Trudi Haemmerli

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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BioNTech’s VEGF Bispecific Strategy: Early Data and Future Prospects BioNTech has recently shared promising early survival data for its PD-L1xVEGF bispecific antibody, BNT327, in triple-negative breast cancer (TNBC)—an aggressive cancer subtype with limited treatment options. These results come on the heels of BioNTech’s $800M acquisition of Biotheus, which includes BNT327, demonstrating its commitment to advancing bispecific antibodies as a novel therapeutic approach. Key Results: In a China-based Phase 1b/2 trial, BNT327 combined with chemotherapy yielded a 12-month overall survival (OS) rate of over 80%, though the OS rate dropped to 69.7% at 18 months. Median progression-free survival (PFS) reached 13.5 months, slightly improving on earlier data. Objective response rate (ORR) was reported at 73.8%, a primary trial endpoint. Why It Matters: VEGF bispecific antibodies represent an emerging class of oncology treatments, combining immune modulation and anti-angiogenesis to target tumors more effectively. They’ve recently gained attention due to successes like Summit Therapeutics and Akeso’s VEGF bispecific outperforming Merck’s Keytruda in lung cancer. However, questions remain about their broader applicability and durability, particularly in overall survival. Future Directions: BioNTech is extending its research globally, with ongoing Phase 2 trials in TNBC across the US, UK, and Australia. Additionally, BNT327 is being tested in non-small cell lung cancer, showing a 57.8% ORR in EGFR-mutant patients. These trials will help determine if the positive signals from China translate to diverse patient populations. Strategic Context: The $800M acquisition of Biotheus underscores BioNTech’s intention to diversify beyond mRNA platforms, including its pivotal COVID-19 vaccine, to establish a stronghold in oncology. This move aligns with broader industry trends, as demonstrated by Merck’s $588M deal for a similar PD-1xVEGF bispecific candidate. The development of VEGF bispecifics highlights the increasing complexity of cancer treatment, offering hope for patients with challenging diagnoses like TNBC. If these early signals hold in larger trials, BioNTech could pioneer a new generation of targeted cancer therapies, contributing to the broader transformation of oncology care. More on the link below: https://lnkd.in/eSknqA_8

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Great presentation 

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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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𝗛𝗼𝘄 𝘄𝗲 𝘁𝗵𝗶𝗻𝗸 𝗮𝗯𝗼𝘂𝘁 𝗹𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗮𝘁 𝗯𝗶𝗼𝗰𝗿𝗮𝘁𝗲𝘀 As some of you know, we’ve seen some wonderful changes in the biocrates leadership team over the last few months: -       Alice Limonciel is now our Chief Scientific Officer -       Sebastian Gottfried is now our Chief Marketing Officer -       Stefan Ledinger is now our Head of Global Sales   Fadi Abdi and I are delighted to welcome them in key leadership roles at biocrates life sciences ag.   Of course, all 3 are already familiar faces at biocrates. It strikes me as a good time to reflect on how we cultivate future leaders.   🌱Supporting team members to progress and assume leadership roles is a great privilege, and knowing that our intentional approach to team development gave us (and them) this opportunity brings me great joy.   At biocrates, we create a space where everyone feels they can make a difference. We encourage colleagues to take ownership of projects, share ideas, and aim for excellence.   ✨My personal goal is to let our emerging leaders shine and guide them to do the same for their teams. That means identifying and supporting the individuals who will push boundaries for many years to come – and help shape advances in metabolomics more broadly. This is our foundation to successfully develop new software and hardware products with a deep impact on metabolomics and population health. I’m incredibly proud of what we’ve accomplished together! I believe that through our leadership choices, we are in a strong position to build on our collaborations with the metabolomics and precision medicine communities. 👉What drives me personally? To magnify our impact on sustainable health.   What are the principles in your organization to #GrowTogether and encourage #FutureLeaders to foster #innovation? Share your views and insights in the comments! #Teambiocrates #Community #Metabolomics #4Pmedicine #Precisionmedicine #Leadership

