Adam Inche

Significant regulatory shift in UK that may impact 𝗖𝗔𝗥-𝗧 delivery: At-patient manufacturing!   With summer holidays and other industry happening, this news may have passed you by (it did me!): As of 23rd July 2025, the MHRA (the UK regulator) legally allows flexible, innovative manufacturing approaches such as Point-of-Care and decentralised/distributed modular manufacturing for ATMPs including CAR-Ts.   𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗯𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱 𝗳𝗼𝗿 𝘁𝗵𝗶𝘀: 🔹 MHRA innovation office has been receiving enquiries around this kind of manufacturing since 2014 – but no regulatory framework was in place to allow for PoC or modular manufacturing. 🔹 As technology advances – particularly ATMPs – new manufacturing modalities are required that can take place in hospitals, clinics and even the patients own home! 💭 𝗜𝗺𝗮𝗴𝗶𝗻𝗲 𝘁𝗵𝗮𝘁, 𝗵𝗮𝘃𝗶𝗻𝗴 𝗮𝗻 𝗮𝘂𝘁𝗼𝗹𝗼𝗴𝗼𝘂𝘀 𝗖𝗔𝗥-𝗧 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗱 𝗮𝗻𝗱 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝗲𝗱 𝘄𝗶𝘁𝗵𝗶𝗻 𝘆𝗼𝘂𝗿 𝗼𝘄𝗻 𝗵𝗼𝗺𝗲. 𝗛𝗼𝘄 𝘄𝗶𝗹𝗹 𝗶𝘁 𝘄𝗼𝗿𝗸? 🔹  The technical solutions are still in development. Notably, Spain has made some great progress on establishing localised CAR-T production centres in Barcelona and Navarra. 🔹 A centralised “Hub” control site will be responsible for the decentralised “Spoke” sites; being responsible for documentation, quality, release and inspections. 🔹 A Decentralised Manufacturing Master File (DM MF) is required to be managed by the control site with annual reporting to MHRA 🔹 GMP and Pharmacovigilance requirements are maintained and must be have appropriate management plans prior to approval   𝗜𝗻 𝘀𝘂𝗺𝗺𝗮𝗿𝘆: This legislation marks a significant regulatory shift, accommodating disruptive innovation in medicine manufacture and delivery. MHRA has adopted a flexible, guidance-led approach supported by stakeholder feedback, with a strong emphasis on collaboration and quality assurance. Links to the MHRA webinar and the guidance document in the comments 👇 𝗧𝗵𝗶𝘀 𝗵𝗮𝘀 𝗯𝗲𝗲𝗻 𝗵𝗮𝗶𝗹𝗲𝗱 𝗮𝘀 𝗮 𝗳𝗶𝗿𝘀𝘁 𝗮𝗺𝗼𝗻𝗴 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀 – but do you think this puts the UK in a strong position for systems developers?  💬 As always, let me know your thoughts in the comments below.

