As a research staff scientist, I was the principal scientist for two new biologics which became marketed products. In Development, I was responsible for the Analytical Laboratories, Pharmacokinetics, Toxicology, Clinical Pharmacology and Process Development Divisions which supported early phase clinical candidates. During my tenure in Development, I oversaw 8 IND filings and the non-clinical support for numerous Phase II-IV programs. I have an M.S. in Biochemistry and a Ph.D. in Microbiology from Michigan State University and completed Post Doctoral training in Immunology at Johns Hopkins University.

Career highlights:

One of my proudest accomplishments was the FDA approval of Xolair, a treatment for persistent allergic asthma, which originated in my research laboratory. Since returning to my home town in upstate New York, it has been equally rewarding to see the growth of our analytical laboratory and the career opportunities it provides to young scientists in the area. The acquisition by ICON cements our position and allows us to enter the arena of the global analytical providers.

What are the most challenging factors in conducting business in your specialty area?

We face the same challenges as others in the CRO business which are providing high quality work within budget and on time. Developing and validating methods for biologics requires a high level of skill and experience and balancing that with the clients’ requirements can be difficult. We believe this can be achieved by open, active communication from all parties. If we only do what is asked for, we are simply providing a commodity. We aim to add real value to the clients’ projects by partnering with them, leveraging our expertise to inform the decision making process and to ultimately deliver on our promises.

How will the development of follow-on biologics impact the industry as a result of extensive patent expirations of leading biologics scheduled to occur through 2017?

Biologics have traditionally fallen under the category of “specialty pharmaceuticals” because of their high cost. The mainstreaming of biologics in pharmaceutical treatment regimens because of their proven benefit in diseases like RA and cancer, suggests that prescribers and payers would likely welcome options presented by biosimilars. This can represent a huge opportunity since patents covering the first wave of biologics in the 1980‘s are beginning to expire, creating opportunities for new players in the field. However, the concept of generics as it’s used for small molecules cannot be applied directly to biologics. The complex physicochemical properties of proteins make it difficult to demonstrate comparability of biologics since they are produced by differing manufacturing processes. The concept of biosimilars has emerged in Europe which presently has class specific guidelines for approval. Unlike Europe, no regulatory path is in place in the U.S. for approval of follow-on biologics. At ICON, we understand how important it is to develop a thoughtful, well measured approach to position ourselves as a leader in this area.

Developing and validating methods for biologics requires a high level of skill and experience and balancing that with the clients’ requirements can be difficult. We believe this can be achieved by open, active communication from all parties.