Maximizing Trial Value in Resource-Constrained Biotechs
In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, speaks with Nathalie Riebel, CEO and founder of Oncospire Consultants, a consultancy specializing in small biotechs. Nathalie points to the $80 billion pharma outsourcing market and the performance and quality challenges that accompany it. The data consistently shows that this massive transfer of work is plagued by delays, quality failures, sponsor dissatisfaction, and governance gaps that remain stubbornly unresolved. The conversation emphasizes the need for small biotechs to effectively manage vendors and drive results. Oncospire’s “Clinical Momentum Method” helps companies to streamline processes and reduce oversight time. Oncospire provides packages for CRO selection, gap assessment (Critical Path Visibility Assessment), and operational improvements, aiming to save small biotechs time and money in the management of their full-service CROs and vendors.
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Guest Profile – Nathalie Riebel, CEO and Founder, Oncospire Consultants
Most people advising small biotechs on their CRO choice and relationships have never actually worked inside a CRO. Nathalie Riebel has — for 15 years. She’s also spent 15 years inside large pharma and the last decade inside small biotech itself, where the stakes are existential and the margin for error is razor thin. That full-circle view is what she now brings to Oncospire Consultants, helping biotech leaders select, manage, and maintain meaningful oversight of the outsourced relationships their programs depend on. Bringing clarity without losing control of their own science.
Introduction and Overview of Court Square Group
- Keith Parent introduces himself as the CEO of Court Square Group, a managed service firm specializing in IT infrastructure for life science companies.
- Court Square Group offers an Audit Ready Compliant Cloud (ARCC™) for hosting and managing applications from preclinical to manufacturing stages and RegDocs365™, a content repository for clinical and regulatory content.
- The company also provides a service called Life Science LaunchPAD, designed to help companies scale from preclinical to manufacturing stages.
- Keith explains the purpose of the podcast, which is to highlight the various roles in the business side of running life science companies.
Keith Parent’s Background and Purpose of the Podcast
- Keith mentions his experience in the industry and the reasons for starting the podcast.
- He introduces the guest, Nathalie Riebel, whom he met at a Marcus Evans event many years ago.
- Nathalie shares her 35-year career journey, including her experience in large pharma, CROs, and small biotechs.
- Nathalie discusses the creation of her consulting company to help small biotechs thrive through optimal management of vendors conducting their clinical trials.
Challenges in Outsourcing and Quality Issues
- Nathalie highlights the significant amount of money pharma spends on outsourcing annually and the delays and quality issues that have been seen across industry surveys in the last 3 years..
- She emphasizes the challenges small biotechs face due to governance gaps and quality failures in outsourcing.
- Keith and Nathalie discuss the transition from large pharma to small biotechs and the challenges employees face in adapting to smaller, less structured environments.
- Nathalie uses an analogy of transitioning the crew from a large cruise ship to a small high tech yacht to explain the differences in management, adaptation, flexibility and resources.
Transitioning from Large Pharma to Small Biotechs
- Nathalie elaborates on the analogy, explaining how employees from large CRO or pharma companies have a steep learning curve to adapt to the smaller, more hands-on roles in small biotechs.
- Keith adds to the analogy by explaining how his company manages the IT infrastructure, similar to the below-the-water-line operations of a ship.
- They discuss the importance of efficiency and clarity in small biotechs compared to the specialized roles in large companies.
- Nathalie shares her methodology for helping small biotechs manage their trials and vendors, focusing on efficiency and clarity.
Five Key Questions for Small Biotechs
- Nathalie outlines five key questions small biotechs need to answer to manage their trials effectively: hitting milestones, overspending, FDA acceptance, CRO performance, and the ability to have data to make go/no-go decisions.
- She explains the importance of these questions in making informed decisions and ensuring the trial’s success.
- Keith and Nathalie discuss the challenges small biotechs face in making go/no-go decisions and the importance of setting up meaningful milestones.
- Nathalie emphasizes the need for small biotechs to focus on the most critical aspects of their trials to avoid wasting resources.
Methodology for Helping Small Biotechs
- Nathalie introduces her methodology, called Clinical Momentum Method TM, which includes packages to help small biotechs select the right CROs and/or help them course correct with a 10-day gap assessment As well as 6-week and 6-month packages to build a fit-for-purpose biotech method internally.
- She explains the importance of fit-for-purpose solutions and how her methodology aims to reduce oversight time for small biotechs.
- Keith and Nathalie discuss the benefits of functional service provider models for small biotechs, which can save up to 40% compared to full-service CROs.
- Nathalie highlights the importance of specialized services for specific regulatory needs, such as TMF systems for gene editing technologies.
Importance of Communication and Vendor Management
- Keith and Nathalie discuss the challenges CROs staff have in transitioning from working with large pharma to working with small biotechs and the importance of communication with CROs.
- Nathalie emphasizes the need for small biotechs to find the right fit for their specific needs and not rely solely on large CROs.
- They discuss the importance of vendor management and the benefits of using specialized services for specific regulatory needs.
- Nathalie shares her experience in bridging the gap between sponsors and CROs and the importance of clear communication and common objectives
Future of the Industry and Closing Remarks
- Nathalie discusses the current state of the industry and the importance of fit-for-purpose solutions for small biotechs.
- She highlights the returning investment in research and the need for more efficient processes in small biotechs.
- Keith and Nathalie discuss the importance of focusing on science rather than spending excessively on non-critical areas.
- Nathalie shares her hope for the future of the industry, emphasizing the need for solutions that fit the specific needs of small biotechs.
Keith Parent’s Closing Remarks
- Keith thanks Nathalie for the conversation and highlights the importance of the topics discussed.
- He encourages listeners to connect with Nathalie and her company, Oncospire Consultants, for further insights.
- Keith mentions potential connections for Nathalie with other industry professionals and companies.
- The podcast concludes with Keith thanking the audience and expressing his appreciation for the discussion.