Drug Discovery and Specialty in Small Molecules, Radiopharmaceuticals, Pre and Post IND PharmaceuticalsDeep understanding of pharmaceutical and biotech industries acquired over 33 years.Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.Pre- and post-IND drug development experience, including translational medicine.Technology platform enhancement and innovation (in-house and in-licensed).Significant business development and strategic planning experience.Exten...

Senior Pharmaceutical Professional Specializing in Global Business Development in the Healthcare Industry Focused on: Medical Devices, Drug Development, Regulatory Affairs, Quality, cGMP, FDA, Pharmaceutical and Clinical ResearchSenior Pharmaceutical Executive concentrating in medical devices, and the pharmaceutical research industries.Global pharmaceutical business development.Regulatory affairs, quality control, clinical research industries and operations.Submission preparation: IND, CTD, ANDA, NDA and MAA.Clinical research including protocol and medical writing.Strategic planning and business analysis.New pharmaceutical development and...

Drug Stability, Pharmaceutical Impurities, and Control Strategies ExpertChemical, physical, and environmental stability and degradation.Preformulation, formulation design and stability.Analytical and impurity (including mutagenic impurity) control strategies, including structure elucidation, characterization, predictive technologies and risk assessment.Photostability, photochemistry and photostabilization.Regulatory issues and authoring, primarily chemistry, manufacturing and controls section.Expert Witness ExperiencePatent case in Europe, regarding differences in stability between prasugrel and clopidogrel, and testified as Expert Witnes...

Pharmaceutical API and QA Consultant with Expertise in Steroids and Norsteroids Manufacturing. Lean Management, Validation, FDA InspectionsActive Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.Steroid plant operations; training, FDA inspections, and manufacturing.Lean management in API manufacturing.Quality assurance management; release operations in packaging processesAPI manufacturing - steroids and norsteroids.Pharmaceutical products scale-ups and technology transfers.Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities,...

Drug Therapeutic Discovery Medicinal Chemist Consultant: Pain, Inflammation, Cardiometabolic, Oncology and AntimicrobialsHit generation, lead identification, and lead optimization. Strategies, implementation plans and problem solving.Drug Discovery - "Concept to Clinic" - Road map and expectations. Goal setting, testing schemes, progression path tracking.Intellectual Property - Assessment, strategies and management. Due diligence on prior art, patentability. Expert witnessDrug discovery across therapeutic areas - Pain, inflammation, cardiovascular, metabolic, oncology and antimicrobial therapeutics.PK/PD (Pharmacokinetic and Pharmacodynam...

Oncology Therapeutics, RNA/DNA Isolation-Purification, PCR-Cloning and Mutagenesis, In Vitro Transcription (IVT), In Vitro Diagnostic and Antibody Production.Biotechnology/Nanotechnology Industry Expert - Oncology Therapeutics, RNA/DNA Isolation-Purification, PCR-Cloning and Mutagenesis, In Vitro Transcription (IVT), In Vitro Diagnostic and Antibody Production. Endogenous Biomarker Characterization, Aptamer and Nucleic Acid Technology DevelopmentPharmaceutical and Biotechnology drug discovery, diagnostic research and development, business development.Identify and implement technologies in strategically relevant areas to maximize value...

Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

Biopharmaceutical Industry Consultant - Computational Technology, Therapeutic Areas; Immunology, Oncology Delivering Clinical Candidates, Structural Biology and Medicinal Chemistry.Biopharmaceutical industry leader-small molecule and antibody drug discovery.Structural biology and medicinal chemistry.Broad knowledge base- hands-on; advanced computer simulations and biology, create, lead projects, identify unseen opportunities. Internal and external collaborative projects.Analysis-evaluation for Pharmaceutical licensing opportunities.Pharmaceutical due diligence, target-technology assessment.Align drug discovery and technology validation eff...

Ph.D. Personal Care and Cosmetic Product Launch, Regulations, Safe Polymers and Polymer Additives, Skin Care, Sun Care, Make-Up and Hair Care Formulation Expert.Research and development of cosmetic and personal care products and ingredients.Research and development of natural products and extracts.Analytical method development (HPLC, HPTLC, UV-Vis, NMR, FT-IR, DSC, TGA).Skin care, sun care, make-up and hair care formulation.UV filter recrystallization.Sensory panels, physical-chemical and rheological assessment.Intellectual property documentation.Cosmetic science and technology trainings.Technical training and support to sales personnel.Fu...

Ph.D. Organic Chemistry Consultant with Expertise in Drug Discovery and Early Development in Pharma and Biotech Industries. Infectious Diseases, Immunology, Oncology, CNS and Metabolic Diseases.Drug Discovery and Development Leader in the pharmaceutical and biotechnical Industries.Deliver candidates into clinical development with focus on infectious diseases, immunology, oncology, CNS and metabolic diseases.Raising venture capital and non-dilutive funding.CRO and CMO landscape Program Manager, setting up partnerships and collaborations.Execute complex research programs in a virtual environment.Project management, timelines and budgeting.Me...