EXPERT PANEL DISCUSSION

MassBio Panel on Advancing Development

Learn Innovative Trial Design and Regulatory Strategies

Join us at the MassBioHub in Cambridge, Massachusetts (USA) on March 12, 2025 for this exclusive event and expert panel discussion showcasing the impact of unified trial design and regulatory strategies on derisking and accelerating clinical development.

Event details:

Arrive for registration – Doors open at 11:30 AM
Panel discussion – 12:00-12:45 PM
Post discussion lunch from 12:45-1:30 PM

This panel-led session, brought to you by MMS and featuring Aiden Flynn, SVP Statistical Consulting, Amanda Beaster, Director Regulatory Strategy, and Ben Dudley, Chief Commercial Officer, will examine real-life design optimization case studies, including using powerful statistical simulation software like KerusCloud. The presenters will explore innovative strategies including Real-world-data (RWD) augmentation, innovative trial designs, model-informed drug development, the role of statistical simulation in optimizing the probability of success, and best-practices for Regulatory risk management when pursuing non-standard designs. At the conclusion of the panel discussion, there will be the opportunity for the audience to ask the experts their most pressing questions in an interactive Q&A.

Registration is open for attendees from pharmaceutical and biotechnology organizations.

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Secure faster regulatory and development pathways

Biotech organizations face a series of high-stakes decisions as they design their clinical development programs. These decisions include trade-offs between factors such as speed and cost, as well as delivery and regulatory risk. In this balancing act, too often, companies default to traditional study designs and endpoints, often missing opportunities for innovative approaches that could reduce patient numbers or secure a faster regulatory pathway.

This hesitation is sometimes driven by lack of knowledge of what is possible, concerns about acceptance by regulators, and implementation challenges.

Increase Speed and Decrease Risk

Close collaboration between scientific leaders in biopharmaceutical companies, statistical design experts, seasoned in R&D strategy and leveraging powerful simulation tools, as well as Regulatory Affairs Strategists can identify the optimal clinical trial designs that meet the parallel aims of improving R&D outcomes. This includes increased probability of success, decreased risk, decreased cost, increased label coverage, and increased speed, while selecting and de-risking the optimal pathway through to acquisition and/or Marketing Authorization.

In some cases, these savings can be measured in years, and for many, in tens of millions of dollars.

Attend the session and learn:

How innovative trial designs, optimized endpoints, statistical simulations, and virtual patient populations can accelerate approvals and reduce patient burden.
How tools like KerusCloud can streamline development by modeling trial scenarios, optimizing patient numbers, and improving decision-making.
How aligning scientific, statistical, and regulatory teams from the outset drives more efficient trial strategies.
What regulatory best practices should be adopted alongside innovative design approaches.

Meet our team

**Ben Dudley**
*Chief Commercial Officer*

Ben Dudley is Chief Commercial Officer at MMS. His career in the industry spans over 25 years in both the biopharma and clinical development services sectors. Ben’s deep, broad expertise spans drug development, customer relationship management, operational leadership, and process optimization. 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.

**Amanda Beaster**
*Director, Regulatory Strategy*

Amanda Beaster, Ph.D., is Director, Regulatory Strategy at MMS. Dr. Beaster is a thought leader in pharmaceutical industry regulations and earned her doctorate in philosophy, microbiology, and immunology from the University of South Alabama. At MMS, Amanda works with pharmaceutical and biotechnology clients to provide strategic guidance on regulatory pathways, empowering trial sponsors to navigate complexity and bring safe, effective treatments to market.

**Aiden Flynn**
Senior Vice President, Head of Strategic Statistical Consulting

Aiden Flynn co-founded Exploristics, and is now Senior Vice President, Head of Strategic Statistical Consulting at MMS. Aiden has 25 years’ experience as a statistician in drug discovery and clinical development. After seven years as a Lecturer at University College London, Aiden spent ten years at GlaxoSmithKline as a Director of Statistical Support for Biomarker Studies across research and development before founding Exploristics in 2009.