Dark Horse guidance – what’s next?

A conversation with Jacob Staudhammer (DHC Senior Consultant) and Christina Fuentes, Ph.D. (DHC Consultant)

Q: Hi, you two! So, before we jump into a discussion of next ideas, we should take a moment to look in the rearview mirror and …

Proposed DRAFT Guidance for FDA Consideration:

You are reading the beginning of the May 15th DHC Proposed Draft Guidance for FDA Consideration document itself. If you’re looking for the DHC press release on the same subject, click here. If you wish to reach out to us …

Anthony offers insights with Endpoints News

In early April, Endpoints News published “Avoiding Cell Therapy Manufacturing Gridlocks — a Do’s and Don’ts Guide,” in which guidance by our CEO, Anthony Davies, figured prominently. (One of his many quotes is above in the header on this page.)…

Will 2022 be the year that blew our minds?

I’ve been thinking lately about what place this year, 2022, may ultimately hold in our memories. By this time next year when we have the benefit of some hindsight, will we be referring to it as the first post-pandemic year …

Cell and Gene Collaborative’s “New Year’s Resolutions”

5 New Year’s Resolutions For Advancing The CGT Manufacturing Paradigm

By Anna Rose Welch, Director, Cell & Gene Collaborative

As I began plotting this article series following my conversation with Katy Spink, COO and Managing Partner of Dark Horse Consulting, …

AAVs: the search for actionable advice and/or paths forward

Anthony, Katy, and Don got together in the last week of September, 2021 to discuss both short- and long-term solutions to the concerns regarding AAV safety and efficacy: everything from the need for spec guidelines to possible AdComm patterns to …

Aducanumab’s approval: what does it mean for cell & gene?

by Katy Spink, DHC’s COO and Managing Partner

There’s no denying that approval of aducanumab (AduhelmTM)1 is the biggest biotech/pharma topic of the quarter. It’s inexplicable on the surface, especially relative to other recent decisions, isn’t it? While I share …

We use cookies to help give you the best experience on our website. By continuing you agree to our use of cookies.