Rainer Strohmenger

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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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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The Double Click: New Episode Now Live!    Here is our second episode of #TheDoubleClick, where we explore "change leadership" in large companies. When disruptive technologies emerge, it's important to strategically invest in disruptive innovation for the tectonic industry shifts as well as sustaining innovation for competitive improvements in current trajectory. Both strategies are valuable and necessary. In this episode, I chat with Luis Arosemena, GSK’s Senior Vice President of Global Commercial Strategy. We discuss what endurance sports teach us about leadership, balancing global strategy with local empowerment, the importance of reimagining healthcare in the age of AI, and what Peruvian ceviche can teach us about leadership. It's a thoughtful discussion with practical takeaways for leaders navigating complexity and change. Watch the full conversation here: https://lnkd.in/e24gb6bN #TheDoubleClick #AheadTogether #Innovation #Healthcare #Technology  

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Another slide from Guardant Health's investor day tells you everything you need to know about the business opportunity driving the stock of clinical testing companies like Natera, Exact Sciences and Guardant Health 🚀🚀🚀 In contrast the NGS companies led by Illumina are fighting it out over a $10B TAM even as they enable this $400B TAM. Tricky 🤔🤔🤔

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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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