Anne Heyes | Vice President, Head of Value Strategy
RTI Health Solutions
MBA Diploma in Health Economics Research University of Keels, United Kingdom BSC Botany University of Sheffiled, United Kingdom Anne Heyes has more than 30 years of experience in indistry and consultancy. She has expertise in all aspects of market access strategy, evidence development and implementation including value strategies, value communications and stakeholder research and has led several teams of specialists responsible for providing clients with effective tailored solutions to support market access for new products. Ms. Heyes has experience in a wide range of therapeutic areas, including rare diseases, oncology, pain, metabolic disorders, immunosuppression, gastroenterology., cardiovascular, urology, central nervous system and hematological disorders. Prior to joining RTI-HS Ms. Heyes held leadership roles in Global Health Economics and Outcomes Research at AstraZeneca where she was responsible for the development and implementation of market access strategies and evidence generation to support new propducts. She then led the market access team within an international consultany. She has experience in drug developmemnt and market access in the clinical and commercial areans in both global and local settings. Ms, Heyes is a member of the International Society for Pharmaceconomics and Outcomes Research.
Appearances:
Day 2 - World Orphan Drug Congress USA 2025 @ 14:20
Panel: Giving voice to rare diseases during joint clinical assessment
Starting January 13, 2028, orphan medicines will be required to undergo Joint Clinical Assessments (JCAs) as part of the EU Health Technology Assessment Regulation (HTAR). Manufacturers must prepare and submit JCA dossiers documenting the comparative efficacy and safety of their products against relevant comparators across EU member states. However, applying the same rigorous standards to orphan medicines as to other drugs presents unique challenges, including small patient populations, limited evidence, treatment variability, and high levels of uncertainty.
This panel will feature Victor Maertens, Government Affairs Director at EUCOPE and a leading expert in European policy and government affairs, Patrick Hopkinson an experienced representative from the pharmaceutical industry, and Sorrel Wolowacz, Vice President at RTI Health Solutions, who is an expert in innovative methods for demonstrating value in orphan medicines. The session will be moderated by Anne Heyes, Vice President at RTI Health Solutions.
The panelists will share insights from policy, patient advocacy, and industry perspectives on how they are preparing for these upcoming changes. They will discuss strategies for overcoming challenges associated with JCAs and highlight key advocacy efforts aimed at ensuring that the unique needs of orphan medicines are addressed under the new framework.
This session is essential for stakeholders seeking to navigate the evolving regulatory landscape while maintaining access to life-saving therapies for rare disease patients.
Sponsored by RTI Health Solutions.
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