Part 1: Value of Phase 2 Commercial Perspective for Drug Developments (VIDEO)

Santosh

As the leader of the launch practice, I’ve advised clients on over 30 launches in my time here at Herspiegel over the past 10 years. In this video, we focus on the importance of commercial readiness for early-stage pharma and biotech companies. If you are leading an early-stage pharmaceutical organization or perhaps you are the first commercial hire in an organization or business unit, this conversation is focused on you. This discussion will give you some best practices as you begin strategic planning for your asset. At Herspiegel, clients continue to inform their strategic asset planning earlier and earlier in their assets life cycle. As to what may have been done 10 to 15 years ago regarding having commercial team members on board in phase 3 of an asset’s life cycle. We are now seeing clients begin commercial planning in phase 2 or earlier to really inform their strategic planning as they prepare an asset for launch.

Let’s start with the value of having a commercial perspective in the drug development process. From your perspective, what are the benefits of having commercial involvement as early as Phase 2? 

Laura

It’s really critical to get a commercial perspective as early as possible. Phase 3 would be too late. There are several important reasons the commercial team has to have a seat at the table earlier on. The first is the need to inform the design of that pivotal clinical trial program in Phase 3, because that’s ultimately going to determine the efficacy of your product, your labeling modeling, and many of the promotional claims that you’ll be able to make at launch, and shape those initial customer perceptions of your product. So you want to ensure that those endpoints are designed not just to achieve approval, but wherever possible, are robust enough to create differentiation for your product.

The commercial team is going to have a completely different lens on what that would look like versus the clinical or the medical team who may already be at the organization. I think they need a seat at the table for this planning. We’re also seeing a trend across many clients where the FDA is advocating for the inclusion of what’s called soft outcomes in clinical trials – things like the patient or their caregiver voice. And they’re encouraging companies to integrate that in their drug development plan. This is a place where commercial input will be very important because they would be able to bring this voice to the organization.

Santosh

In addition to the patient voice, it’s also important for our clients to really know what is valuable for our customers earlier in the process. Universally, having access to value drivers in your clinical trials and health economics and outcomes research plans built is an important aspect of the strategic planning cycle. 

The importance of market access and generating clear evidence that drives value for all customers, not just HCPs and patients, but also payers, and demonstrating the value of an asset are critical factors in driving commercial success for a launch. As many have seen recently, it’s no longer enough to have a product that has strong clinical data. You have to demonstrate more than efficacy, and having to demonstrate value in real rural settings versus a clinical trial through phase 3B and phase 4 plans are very important. We advise our clients to start thinking that through in their phase 2 planning as they begin planning for a successful launch.

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At Herspiegel we’ve advised over 100 biotech companies in the past 6-7 years, and the majority have relied on external partners to augment their strategic thinking as they prepare for launch. With biotech company budgets and resources being very tight, having the expertise and flexibility and the ability to bounce ideas off those partners, build business cases, and inform decisions with credible benchmarking and best practices across the industry is important. 

At Herspiegel we believe that with a company that is launching their first asset, you have to build the plane as you’re flying it. As part of that, you need to rely on strategic thinking and external partners to support you as you build out a best-in-class strategy. 

If you are a small or a growing biotech company, please reach out and we’d be happy to discuss your situation and how we can help support you to ensure commercial success for your asset.