Dr. Ilkin Nehls

Dear Friends, next week I will give a presentation at "world Class Corporate Analytics & Artificial Intelligence 2024" organized by World Class Business Leaders. This year, it is my second time joining an industry agnostic conference - and this has been a real eye opener 👀 : The Pharmaceutical industry 💊 is more regulated than most industries; as a consequence it is more conservative and often late at adopting new technologies, hence i find it fascinating to hear stories and perspective from over industries and to learn from them. If you want to hear my perspective on: 💊 #AI's in #DrugDevelopment: A Look at Live Programs and First Movers 💊 Data-Driven Discovery: How AI is Upending Traditional Drug Development 💊 AI's Impact on Speed, Cost, and Ethics in Drug Discovery 💊 AI in Drug Discovery: Hype vs. Reality 💊 Aligning Expectations and Avoiding Pitfalls 💊 The Future of AI-Powered Drug Discovery: #Culture Shift, Data Mastery, and the Rise of #GenerativeAI Join me in Bad Homburg new week #Logica

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Dear Fellow Pharmaceutical Professionals - I am sharing this survey being conducted by a very talented and accomplished scientist, someone I am proud to call a friend and colleague, knowing this topic is very front and center in our industry. If you have 3 minutes, please consider participating in this research which is focused on understanding the impact of AI on competitive dynamics and innovation in drug development. The survey attempts to elucidate the current state of AI adoption in drug development, understand trends and the challenges of this important and rapidly developing technology in our industry. Thanks in advance!

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The #Bundestag has passed the new Medical Research Act (#MFG) in Germany, with a few amendments from the original draft: 📉 Until June 30, 2028, pharmaceutical companies can agree on confidential reimbursement amounts for new drugs, resulting in a 9% price reduction if the company has a drug research department, relevant projects, and cooperation with public institutions in Germany - this regulation will be reviewed in 2026 ⏰ After concluding price negotiations, manufacturers will have five days to choose between secret or transparent reimbursement amounts 👩‍💻 Additionally, information on the cost-effectiveness of these drugs will be required in electronic prescription systems used by contract doctors 🇩🇪 If at least 5% of approval study subjects participated in clinical trials in Germany, manufacturers could be exempt from the rebate guardrails that were introduced with the Statutory Health Insurance Finance Stabilization Act (#GKVFinStG) in 2022 and allow price premiums only for drugs with the highest levels of additional benefit (major or considerable) 🇨🇳 The draft law now includes provisions to promote academic studies, align pharmaceutical regulations with medical device laws, and recognize third-country inspections, particularly in China Learn more about the changes and their potential impact on #NAVLIN Daily: https://bit.ly/4eUTQM9

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🌟 Your Path to FDA and European Medicines Agency Approval 🌟 With Biostatistik & Consulting GmbH, you're not just navigating the regulatory landscape – you're charting a course towards success. Join hands with us and unlock the potential of your pharmaceutical innovations today! --- If you found this post helpful, save it or share it with your network. Follow Markus Savli for more content like this.

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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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Pharma History Post #20: from the Pharmazie-Museum in Basel, Universität Basel: a package of Persian opium. Some interesting facts: 1. both on the package and the exhibit label, it is mentioned that the package is empty. 2. The box is labeled as poison. 3. The merchant is listed as Nissim Taranto from Constantinople, which dates it to sometime before 1930, when Constantinople became officially Istanbul. The question is: was this imported for legitimate medical use (to treat diarrhoea, pain or as a sleeping aid), as starting material to extract morphine, or for substance abuse? Pharmacy students will learn a lot about the chemistry and the long running search for derivatives that do not create dependancy, but keep the pain-killing effects (and we know how that went, with the opioid crisis in the US), but in my desktop research, I also found a link of this exhibit to philosophy, as it was used in an exhibition about Friedrich Nietzsche...how about that. What are your thoughts on this? Stay tuned for more.

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#News: Bayer and Evotec have updated the focus of their strategic collaboration to develop #precisiontreatments for #cardiovasculardiseases (CVDs). Financial terms were not disclosed.   The collaboration aims to identify and validate #noveltargets, with the goal of building a portfolio of precision #cardiologytherapeutics by leveraging #Evotec's disease modelling capabilities using human #inducedpluripotentstemcells (iPSCs). #iPSCs provide unique opportunities to identify new disease mechanisms and pathways for novel treatments. Under the terms of the agreement, both companies will contribute drug targets and a comprehensive set of high-quality technology platforms.   Bayer and Evotec will share responsibilities during the preclinical development of potential clinical candidates. Bayer will be responsible for any subsequent clinical development and commercialization.   “This development takes our long-standing collaboration with Evotec to a new level, and has the added benefit of lessons learned from working together the past 12 years,” said Juergen Eckhardt, M.D., Head of Business Development & Licensing at Bayer’s Pharmaceuticals Division. “We remain committed to develop innovative therapies for patients in need and to tackle the high burden of cardiovascular disease.”
 Read more from Contract Pharma 👇🏼

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Generative AI is not just a buzzword—it's revolutionizing drug discovery and dealmaking in the biopharma world. In a recent article by Nature Magazine's Biopharma Dealmakers, some jaw-dropping figures were revealed, indicating the scale of investment in AI in biopharma: - Xaira Therapeutics raised a phenomenal $1 billion in funding. - Generate:Biomedicines has secured $750 million since 2018. - Major deals, like Almirall's partnership with Absci, potentially worth $650 million and AstraZeneca's collaboration with Absci, up to $247 million, are reshaping the landscape. But here's the twist: Much of this capital isn't flowing from Big Pharma's deep pockets. Venture capitalists are placing big bets on AI, leaving us to ponder—are they visionaries or chasing fool's gold? Meanwhile, traditional pharma is cautiously dipping its toes through strategic partnerships. When considering AI's real-world impact, we must recognize AI-assisted breakthroughs like AbCellera's Bamlanivimab for COVID-19 and Insilico Medicine's Phase II candidate for idiopathic pulmonary fibrosis. These are more than hype; they're tangible results in the drug development pipeline, providing us with confidence in AI's potential. These successes are certainly encouraging, but it's crucial to maintain perspective. Even with AI assistance, the path from a promising candidate to an approved drug remains long and challenging. The true test will be observing more of these AI-discovered drugs successfully navigate late-stage trials and ultimately reach patients across a broad spectrum of diseases. Curious about how AI is transforming the industry and what it means for the future? I suggest reading the full article to review how companies developing artificial intelligence-based platforms that enable the design of small-molecule and biologic drug candidates have been a focus of biopharma dealmaking in the past year. #AI #Biopharma #Innovation

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It is essential to develop a well thought-out protocol in order to conduct a meaningful RWE study. Please read our introductory summary on RWE study protocol. #mdr #clinicalevidence #RWE

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