Find an Expert
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medicinal Chemistry/ Synthetic Organic Chemistry-Research and Patent Litigation
Experienced Medicinal Chemist and Consultant: expert at synthetic organic chemistry, pharmaceutical chemistry, pharmaceutical patent litigation, patent analysis: 1) Eight years of consulting experience, beginning in Jan. 2012, writing expert reports following patent analysis covering obviousness, claims validation, enablement; depositions given.…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
Medicine and Biotech Materials, Polymers, Nanoparticles, Peptide and Protein Chemistry
Expert has a MSc in chemical engineering and a PhD in pure and applied biochemistry. Her PhD thesis was on enzyme technology (enzymatic synthesis) and molecular imprinting (preparation of chiral liquid chromatography stationary phases). Expert carried out postdoctoral studies in…
Microbial Fermentation, Industrial Microbiology, Biotechnology
Expert. Expert has led fermentation and strain improvement efforts for a variety of anti-bacterial, anti-fungal, statins, ion-channel inhibitors, and immunoregulant natural products produced by actinomycetes and filamentous fungi. Expert led development of the Glarea lozoyensis fermentation process for producing Cancidas®,…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Clinical Chemistry, Laboratory Diagnostics, Immunoassay Development, Therapeutic Drug Monitoring
Expert has extensive experience in the field of clinical chemistry and clinical diagnostics. Development of analytical methods for trace analytes in biological fluids, especially in the field of clinical diagnostics, has been Expert's main job responsibility and success over the…
Biotechnology: All Areas of Business and Technology
Expert has extensive hands-on experience with, and knowledge of, deoxyribonucleic acid (DNA) probe technology, having worked in this area for 10 years. He used nucleic acid probe technology to characterize mammalian viruses and oncogenes while performing research supported by the…
Organic Synthesis, Organometallics, Prostaglandins, Vitamin D, Catalysis
ORGANIC SYNTHESIS; ORGANIC REACTIONS; NATURAL PRODUCT. Expert and his research group have successfully carried through many total syntheses of natural products. In addition, he has originated, reduced to practice, and published many new methods for effecting organic transformations. He also…