Optimizing Alkermes' R&D Model for Success
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Optimizing Alkermes' R&D Model for Success

Craig Hopkinson, M.D., CMO and Executive Vice President, Research and Development, Alkermes

Craig Hopkinson, M.D., CMO and Executive Vice President, Research and Development, Alkermes

Dr. Hopkinson has over 20 years of experience in the biopharmaceutical industry, building and leading clinical development organizations and medical affairs groups. He has led multidisciplinary development teams in neuroscience, oncology, gastroenterology, infectious diseases, cardiovascular conditions, inflammation, genetic diseases, hematology, and neurodegenerative diseases and has extensive knowledge of clinical study design and the regulatory landscape. In his current role, he leads Alkermes' Discovery, Pharmaceutical Development, Early Stage Clinical Development, Late Stage Clinical Development, Regulatory Affairs, Clinical Operations, Project Management, and Medical Affairs functions. He is also responsible for the strategic development and execution of clinical development programs for Alkermes' pipeline of drug candidates.

In an interview with Pharma Tech Outlook Magazine, Dr. Craig Hopkinson describes Alkermes’ evolved R&D approach, as his team focuses on the development of innovative medicines in neuroscience and oncology seeking to bring value to patients.

How do you see the industry currently, considering your extensive experience in R&D and Medical Affairs?

Working in the pharmaceutical industry for the past 25 years, I have seen a steady focus on improving R&D productivity. In the last two decades, billions of additional dollars have been spent on research and development in an attempt to improve pipeline success rates. However, the yield and success of launching medicines, as well as the de-risking of early-stage assets, have not improved significantly. Earlier in my career, we concentrated on translational medicine using a bench-to-bedside approach. Now at Alkermes, we're working on the reverse translation, paying close attention to patients and biological mechanisms in order to better select appropriate endpoints based on the target population of patients most likely to benefit from the drug, and thereby boost the likelihood of early clinical stage research success aiming to de-risk the investment. This aids in early no-go decisions, reducing risk not only in terms of monetary investment but also in terms of accelerating programs moving forward.

The COVID-19 pandemic has led us to reconsider our research methodologies and adopt technological advancements more swiftly

On a more recent note, the COVID-19 pandemic has prompted the industry as a whole to re-evaluate drug development strategy. During this period, companies that used cutting-edge research methodologies outperformed the competition. Companies also had to think differently in terms of research labs and how to keep the lab environments safe for driving the core programs forward.

What made you join Alkermes? Could you highlight some of the initiatives you've led as the Executive Vice President of Research & Development and Chief Medical Officer?

It was Alkermes’ unique culture and a patient-centric approach that brought me to the company four-and-a-half years ago. Alkermes gave me the opportunity to blend my R&D and medical affairs expertise into a seamless continuum. It has also allowed me to focus on innovative ways of driving research and development forward within Alkermes, from ideation all the way through the product's life cycle as we work to maximize the value of our assets.

Our commercial medicines are approved for schizophrenia, bipolar I disorder, opioid dependence, and alcohol dependence -- all challenging therapeutic domains. We are committed to championing approaches to treatment that seek to address many of the complex factors that affect the outcomes for patients, their caregivers, as well as the communities they are in.

Alkermes' roots in drug formulation and delivery reach back more than 30 years. Early in our history, we built our technical capabilities and product development experience through collaborations with other pharmaceutical companies, as well as acquisitions of flagship technologies. Since I joined Alkermes, we have evolved our patient-focused R&D efforts to focus on developing novel medicines based on validated biological targets, to tackle therapeutic challenges in neuroscience and oncology. Focusing on two therapeutic areas allows us to concentrate our resources and strengthen our expertise. Leveraging our advanced medicinal chemistry and protein engineering capabilities, as well as a disciplined, integrated research approach, we work to develop new medicines that are designed to make a real impact on the way people manage their diseases.

Our efforts in oncology currently focus on targeting immunological pathways that influence anticancer immune responses, as well as using our established protein engineering platform to improve cancer-fighting capabilities. In neuroscience, we are working to develop molecules focused on addressing synaptic dysfunction (HDAC inhibition) and restoring abnormal neurotransmission (orexin) for a broad spectrum of potential disorders across psychiatry and neurology.

How do you see the future of the industry? What are some of the trends that will have an impact on the next couple of years?

The COVID-19 pandemic has led us to reconsider our research methodologies and adopt technological advancements more swiftly. Although several of these newly adopted technologies had been considered for years, no attempts had been made to implement them successfully. As a result, many of the technologies that were adopted successfully during the pandemic will be valuable in the future.

Going forward, the company's integrated approach to target evaluation, as well as portfolio assessments, will receive maximum attention. This is to guarantee that we have a strong biologic basis for evaluating the technological viability in understanding the clinical and regulatory paths to achieve target product profiles. In addition, we recognize the market opportunity that is critical to incorporating therapy, competitive assessment, and differentiation strategy for our programs.

What would be your advice to the budding professionals looking to work on the same line of career?

Unmet need is going to continue driving innovation across the biopharmaceutical industry. The epidemic has compelled us to adopt innovative techniques to clinical trials and to adopt technology at a faster rate, and that is going to continue to be a factor for success. At Alkermes, we integrated remote monitoring of our clinical trial data, quickly revised study protocols to conduct remote patient visits, at the same time ensuring mindful data collection. 

Collaboration is also key. We have dedicated advisory boards with expertise in translational medicine, chemistry, and molecular engineering, working alongside our teams and helping drive our initiatives ahead. We also work with clinical advisory committees in therapeutic areas to help us identify and evaluate the clinical and regulatory feedback needed to move programs forward successfully. These collaborations aid budding professionals who are interested in moving directly into the industry or students who want to establish a stronger link between academic medicine and the industry.

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