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Roche just bet $420M on a small UK biotech - no products, no human trial data. Just ONE platform that convinced them. Here’s why this move signals the future of drug development: First, the context. Roche is valued at nearly $200B. It generated $66B in revenue last year and is a global leader in immunology. In 2023, it paid $7.1B upfront for a late-stage bowel disease drug. On Sept 2, Roche’s Genentech unit licensed a preclinical program from Omass Therapeutics: $20M upfront. Up to $400M in milestones. Tiered royalties if commercialized. For a drug that hasn’t entered human trials. So why? Because Roche isn’t just buying a drug. It’s buying access to OdyssION, Omass’ discovery engine, a platform designed to study proteins in their native ecosystem. That means higher fidelity and fewer dead-end programs. This matters most in inflammatory bowel disease (IBD): Nearly 8M people worldwide live with Crohn’s disease or ulcerative colitis. Even with TL1A antibodies dominating headlines (AbbVie, Merck, Pfizer), the unmet need is still massive. Roche wants multiple shots on goal. Look at the portfolio play: • Afimkibart (anti-TL1A) → Phase 3 blockbuster bet • Omass program → early-stage option with a differentiated mechanism This isn’t random. It’s hedging across timelines and science. For Omass, this is validation. Founded in 2016 from Oxford research, it built tech that retains protein interactions inside the mass spectrometer, a notoriously tricky feat. Now Genentech has endorsed it with a deal worth up to $420M. Here's the thing: This is how modern pharma constructs franchises: Not just buying winners, but layering early-stage platforms that expand optionality. It’s less about chasing hype, more about building risk-balanced portfolios. Here's the lesson for biotech leaders: Modern pharma isn’t chasing single winners. It’s building risk-balanced portfolios by layering early-stage platforms. Not hype-chasing, future-proofing. You don’t need Phase 3 data to land transformative deals. If your platform solves a discovery bottleneck: fidelity, precision, delivery, Big Pharma will pay. Omass just proved it. 3 takeaways from this deal: • Platform > single product • Hedge across timelines, not just assets • Optionality is now strategic currency And Roche is showing how to build a franchise that lasts. Biotech deal flow and market trends are complex, but approachable with the right guidance. At Kybora.com, we support leaders navigating these challenges with authentic, insightful content. Follow me for more on biotech M&A, market shifts, & strategy.

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𝗕𝗥𝗘𝗔𝗞𝗜𝗡𝗚 𝗡𝗘𝗪𝗦: Sanofi to Acquire Vicebio for $1.6 Billion 👇 Sanofi has announced a definitive agreement to acquire UK-based vaccine biotech Vicebio for $1.15B upfront, with an additional $450M in development and regulatory milestones. 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: 👉 Lead asset VXB-241 is a bivalent RSV + hMPV vaccine, now in Phase 1 trials 👉 Built using Molecular Clamp technology, which stabilises viral glycoproteins in their native pre-fusion state 👉 Targets RSV, hMPV, and PIV3 > major causes of severe respiratory illness in older adults 👉 Adds a non-mRNA approach to Sanofi’s growing portfolio 👉 Founded by Medicxi in 2019; Emmanuel Hanon (former GSK Head of Vaccines) appointed CEO in 2022. Busy summer in France as this deal marks another major M&A by Sanofi to strengthen its position in respiratory health and vaccine innovation. Huge congratulations to the Vicebio team and to all involved at Sanofi on this transformative milestone 👏 #vaccines #immunology #biotech

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Shall we run developability assays before purification? 🤔 Typically, developability assessments are done after purification — because some assays require purified material. So we were a bit surprised when a biopharma partner asked for a hydrophobicity screen for 6His-tagged molecules that could run directly from crude supernatants, no purification, just dilution. Their requirements were simple but ambitious: 🔹 10–30 µL sample per well 🔹 Working concentration as low as 5 µg/mL (after 1:10 dilution) 🔹 ≤ 60 min per 384-well plate When we ran the 6His-HIC PAIA assay, the results were striking: hydrophobicity data from crude supernatants matched purified samples almost perfectly. Spearman r = 0.96, and relative hydrophobicity profiles were essentially identical. And: several other PAIA developability assays worked just as well in diluted supernatants. That raises some exciting possibilities: 🔹 Could we perform key developability assays earlier, before purification? 🔹 How much time, material, and effort could we save if supernatant-based readouts are reliable? It might make especially good sense when: 1️⃣ Purification is complex or inconsistent 2️⃣ A large percentage of candidates are expected to drop out early   So the question is: 👉 Have you explored developability assays directly in supernatant? 👉 Do you think it could be of advantage as a first pass test? I am Sebastian, founder of PAIA Biotech, posting regularly about developability of biologics and technologies for assessing molecules in early discovery. #developability #antibodydiscovery #leadoptimization #PAIA

