In this episode of the Driving the Business of Science podcast, hosted by Keith Parent, CEO of Court Square Group, guest Mark Connell, Co-Founder and President of SLBST Pharma, discusses the company’s mission to repurpose hydroxychloroquine to treat endometriosis, a condition affecting 7 million American women. Despite limited current therapies, SLBST Pharma aims to leverage the drug’s proven efficacy in reducing lesions by 60%. Challenges include navigating the complexities of drug development, fundraising, and staying agile amidst setbacks. Connell emphasizes the importance of tenacity, community engagement, and the ultimate goal of alleviating pain and improving lives.

In this episode of the Driving the Business of Science podcast, host Keith Parent, CEO of Court Square Group, and guest Michael Joseph, CEO of Technium, discuss their collaboration on global networks for the life science industry. Technium specializes in connecting data from the edge to the cloud, offering secure network services and leveraging AI advancements. Their recent projects include assisting Moderna with their global network during the COVID pandemic and designing a network for Frontier Scientific Solutions to revolutionize the clinical supply chain. Both firms emphasized the importance of security, reliability, and the collegial approach to solving complex problems in the field of life sciences.

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.

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.

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.

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.

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.

Keith Parent, CEO of Court Square Group, discusses with Kevin Bittorf, a partner at SCxCMC Solutions, about the role of CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry. Kevin explains that CMC involves the science and business of manufacturing, emphasizing the importance of continuous improvement to reduce costs and enhance quality. SCxCMC, founded two years ago, provides consulting services to small and medium-sized companies, integrating expertise in pharmaceutical development, process chemistry, formulation development, regulatory affairs, quality assurance, supply chain, and packaging. Kevin highlights the significance of AI in predicting manufacturing issues and the benefits of continuous manufacturing over traditional batch processes. He also mentions upcoming conferences on compaction simulation, continuous manufacturing, and advancing drug development.

Discover how artificial intelligence is transforming the life sciences industry in this insightful episode of the Driving the Business Science Podcast. Host Keith Parent, CEO of Court Square Group and RegDocs365, is joined by Bryan Reynolds, CEO of Docxonomy, to discuss practical strategies for developing and implementing AI in organizations of all sizes. Drawing on decades of experience in unstructured data management and AI, Bryan shares actionable insights into overcoming common challenges, such as protecting sensitive corporate data, streamlining processes, and maximizing ROI.
This conversation highlights how AI can revolutionize workflows, accelerate drug development timelines, and reduce manual effort in clinical and regulatory environments—all while keeping humans at the center of critical decision-making. Whether you're leading a startup or a large enterprise, this episode provides a roadmap for integrating AI effectively without getting overwhelmed by technical complexity.
Key Topics:
•How life sciences companies can safely adopt AI solutions.
•Practical steps to develop an AI strategy, starting small and scaling.
•Using AI to automate repetitive tasks like document creation and regulatory submissions.
•Ensuring security and maintaining “human in the loop” for oversight.
•The benefits of partnering with AI experts to drive innovation.
What You'll Learn:
•Strategies to safeguard intellectual property while using AI.
•How to identify and optimize manual processes with AI.
•The role of AI in compressing drug development timelines and enhancing efficiency.
•Tips for navigating the complexities of AI adoption in the life sciences sector.
Tune in to gain a fresh perspective on how AI can unlock new opportunities and help your organization thrive in a rapidly evolving industry!

Keith Parent, CEO of Court Square Group and RegDocs365, discusses the importance of vendor management in life science with Kalyan Obalampalli (KO), CEO of ClinAI. KO shares his experience in managing $100 million in vendor contracts and the challenges of using Excel for RFPs and vendor comparisons. He highlights the benefits of ClinAI's platform, which streamlines vendor selection and management, providing analytics and data-driven decision-making. KO emphasizes the need for fit-for-purpose vendor selection, the importance of clear templates, and the potential of AI in predicting costs and ensuring fair vendor payments.

Keith Parent, CEO of Court Square Group, discusses the complexities of the life science industry and introduces Chris Matheus from the Global Life Science Alliance (GLSA). Chris, with 30 years in clinical research, co-founded GLSA to connect smaller companies with business development opportunities and experts. The conversation emphasizes the importance of collaboration and networking, highlighting GLSA's role in facilitating connections for regulatory consulting, pre-clinical, and clinical trial management, and innovative solutions such as AI. Chris and Keith also talk about "Friends of Chris Matheus" (FOCM), a networking club he founded to foster industry connections. The conversation underscores the need for efficient, cost-effective solutions to support drug development and innovation.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, discusses with Mario Perkins, President of Triam Ltd, the intersection of IT infrastructure and data management in the life sciences. Triam specializes in data management and analytics, particularly in healthcare and life sciences, and has recently partnered with Court Square. They discuss the shift from legacy systems like SAS to open-source tools like Python and R, disruptive technologies like Altair SLC and RapidMiner that can bridge and enhance this shift, the importance of data quality, and the benefits of AI and machine learning in drug development and clinical trials. They also touch on the transition from on-premise to cloud-based solutions and the role of hybrid approaches in managing large data sets.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, interviews Christa Bleyleben, Managing Partner at MassGlobal Partners. Christa's firm helps international early and growth-stage companies navigate the U.S. market, providing programs for C-level executives to learn business practices, networking, and cultural differences. They work with companies from various sectors, including life sciences, robotics, and AI, and have supported firms from countries like Korea, Japan, and Northern Ireland. Christa emphasizes the importance of understanding U.S. market dynamics, the rigorous due diligence process for investors, and the value of mentorship and networking.  

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, speaks with Arielle Smith, President of Life Sciences at Event Cadence about their event technology platform which supports medical conferences and Key Opinion Leader (KOL) engagement. They discuss the importance of in-person interactions and the evolving landscape of HCP (Healthcare Provider) engagement. Event Cadence's Ensemble software facilitates omni-channel engagement, adapting to different company needs, from small startups to large pharma companies. The conversation emphasizes the value of personal connections and the future potential of KOLs reaching out to pharma companies.

In this episode of the Driving the Business of Science podcast, Keith Parent, CEO of Court Square Group, interviews Sara Tylosky, CEO of Farmacon Global, about the Latin American market for clinical trials. Farmacon Global, a strategic partner with a network of physicians, focuses on rare diseases, oncology, and immunology in Latin America. Sara highlights the region's diversity, cost savings, and fast recruitment, noting that Latin America represents 0.7% of global phase 1 studies but has a population of more than 660 million and 30+ qualified sites. She addresses misconceptions about slow recruitment and regulatory issues, emphasizing the region's alignment with international guidelines and the potential for collaboration with CROs. Farmacon Global aims to expand its phase 1 research opportunities and educate biotechs on the region's benefits.

Interested in learning more about clinical trials in Latin America?  

WEBINAR: Early Clinical Trials in LATAM: A Sustainable Data Strategy 

September 18, 2025. 12 Noon EST

WEBINAR registration via RARE DIEM ALLIANCE 

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.

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.

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.