Equivalence of Complex Long Acting Drugs Workshop

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Description:

Long acting drugs have been proven to increase efficacy, reduce toxicity, and enhance patient compliance, which significantly improve the quality of life for patients with chronic diseases. However, their relatively high cost could make long term use challenging. There is an urgent need to bring generic competitions to the market to make them more affordable. The Equivalence of Long Acting Drugs Workshop brings together the leading regulatory, academic, and industry experts in the field.

This workshop’s goal is to provide attendees with insights into:

  • Recent advancements in generic long acting drugs: from challenges to solutions
  • Existing and new technologies for characterizing raw materials and formulations
  • Linking raw material properties to product performance
  • Advancement in in vitro drug release testing and in vitro in vivo correlation
  • How to use advanced simulation and modelling tools in the formulation and bioequivalence study design
  • And much more…

This workshop is beneficial for professionals from pharmaceutical industries and academia who work with complex formulations, especially long acting drug delivery systems.

Day 1

Section I: Regulatory Challenges and Scientific Initiatives:

  • Dr. Robert Lionberger, “Key Scientific Challenges for Generic Long Acting Injectables”
  • Dr. Yan Wang, “Bioequivalence Approaches for Polymeric Long Acting Drugs”
  • Dr. Bin Qin, “Bioequivalence of long acting injectable suspensions: Current Perspective and Future Directions”

Section II: Technologies for Characterization of Raw Materials and Formulations

  • Dr. Kinam Park, “PLGA polymers: The very familiar strangers in drug delivery”
  • John Garner, “Poly(lactide-co-glycolide) Semi-Solvent Separation: A Tale of Many Polymers in One”

Live Q&A with all presenters

Day 2

Section III: In Vitro Drug Release and In Vitro In Vivo Correlation

  • Dr. Steve Schwendeman “A Cage Model to Understand the Impact of Raw Materials on Formulation Performance In Vitro and In Vivo”
  • Dr. Diane Burgess, “In Vitro Release Testing and In Vitro In Vivo Correlation of PLGA based drugs: challenges to solutions”
  • Dr. Sam Rostein, “Adding Bioequivalence to the In Vitro In Vivo Correlations of Long Acting Injections”

Section IV: Modeling and simulation strategies

  • Dr. Shawn Zhang, “Image-based release modeling for accelerated controlled release system evaluation”
  • Dr. Viera Lukacova, “Challenges in Developing a PBPK Model that Mimics In Vivo Behavior of Long Acting Injectables”
  • Dr. Liang Zhao, “Leveraging M&S to Make Regulatory Impacts for Long Acting Generic Approvals”

Live Q&A with all presenters