PepTalk 2017
PepTalk 2017
Pipeline Five Header

Cambridge Healthtech Institute’s Fifth Annual
Extractables and Leachables
Protecting Quality of Biologics by Ensuring Safety and Compatibility
January 10-11, 2017 | Hilton San Diego Bayfront | San Diego, CA


In biopharmaceutical development and manufacturing, containers, drug combination products, and even disposable equipment may leach chemicals into the product that can pose significant risks to product quality and potentially compromise the stability, safety and efficacy of the biotherapeutics. The Fifth Annual Extractables and Leachables (E&L) conference brings together industry experts and thought leaders to share their insights on the latest updates and guidelines, how to design analytical testing strategies for E&L, case studies on identification and risk assessment of E&L in single-use systems, container closure systems and delivery devices, and the impact of leachables on biocompatibility and safety.

We invite you to present a poster and attend to join colleagues from around the world in this discussion of the key challenges and solutions for E&L testing in biologics.

Preliminary Agenda


UPDATES FROM INDUSTRY AND WORKING GROUPS

Extractables & Leachables Safety Information Exchange (ELSIE) Consortium – Update

Kim Li, Ph.D., DABT, MPH, Senior Manager, Environment, Health, Safety and Sustainability Product Stewardship Toxicology, Amgen

The PQRI Parenteral and Ophthalmic (PODP) Leachable and Extractable Working Group: Outcomes and Updates

Diane Paskiet, MS, Senior Director, Global Scientific Affairs, West Pharmaceuticals

Talk Title to be Announced

Ken Wong, Deputy Director, M.Tech., Extractables & Leachables, Sanofi Pasteur


ANALYTICAL CHARACTERIZATION

Talk Title to be Announced

Yasser Nashed-Samuel, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.

Tools and Methods for Rapid and Comprehensive Extractable Profiling

Speaker to be Announced

Simulation Solvents and Migration Models for E&L

Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.


ESTABLISHING DEVICES AND CONTAINER CLOSURE SAFETY:
NEW TOOLS AND CASE STUDIES

Generic Approaches of Extractable Assessment of Ancillary Devices for Parenteral Dosing

Ping Wang, Ph.D., Principal Scientist, Material Sciences, Janssen R&D

New Studies on Leachables in Protein Production Lines

Gerhard Winter, Ph.D., Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen

New Tools and Improved in vitro/in vivo Models to Study Biocompatibility and Product Contact Assessment

Douglas E. Kiehl, Ph.D., Principal Research Scientist, Team Leader, Spectroscopy, Raw Materials and Extractables & Leachables, Bioproduct Research & Development, Eli Lilly and Company




For questions about the meeting, please contact:

Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: nkashyap@healthtech.com

For partnering & sponsorship information, please contact:

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470
Email: dinerstein@healthtech.com