Dr. Bernard "Barney" King, M.D., M.B.A.
Clinical Study Design, Monitoring
Dr. Bernard D. King is President of Macnas Consulting International, Inc., a strategic consulting firm specializing in product development planning and execution for pharmaceutical, biotechnology, and medical device companies. Macnas also provides due diligence consulting for venture capital, investment, and pharmaceutical firms, with Dr. King's expertise proving particularly valuable to smaller companies facing critical strategic product development decisions.
Professional Experience
With more than 25 years of experience managing business and development operations across the pharmaceutical, medical device, biotechnology, and CRO industries, Dr. King has directed or been directly involved in development programs for over 100 pharmaceutical, medical device, and biologics products. These programs have encompassed more than 250 separate clinical trials conducted across North America, Europe, Eastern Europe, Australia, New Zealand, South Africa, and Asia.
Dr. King's operational assignments have included serving as President and CEO, Head of Development, Vice President of Clinical Affairs, Vice President of Regulatory Affairs, and Medical Monitor for various client companies. His therapeutic expertise spans multiple neurologic disorders including neurofibromatosis 2/schwannomatosis, Alzheimer's disease, Parkinson's disease, neuropathic pain, multiple sclerosis, and stroke, as well as neurodevelopmental disorders such as Fragile-X syndrome, lysosome storage diseases, mucopolysaccharidoses, Pitt-Hopkins Syndrome, and gangliosidoses.
Regulatory Expertise
Dr. King holds Regulatory Affairs Certification for both the United States and the European Union. He has been responsible for and contributed to pharmaceutical, biologic, and medical device submissions including INDs, NDAs, CTAs, IDEs, and PMAs to the FDA, EMA, and regulatory authorities in other countries. He has authored Fast Track (US) and Orphan (US, EU) submissions for pharmaceutical and biologic products and maintains direct relationships with regulatory authorities in the US, EU, Canada, Eastern Europe, India, and Brazil.
Education and Training
Dr. King graduated cum laude from the University of Notre Dame, majoring in English and Preprofessional Studies, and received his M.D. from The Ohio State University College of Medicine. Following completion of residency training in Medicine and Pathology at Ohio State and Cardiology fellowship training at Mt. Sinai Medical Center in New York, he served as an Assistant Professor in Medicine (Cardiology) and Physiology at New York Medical College. He is board certified in Cardiology and Internal Medicine and earned his M.B.A. from the Wharton School of the University of Pennsylvania.
Publications and Teaching
Dr. King is the author of Get It Right the First Time! Pharmaceutical Product Development: Intelligent Solutions for Challenging Issues, published by Macnas Press and available through Amazon and online retailers. He has extensive teaching experience in master's degree programs, covering topics including regulatory affairs, clinical affairs, clinical development, ethics and pharmacovigilance, statistics and data management, and clinical operations.
Professional Recognition
Dr. King is a fellow of multiple professional organizations including the American College of Cardiology, American College of Physicians, The New York Cardiological Society, Society for Cardiac Angiography, and the Royal Society of Medicine. He is also a member of the New York Academy of Sciences and was inducted into Alpha Omega Alpha at Ohio State University College of Medicine.
Expert Consulting in Drug Development
At NexusBio Partners, we specialize in providing expert consulting services for drug development in the biotechnology sector. Our team of experienced professionals offers insights that can help streamline your research processes and enhance your product development timelines. We are committed to guiding you through the complexities of biotech with tailored strategies.