Stephen J. Kennedy30 Glen Drive, Hudson NH 03051

(603) 880-4567 StephenJKennedy@myfairpoint.net

Summary

Medical Devices ˛ Drug DeliveryPolymers ˛ (Bio)Materials ˛ Formulation

25 years Experience in Research and Product Development

Product Development Project Management ˛ Design Control Methods ˛

Process Development ˛ Preclinical Studies ˛ Quality Systems ˛ Preparation ofRegulatory Filings under US and EU requirements

Personal Creative problem-solver ˛ Work well with both Engineers and Scientists ˛

Research Projects or Product Development Projects ˛ Excellent Presentation andWriting Skills ˛ Experienced Manager of R&D Groups

Technical Areas Medical Devices based on Biomaterials ˛ Drug Delivery ˛

Biopolymers ˛ Hydrogels ˛ Emulsions ˛ Surgical Aids ˛ Tissue Augmentation ˛

Wound Healing ˛ Ophthalmic and Orthopedic Applications ˛ PharmaceuticalFormulation

Science Polymer Science ˛ Materials Science ˛ Biomaterials ˛ Formulation ˛

Physical Chemistry ˛ Surface Science ˛ Fluid Mechanics ˛ Rheology ˛

Structure-Property Relationships ˛ Materials Characterization ˛ Data Analysis ˛

Experimental Design

Experience

Prollenium Medical Technologies, Aurora, ON Canada (2/09–present)Director of R&D

‚ Oversee Company Technology Development.

‚ Helped design new facility, laboratories and manufacturing suite. Manage R&D group.

‚ Project Leader—Revanesse® cosmetic dermal filler family based on cross-linked hyaluronicacid. Directed development of prototypes and test methods in R&D, developed validatedmanufacturing process, maintained Design History File.

‚ Prepared Design Dossier. Received Canadian and EU approval. Sales in over 80 countries.

‚ Research: Dermal fillers, osteoarthritis viscosupplements, wound-healing dressing.

Self-Employed (2/08–2/09)ConsultantConsulting services in Materials Science and Formulation

‚ Prepared a technical/business assessment for an hyaluronic-acid-based viscoelastic surgicalaid in women’s health. Developed proposal for dry-eye product. Developed a Bayesianstatistical analysis program for Amyris, a Biotechnology Company (drugs, synthetic fuels).

Anika Therapeutics Inc., Woburn, MA (7/06–2/08)Director of Product DevelopmentProduct Development of Medical Devices based on Chemically-modified Hyaluronan, aBiocompatible Polysaccharide.

‚ Project leader new Viscosupplement for Osteoarthritis (Monovisc™ EU/US approval)Patent Issued.

‚ Product development drug/device combination – treatment of Osteoarthritis

‚ Technical support for cosmetic tissue augmentation product, Elevess™ (PMA SupplementApproval) 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.

Self-Employed (2003–2006)ConsultantConsulting services in materials science and formulation—medical devices, food ingredients,cosmetics, pharmaceuticals

‚ Projects for Tate&Lyle North America, Decatur, IL—‘Resistant’-Starch processdevelopment ˛ Process/Formulations for emulsification, and encapsulation of flavor, otheractives by modified starch ˛ Data analysis for: ‘e-nose’ sensor array, multi-angle laser lightscattering, modulated DSC instruments ˛ Bayesian classification analysis of HPLC/GC dataon competitor samples ˛ Prepared reviews of synthesis and mechanisms of action forartificial sweeteners ˛ Literature, IP, and business review of emulsion andmicro-encapsulation technology for food applications ˛ Real-time analysis programs for plantdata and process modeling at production facility for the artificial sweetener (Splenda®).

‚ TechPak Solutions, Inc., Peabody, MA—Formulation of phase-change, temperature-controlgels for food/pharma packaging

‚ Anika Therapeutics, Inc., Woburn, MA—Rheological characterization of viscosurgical aids

MacroChem Corp., Lexington, MA (6/02–12/02 mass layoff)Director of Formulation and Drug DeliveryEvaluation of drug candidates for transdermal delivery, development of prototype formulations.

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

‚ Acting Manufacturing Director: Supervised scale-up and production of material, underGMP, for two clinical trials. Set raw material and product specifications, prepared batchrecords, wrote CMC section.

