In these unprecedented times, the world has become acutely aware of the need for quality, consistency and continuity in pharmaceutical supply chains, from raw materials to finished products.
Based on the success of previous workshops and input from attendees, this USP workshop will continue to inform public standard setting for therapeutic peptides and oligonucleotides by gathering experts from the analytical, process development and regulatory communities to share best practices and success stories. Both of these product classes are rapidly growing, with novel modifications and formulations for virtually every therapeutic area presenting new challenges. Therefore, best practices and guidance are critically needed to expedite quality products coming to the global market.
Panel discussions and networking events will provide opportunities for audience members to engage with the speakers and USP staff on challenges that they face and potential areas to develop new guidelines and standards.
Key session topics
(See Call for Abstracts for additional details)
- Raw material considerations for drug substance
- Drug products: novel formulation approaches and delivery systems
- Molecular design: improving stability, bioavailability, half-life extension
- Analytical development, characterization and validation
- Green chemistry approaches for synthesis and/or analysis
- Advances in manufacturing and purification technologies: strategies and novel methods
- Control strategies and comparability
- Current and future documentary standards and reference standard materials to support peptides and oligonucleotides
- Regulatory aspects and compliance
- CMC strategies including case studies
- Drug conjugates
- Personalized medicines for both peptide vaccines and oligonucleotides
- Structure-function studies and new targets
The Steering Committee
- Michael De Felippis, Ph.D., Chair, Distinguished Research Fellow, Eli Lilly & Co.
- Gerhard Haas, Ph.D., VP of Quality, Bachem
- Maura Kibbey, Ph.D., Senior Scientific Fellow, USP
- Marc Lemaître, Ph.D., Principal, ML Consult LLC
- Rosario Lobrutto, Ph.D., Head of Scientific Affairs, SandozInc
- Ved Srivastava, Ph.D., VP of Chemistry, Intarcia Therapeutics, Inc.
- Jessica Stolee, Ph.D., Associate Director, Biogen
- Michael Verlander, D.Phil., President, Proactive Quality Compliance, Inc.
Who should participate?
- Scientists developing peptides and oligonucleotides
- QA/QC analysts
- Manufacturing and process development scientists, managers
- Quality and regulatory staff supporting supplier evaluation, agreements and audits
- Contract research organizations
- Contract manufacturing organizations
- Raw material vendors
Call for abstracts
Interested in submitting an abstract for the workshop? We want to hear from you!
Get information about topics and submission instructions.
Registration and Pricing Information
Registration is payable by credit card only. Updated registration fees for this virtual 3-day workshop have been set as follows:
|Participant type||Regular fee, per person|
Cancellation and Substitution Policy
Cancellation must be received on or before FEBRUARY 19, 2021 via email to email@example.com. Refunds will not be issued for cancellations received after this date. It is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to firstname.lastname@example.org
Please contact email@example.com or +1 301-816-8130.