Advancing Antibody-Drug Conjugate Therapies: Key Preclinical and Regulatory Strategies for Clinical Success

Antibody-drug conjugates represent a pivotal advancement in oncology, offering highly targeted cancer treatments that combine precision and potency. However, developing these therapies comes with significant challenges, from their intricate design to safety and resistance issues. This webinar will provide a comprehensive overview of these obstacles and deliver actionable insights into overcoming them.

Attendees will gain a deep understanding of preclinical strategies that address antibody-drug conjugate development hurdles, including in vitro and in vivo evaluation methods essential for optimizing antibody-drug conjugate performance. Additionally, the session will cover the regulatory landscape, emphasizing the importance of early engagement with regulatory bodies and strategic planning to ensure smooth investigational new drug (IND) submissions and regulatory approval.

The webinar will also feature case studies of successful antibody-drug conjugate therapies, highlighting the key factors that contributed to their approval and clinical success. These real-world examples will showcase innovative approaches that are shaping the future of antibody-drug conjugate development. The attendees will learn how to streamline the path from preclinical evaluation to clinical success, ensuring their antibody-drug conjugate therapies are positioned for success in a highly competitive market.

Register for this webinar to explore the latest strategies in antibody-drug conjugate development and gain insights that will accelerate cancer therapy’s journey to market.

Speaker

Michael Koratich, Sr. Director, Business Development, Translational Drug Development (TD2)

Michael Koratich is a seasoned professional with over 25 years of experience in cancer therapeutic development, covering the full spectrum from discovery to clinical trials. His technical expertise includes leading preclinical IND-enabling studies, bioanalytical method development/validation and central lab operations, all with a strong focus on immuno-oncology.

Michael has played a pivotal role in developing advanced flow cytometry techniques, in vitro and in vivo models and driving innovation and success in oncology therapeutic development at every stage of cancer therapeutic development. Michael has most recently served with Eurofins Biopharma Services as their Head of Global Business Development, Bioanalytic Services and then VP of Integrated Laboratory Services for Eurofins Central Laboratory. Michael is currently Senior Director of Business Development for Translational Drug Development, TD2, with primary responsibility for preclinical, regulatory consulting and flow cytometry services.

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