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...

Executive Pharmaceutical Research Physician (MD, PhD) Consultant experienced in Clinical Research (Phase 2-4), Regulatory Affairs (inc. filings), Program Strategy Development, Medical Affairs, Advertising and Promotion, Medical Education, Life-Cycle Management and Launch Activities.Review of digital and non-digital Advertising and Promotion materials for existing brands, as well as new product launches, (U.S. and international) press releases, educational materials, sales rep training, OPDP, (Office of Prescription Drug Promotion) regulations.Life-cycle management and new product launch activities, including:Advisory boards, KOL developmen...

Pharmaceutical, Biotech, Diagnostics and Drug Discover, Commercial Development and Medical Device ProfessionalProduct development programs and projects.Analyze markets, align technology solutions with healthcare market needs, develop insights and business strategy for future customer needs.Develop initiatives programs and drive action plans.Defining and executing winning strategies for successful business growth through deployment of strategic directions, risk management and operational excellence techniques.Pharmaceutical, biotech, diagnostic,and drug discovery.CROs, and medical device markets working within matrix team(s) to identify op...

Bioengineering Consultant with Expertise in Parental Products, Vaccine Production, Protein Purification (Recombinant Protein), Scale up - Downstream Processes, CMC, IND and IMPDPharmaceutical drug development, regulatory affairs, and commercial manufacturing of biologics and combination products.Recombinant proteins of different classes, vaccines, plasmids, small molecules, and combination products involving controlled release formulations.Preform scale up of downstream processes.Development and optimization of protein purification in the recombinant protein production.Regulatory requirements for biopharmaceutical development and manufactu...

Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

Ph.D. Organometallic Consultant Experienced Product Development and Intellectual Property for the Hydrofractioning IndustryFormulating and chemistry of hydraulic fracturing stimulation fluids.Organometallic cross-linkers and catalysts.Adhesion promoters.Sol-gel technology.Hydrophobic and oleophobic coatings.Fluorinated surfactants.Development and testing of coating systems.Patent searching and analysis.Root cause analysis.Expert Witness ExperienceProvided expert witness testimony on organosilicon chemistry: Deposition in a patent infringement case.

Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

Chemical Process Engineering Expert - Pilot and Production Projects, Including Solids HandlingContributing to over 40 years in chemical engineering working with industry leaders: Dupont, Air Liquide, Day Zimmermann and Hercules.Advanced process technology for research and development organizations in the chemical industry of over 30 years.Led major scale-up from bench through production.Over 20 major start-ups to date totaling in excess of over $75 million in capital equipment. (Bench>pilot> commercial expert).Particle and powder technology: Subject Matter Expert (SME) concentrating on drying, spray drying, grinding, particle morphology...

Novel Nanomaterials Expert with Synthetic Procedures (Colloidal, Wet-Chemical, Solvothermal, Hydrothermal, MOCVD, etc.). Nanoparticle Based Profiling, Targeting, Imaging and Therapy of Cancer Cells, Drug Delivery, Pathogen Mimicking for Immunotherapy and Personalized Medicine.Development and troubleshooting of novel nanomaterials based on synthetic procedures (colloidal, wet-chemical, solvothermal, hydrothermal, MOCVD, etc.).Extensive experience with synthesis of (magnetic, plasmonic, radioprotectant nanoparticles) metals (Au, Ag, Pt, Pd), metal-oxides (MO), metal chalcogenides (-S, Se), and magnetic hybrid composites (M@MO), quantum dots...

Medical Affairs, Medical Writer, and Ophthalmology Expert for Strategic Advisory Boards and Product Launch Medical Writer and Corporate Trainer, Medical-Legal ReviewerCreation of backgrounders and slide sets for pharma and medical device companies.Live training.Medical writing: drug dossiers, medical letters, protocols, abstracts, posters, manuscripts, regulatory writing - CSRs.Creation and administration of Investigator Initiated Study Proposals program.Key opinion leader engagement.Anatomy, physiology, and pharmacology of eye.Methods training for the conduct of clinical trials.Medical-legal review of educational background materials and...