title: American Association of Pharmaceutical Scientists National Biotechnology Conference Short Course: Translational Challenges in Developing Antibody-Drug Conjugates: May 24, 2012, San Diego, CA.
abstract: The American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference Short Course "Translational Challenges in Developing Antibody-Drug Conjugates (ADCs)," held May 24, 2012 in San Diego, CA, was organized by members of the Pharmacokinetics, Pharmacodynamics and Drug Metabolism section of AAPS. Representatives from the pharmaceutical industry, regulatory authorities, and academia in the US and Europe attended this short course to discuss the translational challenges in ADC development and the importance of characterizing these molecules early in development to achieve therapeutic utility in patients. Other areas of discussion included selection of target antigens; characterization of absorption, distribution, metabolism, and excretion; assay development and hot topics like regulatory perspectives and the role of pharmacometrics in ADC development. MUC16-targeted ADCs were discussed to illustrate challenges in preclinical development; experiences with trastuzumab emtansine (T-DM1; Genentech) and the recently approved brentuximab vedotin (Adcetris; Seattle Genetics) were presented in depth to demonstrate considerations in clinical development. The views expressed in this report are those of the participants and do not necessarily represent those of their affiliations.
authors.affiliation: Novartis Pharmaceuticals, Clinical Pharmacology, Oncology Business Unit, Florham Park, NJ, USA. thudium@novartis.com
authors.forename: Karen
authors.initials: K
authors.lastname: Thudium
authors.forename: Sanela
authors.initials: S
authors.lastname: Bilic
authors.forename: Douglas
authors.initials: D
authors.lastname: Leipold
authors.forename: William
authors.initials: W
authors.lastname: Mallet
authors.forename: Surinder
authors.initials: S
authors.lastname: Kaur
authors.forename: Bernd
authors.initials: B
authors.lastname: Meibohm
authors.forename: Hans
authors.initials: H
authors.lastname: Erickson
authors.forename: Jay
authors.initials: J
authors.lastname: Tibbitts
authors.forename: Hong
authors.initials: H
authors.lastname: Zhao
authors.forename: Manish
authors.initials: M
authors.lastname: Gupta
mesh_terms: D000080044:Ado-Trastuzumab Emtansine; D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D001709:Biotechnology / Q000379:methods; D000079963:Brentuximab Vedotin; D002986:Clinical Trials as Topic; D006801:Humans; D018796:Immunoconjugates / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D008453:Maytansine / Q000031:analogs & derivatives / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D057170:Translational Research, Biomedical / Q000379:methods / Q000639:trends*; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D018796:Immunoconjugates; D008453:Maytansine; D000079963:Brentuximab Vedotin; D000068878:Trastuzumab; D000080044:Ado-Trastuzumab Emtansine