Sarah Holland

Slides from the recent keynote "Biopharma Dealmaking: Time for a Re-Think" I delivered at the Swiss Healthcare Licensing Group meeting in Montreux in May are now available on the Lumanity website. https://lnkd.in/ePi9Vwse This data rich presentation is important viewing for anyone involved with or interested in biotech corp dev strategy but especially for those pre-commercial biotech "sellers" pinning their hopes on a large pharma partnership. The historically unprecedented increase in the number of biotechs reaching or surpassing clinical PoC stage (5 x or greater over past decade) coupled with a limited number of large pharma "buyers" means odds for vast majority of would be sellers are long. Many more of these biotechs should start to see self-commercializing, especially those pursuing advanced therapeutic modalities, such as cell and gene therapy, as more of a "Plan A" than B. And for many of these companies the time to get started is now, not when they are late in P3 or beyond.

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Unlocking the potential of oncology assets isn't just about groundbreaking science – it's about asking the right questions from day one. The commercialization of oncology products presents unique challenges due to the complex nature of cancer treatment landscapes, evolving standards of care, and the specific needs of patients, healthcare providers, and payers. Understanding where a product fits within these landscapes, navigating regulatory approval paths, and strategically planning patient support and engagement are crucial for a successful launch. As the market for oncology therapies evolves rapidly, it's essential to differentiate your asset and maximize its value proposition. Early and strategic questioning can guide informed decision-making, streamline the commercialization process, and ultimately lead to better patient outcomes.

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A friend called me and chatted ECA last week. During our conversation she asked, “what’s your vision and goal in RWE business in APAC?” I have not really thought about it. RWE business has been routinely run by project teams. In this system, an RWE Subject Matter Expert works as a consultant. A consultant often does not need to think about business“vision”, right? She did not give up, “based on your previous APAC RWE project experience, what are the key factors to be successful?” Well, I don’t really know neither. Some APAC local companies have been very aggressive with their “low cost” strategies. They seem to be very successful too. For me, the keywords for success in RWE in APAC are: novel, local, professional, top quality and high efficiency.

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Despite strong foundational research, Germany faces challenges in integrating cell and gene therapies (CGT) into medical care, risking falling behind internationally. A national CGT strategy was presented yesterday.   Here’s how the strategy differs from the CGT strategy in the US and UK:   𝐂𝐞𝐧𝐭𝐫𝐚𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐚𝐭 𝐏𝐚𝐮𝐥-𝐄𝐡𝐫𝐥𝐢𝐜𝐡-𝐈𝐧𝐬𝐭𝐢𝐭𝐮𝐭 (𝐏𝐄𝐈): Germany plans to centralize regulatory processes for GCT at the Paul-Ehrlich-Institut to streamline the regulatory environment. This involves defragmenting the regulatory landscape and introducing "sandbox" procedures as innovation spaces. ​In the US, multiple agencies such as the FDA and NIH handle different aspects of GCT regulation and development, while the UK has the MHRA and other bodies involved in the regulatory process. 𝐆𝐨𝐯𝐞𝐫𝐧𝐚𝐧𝐜𝐞 𝐚𝐧𝐝 𝐒𝐭𝐚𝐤𝐞𝐡𝐨𝐥𝐝𝐞𝐫 𝐈𝐧𝐯𝐨𝐥𝐯𝐞𝐦𝐞𝐧𝐭: Germany emphasizes a "bottom-up" approach involving diverse stakeholders directly in the governance structure. This includes establishing a governance structure with the participation of significant stakeholders and developing a GCT network map and annual progress reports​. This differs from the US and UK, where strategies tend to have more top-down, centralized approaches often led by major government agencies like the FDA in the US or the MHRA in the UK. 𝐅𝐢𝐧𝐚𝐧𝐜𝐢𝐚𝐥 𝐚𝐧𝐝 𝐒𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐚𝐥 𝐒𝐮𝐩𝐩𝐨𝐫𝐭 𝐟𝐨𝐫 𝐆𝐌𝐏: Germany’s strategy includes specific measures for financial and structural support in GMP production, such as establishing a central GCT-GMP committee and ensuring sufficient financial resources for GMP infrastructures​. This level of detailed infrastructure planning and financial commitment is not as prominently featured in the US and UK. 𝐄𝐦𝐩𝐡𝐚𝐬𝐢𝐬 𝐨𝐧 𝐏𝐨𝐥𝐢𝐭𝐢𝐜𝐚𝐥 𝐄𝐧𝐠𝐚𝐠𝐞𝐦𝐞𝐧𝐭: Germany’s approach includes continuous political engagement and annual progress reporting to ensure political support and adaptation of policies. This structured political integration is more pronounced than in the US and UK, where political support is sought but not as systematically integrated​. 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐇𝐮𝐦𝐚𝐧𝐢𝐭𝐢𝐞𝐬 𝐚𝐧𝐝 𝐒𝐨𝐜𝐢𝐚𝐥 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬: The strategy highlights the importance of maintaining an open discourse involving humanities and social sciences, ensuring that ethical, legal, and social aspects (ELSA) are considered in GCT development​. This broader societal integration is less emphasized in the US and UK strategies, which focus more on the scientific and regulatory aspects. 𝐌𝐲 𝐭𝐡𝐨𝐮𝐠𝐡𝐭𝐬: I welcome the centralization at PEI. This offers the potential for rapid progress. I have mixed feelings about the other points, as they have the potential to slow things down. What's your thoughts on this?

