Launch Strategies in Uncertain Regulatory Environments

Pharmaceutical Executive: What is the funding environment for pharma at the moment?
John Arena: We track the trends in the market, one of which is biopharma funding. Post COVID, there was a decline in biopharma funding, but that has not only stabilized, we're seeing funding in this area pick up and definitely return to growth. Recent research now shows that 70% of the clinical trials are really in the smaller biotech companies, which is significant. And oftentimes these companies have limited resources and organizational experience to commercialize their overall product. So, the way we position that is if they select the right strategic partner, they can go to market on their own, but they've got to be very intentional in how they manage their resourcing to do that.

PE: How can companies strategize given the uncertain regulatory situation in the US?
Arena: This question comes up all the time, and the complexities of bringing these drugs to market continue to mount. It's going to require end-to-end support from regulatory affairs, specialty logistics, market access, commercial distribution, patient services, and field support. The complexities are overwhelmingly high, and our goal is to really help simplify that process and provide a resource that can lean on a large, broad network of expertise to help support them. Engaging a strategic partner with deep regulatory expertise early in the process is a critically important element of early-stage planning, and that cross functional collaboration is paramount to effectively navigate and stay ahead of the constantly changing regulatory requirements.

When you look at Europe, for example, we're working with several companies in region, and there's been changes with the HDA regulation and joint clinical assessment process that took effect in January on oncology products and advanced therapy medicinal products. There's a lot to manage there, and with relatively small teams and oftentimes limited expertise, especially down to the local areas. But, with an eye on expanding globally, the regulatory requirements change and vary dramatically. So, to start really early on in the process to plot out your regulatory pathway, it's then going to inform you know your commercial decisions and your channel strategy, pricing strategy, distribution strategy, patient service strategy, all those key elements need to be accounted for earlier in the process, because the interdependencies are significant, and one misstep can really delay your launch, commercial success, and ultimately, the quality of the patient care that you really aspire to deliver. Having that early expertise involved with the process is really important, especially from a regulatory perspective.

PE: How should companies strategize to take their products global after the initial launch?
Arena: That's oftentimes an ambition with companies looking forward to global expansion. One common misperception is that you can leverage the same go to market strategy used for the US to support your European launches. That's just not the case. The regulatory standards are different, down even to the country level. You really have to have a go to market strategy that's tailored and customized to different countries. It’s also immensely important to plan for launch sequencing that's going to include compliance, supply chain, and regulatory considerations. There’s also licensing requirements and quality standards. There's a lot of factors that will influence pricing, market access, and reimbursement as well, but each market is different. You must deploy a level of local market expertise to tailor your strategy and investment to make sure you're set up for commercial success.