Pharma tackles the ever-present problem of unmet need
- The most challenging aspect of working in pharma is prioritizing which assets and science to bring forward based on pre-clinical and early data, agreed a slate of executives during a panel at the BioPharm America conference in Boston this week.
- Understanding the target, the mechanism and the overall unmet need are just a few of the key factors that play into making those go, no-go decisions when only early data is available, said Lizabeth Leveille, head of Merck & Co.'s Boston Innovation Hub.
- "Unmet medical need" is a buzzword often thrown around by pharma executives. Still, the panelists emphasized that delivering value and securing broad reimbursement from payers only comes from solving a problem that isn't already addressed for patients.
"I spend as much time with our pharmaco-economics and patient outcomes groups as I do with our scientific data," said Salim Mujais, global therapeutic head of immunology, transplant, infectious disease, CNS and pain at Astellas Pharma Inc.
Unmet medical need may seem like an obvious concept, but there are a lot of factors and thought that go into determining this element — everything from patient focus groups to market research to discussions with the Food and Drug Administration.
All of the panelists emphasized that starting talks with the FDA as early in the clinical process as possible is the best way to determine how to meet the needs of patients.
While all panelists had similar advice for how to hit on the next big thing, they had a variety of opinions on exactly what that area might be.
"I think immuno-oncology is here for a while. There’s a lot we don’t understand and a lot to learn," said Merck’s Leveille. She also noted antibacterial resistance and disease-modifying drugs for Parkinson’s disease as hot areas of interest for the big pharma, which is currently leading the way with its immuno-oncology drug Keytruda (pembrolizumab).
Meanwhile, Chandra Ramanathan, Bayer AG's head of its East Coast Innovation Center, emphasized the still prescient need for more therapies in broad primary care areas like cardiovascular disease and women’s health.
"I'm learning a lot about women’s health and it affects women in their 20s, and 30s and their prime reproductive years whether its endometriosis, fibrosis," he said. "There’s a huge unmet medical need."
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