Driving the Business of Science

Send us Fan Mail In this episode of Driving the Business of Science , host Keith Parent , CEO of Court Square Group , and Catherine Lunardi , CEO of GenAIz discuss how Artificial Intelligence (AI) is helping life sciences organizations strengthen compliance and regulatory accuracy across GxP operations. GenAIz, an AI company focused on data orchestration for life sciences, recently launched AIHQ an AI-powered holistic quality management system to automate and digitize critical processes like batch record review and CAPA. Their goal is to reduce costs and risks, with potential savings up to 75%. GenAIz is also developing AI tools to improve tech transfer. They also discuss how the Canadian government supports various AI initiatives through financial incentives to help companies adopt AI and automate processes. 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.

Send us Fan Mail In this episode of Driving the Business of Science , host Keith Parent , CEO of Court Square Group , speaks with Kieran Engels , CEO and Co-Founder of Seuss+ , about the business challenges that sit alongside clinical development. They discuss vendor management, contracts, governance, risk management, and the realities facing small biotech companies working with external partners. Kieran shares her perspective on what helps sponsor-vendor relationships work effectively, including clear expectations, accountability, communication, and a fit-for-purpose approach to oversight. The conversation also looks at the challenges of global clinical trials, remote collaboration, cost management, and the role external support can play when internal teams have limited capacity. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , discusses the intersection of venture capital (VC) and AI in the life sciences industry with Aneesha Raghunathan , Co-founder and CEO of Rightview . Aneesha shares her background in VC and her transition to building AI solutions for life sciences. They discuss the evolution from paper-based to electronic systems, the impact of COVID-19 on investment trends, and the potential of AI in document generation and reconciliation. Aneesha emphasizes the need for AI to enhance quality and efficiency in life sciences, moving from manual reconciliation to real-time error detection. The conversation highlights the importance of AI in improving regulatory compliance and operational efficiency. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , speaks with Matt Kiernan , CEO & Founder of Sensorium Clinical Research . They explore the evolving role of clinical trial site networks in the life sciences ecosystem. Matt shares his journey from starting in the lab to building and exiting multiple companies, including Pharmica Consulting and Intrinsic Clinical Systems, and how those experiences shaped his obsession with culture, entrepreneurship, and creating great places to work. Keith and Matt also discuss how their relationship began with a simple outreach email and evolved into a peer-to-peer dialogue about strategy, growth, and navigating the lonely realities of business ownership in life sciences. The conversation then dives into the site network space, where Matt explains why he chose to focus his next venture on clinical research sites and the structural challenges these small businesses face—fixed costs, fragmented operations, and the strain of wearing “10 hats” while still caring for patients. He outlines how site networks, backed by private equity and enabled by AI, can improve startup timelines, patient enrollment, and sponsor relationships—without losing the local culture and community connection that make sites effective and trusted. Keith brings in his perspective from conferences and sponsor/CRO interactions, highlighting trends like technology fatigue, convergence between CROs and site networks, and the growing interest in AI-driven efficiencies. Together, they frame Sensorium’s mission as building a differentiated, culture-first site network that leverages AI and consolidation while preserving what makes clinical research personal, local, and meaningful for 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , speaks with Dean Remy , Co-founder & COO/ CCO of Mativa Diagnostics about innovation in the life science industry and women’s health. Dean shares insights from his 35-year career across diagnostics, biotech, and therapeutics, with a growing focus on maternal health. Mativa is developing a diagnostic platform for pregnancy that can detect ectopic pregnancy and preeclampsia, significantly improving test sensitivity and providing more comprehensive care pathways. Their AI-enabled, app-driven platform connects women to a free maternal ecosystem that supports both mental and physical health. Dean also discusses Matiba’s planned $125 million fundraising round to develop multiple MVPs—including chips for pregnancy and risk factors, pregnancy maintenance checks, gestational diabetes, STIs, and drugs-of-abuse—alongside a first-in-class maternal biorepository. This biorepository is designed to de-risk investment by spinning out as a uniquely valuable sample and data asset, targeting over 1 million cryopreserved samples across diverse populations, age groups, sample types, and longitudinal time points during and beyond pregnancy. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , speaks with Kristin Seastrand of Siemens Digital Industries Software about how life sciences organizations are modernizing their SAS environments, embracing the agentic enterprise, and preparing for the next wave of digital transformation. Kristin shares insights from over 25 years in life sciences, IoT, and platform modernization, explaining how Siemens’ SAS Language Compiler (SLC) and AI are helping pharma, biotech, and CROs migrate legacy analytics to more flexible, future-proof infrastructures. They discuss how SLC enables companies to reuse existing SAS code, reduce costs, and integrate seamlessly with R, Python, and modern statistical computing environments while maintaining regulatory compliance for FDA submissions. Whether you’re leading clinical operations, biometrics, or data platforms, this episode offers a practical look at how to evolve your analytics stack while keeping auditors, regulators, and your teams aligned. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , discusses the challenges of drug development and shortages with Sarah Norring , Ph.D., Co‑founder and CEO of Plenitude Pharma Inc. Sarah highlights the critical need to address drug shortages and discontinuations, emphasizing the importance of having multiple manufacturers for essential medicines. She shares her background in medical science and her company's focus on bringing back critical drugs, particularly in women's health and oncology. Sarah mentions the FDA's expedited review process for off-patent drugs on the FDA’s drug shortage list, and her aims to bring one to two products to market within the first three years. The conversation also touches on the challenges of fundraising in this niche pharma sector. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , interviews Mitchell Bayer , Managing Principal of Arlen Consulting Group , about the evolution of the life science industry and the role of CROs. Mitch discusses his 24-year career, starting at Medidata, where he spearheaded the ASP ire to Win™ CRO partner program, which grew to 16 partners by 2009. He emphasizes the importance of integrating technology with CROs to enhance competitiveness and efficiency. Mitch highlights the shift from paper-based trials to electronic data capture (EDC) and the potential of AI in streamlining clinical trials. He also discusses the importance of technology that integrates seamlessly with existing systems and reduces site burden. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , interviews Nicholas Dirks , President and CEO of The New York Academy of Sciences . Nick emphasizes the importance of federal funding for basic research and the need for international collaboration while highlighting the impact of the pandemic and the current administration on scientific research, funding cuts, and the exodus of international researchers. He also explains why the Academy’s efforts to connect scientists from around the world in various fields, including AI and biomedical research, is a crucially important aspect of its overall mission to drive scientific innovation and address global challenges. 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.

