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Karen ThudiumSanela Bilic
Karen E. Thudium, Pharm.D., M.Sc., is a senior scientist at Novartis Pharmaceuticals.
Sanela Bilic, Pharm.D., M.B.A., is a director/principal fellow of Clinical
Pharmacology at Novartis Pharmaceuticals.

“What’s in a name? That which we call an ADC by any other name would carry such power” (adapted from Romeo and Juliet, Shakespeare). The advent of targeted therapy (both small molecules and monoclonal antibodies) has led to numerous epic success stories like Gleevec and Herceptin. But these agents will have to share the stage with the advent of antibody drug conjugates (ADCs). The all-encompassing acronym, ADC, carries great fury, as these molecules represent an innovative and powerful biotherapeutic approach to treat disease by conjugating small cytotoxic molecules to antibodies. For example, Adcetris, an ADC approved for Hodgkin lymphoma and systemic anaplastic large cell lymphoma, was approved by the FDA in 2011 after profound clinical trial results (73% and 86% of patients experienced complete or partial response, respectively). And Kadcyla, an ADC consisting of trastuzumab linked to the cytotoxic agent payload (mertansine), was approved by the FDA earlier this year, showing “significantly prolonged progression-free and overall survival with less toxicity” compared to another treatment. From the small biotechnology industry to big pharma, those in the business of drug development are in a full throttle race to get their ADC to the clinic.

However, you must take ADCs by thy power. They require thorough understanding of the biochemical, pharmacokinetic, and pharmacodynamic properties (among others). A front row seat at the AAPS Annual Meeting and Exposition short course Mechanistic PKPD to Overcome Translational Considerations for Antibody Drug Conjugates (ADC) and THIOMABs (TDCS)—Nonclinical to First in Human and Beyond offers you perspectives from ADC thought leaders who have been at the wheel and have first-hand experience using pharmacokinetic/pharmacodynamic approaches to characterize these dominating molecules from preclinical to clinical and through product launch. Attending this short course provides an exceptional opportunity to jump-start your knowledge and interact with the experts who can answer the question, “What’s in a name?”


More About the Authors
Karen E. Thudium is a senior scientist at Novartis Pharmaceuticals in Oncology Clinical Pharmacology. She implements mechanistic PKPD methods to support the preclinical and clinical development of biologics including monoclonal and ADCs. She completed a postdoctoral fellowship at the University at Buffalo and Novartis after receiving her Doctorate of Pharmacy and Masters of Science in Clinical Pharmacokinetics from the University of Rhode Island.
Sanela Bilic is a director/principal fellow of Clinical Pharmacology at Novartis Pharmaceuticals in Oncology Clinical Pharmacology and oversees the Clinical Pharmacology Development and strategy of ADCs. Bilic obtained her master’s in business administration and Pharmacy degrees from Drake University and completed a postdoctoral fellowship at the University at Buffalo and Novartis.