LEADERSHIP:

CAREER SUMMARY

Results-oriented, high-energy, hands-on doctorate-level manager with a demonstrated record involved in creation, administration and execution of projects, and coordination of research and development.  Major strengths are in multi-disciplinary approaches to new product development processes, problem solving, building and management of research and development teams, generation of intellectual property, and organization of pre-clinical and clinical studies.  Excellent communication, presentation, and computer skills.  Experience in leading and motivating people, with and without direct authority.  Certified Project Management Professional (PMP).  U.S. Permanent Resident.

Extensive senior-level experience and successful technical project management in major corporations
(Abbott Laboratories, Johnson & Johnson, Procter and Gamble) in the following areas:

·  Class III, Class II, and Class I medical devices and in vitro diagnostic products.

·  Pharmaceutical drug / medical-device combination products, novel drug delivery systems, transdermal patches.

·  Compliance with 21 CFR Part 820 (QSR), 21 CFR Parts 210 and 211 (cGMP), ISO 13485, and ISO 15197.

·  Development of novel microfabrication and high-speed assembly methods for high-volume, web-based manufacturing of biomedical devices, low-cost biosensors, and pharmaceutical products.

·  Research and Development: Medical Devices, Pharmaceutical Packaging, Disposables, Material Science, Polymers, Plastics, Process Technology, Biomedical Microdevices, Biomechanics, and Microfluidics.

RESEARCH & PRODUCT DEVELOPMENT EXPERIENCE

Managing Director, nanoBioSciences, LLC, San Francisco Bay Area, CA                     2005-Present

A pharmaceutical drug-delivery company developing an innovative line of novel drug-delivery systems. 

·  Responsible for all scientific activities and general corporate administration from company inception. 

·  Develop a new class of advanced microneedle-array based transdermal patches (the “AdminPatch®”) and a microneedle-array based pen-injector device (the “AdminPen™”) that painlessly and conveniently delivers therapeutic levels of pharmaceutical drugs or cosmetic actives (i.e. hyaluronic acid) through the skin.

–   Defined the novel transdermal pharmaceutical product which would address unmet patient needs

–   Ensured broad Intellectual Property coverage and protection

–   Optimized design and shown technical feasibility

–   Selected suppliers and demonstrated manufacturing feasibility

–   Identified suitable animal facilities and prepared protocols for performing pre-clinical studies

–   Established contacts with several potential corporate partners and investors

·  Offer independent engineering and scientific consulting services, program management services, and  strategic product development advice and assistance (clients included Tyco Healthcare).

·  Provide independent investment research services, to companies or individuals contemplating an investment in pharmaceutical, biotechnology, diagnostic or medical device products or firms.  Evaluate the supporting technology, manufacturability, and compliance with FDA cGMP/QSR regulations.

–   Clients included: Charlesbank Capital Partners, Canyon Capital Advisors, MedTech Strategies, etc.

Program Manager IV, Abbott Diabetes Care, Alameda, CA                                         

Development of a fully integrated blood glucose monitoring system combining a meter, electrochemical test strips and lancing capabilities in one compact electro-mechanical device, enabling simple point-and-click testing.

·   Organize and lead core team and subteams to plan, design, and implement project deliverables.

·   Provide strategic planning leadership by setting strategies and priorities based upon identification of critical program tasks and pro-active mitigation of program risks, clearly communicate formulated strategies to the team.

·   Manage and facilitate the completion of the program within boundaries of quality, time and budget.

·   Develop and maintain fastidious project schedules, using MS Project and ProChain Project Scheduling.

·   Ensure compliance of project records such as plans, schedules, design reviews with regulatory and internal design control/quality system requirements.

·   Communicate with Chemistry leads, Engineering leads, Systems Engineering leads, Quality, Regulatory, Sourcing, Marketing, Clinical Affairs, and executive officers on status and issues.

·   Foster an environment of creativity and innovation. Provide advice and technical expertise to functional subprojects.

·   Manage Intellectual Property related to the Program, prioritize and file inventions, perform FTO studies.

·   Lead the BioFluid Dynamics technical area including blood expression from skin tissues, transfer, and analysis.

Principal Engineer, Altea Therapeutics, Atlanta, GA                                                    2003-2005

Development of Skin Microporation Device and Transdermal Drug Delivery Patch.

·  Coordinated development of skin microporation device and continuous transdermal insulin infusion patch.

·  Ensured compliance with FDA Guidance for Combination Products, cGMP and QSR regulations.  Prepared required documentation such as SOPs, Development Reports, MBRs, etc. for Phase I and Phase II clinical trials.

·  Identified failures modes of skin microporation device and re-engineered it to improve product reliability.

·  Planned and conducted pre-clinical animal studies to investigate drug delivery patch prototypes.

