Shane Berman liked this
With yesterday's inauguration of the 47th President of the United States, the clock has officially started on the "first 100 days," an artificial milestone that has come to indicate a lot about dynamics of the incoming administration.⏰
It is about the specific agenda of Trump's second term, though noting that substantive platform information is not yet known. But also, even more importantly, it's about how these points will be executed and what impact this has across various areas. 🔮
When it comes to life sciences, there are a multitude of developments to watch in the next few months. Here are ten top aspects to consider, split across our industry's value chain:
𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 & 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 🔬
• R&D Tax Credits - encourages innovation & may target specific therapeutic areas or modalities
• Biden's Executive Order on AI - already has been repealed on Day 1; future EO may redirect focus toward competitiveness instead of regulation
𝐒𝐜𝐚𝐥𝐞-𝐔𝐩 & 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 🏭
• U.S. Biosecure Act & related measures - pushes to decrease reliance on non-US suppliers, potentially leading to short-term supply chain disruptions
• Deregulatory Push (e.g. EPA, OSHA, etc.) - reduces compliance burden for companies, but may lower rate of monitoring & enforcement by agencies and ultimately lower standards in key areas
𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 & 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥 ⚖️
• Process Flexibility & Acceleration - could result in acceptance of real-world evidence in trials or novel trials designs, as well as more open designations for drug development, but may also increase public scrutiny on safety and effectiveness of drugs
• Influence of Loper Bright Ruling - elimination of "Chevron deference" has impacts not yet felt; reduction of the scope of authority of government agencies & increase in necessary legislative clarity may lead to regulatory uncertainty and gridlock in decisionmaking bodies across the government
𝐏𝐫𝐢𝐜𝐢𝐧𝐠 & 𝐑𝐞𝐢𝐦𝐛𝐮𝐫𝐬𝐞𝐦𝐞𝐧𝐭 💸
• Fate of Inflation Reduction Act (IRA) - if repealed, could delay negotiations on drug prices in Medicare Part B for those named; if pursued further, may lead to push for higher price cuts or more drugs within discussion scope
• Focus on Value-Based Purchasing - encourages experimentation by states in innovative pricing models, putting imperative on cost-effectiveness (esp. for CGTs)
𝐋𝐚𝐮𝐧𝐜𝐡 & 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 💊
• Pending Expiry of Affordable Care Act Subsidies - increases premiums & out-of-pocket costs for millions; higher rate of uninsured
• Prioritization of Medicare Advantage - increases influence of private sector within public system, forcing companies to work more with PBMs
Which aspects are most important for the industry? Are there any other developments that you will be watching? I would love to hear your thoughts.
Regardless, this time will bring both challenges and opportunities for our industry - and it's imperative to plan ahead to maximize success and hedge risk.