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How Early Is Too Early To Establish A Commercial Function In Biotech?

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By Sush Patel, CCO of Replimune as part of the From The Trenches feature of LifeSciVC.

After close to 20 years at Genentech (GNE) shaping and directing marketing and commercialization efforts for novel oncology therapies, I finally took the plunge leaving big Biotech to join a smaller early-stage biotech company called Replimune. Interestingly, several people (both internal and external) have asked me “why do you need a CCO or commercial function” at this stage? As I have been mapping out the first year of the commercial plan and road to launch for Replimune it’s become clear that you really can’t have a commercial seat at the table early enough. This was true at GNE/Roche where the organization worked hard over many years to include commercial perspectives for early assets beyond just a few words in the target product profile.

The widely held view has been that with limited resources don’t we need a real drug and pivotal data in hand before we prematurely spend time and money on commercialization? I would argue it’s even more important at smaller biotechs which understandably live in the here and now and whose DNA is often R&D driven.

It goes without saying that commercial spend needs to be thoughtful and gated but especially in the current situation of well-capitalized biotechs and markets, companies have the luxury of trying to get it right early, and the first time. It starts with truly understanding the market/customer needs and not just today but importantly what we need to achieve future success. Wayne Gretzky’s famous quote says it perfectly “I skate to where the puck is going, not where it has been.” Given how fast the oncology market is moving instilling the discipline to think about standard of care 3-5 years from now is not always easy especially when the organization thinks it knows a disease space.

Understanding how we position, and what we can uniquely own is key to success, as is being ambitious yet realistic as few products truly serve the needs of the whole market. While its invariably true “it’s better to be first than best” the goal can’t just be about the first approval and getting a label quickly. If this indication is never going to get any significant market adoption and help enough of the target patient population how is this helping achieve our mission to deliver transformational results across cancers using tumor directed oncolytic immunotherapy or ensuring this platform will become a cornerstone in the treatment of cancer?

The commercial perspective and strategy should be critically integrated into the development strategy and not be “bolted on” after the fact – that’s rarely a recipe for success. Yes, we need indications with a high chance of therapeutic success and/or speed to market but also ones that have high commercial feasibility and sufficient value. These are hotly debated topics at any company and what’s most important is there is transparency and informed decisions based on all stakeholder perspectives not solely the scientific or clinical direction needed. Having a clear sense of the commercial end goal enhances the BD and partnering strategy. With the commercial perspective and voice now truly embedded at Replimune, I believe there is greater organizational clarity across all functions driving a collective sense of what good looks like.

That said working in my new environment has taken me outside of my comfort zone, especially having come from an organization where the level of rigor in commercial planning was arguably more robust due to resources readily available, However, you quickly learn to go with your gut and effectively utilize the information and resources at your fingertips. I simply don’t have the option to ask my market insights team or other in-house experts for the answer. That said, what I have seen at many larger companies, and I was certainly guilty of at GNE, was often spending too much time trying to assign a level of precision to things where there were simply too many variables and where markets, especially I-O, were changing constantly. In these situations, false precision created more organizational challenges and it was better to simply embrace the ambiguity and range of possibilities. Often having the vision and courage to move in a particular direction or indication/setting, even with limited data or information, ultimately resulted in the greatest reward for patients and the company.

Ironically, many Pharma companies have for some time been striving to be more “agile” like their Biotech kin and see the benefits on new ways of working / being “fit for purpose” and thinking about markets differently as key to success. We have seen that when forced to do so by an unprecedented global event such as Covid, organizational size/inertia can be rapidly overcome, and progress can occur at lightning speed. The impressive Covid response from many companies such as Pfizer has shown what’s possible.

I have found some surprising things moving to a smaller Biotech, several complicated by this occurring during a seemingly never-ending, next variant up, global pandemic. Even for a well-funded and established biotech such as Replimune I have learned some new rules of engagement.

  1. Vendors don’t necessarily want your business??? They are struggling to find people to do the work. You may have to sell them on why working with you will be worth their while.
  2. Hiring and retaining talent is even more challenging. Title elevation and getting to competitive compensation can make the hiring process twice as long and painful – oh and don’t expect a good offer will result in success (kinda got used to that before).
  3. Your network/relationships are key. This is of course critical in any organization, but I have found myself at times really having to “work it” to get people to come the table. At GNE “if you schedule it, they will typically come.”
  4. You do it all. I don’t have “people” for that anymore, it’s generally me, myself, and I. This has got me closer to our customers and the business which has been rewarding but can also be challenging even when working on a new and exciting modality such as our tumor directed oncolytic immunotherapy (TDOI) platform – my marketing lead will be proud of the shameless plug.

What’s personally been the most enjoyable aspect of my first 8 months or so at Replimune is having a blank slate, the breadth of responsibilities, and in a short space of time being able to see a clear impact of the commercial voice and strategy on the organizational thinking and our future direction. I assumed my entrepreneurial spirit and “can do” attitude would set me up well for the transition and in many ways it has. What’s become clear is that there are many things that Biotech does well and that working in a smaller company affords. For example, being at the heart of the decision making, not having pre-conceived ideas on what’s possible or works best and being able to successfully challenge the status quo.

During interviews for biotech, you always hear about “having to wear multiple hats” and I can confirm I now need the services of a milliner (had to look that up, posh name for a hat maker). While there are many benefits of being part of a small, rapidly growing company like Replimune the challenges vs. large Pharma are just different; the highs are really high and the lows often harder to swallow. What’s not so different is the chance to work with talented people who are equally dedicated to the science and bringing novel medicines, such as oncolytic immunotherapy, to transform outcomes for cancer patients which makes the gig pretty awesome whether you work in South San Francisco or Woburn.

In the next 6-12 months, I am excited to focus on hiring more talented commercial leaders to help shape the vision and build the optimal “go to market model” needed to launch not only our first product at Replimune but a new modality for many customers not familiar with an oncolytic or a tumor directed immunotherapy. Changing mindset, behaviors, and established healthcare paradigms is never easy but if we can deliver transformational outcomes for patients, it’s going to be rewarding journey and well worth the effort.

Thanks to Pamela Esposito, Philip Astley-Sparke and Lissette Steele for reading drafts of this post.

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  • Source: https://lifescivc.com/2022/01/how-early-is-too-early-to-establish-a-commercial-function-in-biotech/?utm_source=rss&utm_medium=rss&utm_campaign=how-early-is-too-early-to-establish-a-commercial-function-in-biotech

This Post was originally published on Life SciVC

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