Mario Schäfer

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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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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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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Cross-border biotech deals often fail to deliver expected value. Over 15 years, we’ve closed 90+ deals on 5 continents despite being a boutique team. Here’s the framework that makes it work: Cross-border biotech deals often fail due to regulatory hurdles, pricing issues, and mismatched priorities. Here's how we avoid that fate: 1. Understand each market deeply Every region has its own commercial and regulatory frameworks, IP norms, and cultural context. We invest in learning that upfront because misalignment, not valuation, kills most deals. For instance, in China, most drugs are sold through hospital systems. If you don't know the distributors with hospital access, your product won't move. From volume-based pricing to the National Reimbursement Drug List (NRDL), every layer matters. Missing these details kills value before the deal is even discussed. 2. Surface hidden value others miss Our team has launched, manufactured, developed, and commercialized products in key global markets. That on-the-ground experience allows us to unearth hidden value. In Brazil, we generated additional gross margin by optimizing the global supply chain of our client's product. That gave the greenlight for the deal to proceed. In Japan, we understand the government's approach to drug loss and the policies addressing it. That lets us create favorable deal environments for Phase 2 companies. 1 in 3 cross-border deals only move forward after we reframe how value is understood on both sides. 3. Build strong trust-based personal relationships Teams that trust each other are more likely to collaborate, find solutions, and push internal alignment. Over 15 years, we've built relationships with decision-makers in every key market. That means we can speak directly to the people who matter. A quick yes mobilizes the org. A quick no saves months of useless conversations. 4. Once interest is real, move with precision Cross-border deals stall when teams lose focus. We act as deal leads: removing blockers, aligning terms, and setting the pace. Deals with clear cadence get done. 5. Keep teams lean and clear We run small, senior teams (3–4 core people) across all mandates. Big teams slow things down. Small teams close. In cross-border deals, clarity of purpose and focused execution beats headcount every time. Some quick metrics: • 90+ deals closed globally • Cross-border close rate >70% • Median close time: 6–9 months • Over 50% repeat clients Execution, not scale, is the differentiator. You don't need a big bank to close global biotech deals. You need clarity, follow-through, and credibility across borders. We've built that over hundreds of negotiations, through trust, not volume. If you're exploring global partnerships & want a partner who knows the path and the pitfalls, let's talk. At Kybora.com, we help leaders navigate cross border deals with clarity. Follow me for more on biotech M&A, strategy, global deals, and market shifts.

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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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The biopharma industry is entering a new era of strategic #manufacturing realignment, and the scale of investment speaks volumes. The US–EU trade agreement announced in late July includes a 15% tariff on pharmaceutical imports. While implementation is pending the Section 232 investigation, expected to conclude in August, we’re seeing the continued acceleration of massive investments in domestic manufacturing as companies hedge against long-term policy and supply chain risk. Leading companies are making historic investments to strengthen domestic #supplychains, reduce geopolitical risk, and safeguard long-term patient access. Here’s what’s unfolding: - AstraZeneca: $50B commitment, including its largest-ever manufacturing hub in Virginia - Roche: $50B investment across multiple US states, creating 12,000+ jobs and expanding capabilities in gene therapy and glucose monitoring - Eli Lilly and Company: $27B to build four US “mega sites,” with two dedicated to synthetic chemistries for APIs—a critical capability long dominated by China - Biogen: $2B to expand its North Carolina footprint, reinforcing global supply resilience - Merck: $12B invested since 2017, with $9B more planned by 2028 These investments represent structural realignments in response to policy volatility and a growing recognition that manufacturing must be resilient, secure, and geographically aligned with patient needs. The current moment demands ingenuity in the design, location, and scalability of our manufacturing infrastructure.

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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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