Materials Science and Formulation

Stephen J. Kennedy, Ph.D.

** **** *****, ******, ** 03051

603-***-**** ***************@***********.***

Summary

Polymer • Materials • Formulation Scientist

** ***** ********** ** ******** and Product Development

Technical Areas: Medical Devices • Drug Delivery • Biopolymers • Hydrogels • Emulsions • Biomaterials in Surgical Applications • Tissue Augmentation • Wound Healing • Ophthalmic and Orthopedic Applications • Pharmaceutical Formulation

Science: Polymer Science • Materials Science • Biomaterials • Formulation • Physical Chemistry • Surface Science • Fluid Mechanics • Rheology • Structure-Property Relationships • Materials Characterization • Data Analysis • Mathematical Modelling • Experimental Design

Product Development: Project Management • Design Control Methods • Process Development and Production under GLP and GMP • Preclinical Studies • Preparation of Regulatory Filings and FDA requirements • Supervised both Scientific and Engineering Personnel

Personal: Creative problem-solver • Work well with both Engineers and Scientists • Research Projects or Product Development Projects • Excellent Presentation and Writing Skills • Either Individual Contributor or Manage small R&D Groups

Experience

Consultant, 3/08 to present

Consulting services in Materials Science and Formulation.

• Development of prototype for new cosmetic dermal filler.

• Report: Background and feasibility for a new dry-eye product.

• Bayesian Statistical Analysis program for Biofuels startup.

• Report: Technical/business assessment for new viscoelastic surgical aid in women’s health.

Anika Therapeutics Inc., Woburn, MA – Director of Product Development 7/06 to 2/08

Product Development of Medical Devices based on Chemically-modified Hyaluronan.

• Project leader for new viscosupplementation device (Monovisc CE Mark and IDE) and Technical lead for new combination device, both intended for the treatment of Osteoarthritis

• Technical support for cosmetic tissue augmentation product, Elevess® (PMA Supplement Approval) and development of line extensions

• Contributor to a number of regulatory filings---Europe & US.

• Managed the R&D Group and development of new technology and intellectual property.

Consultant, 2003 to 2006

Consulting services in Materials Science and Formulation---medical devices, food, cosmetics, pharmaceuticals

• Anika Therapeutics, Inc., Woburn, MA -- Rheological characterization of viscosurgical aids

• TeckPak Solutions, Inc., Peabody, MA -- Formulation of phase-change, temperature-control gels for food/pharmaceutical packaging

• Tate & Lyle North America, Decatur, IL -- Data analysis for: `e-nose' sensor array, multi-angle laser light scattering, modulated DSC instruments. Bayesian classification analysis of HPLC/GC data on competitor samples.

• T&L NA -- `Resistant'-starch process development. Development of process/formulations for emulsification, stabilization and encapsulation of flavor, other actives by modified starch

• T&L NA -- Prepared reviews of carbohydrate synthetic methods and mechanisms of action for artificial sweeteners. Literature, intellectual property and business review of emulsion and micro-encapsulation technology for food applications.

• T&L NA -- Analysis programs for plant data and process modelling at the production facility for a carbohydrate-based artificial sweetener, Splenda®.

MacroChem Corp., Lexington, MA - Director of Formulation and Drug Delivery 6/02 to 12/02 (mass layoff)

Evaluation of drug candidates for transdermal delivery and development of prototype formulations.

• Developed a new emulsion process/formulation of the SEPA® permeation enhancer. Evaluated a number of drug candidates and developed prototype cream/gel formulations showing increased transdermal delivery.

• Acting Manufacturing Director: Supervised scale-up and production of material, under GMP, for two clinical trials. Set raw material and product specifications, prepared batch records, wrote CMC section.

Anika Therapeutics, Inc., Woburn, MA - Director of Product Development 1999 to 2002

Product Development of Medical Devices based on Chemically-modified Hyaluronan.

• Leader of technical / scale-up team for Incert® hydrogel project - prevention of adhesions following spinal surgery. Supervised preclinical toxicology studies, production of clinical material, and stability studies. Major contributor to approved investigational device exemption (IDE). Clinical Trial materials produced under tight time constraints and limited resources. Product commercialized in Europe

• Project Manager for cosmetic tissue augmentation hydrogel. Developed proposal for Senior Management, composed the project plan and product specifications. Introduced two novel synthetic techniques as well as test methods. Product later approved in US & Europe.

• Research on chemically-modified hyaluronic acid, other polysaccharide-based biomaterials.

• Four provisional patent applications filed.

• Participated in company strategic planning. Reviewed IP, made quarterly presentations to Science Advisory Board, and developed research proposals for potential partners.

• Developed Design Control SOP’s and managed the Product Development Group.

Protein Polymer Technologies, Inc., San Diego, CA - Senior Scientist 1997 to 1999

Project: block-copolymer polypeptide hydrogels for tissue augmentation to treat urinary incontinence.

