Led by:

• Bin Yang, Senior Scientist, AstraZeneca
• Liping Zhou, Senior Director, Advanced Drug Delivery, AstraZeneca
• Stephanie Reed, Director, Early Stage Formulation Science, AstraZeneca

Discussion topics:

• Why advanced drug delivery
• Physiochemical characterisation
• Feasibility assessment: challenges and mitigation strategies.

Science Exchange Leaders:

• Cesar Calero, Associate Director, Biologics Drug Product Development & Manufacturing, Sanofi

Session Topics:

• Drug-device combinations and compatibility studies during development of viral vectors
• Implementation of closed system drug-transfer devices (CSTDs) for systemic and local delivery
• Working with regulatory authorities on Phase 1/2a trials

Discussion Group Leader:

• Paul Matejtschuk, Section Head, Formulation Science, Analytical and Biological Sciences, Medicines & Healthcare products Regulatory Agency (MHRA)

Discussion Topics:

• What bioanalysis methods are out there?
  • Suitability for different product classes
  • Reproducibility
  • Sensitivity
• New developments in bioanalysis
  • New assay types
  • Automation of assays
• Quality assurance systems used for establishing assays
• Problems encountered
• What new regulatory guidance would you like to see?

Discussion Group Leaders:

• Roger Adami, Vice President, Pharmaceutical Sciences and Business Development at Nitto Biopharma
• Yuji Kasuya, Senior Scientist, Daiichi Sankyo

Discussion Topics:

• Achieving systemic delivery, passive and active
• Using LNPs for cancer therapies
• Nature of the cargo
• Routes of administration
• Review of what happened in pharmaceutical industry induced by Covid-19 pandemic and LNP-mRNA technology
• Preparation for the next pandemic
  • Maintenance of the facility for manufacturing LNP-mRNA
  • Need for the manufacturing cost down of LNP-mRNA
• Need for the more competitive delivery systems
  • Improvement of efficiency for intracellular delivery of mRNA
  • Exploration of new LNP-mRNA technology to related prophylactic/therapeutic areas and convenience of use

Discussion Group Leaders:

• Shashank R. Pinnapireddy, Head of Nanoparticle Research at CSL Behring Innovation

Discussion Topics:

• Nanoparticles for respiratory medicine
• Stability and routes
• Spray drying and lyophilisation

Discussion Group Leaders:

• Susan Rosenbaum, Founder, Chair, and CEO, Lauren Sciences

Discussion Topics:

• Small Molecules and Biologics
• Novel Technologies
• Brain Delivery and Targeting
• Therapeutic Agent Modification
• Degradation, Stability, Circulation
• Administration Methods
• Therapeutic Potential
• Translation and Safety

Discussion Group Leaders:

• Venkat Garigapati, Scientific Director at Takeda Pharmaceuticals
• Jing Ling, Associate Principal Scientist, Merck
• Dhara Raijada, Senior Scientist – Formulation – Advanced Drug Delivery at AstraZeneca

Discussion Topics:

• Challenges with oral delivery
  • Low bioavailability in clinical data
  • Barriers in the GI tract
  • Permeability
  • Lack of in-vitro and simulation models
• Bioavailability and dose achievements with current clinically validated oral technologies
• Exciting and innovative solutions
  • Nanoparticles
  • Gels
  • Oral ingestible devices
  • Active transport

Discussion Group Leader:

• Joel Richard, former Chief Scientific Officer at Medincell
• René Holm, Professor, University of Southern Denmark

Discussion Topics:

• Bottlenecks & The Need for Innovation
• Long Acting Injectables
• Blood-Barrier
• Intracellular Delivery
• Nanoparticles for Tumour Targeting 

Discussion Group Leaders:

• Yamini Shah, Professor at L. M. College of Pharmacy
• Cees van Rijn, Professor of Nanotechnology and Microfluidics

Discussion Topics:

• Developing Powder Formulations – Challenges and Motivation
• Particle Morphology: Size and Shape Effects on Delivery 
• Patient Centricity
• Clinical Trials: Challenges
• Off-Target Effects

Discussion Group Leader:

• Martinus Capelle, Scientific Director, Head of Technical Integrator at The Janssen Pharmaceutical Companies of Johnson & Johnson

Discussion Topics:

• Protein Aggregation & Solubility Redesign
• Vaccine Formulation & Logistics
• Stability & Degradation Challenges
• Applied Physics:  Mixing, Filling and Temperature Calculations

Discussion Group Leader:

• Michael Munson, Senior Research Scientist, Advanced Drug Delivery, AstraZeneca

Discussion Topics:

• How to Develop Nanoparticles
• Safety issues
• Deigning Nanoparticles
• Improving Delivery Efficiency