BioSpace’s Post

The Four Horsemen of the Pharmapocalypse: Manufacturers 🐎 🏭 We start our exploration of the #pharmaceutical industry with the drug manufacturers. 🌡️ These companies are responsible for the research & development of new drugs and manufacturing drugs that gain regulatory approval. My next couple of posts will dig into the earnings results of one of the largest drug companies in the world, Eli Lilly and Company, to see how these companies operate. 🔍 Eli Lilly earns tens of billions of dollars each year on the sale of its drugs for #diabetes, #cancer, #pain, and #neurodegeneration. Today, we’ll explore the company’s spending on research & development, as pharmaceutical companies live or die based on their ability to discover and gain approval for new drugs. 💊 Eli Lilly plans to spend $9 billion this year on the research and development of new drugs. That’s a lot of money!!! 💸 Eli Lilly’s shareholders would only permit this level of spending if they anticipated a strong return on that investment. 📈 The company’s recent track record of #innovation success gives #investors confidence that this level of spending is warranted. However, new drug development is a fickle business and today’s darling can easily become tomorrow’s dog. 🎢   Drug development is a very risky business and only 14% of drug research projects will ultimately gain regulatory approval. Allocating capital to projects that succeed and away from those that fail separates the successful pharmaceutical companies from those that win. ⚖️ As a #patient with a #chronicillness, I am grateful that there is a strong economic incentive for pharmaceutical companies to continue to innovate. The reality is that without these incentives, investors would demand these companies slash their research budgets and the discovery of new drugs would be negatively impacted. Who knows where my #multiplesclerosis journey would have taken me without the drugs that have enabled me to remain productive. 🙏🚶♂️💪

💊Pharmaceutical giants, including J&J and Merck, stand at a crossroads as they brace for substantial revenue declines with the expiration of blockbuster drug patents. This impending loss highlights the urgency for these industry leaders to reassess their business models, R&D pipelines, and market approaches. The challenge lies in replacing the revenue streams generated by these drugs while adapting to a rapidly evolving healthcare landscape. 👩🔬This transformative phase necessitates a renewed emphasis on innovation, with companies exploring novel therapies, digital health solutions, and strategic partnerships. As the industry navigates this transition, there's a growing recognition of the importance of diversification and resilience in the face of patent cliffs. 📊Moreover, the evolving dynamics underscore the need for regulatory agility and a proactive response to emerging health trends. Adapting to a more patient-centric approach, leveraging data-driven insights, and embracing disruptive technologies become imperative for sustained success. ⚗️The pharmaceutical sector's ability to navigate this crossroads will determine its future competitiveness and impact on global health. Observers and stakeholders keenly watch how these industry giants pivot and innovate to secure their positions in a rapidly transforming market. #PharmaIndustry #innovationinhealthcare #pharmaceuticals #drugdiscovery #researchanddevelopment #pharmaceuticals #cdmo #researchanddevelopment #pharmaceuticalmanufacturing #apidevelopment #pharmaindustry #drugdiscovery #smallmolecule #cmcs #chemistrythatmatters #PharmaCDMO #drugdevelopment #contractmanufacturing #CMOservices #pharmasupplychain

#News: #BigPharma took another hit in court Monday as a federal judge in New Jersey threw out challenges by Johnson & Johnson and Bristol Myers Squibb to the drug price negotiations outlined in the #InflationReductionAct. AstraZeneca and trade group Pharmaceutical Research and Manufacturers of America (#PhRMA), along with several provider-side allies, have already lost their legal challenges to the 2022 law, and the Centers for Medicare & Medicaid Services is pushing ahead with negotiations over the first 10 drugs in the program. Those negotiated rates will take effect in 2026, and #pharma companies are now reconsidering their #R&D strategies as the #venturecapital community ponders where to focus its investments. One big consideration is the IRA’s so-called “pill penalty,” which caps #patentprotection at 9 years for #smallmolecules, compared with 13 years for #biologics. #Drugdevelopment had already been trending toward biologics. This drug class received 30% more #VCfunding in 2022 than small molecule candidates, noted John Stanford, executive director of life sciences venture capital coalition Incubate Fund—but the gap jumped to 50% in 2023, and Stanford contends that the IRA is driving much of that shift. “If your promising product is a small molecule, the VC community is far less interested than we were before the IRA,” Stanford told BioSpace. “It makes no sense for people to invest when you can get 9 years’ return, just from the economic standpoint.” Read more from BioSpace 👇🏼 https://lnkd.in/eM-w28gv

