It takes flexibility and adaptability to switch a company’s focus. Here, Alkermes’ Chief Operating Officer Blair Jackson discusses how his team pivoted from developing CNS to oncology therapies and the skills it required.
Pharm Exec: How did Alkermes evolve from a solely CNS-focused company to one expanding its focus in the immuno-oncology space?
Jackson: Alkermes has a rich history of drug development across many disease areas utilizing both proteins and small molecules. Our mission of developing innovative medicines to help address unmet needs for serious diseases arose from a critical assessment of the healthcare environment. In many areas, patients are either denied access to or there aren’t adequate medication options to address their medical needs. We initially focused our development efforts on the highly stigmatized and underserved areas of addiction and serious mental illness. Our work in these areas has resulted in three important proprietary products.
Our expansion into immuno-oncology (I-O) was prompted by a recognition that despite the rapid advancement in I-O in recent decades, there are still large numbers of patients experiencing limited treatment options. Additionally, innovation within our protein engineering groups inspired our quest to pursue development of a novel molecule with the potential to offer a treatment option for patients who previously failed to respond or stopped responding to checkpoint inhibitors. Through this work, our first cytokine-based therapeutic candidate, investigational nemvaleukin, was born. Through a comprehensive early stage clinical program, we are investigating the potential applicability of investigational nemvaleukin across multiple tumor types. Recently we initiated two potential registrational studies with nemvaleukin in platinum resistant ovarian cancer and mucosal melanoma.
Pharm Exec: What have been the most important internal drivers to advancing Alkermes’ I-O research?
Jackson: Our foray into oncology and advancing our I-O research is a result of four important factors:
Our mission. As a company, we are united in our mission to apply great science to develop innovative medicines for difficult-to-treat diseases to make a real impact on the lives of patients, families, and communities. Entering oncology was a natural progression for Alkermes. We knew that immunotherapies have been game-changing in the way cancer is treated, but unfortunately many patients only see limited impact or no benefit at all. This paradox was our inspiration: Can we leverage our deep, scientific expertise and protein engineering capabilities to help people with difficult-to-treat cancers?
Our people. We have an incredibly talented team of innovators and trailblazers at Alkermes who strive to create a meaningful impact on people’s lives. We have tapped into the experience of our researchers and scientists trained in multiple therapeutic areas, including immunology, molecular biology, and oncology, to inform our work.
Our technological capabilities and disciplined research approach. Our efforts in oncology are focused on targeting established immune pathways that can modulate anti-cancer immune responses. We are leveraging our advanced medicinal chemistry and protein engineering capabilities to develop these unique approaches. We have also streamlined our R&D strategy to ensure a comprehensive, yet efficient pathway from discovery to clinical development to potential regulatory approval.
Our stakeholders. This is a diverse group of people including shareholders, employees, and the patient community. All are incredibly supportive of our efforts and have a united focus to see our research efforts succeed to one day deliver new treatment options to people suffering from cancer.
Pharm Exec: What were the greatest challenges you faced as a leader during your company’s transformation?
Jackson: As we embarked on entering a new therapeutic space, we were faced with several challenges—some expected and some completely unanticipated. Perhaps the greatest challenge that we had to contend with was building the right team to execute on the research plan. Alkermes was known publicly as a leader within the CNS space and as a company that had not worked in oncology for over 15 years. Despite a few members of the leadership team having deep oncology experience, we needed to establish a dedicated oncology group with strong experience operating in the highly competitive and dynamic I-O space. We were trying to recruit people to a CNS-focused company and asking them to lead an oncology program. With the employment market being extremely tight, this was a difficult task. Overcoming this challenge came down to people, communication, and science. We leveraged the diverse backgrounds and reputations of our leadership team to identify potential candidates in their network with the skill sets that would best augment our internal capabilities. These candidates were provided with a deep dive into our discovery and research capabilities and an overview of our development strategies. By clearly and concisely describing our scientific advancements, we were able to communicate the thoughtful nature of our research approach and highlight the long-term vision for our oncology portfolio.
Pharm Exec: How did your professional background support this effort?
Jackson: Expanding the research focus of a company requires a management team that is comfortable navigating through a changing environment and adjusting course quickly in the face of difficult challenges. These skills are often obtained by getting a wide range of experience by making changes in your career, such as working at different companies or trying multiple functional areas. My career has followed that same path. I have worked for Alkermes for the bulk of my career and have had the opportunity to work in research, finance, business development, and operations. Each change in my career path required adapting to a new working environment and brought with it new challenges. These experiences have been invaluable to me as we deal with the rapid growth and change at Alkermes.
Pharm Exec: How can other companies learn from Alkermes’ expansion as they enter new therapeutic areas?
Jackson: First, it is imperative to take a step back and perform a critical review of research capabilities, development infrastructure, and commercial expertise to determine if a company is ready to enter a new therapeutic area. Seasoned biopharmaceutical executives recognize that expansion beyond a core area of expertise can be laden with challenges. Self-reflection is key, where leaders must honestly assess the company’s ability to compete in a new domain and thoughtfully complete a gap analysis.
Collaboration is also a critical component, and you need not only the passion and support from your employees, board, and shareholders but also the partnership of clinical researchers and experts across relevant disciplines