Biotech and pharma organizations face a series of high-stakes decisions as they design their clinical development programs. These decisions often involve trade-offs between speed, cost, patient burden, and regulatory risk. In this balancing act, many sponsors default to traditional study designs and endpoints, missing opportunities for more innovative approaches that could reduce sample sizes or accelerate the path to approval. This hesitation is often driven by uncertainty around regulatory acceptance, a lack of awareness of available tools, and concerns about implementation.
Close collaboration between clinical and statistical experts, and regulatory strategists, especially when leveraging powerful simulation tools, can pave the way for more effective trial designs that increase the probability of technical and regulatory success, reduce development timelines and costs, and improve regulatory patient outcomes. Regulatory professionals are uniquely positioned to shape and influence these discussions early, helping teams enable innovation with regulatory foresight. This integrated, strategic approach can save years of development time and tens of millions of dollars.
This discussion-driven session will feature Steve Heitner, VP Clinical Research of Cytokinetics, Aiden Flynn, SVP Statistical Consulting at MMS, and Ben Kaspar, VP Regulatory Strategy at MMS. The discussion will be moderated by April Nguyen, Associate Director Regulatory Strategy at MMS and RAPS SF Chapter volunteer. The panel will explore novel strategies—including real-world data (RWD) augmentation, innovative trial designs, and statistical simulations—that can reduce development timelines and patient burden. The session will explore regulatory considerations and best practices for engaging with FDA and other agencies when pursuing non-standard trial designs.
At the conclusion of the panel discussion, there will be an opportunity for the audience to ask questions and engage directly with the speakers in an extended interactive Q&A.
Registration Fees & Deadlines
Free
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda
5:00-5:30 pm Registration/networking
5:30-7:00 pm Moderated panel discussion and audience Q&A
7:00-8:00 pm Networking
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.
Panelists
Steve is Vice President and Head of Clinical Research at Cytokinetics. He joined the company in 2020 where he led and facilitated strategies across all cardiovascular programs. Steve has been instrumental in managing clinical trials with complex designs while ensuring cross-functional collaboration.
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.
Aiden Flynn, PhD
SVP, Head of Strategic Statistical Consulting at MMS
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.
Ben Kaspar
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, 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.
Sponsored
MMS
Donated Food and Drink
Location
Cytokinetics
350 Oyster Point Blvd
South San Francisco, CA 94080
For directions, please click here.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.