VanguardHealth Consulting

How Geopolitical Economic Changes Are Impacting Big Pharma In an era of increasing geopolitical and economic shifts, the pharmaceutical industry is facing unprecedented challenges. The once-stable global supply chains and international collaborations that Big Pharma relied on are now under pressure from protectionist policies and economic uncertainties. Historically, Big Pharma has leveraged global supply chains to enhance efficiency and reduce costs. By outsourcing manufacturing to countries with lower labor costs, companies improved their Return on Assets (ROA). However, recent geopolitical tensions and initiatives like the U.S. CHIPS Act and the Inflation Reduction Act are pushing for reshoring vital industries, including pharmaceuticals. This shift towards domestic production increases capital investments in local infrastructure, potentially squeezing ROA figures as companies adjust to higher operational costs. The looming “patent cliff,” where numerous blockbuster drugs will lose patent protection by 2026, poses a significant challenge. This loss, estimated to impact over $200 billion in annual revenue, forces companies to innovate or acquire new assets. However, rising protectionism in key markets like the U.S. and Europe complicates international acquisitions, limiting Big Pharma’s ability to fill their pipelines quickly. Smaller biotech firms, facing capital constraints, struggle to innovate and grow, further straining the industry’s innovation pipeline. Global inflation and supply chain disruptions have increased the costs of raw materials, labor, and transportation, driving up production costs1. These factors are likely to be passed on to consumers through higher drug prices. Additionally, new policies like the Inflation Reduction Act aim to control drug prices, adding further pressure on Big Pharma to balance increased costs with maintaining market competitiveness. In response to these global pressures, pharmaceutical companies are shifting towards regionalized supply chains and domestic R&D investments to enhance operational resilience1. While this approach reduces reliance on global networks, it requires significant upfront capital, impacting financials. Strategic mergers and acquisitions are expected to rebound slightly, but ongoing macroeconomic challenges and regulatory pressures will likely constrain the pace and scale of deal-making. Future The future of Big Pharma in this evolving landscape will depend on its ability to adapt through investment, strategic partnerships, and advanced technologies. Whether faced with economic fragmentation or regional cooperation, the industry’s success will hinge on balancing local production with global innovation. Companies that navigate these complexities effectively will emerge more robust and competitive.

These findings underscore the critical importance of minimizing 𝐜𝐨𝐥𝐝 𝐢𝐬𝐜𝐡𝐞𝐦𝐢𝐚 time to preserve the 𝐦𝐨𝐥𝐞𝐜𝐮𝐥𝐚𝐫 𝐢𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 of tumor samples, thereby increasing the 𝐚𝐜𝐜𝐮𝐫𝐚𝐜𝐲 of cancer drug 𝐭𝐚𝐫𝐠𝐞𝐭 𝐢𝐝𝐞𝐧𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧. 𝐎𝐮𝐫 𝐫𝐞𝐥𝐢𝐚𝐛𝐥𝐞 𝐦𝐨𝐥𝐞𝐜𝐮𝐥𝐚𝐫 𝐝𝐚𝐭𝐚 strengthens the robustness of 𝐝𝐫𝐮𝐠 𝐝𝐢𝐬𝐜𝐨𝐯𝐞𝐫𝐲 𝐩𝐫𝐨𝐠𝐫𝐚𝐦𝐬 and could ultimately lead to the development of more 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐜𝐚𝐧𝐜𝐞𝐫 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭𝐬. #personalizedmedicine #BeyondGenomics #TargetDiscovery

The FDA has issued draft guidance for conducting multiregional clinical trials in oncology, aiming to assist sponsors in securing FDA approval. The guidance emphasizes the importance of conducting trials across continents and pre-specifying methods for evaluating regional effects. A notable concern highlighted is the declining participation of U.S. individuals in multiregional cancer trials, potentially impacting the relevance of trial results to the U.S. population. Feedback on the draft guidance is invited and can be submitted until Monday, November 18. #FDA #clinicaltrials #oncology #cancerresearch

