Marc Krueger, PhD

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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In the biotech world, the early phase determines success or failure But the figures are alarming: 2023 biotech start-ups in Germany received just 203 million euros in early-stage funding. This is the lowest figure in the last six years - and well below the average of 325 million euros. → 24 er Zahlen For comparison: In the USA, several billion US dollars are invested in biotech start-ups in the seed and Series A phase every year. In 2023 alone, the volume was over 14 billion US dollars. What does that mean in concrete terms? Many start-ups do not fail because of the science. They fail because they run out of money before they can develop their product to market maturity. Early-stage financing is the bottleneck. Because this is precisely where it is decided whether we promote innovation in Europe OR whether it migrates. ➡️ What do I think is needed? Specialized early-stage funds for biotech. The biotech sector has different dynamics to traditional tech start-ups. Research takes longer, is more capital-intensive and riskier. Investors who understand these mechanisms are needed. Public co-investment programs must be a must-have. The state must act as an anchor investor to mobilize private capital. Tax incentives for early-stage investors are also essential. Those who invest in high-risk innovations should be rewarded with tax incentives. It is important to note that early-stage financing is not a subsidy. It is the prerequisite for turning cutting-edge European research into commercial success. If we do not close this funding gap, we in Europe will have to continue to watch our innovations grow in the USA.

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Alvotech is aiming to bring a number of new products to global markets in the coming months. Today we were very pleased to announce Alvotech's latest marketing approval in Europe, of our first biosimilar in ophthalmology. We are working with strong commercial partners such as Advanz Pharma, STADA (DE) and Biogaran (FR). Together we aim to increase access to cost-effective vision-protective care for millions of patients in Europe. This is just the latest step in Alvotech's ongoing mission, to broaden access to vital biologic medicines globally. Biosimilars bring down the cost of biologic medicine and support the sustainability of our healthcare systems, freeing up resources for further advances and breakthroughs in therapy. #betteraccess #betterlives #Europe Alvotech's press release: https://ow.ly/2ESA50WJKw0

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FUTURE TRENDS IN CELL AND GENE THERAPY (2026–2030): CRISIS, OPPORTUNITY OR BOTH?/ After a turbulent 2024–25, I kept getting the same question: where does cell & gene therapy go next? This position paper tries to summarize a pragmatic roadmap for founders and investors. Our perspective is informed by recent experience, including our exit from Esobiotec (acquired by AstraZeneca). Thesis: The next five years will be shaped by four forces — in vivo delivery, cost curves (CMC), access policy, and China — with AI powering design, manufacturing, and clinical execution. From 2026 onward, expect fewer but “shocking” wins that reset expectations. What’s changing: ● From hype to hard problems. CAR‑T and gene therapy delivered real cures, now the frontier is solid tumors, larger genes, and scalable delivery. ● In vivo moves center stage. Recent landmark deals signal that editing or programming cells inside the body will define the next platform wave. ● Cost curves bend. Rapid CAR‑T (7–10 days), point‑of‑care manufacturing, and automated QC turn CMC into a core moat. ● Access vs. innovation finds rules. Hospital exemptions and right‑to‑try expansions will force clearer coexistence between academic access and commercial pathways. ● China changes the price and pace. Massive trial volume and lower costs put global pressure on CGT pricing, and open new cross‑border development routes. ● AI becomes non‑optional. From target and capsid design to bioreactor control and trial ops, AI is now a competitive baseline. Investor playbook 1️⃣ Back delivery (in vivo & non‑viral): the platforms that scale beyond bespoke products. 2️⃣ Build CMC + data moats: speed, reliability, and AI‑driven manufacturing as first‑order strategy. 3️⃣ Globalize early, design for access: partner with leading hospitals, plan China/EU routes, and align incentives (outcomes‑based models). Inside the paper you’ll find a 1‑page landscape map (p.1), a deal & signal table (p.9), and concrete takeaways for teams navigating the next cycle. 👉 Download/print the full paper: https://lnkd.in/dqzZX7ZX #celltherapy #genetherapy #biotech #venturecapital #AIinBiotech #CMC

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I’m energized by the compelling data emerging around BioNTech SE BNT113 in head and neck cancer treatment. Coupled with recent investor conversations, it’s clear there’s real momentum behind the shift toward in vivo immunotherapy. By programming the immune system directly within the body, this approach promises to streamline production and logistics—potentially delivering transformative care at a dramatically lower cost than traditional cell and gene therapies. To put things in perspective: developing a typical cell or gene therapy today can cost upwards of US $1.9 billion from R&D through clinical trials. And that’s just R&D, Cost of goods/manufacturing alone for a gene therapy can be between $500,000 and $1 million. In contrast, true in vivo approaches (which bypass ex-vivo cell manipulation and personalized manufacturing) could dramatically reduce costs and broaden accessibility. BNT113 exemplifies this potential—a solution that could be cheaper, scalable, and faster to deploy. I’m excited to see how this innovation reshapes the therapeutic landscape—and thrilled to be part of this conversation in making immunotherapy more efficient and accessible. References: https://lnkd.in/exCJK4t8 https://www.genengnews.com

