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Tag: Regulatory Strategy

Michael A. Pereira | Executive Leader in Regulatory, Quality, and FDA Compliance for Drug, Device, and Biologic Industries

Michael A. Pereira is a seasoned regulatory and quality executive with over three decades of experience guiding companies through the complex intersection of FDA compliance, global regulatory standards, and business operations. Known for his ability to build and remediate Quality Management Systems across diverse healthcare sectors—including drug, device, biologic, and combination products—Michael has led strategic initiatives for startups and global enterprises alike. With a rare ability to bridge technical and business teams, he brings clarity, structure, and strategic foresight to every challenge, earning a reputation as a trusted leader and advisor in highly regulated industries.

Sherman Boone: Bridging Policy, Regulation and International Finance for a More  Resilient Global Economy.

I’m excited to share my professional journey as a financial economist, international advisor, and regulatory strategist with extensive experience in global financial governance, risk management, and policy leadership. Over the years, I’ve had the privilege of shaping key regulatory frameworks, financial standards, and economic policies that impact markets worldwide. As I transition toward board and advisory roles, I look forward to applying my expertise in governance, strategy, and cross-border finance.

Aaron L. Carrithers, M.D.: Driving Innovation, Bridging Science and Business and Delivering Real-World Impact in Healthcare.

As a physician-scientist and biotech executive, I have dedicated my career to bridging the gap between groundbreaking medical research and commercial success. From securing multimillion-dollar funding to leading strategic M&A deals, my passion lies in driving healthcare innovation that delivers real-world impact. Here is my biography.

Navigating Regulatory Risks: A Strategic Approach

In an era of increasingly complex regulatory landscapes, corporate boards must adopt proactive strategies to navigate compliance risks while fostering strategic growth. The 4Ps strategy—Position, Plans, Perspective, and Patterns of Action—provides a structured framework for organizations to build resilient risk management approaches. By defining regulatory boundaries, crafting adaptive compliance plans, embedding core values into governance, and ensuring consistent execution, boards can turn compliance into a competitive advantage. Emphasizing ethical leadership, technological integration, and continuous monitoring, this strategic approach enables companies to anticipate regulatory shifts, mitigate risks, and unlock opportunities for long-term success in an evolving global economy.

Matthew Smollin, PharmD: A Pioneering Leader in Medical Affairs and Clinical Innovation

Matthew Smollin, PharmD, is an accomplished leader in medical affairs and clinical innovation with over 15 years of clinical experience and a decade of industry expertise spanning clinical research, regulatory strategy, and team leadership. As Vice President of Medical Affairs at Karius, Inc., he directs medical and scientific strategies, guiding breakthrough advancements in molecular diagnostics while navigating complex FDA and Medicare regulatory processes. Throughout his career, he has successfully built and managed high-performing teams, fostered strong relationships with key opinion leaders, and played a pivotal role in clinical trial design, publication strategy, and scientific engagement. A respected speaker and thought leader, Dr. Smollin’s expertise in infectious disease diagnostics and next-generation sequencing has shaped industry best practices and advanced clinical innovation. His dedication to scientific excellence, strategic vision, and ability to translate complex medical insights into impactful solutions make him a driving force in the evolution of precision medicine and diagnostic technologies.

Ralph Cardinal: Innovating the Future of Medical Devices Through R&D Excellence and Strategic Leadership.

I’m excited to share my executive biography, highlighting my experience in R&D, regulatory strategy, and product innovation within the medical device industry. As I transition into board and advisory roles, I look forward to leveraging my expertise to help med-tech companies scale, innovate, and navigate regulatory landscapes.

Gregory Lucas: Expert in Global Risk Management, Regulatory Compliance, and Strategic Financial Leadership

Gregory Lucas is a seasoned financial executive and risk management leader with over 40 years of experience in banking, financial services, and regulatory compliance. Throughout his distinguished career, he has played a pivotal role in developing and executing enterprise-wide risk frameworks, regulatory transformation initiatives, and governance enhancements for major financial institutions, including Citigroup and Sumitomo Mitsui Banking Corporation. With deep expertise in enterprise, market, credit, liquidity, and operational risk, Gregory has successfully led high-performing teams, guided strategic risk mitigation efforts, and engaged with global regulatory bodies to ensure compliance and financial stability. Now transitioning into board service and advisory leadership, he seeks to leverage his extensive experience in risk oversight, corporate governance, and financial strategy to help organizations navigate complex challenges and drive sustainable growth.

Ryan Matley: A Visionary Leader in Energy Innovation and Regulatory Strategy

Ryan Matley is a highly accomplished energy professional with over 15 years of expertise in the electric and natural gas utility industry. Known for his ability to deliver innovative solutions within financial, technical, and regulatory constraints, Ryan has a proven track record of achieving impactful results through collaboration and adaptability. His exceptional communication skills and analytical insight have enabled him to lead complex regulatory strategies, develop customer-focused renewable energy products, and manage large-scale operational initiatives. Ryan’s dedication to fostering sustainable energy practices and driving industry transformation underscores his reputation as a trusted leader in the energy sector.

Michael Eckstut – Senior Life Sciences Executive and Strategic Advisor

Michael Ekstut is a seasoned business leader with over 30 years of experience in the life sciences industry, specializing in drug discovery, development, and regulatory strategy. He has held senior leadership roles at industry-leading companies, including Certara, where he guided the company’s commercial and product strategy in the regulatory and access sector. Michael is known for his strategic vision and ability to drive innovation, optimizing clinical development programs and supporting biopharma companies in navigating complex regulatory landscapes. His deep expertise in business consulting, technology, and operational management has enabled him to successfully advise executives and investors across pharmaceuticals, biotechnology, and medical devices. Currently serving as a Senior Advisor at InSilicoTrials, Michael continues to leverage his vast experience to help organizations maximize the impact of their clinical development programs and investments.