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Do you know how growth factors can cause a cell to differentiate and change function? We explain in our weekly blog: https://lnkd.in/etAqwuX7

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The definition of commercialization is changing rapidly with new products and therapies in development. Once focused on sales and marketing, it now requires a solid understanding of scientific value, early stakeholder engagement, and new measures of success. I’m resharing this blog from last year because its insights are still relevant today. Just as car buyers now prioritize safety and efficiency over aesthetics, prescribers and patients want a deeper understanding of the scientific value of any product they consider. When we involve medical affairs in commercialization, we bring better drugs to market, improve patient outcomes, design optimal trials, and use resources efficiently. https://lnkd.in/e9pqMyGJ 

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Exciting developments are on the horizon! Our latest analysis, based on data pooled from 690 patients, has once again showcased groundbreaking advancements in the detection of colorectal cancer and advanced adenomas (AAs). With sensitivities that lead the industry, our Mainz Biomed team is thrilled to progress this innovative test towards the planned FDA PMA study. In the realm of future colorectal cancer screening, high clinical sensitivity for advanced adenomas is imperative. Dr. Folasade May's recent article underscores the significance of detecting cancerous polyps to maintain the focus on prevention rather than mere detection in screening efforts. While some new blood-based screening tests can indicate the presence of colorectal cancer, they fall short in preventing its occurrence altogether. For further insights, you can explore Dr. May's article here: https://lnkd.in/gnZ72Yjy

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A team from ZHAW Zurich has showcased the transferability of CHO-cell-based mAb production processes from geometrically dissimilar stirred bioreactors for fed-batch and perfusion processes, the team has opened up new possibilities for cost savings and increased yields. Their study found that the high volumetric productivity in the perfusion processes can lead to cost savings, smaller bioreactor sizes, and maintained manufacturing capacity in production plants. Alternatively, yields could be increased by a factor of 2.8 to 3.2 while still using the same bioreactor size. We look forward to seeing how it will impact the future of antibody production. #biotech #antibodyproduction #research https://lnkd.in/eA9992FV

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Interesting to see that ISPOR is highlighting Investors as key stakeholders in the welcome address today.

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🗣 For the past several months, I've been engaging in an unprecedented high number of conversations with former colleagues and contacts who have been made redundant from big pharma companies. The pharmaceutical industry is entering a new phase where major corporations are forced to reduce their workforce. This has led to a large influx of highly skilled professionals, with decades of experience in cutting-edge science, entering the job market in the past 18 months.  But if the big companies are cutting, the biotech landscape is thriving. Particularly in Switzerland, innovative companies are flourishing and are able to secure foundings. 💡 This article offers an excellent summary of the Swiss BioTech Report 24, providing individuals exploring a new career direction with a fresh and optimistic perspective on the pharmaceutical industry. #swissbiotech #pharmaindustry #career https://lnkd.in/gmyHDEkS.

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Despite the pharmaceutical industry being one of the largest industries on the planet with hundreds of billions spent every year on R&D, there are very few professional academic groups studying pharma R&D productivity. One of the groups I follow closely is St Gallen Consortium led by Alexander Schuhmacher and Oliver Gassmann (my C-level friends in pharma, make a note and sign up for their new publication alerts in Google Scholar). Here is a new paper published by Alexander Schuhmacher on OPEN SOURCE AS A STRATEGY TO ENHANCE R&D PRODUCTIVITY. Super important topic - most pharma companies do not open source their frontier models even when doing exploratory research. Check out the paper and the table in the comments to learn why it is important to engage in Open Source. Link and table in the comments. #OpenSource #OpenScience #AI #Pharma

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With the significant reduction of venture capital funding observed over the last two years, it is very important for early stage companies to collaborate with a CDMO aware and adapted to the resulting challenges. Novel operating models enabling timely and cost-effective ways-of-working to progress towards FIH clinical trials are key to permit early stage companies reaching their value inflection points. The ENABLE BIOTECH team has just created such a framework taking into consideration the challenges early stage companies face today.  

