My Biopharma Situation Analysis 2025: Part I

Happy Christmas and merry holidays everyone!

This year, my present to myself is making time and space to ponder the future of the biopharma industry - a hobby of mine since my time at Novo Nordisk.

When I started at Novo in 2017, I was tasked to create a US Situation Analysis - a 'single source of truth' narrative on the opportunities and challenges in the US market combining perspectives from different teams and functions. It was the first time I was given free reign to explore, ponder, and think as I please as part of my job - and I loved the experience. Most of all, I loved challenging myself on not only on how much more of the future I could see, but how might I discern a path to get there based on our capabilities & resources.

Since then, I now create Situation Analyses for fun - like this article I wrote in 2022, or this set of slides I created. However, there is little fun and value keeping these thoughts to myself - so I'd like to share with you all some of my thinking.

Over the next seven days - starting today - I'll be sharing one essay a day on key trends I see within the industry, building into a set of actions I would take and mindsets I would adopt if I started 2025 in an executive leadership position. As a disclaimer, these thoughts are wholly my perspective, and are not representative of any other person or organization. Any similarity is entirely coincidental, a testament that you can find great strategic minds in biopharma today just about anywhere.

Let's go.

Part I: Get ready for a lot more drugs (really) soon?; rising productivity in life science Research & Development (R&D)

Just as technology has sped up our capability to be creative, often by removing rote tasks that impede our ability to design, test, and iterate, so too has it begun improving productivity in the life science industry. It isn't just R&D (e.g. here ... and here ... and here ... and so forth) - it's across the entire journey a drug takes to get to market, from regulatory submissions and manufacturing (including these moonshots) to the entire delivery supply chain. While change has always been painful (check out this Deloitte report from 2018 decrying the declining ROI of R&D spend), there is little doubt in anyone's mind that a future with tons of therapeutic options is coming soon?.

Why soon? and not now? There are a few barriers to overcome before the value these productivity improvements create can truly be unleashed. The most visible is naturally, the clinical trials process; any challenges in trial recruitment due to not picking the right sites, not identifying the right candidates, or lack of resources at that site can result in huge delays. Manufacturing at scale is another, especially for complex products (like cell or gene therapies). Another is regulatory approval, although it's improved significantly over the years and will likely continue to grow faster and more timely.

To be brutally honest, I'm aware that broadly regulation is often cited as the 'thing' standing in our way (especially since solving the first two problems may actually require work and effort - sorry not sorry). I think this is somewhat silly since there's an even larger bottleneck that no one really wants to talk about; the lack of true integration between drug development and commercialization. Few companies handle the integration between brand teams and R&D teams very well, despite the very real synergy that can result from cross-functional collaboration. Yet, biopharma - particularly large pharmaceutical companies - often have siloed teams with very different incentives that dissuade such collaboration, not to mention a culture that sometimes finds agility anathema. This is not to say that there aren't top leaders dedicated to modernizing their organizations and overcoming such barriers, but be honest - can you name more than a handful at your organization? I'll wait.

This legacy of calcification drags down an organization's ability to leverage greater R&D productivity. When commercial is brought in only after the start of Phase III because 'that's just the way we do things,' you may end up with a pivotal trial that won't drive payer interest - and lower your likely revenue. When commercial dismisses a clinical point of view from R&D - perhaps a novel endpoint, perhaps a new PRO - because 'it's not how things are done in the real world,' they miss a real opportunity to explore market shaping as a way to ensure commercial success. Similarly, when R&D grows too academic - 'it has to be this site' or 'it has to be this patient population' - they may too also miss easy enhancements to development that will, bluntly, result in the financial success & resourcing to be invested in the next big innovation.

When you think about all the missed shots and missteps here - and when you frame it in the political theater common in life science organizations - it makes you truly wonder why anyone would label regulation as the key bottleneck as opposed to the potentially consequential amount of internal dysfunction the enterprise has.

I want to zoom out to reinforce why this - integrating commercial insights with drug development as early as possible - is a critical must-win battle for the industry to get right. We are currently living on the cusp of the greatest renaissance in life sciences productivity we have ever known and the possibilities are endless - from purely personalized therapy, 'on premise' drug manufacturing ('make your own insulin at home!'), or even those tanks from Star Wars that will heal you with just a bath. However, this productivity means nothing to your organization if they result in products no one needs, no one wants, and no one will pay for. To truly realize all the value this trend can create, it isn't enough that R&D or commercial evolves in isolation - the two must evolve together.

Progress, even in the life sciences, never waits for people or companies to be ready. If you as a leader aren't or your organization isn't prepared for whenever soon? happens, then your legacy will be just as a stepping stone for others with more foresight or simply more luck.

All in all though, I'm excited to see how the industry evolves as R&D engines shift into a new gear. Despite the cold rationality of my analysis, I am honestly most excited for patients; progress towards a world where we will always have hope to live a healthier life because of a mastery of our own biology. The dream of this utopia - this greater good or universal benefit - is also why emotionally, I feel so strongly that biopharma has a duty to do everything it can to support our steps to that goal. That includes taking a hard look at ourselves and asking, is there more we can do? Do we need to change?

Before I leave you today, however, I should mention; there is another critical bottleneck to all this productivity actively translating into a real explosion of new therapies. And that will be our topic for Part II.

But, what do you think about this trend? Where do you think it will take us? What could possibly be the trend for Part II?! Let me know any way you wish - comment, private message, email, scary murder note, etc. - and thank you for taking the time to join me today.

If you like it, leave a reaction or a follow. More importantly, if you didn't like it, feel free to tell me why (I'd say 'downvote the shit out of it,' but LinkedIn does not have this functionality).

Either way, thanks again. Talk soon.

-WY