Jon Rowley

Grant revenue is not revenue. I'm all for non-dilutive funding, if and only if the SBIR/STTR-funded project accelerates your strategy with development of a product that will be sold (so science fair projects). However... *grant revenue is not validation dollars on the top line.* What you have shown is an ability to write grants, the basis for the research that led to the startup (in the case of academic spin-outs) in the first place. What you have not shown is 💸 the desire for customers to purchase your product(s) ➡ an ability to articulate a go-to-market plan, or 🔐 a down in the trenches understanding of product-market fit. Startups are a game of the quick and dead -- take the time and money you would spend writing these grants early in the life of your company and hit the road, listen to your customers, learn where and how your products fit, and start selling. Your P&L shows me your real progress there -- As an investor and advisor, I would rather see $10,000 in revenue from sales from a handful of customers in 2 quarters than a X% chance you get a $1M grant in 9 months.

33

18 Comments

I'm delighted to share news of this new AI-focused drug discovery company, Xaira, built on foundational technology from David Baker and led by Marc Tessier-Lavigne. The company applies AI tools to unlock opportunities in drug discovery for aspects of biology that we believe are not readily obtainable with conventional methods. I co-led NEA's investment in Xaira, along with my NEA partner and the firm’s co-CEO Mohamad Makhzoumi, and I will be joining Xaira’s board. Our enthusiasm for Xaira based on our belief that applying AI and large language models to biology holds immense promise and is still in its early stages. Currently, the application of AI to biology relies on model architectures borrowed from the tech world. A lack of well-curated clinical training sets hinders building and training these models effectively. This limits the advancement of AI in solving biological problems compared to other fields. Xaira aims to bridge this gap. We now have a clear understanding of the data needed to answer fundamental biological questions. By iterating on leading life science models and using focused perturbation data generated through our large-scale experiments, Xaira will generate data specifically suited to building advanced model architectures that are optimized for biology -- and hopefully, unlock therapeutic opportunities for patients who are not being optimally served by existing therapeutics.

489

13 Comments

ViroCell Biologics, a leading CDMO specializing in GMP viral vector manufacturing, successfully closed an oversubscribed convertible note offering to support its growth. New investor First Light Asset Management LLC led the funding round, joined by existing investors Sartorius Stedim Biotech S.A. and Dorset Opportunity Fund LP. The proceeds will fuel ViroCell's growth, meeting the rising demand for its viral vector design and manufacturing expertise. The company provides pre-clinical and clinical viral vector services, supporting the development of innovative cell and gene therapies. With regulatory approval from the UK's MHRA, ViroCell's services are in high demand, resulting in a substantial Master Services Agreement with a prominent US cancer center. CEO John W. Hadden II expressed gratitude to investors, especially First Light Asset Management LLC, for their confidence in the company's market position and growth potential. Matt Arens, CEO and Founder of First Light Asset Management LLC, emphasized the team's dedication to supporting ViroCell's ambitious growth journey. This investment will enhance the CDMO's services for cutting-edge CGT research organizations globally. ViroCell Biologics aims to be the preferred partner for entities developing CGT therapies, leveraging its expertise to streamline the clinical development process. Read more: https://lnkd.in/dSkMGaQn Farzin Farzaneh, PhD John W. Hadden II Todd Davis

21

The Silent Tutors: How LLMs Are Bridging Knowledge Gaps in Cell Therapy Manufacturing

3

I wonder if change in a mature industry is incremental or disruptive? I've been on the road last 3 weeks. One of my realizations is that the pharma/biotech industry is having a really hard time understanding the implications of AI in their field. Our conversations are centered on how AI might augment our old way of doing things. Not so much on will there be newer ways of doing things? Biological research is a complex balancing exercise between mechanistic understanding and pure empirical evidence. We are progressively better at understanding - or as I would say hypothesising - about how a disease works and how a drug might 'cure' it. A submission of mechanism of action is more common in IND applications but as far as I can tell it's not a pre-requisite. The greatest successes of drug research are solid empirical hit and trial. Very successful ones at that. The hay day of drug research in the 60s to 90s was because big pharma figured out how to do compound screening effectively at scale. Will AI give us new ways to do this in more effective ways? I would be extremely surprised if that were not to be the case. a. we have never had access to the kind of data that we do now b. we have never had a tool like modern AI to sift through data Those two combined will give us ways to do empirical research like we haven't done before. That much is clear. Will it change the relative dearth of blockbuster drugs? That is a whole another subject. What is clear to me is that the current focus on mechanistic understanding will have to evolve to incorporate AI. We will have newer ways to do things - not necessarily change or abandon old ways. Link to a blog that Abhishek wrote in 2020 which seems truer than ever before.

