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Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…
Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert’s scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, tissue, etc.). These methods are essential for the pharma…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development
Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is…
Analysis, FEA, CFD, Medical Devices, Heat Transfer, Elastomers, Diffusion, Solar, Coupled Systems
Real invention and innovation most often springs from cross-fertilization and analogies from broad experience, quite apart from an entire career in a narrow field. See, for instance, Holyak and Thagard, "Mental Leaps: Analogy in Creative Thought". Expert is a broad…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections
Expert has over 10 years experience in the areas of QC Stability (Drug Product and API). In addition, Expert has many years of experience in drafting QC Stability sections for the following submissions for the FDA: IND, NDA, BLA, PAS,…