Send us Fan Mail 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. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , speaks with Dr. Peter Reinhart, Ph.D. , Director of the Institute for Applied Life Sciences (IALS) at UMass Amherst. Dr. Reinhart shares his journey from academia to founding startups, including developing therapeutics for Alzheimer's and Parkinson's. IALS, funded by a $95 million award from the Massachusetts Life Science Center, provides translational research facilities and supports startup companies. The institute offers unique resources like large lab spaces, advanced equipment, and a collaboration with the Isenberg School of Management to foster entrepreneurship. Reinhart emphasizes the cost advantages and growing capacity for startups in Western Massachusetts. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , and Jenna Rouse , Global Head of Clinical Operations at Simulations Plus discuss the benefits of simulation-based clinical research training, which allows sites to practice protocol-specific tasks without risking patient safety. Jenna shares a case study where simulation training improved procedural accuracy from 14% to 86% over six months. The discussion emphasizes the importance of effective training in clinical trials to ensure compliance and patient safety. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , speaks with Ezekiel Kelley , VP of Engagement and Growth at the Frederick Innovation and Technology Center (FITCI) , about the importance of incubators in driving innovation. FITCI, a business incubator in Frederick, Maryland, supports life science startups by providing resources, office and lab space, and connections to state and federal resources. FITCI has grown from 40 to nearly 120 companies in two years, many collaborating with the FDA, NIH, and Fort Detrick. The center offers shared lab space, accelerated courses, and an advisory board of experienced founders. FITCI's success is attributed to its nonprofit status, cost-effective operations, 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , and Jeremy Bromberg , an independent operations advisor with a background in life sciences and pharmaceutical market research, share insights on improving business operations. The conversation highlights the importance of compliance, effective pricing strategies, and organizational structure. Jeremy stresses the need for specialized knowledge in life sciences, the significance of aligning employee skills with company needs, and the critical role of management in balancing sales, execution, and logistics. Jeremy also outlines the steps to build a successful professional services firm, starting with understanding the firm's vision and goals. Keith and Jeremy both emphasize the importance of adhering to regulations and continuous learning to succeed in the life science industry. 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.

Send us Fan Mail In this episode of the Driving the Business of Science podcast, host Keith Parent , CEO of Court Square Group , and Roy Strunin , Director of Marketing at BrandUp Strategy , discuss the intersection of business, science, and marketing in the pharmaceutical, biotech, and medical device industries. Keith highlights the collaboration between Court Square Group, a managed service firm specializing in IT infrastructure for life science organizations, and BrandUp Strategy, a full-service marketing agency supporting life science service providers. Roy shares his background in life science marketing and the founding of BrandUp Strategy. Together, they explore the differences between technology companies and life science firms, emphasizing the critical role of regulatory compliance. The conversation also examines how thought leadership and digital marketing work together to build awareness, establish credibility, and spark meaningful conversations that drive growth in life science organizations. 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.

Send us Fan Mail 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.

Send us Fan Mail 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.

Send us Fan Mail Keith Parent , CEO of Court Square Group , discusses the intersection of science and business in drug development with Dr. Joseph Geraci , Founder, Chief Scientific and Technical Officer of NetraMark . Dr. Geraci, with a background in mathematics and AI, focuses on understanding patient populations and improving clinical trials. He explains how NetraMark's AI technology can analyze small, complex data sets to identify treatment and placebo responder subpopulations and improve drug efficacy. Dr. Geraci emphasizes the potential of adaptive trials and the importance of personalized medicine. He predicts the future of AI in clinical trials will involve modular AI systems integrating pattern-finding and language interfaces to enhance drug development and patient care. 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.

Send us Fan Mail 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. 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.

Send us Fan Mail 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. 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.