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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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It's amazing to see so many biotech and antibody-based startups on the list of Top 100 Swiss Startups this year. However, it's not much of a surprise. With one of the most supportive environments in the world for the life sciences sector, Switzerland provides the perfect conditions for biotech startups to take root and grow. I can't wait to see which organisations make the list next year. #Biotech #SwissInnovation #Startups #Top100SwissStartups

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If you have a moment, read my thoughts on the future of immune tolerance at Topas Therapeutics GmbH

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Another great editorial from Louis Garguilo on the BioSecure Act... I'd only add that I wonder if the argument concerning the knock-on impact on the broader WuXi ecosystem may be an under-estimation of such "collateral damage". As we saw last week at CPhI, even US- and European-headquartered companies with operations in China, (i.e. with no connection to Wuxi Apptec whatsoever), are seemingly being forced to downplay their China links... and it may extend further still. Whether the stated intent or not, in a risk-adverse industry does BioSecure risk undermining the wider use of CRO/CDMOs in China? I sincerely hope not...this would cause a significant reduction in high-quality science/resources available to the industry, and of course have a concomitant impact on drug development timelines and costs.....and all the while, the patient is left waiting.

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𝐓𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦𝐢𝐧𝐠 𝐀𝐜𝐜𝐞𝐬𝐬 𝐭𝐨 𝐃𝐫𝐮𝐠 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 – 𝐅𝐚𝐬𝐭𝐞𝐫, 𝐒𝐚𝐟𝐞𝐫, 𝐚𝐧𝐝 𝐀𝐟𝐟𝐨𝐫𝐝𝐚𝐛𝐥𝐞! 🚀 Imagine Biotech we are shaping the narrative that there are alternative solutions to legacy scientifc due diligence procedures, by using advanced AI/ML and 3D modeling technologies that offer greater accuracy, reliability, and cost-effectiveness we compared to traditional animal trials.

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Asking for a friend 😎 "Dear ChatGPT, what is Philipp famous for?" Philipp Baaske, co-founder and Co-CEO of NanoTemper Technologies, is renowned for his entrepreneurial spirit and significant contributions to the biotechnology and life sciences industries. He is particularly famous for: 1. Innovative Technology Development: Philipp Baaske has played a crucial role in the development and commercialization of cutting-edge biophysical instruments that have transformed approaches in drug discovery and molecular research. NanoTemper Technologies is known for its precision instruments like the Monolith and Prometheus, which are used globally in academic and pharmaceutical research to study molecular interactions. 2. Leadership in Biotechnology: Under his leadership, NanoTemper Technologies has grown from a university spin-off into a profitable and internationally recognized company. His vision has helped bridge the gap between academic research findings and practical, market-ready biotechnological applications. 3. Contributions to Scientific Community: Philipp is also recognized for his active role in fostering collaborations and knowledge exchange within the scientific community. He frequently engages in discussions and events that promote innovation and application in biotechnology and pharmaceutical sciences. 4. Entrepreneurial Success: His journey from starting NanoTemper in a university setting to leading a successful global company serves as an inspiration to many budding entrepreneurs in the biotech field, showcasing the potential of turning scientific expertise into successful business ventures. Philipp Baaske's impact extends beyond the technical innovations of his company to include his influence on industry standards and practices, making him a notable figure in the international biotech community. Funny and interesting to read what ChatGPT thinks about me. What would you ask for a friend? Life is better with humor 😂 #biotechnology #entrepreneurship #startup ————————— I am Philipp - founder, CEO & business angel. My bootstrapped company NanoTemper is a global leader for biophysical tools for biotech. Like my content? Click my name + follow + 🔔

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In case you have missed it: follow bespark*bio on LinkedIn and learn more about 7 hidden traps of #biotherapeutics development and how we can help to navigate. 7 traps.... 7 days - we reveal one trap each day! #Biotech #Pharma #LifeSciences #ProcessDevelopment #Innovation #Biomanufacturing #ViralVectors #GeneTherapy #GeneAndCellTherapy

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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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TREE MAPS Driven by sentiment and the magnitude of an event, our tree map provides a high-level overview of your markets. With one quick look, you can see that Pharma Switzerland is buoyed by a positive sentiment and scales well versus its peers. When you dive in you can see the events that comprise this score. We have considerably more planned for this feature, but we love shipping a fast and reliable V1.

