June 28-30, 2016

Palm Springs, California

Day One
Wednesday June 29th 2016

Day Two
Thursday June 30th 2016

Registration and Breakfast

Chair’s Opening Remarks

PFS Evolution: Innovation in Design, Controls and Manufacture

Unpicking Global Regulatory Guidelines for Combination Product

  • John Smith Director, Global Regulatory Affairs , Allergan


  • Fully understanding the differences in regulation and classification of combination products depending on geographical jurisdiction
  • Developing strategies for efficiently streamlining international product approval
  • Ensuring regulatory requirements have been aligned with combination product development

Linking Device Design Best Practices & Design Controls


  • Integrating medical device design best practices to enable more robust product development
  • Producing more efficient injectable device manufacturing: design for six sigma, manufacturability, device modeling and DOE studies

Successful, Cost-Effective & Efficient Industrialization & Scaling Up of Medical Device Manufacturing Pipelines

  • Edwin Harmon Director of Manufacturing Operations , Genzyme


  • Designing, sourcing and qualifying industrial scale production operations in a time and cost effective manner
  • Understanding the differences in regulatory demands place upon manufactures for combination products: CDER and CDRH
  • Reliably reproducing device testing on an industrial scale to meet regulatory requirements
  • How to best account for potential variability in the development and manufacture of combination products: integrating innovative device design and manufacturing procedures
  • Evaluating operational requirements to optimize the machine selection process

Outsourcing for the Development & Manufacturing of PFS

  • Shem Fischer Medical Manager, Contract Manufacturing, Oratech


  • Addressing device development, formulation, filling and packaging operations
  • Analyzing new unit dose delivery technology
  • Developing solutions for the manufacture of niche volume quality devices

Morning Refreshments & Speed Networking

Understanding the Design Robustness of a Prefillable Syringe System

  • Ross Allen Associate Senior Consultant Engineer , Eli Lilly and Company


  • Understanding the interaction between the drug formulation, the primary container closure system and the device
  • Analyzing the functional performance of prefillable syringes and the impact of protein concentration and viscosity, barrel silicone level and distribution, plunger geometry and siliconization, contact pressures
  • Identified technical risks for prefillable syringe system designs and understanding the system design robustness to drive improvements in control strategies

Overcoming Challenges in the Manufacturing of Pre-Filled Syringes


  • Successful identification of PFS manufacturing bottlenecks
  • Devising innovative solutions to overcoming manufacturing challenges for PFS devices
  • Implementing procedures into the operational framework to streamline manufacturing

Integrated Approach to Filling Technology Selection Needs & Challenges for a Pipeline of Antibody Drug Candidates from Monoclonal Antibodies to Oncolytics Utilizing Containers Ranging from PFS to Custom Containers

  • Nan Lin Manager Drug Product Technology , Regeneron


  • How to best validate equipment for filling and packaging processes to suit your specific device needs
  • Devising robust strategies for the inspection of filling segments to produce reliable and reproducible validation of aseptic filling
  • Advancing multi-filler technology to improve the speed, volume and ability to accurately fill all container types

Networking Lunch

Detailing Drug Formulation & the Impact on Injectable Devices

Effect of PFS Siliconization on Particulation & Other Product Quality Attributes of Bioformulations


  • Silicone oil leachate content and characterization
  • Product quality assessment of multiple protein at different levels of silicone oil

The Product Quality Research Institute (PQRI) Approach to Leachables and Extractables: Application of Thresholds and Best Practices to Prefilled Syringe Systems

  • Diane Paskiet Faculty Member PQRI Extractables and Leachables, West Pharmaceutical Services


  • Analyzing the stability issues of biologics resulting from incompatible materials
  • Characterizing the integrated delivery system and individual components within the context of material safety and compatibility to protect patients
  • Describing the PQRI strategy for safety thresholds and best practices for identifying extractables and potential leachables

Afternoon Refreshments & Networking

Assessing the Risk of Interaction Between Extractables & Leachables (E&L) & Therapeutic Proteins


  • Detailing the need for this risk assessment
  • Addressing the tools and processes for performance of risk assessment
  • Analyzing the caveats and limitations to E&L risk assessments
  • Looking to the future of E&L risk assessment testing

A Visualization Approach to Characterizing Complex Mixtures of Extractables/Leachables (E&L) & Other Pharmaceutically Relevant Compounds using High Resolution LC-MS with 2-D and 3-D Mass Mapping

  • Doug Kiehl Team Leader - Spectroscopy, Raw Materials and Extractables & Leachables, Eli Lilly and Company


  • Detecting, identifying and profiling of E&L associated with packaging and container systems, delivery devices and process equipment
  • Establishing of a comprehensive profile of extractable chemical entities. And overcoming analytical challenges.
  • Discussing the application of 2-D/3-D mass mapping, mass difference correlation and visualization of high resolution exact mass LC-MS datasets to simplify interpretation of complex mixtures.

Panel Discussion: Analyzing Extractables & Leachables & Device Design

  • Doug Kiehl Team Leader - Spectroscopy, Raw Materials and Extractables & Leachables, Eli Lilly and Company
  • Diane Paskiet Faculty Member PQRI Extractables and Leachables, West Pharmaceutical Services


  • Biocompatibility testing for plastics and deliver devices, and linking in a meaningful way with extractables & leachables testing
  • What does appropriate E&L testing look like for single-use system (SUS) components for manufacturing process?
  • E&L chemical entities and potential protein interactions: How important is it to evaluate this, and how might this be achieved in a consistent and meaningful manner across industry?

Chair’s Closing Remarks

End of Day One