36

1 Comment

Nice in depth (and nostalgic) analysis of the new Illumina SmolSeq (🐱) by Keith Robison. Some really insightful points, most importantly IMO that SmolSeq is artfully positioned to create some competitive turbulence for Element Biosciences: "But now, $50K gets a very highly performing machine and $100K one which will fit many startup aspirations.  AVITI is still a sweet instrument, but Illumina just made that conversation more complicated." Also, why so shy about a DX version - "But even more surprising is that Illumina didn't outline a clear roadmap for clinical versions of the MiSeq i100 [🐱] - the DX model of the MiSeq received FDA clearance. The simpler workflows and smaller footprint would seem to make MiSeq i100 [🐱] a natural to try to put into pathology labs. So why the hesitancy to outline a path to get these into lucrative clinical markets?"

78

16 Comments

"[Patents] take a long time, at least in the biotech world, which is kind of okay because most of the time we're not in a hurry. Like we have time to kill while things are in development." ⏳ In Part 3 of my conversation with Kate Neville, Partner at Marshall, Gerstein & Borun LLP, we dive deep into the realities of biotech patent timelines and why the lengthy process can actually benefit startups during development phases. Some highlights from our conversation below: – The critical importance of investing in IP early - why spending money upfront on strong patent applications pays dividends later 🧬 📝 – Strategic approaches to international patent filings and how to choose which markets matter most for your biotech 🌎 – Why your science and IP strategy should evolve together, and how to protect confidential information when presenting to investors 🔒 – The shifting landscape of platform technology patents and navigating broad vs. narrow protection claims 🌐 Such an insightful discussion about the fundamentals of IP strategy for biotech startups - Kate's expertise really shines through as she breaks down complex patent concepts into actionable advice. Apple Podcasts & Spotify links in the comments below! 👇 #biotechnology #lifesciences #podcast

37

6 Comments

This week we’re scheduled to get some clarity on FDA’s Elevidys Accelerated Approval. There are three main categories that the FDA is due to weigh in on – each precedent-setting in its own way: The first is whether the current narrow Elevidys label will be expanded beyond 4- and 5-year-old Duchenne patients. Recall, the EMBARK Confirmatory trial enrolled patients ages 4-7. Sarepta’s sBLA submitted in December ‘23 also included some early subset data from ENVISION (and older supporting data from ENDEAVOR) that could potentially support age expansion. Sarepta has treated patients as old as 25 years old with Elevidys in the context of clinical trials. Sarepta believes their Elevidys label should be age agnostic. The second is whether Elevidys will remain on market with Accelerated Approval or be converted to a full approval, at least for the 4-5 year olds. Recall, whether granted access to the market via accelerated approval or full approval, the price is likely to remain $3.2M. Sarepta does not appear to be discounting or offering outcomes-based agreements or warranties so $3.2M is probably the actual price tag (with Sarepta making minor pricing concessions to distribution channels). Finally, because the sBLA included supporting subset data from ENDEAVOR and ENVISION, Sarepta is asking for removal of the ambulatory requirement that is currently in the Elevidys Accelerated Approval label. Alas, analysts see the evidence for efficacy in non-ambulatory patients as too limited and preliminary to warrant approval. But time will tell. Since back in the Garabedian days, I’ve learned to never bet against Sarepta. If Sarepta gets all that it has asked FDA for, after this week, Elevidys’ will have full approval with a label open to all age Duchenne patients, regardless of ambulatory status. But that scenario is unlikely; the FDA response will probably be more mixed than binary. However, any expansion of label has implications for payers, as more patients from the prevalent Duchenne population would have access immediately. And at $3.2M per patients, insurers, reinsurers and self-insured employers will be watching because...$3.2M here and $3.2M there and pretty soon you’re talking real money. Sarepta has assured the investment and patient community that it is ready to meet product demand, regardless of how the FDA chips fall. So there you have it.  We should know by week's end. #sarepta #elevidys #cgt #atmp #acceleratedapproval #reinsurance #duchenne

75

13 Comments

Using 'representation vectors' instead of prompt engineering to modulate #LLM responses enables tuneable behavior: https://lnkd.in/eUwSUvtg

10

1 Comment

❗ One of the things I like most about Aron Knickerbocker is that he isn't hyping the hypable. 🤖 His company, Aulos Bioscience, was the first to put an AI-designed #monoclonalantibody in humans. It would be easy to glorify the #artificialintelligence. ⏩ Instead, he says the IL-2 human mAb Aulos is developing COULD have been designed solely by humans. But, Aulos' humans knew how to use tech to do it faster. 📺 🎧 Get Knickerbocker's pragmatic take on AI in biotech, and learn his secret to building successful biotechs (spoiler: it's all about the data) on this week's episode of the #businessofbiotech. Watch here https://lnkd.in/eur__HP, or listen anywhere you subscribe to podcasts. Life Science Connect Bioprocess Online

