QbDVision

🎉 We are proud to be co-leading @qbdvision's $13M raise—alongside @npv_vc and Create Health Ventures! Having pioneered the #DigitalCMC category, QbDVision is enabling global biopharma companies—including 3 of the top 6—to bring life-saving therapies to market faster and more efficiently than ever before! It’s a new era for Life Sciences: digitally driven, intelligently organized, and built to scale. Congratulations Yash Sabharwal, @ryanshillington, @Luke_Guerrero, Michael Stapleton, Phillip Johnson, and the entire team at @qbdvision! Read the full announcement: qbdvision.com/2025-new-fundi…

If you are attending the 2025 #DigitalCMCSummit, be sure to connect with Isabel and join her on how to enhance collaboration, improve real-time data sharing, & streamline platform management for more efficient development and #manufacturing processes. #CDMO @qbdvision #AAV

BREAKING NEWS The 2024 #NobelPrize in Physiology or Medicine has been awarded to Victor Ambros and Gary Ruvkun for the discovery of microRNA and its role in post-transcriptional gene regulation.

A couple additional thoughts: There’s always tradeoffs. In the above example, the latter decision indeed achieves a faster readout. But you'll eventually need to do PD while also ensuring it's comparable to the Ph1 product & run a bridge study group. This can be expensive and potentially cause delays. Another common question is whether to build internal manufacturing capability vs. rely on CDMOs. The former may be short-term expensive, but long-term cost saving. Part of why these decisions are difficult is that you're "locked in" to the manufacturing process as described in the Module 3 of your IND. CMC is often an underlooked component for early-stage spinouts, but can make or break timelines unless it's thought ahead. Takeaway: get yourself a CMC advisor earlier than later

For biotechs developing complex therapies, management teams face some of the toughest decisions around manufacturing & CMC. For example - should you delay the Ph1 trial to first optimize the manufacturing process, or move ahead with a less efficient process for a faster readout?

There’s an important lesson in biotech re: Rumsfeld’s “unknown unknown” speech. You can manage “known knowns” and “known unknowns” by hiring people with experience. You can only manage to survive “unknown unknowns” by building a great culture. images.app.goo.gl/B2dJZomDxj1u4e…

Want to dive into solving cell therapy challenges? ARM & @NIIMBL's A-Cell outlines best practices for Chemistry, Manufacturing & Controls in the cell-based therapy field. A full webinar series on best practices can be found on our YouTube channel: ➡️youtube.com/playlist?list=…

Minister for Enterprise, Trade and Employment Simon Coveney and @IDAIRELAND announced the creation of 100 jobs across 5 high growth ( @XenonArc, @Totalprocessing, Alliance Strategies, @qbdvision, @MovanoInc) companies from Europe and the US. #IrelandINC irishtechnews.ie/ida-ireland-an…

For those watching the $SRPT mtg: Don't discount the manufacturing issue, which FDA raised and one adcomm member has asked about. Could become major hurdle to SRP-9001 becoming available. Scale-up can be difficult.

⏯️ Now On-Demand! "Weaving the Digital Fabric of CMC" Learn the power of structured data in a unified digital CMC platform for better process intelligence. Watch now: qbdvision.com/weaving-the-di… #DigitalCMC #Pharma #Biotech #DigitalThreads #DigitalFabric

📢 Last chance to sign up for "Weaving the digital fabric of CMC"! 📅 April 27th, 2023 | ⏰ 12:00 PM EDT ⏳ Register now and don't miss this opportunity to unlock the full potential of your CMC processes. 🔗hubs.ly/Q01MMQ0M0 #DigitalCMC #DrugDevelopment #Webinar

Meet the incredible Yash Sabharwal, Founder & CEO of @qbdvision! Read his insights on fundraising and managing a remote team--and about his hardest lesson learned. s3vc.com/news-and-insig…

The EU drug development sector is fast becoming a global hub of Digital CMC expertise, that’s why we’re opening our first European office in Cork, Ireland! See how we’re building international momentum for the Digital CMC movement in our latest blog: hubs.ly/Q01L97gR0

We're back in 2023 with new sessions, new speakers, and a new sense of discovery! Join us live in Austin, Texas from OCT 31 – NOV 2 to unlock the power of your science. Sign up to learn more about the 2nd Annual #DigitalCMC Summit this fall: #updates" target="_blank" rel="nofollow noopener">qbdvision.com/digital-cmc-su… #liveevents

We have arrived! Today we announce the opening of our first EU office in Cork, IE. With a growing interest in cutting-edge CMC solutions, Ireland was a natural choice for our expanding global team. Read more👇

This paper is for all quality professionals who are working to understand the key areas where real-time release testing (RTRT) will impact the pharmaceutical quality system... More here - okt.to/eUpzVD

Remember our most recent white paper release? (bit.ly/DHCBeyondEmpty…, ICYMI) Attend this webinar in March and you'll be able to hear directly from one of its authors (including many other luminaries in the field)! insights.bio/cell-and-gene-…

On this week’s Blueprint podcast we are sharing an engaging conversation from #BMWS22 with Luke Guerrero of @qbdvision where we discussed The Maturity Curve and Collaboration in Digital Transformation for Life Sciences. 🎧 Listen to the full episode: bit.ly/3x7eJPJ

BioGPT: Generative Pre-trained Transformer for Biomedical Text Generation and Mining: academic.oup.com/bib/advance-ar… github.com/microsoft/BioG…

Are you familiar with FDA's new CMC Dev & Readiness Pilot? Are you considering applying? If you haven't read Kim Benton's CDRP primer, here it is! Read...and then reach out if you'd like support in evaluating criteria or crafting your application. darkhorseconsultinggroup.com/kim-benton-on-…