·  Set up the laboratory for engineering studies and evaluation of microporation device and drug infusion system.

·  Performed numerical modeling of drug delivery processes and microporation of skin.

·  Participated in selection and evaluation of microfabrication vendors and high-speed assembly.

·  Generated intellectual property; co-authored, prepared, and filed four patent applications.

·  As a Principal Investigator, prepared SBIR grant applications for submission to NIH and NSF.

Senior Scientist, LifeScan / Johnson & Johnson, San Jose, CA                                    2000-2003

Microneedle/Strip Development for a fully integrated “All-In-One” Glucose Meter.

·  Designed, fabricated, analyzed, and evaluated microneedles for body fluid extraction and glucose detection.

·  Developed next-generation glucose measuring strip utilizing microneedle technology for “all-in-one” glucose meter while taking into account numerous manufacturing, cost, and performance issues.

·  Identified and assessed various microfabrication techniques, established working relationships with suppliers.

·  Performed analysis of complex microfluidic and biomechanical phenomena in microsystems and human skin.

·  Designed and optimized microneedle and sensor elements using CAD and numerical modeling packages, prepared engineering drawings, identified proper materials, and submitted designs for microfabrication.

·  Set-up microneedle and sensor evaluation laboratory, created testing protocols, analyzed obtained data.

·  Together with clinical research group defined and prepared clinical protocols and performed studies.

·  Formulated patent strategy for the project, co-authored, prepared, and filed six patent applications.

Scientist, Procter and Gamble, Cincinnati, OH, Corporate Research Division                   1998-2000

Development of Microneedle Arrays for Drug and Cosmetics Delivery.

·  Developed novel drug delivery and glucose monitoring methods based on microneedle technology.

·  Proposed novel portable electrochemical biosensor for continuous minimally-invasive glucose monitoring.

·  Suggested novel inexpensive methods for high-volume microneedle fabrication.

·  Numerically modeled diffusive and pressure-driven transport of various drugs into and through skin.

·  Modeled microneedles-skin interface using multi-physical numerical analysis to define the best operational conditions and optimal microneedle geometrical shape which is compatible with microfabrication methods.

·  Provided computational fluid dynamics expertise for the key P&G Corporate Research Division projects.

·  Prepared and submitted microneedles for in vivo and in vitro studies and analyzed the obtained results.

·  Formulated patent strategy for the project, co-authored, prepared, and filed seven patent applications.

EDUCATION

Ph.D., Chemical Engineering, University of Notre Dame, Notre Dame, IN, USA            May 1999

GPA: 3.82/4.00; Advisors: Professor A.E. Miller, Professor H.C. Chang

M.S., Mechanical Engineering, Moscow State University, Moscow, Russia                  June 1992

GPA: 4.84/5.00

PMP, Project Management Professional, Project Management Institute, USA      

Continuing Education Courses   

Abbott New Leader Program, Situational Leadership II, Bottom-Line Project Management I & II, Desing Control, ProChain Project Management, On-Site Clinical Studies, P&G Worldwide Team Effectiveness.

SKILLS

Computer (Engineering Design, Analysis, CFD, FEM, and Statistical Packages)

·  Design of medical devices and process equipment using SolidWorks, ProEngineer and AutoCAD: DFM, DFR.

·  FEM analysis, CFD fluid dynamics modeling, and virtual optimization of mechanical, electrochemical, and biomedical processes in human tissues, medical devices, and pharmaceutical products as well as in manufacturing process equipment with CosmosWorks, CFDRC, Fluent, FIDAP, Gambit, Maple, FORTRAN, C, Excel, and Matlab.

·  Advanced knowledge of Microsoft Project, Microsoft Office, MS Word, MS Excel, PowerPoint, Outlook, Lotus Notes.

Engineering

·  Process equipment design, troubleshooting, and optimization.  Polymer mixing, spraying, and drying. 

·  Multi-layer web handling – drying, unwinding, winding, wrinkle removal, lamination.

·  Packaging characterization and validation studies. Accelerated aging studies.

·  Skin permeation studies of therapeutic drugs and cosmetic actives.  Wound healing studies.

·  Analysis of human and animal skin with Vertex MicroVu, TEWL, and fluorescent dyes.

·  Evaluations of skin mechanical properties and microstructure with Cryo-SEM Microscopy.

·  Body fluid (blood and ISF) extraction through skin using microneedle technology and skin-interface rings.

·  Characterization of blood flow into diagnostic strips, capillary microchannels, and cells.

·  Electrochemical measurements of glucose and other analytes in blood and ISF.

·  Hands-on knowledge of web-based high-volume continuous manufacturing processes.

·  Designed, used, and maintained a variety of R&D and process equipment used for micro- and nanofabrication.

