07.18.25 -- STREAM Edition: Clinical Trial Strategy And ADC Dev Partnership

This week's episode is one from the road, recorded in front of a live audience in Boston's Seaport neighborhood during the BIO conference. Amber Salzman, Ph.D., CEO of Epicrispr Biotechnologies, explains how epigenetic editing is revolutionizing genetic medicine by controlling gene expression, without cutting DNA like traditional CRISPR technologies.

Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.

In this chapter of Business of Biotech episode 252, Alnylam Chief Commercial Officer Tolga Tanguler addresses challenges and opportunities in the RNAi therapeutics commercialization effort. Catch the full episode here!

As the Bioprocess Online Live panel discussion Accelerating ADC Process Development wraps up, expert panelists Dr. Léo Marx (Debiopharm), Dr. Monika Lamba Saini (ADC Therapeutics), and Dr. Philipp Spycher (Araris Biotech) address audience questions on AI-driven stratification of patients and biomarkers in clinical patient enrollment and IP strategies and collaboration.

Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.

This expert discussion focuses on residual impurities for gene therapy drug products, risk assessment, and characterization of product-related impurities in LVV based gene therapy products.