29

Check out this beautiful video from @altM.bio that serves as a mini explainer, busting some of the biggest myths about biomaterials. It dives into the three most important aspects when choosing sustainable alternatives: quality, cost, and scalability. If you’ve ever had questions about biomaterials, this video answers them all in the most compelling way. Don’t miss it! #Biomaterials #SustainableInnovation #CircularEconomy #FutureOfMaterials #SustainableAlternatives #MaterialScience #GreenTech #EcoInnovation #SustainabilityMatters #ClimateAction #CleanTech #Bioeconomy #ResponsibleManufacturing #InnovationForSustainability #SustainableSolutions

26

1 Comment

Excited to announce the 2025 Gordon Research Conference (GRC) on Protein Engineering, this second GRC on Protein Engineering will be held at Bryant University in Smithfield, RI from July 27th to August 1st 2025 https://lnkd.in/g-763SeF. please come join us if you would be interested in this exciting field. Different fields have experienced a transformative expansion in research distinction and capabilities. There now exists a strategic opportunity for protein engineering to take the lead and spearhead the integration of this joint effort, reflected by The Nobel Prize in Chemistry 2024. We believe that this GRC conference will create a gateway for the next generation of engineers and researchers, and will be a vehicle toward future development in the midst of an amazing convergence of multiple cutting-edge areas in protein engineering and its applications. Confirmed speakers include the Nobel Laureate Prof. Frances Arnold and distinctive scientists showing below: 1.            Fundamental Principles of Protein Engineering Possu Huang (Stanford University)/Frances Arnold (CalTech, Nobel Laureate)/Huimin Zhao (University of Illinois at Urbana-Champaign) 2.    Biosensors and Imaging Jennifer Prescher (UC Irvine)/Jin zhang (UC San Diego)/Robert Campbell (Tokyo University)/Nathan Shaner (UC San Diego) 3.    Rational Design of New-to Nature Proteins Jiri Damborsky (FNUSA-ICRC & Masaryk University, Czech Republic)/Joelle Pelletier (University of Montreal)/Sílvia Osuna (University of Girona & ICREA, Spain)/Koga Nobuyasu (Osaka Univ, Japan) 4.    AI for Protein engineering Zhongyue John Yang (Vanderbilt University)/ Jennifer Listgarten (UC Berkeley)/Doug Barrick (Johns Hopkins University) 5.    Biocatalysis and Industrial applications Carlos Martinez (Pfzer)/ Stephanie Galanie (Merck)/Zhi Li (National University of Singapore, Singapore)/Brent Dorr (Ginkgo Bioworks) 6.    Protein Engineering for Synthetic Biology Pimchai Chaiyen (Vidyasirimedhi Institute of Science and Technology (VISTEC), Thailand)/Weixin Tang (University of Chicago)/Jay Keasling (University of California, Berkeley) 7.    Directed Evolution for Enzyme Optimization Yang Yang (University of California Santa Barbara)/Leilei Zhu (Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences, China)/Miguel Alcalde (Institute of Catalysis, CSIC, Spain)/Chang Liu (University of California, Irvine) 8.    Protein engineering for Immunotherapy and other diseases Anna Wu (Beckman Research Institute, City of Hope)/Xue Gao (University of Pennsylvania)/Bingfei Yu (University of Southern California)/Wilson Wong (Boston University) 9.    Repurposing Protein for Novel Chemistry and Applications Stefan Lutz (Codexis Inc)/Xiongyi Huang (Johns Hopkins University)/Xiaojing Gao (Stanford University)

46

3 Comments

Regenerative therapy is the future of medicine that holds the promise for an end to many chronic debilitating diseases and the increase of health span in humans and animals. SMSbiotech is introducing an accessible and affordable approach to regenerative therapy using their unique and novel stem cells….

2

Immune-Onc Therapeutics shared Phase 1b trial data on IO-202, our first-in-class anti-LILRB4 antibody, in combination with azacitidine for #CMML. The results are incredibly promising: ✔️ 50% Complete Remission (CR) Rate ✔️ 66.7% Overall Response Rate (ORR) ✔️ Exceptional outcomes in high LILRB4 expression patients (CR: 83%; ORR: 100%) As the CEO of Immune-Onc Therapeutics, I am inspired by the dedication of our team and grateful for the patients and clinical investigators who made this progress possible. These results bring us closer to transforming care for #CMML patients.

