Michael Stadler

+++ 𝗤𝟭 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝟮𝟬𝟮𝟰 𝗮𝗻𝗱 𝗰𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝘂𝗽𝗱𝗮𝘁𝗲 +++ We started the year with good progress across our oncology pipeline and our commercialization activities. Some key events: 🔬 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆: We and our collaboration partner Duality Biologics dosed the first patient in a Phase 3 clinical trial with our #ADC candidate BNT323/DB-1303 in breast cancer patients, advancing towards BioNTech’s goal of ten or more potentially registrational trials running by the end of 2024. 🩹 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵: We are focusing on preparing for variant-strain adaptation of our COVID-19 vaccine to be ready for a commercial launch ahead of the upcoming 2024/2025 vaccination season, pending approvals. 🌎 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀: We appointed our General Manager Fatma Ocak for the U.S. in line with our commercial preparations to drive our first expected global #oncology product launch. 𝗟𝗶𝗻𝗸 𝘁𝗼 𝗣𝗥 𝗮𝗻𝗱 𝗳𝗼𝗿𝘄𝗮𝗿𝗱-𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝘀𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀: https://lnkd.in/ePDQiHbH  

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10 Largest #MedTech companies - 2024 Forecast Annual volume of primary TJAs will grow 70% to 2,257,326 Higher growth in demand for THAs compared to TKAs (1,219,852 THAs vs. 1,037,474 TKAs by 2050). Active orthopedic surgeons is projected to decrease 14% by 2050 In 2017, the average primary TJA caseload per active orthopedic surgeon was 65.2 procedures while the projected TJA-ASRs for 2050 is 139.4. The number of TJAs performed per surgeon will double by 2050 to meet the projected demand. Increasing the number of orthopedic surgeons by 10% every five years could ensure the caseload per surgeon remains similar to the 2010 to 2017 numbers Further areas of growth moving forward will be artificial intelligence (AI) and data interoperability, which form the basis for effective digital health strategies, supporting the shift toward value-based care – the best, cost-effective health outcomes for patients. These indicators for increased orthopedic surgeries, growing ASCs, and embracing digital health will have machine tool builders seeing more demand for high-efficiency equipment as job shops and contract manufacturers produce more implants, bone screws, plates, and the surgical tools required to complete each procedure. Automation will continue its growth in manufacturing as lack of skilled workers remains a challenge but the reshoring of medtech manufacturing will demand more efficient operations.

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The pay gap: Best paid in pharma still not anywhere close to other industries And 2023 stock returns are all over the place: from -40% to more than 60%. Incidentally, there was no clear connection between pharma CEO salaries and stock performance in 2023. In fact, the correlation coefficient between CEO compensation and stock returns was negative (-0.1345) in a dataset of 14 prominent pharmaceutical CEOs. Selected six CEO outliers in the data at Moderna, Amgen, Johnson & Johnson, Vertex Pharmaceuticals, Eli Lilly and Company and Novo Nordisk for an interactive visual in this article: https://lnkd.in/ga_XVYaM

