AI is rapidly entering biometrics workflows — but what actually holds up under FDA review, and where do teams most often go wrong?

Speakers & Moderator

In this episode of AI on the Hill, we bring together perspectives from the U.S. FDA, global biostatistics leadership, and legal experts to unpack how AI is being evaluated in regulated clinical development today, beyond hype, demos, or exploratory use cases.

The conversation dives into the real pitfalls sponsors face when applying AI to biometrics, including bias risks, validation gaps, governance challenges, and the blurred line between decision support and submission-grade evidence. Panelists discuss why AI is not yet ready to serve as a clinical endpoint, how AI-generated analyses may (or may not) complement pivotal trials, and what FDA reviewers actually look for when AI influences statistical analysis or decision-making.

Key topics include:

This episode is essential listening for professionals in biostatistics, biometrics, clinical development, regulatory affairs, and AI-enabled analytics who want a clear, regulator-aware view of where AI truly fits, and where caution is still required.

Recorded live | Public Zoom Webinar

This is an excerpt from Pipettes to Prompts — From Pipettes to Prompts: Reprogramming Science with AI (Part 6/6).

René and Yaoyu dive into the founder’s journey — from the thrill of building Cypher AI to the challenges of entrepreneurship, AI ethics, and keeping humans in charge of technology. Yaoyu shares moving stories about innovation, responsibility, and his belief that technology must serve humanity.

Tune in for insights on:

Lessons from launching Cypher AI

AI’s evolving role in science and productivity

Why “humans in the loop” is the future of innovation

You can connect with our host, René Bastón, on LinkedIn: https://www.linkedin.com/in/renebaston/

And our guest, Yaoyu Yang, on LinkedIn: https://www.linkedin.com/in/yaoyuyang/

For more information on any of the topics discussed, visit the Hill Research Podcast at: https://www.hillresearch.ai/podcast

This is an excerpt from Pipettes to Prompts — From Pipettes to Prompts: Reprogramming Science with AI (Part 5/6).

After years inside Ginkgo Bioworks, Yaoyu recognized a universal truth: scientists still live in Excel Hell. In this episode, he breaks down why even the most sophisticated lab systems can’t replace spreadsheets — and how that frustration inspired the founding of Cypher AI.

Tune in for insights on:

Why scientists cling to Excel despite better tools

The real-world pain points of lab software

How flexibility and creativity drive scientific innovation

You can connect with our host, René Bastón, on LinkedIn: https://www.linkedin.com/in/renebaston/

And our guest, Yaoyu Yang, on LinkedIn: https://www.linkedin.com/in/yaoyuyang/

For more information on any of the topics discussed, visit the Hill Research Podcast at: https://www.hillresearch.ai/podcast

This is an excerpt from Pipettes to Prompts — From Pipettes to Prompts: Reprogramming Science with AI (Part 4/6).

Yaoyu recounts his years at Ginkgo Bioworks, where he helped design large-scale software systems for synthetic biology. He explains how “foundry thinking” changed his view of biology, and why building the right abstractions is as much art as engineering.

Tune in for insights on:

How Ginkgo’s foundry model transformed biotech

Building scalable tools for biological engineering

Lessons from the Redwood Award–winning team

You can connect with our host, René Bastón, on LinkedIn: https://www.linkedin.com/in/renebaston/

And our guest, Yaoyu Yang, on LinkedIn: https://www.linkedin.com/in/yaoyuyang/

For more information on any of the topics discussed, visit the Hill Research Podcast at: https://www.hillresearch.ai/podcast

This is an excerpt from Pipettes to Prompts — From Pipettes to Prompts: Reprogramming Science with AI (Part 3/6).

Can AI ever replace scientific intuition? In this thought-provoking exchange, Yaoyu shares why he believes in human intelligence over computational intelligence, and René challenges the common myths about fully automated discovery.

Tune in for insights on:

The limits of “AI scientists”

Why human intuition still matters in discovery

Balancing automation with creativity

You can connect with our host, René Bastón, on LinkedIn: https://www.linkedin.com/in/renebaston/

And our guest, Yaoyu Yang, on LinkedIn: https://www.linkedin.com/in/yaoyuyang/

For more information on any of the topics discussed, visit the Hill Research Podcast at: https://www.hillresearch.ai/podcast

This is an excerpt from Pipettes to Prompts — From Pipettes to Prompts: Reprogramming Science with AI (Part 2/6).

