Maximilian Vargas, PhD MBA, is vice president and US Access Strategy team lead for Certara. His experience cuts across all major therapeutic areas and care settings with special emphasis on CV/metabolics, oncology, gene therapies, ophthalmology, GI, and dermatology. After earning a bachelor’s degree from Wesleyan University, Max earned a PhD in Biochemistry and Molecular Biology and MBA in Healthcare Policy and Management at the University of Connecticut.
Caitlin Verrilli, MBA, is Director, US Access Strategy, for Certara, where she specializes in data presentation and visualization, Medicaid and Medicare policy and reimbursement strategies. Prior to Certara, Caitlin worked at Ipsen; and at BPHC, part of the NYS Medicaid DSRIP program, as Director of Project Management; and at NYC Health & Hospitals, where she was project director for grant-based programs. Caitlin holds an undergraduate degree from Columbia University and an MBA from Columbia Business School.
As IRA provisions are activated, the law’s impact on biologics and biosimilars will become more apparent. By using both the carrot and the stick, the IRA may finally bolster the market, increasing uptake of biosimilars to benefit patients and help lower costs.
Despite these wins for many patients, the new law is already impacting the discovery and development of new drugs for people living with orphan diseases. Not only are drugs that could treat more than one disease being disincentivized, small molecule medicines, which play an important role in treating neurological disorders, cancers, and other diseases, may also be disadvantaged by the law.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.