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𝐑𝐨𝐜𝐡𝐞 𝐭𝐨 𝐟𝐚𝐬𝐭-𝐭𝐫𝐚𝐜𝐤 𝐰𝐞𝐢𝐠𝐡𝐭-𝐥𝐨𝐬𝐬 𝐩𝐢𝐥𝐥 𝐭𝐨 𝐜𝐨𝐦𝐩𝐞𝐭𝐞 𝐰𝐢𝐭𝐡 𝐫𝐢𝐯𝐚𝐥𝐬 Roche has announced plans to accelerate the production of a new weight-loss pill to vie with competitors like Eli Lilly and Novo Nordisk in the expanding obesity treatment market. Thomas Schinecker, CEO of Roche, conveyed to the Financial Times that the company anticipates its inaugural obesity drugs to hit the market much sooner than expected, potentially as early as 2028. The forthcoming offerings include a weight-loss injection slated for phase II trials and a pill that demonstrated a 6.1% weight reduction relative to a placebo over a four-week period. Following the acquisition of biotech firm Carmot last year for up to $3.1 billion, Roche is set to introduce several drugs under this deal, with details revealed for three key assets. Schinecker mentioned that the acquisition could yield approximately seven drugs, some still in early developmental stages. Last week's data publication regarding the pill caused Roche's stock to surge by 6% on that day, while impacting the shares of rival companies Novo Nordisk and Eli Lilly, raising concerns about Roche’s potential to challenge their market dominance. Analysts at Goldman Sachs have projected that the obesity drug market could exceed $130 billion by 2030, as various companies aim to launch their treatments. Despite this, Roche must bridge the gap with frontrunners who are developing more potent and effective treatments. For instance, Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro have led to 15% and 20% weight losses, respectively, in trials extending beyond a year. Other pharmaceutical firms, including Boehringer Ingelheim and Pfizer, are also in the race to develop obesity drugs, while US biotech Viking Therapeutics saw a 30% jump in shares after announcing progress to late-stage trials for its obesity pill. Schinecker highlighted that Roche’s pill is easier to scale up as it is synthetically produced, unlike the peptide-based drugs like those from Novo Nordisk. However, Emily Field from Barclays noted that it’s premature to determine if Roche can disrupt the advantage held by Novo and Lilly. Roche has recently streamlined its drug development pipeline, cutting 25% of underperforming drugs and focusing on a smaller selection of promising candidates, including those for obesity and Alzheimer’s diseases. This strategic shift allows for better allocation of resources towards more promising projects. Despite recent setbacks in research, including a failed lung cancer drug trial, Roche remains optimistic about its obesity drugs, potentially integrating them with other treatments for related conditions. Additionally, strong sales from other drugs like Vabysmo and Ocrevus have led Roche to upgrade its 2024 earnings forecast to the high single-digit range, up from the previously anticipated mid-single digit increase. FT, 30.7.24 #biopharma #insights

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𝐑𝐨𝐜𝐡𝐞'𝐬 𝐂𝐓-𝟑𝟖𝟖 𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐬 𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐢𝐧 𝐎𝐛𝐞𝐬𝐢𝐭𝐲 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Roche has announced promising results from a Phase Ib trial of its dual GLP-1/GIP receptor agonist, CT-388, designed for treating obesity and type 2 diabetes. Over 24 weeks, participants receiving weekly CT-388 injections achieved a significant placebo-adjusted weight loss of 18.8%. Additionally, 100% of participants experienced over 5% weight loss, with 70% losing over 15% and 45% over 20%. The treatment also normalized glycemia in all pre-diabetic participants. CT-388 showed a favorable safety profile, with side effects consistent with its drug class. These findings highlight its potential as a leading therapy in obesity and glucose control. Further trials, including one focusing on obese patients with type 2 diabetes, are ongoing. Dr. Levi Garraway, Roche’s Chief Medical Officer, emphasized the significant and meaningful weight loss achieved, underlining CT-388's potential as a best-in-class therapy for obesity and diabetes. Given the global obesity crisis, affecting over four billion people and burdening healthcare systems, CT-388 could be a crucial development in addressing this urgent health challenge. CT-388 targets the GLP-1 and GIP receptors, which help regulate blood sugar and appetite. Its unique dual-targeting approach minimizes receptor desensitization, potentially leading to prolonged effectiveness. Roche plans to release further data from ongoing trials in the second half of 2024. With the obesity market projected to grow to $100 billion by 2030, CT-388 positions Roche as a strong competitor against Novo Nordisk and Eli Lilly. Further trials are ongoing, with additional data expected later this year. Source: Roche, Financial Times 16.5.24 #biopharma #insights #glp1 Roche's CT-388 Achieves Breakthrough in Obesity Treatment

