Find an Expert
Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…
Process Development, Commercialization, Scale-Up; Separation and Purification – Filtration, Activated Carbon
During his career, Expert functioned as a senior-level executive (Senior VP positions) with over 40 years of experience in the Chemical Process and Materials industries. His track record is characterized by: merger and acquisition experience, development of new product lines…
Molecular Biology, Genetics, Cancer Biology, Radiation Biology, Genetic Engineering
Expert was continuously funded 1990-2018 by the NIH (NCI, NIGMS), typically as PI of 2-3 concurrent R01 grants, and is currently funded by the American Lung Association (2020-2022). Expert published more than 130 reports of original research and reviews that…
Life Sciences, Biotechnology, Pharmaceutical, IP, Biology, Patents, Molecular Biology, BD
Expert has a Ph.D and two postdocs in Physiology, Molecular Biology and Genetics. B.S in Chemistry/Biochemistry. Over 25 years of experience (at an executive level and as a consultant) in the Life Sciences industry. Founder and President of a life…
Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, chemical, computer and electronics technologies. With more than…
Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a University Hospital for 12 years before joining the…
Biotechnology, Molecular Biology, DNA Forensics, Immunology, Virology, Vaccines, Antibodies, PCR, RNA, FDA submissions
Expert has over 40 years of experience in Biochemistry, Molecular Biology, Molecular Genetics and Biotechnology. His academic research career led to 80 publications and 5 Biotechnology patents which enjoy a high impact rating and feature innovative methods in DNA, RNA…
Intellectual Property and Patent Law: Chemicals, Materials, Energy, Biotech; and Chemical Engineering
He has extensive experience developing commercial biorefinery technologies for the production of chemicals, materials, and energy from biomass. He has developed patent-pending biorefinery technologies as lead inventor. He is aware of the spectrum of feedstocks, technology pathways, co-product opportunities, economic…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Biotechnology, Biochemistry, Molecular Biology: Enzymology, Protein Biochemistry, Industry
As a researcher in plant molecular biology, he published scientific data relevant for genetic modification of crops. He generated and characterized genetically modified plants, and published these data in peer-reviewed scientific journals. This research, and tangential research, allowed him to…