Lin Wang
Company: Gilead Sciences
Job title: Director
Seminars:
Developing Analytical Strategies for Complex Peptide Therapeutics: Conjugates, Macrocyclics & Long Peptides 9:30 am
In the dynamic landscape of peptide therapeutics, the development of robust analytical strategies is crucial for ensuring the safety, efficacy, and regulatory compliance of complex peptide molecules. This workshop delves into the intricacies of analytical methodologies for a wide array of peptide modalities, including conjugates, macrocyclics, and long peptides. Led by industry experts with extensive…Read more
day: Pre-Conference Day
Peptide Regulatory Odyssey: Navigating CMC Compliance Across Europe & the US 1:40 pm
Delving into the regulatory dichotomy: Understanding how peptides, commonly treated as biologics in Europe, are categorized as small molecules by the FDA, demanding a multifaceted approach to CMC adherence Tackling critical considerations like impurities, stability, process validation, and analytical methods validation, aligning with small molecule CMC directives while upholding biologic quality standards Implementing tailored strategies…Read more
day: Conference Day Two