Analytical (Six Sigma, CFD and FEA Modeling, Patent Strategy Formulation)

·  Advanced knowledge of Six Sigma, Process Excellence, and Design Excellence tools and methodologies.

·  Biosensor algorithm development for blood glucose measurement.

·  Fluid flow analysis of blood expression from finger and arm and filling capillaries and glucose strips with blood.

·  Identification of physical mechanism for complex biomedical, electrohydrodynamic, and chemical processes.

·  Expert in a variety of analytical techniques including computerized symbolic computations allowing analytical analysis of non-linear partial differential equations: center manifold projection, dynamical and control systems.

·  Skillful in numerical simulations of biomedical and (electro) chemical processes in complex systems.

·  Formulation and implementation of patent strategy for development projects.

MEDIA REFERENCES

·         “FDA Combo Product GMP Guidance Will Help Clarify Jurisdictional Boundaries”, The Gold Sheet, F-D-C Reports, December 2004.

·         “CFD Software Streamlines Product Development”, R&D Magazine, Reed Elsevier plc group, April 2004.

·         "Design & Fabrication of Biomedical Microdevices", FLOWSHEET, AIChE, Feb 2002.

SELECTED PATENTS AND PUBLICATIONS

· V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, E. Kiser, “Methods of fabricating physiological sample collection devices”, US7060192

·  V.V. Yuzhakov, F.F. Sherman, G.D. Owens, V. Gartstein, " Intracutaneous microneedle array apparatus", US 6931277

·  M. Teodorczyk, E. Kiser, L. Olson, D.V. McAllister, V.V. Yuzhakov, K.W. Leong, “Electrochemical test strip with an integrated micro-needle and associated methods”, EP 1391716

·  V. Gartstein, D.D. Nebrigic, G.D. Owens, F.F. Sherman, V.V. Yuzhakov, “Intracutaneous edged microneedle apparatus”, US Patent No. 6652478

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, E. Kiser, “Methods of fabricating physiological sample collection devices”, US Patent Appl. No. 20030212346

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, “Physiological sample collection devices and methods of using the same “, US Patent Appl. No. 20030212344

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, “Physiological sample collection devices and methods of using the same “, EU Patent Appl. No. 1360933

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, E. Kiser, “Methods of fabricating physiological sample collection devices“, EU Patent Appl. No. 1360932

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, E. Kiser, “Physiological sample collection devices and method of using the same”, EU Patent Appl. No. 1360931

·  M. Teodorczyk, E. Kiser, L. Olson, D.V. McAllister, V.V. Yuzhakov, K.W. Leong, “Electrochemical test strip with an integrated micro-needle and associated methods”, US Patent Appl. No. 20030150745

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, E. Kiser, “Physiological Sample Collection Devices And Methods Of Using The Same”, US Patent Appl. No. 20030143113

·  V.V. Yuzhakov, V. Gartstein, G.D. Owens" Microneedle apparatus used for marking skin and for dispensing semi- permanent subcutaneous makeup", US Patent No. 6565532

·  V.V. Yuzhakov, D.V. McAllister, "Physiological Sample Collection Devices and Methods of Using the Same", EU Patent Appl. No. 1284121

·  V.V. Yuzhakov, D.V. McAllister, "Physiological Sample Collection Devices and Methods of Using the Same", US Patent Appl. No. 20030028125

·  V.V. Yuzhakov, D.V. McAllister, "Devices for Analyte Concentration Determination and Methods of Using the Same", US Patent Appl. No. 20030028087

·  V.V. Yuzhakov, D.V. McAllister, "Test Strip for Analyte Concentration Determination of a Physiological Sample", EU Patent Appl. No. 1281352

·  V.V. Yuzhakov, D.V. McAllister, L. Olson, K.W. Leong, M. Teodorczyk, E. Kiser, "Physiological Sample Collection Devices and Methods of Using the Same", US Patent Appl. No. 20020168290

·  F.F. Sherman, V.V. Yuzhakov, V. Gartstein, G.D. Owens, "Method for Manufacturing an Intracutaneous Microneedle Array", US Patent No. 6471903

·  F.F. Sherman, V.V. Yuzhakov, V. Gartstein, G.D. Owens, "Method of Manufacturing an Intracutaneous Microneedle Array", US Patent No. 6451240

·  V. Gartstein, D.D. Nebrigic, G.D. Owens, F.F. Sherman, V.V. Yuzhakov, "Intracutaneous Microneedle Array Apparatus", US Patent No. 6379324

·  F.F. Sherman, V.V. Yuzhakov, V. Gartstein, G.D. Owens, "Apparatus and Method for Manufacturing an Intracutaneous Microneedle Array", US Patent Appl. No. 20020020688