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Currently, 20% of all European biotechs have their headquarters in Switzerland. This is not for no good reason. Organisations like the Paul Scherrer Institute help support the development of life science and biotech startups by connecting them with the larger startup ecosystem. This, combined with the country's favourable economic and regulatory environment, makes for highly successful industry. #SwissInnovation #Biotech #Startups #Entrepreneurship

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Another important step.

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The April Sector Snapshot from Alliance for Regenerative Medicine highlights important trends driving #celltherapy development. ARM is dedicated to bringing this valuable data forward to help gain clearer insights into the current state of the advanced therapy industry. Learn about recent approvals for #geneediting therapies like Casgevy and Libmeldy, as well as breakthroughs in cell therapy such as Lifileucel and Fidanacogene Elaparvovec. The report underscores a promising year ahead for cell therapy, with a focus on treating #solidtumors and #autoimmunediseases. Download the full PDF report now to see the outlook of the 2024 regulatory pipeline and trends driving cell therapy development. 

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I’m grateful to FABA-USA for giving us an opportunity to present an exclusive webinar where I’ll be sharing the innovative work we’ve been doing at Sapien Biosciences Biobank over the past 12 years. Through our partnership with Apollo Hospitals, we've built a high quality, ethically curated biobank of Indian patient samples and rich metadata, laying the groundwork for cutting-edge medical breakthroughs. In this session, I’ll highlight how we've leveraged this unique resource to validate and develop new diagnostics and drug candidates aimed at personalizing medicine. 🧬What you’ll gain from attending: 1) Real-world applications: See how we’re using our biobank to address complex challenges in disease diagnostics and drug development. 2) Opportunities for collaboration: Whether you're in #research, #diagnostics, biotech or pharma, there are many possibilities to explore for impactful collaborations. 3) Focus on cancer: Tomorrow's session will feature a deeper dive into cancer research, but our biobank spans all chronic diseases – from liver and kidney diseases to cardiovascular, diabetes, lung diseases, and more. With the rise in chronic diseases due to increasing longevity, the need for better diagnostic tools and treatments has never been more urgent. Our biobank is uniquely positioned to help address these challenges, and drive actionable insights for the future of medicine and well-being. 🔗 Join in, ask questions, suggest how we can maximize the potential of this invaluable resource. I look forward to engaging with you all tomorrow! #Webinar #Biobank #PersonalizedMedicine #DrugDevelopment #ChronicDiseases #Innovation #Collaboration #MedicalResearch #CancerResearch #Bioinformatics #HealthcareSolutions #Longevity #CKD, #CLD, #IBD, #ILD, #psoriasis #Health

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How does the BioInnovation Institute measure impact? When I started 5 years ago we quickly decided that measuring how much financing our companies raised was the right KPI - it was hard, measurable, and integrated all the effects we wanted to make on the start-ups. (Plus we had a board meeting the next day and we could pull it together pretty quick). We’ve had 5 years to reflect on that choice , and it seems insufficient now. Our startups are advancing to clinical trials (Breye Therapeutics ApS Kariya Pharmaceuticals ) and selling sustainable products (Matr Foods EvodiaBio Sundew ). Most recently BOOST Pharma announced positive clinical data in Brittle Bone Disease showing reduced bone fractures in children. Financing raised showed what our programs could do for start-ups, but its the products they create that are going to improve Human and Planetary Health - and that is the impact we wish to measure and report. The Danish newspaper Børsen featured our CEO Jens Nielsen today and our thoughts on how BII thinks about impact 5 years into this unprecedented experiment. Maybe one day we can tell you about approved medicines, lives saved , and CO2 and water spared ? Stay tuned…. Link below

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