Newsletter | April 20, 2023

04.20.23 -- Financing For Emerging Biotechs: Recent Trends & Predictions
 
Featured Editorial
Financing For Emerging Biotechs: Recent Trends And Predictions For 2023
 
By Rich Ramko and Ashwin Singhania, EY

After a stellar 2020 and 2021, overall early-stage financing for small and midsize biotechs declined significantly in 2022 due to a range of factors. Ernst & Young provides insights into those factors and trends, as well as the key focus areas for biotechs in 2023.
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity And Supply Continuity
 
By Danica Brown and Theo Zacharatos, ValSource Inc.

The long-awaited revision to ICH’s harmonized tripartite guidance on quality risk management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
Industry Insights
The Dynamic Regulatory Environment Of Drug-Device Combination Products
White Paper | By Diane Paskiet, West Pharmaceutical Services, Inc.

Examine the dynamic regulatory environment of drug-device combination products, as well as concrete steps to take to navigate regulatory complexities and decrease time-to-market.
Similar Enough Product Characterization To Support Process Changes And Biosimilar Development
Webinar | MilliporeSigma Biosafety Testing Services

Small differences in manufacturing conditions can have dramatic effects on a product’s structure and biological activity. Characterization is essential to understand the impact following process changes and successful biosimilar development. We will provide best approaches for comparability studies.
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