Project Optimus and what you need to know about it

Project Optimus and what you need to know about it

Author: Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry July 21, 2026 Duration: 25:01
Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace? In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology. Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability. Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

Hosted by Alexander Schacht and Benjamin Piske, both practicing biometricians and leaders within the pharmaceutical industry, The Effective Statistician-in association with PSI is a conversation about the practical realities of the profession. This isn't a theoretical lecture series; it's a resource built from the ground up by statisticians who navigate the same challenges you do every day. The discussions focus on actionable strategies for increasing your influence and efficiency, whether you're analyzing data, presenting findings, or guiding a team. You'll hear perspectives on developing leadership qualities even without a formal management title, and gain insight into current debates within the scientific and regulatory communities. The aim is to provide context for the health sector's evolving landscape, translating complex industry dynamics into relevant knowledge for your work. Tune in for a candid exploration of what it means to be a modern statistician, designed to help you refine your approach and achieve a more significant impact. This podcast serves as a professional toolkit, created in association with PSI (Promoting Statistical Insight), for statisticians at any career stage looking to deepen their expertise and navigate their roles with greater confidence and clarity.
Author: Language: English Episodes: 50

The Effective Statistician - in association with PSI
Podcast Episodes
Will AI Replace Statisticians? The Future of Statistics in Pharma [not-audio_url] [/not-audio_url]

Duration: 24:32
Will artificial intelligence make statisticians obsolete—or make our expertise even more valuable? In this episode, I speak with independent statistical consultant Chris Harbron about how AI could reshape the role of sta…
Understanding and Mitigating Endpoint Bias in External Control Arms [not-audio_url] [/not-audio_url]

Duration: 28:41
External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations. In this episode, I speak with Ben Ackerman, Director of Real-…
The Future of Statistical Methodology in Drug Development [not-audio_url] [/not-audio_url]

Duration: 31:52
This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI int…
Rethinking Programming Validation and Traceability in Clinical Trials [not-audio_url] [/not-audio_url]

Duration: 23:24
In this episode of The Effective Statistician, I speak with Andrew (Andy) York about the evolving world of programming validation, traceability, and quality assurance in clinical trials. Andy has decades of experience in…
How Applied Improvisation Develops and Reinforces Interpersonal Skills [not-audio_url] [/not-audio_url]

Duration: 33:16
In this episode, Alun Bedding speaks with Richard Zink about how **applied improvisation** can help statisticians become more effective communicators and leaders. They explore how improv techniques—like “yes, and,” activ…
What does a clinical lead expect from a statistician? [not-audio_url] [/not-audio_url]

Duration: 32:12
Episode Overview In this episode, I speak with Anna Mosikian, a physician by training and Global Clinical Program Lead working at the intersection of clinical development and strategic marketing. Anna brings a powerful p…
Measuring Trust – A Key to Effective Leadership [not-audio_url] [/not-audio_url]

Duration: 27:51
Trust is one of the most fundamental elements of effective leadership—and yet, most organizations don’t measure it properly. In this episode, I speak again with my good friend Alun Bedding about how we can move from talk…