Newsletter | March 27, 2024

03.27.24 -- FDA's Gene Editing Guidance: New & Remaining Questions

FEATURED EDITORIAL

FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions

By Brent Morse and Nate Manley, Dark Horse Consulting

On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.

Next-Generation RNA Modality Supply Considerations

Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality and IP-related considerations for managing the supply chain for next-generation RNA modalities.

Building A Biotech Hub With Intellia Therapeutics' John Leonard, M.D.

We spend a lot of time talking with our guests about building biotech companies. That’s true of this episode too, but today we’re taking a step further with John Leonard, M.D., longtime CEO at Intellia Therapeutics.

INDUSTRY INSIGHTS

Overcome The Hidden Complexities Of mRNA Process Development

Webinar | Sartorius

Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.

Oligonucleotide Development And Manufacturing Workflow

Infographic | Cytiva

Learn more about oligo workflows and solutions for oligonucleotide process development, from scalable oligo synthesis to cleavage and deprotection, purification, and buffer exchange.

Optimizing Biologics Manufacturing Processes With Raw Materials

Webinar | Thermo Fisher Scientific

Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from preclinical to licensure.

Modeling The Economics Of Vaccine Manufacturing

White Paper | MilliporeSigma

Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.

A Deeper Dive On Mitigating Financial Risk Before Selecting A Vendor

Webinar | inSeption Group

In this webinar series installment, presenters focus on avoiding potential risks such as unexpected budget changes and unplanned change orders that could jeopardize the success of a clinical trial.