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Rakesh Dixit, PhD, DABT
Vice President, Research & Development; Global Head, Biologics Safety Assessment - Medimmune

Challenges and Opportunities in Development of Biologic Drugs


Biologic drugs, including monoclonal antibodies are revolutionizing the treatment of human diseases. There are nearly 60 antibodies that are approved and over 300 or more biologic drugs are at various stages of drug development. This year alone, the FDA has approved 4 new antibodies in cancer treatment and more antibodies are likely to be approved.

With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates and antibody-peptide fusion proteins. These formats are expanding the biologics world and new treatment modalities, however, these new formats have increased the challenges for drug development.

This presentation will discuss the challenges and opportunities in development of biosimilars and biobetters or the next generation of biologic drugs, including bispecific antibodies and antibody drug conjugates.

This will include a discussion on opportunities and challenges for early development, CMC, translational safety, PK-PD and efficacy of this next generation of biologics such as ADCs and bispecific drugs.

Presented by

Rakesh Dixit, PhD, DABT

Vice President, Research & Development; Global Head, Biologics Safety Assessment - Medimmune

Dr. Rakesh Dixit has more than 30 years of experience in the biopharmaceutical drug industry, including Merck, Johnson & Johnson and Medimmune (AstraZeneca). At his current role as the Vice President of R &D and Global Head of Safety Assessment-Translational Sciences in Medimmune, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings.

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015.

Learning objectives
  • What are the main challenges in developing biologic drugs?
  • What are the opportunities for organizations setting out to develop biologic drugs?
  • How can organizations overcome the barriers to developing biologic drugs?
  • Why is this new territory of biologic drug development so important to the industry?
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