July 17, 2012

FLH Partner Brian J. Malkin Speaks at ACI's Clinical Trials Conference on July 17, 2012 in Boston

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will present a controversial topic concerning the type of clinical trials that FDA will require for biosimilar product applications entitled: "Safely Conducting Biosimilars Clinical Trials: Understanding FDA's Requirements for Biosimilar Clinical Trials". Mr. Malkin will address what FDA has said about its "selective and targeted approach" for biosimilar clinical trials and how biosimilar applicants may be able to rely on certain clinical trial data from the innovator's product, as well as assessing the risks and benefits for conducting such clinical trials. Mr. Malkin's presentation is part of the American Conference Institute's 14th Advanced Summit on Clinical Trials: Ensuring Safe and Compliant Domestic and International Clinical Trials on July 17-18, 2012 in Boston.