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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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Completely agree, Citeline! There is huge potential for AI in drug discovery, but we need to rethink the problems we are trying to solve.    At Valo Health, we start drug discovery by unraveling the complexities of disease from large scale human datasets. Our advanced AI/ML tools enable us to learn in new ways from this data, identify new drug targets and explore vast chemical spaces for new small molecules.    We’re already seeing this approach impact our partners’ R&D - and we believe it’s really just the beginning of how we can transform drug discovery. Link in comments.

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𝗧𝗵𝗲 𝗵𝗮𝗿𝗱𝗲𝘀𝘁 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗶𝘀𝗻’𝘁 𝘀𝗶𝗴𝗻𝗶𝗻𝗴 𝗮 𝗱𝗲𝗮𝗹 — 𝗶𝘁’𝘀 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝗶𝗻𝗴 𝗼𝗻𝗲. In most biotech and pharma companies, #B𝘶𝘴𝘪𝘯𝘦𝘴𝘴D𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 usually means 𝗹𝗶𝗰𝗲𝗻𝘀𝗶𝗻𝗴 — collaborations, royalties, valuation models. That’s essential work, but it’s only half the story. #𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗕𝗗 — what happens as a product nears approval or enters the market — is a different discipline. It’s where assumptions give way to execution. In #𝘭𝘪𝘤𝘦𝘯𝘴𝘪𝘯𝘨, we 𝘥𝘦𝘢𝘭 𝘸𝘪𝘵𝘩 𝘰𝘱𝘵𝘪𝘰𝘯𝘢𝘭𝘪𝘵𝘪𝘦𝘴: forecasts, discount rates, scenarios. In 𝘤𝘰𝘮𝘮𝘦𝘳𝘤𝘪𝘢𝘭 𝘉𝘋, we 𝘥𝘦𝘢𝘭 𝘸𝘪𝘵𝘩 𝘳𝘦𝘢𝘭𝘪𝘵𝘪𝘦𝘴: supply chains, pricing, launch timing, payor access, distribution. It’s no longer about how to split value but how to #𝘥𝘦𝘭𝘪𝘷𝘦𝘳 it. 🔍 𝗧𝗵𝗲 “𝗦𝗲𝗰𝗼𝗻𝗱 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗣𝗿𝗼𝗯𝗹𝗲𝗺” Health Advances once wrote a piece that still resonates: “𝗢𝗻𝗲-𝗛𝗶𝘁 𝗪𝗼𝗻𝗱𝗲𝗿𝘀 — 𝗧𝗵𝗲 𝗦𝗲𝗰𝗼𝗻𝗱 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗣𝗿𝗼𝗯𝗹𝗲𝗺 𝗶𝗻 𝗕𝗶𝗼𝘁𝗲𝗰𝗵.” Many biotechs succeed once but stumble on the second product because they stay optimized for 𝘥𝘦𝘢𝘭-𝘮𝘢𝘬𝘪𝘯𝘨, not 𝘣𝘶𝘴𝘪𝘯𝘦𝘴𝘴-𝘣𝘶𝘪𝘭𝘥𝘪𝘯𝘨. They master partnerships but not launches--didn't bridge strategy and execution. That’s where the partnership between the 𝗖𝗵𝗶𝗲𝗳 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗢𝗳𝗳𝗶𝗰𝗲𝗿 and 𝗖𝗵𝗶𝗲𝗳 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗢𝗳𝗳𝗶𝗰𝗲𝗿 becomes defining. The CBO brings the 𝘰𝘶𝘵𝘴𝘪𝘥𝘦 𝘸𝘰𝘳𝘭𝘥 𝘪𝘯 — anticipating what partners and payors need. The CCO brings the 𝘪𝘯𝘴𝘪𝘥𝘦 𝘸𝘰𝘳𝘭𝘥 𝘰𝘶𝘵 — ensuring science and strategy reach patients. When they work in sync, 𝘀𝗰𝗶𝗲𝗻𝗰𝗲 𝗯𝗲𝗰𝗼𝗺𝗲𝘀 impactful 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀. When they don’t, companies risk confusing activity for progress. The best organizations share one lens — 𝘵𝘩𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵 𝘱𝘦𝘳𝘴𝘱𝘦𝘤𝘵𝘪𝘷𝘦. Because at the end of the day, the product is where science, strategy, and patient value meet. 🚀 𝗧𝗵𝗲 𝗕𝗗 𝗦𝗵𝗶𝗳𝘁 𝗧𝗵𝗮𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀 Commercial BD often begins two years before approval — during launch planning — when BD supports commercial teams on launch strategy and readiness, access, ITM (in-the-market) vs. TTM (to-the-market) pathways, and real-time insights to shape future BD priorities. At that point, #BD becomes #operational, financial, and mission-critical. 🙏 𝗔 𝗡𝗼𝘁𝗲 𝗼𝗳 𝗧𝗵𝗮𝗻𝗸𝘀 I learned many of these lessons early from exceptional leaders who shaped how I think: Anthony C. Hooper (Tony) (𝗔𝗺𝗴𝗲𝗻) — every deal must serve patients, not spreadsheets; D. Mark McClung (𝗔𝗺𝗴𝗲𝗻) — connect strategy with field reality; Jeff Ajer (𝗕𝗶𝗼𝗠𝗮𝗿𝗶𝗻) — commercial discipline and compassion can coexist. Their #mentorship grounded my belief that in biotech, 𝗲𝘃𝗲𝗿𝘆𝗼𝗻𝗲 𝘀𝗵𝗼𝘂𝗹𝗱 𝘁𝗵𝗶𝗻𝗸 𝗹𝗶𝗸𝗲 𝗮 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗽𝗲𝗿𝘀𝗼𝗻 — scientist, BD lead, or C-suite alike. Because a “deal” makes a headline. A “launch” builds a company. https://lnkd.in/etf5tfMt

