At this year’s Advanced Therapies Week in Miami, DHC is going to be doing something unprecedented. We’re convening our full panel of ex-FDA regulatory experts together at the Dark Horse Lounge (booth #700) for four events. Stop by to meet …
by Katy Spink, DHC’s COO and Managing Partner
Welcome to the end of Q3’22, a time that feels like an excellent opportunity for an update on my thoughts from earlier this year regarding what 2022 could mean for cell and …
By Dark Horse Principal Kevin Whittlesey, Ph.D.
In the field of cell and gene therapy we’re seeing more excitement and growth each year, and the recent ZYNTEGLO® approval adds to that. The significance of the new approval is due to …
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 …
by Katy Spink, DHC’s COO and Managing PartnerI’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 …
a discussion with Don Fink
Q: To kick things off, would you please remind us of why it’s even possible to consider providing proposed guidance to the FDA?A: Absolutely. On the FDA website there are what’s called Instructions for …
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 …
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 …
By Anthony Davies, Rob Allen, and Ian Pardo
We at Dark Horse are intrigued by the Medicines and Healthcare products Regulatory Agency (MHRA)’s latest: the advent of an “innovation passport” to create an accelerated route—or at the very least, clear …
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This page provides you with a complete list of our past issues.
In honor of the inaugural issue of The Quarter Horse, Katy Spink, Dark Horse’s COO, sat down with Donald Fink, Master Practice Expert in Regulatory, to discuss the patterns of C> regulatory rejections/delays during the past 15 months.
Katy: We’ve …
Happy Eve of Not #JPMorgan: here are my in-no-particular-order Top 10 predictions for the year in cell and gene therapy, not so much as a Nostradamus impression, but hopefully more a provocation of thought…
#1 The investment and acquisition arms…