Cut the Chat Life Science Insider

A candid conversation on how small biotechs can build lean clinical development teams, decide what to keep in-house, work smarter with vendors, and protect their critical path without overbuilding.

How do you build a biotech team that is lean, accountable, and ready to execute?

In the first episode of Season 4 of Cut The Chat, Life Science Insider, Sabine Hutchison speaks with Ross Pettit, Chief Development Officer at Kestrel Therapeutics, about the practical realities of building a clinical development function in a small biotech.

Ross brings more than 30 years of clinical development experience across pharma and biotech, and in this conversation, he shares a clear view on what small sponsors should keep close, what they should outsource, and why senior experience early can make all the difference.

Together, Sabine and Ross discuss:

• why biotechs should outsource scale, not accountability
• how to decide which roles to hire and when
• why program management and financial planning are often underestimated
• what makes consultants feel like true team members
• how vendor relationships depend on trust, transparency, and healthy tension
• why clinical operations is a strategic function, not just execution

This episode is for biotech leaders, clinical operations teams, and anyone thinking about how to build the right team around an asset without burning runway on the wrong structure.

A practical conversation on how biotechs can read RFPs differently, avoid the fluency trap, challenge assumptions, and choose vendors that can actually deliver.

Every biotech faces this moment: the RFP looks perfect, polished, aligned, convincing. But does it actually signal readiness?

In this episode, Seuss+ CEO Kieran Engels joins Julia Vassiliadou (F2G) to break down why a beautiful proposal can mislead sponsors, what real signals of vendor readiness look like, and how biotechs can tailor the selection process to avoid costly mistakes.

Together, they unpack:

• Why we confuse polish with capability
• The four signals that a vendor is genuinely ready
• How to challenge assumptions during bid defenses
• Why risk-based thinking (ICH E6 R3) should shape sponsor decision-making
• How governance, oversight, and setup determine long-term CRO success

Whether you’re selecting your first CRO or refining your next vendor strategy, this conversation gives you the tools to see beyond the surface and choose smarter.

🎧 Listen now and don’t let polish fool you.

Clinical systems compliance sounds like a box to tick, until the box breaks your trial.

In this episode, Seuss+ CEO Kieran Engels and Lauren Alani, Director of Digital Innovation, reveal the blind spots many biotechs miss when it comes to system validation and data integrity.

From “fake data” to AI oversight, they unpack why compliance is not just about regulation these days, it’s about protecting the science, the patients, and the investment.

🎙️ Listen now to Beyond the Checklist: The Hidden Risks in Clinical Systems Compliance

📄 Read the whitepaper: Uncovering Hidden Risks in Clinical Systems Compliance

Quality isn’t just a checkbox — it’s a biotech differentiator.

What does “quality” really mean in biotech? And why does it so often get treated as a box to tick instead of a strategic advantage?

In this episode of The Life Science Insider, Sabine Hutchison speaks with Sandra van Loon about the realities of quality in biotech and clinical development. Together, they unpack why quality is more than compliance, what happens when it’s neglected, and how founders and leaders can make it a real driver of trust, execution, and long-term success.

🔹 Topics include:

• The difference between compliance and true quality
• Why quality failures cost more than quality systems
• How biotechs can embed quality early without slowing down
• Leadership lessons for building patient- and partner-ready organizations

In this episode, Seuss+ CEO and Co-Founder Sabine Hutchison sits down with Klaas Zuideveld, CEO of Versameb, to discuss the scientific, clinical, and societal implications of RNA-based therapies targeting stress urinary incontinence, a condition affecting hundreds of millions of women worldwide. Klaas shares his insights into Versameb’s lead program, VMB-100, and how their regenerative mRNA platform aims to transform women’s health by offering scalable, minimally invasive solutions. From novel anatomy discoveries and IND clearance to market misconceptions and funding barriers, this conversation unpacks the urgency, and opportunity of driving innovation in underserved therapeutic areas. Together, they explore why executional clarity and equity are essential for unlocking the future of RNA in clinical development.

