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 will provide you with all our archived issues. (So far, that’s just our first three but trust us, you’ll appreciate this page eventually…)
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…
by Katy Spink, DHC’s COO and Managing PartnerAddendum below* added on 1/5/2021
The end of 2020 didn’t arrive a moment too soon for most people I know, and the field of cell and gene therapy at large must have felt …
by Katy Spink, Dark Horse COO
Recent events in the battle to contain the global COVID-19 pandemic have me recalling one of the most memorable lessons of my graduate school education, and thinking about parallels in Cell and Gene Therapy …
By Robert Allen, Ph.D.
Get organised and get smart. The virtual audit: Ensuring quality and compliance during the current global pandemic Learn more about this offeringExecutive summary of Dark Horse Consulting Group’s April 2020 Whitepaper
This isn’t really a sentence that early 2019 me would have foreseen myself writing but, here we are. I wish to propose a new paradigm for addressing novel global pandemics: serological (blood) testing for immunity. Such a standard is proactive, …
by Anthony Davies
**I am aware that I’m posting this on the dawn of the American election event that is Super Tuesday, 2020. I do not intend my comments here as any sort of endorsement of any of the …
Photo credit Anita Barcsa Photography
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