Anika Therapeutics, Inc., Woburn, MA (1999–2002)Director of Product DevelopmentResponsible for technical aspects of product development and technical support of manufacturing.

‚ Project Leader Incert® hydrogel project - prevention of adhesions following spinal surgery.Supervised preclinical studies and stability studies. Contributor to approved investigationaldevice exemption (IDE). Clinical Trial material produced under tight time constraints andlimited resources. Commercialized in EU.

‚ Project Leader for cosmetic tissue augmentation hydrogel. Developed proposal for SeniorManagement, composed the project plan and product specifications. Introduced two novelsynthetic techniques as well as test methods. Product later approved in US & Europe.

‚ Research on chemically-modified hyaluronic acid, other polysaccharide-based biomaterialsand four provisional patent applications filed.

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

‚ Developed Design Control SOPs and managed the Product Development Group.

Protein Polymer Technologies, Inc., San Diego, CA (1997–1999)Senior ScientistBlock-copolymer polypeptide hydrogels for tissue augmentation to treat urinary incontinence.

‚ Rheological characterization of prototype hydrogels. Developed QC methods andspecifications for mechanical properties. Member of the design control team. Assisted inpreparation of an approved IDE.

‚ Developed a molecular model, led to a critical process change and significant performanceimprovement.

‚ Supervised research engineers. Technical presentations to investors and at conferences.

U. of Texas at Brownsville, Brownsville, TX (1995–1997)Assistant Professor Chemistry

‚ Instructor for General Chemistry, General Chemistry Laboratory, Physical Science, PhysicalChemistry, and Physical Chemistry Laboratory, Advisor for Engineering Tech Program.

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

CasChem Inc., Carlstadt, NJ (1993–1995)Senior Research ChemistProduct development of buffer gels for use in fiber optic telecommunication cable.

‚ Developed test method for yield stress measurement—a critical design parameter.

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

‚ Supervised technician, and coordinated testing in analytical department.

‚ Technical support of customers—all major telecom equipment companies in North America.

‚ New products included a low-yield-stress gel and a fire-retardant gel, for in-building.

Duquesne University, Pittsburgh, PA (1992–1993)Adjunct Faculty

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

Alcoa Technical Center, Pittsburgh, PA (1987–1992)Staff Scientist –Fluid State Modeling GroupRheological characterization and process modeling of reacting and non-reacting polymer systems.Supervised Technicians. Some projects were:

‚ Thermoset resin cure-kinetics model: pultrusion process for resin/glass fiber composites

‚ Flow model of interface stability in multilayer thermoplastic coextrusion (packaging).

‚ Nonlinear dynamics model of ‘chatter’ in aluminum sheet rolling.

‚ Simulation model for deformable roll coating.

‚ Design and construction of turbulent-flow simulator – effect of chemical composition andturbulence on droplet size distribution in two-phase sheet-rolling lubricants.

‚ Automatic calculation of contact angle of molten aluminum on ceramic substrates fromscanned image.

Dowell Schlumberger, Tulsa, OK (1985–1987)Senior Scientist – Fluid Mechanics Group

‚ Designed and constructed a unique rheometer for the study of polymer and surfactantstabilized emulsions in turbulent flows for the development of hydraulic fracturing fluids.

‚ Rheological characterization of viscoelastic surfactants for gravel-packing applications.

MIT, Cambridge, MA (1983–1985)Postdoctoral Research Associate

‚ Theoretical Physical Chemistry – Models of surface-induced phase transitions

UC San Diego, La Jolla, CA (1977–1983)Graduate Student

‚ Theoretical Physical Chemistry – Statistical Thermodynamics and Polymer Physics.

Bell Laboratories, Murray Hill, NJ (1975–1977)Senior Technical Associate

‚ Experimental Biophysics. X-ray scattering for the structure of cell-membrane lipid bilayers.

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

Patent and some Provisional Patents

‚ US8323617 B2, Treatment of Arthritis and other Musculoskeletal Disorders with CrosslinkedHyaluronic Acid’, by Tamera B. Gooding, Stephen J. Kennedy, and Charles H. Sherwood

‚ 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

References available upon request.