Alix Mackay’s Post

⏱ Despite a seemingly ideal climate for biopharma innovation, R&D productivity remains low 🔻 : In 2022, 4,300 clinical trials began, yet industry R&D spending from 2012 to 2022 rose 44% (to $247 billion), while US novel drug approvals averaged 43 per year. Developing a single novel asset now costs up to $2.8 billion. 🔑 Key issues include: 👉 Low success rates (only 13% of Phase 1 assets launch) 👉High development costs (60-70% of total costs) 👉Long cycles (12 years on average) 👉Extended timelines (up to 80% of trials fail to finish on time) 🏎 Speed is critical. Being first to market can mean outsized success, especially with the US Inflation Reduction Act impacting drug prices. For patients, unmet need is acute, with over 6,000 rare diseases lacking therapies and low survival rates for many cancers. Accelerating development by 12 months can add $400 million in net present value and deliver immense benefits to patients. 🚀 The solution lies in addressing these challenges head-on: Improving success rates by leveraging data and advanced analytics. Reducing development costs through innovative trial designs and technologies. Shortening cycle times with streamlined regulatory processes and enhanced collaboration. Together, we can drive change and improve outcomes in biopharma R&D. Join the conversation and share your thoughts on how we can accelerate innovation in this critical sector. ♻️ Repost this to spread awareness. Credit Mckinsey. #Biopharma #ClinicalTrials #R&D #Innovation #DrugDevelopment #Pharma #Healthcare #MedicalResearch #Biotechnology #LifeSciences #Pharmaceuticals #HealthcareInnovation #ClinicalResearch #DrugDiscovery #MedicalInnovation #RareDiseases #CancerResearch #DrugApproval #HealthcareCosts #MedicalBreakthroughs #ScientificResearch #PharmaTrends #R&DInvestment #ClinicalDevelopment #MedicalAdvancements #ResearchAndDevelopment #DrugPipeline #Biotech #PharmaInnovation #HealthcareIndustry #DrugPricing

Wow, worth a closer look. The most comprehensive study on pharma R&D just published. Really challenges current assumptions. Concludes US pharma sector is most research-intensive industry in the world (yes, across all industries).

Honored to be quoted by Fierce Biotech reporting on our analysis of the #InglationReducationAct's likely impacts on corporate #finance and #innovation. "...two new studies suggest <<<the industry's>>> fears may be overblown. Analyses of R&D spending and equity #investment in #biotech predict that the industry is capable of weathering a drop in revenue due to lower drug prices, with no corresponding loss in new approved drugs. Big Pharma “can protect both their earnings and their pipeline with pretty straightforward reallocation of R&D to late-stage development [and] continued or increased #licensing or #acquisition of early-stage products,” Fred Ledley, M.D., told Fierce Biotech in an interview. Ledley thinks the leaders already know that their companies can deal with lost revenues from lowered drug prices.  “They spent a decade implementing what they call ‘agile management’ to reallocate spending to where it's going to be most effective,” Ledley said. “They found ways to be very profitable and very productive for 20 years with all sorts of changing circumstances, and we don't think this should be a threat.” https://lnkd.in/gcuv-grX Center for Integration of Science and Industry at Bentley University, Bentley University Center for Health and Business Institute for New Economic Thinking West Health Policy Center

Stories making headlines today in the biopharma industry: In a significant turn of events, numerous life sciences and biopharma majors such as Amgen, AstraZeneca, and GSK are lobbying on a potential bill that could restrict US firms from engaging with Chinese life sciences contractors. This comes amidst growing concerns around WuXi. In other news, Biogen's Alzheimer's medication, Leqembi, has reported an incremental yet steady commercial rise, clocking global in-market sales of nearly $19 million in the opening quarter. Despite the gradual market penetration, Biogen is confident of the growth trajectory for its Alzheimer's treatment, developed in partnership with EiSai. The company has strengthened both its product portfolio and team, setting up for robust future growth. In a bid to revolutionize drug development, biotech firm Moderna joins hands with artificial intelligence lab, OpenAI. This partnership will introduce Generative Pretrained Transformer (GPT) technology into the drug development process. Stéphane Bancel, CEO of Moderna, expects this alliance to facilitate the launch of several new products in the coming years. CureVac, once a crucial player in the Covid-19 vaccine landscape, is taking measures to streamline costs across its operations. The company has confirmed that about 150 employees will exit voluntarily. The predicted cost savings are expected to kick in during the second half of the year, ensuring continuity of funds until the end of Q4 2025. Finally, Centessa has announced a public offering that could amass up to $107.6 million, enhancing its financial stability into mid-2026. Meanwhile, German biotech firm Vivoryon has decided to suspend its Phase 2 Alzheimer’s trial after the VIVIAD trial, involving Varoglutamstat, did not achieve the desired results. This move should extend its financial runway into Q2 2025. #pharma #biotech #topstories #biodatastudio

