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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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 …
by Katy Spink
I was born and bred in California. As an adult, I’ve been working in California’s cell & gene therapy space since long before anyone in their right mind would have used “cell & gene therapy” and “gold” …
By Anthony Davies
Say what you will about Novartis; it’s always interesting over there by the Rhine. It’s been a rollercoaster of news about Zolgensma lately—from the timing of the data manipulation reporting…to the excellent 3Q earnings…to Japan and the …
By Anthony Davies
Considering the pace of the arms race for haemophilia therapies, the recently-announced collaboration between Novo and Bluebird feels quite late. Given what we know about their current progress, they’re unlikely to reach a long-term therapy first or …
Photo credit Anita Barcsa Photography
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