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Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
Biological Safety, Biosecurity, Dual Use Research of Concern, Microbiology
Ms. Expert has extensive experience conducting research with pathogenic E. coli and influenza viruses under the appropriate biosafety levels including BSL-3+ and BSL-3Ag. She has experience with reverse genetics, VLP formation, retrovirus manipulation, reporter assays, RNA isolation, and RT-PCR. She…
Bioprocess Development
Expert specializes in the development and selection of recombinant protein expression platforms, translating discovery candidates into development programs and the generation of preclinical material. She has successfully built infrastructure, incorporated process improvements and identified innovative approaches for development. She effectively…
Plant Cell Molecular Biology, Biochemistry, Bioenergy, Algal Biotechnology, Biomass Processing
Expert has a strong track record at internationally competitive level in plant cell molecular biology and biochemistry, mass spectrometry and proteomics, gene discovery and post-genomic systems biology and development of analytical techniques, achieved over 16 years of leading projects in…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Competitive Intelligence from Primary Sources in Pharmaceuticals, Diagnostics, and Medical Devices.
•Business research and development professional with a successful record targeting and developing Fortune 500 clients. •Founded pharmaceutical and information technology business intelligence firm and served as Business Development & Research Director for 15 years. •Expertise assessing the unique challenges facing…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
molecular modelling, QSAR, drug design, cytokine mimics, complex systems, nanotechnology, biomaterials, machine learning, AI, evolutionary methods
Expert has a PhD in radioastronomy and microwave spectroscopy and degrees in chemistry, chemical engineering, and physics. He is boundary-crossing, multi-skilled lateral thinker with unusually broad, highly relevant formal academic training in physics, chemistry, chemical engineering, and mathematics. He has…
Plant Biotechnology, Agiculture-Plant Breeding, Analytical Bbiochemistry- Mass Spectrometry
Expert having completed a post-doc and 12 years in academia went into the plant biotechnology industry at the very beginning. As such he has been involved in crop genetic engineering from the beginning with over 20 years of experience in…