Leading Pharmaceutical Regulatory Experts

I’m a lifesciences compliance strategist with a passion for building real-world, right-sized programs in fast-moving environments. With deep experience in pharma and medtech, I specialize in translating regulatory complexity into practical, actionable frameworks. I’ve spent 7+ years navigating the gray areas of compliance—from training physicians on industry expectations to building startup programs from the ground up. I believe compliance should be ethical, functional, and human-centered—and that culture is built through clarity, storytelling, and respect, not fear. Outside of policy and audits, I speak regularly on startup compliance and love turning “boring” topics into memorable moments. I'm here to connect, create, and contribute.

Dr. James Utley is a pioneering scientist at the forefront of cellular therapy, AI, and data science. A Johns Hopkins-educated Immunohematology expert and Certified Advanced Biotherapies Professional (CABP), he also holds advanced certifications in data science and machine learning. While serving as Technical Director at a major healthcare organization, Dr. Utley oversaw more than 150,000 successful cellular transfusions and spearheaded advancements that significantly improved patient outcomes. This experience included leading initiatives for the Department of Defense, where he revolutionized cellular transfusion practices. His innovative approach is further exemplified by his FDA-approved work and numerous publications in leading scientific journals. Dr. Utley is also known for his bold, hands-on approach to research, embodying the spirit of a "biohacker" by pushing the boundaries of CRISPR and genetic engineering through self-experimentation. This unique blend of rigorous scientific training and unconventional methods has earned him the moniker "the pirate" within the biohacker community.

## Dr. Tim Scott Dr. Tim Scott isn't your typical physician. After a decade in emergency medicine witnessing the devastating consequences of metabolic dysfunction firsthand, he realized a hard truth: our healthcare system excels at crisis management but fails miserably at preventing disease. As the founder of Rixa Health, Dr. Scott has pioneered an approach to medicine that looks beyond symptoms to address the root causes of today's most prevalent health issues. His expertise in metabolic health, functional medicine, and cutting-edge therapeutics has helped thousands of patients reclaim their health after years of being told their lab work was "normal" despite feeling terrible. Known for his direct, no-nonsense approach, Dr. Scott combines advanced medical knowledge with practical solutions that work in real life, not just in textbooks. He specializes in reversing metabolic disorders, optimizing hormonal health, and using peptide therapies to address complex health challenges that conventional medicine often misses. Dr. Scott is passionate about empowering patients through education, believing that understanding your body is the first step to healing it. When he's not transforming patients' health, he's advancing the field through education, speaking engagements, and training the next generation of metabolic health practitioners.

I am a seasoned mental health and addiction specialist, dedicated to the field of treatment and recovery since 2015. I hold a bachelor’s degree in psychology and a master’s in clinical mental health counseling from South University in Royal Palm Beach, FL, and I am credentialed as both a Licensed Clinical Mental Health Counselor (LCMHC) and a Licensed Clinical Addiction Specialist (LCAS). Over the years, I've gained hands-on experience in various areas, including psychiatric acute stabilization, psychiatric partial hospitalization, and both in-patient and out-patient substance use treatment. My journey has taken me through clinical counseling, program development, and organizational leadership. Before joining New Waters, I served as the Clinical Director at Gupta Psychiatry and Wellness in Raleigh, NC, where I helped shape a respected substance abuse partial hospitalization and intensive outpatient program. I am a firm believer in the transformative power of quality clinical programming and its impact on long-term sobriety. With a compassionate approach, I am committed to helping individuals and families overcome substance use disorders, guiding them toward a life free from addiction.

Igor Ujhazi is a seasoned expert in digital governance, regulatory technology (RegTech), and public sector innovation. With a background in leading global digital transformation initiatives, he specializes in e-government, digital fiscalization, AI integration in tax and customs administration, and sustainable governance strategies. Igor serves as Chief Executive Officer at The RegTech, a company based in Dubai UAE and focused on delivering tailored, cost-effective digital solutions for governments, particularly in emerging economies. He is also an alum of the Transatlantic Inclusion Leaders Network and an advocate for equitable digital access through pragmatic, policy-driven innovation.

I specialize in B2B marketing strategy and execution for technology and business service companies, with a focus on results-focused search marketing. My clients include Udemy, Hims & Hers Healthcare, and numerous SMEs.