RAPS Bay Area: In-Person Discussion on Trial Design & Regulation
We’re pleased to partner with RAPS for this engaging, in-person event focused on the evolving role of regulatory professionals in trial design strategy. Through an interactive, discussion-driven format, our expert panel will explore how collaboration between regulatory, clinical, and statistical teams can accelerate development timelines, reduce patient burden, and mitigate regulatory risk. Learn how early cross-functional alignment leads to more efficient pathways and better-informed decisions.
Registration Fees
This event is free to attend for both RAPS members and non-members, join us for an insightful evening followed by refreshments.
Event details:
- Date: Thursday 26th June 2025
- Location: Cytokinetics Headquarters, 280 E Grand Ave, South San Francisco, CA 94080
- 5:00-5:30pm (PST) Registration/networking
- 5:30-7:00pm (PST) Moderated panel discussion and audience Q&A
- 7:00-8:00pm (PST) Networking
Agenda
This RAPS panel-led session, brought to you by MMS and featuring Aiden Flynn, SVP Statistical Consulting, Ben Kasper, VP of Regulatory Strategy, Stephen Heitner
VP, Clinical Research at Cytokinetics and April Nguyen, Senior Global Regulatory Affairs Manager and Panel Moderator 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.
Register Now
Deadline for registration is Friday 20th June.
This event is free to attend for both RAPS members and non-members. Registration is now open.
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.
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.
- 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.
Speaker bios
Senior Global Regulatory Affairs Manager
Moderator:
April puts patient care at the forefront of everything she does – from supporting life-changing therapies in her Regulatory Strategist role at MMS, to advocating for care in marginalized communities as a patient advocate. With her background in public health and pharmacy, she brings a unique blend of scientific understanding and strategic business insights to the regulatory submissions she coordinates as NDA Lead.
Dr. Nguyen is a public speaker in the pharmaceutical industry and public health space, and has previously served on the Advisory Board for the Industry Pharmacists Organization. In addition to serving as an active volunteer with the local RAPS-SF chapter, she is the founder of the international initiative Pharmacy Legislative Week. She has been recognized nationally as one of the Top 50 Influential Pharmacy Leaders.
VP, Clinical Research at Cytokinetics
Panelist:
Prior to joining Cytokinetics, Steve served as Associate Professor of Medicine and Chief of the Knight Cardiovascular Clinical Research Institute at Oregon Health and Science University. As a result of Steve’s experience and accomplishments in cardiovascular medicine, he has been recognized internationally for his contributions in the field, particularly in hypertrophic cardiomyopathy and cardiac amyloidosis.
Steve received his M.D. from the University of the Witwatersrand in Johannesburg South Africa. He completed his internal medicine residency and chief residency at Albert Einstein Medical Center in Philadelphia, PA and his cardiology fellowship at Cooper University Hospital in New Jersey.
Senior Vice President, Head of Strategic Statistical Consulting
Aiden is currently Senior Vice President of Statistical Consulting at MMS, where he plays a key leadership role in advancing innovative statistical solutions and expanding the company’s global impact in clinical development. Prior to the acquisition of Exploristics by MMS in 2025, Aiden was the CEO of Exploristics.
Aiden brings deep expertise in emerging clinical development strategies, including Precision Medicine and biomarker discovery, validation, and integration. He has worked extensively with regulatory agencies such as the FDA and EMA to help shape tools and guidelines supporting biomarker use in clinical studies.
He has authored over 40 publications in peer-reviewed journals and books and is a frequent invited speaker at international conferences. Aiden also serves on the Precision Medicine Advisory Board at Merck Biopharma and contributes strategic guidance as part of the Precision Medicine Steering Group for the Department of Health. Additionally, he holds the role of Commercial Director on the Board of Directors at PSI.
Vice President, Regulatory Strategy
Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life cycle, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas, including rare diseases.
With a unique combination of strategic expertise and submissions best practices, Ben and his 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.