Marco Baccanti

“My meeting with LiKang's Chairman, Mr Zhuang Zhong, in Nanjing last Friday confirms that Intellego's products are currently being marketed and are in use with several larger hospitals in China while LiKang continues to prepare the broader market launch to coincide with new Chinese disinfection regulations which are expected to come into force in 2026 and to require the use of products such as Intellego's. LiKang is actively following the regulatory process and preparing the market. We reaffirmed our mutual commitment to our collaboration and our belief in its full potential“, says Intellego chairman, Greg Batcheller. Usage of our dosimeters in China is increasing and we look forward to the national regulations, expected in 2026, when 30 000+ hospitals MUST use products like Intellego’s (that these regulations were coming has been known for some time.) Due to this and based on previous cases, its now likley that its just a matter of time before EU, the US and other markets implement the same regulations.

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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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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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EU Grants Approval to Zemcelpro, a Cord Blood–Derived Stem Cell Therapy for Blood Cancer Patients - https://lnkd.in/ggEfsTXJ In August 2025, the European Commission (EC) granted conditional marketing authorization (CMA) to Cordex Biologics, a subsidiary of ExCellThera, for Zemcelpro® (UM171 Cell Therapy), a personalized stem cell therapy derived from a single cord blood unit for blood cancer patients who lack access to a suitable donor for a traditional transplant. ExCellThera announced the news on August 27, 2025. Clinicians emphasize the therapy’s transformative role. Dr. Fabio Ciceri, Professor of Hematology at Vita-Salute San Raffaele University in Milan, explained: “The curative potential of allogeneic stem cell transplantation is still limited by access to a suitable donor. UM171 Cell Therapy offers an option timely available for patients in need.” David Millette, CEO of ExCellThera and Cordex Biologics, framed it as a turning point: “As the first and only cell therapy approved for patients without access to suitable donor cells, Zemcelpro offers a vital new stem cell transplant option—and renewed hope—for those who have been left without one.” Read more at: https://lnkd.in/ggEfsTXJ #cordblood #stemcell #celltherapy

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T-cell engagers – is it all about affinity? TCEs have been a revolution in oncology, particularly blood cancers but also recently in solid tumors. The basic idea is you have a bispecific drug that binds to a T-cell with one arm (typically via CD3) and a tumor antigen with the other. This forms a connection (synapse) between the cells, causing the T-cell to be activated and kill the cancer. Straight forward in theory, less so in practice! The first generation of TCEs bound CD3 with high affinity and led to significant cytokine release syndrome in patients. There was a need for better drugs balancing potency and safety. In 2003 it was reported that the threshold to activate T-cell killing was distinct and more sensitive than the threshold for cytokine release. In other words, there was a sweet spot for potency with reduced side effects. A Goldilocks zone! Over the past 15 years there have been a number of reports on TCEs with reduced affinity to CD3. Some are even starting to show promise in the clinic but what does reduced affinity mean? This seems to be as mythical as a fairy tale. Reports seem to claim anything from double digit nanomolar to micromolar binding. On a monthly basis I get requests to humanize CD3 antibodies often with an additional note to “reduce affinity to X nM”. But is it really that simple? Should we just be building standardized CD3 binders and using them plug-and-play for all purposes? Biology is rarely this simple! Christian Klein and colleagues have just published an excellent opinion piece on this topic. Well worth a read for anyone designing TCEs. Link in first comment. What people often seem to forget is you don’t just have to balance binding to CD3e but also the tumour antigen (TA). The epitope on the TA will have an impact on the optimal CD3 affinity, as well as the geometry required to form the optimal synapse. A recent study analysing structures and synapse formation showed that equivalent potency depends on contact distance and flexibility. Optimal killing can be achieved with formats that mediate close contact with high flexibility or far contact with low flexibility. However, few papers have done a head-to-head assessment of the interdependence of both CD3 and TA affinity. This perhaps marks the start of the 3rd wave of TCEs, where a more holistic approach is taken to optimization of all components in the puzzle rather than just CD3 affinity. TCEs in autoimmune disease are also starting to take off. If we want to develop the best possible TCEs across all antigens and indications we need to learn from Goldilocks and identify the TCE that is “just right” for the particular application. ----- I'm Ian, I post about antibody engineering, recombinant proteins and my journey to bootstrap Gamma Proteins into a leading supplier of Fc receptors. If you like my content please reshare with your network and follow me to see more.

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The UK Biobank identified 1.5 billion variants using Illumina DRAGEN secondary analysis, providing unprecedented insights into human health, disease, and genetic diversity for pharma partners and researchers worldwide. Read the full study.

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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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