Conferences & Engagement

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Regal Intel is proud to announce its participation in the Orphan Drug Summit 2025 in Boston, where our own Dr. Sanjay Ahuja will be a featured speaker on the crucial "Unlocking Funding and Market Access for Orphan Drugs" panel. This summit, with its focus on real-world case studies, showcasing innovation, expert insights, multidisciplinary approaches, smart technologies, and collaborative discussions, perfectly aligns with Regal Intel's mission to drive the success of complex pharmaceutical products in challenging markets. Our commitment to navigating intricate regulatory landscapes, optimizing commercialization strategies, and leveraging cutting-edge analytics directly supports the advancement of therapies for rare diseases, ultimately ensuring these vital treatments reach the patients who need them most.

Regal Intel understands that bringing orphan drugs to market involves unique complexities, from initial research and development to patient access and commercial viability. We specialize in providing comprehensive, data-driven solutions that address these challenges head-on. Our expertise spans strategic regulatory planning, robust clinical evidence generation, and the establishment of resilient global supply chains, all critical components for attracting investment and achieving sustainable market penetration for rare disease therapies.

Regal Intel's Dr. Sanjay Ahuja will contribute to a critical discussion on the multifaceted challenges and opportunities in securing funding and ensuring market access for orphan drugs. This panel will delve into strategic approaches across the entire product lifecycle, emphasizing how robust regulatory pathways, innovative clinical evidence generation, Artificial Intelligence, and resilient quality and supply chain systems are paramount to attracting investment and achieving sustainable commercialization. The discussion will highlight the interconnectedness of these elements in overcoming the unique hurdles faced by rare disease therapies, ultimately paving the way for broader patient access.

The panel will explore how a proactive and sophisticated global AI regulatory strategy, including the strategic use of expedited pathways, can significantly enhance an orphan drug's attractiveness to investors and accelerate its path to sustainable market access. Discussions will also focus on innovative clinical trial designs, the critical role of Real-World Evidence (RWE), and robust post-market surveillance plans in generating compelling data for funding decisions and long-term market acceptance. Furthermore, the importance of comprehensive Quality Management Systems (QMS), meticulous supplier qualification, and a resilient global supply chain strategy—including strong import/export compliance and certifications—will be addressed as non-negotiable factors for assessing a drug's commercial viability and potential for broad market access.

Panel Title: Unlocking Funding and Market Access for Orphan Drugs Date: Wednesday, July 16, 2025 Time: 11:00 AM - 11:30 AM EDT Moderator: Alan Minsk | Arnall Golden Gregory LLP

Panelists:

• Vishal Singal | Beghou Consulting
• Maxim Miller | Caerus Intel LLC
• Christian Rubio | EverythingALS
• Chris Smith | SmithSolve
• Sanjay Ahuja | Regal Intel

We look forward to connecting with you at the Orphan Drug Summit 2025 and engaging in these vital discussions.