Is pharma getting better at failing early? Or is it just failing more? Fantastic analysis from my colleague Daniel Chancellor and the Citeline Commercial team. Stand-by for the full report coming soon! A few years ago Citeline published a clinical success rate paper in collaboration with Biotechnology Innovation Organization and Daniel Chancellor took a look at how the trends are shaping up since then: "We noted a gradual drop in likelihood of approval from the first paper in 2016 of 9.6% to just 7.9% in 2021, and this has continued to fall today. As the chart shows below, this has been driven by underperformance of Phase I and II trials - which is actually a good thing. It is better to terminate drug programs at the earliest stages before costs stack up, rather than facing the difficult news at Phase III, from regulators, or even the harsh reality of the market. Judicious go/no-go decisions enable precious R&D budgets to be allocated more efficiently, and the overall number of drug approvals each year is at historically high levels. Is this just a positive spin though? There are still a lot of failures during Phase III, despite the widespread adoption of precision therapies, biomarkers, genetic validation of drug targets - all factors that support higher success rates. Or are higher failure rates just indicative of moving into more complex diseases with a higher barrier to entry and/or existing treatment options?"

Great short article on M&A in Pharma.and Life Sciences for 2024 from PwC.

Biopharma’s Swift Pace 🚀 The biopharmaceutical sector is racing at ultimate speed 🏁, with innovations emerging faster than ever before. According to a McKinsey report, new medications are reaching 50% of their life time sales by almost two years earlier 📈. This rapid pace promises prompt benefits for patients, while also intensifying the pressure for companies to capitalize 💰and gain profits in shorter timelines. The driving forces behind this evolution include: • Fierce competition in the market 🥊 • Shifts in regulatory policies ⚖️ • Emergence of biosimilars 🧬 Strategies for the future encompass: 1. Speeding up drug development 🧪 * Implementing advanced technologies like AI and machine learning to streamline research. * Adopting adaptive trial designs to reduce development time. 2. Developing Innovative drugs 💡 * Investing in precision medicine to develop targeted therapies. * Prioritizing rare diseases and unmet medical needs for breakthrough status. 3. Being agile in all areas 🌀 * Focusing on digital transformation in operations and marketing. * Fostering a culture of continuous learning and innovation. In this evolving landscape, adaptability and innovation stand as crucial elements for achieving success 🌟. #biopharma #pharma #biotech #mckinsey #biosimilars #healthcare #drugdevelopment #innovation #competition

Why would anyone leave a scientific career to go build ... mouse tech? 90.4% of drugs fail in humans. It costs $2.3B and takes 12 years to get a drug to market. Only ~50 new drugs are approved per year in the entirety of the US. Animal studies determine what goes into humans. If you can reduce the failure rate by 2% (from 90% to 88%), resulting in 10 more drugs/year, you will have the impact of a major pharmaceutical conglomerate. Many things can be done to improve translation that aren't being done. At the moment, we don't even know what works in mice, since at current economics, studies are rarely replicated. Many more people should be thinking about this. Deep dive below. Thank you to Cecilia Kruszynski de Assis for the insightful questions. https://lnkd.in/gBN-NUiq

Did you download our latest #whitepaper? We recently launched a piece analyzing the paths of five prominent #biotech companies that have taken different approaches to grow into larger #commercial organizations with successful launches. Download the whitepaper today: https://lnkd.in/eDdHUNk3 #lifesciences #pharma #productlaunch #therapeuticareas Mariah Hanley, Principal, Putnam