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Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Personalized Medicine, Genomics, Proteomics, Bioinformatics, Oncology, Biotechnology, IBD
As the director of the Employer Genomics and Proteomics Center and of the Dana Farber/ Harvard Cancer Center Proteomics Core, Expert has ample expertise in bioinformatics, since each of these facilities includes a whole core for bioinformatics. Expert supevises a…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
Pharmaceutical Drug Development, Strategic Executive Management, Biopharma Mergers and Acquisitions
Expert has over 20 years of experience. He is extensively active and has significant experience and expertise in Europe and the US in the areas of drug development and financing throughout Europe and the US. He was responsible for the…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Statistical Consulting, Biostatistics, Statistical Support to Litigation
Expert has over 13 years experience as statistician and Director of Biometrics in the pharmaceutical industry. In addition, he has 8 years experience as a Professor of Statistics at the University of Florida. He served as functional manager for statistics,…
Medical Consulting, Medical Writing, Effective Ad Strategies Targeting Physicians
Expert is a physician and medical writer with 16 years of experience. He has written research protocols and completed the studies while at NYU Medical Center. While in clinical practice, he published 8 articles in medical journals and published 5…
Virology, Anti-infectives, Gene Therapy, Bioterrorism Research
He has extensive experience in the development and use of viral vectors for gene transfer and in particular has worked with both adenovirus and AAV vector delivery systems. His work with adenovirus vectors included some of the earliest research focused…
Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert (prefers “Expert”) has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) extensive technical consulting and…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…