Home WebinarsThe Importance of PEGs in the Small Molecule API Market

The Importance of PEGs in the Small Molecule API Market

WEBINAR

In the evolving landscape of drug development, the incorporation of Polyethylene Glycol (PEG) has emerged as a pivotal strategy for enhancing therapeutic efficacy. This webinar will delve into the nuances of PEG manufacturing, highlighting the critical importance of development, manufacturing, testing, and regulatory considerations when using PEGs in small molecule drugs. Many factors must be considered to ensure the success of your program, and a deep regulatory understanding is necessary to ensure you have the right product for the right use case. It’s essential to select a partner with the expertise to navigate the intricacies of PEGs and provide custom solutions tailored to your needs.

In this webinar, you will learn:

What the key requirements are for successful PEG development, production, and testing
How a custom PEG solution can provide value to your program
When GMP PEGs become a necessity

Speakers

Raymond Behrendt

Merck

Senior Process Development Manager, activated PEG, lipid and small molecule

Raymond is process development manager within the European life sciences services CDMO group. He develops and optimizes chemical pharmaceutical manufacturing processes — including scale-up and transfer to the Manufacturing Sciences & Technology group — and leads root-cause investigations for clinical and commercial-scale production of activated PEGs, lipids, and small molecules. He joined Merck in 2009 after holding various R&D roles. He holds a Ph.D. in chemistry from the Technical University of Munich / Max‑Planck Institute, Germany.

Lotfi Bouchekioua

Merck

Regulatory Affairs Expert

Lotfi is a regulatory affairs expert within our global regulatory affairs organization, specializing in CMC regulatory strategy and compliance. He develops and implements global CMC regulatory strategies for priority assets, leading submissions and lifecycle management activities multiple markets. He serves as a key liaison with global Health Authorities, managing CMC-related queries to accelerate approvals and ensure regulatory alignment. He joined Merck in 2023 after holding various roles in regulatory affairs. He is a pharmacist with a master's degree in health law.

Alan Gunderson

Merck

Strategic Marketing Manager - Small Molecules

Alan is a strategic marketing manager supporting {hompany}'s global small molecule CDMO services offer. He has more than 15 years of experience in the HPAPI manufacturing industry with time spent as a production chemist as well as a client project manager, synthesizing and managing programs from preclinical through commercial phases. Alan holds a B.S. in Chemistry from the University of Wisconsin - Madison as well as a PMP certification from the PMI Institute.