Interesting article. Nearly everyone (drug sponsors, the entities quoted herein, FDA themselves, and DHC also) agrees that at times a written response only (WRO) may not be an ideal substitute for a meeting, and yet it happens quite regularly for many legitimate reasons. On staff at Dark Horse we have a number of former-FDA experts who can be of help to clients who wish to maximize the use of any Agency interaction, including WRO. Our experts excel at identifying the most appropriate interaction pathway, drafting correspondence with RPMs, striking the balance of necessary information in briefing books, explaining missing context from WROs, etc. Reach out at https://bit.ly/DHCconsult to request support.
Dark Horse Consulting Group Inc.
Biotechnology Research
Walnut Creek, California 7,124 followers
Cell and Gene Therapy Experts
About us
AT DARK HORSE CONSULTING, we work to accelerate cell and gene therapies through our unmatched expertise. Our consulting team has extensive CGT industry experience with knowledge spanning manufacturing, process development, comparability, analytical dev, quant modeling, quality systems, regulatory support, preclinical dev, device dev, program management, facility design and engineering, market research, and due diligence and business strategy. Many of our consultants also bring experience from adjacent, more mature, sectors, including traditional biologics, small molecules, medical devices, and management consulting. Client requests range from scientific expertise to tactical needs to strategic considerations to business development. We understand the unique challenges faced by Cell and Gene Therapy developers like none other. We apply best practices from across this and other industries to address the needs of our clients, who range from biopharmaceutical companies to tools & tech providers to investment firms.
- Website
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http://www.darkhorseconsultinggroup.com
External link for Dark Horse Consulting Group Inc.
- Industry
- Biotechnology Research
- Company size
- 51-200 employees
- Headquarters
- Walnut Creek, California
- Type
- Privately Held
- Founded
- 2014
- Specialties
- manufacturing support, process development and comparability, regulatory support, quality systems, analytical development, quantitative modeling, device development, preclinical development, project & program management, market research, intellectual property, financing and due diligence, cell therapy, gene-modified cell therapy, gene therapy, and cell and gene therapy
Locations
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Primary
Get directions
1255 Treat Blvd
Walnut Creek, California 94597, US
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Get directions
The ClubHouse St. James
8 St James' Square
London, SW1Y 4JU, GB
Employees at Dark Horse Consulting Group Inc.
Updates
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Getting ready to attend Boston's CAR-TCR Summit Series in a couple of weeks (Sep 17-20)? Don't forget to attend the Late Stage Manufacturing Track, chaired by Sara Mills, DHC Senior Principal and head of Cell Tx CMC!
Will you be attending CAR-TCR in Boston in September? (If you're not already registered, you can do so here: https://ter.li/mcx1tq and be sure to use the 20% off code below.) And make a note to self to be sure to attend the Late Stage Manufacturing track, which will be chaired by our own Sara Mills, Sr. Principal and Head of Cell Therapy CMC!
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Be sure to join our own Tal Salz tomorrow at 11 am Eastern for a discussion on modernizing CAR T manufacturing. While centralized CAR-T manufacturing is the industry standard, some believe the future will be decentralized, taking place at or near patients’ POC. Others think POC manufacturing isn’t scalable and is laden with QC and regulatory challenges. Tal will be joining Cell & Gene host Tyler Menichiello as well as CTMC - a joint venture between Resilience + MD Anderson Cancer Center's Jason Bock, and Cartesian Therapeutics' Emily English. Register for free here: https://lnkd.in/gPb6eCmy
Modernizing CAR T Manufacturing: Is Point of Care The Future?