54

A new company called Xaira Therapeutics just launched with over $1B+ billion in funding for using AI in drug discovery R&D. To give you some context, the last time we saw this level of fundraising was for Roivant Sciences, which focuses on creating companies around abandoned drugs, and Altos Labs, with $3B for cellular rejuvenation programming. But this is the 1st for an AI drug discovery R&D company. Interestingly, a significant portion of the company's technology originates from the Institute for Protein Design at the University of Washington, which is renowned for its work in protein science. This institute is led by Prof. David Baker, the co-founder of this and also the Charm Therapeutics. Read the full story here: https://lnkd.in/eCZfV4CW #drugdiscovery #artificialintelligence

14

1 Comment

NY Illumina/GRAIL lawsuit Part 1: Conflicted Deal Process (continued from https://lnkd.in/gCFnVprG) The complaint goes into detail on the negotiation that took place during August 2020 as GRAIL pushed Illumina up for an initial $6B offer (🤯) to $8B (🤯🤯) to $10B including performance bonuses (🤯🤯🤯). And then this - there was NO DUE DILIGENCE: "On September 6, 2020, management apprised the Board of additional information concerning a potential transaction with GRAIL. The presentation noted that despite multiple offers and counters, “formal diligence” had not yet been conducted, but would focus on multiple issues. SIX DAYS LATER, on September 14, 2020, the acquisition was unanimously approved by the Illumina Board. Aravanis also attended this meeting." This confirms by worst fears - Illumina spent over $8B on a deal that never underwent due diligence 🤯 My theory is that Illumina had hired Aravanis from GRAIL and so figured they had the inside scoop on what was going on in GRAIL. They somehow ignored the fact that the person they were relying on to advise them on the deal stood to make $10M or more if Illumina purchased GRAIL. Sheer idiocy by the board: Aravanis clearly should have played no part in the process but was present at the board meetings. This is so obvious a f*ck up that a coverup was later attempted: also from this complaint: "Chairman Thompson and the Board published two letters to shareholders that falsely claimed that (due to his large GRAIL holdings) Aravanis had been “recused from any decisions to sign and close the GRAIL acquisition.” The Aravanis hiring was only most obvious conflict of interest - the entire negotiation was full of problems resulting from the intertwined relationships between the two companies (half the GRAIL board were ex-Illumina execs and board members). From the complaint: "Illumina’s one-month Acquisition process appears to have suffered from other process failures. Board members learned from an anonymous survey of Illumina’s directors and officers that during [the] GRAIL acquisition, there were multiple streams of unauthorized communications between an Illumina Board Member and GRAIL Board Members and the bankers.” Speaking of banker, famously Goldman Sachs represented both Illumina and GRAIL in the deal; note though that the higher the price of the deal, the higher their compensation 🤯

91

19 Comments

Just before American Society of Clinical Oncology (ASCO) next week, Tempus AI have announced the have filed for an #IPO with the SEC this week! 🩸Tempus, who were founded back in 2015 are 'looking' to raise $100 million in public offering. 📖 If you dont know the story surrounding Tempus, then it is well worth a read. Founded, by Eric Lefkofsky (who is also the Groupon founder) after his wife was diagnosed with #breastcancer, he had the mission to deliver personalized patient care to patients through collection of molecular, clinical and genomic data by utilizing AI. 🚀Milestones so far include; - Funding of over $1 billion to date. - Investors include Google, Novo Holdings & Franklin Templeton! - Over 450 unique data collections across 2000 healthcare institutions. - Over 95% of pharmaceutical companies use Tempus offerings. - Over 7000 physicians use their tech which equates to more than 65% of academic medical centers in the US. - Over 2300 employees! - Valuation of over $8 billion! 💭Personally, I have never recruited for Tempus AI but, having spent the past 6 years learning more about their journey, it is hard not to root for them during this next phase. 🍿The market competitors will be watching closely no doubt... #cancer

19

I have been in the Pharmaceuticals and Biotech niche for over 10 years. Most people think “success” in this field means developing groundbreaking drugs. And sure, that’s true. But here are 3 unexpected outcomes I ended up experiencing that I value way more: 1. Mastering the art of strategic patent management 2. Leveraging data for competitive advantage 3. Building a network of industry innovators Share your thoughts or contact us for a demo! 🌟📊 #PharmaSuccess #Innovation

2

1 Comment

For anyone building diagnostics: Very cool approach to gain valuable insights into FDA decision summaries. Brendan O'Leary scraped the FDA’s decision summaries and provided some simple R code for anyone to get up and running in no time to prod and probe those summaries. Very nice work!

25

1 Comment