Ready for Anything

“All things are ready, if our mind be so.” These powerful words, spoken by Henry V as he rallied his troops in William Shakespeare’s drama, resonate today for biopharma companies considering new therapeutic areas – especially ones dominated by established, well-entrenched players. Entering a new therapeutic space – like going into battle – requires courage, commitment, competence, and (perhaps most of all) sound preparation.

Why expand into a new therapeutic area at all? This is the fundamental question. Thinking about the answer can reveal insights into how a company sees itself fulfilling its mission to help patients now and in the future. Most companies start with narrow expertise and aggressively pursue R&D and commercialization in that area until forced by market pressures to diversify. These pressures include genericization of key commercial assets, competition, or shifting treatment landscapes. A smaller subset of companies aren’t forced to diversify, but instead leverage technical innovation (either organic or acquired) to advance their mission forward. Regardless of the catalyst, seasoned biopharma executives know that expansion beyond a core expertise can be fraught with many challenges, so a great deal of inward reflection and preparation is required.  

Finding the right path forward is often not solely driven by the specific disease area, but by the attributes of the company itself. A critical review of research capabilities, development infrastructure, and commercial expertise can be used to determine if a company is compatible with the potential new direction. Leadership teams must make honest and critical assessments of the company’s ability to compete in each of these domains and carefully complete a gap analysis to ensure any shortcomings are addressed. Only once these questions are satisfactorily answered can you begin to determine if therapeutic expansion is right for the business.

Nearly a decade ago, Alkermes found itself at these exact crossroads. Our entry into immuno-oncology was precipitated by innovation within our protein engineering group, as we considered applying our technology to new diseases. Seeking to augment our capabilities within biologics, we acquired a number of technologies from Acceleron Pharma that would allow us to manipulate protein structures to improve the clinical characteristics of a wide range of therapeutically relevant proteins. Through this work, we were able to design an investigational cytokine with the potential to harness the efficacy of the IL-2 pathway, while mitigating the tolerability issues that have limited IL-2 therapy in oncology. The molecule was a real breakthrough in protein engineering and had the potential to change oncology space. Despite internal positivity, we still asked ourselves one more critical question. “Even if we could do it, should we do it?” Or, digging deeper, we  had to ask ourselves whether the move was aligned with our mission: applying science to develop innovative medicines for serious, chronic diseases and raise the bar on how patients can survive – and thrive – with advanced treatments.

Expanding into a new therapeutic area is a weighty decision and a journey you can’t make alone. You need the passion and expertise of employees, the support of the board and shareholders, and the partnership of clinical researchers outside of the company. As a company built on science, we felt we had all the right assets and the stakeholder support to move ahead. To complement our technology and guide our approach, we tapped into the experience of our researchers and scientists trained across multiple therapeutic areas, including immunology, molecular biology, and oncology – always advisable if you have this option.

The value and impact of any decision to expand will be revealed – in time. For us, success means bringing our oncology drug to market. Until then, it is important to stay agile, to adapt to new information, and to learn as we progress through development. We have come a long way in oncology so far, from initial discovery to ongoing clinical trials that have shown promising signs of safety and efficacy in certain solid tumors. 

The R&D journey requires patience, ingenuity and determination. But if you start by asking the right questions and give yourself room and flexibility to explore new paths – or “follow your spirit” as King Henry puts it – as new answers emerge, you may eventually deliver innovation that significantly benefits patients in need.