Day One

Tuesday, 2nd September, 2014

8.00 Registration & Breakfast

9.00 Chair’s Opening Remarks

Steph Barat
Executive Director, Scientific Affairs, Pharmacology and Toxicology
Forest Laboratories

Toxicological Profiles of Pre-Filled Syringes

9.15 Leachable Evaluations and USP Guidance

  • Sources of leachables
  • Risk assessments of the leachable profile
  • USP guidance

Daniel Norwood
Research Fellow
Boehringer Ingelheim

9.45 Safety Qualification of the Container Closure System Based for a Pre-Filled Syringe Based on Proposals Developed by the Product Quality Research Institute

  • Summarize PQRI proposed classification scheme and progress made on validation of proposed classification scheme
  • Provide a PFS case study focusing on E&L qualification using the propsed PQRI classification scheme
  • Demonstrate the utility of the ELSIE database in rapid assessment of the PFS E&L profile 

Doug Ball
Research Fellow, Regulatory Strategy & Compliance
Pfizer

10.15 Toxicologic Considerations in Parenteral Development

  • Guidance driving the design of a nonclinical program
  • Toxicologic considerations for parenteral development
  • Formulation Considerations

Tage Carlson
Director, Medical Products Research and Development
Baxter

10.45 Morning Refreshments and Networking

Identifying the Best Syringe Material for Your Drug

11.45 Unleashing the Power of Plastic

  • Design possibilities for PFS
  • Comparison of glass and plastic features
  • Exploring potential design features for an autoinjector 

John Zowtiak
Director, Device Development
Johnson & Johnson

12.15 Stability of Biopharmaceuticals in Plastic Pre-Filled Syinges in Comparison with Glass Pre-Filled Syringes

  • Stability of biologic drug products in plastic in comparison with glass PFS
  • Stability of biologic drug products in plastic PFS in response to mechanical stress
  • Functionality of plastic PFS in comparison with glass PFS

Swaroopa Paratkar
Research Investigator
Bristol-Myers Squibb

12.45 Interactive Solution Finding: Your Chance to Assess Which Material is Right for your Drug Product

  • What factors of the drug product influence selection of material?
  • How can you look to convert from one material to the other? 

Discussion leaders:

John Zowtiak
Director, Device Development
Johnson & Johnson

Swaroopa Paratkar
Research Investigator
Bristol-Myers Squibb

13.15 Networking Lunch

Biological Drugs in PFS

14.15 Assessing the Syringeability of Antisense Oligonucleotide Solutions

  • Study of viscosity vs injection force
  • Human volunteer testing
  • Implications for appropriate dosing materials

Russell Watt
Senior Research Associate, Pharmaceutical Development
Isis Pharmaceuticals

14.45 Special Considerations for Biological Products in Pre-Filled Syringes

  • Stability concerns from environmental changes
  • Ensuring microbial control through the product lifecycle
  • Understanding the impact of silicone and trace materials on product

David Grote
Site Quality Head cGMP
Teva Pharmaceuticals

15.15 Characterization of the impact of aging on the silicone layer of empty PFS for biologics

  • Impact of empty storage on the levels and distribution of silicone oil
  • Assessment of impacts on initial functionality

Jared Bee
Senior Scientist
MedImmune

15.45 Afternoon Refreshments

Injectable Device Development

16.15 Minimizing Variability when Developing Syringes and Devices 

  • Variability in autoinjectors and syringes
  • Product consistency and siliconization
  • Meeting regulatory expectations

Mike Hrytsak
Manager, Device Development
Regeneron Pharmaceuticals

 

16.45 Chair's Closing Remarks

Steph Barat
Executive Director, Scientific Affairs, Pharmacology and Toxicology
Forest Laboratories

17.00 Close of Day 1