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Transformation
Extensive experience as managing director of several businesses. Started up several businesses and developed to €100m plus profitable sales. Supported several M&A activities including valuations. Running large organisation to improved profitability. Successfully turned around several under-performing businesses to show strong…
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…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Parasitology, Immunology, Agricultural Systems
He has many years research experience in understanding and mitigating the impact of a range of agricultural pests such as parasitic worms and ticks. He has carried out numerous small and large animal drug efficacy and residue trials which have…
Food Technology, Grain Processing, Edible Oils, Feasibility Studies, Project Appraisal
Mr. K.L. Expert has eight years of (1.5 years in private and 6.5 years in public sector organizations) experience as a research and Development Scientist. Designing and setting up a laboratory for testing of fire proof plywood. Process Development for…
Marketing, Advertising and Marketing Customs and Practices: Deceptive Marketing; Retail, Unfair Business Practices; Deceptive Advertising; Unfair Advertising; Unfair Competition; and IP and Trademarks
Expert is a Senior Marketing, Business and Advertising expert, since 2002. Marketing, and Advertising problem solver, since 1971; Business Strategies; he has been a Marketing Consultant, Expert Witness, and Senior Lecturer/Presenter for over two decades. He is deposition-tested and has…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…
Substance Use Disorders, Healthcare, Call Center Operations, Compliance, Quality Improvement, Strategic Planning, Mail Order, and Healthcare
C-SUITE EXECUTIVE Expert is a results-oriented, tested “C” class executive with extensive experience at driving the strategic direction and enhancing the operational functioning of organizations. Reputation for serving as the executive point of contact for all stakeholders, recommending data-driven change…
Hazardous and Solid Waste Management, Waste to Energy, etc.
Expert has worked on hazardous waste management for more than 8 years. She is an expert at management, characterization, treatment, and disposal of industrial hazardous waste at a hazardous waste treatment and disposal facility. She has experience of handling wastes…
Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug.…