Expedited regulatory pathways offer trial sponsors the opportunity to bring therapies to patients faster—especially in areas of high unmet need, such as oncology and rare diseases.
But navigating these pathways effectively requires strategic planning, cross-functional alignment, and a deep understanding of regulatory expectations both in the U.S. and EU.
This session offers a practical overview of key acceleration programs—such as Fast Track, Breakthrough Therapy Designation, Accelerated Approval, Priority Review, and the EMA’s PRIME and Conditional Marketing Authorisation—and how to apply them at the right time in your development journey. Experts will discuss how to design studies that align both protocols and endpoints with regulatory strategy, anticipate requirements for expedited review, and avoid late-stage surprises. With the FDA’s proposed National Priority Review Voucher program on the horizon, sponsors also need to stay ahead of emerging opportunities to support faster access.
Ben Kaspar, VP Global Regulatory Strategy at MMS, shares lessons from years of experience guiding INDs, NDAs/BLAs, and accelerated designations across multiple therapeutic areas. He’ll be joined by Sam Miller, VP of Statistical Consulting Services, who explores the role of modelling, early efficacy markers, and surrogate endpoints in supporting accelerated approvals.
The session concludes with a live panel discussion moderated by Ben Dudley, Chief Commercial Officer at MMS, where panelists share real-world insights and answer audience questions.
Key Takeaways Include:
- How to match FDA and EMA acceleration programs to your development goals
- Ways to leverage surrogate and intermediate endpoints for faster approvals
- What to do if an official designation isn’t granted and how to stay on track
- How the upcoming FDA National Priority Review Voucher program may affect strategy
- The role of early efficacy markers and modelling in regulatory decision-making
Key Takeaways Include:
- How to match FDA and EMA acceleration programs to your development goals
- Ways to leverage surrogate and intermediate endpoints for faster approvals
- What to do if an official designation isn’t granted and how to stay on track
- How the upcoming FDA National Priority Review Voucher program may affect strategy
- The role of early efficacy markers and modelling in regulatory decision-making
Meet the Speakers
Ben Kaspar
VP, Global Regulatory Strategy, MMS
As VP, Regulatory Strategy at MMS, Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases. Ben and the MMS strategists can also adapt regional strategies to meet the needs of a global development plan, reflecting applicable domestic and international requirements, working with regionally based representatives as needed to achieve the sponsor’s ambitions. With a unique combination of strategic expertise and submissions best practices, Ben and team have been responsible for numerous Investigational New Drug Applications (INDs), multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and an average of 10 New Drug Applications each year. Ben is a graduate of Case Western Reserve University with a master’s degree in Biochemistry.
Sam Miller
VP, Statistical Consulting Services, MMS
Sam has over 25 years’ experience as a statistician in the pharmaceutical industry and as Vice President, Consulting Services he oversees the Biometrics Strategic Consulting team. As well as ensuring key statistical provision for a range of complex projects with a focus on optimal trial design, he is also Product Owner for KerusCloud, MMS's clinical trial simulation platform. With a BA in Mathematics from the University of Cambridge and an MSc in Statistics from University College London, Sam has broad knowledge of statistical analysis and design techniques and gained in-depth experience of the industry at GlaxoSmithKline where he provided statistical support to clinical projects at all stages of discovery and development. This included everything from FTIH studies through proof of concept and dose-ranging trials to pivotal studies supporting regulatory submission, as well as statistical input to portfolio-level decision-making across multiple drug projects. Sam has co-authored over 50 articles in medical and statistical publications and has extensive expertise in experimental medicine, adaptive designs and the application of Bayesian approaches to clinical trial design and analysis. This enables him to take an innovative and flexible approach to developing new methods for facilitating earlier and better-informed decision-making in the development path of novel treatments.
Ben Dudley
Chief Commercial Officer, MMS
Ben is a seasoned executive with experience gained over a 27-year career in the industry, in both the biopharma and clinical development services sectors. Ben’s deep, broad expertise spans drug development, sales and customer relationship management, operational leadership, and process optimization. He has led truly global teams and diverse delivery portfolios.
Before joining MMS, Ben served as EVP, Head of Global Project Leadership at Parexel, where he was responsible for delivering the full-service clinical project portfolio globally, across biotech and large-pharma segments. Prior roles at Parexel included key sales leadership and strategic partnership positions with large pharma customers. His impressive career also includes leadership roles at Covance and AstraZeneca, where he consistently demonstrated his ability to lead and innovate across various operational, functional, and commercial domains.
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