event.on24.com
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It's time for a new case study! Read up on this example, in which development of a CAR-T cell therapy licensed from an academic institution required DHC support in developing a pre-IND and IND-enabling nonclinical strategy. (h/t Sean O'Farrell!) https://lnkd.in/dBA-9FAT
Transforming an Academic Nonclinical Data Package for IND Readiness - Dark Horse Consulting
darkhorseconsultinggroup.com
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Don't miss Cell & Gene's Podcast Episode 83 with Kimberly Benton and Erin Harris in which they discuss BLAs (recent approvals + those currently under review), FDA draft guidances, and regulatory advice for CGT developers. While you're at it, be sure to subscribe to Cell & Gene: The Podcast! https://lnkd.in/d8uMeZzX
🎙 Episode 83 of Cell & Gene: The Podcast is available! Dark Horse Consulting Group Inc. Kimberly Benton, Ph.D. joins me to discuss Biologics License Applications (#BLA) of recent approvals as well as those currently under review. She shares information about #FDA #draftguidances, and she provides a #regulatory outlook as well as sound advice for #CGT developers. Subscribe wherever you #podcast to tune in. #cellandgenetherapy #regulatorycompliance #biotech #raredisease https://lnkd.in/gfZ7JVYp
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It's been a wonderful summer with Deanna Portero: thank you so much for all your hard work at DHC, especially in developing a comprehensive internal regulatory database that will serve as a curated repository of critical information and resources for global agencies. Wishing you all the best -- stay in touch!
Today we welcome DHC's summer intern for the year, Deanna Portero, who comes to us courtesy of Alliance for Regenerative Medicine's outstanding GROW internship program. Deanna is a 2nd year dual-degree MPH/MBA student at The Johns Hopkins University - Carey Business School / Johns Hopkins Bloomberg School of Public Health, scheduled to graduate next year. This summer she'll be working with Master Principal and Head of Regulatory Kimberly Benton, exploring regulatory convergence and regulatory reliance across major regulatory agencies and creating a comprehensive internal resource to enable rapid retrieval of relevant, current guidance documents. We're thrilled to spend the summer with you, Deanna!
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Check out the latest guest column over at Cell & Gene, where DHC Senior Consultants Anne Lamontagne, Blake Bergam, and Uzma Shoukat-Mumtaz have put together a guide to selecting cell & gene therapy tools, tech, and services. "Rapid growth in the CGT field in recent years has been shaped by an upswelling market of supporting tools, technology, and services (TT&S) vendors. While making informed decisions within a crowded landscape can seem daunting, the recommendations provided in this article will support a more structured selection process across the TT&S value chain segments." Enjoy! https://lnkd.in/g334AkGz
A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services
cellandgene.com
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We'll be there - will you?
Who's joining us in Lisbon this September? 🎉 Advanced Therapies Europe 2024 is now live on LinkedIn! 🚀 Head over to our event page to let us know you're coming and see who else is attending... Make sure to follow the event page for the latest updates, announcements, and exciting competitions. We can't wait to share this experience with you! #Event #Networking #RSVP #FollowUs #ATE24
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8/15 with Kimberly Benton, here we come!
🎙 Quick reminder that Episode 82 of Cell & Gene: The Podcast is out now, featuring CureDuchenne's Debra Miller and Dr. Michael Kelly. Tune in anywhere you #podcast to catch this insightful episode. Stay tuned for Episode 83, launching on 8/15, featuring Dark Horse Consulting Group Inc.'s (DHC) Kimberly Benton, Ph.D. With over 20 years at #FDA's #CBER, Kim now leads regulatory efforts at DHC. During our chat, she dives into #BLA for recent approvals and those in review, touches on key #DraftGuidances, and offers a #regulatory outlook for #CGT developers. Subscribe now wherever you podcast to stay updated on the latest trends and insights in #cellandgenetherapy.
Identifying Drug Development Opportunities for DMD with CureDuchenne
cellandgene.com
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Do you remember back in May when Brent Morse and Alicja Fiedorowicz co-authored a piece on "Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Therapies?" for BioProcess International? Part 2 is up; read it here! https://lnkd.in/gqwe7Q9P ...and if you want to catch up on Part 1 first, you can find it here: https://lnkd.in/gnAEeZiF
Hematopoietic Stem and Progenitor Cell Therapies
bioprocessintl.com