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Have confidential rebates for pharmaceuticals in Germany just been killed off? The Bundesrat (Federal Council) has rejected the government’s proposal (tinyurl.com/a48x7run) in the first reading of the Medical Research Act.   The Bundesrat followed the recommendations of its Health Committee. An explanatory statement noted: “The introduction of a secrecy option for the negotiated reimbursement amount leads to a great lack of transparency for the health economic considerations that are necessary today. At the same time, the high bureaucratic and financial cost of equalising the difference is offset by only questionable benefits.”   The procedures for equalising the difference between the reimbursement amount and the actual dispensing price were criticised as unclear. Surcharges paid for the production of drugs in pharmacies or repackaging medicines would also need to be corrected. The overpayment of VAT would also present problems.   The Federal Council remarked that “there is no stipulation that there would be an obligation to provide information on confidential reimbursement amounts to the state monitoring authorities, if required as part of monitoring activities.”   With regard to the growing problem of parallel exports from Germany to other EU Member States, the Bundesrat sees a need for a new solution: “Orientation towards prices in other European countries is still desirable, especially to reduce shortages in individual countries that arise owing to cost-related cross-border flows of goods.”   The health insurance funds were quick to welcome the Bundesrat’s position on #confidential #rebates: Stefanie Stoff-Ahnis, Chair of the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds), said: “Secret prices undermine the principle of economic efficiency. If doctors are deprived of price transparency, they will no longer be able to prescribe economically. If secret prices prevail, they will significantly increase the already rising spending on medicines by many billions of euros. Secret prices mean considerable additional costs for people who pay insurance premiums without improving care. The pharmaceutical industry must not be given this gift to increase their profits.”   Jens Martin Hoyer, Deputy Chairman of the AOK Federal Association, which represents the country’s largest group of health insurance funds, suggested that “hardly anyone seems to think secret prices are a good idea: neither the medical profession, nor private health insurers—and even parts of the pharmaceutical industry—are explicitly against it. This begs the question: who will actually benefit from this in the end?”   Johannes Bauernfeind, Chairman of AOK Baden-Württemberg, remarked: “I consider the drug manufacturers' promise to grant higher rebates to the SHI system to be naïve.”   The pharmaceutical industry has yet to comment on the Bundesrat’s rejection of confidential rebates. It remains to be seen how the government will respond. #Germany

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Rare diseases do not mean ‘rare’ symptoms to manage. For people living with generalized pustular psoriasis (#GPP) and their loved ones, the burden of the disease on their lives is tremendous, spreading across their entire lifetime. The CHMP positive opinion is another milestone for people living with GPP, offering continuous treatment to potentially help them prevent, as well as resolve debilitating flares.   GPP is a chronic and heterogenous disease, often leading to isolation and anxiety about future flares. The possibility of managing the condition, including stopping flares before they happen and reducing painful skin symptoms, means people living with the disease will have predictability and control in their lives.   I’d like to congratulate everyone involved – the Boehringer Ingelheim teams, scientists, healthcare professionals, and of course the GPP community, who inspire us every day in our pursuit of a flare-free future. This reiterates our commitment to address high unmet needs in rare diseases across therapy areas. #Dermatology https://lnkd.in/dfs5_HKf

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In the Newsweek article, "The Many Faces of Oncology”, our Co-Founder & CEO, Fabian Gerlinghaus, highlights a significant issue: 'About 20 percent of patients are dying on the waitlist even though they are eligible for approved cell therapies because the industry is unable to meet patient demand.' This is a medical emergency. Learn more about how Cellares' Cell Shuttle platform integrates and automates the entire cell therapy manufacturing process, reducing labor and space requirements by 90% and processing 16 cell therapies simultaneously. This industry 4.0 approach aims to meet global patient demand for these life-saving cell therapies. Read now: https://lnkd.in/gsYX84RB For more Cellares coverage, check out the 🔗 link in the comments!

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During the #Finance Days at analytica, life sciences companies revealed their secrets of success. Here are some insights shared by our CEO Ulrich Scherbel in a panel discussion together with Dr. Andreas Eckert - Chairman of the Supervisory Board at Pentixapharm, and Dr. Claus Kremoser - CEO WMT. - "Success depends on a strong and motivated team, outstanding technology and the right investors. The team in particular depends on a good mix of experienced and young, hungry colleagues; diversity is also a decisive factor here." - "To be successful, you must never stop striving for something new and must not allow yourself to be dissuaded from your chosen path." - "In the life sciences / biotech sector in particular, it is important to have staying power as, unlike in other industries, success only comes later." What's your secret of success? #success #biotech #investors

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This is a very interesting article on Saudi Arabia's significant strides toward becoming a regional hub for clinical trials, thanks to its robust infrastructure, favorable regulations, and strategic initiatives to attract global pharma. DISTILL has its HQ in Dubai and is very present in the MENA region. Our platform is well designed to streamline clinical trials, making data management efficient and secure, which is crucial for meeting the evolving regulatory standards and fostering innovation in clinical research. Ping me to know more about DISTILL EDC.   For further insights, read the full article here: https://lnkd.in/g5JGfsAP

