Driving the Business of Science – Details, episodes & analysis

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, interviews Joseph Jerry, Ph.D., a researcher at UMass Amherst and Science Director of Pioneer Valley Life Sciences Institute (PVLSI). Dr. Jerry explains PVLSI's role in translational research, particularly in breast cancer, and the creation of the breast research registry and HistoSpring. They discuss the importance of diverse patient populations, the use of human tissues for research, and the potential of organoids. The conversation highlights the collaboration between academia, healthcare, and industry in advancing scientific research.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group,  and Dave Kwajewski, Executive Director of Business Development at Corealis Pharma, discuss the challenges and strategies in selling science. Dave, with 22.5 years in sales, emphasizes the importance of understanding scientific processes and the evolution of sales techniques, from traditional trade shows to AI-driven interactions. He highlights the need for companies to focus on their strengths, especially in early drug development, and advises leaders to hire smartly and understand market realities. Keith and David agree on the value of networking and personal interactions in building trust and closing deals.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, hosts Samantha Trotman Burman to discuss mental health across the life science spectrum. Samantha, CEO and co-founder of StoryCatch Partners, shares her journey in mental health advocacy, driven by personal experiences and the need for better support and data collection. She emphasizes the importance of integrating mental and physical health data, using real-world examples like knee replacements and heart surgery. Samantha highlights the role of caregivers and the impact of mental health on them. She also discusses the company's acquisition of EmpiraMed, its B Corp status, and the potential for comprehensive mental health registries to drive systemic change.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Keith Parent, CEO of Court Square Group discusses pharmacovigilance compliance for small and mid-sized sponsors with Betty Cory, President of Regxia. Betty explains that pharmacovigilance monitors drug safety in real-world use, often revealing unforeseen adverse effects. Small companies struggle with managing vast amounts of data, necessitating electronic systems. Betty emphasizes the importance of finding partners who understand small businesses' needs and can provide tailored solutions. Court Square Group's platform, RegDocs365™, is highlighted as a fit-for-purpose solution. Betty also shares her background and the philosophy of Regxia, which focuses on becoming an integral part of clients' operations.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Keith Parent, CEO of Court Square Group, talks with Catherine Lunardi, CEO of GENAIZ, about the challenges and opportunities of implementing Artificial Intelligence (AI) in life science companies. Catherine explains her company's Intelligent Automation solutions, particularly their data orchestration platform. They discuss their partnership, which began at an economic development forum in Massachusetts. Catherine shares her background in pharmaceuticals and the inspiration behind GENAIZ, emphasizing the importance of AI in streamlining data management. They highlight successful projects involving a cross-referencing tool for large document volumes and introduce GENAIZ's semantic search engine for literature reviews. 

GENAIZ offers a powerful Data Orchestration platform purpose-built for the life sciences industry. We empower Pharmaceutical Sponsors, CDMO’s, CROs, Hospitals, Clinical Trials, and Academic Labs to make their data “talk” fast using advanced, Intelligent Automation solutions. Our Intelligent Automated solutions break down silos across Regulatory, Quality, Laboratory, and R&D functions—streamlining processes, enhancing compliance, and accelerating decision-making.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses De-Risking the Early Phase Clinical Trial Supply Chain with Jim Kernan, CEO of PRONAV Clinical, a 40-year veteran of the pharmaceutical industry. Their conversation focuses on early-phase clinical supply chains, highlighting the shift from linear to multi-nodal supply chains in biotech. Jim explains the role of the Qualified Person (QP) in ensuring GMP compliance and data management, emphasizing the importance of secure data handling. They also discuss the complexities of cold chain logistics, particularly the challenges of maintaining -80°C temperatures for biologics, and the validation of labeling processes for ultra-low temperature products. Jim mentions the Clinical Bridge initiative to share knowledge and experiences with emerging biotech and pharma companies.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Elevating Life Science Meetings & Events, Keith Parent, CEO of Court Square Group, discusses with Sam Ali, co-founder of Precision Evolution Global, the importance of attending and participating in industry events. Effective industry events aimed at decision-makers in pharma, biotech, and CROs, covering clinical trials, drug discovery, and pharma supply chains, connect key stakeholders who might otherwise struggle to find each other. As Sam explains, traditional conference models often fail to facilitate meaningful connections that extend beyond the event itself.  Their company was founded specifically to address this gap by creating events that attract decision-makers and elevate conversations beyond the venue. Post-COVID, in-person events have seen increased attendance and impact.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, discusses the business aspects of drug development with James Blackwell, Ph.D., MBA, President of Windshire Group. They explore the importance of quality in life science, emphasizing the need for a holistic approach beyond compliance. Blackwell highlights the significance of modality-agnostic strategies, the impact of AI on efficiency, and the necessity of a simple yet effective quality system. He shares insights on managing compliance, the importance of senior leadership, and the potential cost savings from effective quality systems, citing an example where a challenging, but well-executed investigation saved AbbVie ~$8.5 billion by avoiding a delay in the launch of Humira. They also discuss the critical role of consultants in improving quality and operational excellence.

 Key Takeaways

• Explore how AI can be leveraged to improve quality and efficiency in GMP operations.
• Assess your organization's quality culture and ensure senior leadership is fully aligned on the importance of quality.
• Review your organization's change control processes to prevent issues like the lead contamination example discussed.
• Evaluate your organization's response to regulatory observations and ensure a systemic approach to addressing root causes, not just a checklist approach.
• Consider bringing in external quality expertise to help assess and improve the organization's quality systems, if needed.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

In this episode of Driving the Business of Science, Stakeholder Engagement: CROs, Vendors, and Sites, Keith Parent, CEO of Court Square Group, discusses the complexities of stakeholder engagement in the life science industry with Kimberly Guedes, VP of Clinical Operations at Intensity Pharmaceuticals. Keith and Kim explore the challenges facing small biotechs when partnering with large CROs, emphasizing the need for fit for purpose, cost-effective solutions like RegDocs365™. Kim discusses the importance of selecting the right CROs and vendors, especially for niche therapeutic areas like CNS. Keith and Kim also discuss the high costs of clinical trials, the necessity of careful planning, and the impact of global regulatory differences. Additionally, Kim shares her involvement with the Alzheimer's Association and the importance of support for caregivers and patients.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.

Keith Parent, CEO of Court Square Group, hosts Shelley Amster on the "Driving the Business of Science" podcast. Shelley, with over 45 years in women's health, discusses her extensive experience in mentoring startups and connecting them with strategic partners and investors. She highlights the challenges faced by small biotech companies, particularly in women's health, and the importance of mentorship and collaboration. Shelley shares perspectives from her role as an Entrepreneur in Residence, helping Israeli companies establish a presence in the U.S. She emphasizes the need for startups to understand the business aspects of their technology and the value of warm introductions and strategic partnerships.

Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.

Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.

In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.

Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.