• Rheological characterization of prototype hydrogels. Developed QC methods and specifications for mechanical properties. Member of the design control team. Assisted in the preparation of an approved IDE. Product is currently in clinical trial.

• Invented a molecular model, which led directly to a critical process change and performance improvement.

• Supervised research engineers. Made technical presentations to investors and at Society of Biomaterials Meeting.

U. of Texas at Brownsville, Brownsville, TX - Assistant Professor Chemistry 1995 to 1997

• Instructor for General Chem, General Chem Lab, Physical Science, Physical Chem, Physical Chem Lab.

• Faculty advisor for setup of Engineering Technology Program.

• Research: Rheology of complex fluids. Consultant for A. E. Staley Co. on starch slurries.

CasChem Inc., Carlstadt, NJ - Senior Research Chemist 1993 to 1995

• Product development of buffer gels for use in fiber optic telecommunication cable. Rheological testing and mathematical modeling of mechanical behavior. Developed test for measurement of yield stress.

• Formulation work with fumed silicas, surfactants, thermoplastic elastomers, antioxidants, synthetic and natural oils. Supervised pilot plant and provided technical support for manufacturing.

• Supervised technician, and coordinated testing in analytical department.

• Technical support of customers, which included all major telecom equipment companies in North America.

• New products included a low-yield-stress gel as well as a fire-retardant gel, for in-building applications.

Duquesne University, Pittsburgh, PA - Part-time Adjunct Faculty 1992 to 1993

Instructor for General Chemistry and Physical Chemistry, Lecture and Laboratory Courses.

Alcoa Technical Center, Pittsburgh, PA - Staff Scientist 1987 to 1992

Member of Fluid State Modeling Group. Rheological characterization and process modeling of reacting and non-reacting polymer systems. Supervised Technicians. Some projects were:

• Thermoset resin cure kinetics model for pultrusion of resin/glass fiber composites through heated dies.

• Flow model to predict interface stability in multilayer thermoplastic polymer flow through a coextruder.

• Nonlinear dynamics model for chatter in Al-sheet rolling. Simulation model for deformable roll coating.

• Design and construction of turbulent-flow simulator, with laser backscattering probe, to study the effect of chemical composition and turbulence on droplet size distribution in two-phase sheet-rolling lubricants.

• Computer analysis program to calculate contact angles for molten aluminum on ceramic substrates.

Dowell Schlumberger, Tulsa, OK - Senior Scientist 1985 to 1987

Member of Fluid Mechanics Group.

• Designed and constructed a unique rheometer for the study of polymer and surfactant-stabilized emulsions in turbulent flows, for use in the development of hydraulic fracturing fluids.

• Rheological characterization of viscoelastic surfactant solutions for gravel-packing applications.

MIT, Cambridge, MA - Postdoctoral Research Associate 1983 to 1985

• Theoretical Physical Chemistry with Professor John M. Deutch. Models of surface-induced phase transitions, utilizing real-space renormalization group techniques.

UC San Diego, La Jolla, CA - Graduate Student 1977 to 1983

• Theoretical Physical Chemistry with Professor John C. Wheeler. Statistical Thermodynamics and Polymer Physics. Equilibrium polymerization models based on n=0 vector model of magnetic critical phenomena.

Bell Telephone Laboratories, Murray Hill, NJ - Senior Technical Associate 1975 to 1977

• Experimental Biophysics with Dr. James B. Stamatoff. X-ray scattering studies of the structure of cell-membrane lipid bilayers.

Patent Applications and some Provisional Patents

• ‘Treatment of Arthritis and other Musculoskeletal Disorders with Crosslinked Hyaluronic Acid', by Khalid K. Sadozai, Charles H. Sherwood, Kyle X. Bui, Tamera B. Gooding, Michael J. Bassett and Stephen J. Kennedy, US and PCT applications filed.

• ‘Hydrophobically-modified Surface-Active Hyaluronic Acid Via End-Cap Addition’, Application No. 60/271,024, by S. Kennedy, K. Sadozai, P. Bulpitt, and C. Sherwood

• ‘Hydrophobically-modified Hyaluronic Acid, Random-Graft Modification’, Application No. 60/271,179 by S. Kennedy and P. Bulpitt

• ‘Ophthalmic Viscoelastic Based on Konjac Glucomannan’, Application No. 60/271,178, by S. Kennedy and T. Gooding

• ‘Alginate-Based Viscoelastic for Ophthalmic Surgery’, App No. 60/271,181, S. Kennedy, T. Gooding

Education

Ph.D. Physical Chemistry, University of California at San Diego, 1983

M. S. Physical Chemistry, University of California at San Diego, 1979

B. A. Chemistry, Rutgers College, Rutgers University, 1975

Publications, Papers, List of Company Technical Reports, and References available upon request.

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