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New preprint from the Gero team showcases more evidence for the entropic theory of human aging. Link is in the comments! Great work by Peter Fedichev Kirill Denisov Jan Gruber

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🌟 Exciting News! Certainty, Certara's Client Summit is coming to Europe! Join us for in Mainz, 🇩🇪 for two days of deep dives into drug development, where you'll connect with industry leaders and explore the latest in clinical pharmacology, modeling, simulation, and data analytics. One of the best parts of my role is engaging with our clients across all offerings, hearing their stories, and witnessing the incredible impact our collaborations have on teams and, ultimately, patients. Bringing together the multidisciplinary Certara community has sparked new ideas, created meaningful results, and forged stronger connections. 💡 At our first annual client summit, Certainty, we explored how modeling and simulation support clinical data analytics, biostatistics, regulatory submissions and medical writing generating fresh ideas and new collaborations . 🚀 After a successful kickoff in Philly and great feedback from SDEs in Japan, Korea, & China, we are thrilled to bring this dynamic event to Europe. Don't miss the chance to hear from Certara leaders and clients including William Feehery, Piet Van Der Graaf, Andreas Wallnoefer, Paolo Bettica, Simon Westbrook, Nathalie Wagner, Leif E. Pedersen, 🤖 🧠 Thibault GEOUI 🧬 💊, Ioannis Loisios-Konstantinidis, Masoud Jamei , Nick Brown & many others as we look ahead to 2025! 🔗 Check out the comments for the agenda and registration details! #DrugDevelopment #ClinicalPharmacology #ModelingAndSimulation #DataAnalytics #preclinical

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As CPHI's recent research suggests, 49% of CDMOs are "highly positive" about contract services growth over the next 18 months, primarily driven by investments in late-stage drug candidates and proving the industry's resilience and adaptability following the fluctuations of the COVID-19 era. However, it's no secret that funding for early-stage assets has been more elusive, which poses a challenge for CDMOs that rely on a steady flow of projects moving through the development pipeline. More importantly, CDMOs can position themselves through their advisory services and become strategic partners by adding value throughout the development cycle. Still, with every challenge, there's an opportunity: leveraging robust data and demonstrating these early-stage candidates' potential effectiveness and market viability, CDMOs can turn this challenge into a strength. Collecting comprehensive data isn't just about proving the science—it's about telling a compelling story that resonates with stakeholders, payers, and regulators alike.  https://lnkd.in/e7SpUrf5

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📢 Industry Watch: EU Antitrust Decision on the Novo-Catalent Deal The upcoming decision by EU antitrust regulators on the Novo-Catalent deal is stirring a mix of opinions among industry stakeholders. In a recent article, I had the opportunity to share my perspective on this pivotal development. At Pyramid Labs, our decades of expertise in clinical and commercial DP manufacturing drive us to innovate continuously. Our new high-speed line for pre-filled syringes and cartridges reflects this commitment and creates new opportunities to serve our clients' evolving needs. I invite you to read the article below and share your thoughts in the comment section. How do you see this decision shaping the future of our industry? #CDMO #DrugProduct #FillFinish #Catalent #Novo

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Bringing an FDA-approved drug to market can cost over $5 billion, factoring in the full R&D process and unsuccessful trials—highlighting the critical need for strong R&D investments and quality partnerships. Despite fluctuating markets, essential services and breakthrough assets will always attract capital. However, not all investments are equal. Choosing the right partner is vital for financial backing and shared alignment to navigate challenges and deliver life-saving treatments. The impact of a value-based PE partnership that provides management support, growth investment, and board advisory is invaluable. As patients increasingly demand innovative, effective therapies—raising R&D costs—our efforts must be resilient and ambitious. Each investment should advance science to meet patient needs and set therapies up for long-term success. I've had the privilege to work with leading PE firms dedicated to life sciences and human health, whose mission is to support those investing on behalf of the company. This partnership-driven approach has made a difference for me and for the companies that benefit from their expertise. https://lnkd.in/d3KcSBBv

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An excellent read to go through (in the India context)! The past few years, there has been a sharp rise in interest (coming from the demand also) to building a leadership path in biotherapeutics - related to biosimilars as well as bio-manufacturing (bio-CDMO) activities. This article very nicely articulates the challenges that are associated with the "structural determination of antibodies". Not an impossible task though but would require "developing a high level of competency" in the thorough structural characterization of biomolecules as best as possible. The coming years (from the India point of view) are going to be highly critical in evaluating our success in taking this bar to a different level. Serious investments, and most importantly, the commitments to build a strong R&D ecosystem within our biotech sector (for tackling these challenges) would go a long way to enjoy the benefits, in the days ahead - this remains to be tested though!

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