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Optimal cross functional collaboration starts with value: Sometimes, working as an MSL in an infield team can be a challenge. ** There can be tension between you and your sales colleagues: who gets to do which activities, who gets to interact with which HCPs and who gets to discuss particular topics. It can almost feel like a competition and can lead to mistrust and negativity. If this is the case, this can greatly interfere with your job satisfaction and happiness. That makes it worth addressing. I strongly believe the root cause of many problems in the infield team, is the lack of clarity on the unique added value of each role. Indeed, if it is clear how EACH of you can contribute best, there is no need for competition. And this is where it gets interesting: There is a lot written and said about the role of the MSL (it’s one of my favourite topics and I am surely not the only one….) and the value it brings. And we talk a lot about how we can demonstrate and measure this impact. But think about it: has the same attention and clarity been given to how your sales colleagues contribute to the success? Over the last decade or so, the responsibilities and possibilities of the sales teams have been decreasing. Activities they used to do, stakeholders they used to interact with, are now off-limits. But in many cases, nothing new has come to take its place. So it is important they sit down and redefine what their added value is and which activities and stakeholders are uniquely theirs. Because their contributions are still very important, even though they are not the same as they used to be. Only when your sales colleagues are able to redefine their impact, their role and activities, can you work alongside each other and have a cumulative impact. So. Sit down with your infield colleagues. Have an open discussion; what will each of you do to achieve your goals? And how will you support each other in this? And then, base your further plans on this. Any other factors in cross functional collaboration? Please share in the comments! #medicalaffairs #msl #pharma **disclaimer: fortunately, there are many teams where collaboration is very smooth and happy, and there is a culture of trust and support. Great! This discussion, however, will still be useful for you. Give it a try!

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TLDR Biotech for June 27 - 30 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥𝐬: AstraZeneca, Sanofi's infant RSV vaccine gets thumbs-up from German vaccine advisory panel 💉 + 3 more stories 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Lantheus purchases two radiopharmaceutical assets from Life Molecular Imaging 💼 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬: J&J touts stellar Ph3 myasthenia gravis results 🧪 + 1 more story 𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐋𝐚𝐮𝐧𝐜𝐡𝐞𝐬: Ensho Therapeutics launches with assets acquired from Eisai 🚀 𝐅𝐮𝐧𝐝𝐫𝐚𝐢𝐬𝐞𝐬: Savara $100M underwritten offering 💰 + 2 more stories 𝐋𝐚𝐰𝐬𝐮𝐢𝐭𝐬: Daiichi-Sankyo wins patent dispute against Seagen (Pfizer) ⚖️ 𝐌𝐚𝐫𝐤𝐞𝐭 𝐑𝐞𝐩𝐨𝐫𝐭𝐬: Analysts predict change in Osteoporosis market winds; Amgen punching air 📊 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐀𝐜𝐜𝐞𝐬𝐬: CMS provides details on cell & gene therapy access pilot 🏥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲: Supreme Court overturns Chevron doctrine, potential FDA ramifications 🏛️ All this and more in today's TLDR Biotech newsletter - link to the latest issue: https://lnkd.in/gign9-Sw Or subscribe to get it straight to your inbox: https://lnkd.in/gh68uhTQ #tldrbiotech #biotechnews #pharmanews

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Would be interesting to image how this HTA would have been evolved under #EUHTA #GetReadyForEUHTA

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Specialty drugs have become a dominant force in the market, accounting for more than half of drug expenditures in 2022. Notably, immunology (451%), oncology (349%), and HIV (206%) have seen substantial growth since 2012. In 2022, the financial growth associated with specialty drug products surpassed the growth of traditional drugs, representing a 51% share of total non-discounted drug spend. That’s no surprise, given the significant increase in product approvals over the last few decades. Please see attached the Sun-life Stop-loss Report an around the 2023 High-cost claims and injectable drug trends analysis report. Polaris Specialty Pharmacy Signio Rare & Complex Polaris Pharmacy Services National Association of Specialty Pharmacy (NASP) Pharmacy Podcast Network Pharmaceutical Commerce Magazine Pharmacy Benefit Management Institute Jeffrey Hogan Mike Agostino Brian Klepper Sol Carro Díaz David Rombro Simcha Hyman Nathan Zuber Doug Albers Brian Mason

