Aqua 303

This short course examines safety issues surrounding immunotherapies and particularly Antibody-Drug Conjugates in an intimate setting with two of the world’s leading ADC experts. Following a review of current cancer immunotherapies in development, including CAR T cells, CD-3 T cell-based bispecifics, and immune checkpoint inhibitors and agonists, the safety of ADCs will be explored in depth. ADC design and translational strategies for safety risk mitigation will be discussed, along with conjugation, payload, and engineering impacts on the therapeutic window.

Detailed Agenda

5:45 pm Welcome and Opening Remarks

1. The Safety of Cancer Immunotherapy Biologics (RD)

  • Immune checkpoint inhibitors and agonists
  • CD-3 T cell based bispecifics
  • CAR T cells
  • Bispecific TCR-based immunotherapy (ImmTacs)
  • Testing for safety of immunotherapy preclinically
  • Translation safety of immunotherapy
  • Safety risk mitigation of immunotherapy molecules

6:15 Dinner Break

2. The Safety of ADCs

2.1.1 ADC Design Strategies for Safety Risk Mitigation (GB)

  • Strategies for managing on- and off-target toxicities
  • Designing the targeting moiety
  • Designing the payload and linker
  • Conjugation approaches and their impact on the therapeutic window

2.2.1. Translational Strategies for Safety Risk Mitigation (RD)

  • Translational safety of ADCs
  • Preclinical conduct of toxicity studies (dos and don’ts)
  • How to assess TI properly and use this data in ranking various ADCs
  • Clinical development of ADCs and safety risk mitigation strategies

8:45 Close of Short Course


Dixit_RakeshRakesh Dixit, PhD, DABT, President & CEO, Bionavigen, LLC

Rakesh Dixit, PhD, DABT, is currently the President & CEO of Bionavigen Consulting and Drug Development company based in Gaithersburg, MD, USA. Dr. Rakesh also holds the position of Scientific Advisor of Amador Bioscience, a leading global partner for biotherapeutics development. Dr. Dixit is currently a consultant/advisor for nearly 10 biopharmaceutical companies, engaged in the development of gene and cell therapy, ADCs, bispecific, immuno-oncology biologics, oncolytic viruses, small molecule drugs, diagnostics, translational biomarkers.

Dr. Dixit was the Global VP and Global Head of Biologics Safety Assessment, Pathology and Laboratory Animal Medicine at AstraZenecafor for nearly 13 years. As a senior executive member of Worldwide Research and Development, he was among key voting members of AstraZeneca Safety Review Board, Research Review Committees, Early Product Development Decision Committee, Research & Development Leadership Teams.

Dr. Dixit is an accomplished key opinion leader in biologics development, with over 30 years of industry experience (Merc & Co., Inc, Johnson and Johnson, AstraZeneca-Medimmune), over 10 global NDA/BLA filings, over 80 peer-reviewed papers in renowned scientific journals and 130+ invited lectures/presentations at international conferences. He serves as an expert reviewer and in appointed committees for many programs managed by U.S. National Academy of Sciences and US National Institutes of Health (including National Cancer Institute). In 2015 Rakesh was selected by pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE.

Voss_StephanieStephanie Voss, PhD, Group Leader, Bioconjugation & Protein Chemistry, Heidelberg Pharma Research GmbH

Stephanie Voss is a group leader for Bioconjugation & Protein Chemistry at Heidelberg Pharma Research GmbH, a pharma company located near Heidelberg focused on the research and development of anti-cancer drugs. Stephanie obtained her chemistry diploma in 2010 at the University of Göttingen. Following a research stay in India at the IISER in Pune, she started her PhD in Protein Chemistry at the Max Planck Institute of Molecular Physiology in Dortmund. During her PhD she developed novel GTPase sensors using site-specific conjugation techniques. After a brief postdoctoral stay at the Chemical Genomics Centre in Dortmund she joined the Biochemistry Department at Heidelberg Pharma and is now working on the development of new ADCs based on the RNA polymerase II inhibitor alpha-Amanitin.

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