When and why medical expertise is needed in the emerging biotech journey

Emerging biotechs are experts in the discovery and clinical development of investigational agents and individuals in leadership roles at these companies often recognize the value of core medical affairs activities. Engagement with physicians, planning for post-launch evidence generation, scientific platforms, and disciplined publications activities are universally recognized as essential among biotechs. 

The primary challenge for these leaders, and their investors, is to manage how and when in the pre-launch development lifecycle to develop medical affairs expertise and associated core programs. When done right, this can accelerate corporate and asset value but must avoid prematurely investing in programs that may not make it across the commercial finish line. 

Sam Falsetti, Global Chief Biotechnology Officer at ApotheCom, an Inizio company, believes there is a disciplined approach that biotechnology leaders can apply to make medical affairs investment decisions across phases of a product’s lifecycle. 

It’s never too early – but it must be scaled and tailored  

It’s never too early to engage with and start thinking about medical affairs – as long as a biotech is in clinical development, there’s always a need for expertise and resource on some level.

What these companies need to focus effort and attention on is that their wants match their stage in development, the financial status of the company and their corporate goals. 

There is a lot of strategic value in medical affairs but some companies fail to engage medical early in their lifecycle and create solid and scalable foundational programs. Instead, they tend to defer investments until a fully scaled medical affairs organization is needed pre-launch. Creating a solid foundational medical affairs framework early will create an immediate return on investment across investment communications, clinical development, evidence generation planning, publications, and external KOL engagement.  

A typical package of support for an early stage biotech may consist of a therapeutic area landscape assessment, external KOL identification/engagement and a scientific platform.

A scientific platform, for example, is a high-value asset, but many emerging biotechs don’t have the internal time or manpower required to develop one in the early clinical stages where their focus is on trials. This is perhaps exacerbated by the thought that scientific platforms are a medical framework that only medical affairs can utilize. 

However, scientific platforms are a critical alignment tool across investor communications, corporate communications, clinical, and medical affairs. While a full-scale platform may not be needed immediately, creating an aligned, evidence-based scientific narrative will create the scalable foundation for multidisciplinary communications.  This can include creating some centralized messaging like primary positioning statements or a ‘North Star’, some key evidence and secondary statements, all of which helps to start building a narrative that can help articulate the value of a candidate. 

This scientific narrative can be a foundation for investor communications, pre-IPO readiness, clinical documents, external KOL engagements, publications, and diligence discussions. Further, the evidentiary assessment component of the platform can guide evidence planning, assist in portfolio reviews, and support clinical development planning. 

Creating a scalable platform that is, from the onset, aligned with corporate and asset strategy, as well as key activities, can immediately generate value for an emerging biotech. 

Three key moments 

While the ‘never too early’ statement is a general truism, there are three key moments every biotech should keep in mind when thinking about leveraging medical expertise. 

Pivoting financially or in leadership

Where a company is going through investment rounds, IPO prep, a large C-suite turnover or refocusing a company between the development and commercial stage, there needs to be a focus on evidence assessment, asset/company differentiation, and disciplined communication approaches. Medical affairs expertise can be critical and help better navigate these situations. 

Phase II

Biotech should, at a minimum, engage an external commercialization partner with medical expertise at peri-phase II. This milestone is critical for derisking an asset and for communicating potential asset value and differentiation across an array of audiences. Additionally, there is typically a high degree of investor demand, and often patient advocacy pressure to move to phase III very quickly. Bringing in medical affairs prior to phase II readout can help a biotech leadership team get ahead of these pressures with expertise and planning to assist in quick execution. For example, bringing in medical affairs to help lead scenario planning and external KOL engagement to validate and extend potential phase II scenario findings will be critical to pressure test communications, clinical planning, and evidence generation planning.

Pre-launch

Accelerated approval pathways have muddied the waters a little when it comes to knowing what and when pre-launch is. Approval could be granted for a phase II product or follow a phase III trial which is what will be more typically expected. Wherever a company is expecting to launch, pre-launch scenario planning is a must and they need to start implementing formal structures and capabilities around evidence generation planning, medical affairs, scientific communications, and KOL ID/ engagement.  

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Inizio Biotech understands that every day is an opportunity to help you nurture and build towards the true value of your asset. Providing best-in-class medical services and strategic guidance across your 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.