Expert in Biodegradable Systems for Controlled-Release Drug Delivery
Expert provides consulting for technical areas of product development, analytical R&D and Quality Control laboratories. Expert offers a number of solutions specifically aimed at desired delivery route, either based on generally available formulation strategies or through proprietary, patent-protected technologies. Expert also serves as outsourcing interface between internal admin and CROs and CMOs
Subject matter expert in analytical and physical chemistries of biodegradable drug delivery vehicles, strategies of their usage in case of vaccine, protein, and small molecule APIs for different routes of controlled delivery. Expert can help comprehensively characterize biodegradable Drug Products for the chemistry manufacturing and controls (CMC) part of regulatory submissions for the approval of clinical trials, and the authorization to market a new product.
• PHYSICO-CHEMICAL CHARACTERIZATION OF BIODEGRADABLE POLYMER AND DEVICE (synthesis and structural characterization; molecular masses (Mw, Mn, Mw/Mn); polymer end-groups; surface tension; hydrolysis pathway and reaction rate kinetics;pK; partition coefficients; unreacted monomers; residual solvents; degradation products; diffusion coefficient of water and other molecules; hydrophilic-lipophilic balance, HLB; physical form of vehicle- semisolid, microspheres, nanoparticles, coatings, strands)
• EXCIPIENT COMPATIBILITY (pros and cons to use different excipients, including MPEG, PEG, Poloxamer; polymer solubility parameters; plasticization effect; matrix homogeneity; uniformity of drug distribution)
• FORMULATION STABILITY IMPROVEMENT based on deep understanding of the underlying mechanisms of drug instability and degradation, including physical and chemical pathways as well as internal and external factors affecting drug stability within the delivery matrix (matrix-drug interactions, internal environment, site of delivery).
• ANALYTICAL METHOD DEVELOPMENT, VALIDATION, TRANSFER, STABILITY STUDIES AND RELEASE TESTING PROCEDURES FOR DRUG SUBSTANCES AND DRUG PRODUCT USING MODERN ANALYTICAL TECHNOLOGIES (HPLC; IEC; IEF; low and general range GPC/SEC; MALLS; FT-IR/NIR/Raman; NMR; LC-MS; GC-MS; dynamic viscosity; TGA; DSC; KF; dynamic LLS)
• IN VITRO RELEASE (IVR): modeling and simulation to predict and correlate matrix degradation, drug release kinetics and release parameters.
• TECHNOLOGY OPTIMIZATION (flexible delivery times of controlled release, the improvement of the bioavailability of low soluble drugs, the delivery of two or more drugs from the same formulation, the possibility of having clearable polymer carriers, the improvement of the targeting to tissues or cells, proper manufacturing techniques).
• COMPLIANCE. Expert success is based on the fact that he offers the highest quality and best value consulting available while meeting the necessary regulatory requirements with Code of Federal Regulation (CFR), Guidance for Industry (GFI), CDER, CBER, FDA, EMEA, ICH.
Consulting for technical areas of biodegradable polymer technology and product development, analytical R&D and QC labs.Audit or gap analysis of analytical development/validation and QC labs for technical integrity and cGMP complianceConsulting in Modeling and Simulation of "matrix-drug" interactions to predict and correlate IVR matrix degradation,
kinetics and drug release parametersSelection, coordination and management all contract analytical, formulation, manufacturing activities with multiple external CROs/CMOs.Consulting for Pharmaceutical and Medical Device Quality Assurance
Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California
|Year: 1985||Degree: D.Sc.||Subject: Bioorganic Chemistry||Institution: National Academy of Sciences, Ukraine|
|Year: 1972||Degree: Ph.D.||Subject: Polymer Chemistry||Institution: Saint Petersburg Technological University|
|Year: 1968||Degree: BS||Subject: Chemical Engineering||Institution: Odessa State Polytechnical University|
|Years: 1998 to 2008||Employer: AP Pharma||Title: Associate Director, Analytical Chemistry||Department:||Responsibilities: Analytical Chemistry and CMC of Biodegradable Drug Delivery Systems for Controlled Drug Release|
|Years: 1996 to 1997||Employer: Athena Neurosciences||Title: CMC Consultant||Department:||Responsibilities: Proteins, small molecules formulation and delivery|
|Years: 1981 to 1996||Employer: Physico-Chemical Institute of the National Academy of Sciences||Title: Head of the Biopolymers Department||Department:||Responsibilities: Chemistry, technology, pharmaceutical applications of MELANIN copolymers, and their conjugates with proteins.
CMC of oral dosage forms formulations.
|Years: 1981 to 1996||Employer: Odessa State Academy of Food Technologies||Title: Professor, Chair of Analytical Chemistry||Department:||Responsibilities: Scientific and Program Head for Analytical Chemistry Department. Lecturer in Analytical Chemistry, Physical Chemistry, Chemistry of Natural Polymers.|
|Years: 1973 to 1978||Employer: Plastpolymer, Saint Petersburg||Title: Head of Block-co-polymers Lab||Department:||Responsibilities: Subject matter expert in new methods of synthesis of biodegradable co-polymers and their usage in Pharmaceutical and Medical Device industries.|
|Years||Country / Region||Summary|
|Years: 1990 to 1992||Country / Region: Russian, Germany||Summary: Implemented new synthetic strategy for “living block-co-polymerization” and its use for the preparation of silicone and acrylate hydrogels with desirable for IOL/CONTACT LENSES hydrophobicity/hydrophilicity ratio (mutual project with Svyatoslav Fyodorov Moscow Research Institute of Eye Microsurgery, and Carl Zeiss,Germany )|
|Years: 1986 to 1987||Country / Region: Russia||Summary: Pioneering work on chemistry and technology of MELANIN pigments – a new type of “switched” antioxidant copolymer possessing powerful antistress and radio-protective activities. Proprietary formulation under the trade name “ENOMELANIN” was used in Ukrainian clinics during accident on Chernobyl atomic power station.|
|Years: 1981 to 1983||Country / Region: Russia||Summary: Expert managed all CMC activities for launching first Russian solid oral dosage form tranquilizer PHENAZEPAM onto European Market|
|Associations / Societies|
|Controlled Release Society (CRS), American Chemical Society(ACS)|
|Licenses / Certifications|
|Academician of Ukrainian Technological Academy|
|Awards / Recognition|
|National Academy of Sciences Award for Pioneering Work in Switched Co-polymer Antioxidant Systems,
Mendeleev Chemical Society Award for Outstanding Analytical Chemistry Paper,
Ukrainian Technological Academy Award for Outstanding Achievements in Chemistry and Technology of Melanin Pigments,
“Plastpolymer” Society Award for New Technology of Block-co-Polymers
|Publications and Patents Summary|
|He has 132 publications, 35 patents, 1 monograph and 1 text-book chapter in biopolymers|
|Training / Seminars|
|Expert has delivered a number of invited presentations, e.g., “Different strategies for protein formulation in biodegradable polymer particles”, and training sessions, e.g., “Compositional and failure analysis of polymers: practical approach”|
| Expert has extensive experience in selecting qualified vendors of pharmaceutical excipients for various drug delivery systems, formulation development services, analytical chemistry services, and processing/manufacturing services.
He has selected CROs/CMOs for the conduct of different studies that were included in IND/NDA submissions to the FDA
|Other Relevant Experience|
| Expert has an unparalleled expertise in chemistry and technology of MELANIN co-polymers, and their pharmaceutical applications.
As a Full Professor and Chair of Analytical Chemistry, Expert taught different courses of Chemistry in well-known University,
As a Scientific Advisor, Expert prepared 10 Ph.D.s