·  V.V. Yuzhakov, V. Gartstein, G.D. Owens, "Microneedle Apparatus Used For Marking Skin And For Dispensing Semi-Permanent Subcutaneous Makeup", WO Patent Appl. No. 0191846

·  F.F. Sherman, V.V. Yuzhakov, V. Gartstein, G.D. Owens, "Apparatus and Method for Manufacturing an Intracutaneous Microneedle Array", US Patent No. 6312612

·  V.V. Yuzhakov, F.F. Sherman, G.D. Owens, V. Gartstein, "Apparatus and Method for Using an Intracutaneous Microneedles Array", US Patent No. 6256533

·  V. Gartstein, D.D. Nebrigic, G.D. Owens, F.F. Sherman, V.V. Yuzhakov, F. Arias, "Intracutaneous Edged Microneedle Structure", WO Patent Appl. No. 00074766

·  V.V. Yuzhakov, F.F. Sherman, G.D. Owens, V. Gartstein, "Intracutaneous Microneedle Array Apparatus", WO Patent Appl. No. 00074765

·  F.F. Sherman, V.V. Yuzhakov, V. Gartstein, G.D. Owens, "Method of Manufacturing An Intracutaneous Microneedle Array", WO Patent Appl. No. 00074764

·  V. V. Yuzhakov, A. E. Miller, H.-C. Chang, "Pattern Selection during Electropolishing due to Double-Layer Effects", Chaos, V. 9, pp. 62-77, 1999.

· V. V. Yuzhakov, H.-C. Chang, A. E. Miller, "Pattern Formation during Electropolishing", Physical Review B, V. 56, pp. 12608-12624, 1997.

·  S. Bandyopadhyay, A. E. Miller, H.-C. Chang, G. Banerjee, V. V. Yuzhakov, D.-F. Yue, R. E. Ricker, S. Jones, E. Baugher, M. Chandrasekhar; "Electrochemically Assembled Quasi-Periodic Quantum Dots Arrays",  Nanotechnology, V. 7, pp. 360-371, 1996.

·  N. N. Smirnov, V. V. Yuzhakov, "Steady and Unsteady CO Oxidation on Platinum with Allowance for External Diffusion Retardation,"  Combustion, Explosion, and Shock Waves, V. 32, pp. 641-648, 1996.

·  N. N. Smirnov, V. V. Yuzhakov, "Dynamics of Catalytic Oxidation of CO on Pt with Account for Exodiffusional Retardation."  Combustion, Explosion, and Shock Waves, V. 29, pp. 719-723, 1993.

·  N. N. Smirnov, V. V. Yuzhakov, "Diffusion-Controlled Oxidation of Carbon Monoxide on a Platinum Catalyst" in  Problems in Continuum Mechanics [in Russian], Editor E. I. Shemyakin, pp. 172-187, 1993.

INVITED LECTURES AND CONFERENCE PRESENTATIONS

· V. V. Yuzhakov, “Advanced micro-needle Patch (AdminPatch™) for Minimally Invasive Transdermal Drug Delivery,” Invited Presentation at 1st Annual Skin Summit: Transdermal Drug Delivery & Development & Beyond, Philadelphia, PA, February 22-23, 2007.

 · Yuzhakov V.V., Smith A., "Numerical Modeling of Skin Microporation for Continuous Transdermal Insulin Delivery with PassPort™ Patch", Invited Presentation at Georgia Tech Symposium on Computing Systems and Networking Technologies, Atlanta GA, February 18, 2005
Click here for the abstract

· V. V. Yuzhakov, “PassPort™ Patch for Continuous Delivery of Therapeutic Macromolecules through the Skin”, Invited Lecture at Institute for Bioengineering and Biosciences, Georgia Institute of Technology, Atlanta, GA, August 10, 2004.

· V. V. Yuzhakov, “PassPort™ Patch for Continuous Delivery of Therapeutic Macromolecules through the Skin”, Invited Presentation at AAPS Workshop on Development, Licensing and Marketing of Injection Drug Delivery Devices for Biotechnology Products, Boston MA (2004) 

· V. V. Yuzhakov, "Fabrication of Highly-Ordered Periodic Nanostructures and Self-Assembled Patterned Magnetic Media", Invited Lecture at IBM Almaden Research Center, May 2002.

· V. V. Yuzhakov, "Design and Fabrication of Biomedical Microdevices", Invited Lecture at AIChE Norcal Meeting, January 2002.

·  V. V. Yuzhakov, "Design and Fabrication of Biomedical Microdevices", Invited Presentation at Molecular Devices Workshop 2001, University of Notre Dame, Notre Dame IN, July 2001.

·  V. V. Yuzhakov, et. al., Micro Electro-Mechanical Systems (MEMS) - the next logical step in silicon revolution, P&G Analytical Chemistry Symposium, Cincinnati OH, September 2000.