FEB 14, 2019 01:30 PM PST

Organs On a Chip: A Revolution in Drug Development?

C.E. CREDITS: RACE
Speakers
  • Scientific Director, Analytical Development, Small Molecule Pharmaceutical Development, The Janssen Pharmaceutical Companies of Johnson & Johnson
    Biography
      Dr. Yoder received his PhD in analytical chemistry from the University of Illinois at Chicago. He has over 15 years of industrial experience in analytical development and characterization supporting API and formulation development. He has solid experience in oral (solid and liquid), parenteral, inhalation dosage forms (MDI, DPI, and nebulized products), and large molecule therapeutics. He also has broad experience in characterization of small molecules and bio-macromolecules and he has exploited several analytical tools to support API and formulation development initiatives.

    Abstract:

    Pharmaceutical research and development efforts are often both inefficient and suffer from a high attrition rate of drug candidates within the clinical phase of development.  Most drug trials either fail to meet their expected endpoints or show minimal statistical differentiation between active and placebo (i.e. efficaciousness).  In other instances, failures might occur due to safety reasons.  Clearly, a fundamental understanding of drug properties in the discovery and early phases of development as well as an accrual of knowledge regarding mechanisms of disease and clinical trial learnings is essential to increase productivity and success for ongoing drug development efforts.

    Assuming that much of prior knowledge from prior drug development and trial efforts could be aggregated within some form of data management system, it has been proposed that systematic modeling and simulation-based trial designs could enhance the odds for successful commercialization of new drug entities.  To that end, the application of micro-physiological systems (MPS) or organs-on-a-chip in drug discovery for the development of enhanced in-vitro models to simulate or predict in-vivo processes has begun to show a lot of potential.  

    While the utilization of MPS-based technologies could someday reap enormous scientific and regulatory benefits for patients, certain barriers must still be overcome which are impactful to the evolution and future implementation of these technologies.  The intrinsic challenges as well as potential solutions will be discussed.
     

    Learning Objectives: 

    1. Learn about intrinsic challenges and potential solutions
    2. Immediate outcomes of utilizing reliable in-vitro models


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