《Hot topics in antibody-drug conjugate development》.pdf

ConferenCe report | news AnAlysis Hot topics in antibody–drug conjugate development American Association of Pharmaceutical Scientists National Biotechnology Conference Sheraton San Diego Hotel and Marina, San Diego, CA, USA, 19–23 May 2013 The National Biotechnology Conference, is a premier meeting for biotechnology professionals covering a broad range of hot topics in the biotechnology industry. Attracting participants from academia, industry and regulatory, this meeting features sessions that aim to address emerging subjects of interest and allows for open exchange between scientists. The 2013 conference featured leading researchers in the fields of antibody–drug conjugates (ADCs) and immunogenicity. Herein, we present a summary of the ADC hot topics, including bioanalytical and PK considerations, quantitative evaluation of the impact of immunogenicity and ADME to understand ADC drug–drug interactions, and clinical considerations for ADC development. This article aims to summarize the recommendations that were made by the speakers during various sessions throughout the conference. This Conference Report highlights key outcomes papers, with a specific focus on bioanalytical Karen Thudium* from several sessions focused on antibody–drug strategies and challenges for clinical immuno­ Sanela Bilic conjugates (ADCs) at the 2013 American Asso­ genicity and PK assays, drug–drug interactions Novartis Pharmaceuticals, Clinical ciation of Pharmaceutical Scientists (AAPS) (DDIs) and in vivo characterization of ADC Pharmacology, Oncology Business National Biotechnology Conf