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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…
Filamentous Fungal Strain Engineering
Expert has worked in Industrial Biotechnology for over 35 years to genetically engineer various filamentous fungi for protein production. Generally, he worked as a Bench Scientist at the enzyme companies Genencor, Danisco and DuPont. Expert has experienced startup environments and…
Pharmacology; Infusion, Strategy, Short and Long Term Solutions, Client Challenges
Expert, as a clinical manager, is very dedicated to delivering quality outcomes for patients with demonstrated accomplishments in leading the strategy and development of mission-critical healthcare administration and solutions within the ever-changing healthcare institutions, each day is filled with producing…
Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Medical Device Development
BSME - Mechanical Engineer: 40+ years Medical Device design & development (13 patents) - Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement…
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…
Global AR/VR and Emerging Technology Strategy
Expert is one of the foremost experts in Augmented and Virtual Reality and she speaks globally on all emerging technology. She has given over 100+ Keynotes on future tech and how it will impact our lives. Expert is the Founder…
Infusion Nursing
Energetic, self-directed clinical educator with 25 years’ experience in infusion and oncology therapy in the home, clinic, and hospital setting. Expertise in all aspects of home infusion, standards of care, and evidence-based practice to promote clinical excellence and positive outcomes…
Pharmaceuticals
PROFESSIONAL EXPERIENCE: Development, implementation and monitoring of clinical pharmacy services consistent with current practice guidelines for the following units: Neonatal Intensive Care, Pediatric Oncology, Pediatric Surgery, Pediatric Emergency Medicine, General Pediatrics, and Pediatric Intensive Care units. Formulary management and drug…
Healthcare, Contracting, Procurement, Supply Chain and Sustainable Cost Savings
Expert has over 25 years of experience as a healthcare supply chain, purchasing operations leader, medical device manufacturing consultant with proven accomplishments in speed to market traction, supply cost reductions, strategic sourcing, strategic partnerships and performance management leadership experience. He…