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As evitria AG is owned by private equity Patricia Industries, it is always interesting to analyze what other PE backed investments are going on in that area. I have compiled a full overview of transactions affecting #CDMOs in my article in BioPlan Associates, Inc. 22nd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production https://lnkd.in/eNSFgrMB. Thank you Donnie E. Gillespie to include me again in this industry leading documentation full of interesting facts and statistics. The survey collected extremely valuable data and is regarded as the industrial reference - just to name a few interesting examples here: For instance, it is reported that ≥90% of the world’s mammalian cell culture capacity is utilized for #antibody production, or that the average titer of commercial scale mAb production is still relatively low at 3.1 g/L and 3.9 g/L overall for all development stages – far away from individual cases with titers in the 8-12 g/L range. Therefore, it is not surprising to see that “improving the production titer” ranked second in factors to reduce COGS. Interestingly the average cost for recombinant proteins was ~300 $/g, although almost 25% of the analyzed facilities could achieve costs below 100 $/g. However, costs of >100 K$ annually per antibody treatment are not necessarily related to expensive manufacturing, but rather to high and frequent doses. But check it out yourself to find other interesting facts about bioprocessing.

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For decades, oncology drug development has largely centered on the primary tumor. Yet despite billions invested, this narrow focus has not delivered the breakthroughs patients desperately need. Another Bi-specific antibody, another ADC — these can generate capital, but they don’t change the paradigm. At Novita, we’ve chosen a different path. We are advancing a first-in-class fascin inhibitor that directly targets metastasis, the true driver of mortality in cancer. By keeping our molecule distinct — rather than attaching it to a fixed cytotoxic payload — we empower clinicians with the flexibility to pair it with the therapy backbone best suited to each patient’s needs. This is not the easy route, but it is genuine innovation: complementing the battle on the primary tumors by preventing their spread and giving the immune system a stronger chance to win. Stopping metastasis remains one of oncology’s greatest unmet needs — and it is exactly where Novita intends to lead. Increase Patient survival - full stop! #Oncology #Biotech #Innovation #FascinInhibition #PatientFirst

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Eli Lilly and Company’s latest earnings call sheds new light on the evolving conversation around US drug pricing and the return of the Most Favored Nation (#MFN) policy proposal. CEO David Ricks offered a reminder that while global pricing reform may be warranted, applying ex-factory European price points to a fragmented and opaque US healthcare system introduces significant risk, not only to patient affordability, but to long-term innovation and industry competitiveness. While Lilly supports more balanced cost-sharing across developed nations, Ricks made clear that US pricing discussions must account for deeper systemic inefficiencies like high out-of-pocket costs, reimbursement complexity, and a web of intermediaries that distort value. Policy aligned to global benchmarks must also confront domestic infrastructure. Without that parallel reform, the outcome risks undermining both access and the ecosystem required to sustain therapeutic advancement. #USmanufacturing #drugpricing #biopharma

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