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𝗧𝗮𝗸𝗲𝗱𝗮 𝗲𝘅𝗶𝘁𝘀 𝗰𝗲𝗹𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝘆—𝗯𝘂𝘁 𝘁𝗵𝗶𝘀 𝗶𝘀𝗻’𝘁 𝘁𝗵𝗲 𝗲𝗻𝗱 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗼𝗿𝘆 Takeda just announced they’re ending all ex vivo cell therapy work as part of a strategic portfolio shift. It’s easy to read this as a death knell for the modality. But history tells a different story. Promising modalities don’t die—they hibernate. Builders keep iterating through the quiet periods. Then, when the science catches up, pharma rushes back in. We’ve seen this pattern before:  • 𝗔𝗗𝗖𝘀 — Largely abandoned after early toxicity failures. Revived through better linkers, novel payloads, and smarter patient selection. Now a cornerstone of oncology.  • 𝗥𝗡𝗔 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 — Stalled for years due to delivery challenges. Rescued by breakthroughs in siRNA and antisense chemistry. Now foundational to drug discovery.  • 𝗺𝗥𝗡𝗔 — Dismissed as too unstable and impractical. COVID vaccines changed everything overnight. Now every major pharma has an mRNA program. Ex vivo cell therapies might be in their “winter” phase. The challenges—complex manufacturing, hostile tumor microenvironments, limited persistence—are real but not insurmountable. The next wave is already forming: automated manufacturing platforms, multiplex genome editing, novel conditioning regimens, off-the-shelf products, and TME-resistant designs. If you’re building in cell therapy right now, you’re exactly where the winners were during past troughs. When the breakthrough arrives—and it will—pharma will flood back in, just like they always do. The question isn’t 𝘸𝘩𝘦𝘵𝘩𝘦𝘳 cell therapy will rebound. It’s 𝘸𝘩𝘰 𝘸𝘪𝘭𝘭 𝘴𝘵𝘪𝘭𝘭 𝘣𝘦 𝘣𝘶𝘪𝘭𝘥𝘪𝘯𝘨 when it does. https://lnkd.in/eKy6hMpx

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Think CMC is just about process development and documentation? Think again. The biotech founders who succeed understand that CMC challenges extend far beyond the technical basics. Here are the strategic hurdles that separate thriving biotechs from the rest: 1. Regulatory Navigation: Phase-appropriate data sounds simple until you're staring at FDA guidance documents. What's "sufficient" for Phase I? What level of process characterization will satisfy Phase III requirements? Get this wrong, and you're rebuilding everything. 2. Supply Chain Resilience: COVID taught us that global disruptions are the new normal. Your single-source raw material supplier in China just went offline. Your backup plan? Hope isn't a strategy. 3. Innovation vs. Cost Balance: Every startup wants cutting-edge manufacturing, but your runway is finite. How do you balance breakthrough approaches with risk-based, cost-effective development? The wrong choice kills companies. 4. Partnership Paradox: You need CDMOs and consultants, but every outsourced function is knowledge you don't own. How do you maintain control and institutional memory while leveraging external expertise? 5. Product-Specific Strategy: Your monoclonal antibody isn't like everyone else's. Your cell therapy has unique manufacturing challenges. Cookie-cutter CMC approaches fail when your biology is novel. 6. Cross-Functional Orchestration: CMC doesn't exist in isolation. When your clinical team changes endpoints, your analytical methods need updating. When regulatory shifts requirements, your quality systems must adapt. Silos kill timelines. The difference between winners and losers? Losing startups treat CMC as a checklist to complete (in the best case) and think CMC is a side gig (in the worst case). Winning startups treat CMC as a dynamic, integrated strategy from day 1 that evolves as the project advances. ✔️ They build roadmaps that anticipate challenges. ✔️ They invest in systems that scale. ✔️ They create processes that adapt. Which of these challenges caught you off guard? What would you add to this list? Let's help the next generation of founders avoid these pitfalls. 💬 #BiotechChallenges #CMCStrategy #DrugDevelopment #StartupStrategy #BiopharmaDevelopment

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