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Project Team: Other Recent Projects

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Advisors Profile

ADMEPharmaceutical executive with 25 years experience including leadership of Clinical Pharmacokinetics and Pharmacodynamics
Biomanufacturing and biologics process developmentFormerly with Immunex and Coulter Pharmaceuticals, led the Process Development and Materials Management departments of all products from pre-clinical development through commercialization.
Biopharm. Analytics and DevelopmentFormer Vice President with expertise in biopharmaceutical development, formulation, quality systems and operations
Biopharmaceutics DevelopmentFormer Senior Vice President and CSO with extensive experience in development of biopharmaceuticals
CMC - Process ChemistryFormer Senior Director of Process Chemistry. Designed processes for supply chain management and sourcing/vendor management.
CMC - Process ResearchFormer Group Director of Process R&D. Extensive experience in preclinical and clinical drug development.
CMC/Drug SubstanceFormer Senior Director of Process Chemistry. Designed processes for supply chain management and sourcing/vendor management.
CMC/Drug Substance Former Group Director of Process R&D. Extensive experience in preclinical and clinical drug development.
Clinical Development and PharmacologySenior Physician-Executive with 16 years industry experience including as Senior Vice President of Global Drug Development
Clinical and Regulatory AffairsFormer Senior Vice President of Pharmaceutical Research and Development with relevant clinical expertise
Drug DeliveryExperienced pharmaceutical consultant with background in drug delivery technology
Drug ProductFormer Director of Pharmaceutics R&D with over 20 years experience in preformulation studies and drug product development.
Drug SafetySenior executive with 30 years experience. Former Senior Vice President with global responsibility for toxicology, pathology and metabolism
Drug Substance & Overall Drug Development PlanningFormer Group Director of Process R&D. Extensive experience in preclinical and clinical drug development.
EngineeringEngineer with over 20 years experience in planning, design and operation of both organic chemistry and biologics facilities from laboratory- to full manufacturing scale.
FermentationFormer Director of Fermentation and Bio-catalysis Development
FormulationFormer Director of Pharmaceutics R&D with over 20 years experience in preformulation studies and drug product development.
Formulation Former Executive Director of Pharmaceutical Sciences with over 25 years experience in drug formulation/drug product.
GentoxFormer Director of Toxicology, with expertise in genetic toxicology. Member of US PhRMA committee that established the ICH genetic toxicology guidelines
Gentox and Product Development StartegyFormer Executive Director, Clinical Research Strategic Partnering, Clinical Development, and former Executive Director, Product Safety Assessment, Preclinical Development, Member of US PhRMA committee that established the ICH genetic toxicology guidelines.
Global Tox StrategyServed most recently as Senior Vice President Drug Safety Evaluation with a top tier Pharma company
Manufacturing StrategyFormer head of Manufacturing Strategy, with expertise in multi-site manufacturing operations, quality systems, and scale-up issues.
Operational ManagementEngineer with over 20 years experience in planning, design and operation of both organic chemistry and biologics facilities from laboratory- to full manufacturing scale.
Overall Development and Risk ReductionPharmaceutical executive with broad experience in drug delivery, business development regulatory affairs and cGMP
Packaging EngineeringFormer manager of Package Development and a member of the Drug & Pharmaceutical Packaging Committee
Quality, Performance Engineering and DistributionFormer head of Performance Engineering & Worldwide Quality as well as manager of International Distribution.
Regulatory Perspective on Contracts and OperationsFormer Director of International Quality Assurance with world-wide internal auditing responsibility for bio-manufacturing facilities for a major European pharmaceutical company
Tox, ADME, Safety PharmacologyFormer Executive Vice President, Global Drug Safety, Metabolism and Safety Pharmacology
ToxicologySenior executive with 30 years experience. Former Senior Vice President with global responsibility for toxicology, pathology and metabolism
cGMP Compliance AuditPharmaceutical executive with broad experience in drug delivery, business development regulatory affairs and cGMP