Navigating the complexities of market entry into Australia and New Zealand's pharmaceutical, biotechnology, and MedTech sectors can be daunting. Success hinges on mastering complex regulatory and market access pathways. It requires a strategic partner who not only understands the intricacies of the healthcare systems but also possesses the capability to navigate rigorous regulatory frameworks and market access challenges. This is where the strategic collaboration between Commercial Eyes Pty Ltd Regulatory, Quality, and Compliance and Access, Research, and Intelligence teams becomes your advantage. Learn more in our latest blog: https://lnkd.in/gh5EA4bz #CommercialEyes #ResultsThatMatter #MarketAccess #MarketResearch #RegulatoryAffairs #MedTech #Pharmaceuticals #BioTech

The Inflation Reduction Act: How Drug Price Controls Could Disrupt Clinical Trials and Stifle Medical Innovation https://hubs.la/Q01-phrN0 Drug pricing controls imposed by the Inflation Reduction Act of 2022 may appear positive for patients in the short term. However, these controls may have unintended consequences on biopharmaceutical drug development programs and investments in the long term unless this pressure is offset by the opportunity to modernize the way clinical trials are conducted. Smaller and emerging biopharmaceutical companies are struggling to overcome these new challenges. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, sees an opportunity amidst these developments and has a plan to help biopharmaceutical and medical device sponsors overcome these cost pressures by minimizing the expense of executing early-phase clinical trials. We have a plan to help address the current crunch for the Biopharmaceutical industry. Let us know your thoughts below in comments. Jeeva Informatics Solutions Inc. #IRA2022 #Inflationreductionact #Drugpricing #clinicaltrials #emergingpharma #Biopharma Virginia Bio Institute for Biohealth Innovation BioHealth Innovation, Inc. BioBuzz VIPC | Virginia Innovation Partnership Corporation Biotechnology Innovation Organization

Click below to learn more about the exciting growth at Jubilant HollisterStier and how it further bolsters pharmaceutical manufacturing right here in North America. #contractmanufacturing #pharmaceuticalmanufacturing #JubilantHollisterStier #biomanufacturing #manufacturing #sterilefillfinish #biotech #biologics #fillfinish

“We got through technical diligence no problem, everyone was excited about the deal and then the market access people said ‘we don’t believe your price’ and poof the deal vanished” I hope you will join me at a webinar I am holding where I will talk about some of the pricing and market access themes and insights for companies developing pharmaceuticals in the early clinical stages and looking for big pharma partnerships. I will highlight the 6 key questions companies need to ask of their assets to try to ensure that they are developing their drug in the right way to ensure strong market access amd secure a partnering deal. This will be an opportunity for you to ask me questions about these issues and explore how you might try to find answers to these 6 key issues that market access colleagues at big pharma companies will ask of your asset in diligence and hopefully avoid nasty surprises. https://lnkd.in/e6CjPvPc #dealmaking #pharmaceuticals #pricingandaccess #marketanalysis #pricing #biotech #pharma #marketaccess PharmaVentures

Next-generation therapies (NGTs) are playing an increasingly important role in the pipelines and portfolios of leading pharmaceutical companies, driven by market trends like the looming patent cliff and scientific advancements such as the mRNA proof of concept. In particular, mRNA-enabled therapies gained worldwide attention when Pfizer, BioNTech SE and Moderna succeeded in using the technology for the fast development of highly effective COVID-19 vaccines. However, the relative novelty and complexity associated with the development, supply chain, and commercialization of NGTs are putting the industry’s established operating model to the test. Porsche Consulting has identified what should be done to adjust the operating model and become a true NGT champion: ▶️ CHOOSE THE RIGHT PARTNER Gain competitive advantages with smart partnerships. ▶️ BECOME A TECHNOLOGY LEADER Specialize in specific NGT fields and focus. ▶️ SECURE SUPPLY CHAIN Analyze availability of material and define sourcing and manufacturing strategies. ▶️ SET UP MANUFACTURING PARADIGM Focus on efficient automated manufacturing processes with a more decentralized footprint. ▶️ WORK WITH POLICY MAKERS  Develop study designs and administration strategies together with key stakeholders. ▶️ ASSUME A COMMERCIAL MINDSET Develop concepts for value-based pricing to increase return on investment. ▶️ PROVIDE END-TO-END SUPPORT Establish platforms to allow a smooth end-to-end patient journey. Find out more about the approach for mastering next-generation therapeutics in the Porsche Consulting Strategy Paper “Pharma’s transformation towards next-generation therapeutics”: https://lnkd.in/emBUAazG #Pharma #NGT #NextGenerationTherapeutics #CellAndGeneTherapy 

Quick and interesting read on the pharmaceutical outlook for 2024. What surprised me the most was the significant downturn in innovative medicines for 2024 vs. 2023. Perhaps this is driven by the restrictions set by the Inflation Reduction Act? It will be interesting to see how generative AI will be applied and leveraged to combat these barriers in 2024. #pharmaceutical #pharma #drugdiscovery