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.

In the second episode of season 2, host Sabine Hutchison, Seuss+ CEO and Co-Founder, is joined by the dynamic Kirsten Detrick, whose extensive experience in biotech and pharma comes through in her insightful advice to listeners.

Many biotechs think they don't need to focus on the commercialization aspect of the business because they’re planning to sell the asset or partner with another organization to take it to market. Others believe they’ve got such a great molecule it will sell itself. Kirsten doesn’t agree. This episode takes a different look at commercialization, particularly exploring why it’s crucial from the start.

In a conversation jam-packed with insights, Sabine and Kirsten cover product differentiation, target product profiles, commercialization, and more. You won’t want to miss this episode: Kirsten mines her three decades of experience acquiring and launching multi-billion-dollar blockbusters and shares four areas for biotechs to focus on.

One fact becomes clear: commercialization isn’t just something to think about at the end of a successful clinical trial, it should be embedded from day one. Listen to this episode to find out why and how.

Kirsten Detrick Bio

Kirsten Detrick is a senior biotech executive who pursued a distinguished career with Fortune 10 biopharma organizations and who now serves as a strategic adviser for life sciences start-ups in the US and Europe as the Founder of Parke-Hadley Advisors LLC. Detrick has more than 30 years of experience as an established P&L leader, a strategic marketing and sales expert, and a general manager. She has successfully commercialized and launched multiple new therapeutics and built corporate drug pipelines for global biopharma organizations including Amgen, Bristol Myers Squibb, and Takeda.

In total, Kirsten estimates that if you added up the annual revenue from the "peak" sales on the drugs she's led or launched, it would total more than $26.5 billion. Remember - that would be just ONE year of revenue! More importantly, Kirsten's proud of the work she'd done to help hundreds of thousands of patients fight grievous illnesses like rheumatoid arthritis, psoriasis, ulcerative colitis, Crohn's disease, acute coronary syndromes, osteoporosis... the list of categories in which Kirsten has worked is very, very long.

Join the discussion and listen to the full episode here.

Sabine Hutchison talks to the inspiring investor Stephanie Oestreich.

In the first episode of season 2, host Sabine Hutchison, Seuss+ CEO and Co-Founder, is joined by the inspiring Stephanie Oestreich, whose work at the Myeloma Investment Fund (MIF) involves applying financial investment, scientific knowledge and valuable connections to reach a cure for every single Myeloma patient.

At MIF, Stephanie uses the investment and drug development knowledge and skills she has gained in several leadership roles in biotech and big pharma.

In this engaging conversation, Sabine talks to Stephanie about the challenges involved in running a specialty fund, and what she looks for in potential investments. Stephanie shares that MIF’s North Star is finding a cure for patients, and why it’s valuable for investors to visit clinical trial sites to see their work in action.

Stephanie Oestreich – Bio

Stephanie Oestreich is Managing Director of the Myeloma Investment Fund (MIF). She serves on the boards of the German American Business Council in Boston and the Harvard Kennedy School’s Women’s Network and is the chair of the McCloy Alumni Association.

She is also on the faculty of MIT, a member of the Launchpad Venture Group, an advisor at grIP Venture Studio, to Biognosys (a Bruker company), Invitris, CART company CelineTx and to the drug development and investment company OrangeGrove Bio, Additionally she works on the W20 Entrepreneurship task force, the official engagement group of the G20.

Stephanie has held several leadership roles in biotech, including Chief Business Officer at Galecto, Vice President at cell therapy company Mnemo Therapeutics, Venture Partner at RA Capital and Executive Vice President at Evotec, where she built its North American investment arm and started an incubator with Samsara BioCapital. She has worked as International Business Leader at F. Roche Hoffmann-La Roche Ltd., and for Novartis in Business Development and in Commercial.

Stephanie conducted the research for her Ph.D. in biochemistry in the lab of a Nobel Prize winner at Harvard Medical School and obtained an MPA from the Harvard Kennedy School.

She is also a semi-professional violinist, performing with Philharmonic orchestras in Carnegie Hall and other international venues and conducting workshops with live orchestras, demonstrating the similarities between teams and leadership in music and management.

Join the discussion and listen to the full episode here.