Anthony Boyd, PharmD, BCPS

Health systems coordinate pharmacy, payers, clinicians, labs, and electronic health record (EHR) teams to deliver ultra-high-cost gene therapies.

Early electronic health record (EHR) collaboration, scalable clinical infrastructure, and payer strategy planning are essential for pharmacists as cell and gene therapies expand across disease states.

Managing high-cost oncology therapies requires extensive cross-functional coordination, with pharmacists playing a central role.

A panelist discusses how the 505(b)(2) regulatory pathway provides a streamlined approval process for modified versions of previously approved drugs, allowing pharmaceutical companies to rely partly on existing safety/efficacy data while still requiring new clinical data, commonly used across various therapeutic areas including reformulations, new dosage forms, and drug combinations.