Peptides represent one of the fastest-growing segments in the biopharmaceutical market. Being able to manufacture peptides with consistent high quality is an important priority for manufacturers of this drug class. In 2013, USP established an Expert Panel on Therapeutic Peptides, tasked with tackling important issues related to peptide quality standards. As the global manufacturing landscape continues to transform, public standards for the quality of peptides will play a growing role in the supply chain integrity of these drugs.
After a successful program in 2015 focused on raw material control strategy, the types of impurities and appropriateness of impurities methods, peptides in vaccines, conjugated peptides, and regulatory considerations, USP is bringing its Synthetic Therapeutic Peptides Workshop back again in 2016 for a more in-depth program. It will examine manufacturing considerations, impurities, specifications, novel peptide therapeutics, and regulatory considerations.
- To better understand USP’s standards for peptide products
- To discuss control strategies for raw materials and impurities
- To learn regulatory expectations for peptides, conjugated peptides, and peptide vaccines
- To achieve common regulatory understanding between USP, industry, and FDA
- To provide feedback about proposed changes/new information on peptide monograph(s) and chapter(s)
- To explore compendial science topics in order to inform the development of specific monograph(s) and chapter(s)
Who Should Participate?
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Workshop Steering Committee
- Donna Christner, Ph.D., CMC Lead; U.S. Food and Drug Administration (U.S. FDA); Division of Bone, Reproductive and Urologic Products; Center for Drug Evaluation & Research
- Gary Erickson, Ph.D., CEO, CBL Biopharma LLC.
- Cory Evans, Ph.D., Chemist, U.S. FDA, Division on Manufacturing Technologies, Office of New Animal Drug Evaluation, Office of Foods and Veterinary Medicine, Center for Veterinary Medicine
- Michael De Felippis, Ph.D., Senior Research Fellow, Eli Lilly and Company
- Elena Gubina, Ph.D., Biologist; U.S. FDA; Division of Cellular and Gene Therapies; Office of Cellular, Tissue and Gene Therapies; Center for Biologics Evaluation and Research
- Gerhard Haas, Ph.D., Vice President of QA/RA, Bachem AG
- Marion King, Ph.D., Analytical Development Manager and Head of the Global Analytical Centre of Excellence, Ipsen Manufacturing Ireland Ltd.
- Michael Pennington, Ph.D., President and CEO, Peptides International, Inc.
- Ved Srivastava, Ph.D., Head of Peptide Chemistry, GlaxoSmithKline
- Maura Kibbey, Ph.D. Director, Science & Standards, Biologics, USP
- Michael Verlander, D.Phil., Consultant
Following the workshop, USP will be hosting the BIO1-Peptides Expert Committee Meeting on November 16-17. If you are interested in attending the Expert Committee meeting as a virtual observer via WebEx, click here to fill out the Observer Request form.
Advance registration will be available through November 9, 2016. After that date, registration will be available on site at the USP Meetings Center.
Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the "Register" button.
Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks, lunches, and a networking reception. Registration fees for this workshop have been set as follows:
|Participant Type||Regular Fee Per Person (1–2 individuals from the same organization)||Discounted Fee Per Person (3 or more individuals from the same organization; all must register at the same time to receive the discounted fee)|
|Student (Full-time; valid I.D. required)||$175||
|Virtual Participant (not attending in person)||$395||Not available|
When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).
Cancellation and Substitution Policy
Cancellation must be received on or before October 24, 2016 (21 days prior to the event) via email to firstname.lastname@example.org. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations. However, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to email@example.com.
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.
Please contact firstname.lastname@example.org or +1 301-816-8130.
Local Area Information
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