Large and Small Molecules Pharmaceutical: Development, Branding, Strategy, Licensing, and Licensing Expert.Pharmaceutical marketing, strategy, and product commercialization leader with over 15 years of experience in pharmaceuticals small and large molecules commercial representation on development teams.Commercial aspects of product development from preclinical through post-launch phases and in identifying key unmet needs and defining market opportunities.Strategic and commercial analyses with actionable recommendations for products, business development, markets, research and development, and portfolios.Proven ability to optimize a produ...

Biopharmaceutical Marketing Executive - Broad Commercialization Expertise in Marketing Strategy, Commercial Assessment, New Product Development and Launch PlanningBiopharmaceutical marketing executive with broad commercialization expertise including strategy development and execution for new product launches, label changes, and market events across lifecycle stages and customer segments.Primary care and specialty categories, including cardiovascular/atherosclerosis, osteoporosis, metabolic, antiemetics, oncology, and biosimilars.Marketing strategy, commercial, market, and competitor assessment, launch excellence, new product development an...

Medical Chemist Specializing in Synthetic, Chemistry, Medicinal Chemistry and Due Diligence Evaluation of Preclinical Packaging. Drug Licensing for Clinical Development, Pre-IND, (Pre-Investigational New Drug Application), With an Emphasis on Early Clinical Trials, Prior to Out licensing CompoundsMedical Chemist specializing in synthetic, chemistry, medicinal chemistry and due diligence evaluation of preclinical packaging.Drug licensing for clinical development, pre-IND, (Pre-Investigational New Drug Application), with an emphasis on early clinical trials, prior to out licensing compounds.Identification of clinical candidates for potential...

Development and Implementation of Phase-Specific Quality Systems and Pharmaceutical Production and TestingPharmaceutical quality assurance management and corporate quality strategy planning.Development and implementation of phase-specific quality systemsIdentifying and correcting road blocks to efficiency and complianceGMP facility design, construction management, validation and licensing of GMP manufacturing facilities.Proven success in U.S. and E.U Inspections of manufacturing and laboratories.Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

Commercial Pharmaceutical Strategy: New Product Launches, Profit and Loss Management, sales and Marketing. National and International Pharmaceutical LicensingCommercial leadership in the global life sciences industries, with extensive experience guiding both large and small life-science companies.Life science commercial strategy development.Product development (commercial): Clinical study design, labeling development, and KOL networks.Product launch in various disease states and platforms including diagnostics, vaccines and nutriceuticals.Market access strategy development: expert recommendation, Key Opinion Leader (KOL) in support, pr...

National-International Therapeutic Expert Focused on Inflammation/Autoimmune Disease, Transplantation, Respiratory Diseases, Infectious Diseases, Vaccines, Diagnostics, and Oncology.Strategy and streamlined processes for the identification and evaluation of strategic partnerships.Ability to obtain alignment, prioritize and build consensus from internal stakeholders.Diverse therapeutic area expertise in both global and U.S. markets, including; inflammation/autoimmune disease, transplantation, respiratory diseases, infectious diseases, vaccines, diagnostics, and oncology.Academic collaborations, technologies, early and late stage products, p...

Ph.D. Biochemist Specializing in Protein Purification and CharacterizationProtein purification and refolding.NMR and Crystallography protein purification using LC-MS to characterize proteins.Over 40 years of industry experience in drug developmentCurrent GMPSpecializing in developing new and very effective purification methods.Specializing in assay development.Purification of human insulin and Insulin analogs.Human monocyte/neutrophil elastase inhibitor, developed the expression of MNEI in E coli.Undisclosed Company, President and Founder, 2006 - 2013Acquired facilit...

Pharmaceutical Srategic Product and Portfolio Management Consultant for Generic Pharmaceuticals and Biosimilar drugs for Domestic and International Marketing. IP, Regulatory, and icensingGeneric pharmaceutical strategic product and portfolio management for generic pharmaceuticals.Biosimilar drug development, intellectual property, regulatory and licensing.Generic commercial issues and legal strategies for developing generic medicines.Commercial aspects of generic industry with extensive international experience at senior level.European marketing and business development in the generic pharmaceutical industry.Consultant to non-European com...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Pharmaceutical Development Expert: Planning, Portfolio, Technical Analysis and LicensingPharmaceutical and biotechnology business development and new product planning.In and Out licensing and strategic partnering.Commercial analysis and forecasting.Pharmaceutical life cycle management.Start-up of Pharmaceuticals, business building in proprietary, generic, and OTC pharmaceuticals and biotechnology, providing modeling and commercial assessments.Undisclosed Company, Chief Consultant, 2014 - PresentPrepared for pharmaceutical start-up forecast models and...