A look inside the proposal engine room - and how sponsors can rethink pricing, pressure, and partnership.

Why do so many biotech sponsors feel blindsided by CRO proposals and change orders?

In this episode of The Life Science Insider, Kieran Canisius speaks with Joel White, Founder of Marketcap Consulting, about the mechanics behind clinical trial budgets, how CRO pricing actually works, and why misalignment happens.

Joel shares what he’s seen across 70+ pricing strategy projects, including blind spots in sponsor-CRO relationships and equipping teams to better manage expectations and minimize downstream issues.

You’ll hear:

• The behind-the-scenes realities of proposal creation
• What sponsors unintentionally get wrong about pricing
• How better sponsor inputs can prevent painful change orders

In this episode of The Life Science Insider, Kieran Canisius speaks with Limor Ben Har, COO of Prilenia Therapeutics, about what it takes to lead through complexity. Together they unpack the true meaning of biotech resilience - how a science-driven, patient-focused team turned unexpected data into a strategic partnership and renewed momentum.

Limor offers candid insight into neurodegenerative development, market expectations, and the power of staying mission-aligned through it all.

🎧 Subscribe to The Life Science Insider and follow Seuss+ for more behind-the-scenes biotech leadership stories.

The Life Science Insider is back with a brand-new video-first format — and this kickoff episode gets real fast.

In this raw, unscripted premiere, Seuss+ Co-Founders and Co-CEOs Kieran Canisius and Sabine Hutchison flip the script and interview each other—no prep, no pitch, just real talk about what’s quietly breaking biotech programs.

With decades in the biotech trenches, they expose the often-overlooked missteps in vendor selection, investor dynamics, and clinical execution that derail even the most promising studies.

You’ll hear:

• What vendors are still getting wrong in bid defense
• How “First Patient In” pressures can distort decisions
• Why poor vendor selection quietly unravels biotech success
• What needs to change—and what success actually looks like

💬 This episode is for biotech leaders, VCs, clinical ops professionals, and anyone tired of the trial-and-error approach to trial execution.

🔗 Learn more about Seuss+: https://www.seuss.plus

In this episode, Christina Busmalis and Sabine dive deep into the evolving intersection of AI and drug development. They explore the challenges and opportunities posed by digital endpoints, AI in drug discovery, and the growing role of sensors in clinical trials. Christina discusses the complexities of integrating AI in scientific processes, emphasizing the importance of trust in AI-generated data and the validation required to make these tools effective in real-world applications. The conversation also touches on the changing landscape of hiring in the biotech sector, highlighting how new graduates are bringing fresh perspectives and a willingness to embrace technology in scientific research. The episode concludes with insights on fostering collaboration between tech and science teams, with Christina sharing her experiences in bridging the gap between these two worlds at BenevolentAI.

We explore the transformative potential of digital endpoints in clinical trials, emphasizing their role in revolutionizing data collection for patients, regulators, and payers. Despite the FDA's recent qualification of the first digital endpoint, widespread adoption faces hurdles like unclear benefits, lack of use cases, and implementation complexities.

The Digital Medicine Society (DiMe) addresses these challenges through the "Building the Business Case for Digital Endpoints" initiative. This collaborative effort, involving nearly 40 organizations, aims to develop a framework to demonstrate the value of digital endpoints, aligning them with business goals and industry standards. The initiative provides open-source resources to encourage adoption and showcase the tangible benefits of digital strategies.

The episode features insights from Victoria Bangieva of DiMe and Lauren Alani of Seuss+, who discuss operational challenges and validation hurdles in deploying digital endpoints. They emphasize the importance of collaboration, robust validation, and a research-driven approach to implementation. The discussion highlights the significant ROI associated with digital endpoints, such as shorter trial durations and reduced recruitment costs, achieved by capturing real-time data in natural settings. This enhances the likelihood of successful clinical trials and encourages further investment and collaboration in the field.