Biomedical and Polymer Expert: Wound Dressing, Hydrogels and Transdermal Delivery
Consultant #707
Expertise
Biomedical Scientist with experience in:
- Wound dressing.
- Transdermal and topical drug delivery systems.
- Drug delivery systems.
- Conductive adhesives.
- Medical electrodes.
- Hard and soft tissue adhesives.
- Cardiovascular, urinary tract and orthopedic implants.
- Dental materials.
Broad background in polymer chemistry and technology:
- Hydrogels.
- UV and E-Beam radiation grafting and crosslinking.
- Water soluble polymers.
- Monomer/polymer synthesis.
- Structural property relationships.
- Chemical vulcanization.
Experience
Independent Consultant, 1997 - Present
Undisclosed Firm, Director New Product Development and Regulatory Affairs
- Developed new conductive adhesive hydrogels for use in medical electrodes for neuromuscular stimulation applications.
- Provided technical expertise in expediting all materials related problems:
- Identified biomedical extrusion grade polyurethane rubbers for lead wire manufacturing.
- Identified improved hot melt adhesives for electrode assembly.
- Prepared and filed 510(k) submissions.
Cambrex Hydrogels, Harriman, NY, 1989 - 1995
Polymer Research and Development Manager
- Hired, trained and supervised a staff of 5 scientists and technicians.
- Developed customer-oriented research projects designed to meet or exceed customer requirements and expedite project cycle time.
- Met corporate goals for Total Quality Management through a complete re-evaluation of all research and development and G.C. procedures for raw materials, intermediates and products using various statistical methods including Statistical Process Control (SPC).
- Established SPC as a management technique to improve product quality and manufacturing efficiency and furthered adoption of cGMP's.
- Filed 5 patents of which 3 have issued and 2 were abandoned by the new owners.
- Saved a $750,000 electrically conductive hydrogel as the result of process and product improvements.
- Initiated and managed a 14-month program in transdermal and topical drug delivery that included outside research contract.
- Established the utility of monolithic hydrogel delivery systems and identified new hydrogel compositions for site-specific oral drug delivery.
- Discovered a new class of high adhesion electro-conductive hydrogels.
- Conceived and implemented a project to develop a flowable gel deep cavity wound dressing based on interpenetrating polymeric networks.
Vice President, Research and Development
- Solved problems associated with the development of a family of polypeptide based tissue adhesives for dermal wounds, reconstructive surgery and ophthalmology.
- Reorganized the 18-member research group into teams to concentrate on basic problems inherent in the core technology.
- Established product and process control protocols for identification of key problems associated with earlier synthetic analogues of the mussel adhesive.
- Isolated co-factors, possibly contributing to the adhesive character of the mussel adhesive.
- Developed two non-medical applications for this technology, corrosion coatings and metal sequestering.
Valleylab, Inc. Div. Pfizer Hospital Product Group, Boulder, CO, 1984 - 1989
Manager, Technology Development
- Hired, trained and managed a staff of 5 scientists and technicians.
- Managed an intensive program of formulation optimization for process and product development of electro surgical grounding pads and TENS and EKG electrodes.
- Successfully completed the program and transferred the processes to toll manufacturer.
- Successfully defended company's patent applications, which resulted in establishing a proprietary position in their cross linked hydrogen technology.
- Developed hydrogen adhesives for wound/burn dressings.
- Established an exploratory project in transdermal drug delivery system and demonstrated efficacy for analgesic and NSAID containing patches.
Howmedica, Inc., Corporate R&D Lab Div., Pfizer Hospital Products Group, Groton, CT, 1979 - 1984
- As Manager, Technology Development, directed wide-ranging technology assessment project for the Corporate Business Development Group with special emphasis on least invasive surgery.
- Responsible for project planning and financial management for the department.
Manager, Polymer Research from 1979 - 1982.
Myerson Tooth Corp., Howmedica, Inc., Cambridge, MA, 1976 - 1979
- Manager Dental Materials Research
Pennwalt Corp., Flourochemicals & Plastics Div., King of Prussia, PA, 1968 - 1976
- Project Leader
Raychem Corp., Menlo Park, CA, 1966 - 1968
- Staff Scientist
Union Carbide Corp., Chemicals and Plastics Div., Bound Brook, NJ, 1963 - 1966
- Research Chemist
Honors & Publications
Academic and Professional Affiliations
- American Chemical Society
- The Society for Biomaterials
- Member U.S. Delegation of the International Standards Organization, TG-105 Meeting in Berlin, West Germany, WG2 Color Stability and Synthetic Resin Teeth.
- Referee for Papers in Polymer Science in the "Journal of Biomedical Materials Research."
- American National Standards Committee, MD-156, Dental Materials, Instruments and Equipment, Past Chairman of the Plastic Resin Teeth and Plastic Veneering Materials. Sub-committees, ANSC MD-156 Certificate of Appreciation.
Additional Courses
- Hartford Graduate Center, Engineering Management.
- Hartford Graduate Center, Financial and Managerial Accounting.
- American Management Association, Senior Project Management.
- American Management Association, Successfully Managing People.
- Q/P Management Inc., Process Capability Workshop.
- Purdue University, Hydrogens for Medicine and Pharmacy.
- Tempera Total Quality Management (3M) Training Course.
- Tempera GMP Training Course for Bulk Pharmaceutical Manufacturers.
- Pfizer Hospital Products Group Clinical Affairs State- of-the-Art Seminar.
- Pfizer Hospital Products Group Sterilization State-of-the Art Seminar.
- Pfizer Management Course in Negotiating with Superiors and Subordinates.
- Kepner-Tragoe, Decision Making and Problem Analysis.
- Pfizer Management Development Program.
- Dale Carnegie, Human Relations.
Credentials
- Post-Ph.D., Organic Chemistry, Ohio State University
Guest Speaker and Lectures
- Tufts University, School of Dental Medicine, Guest Lecturer on Dental Polymers.
- University of Washington, Bioengineering Center, Seminar Presentation, "The Polymer Chemistry of Denture Fabrication."
- New London County (CT) Dental Society, Guest Speaker, "Research Activities at Howmedica Corporate Research Laboratories."
Publications
- Twenty-two publications and one U.S. patent.
Education
- Ph.D. Organic Chemistry, University of Washington
- B.S. Chemistry with Honors, University of Illinois
