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Disposition of Biologics

Disposition of Biologics

December 12-13, 2019

Merck Research Laboratories, Boston, MA

 


Biologics have become an important and rapidly growing component of modern medicine, which has fundamentally altered treatment paradigm for many diseases. This class of drug molecules involve myriad of biotechnology products ranging from therapeutic proteins (such as monoclonal antibodies, fusion proteins, antibody-drug conjugates) to peptides, vaccines, oligonucleotides, and gene and cell therapies.

View the Workshop Program

While biologics provide an unprecedented opportunity to treat, diagnose, and prevent many health problems, they also present unprecedented challenges to drug discovery and development scientists. One of the key challenges is fundamentally different absorption, distribution, metabolism, and excretion (ADME) behavior of biologics compared to traditional small molecules. In fact, the disposition of biologics is not only unique, many determinants responsible for the pharmacokinetics (PK) of biologics are not yet known. Consequently, most of the discovery and development efforts are empirical at present, and disposition behavior of biologics is largely not elucidated when advancing these molecules to preclinical or clinical stages.

This workshop is designed to help biopharmaceutical scientists overcome this knowledge-gap via educational and state-of-the-art presentations and case-studies from world-renowned experts in the field. The major goals of this workshop are:

  • To educate scientists on basic principles and key determinants for the disposition of clinically advanced biologics (e.g., monoclonal antibodies, antibody-drug conjugates, bi-specific antibodies, engineered T-cells, etc.)

  •  To demonstrate how the knowledge of disposition helps in the design and optimization, development, clinical translation, and regulatory filing of biologics

  •  To introduce disposition characteristics of futuristic biologics (viral vectors, oncolytic virus, oligonucleotide, engineered immune cells, etc.)

Who Should Attend?

Biopharmaceutical scientists in industry, academia, and non-profit organizations who are involved in or interested in the discovery and development of novel biologics. They will learn about:

  • What are the key determinants responsible for whole-body and tissue-specific disposition of different biologics

  • How biophysical characteristics like size, charge, and glycosylation affect disposition of biologics

  • Effect of target engagement on the disposition and toxicity of biologics

  • How to determine optimal dosing regimen for biologics with nonlinear pharmacokinetics

  • Impact of immunogenicity on the disposition, efficacy, and toxicity of biologics

  • Drug-interaction potential of biologics and assessment strategy

  • Which biological modality to choose to maximize the probability of clinical success

  • How to employ the knowledge about disposition of biologics to support the discovery, development, clinical translational, and regulatory filing of biologics 

How Will I Benefit from Attending?

By attending this workshop, scientists will:

  • Learn how to assess and characterize disposition profiles of biologics

  • Learn how to predict the disposition of biologics

  • Examine how quantitative methods such as PK/PD Modeling and Simulation and Quantitative Systems Pharmacology are used to support the discovery and development of biologics

  • Get introduced to case-studies that can be leveraged to help ongoing or future projects in their organization

  • Gain insights into futuristic biologics that may become part of their organization’s portfolio going forward

  • Network with other scientists and world-renowned experts who are working with similar biologics

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