NOVEMBER 2022LIFE SCIENCES REVIEW8IN MY OPINIONr. 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 Life Sciences Review 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.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.By Craig Hopkinson, M.D., CMO and Executive Vice President, Research and Development, AlkermesDCraig HopkinsonOPTIMIZING ALKERMES' R&D MODEL FOR SUCCESS
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