DHC really hit it out of the park. And in record time. This has been an invaluable exchange in my eyes.
We approached Dark Horse for recommendations regarding our fill & finish processes. DHC was informed on the industry standards, advised on the best fit for us and provided us with the expertise we needed, as well as offering additional strategic assistance. We greatly appreciate the work Dark Horse has done for us and would use them again were we in the same position.
Over the past 2.5 years, we’ve engaged Dark Horse for their expertise across the board, utilizing nearly their entire service portfolio. I consider their comprehensive knowledge and dedication to meeting the needs of our program(s) to be an integral part of our continued success as a multiple-product clinical-stage.
We used DHC over the years to provide different levels of consulting services for our cell therapy platform. Most recently we utilized DHC and the services of Don Fink to perform an additional and very detailed project. Don immediately understood the scope of work, quickly identified additional information required, and executed the scope on time, providing an excellent final report which exactly met our needs. The speed of completion and the attention to detail were impressive, and provided value added information for our internal team- both to create internal alignment and to prioritize activities moving forward.
Dark Horse Consulting has provided us with thorough CMC support since we initially engaged with them a year ago. They have been able to support and strengthen our pipeline by supplementing our existing processes with their preclinical service offerings. From starting materials to regulatory readiness, DHC has given us input that has been pivotal in our process development.
In my opinion Dark Horse Consulting is anything but the ‘dark horse’ team to select when choosing a consultancy to accomplish what you need and more. Given their depth of experience, expertise and connections this is a team you’d predict to win – a team you want adding value to your efforts. Retaining this firm is not for the faint of heart or weak of expectations. This is a team which will pull no punches, recognize no limitations, raise the bar higher than anyone internally has dared, compete harder, and accomplish more. Dark Horse Consulting’s founder, Anthony Davies, is a renaissance man of biologics development who has set the tone for his firm as one which will act with respectful honesty (even when it’s not the news a client wants to hear), transparent integrity, and rigorous compliance with the highest standards and yet perform comfortably with the tough trade-offs and practical parameters often facing biotech companies. My only hesitancy in hiring Dark Horse Consulting would be if I wasn’t prepared to fully commit to getting things done and done the right way.
For over 2 years, DHC has supported us across a variety of service areas and continues to do so as we progress through our next stages of commercial readiness. We implicitly trust in the technical knowledge of our Dark Horse contact(s), as well as in the consultant’s abilities to efficiently and effectively support our movement forward.
We initiated a relationship in 2019 with Dark Horse specifically to gain support in our regulatory affairs and quality management. With DHC’s deep expertise across many facets of cell and gene therapy and technology, we quickly realized that they can offer much more and have significantly expanded the areas in which we are working with them. They have quickly become an indispensable part of our team.
I recently had the pleasure of working with Dark Horse on a significant cell therapeutic diligence project. The Dark Horse team delivered a high quality product with rapid turnaround. I was impressed with the Dark Horse Team and their thorough contribution was an invaluable component of our investment thesis.
It has been a pleasure collaborating with Dark Horse Consulting. They provide deep expertise and the ability to clarify and focus federal regulators’ attention on critical issues. Such contributions are invaluable in moving complex biologicals smoothly along the path to approval.
Dark Horse Consulting has supplied invaluable support to the Stanford University Stroke Disease Team. They have coordinated functions as diverse as pilot and outsourced cGMP manufacturing, analytical development, quality systems and regulatory affairs. Further, their subject matter expertise has greatly enhanced the Neurosurgery Department’s interactions with the CIRM and the FDA.