Credentials and Associates
Principal
James Bernstein, Ph.D., has 25 years of experience in the pharmaceutical industry working in the CMC sector, from pre-IND through market registration. Prior to founding Live Oak Pharmaceutical Consulting in 2007, he was a pharmaceutical development manager at GlaxoSmithKline. His career in the industry is split almost equally between the drug substance and the drug product sides of CMC development. His primary expertise is in the management and strategy of the CMC development effort. His experiences and interests include the use of drug candidate biopharmaceutical properties, integration of CMC development with clinical development, the development of compounds for the Japanese market, the development of compounds with Japanese partners, support of GLP and GMP functions, evaluation of intellectual property, and the teaching of CMC development. Prior to working in the pharmaceutical industry, he worked for two years characterizing high-strength polymers at DuPont. Dr. Bernstein received a Ph.D. in Physical Chemistry from the University of North Carolina at Chapel Hill, and a B.S. (Chemistry and Physics) from Centenary College of Louisiana.
Associates
Live Oak Pharmaceutical Consulting Inc. has assembled a team of experienced associates to cover a wide range of the CMC and non-clinical functions. These associates have extensive experience in their respective fields and demonstrated effectiveness in working on a development team. They see development events in a perspective developed over many projects and 10 to 25 years of experience. Associates work under an agreement with Live Oak Pharmaceutical Consulting that provides confidentiality and intellectual property protection to the client. Current fields covered by Live Oak associates include:
- CMC regulatory science and quality assurance with extensive experience in FDA interactions
- Due diligence activities and drug candidate evaluation
- Analytical development for drug substance and drug product, including method development and stability studies
- Synthesis and process development
- Sourcing of synthetic starting materials, intermediates and drug substance (API)
- Auditing and GLP/GMP consulting, including Certified Quality Auditor (CQA)
- Polymorphism, salt selection, and other physical pharmacy topics (such as surface area, particle size, thermal behavior, and microscopy)
- Supply chain management and lifecycle planning
- Toxicology, including study management and impurity qualification • Organizational development and training
- Technical writing and review
- Comparator IND submissions