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𝐑𝐨𝐜𝐡𝐞 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝐈 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐂𝐓-𝟑𝟖𝟖 𝐢𝐧 𝐎𝐛𝐞𝐬𝐢𝐭𝐲 𝐚𝐧𝐝 𝐓𝐲𝐩𝐞 𝟐 𝐃𝐢𝐚𝐛𝐞𝐭𝐞𝐬 Roche (SIX: RO, ROG; OTCQX: RHHBY) Roche announced positive results from the Phase I trial of CT-388, a dual GLP-1/GIP receptor agonist for obesity and type 2 diabetes. A once-weekly injection of CT-388 over 24 weeks resulted in significant weight loss in obese adults compared to placebo. The mean placebo-adjusted weight loss was 18.8% (p < 0.001). At week 24, 100% of CT-388 treated participants lost >5% of their weight, 85% lost >10%, 70% lost >15%, and 45% lost >20%. The treatment was well tolerated, with mild to moderate gastrointestinal-related adverse events. “We are very pleased with the significant and clinically meaningful weight loss seen with CT-388,” said Levi Garraway, M.D., Ph.D. Levi Garraway, Roche’s Chief Medical Officer. “These results are highly encouraging for further development of CT-388 for obesity and type 2 diabetes, highlighting its potential as a best-in-class therapy.” Obesity, affecting over four billion people globally, poses significant health challenges, including type 2 diabetes, cardiovascular diseases, and chronic kidney disease. CT-388, an incretin-based medicine, aims to regulate blood sugar and reduce appetite by activating GLP-1 and GIP receptors. An additional cohort from the Phase I trial will evaluate CT-388 in obese patients with type 2 diabetes over 12 weeks, with results expected in the second half of 2024. #ClinicalTrials #Obesity #Type2Diabetes #Biotechnology #Pharmaceuticals #MedicalResearch #GLP1 #GIPReceptor #IncretinTherapy #HealthcareInnovation #WeightLoss #DiabetesManagement

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𝗔𝗿𝗲 𝗬𝗼𝘂 𝗥𝗲𝗮𝗱𝘆 𝘁𝗼 𝗘𝗺𝗯𝗿𝗮𝗰𝗲 𝗔𝗜?   According to the latest data from the Edelmann Trust Barometer, while 45% in developed nations are yet resisting AI, others are racing ahead. What side of history will you be on?   👉 𝗔𝗜 𝗶𝘀 𝗻𝗼𝘁 𝗷𝘂𝘀𝘁 𝗮 𝘁𝗿𝗲𝗻𝗱; it’s a transformative force that's reshaping our world. The pharmaceutical sector, in particular, stands to gain immensely from AI, driving faster drug discovery and personalized medicine. 👉𝗘𝗺𝗯𝗿𝗮𝗰𝗲 𝘁𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲: In developing regions, AI adoption is soaring, with 51% in China and 47% in India leading the change. 👉𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗪𝗲𝘀𝘁: Despite advancements, countries like France and Canada yet show resistance, with over 50% hesitant to adopt AI technologies. This resistance highlights a critical gap in AI literacy that needs urgent attention. 👉𝗜𝗻𝘃𝗲𝘀𝘁 𝗶𝗻 𝗔𝗜 𝗟𝗶𝘁𝗲𝗿𝗮𝗰𝘆: As AI becomes integral to innovation, it is essential to invest in understanding and skills. By boosting AI literacy, we can reduce resistance and equip ourselves to harness AI’s full potential. 👉𝗬𝗼𝘂𝗿 𝗢𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆: Don’t miss out on the AI transformation. It’s time to align your strategies with the future of innovation by embracing AI and investing in education to stay competitive.   🔔 𝗦𝘁𝗮𝘆 𝗔𝗵𝗲𝗮𝗱: Subscribe to Pharma AI Weekly for the latest insights and trends in AI and pharmaceuticals. 💡   ♻️ 𝗥𝗘𝗣𝗢𝗦𝗧 𝗶𝗳 𝘆𝗼𝘂 𝗳𝗶𝗻𝗱 𝘁𝗵𝗶𝘀 𝗵𝗲𝗹𝗽𝗳𝘂𝗹. #AIinPharma #AIinHealthcare #PharmaInnovation #HealthcareInnovation

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Join #IPCCouncilor Menno de Rie in exploring the factors of adult life that impact #psoriasis treatments, providing insights on effectively managing patients: https://lnkd.in/gkNsDPCv #IPCCommunity #PsoriasisNews #PsoriasisResource

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