VAMA 6th Annual Value Added Medicines Meeting: Adapting for Change

Meeting synopsis | March 24, 2026 | New York City

The Value Added Medicines Alliance (VAMA) convened senior leaders from across the 505(b)(2) and value-added medicines ecosystem in New York City for its highly successful 6th Annual Meeting, Adapting for Change. In keeping with the high bar set in prior years, the 2026 program again featured an exceptional faculty experienced regulators, strategists, and innovators, focused on the practical decisions companies must make as policy, pricing, and commercialization dynamics rapidly evolve.

Against a backdrop of shifting FDA leadership, PBM reforms, the ongoing impact of the Inflation Reduction Act on small molecule lifecycle planning, and renewed focus on Most Favored Nation (MFN) pricing, the meeting delivered a concise, executive level forum to pressure test assumptions and identify actionable strategies for 2026 and beyond.

Speaker highlights

As in previous years, VAMA assembled a faculty with deep, on the ground expertise spanning law, market access, pricing, and commercialization execution. Featured speakers included:

·         Mark Raza, JD  Principal Deputy Chief Counsel (FDA Office of Chief Counsel/HHS OGC); long time FDA legal leader with extensive experience across biological products, devices, emergency preparedness and response, and information disclosure.

·         Tom Evegan Principal and National Consulting Leader, Life Sciences at RSM; advisor to hundreds of manufacturers on government pricing, gross to net strategy, managed markets, and commercialization readiness.

·         Steve Casey VAMA founder and value-added medicines commercialization leader; focused on efficient, ROI driven strategy from concept through launch and lifecycle value creation.

·         Bill Garbarini  Healthcare technology entrepreneur and former CEO of Pixel Care; shared practical lessons from building alternate distribution platforms designed to improve patient experience and control the journey.

·         Thomas Goss, PharmD Co-founder, BeaconOne Healthcare Partners; specialist in health economics and outcomes research with extensive publication history and CMS MEDCAC committee service.

Key themes and takeaways

·         Regulatory reality is changing in real time. Participants discussed how leadership turnover and a less experienced reviewer base can change expectations and why teams should plan earlier for potential friction points that can trigger delays.

·         PBM disruption is reshaping gross to net strategy. With new transparency and rebate dynamics, commercialization plans must be resilient to evolving channel economics and incentive structures.

·         MFN pricing raises the bar for value defense. The group explored how value added products can differentiate clinically and economically and how to build an evidence narrative that supports price in a more benchmark driven environment.

·         Distribution innovation is becoming a competitive advantage. Alternate models that strengthen patient access and reduce dependency on traditional intermediaries were highlighted as practical pathways to protect outcomes and experience.

The meeting reinforced a unifying point: the 505(b)(2) pathway is uniquely positioned to create defensible differentiation but only for teams that fully understand and apply best practices across the entire spectrum of commercialization and value development including regulatory strategy, evidence generation, market access, and commercial execution.

Thank you and what's next

VAMA thanks our speakers, members, and attendees for making the 6th Annual Meeting a standout success. The insights shared underscored a clear message: as policy and market conditions continue to shift, value added medicines teams can turn disruption into opportunity by aligning regulatory planning, evidence generation, pricing strategy, and distribution design. We look forward to continuing the conversation and welcoming the community back for next year’s program.