Bridging the gap between science-driven and commercially-minded decisions in emerging biotech

John L’Ecuyer, Executive Director, Business Development at Putnam, an Inizio Advisory company, outlines the need for emerging biotech to bridge the gap between scientifically- and commercially-driven decisions to maximize the value of their pipeline.

He gives an overview of two use cases for incorporating commercial and scientific insights in early stages of clinical development, and lists the questions you need to start asking in Phase I to shape a strategy that will build a value story around the asset.

In an ideal world, every emerging biotech company would make scientifically- and market-driven strategic decisions from very early in their development journey.

The reality is that many early-stage biotechs have limited resources for early-stage commercial input, as their focus tends to follow the scientific rationale and prioritize opportunities with the most likelihood of technical success. In Phase I, and often into Phase II – clinical often has the dominant voice at the table, and commercial may be under-represented. 

But, to realize the full potential of their asset, emerging biotechs need to consider two things from the moment they begin to invest significantly in their product:

• What is the addressable patient pool for our asset, and what is the opportunity worth? 
• How do I translate scientific evidence into commercial value? 

Ultimately, they need to focus on incorporating market and commercial perspectives into their decision-making at the earliest stage their funding allows in order to maximize value at commercialization, M&A or licensing. 

Further arguments for engaging commercial expertise early

Aside from the value creation argument, early commercial support has further advantages, notably:

Fail fast, fail early to save on resources

It’s a lot less expensive to fail in Phase I than to continue a program if there’s very little potential for commercial adoption. There are lots of examples of companies that have advanced programs where a product has shown safety and some efficacy signals but is not going to be differentiated from current or emerging products. It saves companies a lot of time and resources and investor confidence if they ask, “What will the future landscape look like when we launch? Where will our asset be positioned, how is it differentiated, and what is the commercial potential?” 

Dealing with complex mechanisms of action (MOA)

In complex therapy areas or drugs with complex MOAs or where the target is not well understood, there is a need to canvas scientific literature and KOLs to understand where a molecule may be positioned in the treatment paradigm. This requires deep insights into the scientific literature and clinical (and pre-clinical) evidence. Many emerging biotechs simply don’t have the resources in-house for a comprehensive review of the scientific literature and a robust framework for prioritizing clinical development opportunities for their platform or molecule.

What to ask and when

THE question to ask for emerging biotech then is: ‘What is a compelling Target Product Profile and clinical development path that is going to obtain regulatory approval AND is going to lead to market adoption and commercial success?’

However, a ‘one-and-done’ approach is not sufficient to answer this question. There are vital questions that should be asked in early development and re-asked throughout the journey to market for any promising molecule. They help frame the commercial opportunity for investors in the early phases, then articulate the market proposition at the point of commercialization. 

• Where should we position our product?
  • What’s the scientific rationale?
  • What’s the unmet need?
  • What is the size of the addressable patient pool? 
  • What’s the competitive intensity? 
  • What are some of the market access barriers and drivers? 
• Which opportunities should we prioritize and why? 
• What’s the commercial potential of our product and portfolio? 
• What are the reasons to believe in our product? 
• What is the potential market adoption? 

Answering these questions – with the depth and granularity appropriate to the asset’s stage in the clinical development continuum – is critical in shaping the development path and go-to-market strategy. 

Inizio: the knowledge that bridges science and markets

Emerging biotech needs to understand where they can go with their molecule and demonstrate to boards or to investors their value proposition and their business case.

Understanding where to position a therapy in the future treatment landscape requires a deep understanding of pre-clinical and early clinical evidence bridged with commercial knowledge.

Inizio Biotech understands that every day is an opportunity to help you nurture and build towards the true value of your assets. Providing best-in-class services across the clinical development and commercialization journey, our biotech solutions guide, validate, and inspire the decisions that will maximize the value of your assets. Find out more here.