𝐀𝐝𝐝𝐫𝐞𝐬𝐬𝐢𝐧𝐠 𝐑𝐚𝐜𝐢𝐚𝐥 𝐃𝐢𝐬𝐩𝐚𝐫𝐢𝐭𝐢𝐞𝐬 𝐢𝐧 𝐁𝐫𝐞𝐚𝐬𝐭 𝐂𝐚𝐧𝐜𝐞𝐫 𝐎𝐮𝐭𝐜𝐨𝐦𝐞𝐬 A recent study published in the Journal of Clinical Oncology reveals startling statistics - Black women face a significantly higher risk of death from breast cancer compared to white women, with disparities ranging from 𝟏𝟕% 𝐭𝐨 𝟓𝟎% across different tumor subtypes. Factors such as socioeconomic inequalities, delayed diagnosis, and limited treatment access contribute to these inequities. This underscores the 𝐮𝐫𝐠𝐞𝐧𝐭 need for comprehensive interventions at all levels. Successful programs like ACCURE and Equal Hope have shown that multilevel interventions can reduce the gaps in cancer survival rates between Black and White women. It's a call to action for healthcare providers, policymakers, and communities to collaborate and enhance outcomes for Black women battling breast cancer. We hope that gen-t with its multi-omics R&D platform, will contribute, through Brazil's genomic diversity, with data that can eliminate or at least reduce these disparities. #BreastCancer #HealthEquity #Oncology #clinicalresearch

Improving patient lives!!

Intended for HCPs with an interest in GEA:   At Jazz, we believe all people, including those who live with complex conditions with limited options, deserve new therapeutic options to help improve outcomes.   The HERIZON-GEA-01 clinical trial seeks to explore the safety profile of our investigational treatment for people living with advanced/metastatic human epidermal growth factor receptor 2 (#HER2) positive gastroesophageal adenocarcinomas (#GEAs) and learn if it’s more efficacious than the current standard of care.   This trial is currently enrolling eligible patients, learn more: https://lnkd.in/g8RNyyQ8

The importance of evidence-based lung cancer screening for non-smokers with a family history of the disease is highlighted in a recent article published in the 𝗝𝗼𝘂𝗿𝗻𝗮𝗹 𝗼𝗳 𝗧𝗵𝗼𝗿𝗮𝗰𝗶𝗰 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆. The article discusses the potential benefits and harms of screening low-risk individuals for lung cancer, particularly those who have never smoked but have a family history of the disease. It highlights several large-scale observational trials in Asia that have shown high lung cancer detection rates in light- or never-smokers with a family history, but questions the evidence of mortality reduction without 𝗿𝗮𝗻𝗱𝗼𝗺𝗶𝘇𝗲𝗱 𝗰𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝘁𝗿𝗶𝗮𝗹𝘀. The authors argue that screening low-risk populations may lead to substantial overdiagnosis, detecting cancers that may not progress to cause symptoms or death, thus exposing individuals to unnecessary harms. The article also compares different national and societal guidelines on lung cancer screening, emphasizing the need for high-quality implementation and consideration of individual risk factors. #lungcancer #clinicaltrials #oncology link to paper in the comments.

The importance of evidence-based lung cancer screening for non-smokers with a family history of the disease is highlighted in a recent article published in the 𝗝𝗼𝘂𝗿𝗻𝗮𝗹 𝗼𝗳 𝗧𝗵𝗼𝗿𝗮𝗰𝗶𝗰 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆. The article discusses the potential benefits and harms of screening low-risk individuals for lung cancer, particularly those who have never smoked but have a family history of the disease. It highlights several large-scale observational trials in Asia that have shown high lung cancer detection rates in light- or never-smokers with a family history, but questions the evidence of mortality reduction without 𝗿𝗮𝗻𝗱𝗼𝗺𝗶𝘇𝗲𝗱 𝗰𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝘁𝗿𝗶𝗮𝗹𝘀. The authors argue that screening low-risk populations may lead to substantial overdiagnosis, detecting cancers that may not progress to cause symptoms or death, thus exposing individuals to unnecessary harms. The article also compares different national and societal guidelines on lung cancer screening, emphasizing the need for high-quality implementation and consideration of individual risk factors. #lungcancer #clinicaltrials #oncology link to paper in the comments.

Last week, the White House Office of Science and Technology Policy (OSTP) hosted the White House Clinical Trials Forum to highlight progress and encourage action to equitably accelerate clinical trials. The event was attended by experts and leaders to discuss strategies and improvements in clinical trials infrastructure, with a focus on more effective health outcomes. Additionally, the OSTP is committed to strengthening clinical trials infrastructure to achieve better health outcomes, as envisioned in the National Biodefense Strategy. #clinicaltrials https://lnkd.in/gK3dzYN9