René and Yaoyu discuss the creation of Aquarium, a laboratory operating system that lets researchers design and execute experiments as code. Yaoyu explains how he helped bring software engineering discipline into wet-lab science and why reproducibility depends on good abstractions.

Tune in for insights on:

Translating experiments into executable code

The origins of lab automation at the University of Washington

Why abstraction is both engineering and art

You can connect with our host, René Bastón, on LinkedIn: https://www.linkedin.com/in/renebaston/

And our guest, Yaoyu Yang, on LinkedIn: https://www.linkedin.com/in/yaoyuyang/

For more information on any of the topics discussed, visit the Hill Research Podcast at: https://www.hillresearch.ai/podcast

This is an excerpt from Pipettes to Prompts — From Pipettes to Prompts: Reprogramming Science with AI (Part 1/6).

In this episode, host René Bastón, Venture Partner at Covenant Venture Capital, speaks with Yaoyu Yang, Founder & CEO of Cypher AI and former engineer at Ginkgo Bioworks, about his unlikely leap from electrical engineering to biology.

Yaoyu shares how a single class in biology transformed his academic path, leading him from circuits to cell systems, and how curiosity became his strongest career engine.

Tune in for insights on:

Bridging engineering and life sciences

How curiosity fuels scientific breakthroughs

The mindset behind cross-disciplinary innovation

You can connect with our host, René Bastón, on LinkedIn: https://www.linkedin.com/in/renebaston/

And our guest, Yaoyu Yang, on LinkedIn: https://www.linkedin.com/in/yaoyuyang/

For more information on any of the topics discussed, visit the Hill Research Podcast at: https://www.hillresearch.ai/podcast

In this episode of AI on the Hill, host René Bastón sits down with Yaoyu Yang, Founder & CEO of Cypher AI, to explore one of the most fascinating questions of our time: Can AI truly be a scientist?

With over a decade at the intersection of biology and software, Yaoyu has built systems that redefine how experiments are designed and executed, from developing Aquarium at the University of Washington to architecting platforms at Ginkgo Bioworks, and now leading Cypher AI, where he’s building the world’s first AI software engineer for scientists.

Together, they discuss how human-in-the-loop AI is empowering, not replacing, researchers, what it means to turn pipettes into prompts, and how the future of discovery will depend on collaboration between human creativity and machine intelligence.

This episode dives deep into the evolving relationship between humans, AI, and science, and what it means to rethink intelligence itself.

This is an excerpt from From Wall Street Beats to Biotech Breakthroughs — Dean’s journey from DJ booths and banking to leading AI-driven clinical trial innovations (Part 6/6).

In this final episode, host René Bastón, Venture Partner at Covenant Venture Capital, wraps up the conversation with Dean Zheng, Clinical Outsourcing Professional at Pfizer, by exploring the career and life lessons Dean has learned along the way.

Dean reflects on why he has no regrets about his unconventional career path and how experiences from DJing to investment banking shaped his professional mindset. He shares the importance of setting both short- and long-term goals, thinking strategically about career moves, and keeping perspective on the bigger picture.

Tune in for valuable insights on:

The benefits of diverse career experiences

Strategic thinking for long-term success

Balancing professional ambition with personal goals

You can connect with our host, René Bastón, on LinkedIn:

And our guest, Dean Zheng, on LinkedIn: https://www.linkedin.com/in/dean-mingyang-zheng-0ab336108/

For more information on any of the topics discussed, visit the Hill Research Podcast at:

This is an excerpt from From Wall Street Beats to Biotech Breakthroughs — Dean’s journey from DJ booths and banking to leading AI-driven clinical trial innovations (Part 5/6).

In this episode, host René Bastón, Venture Partner at Covenant Venture Capital, explores with Dean Zheng, Clinical Outsourcing Professional at Pfizer, how pharma companies are rethinking their relationships with vendors.

Dean breaks down the pros and cons of in-house, fully outsourced, and hybrid Functional Service Provider (FSP) models. He explains why a hybrid approach—embedding vendor talent within sponsor teams—offers transparency, faster turnaround times, and reduced risk, especially for smaller biotech firms.

Tune in for valuable insights on:

The benefits and drawbacks of different vendor models

How hybrid FSP partnerships drive efficiency

Reducing risk while maintaining quality in clinical trials

You can connect with our host, René Bastón, on LinkedIn:

And our guest, Dean Zheng, on LinkedIn: https://www.linkedin.com/in/dean-mingyang-zheng-0ab336108/

For more information on any of the topics discussed, visit the Hill Research Podcast at: