Product Development/R&D professional specializing in the timely and effective transitioning of discovery stage technology to commercialization. Ph.D. molecular biologist/biochemist with technical experience in the development of implantable medical devices and tissue-based products for drug delivery, orthopedics, and cell therapy. Inventor on 10 issued US patents. Patent agent with extensive experience in patent portfolio development and management, technology evaluation, acquisition and in-licensing. A results oriented project leader with broad interdisciplinary technical expertise and excellent interpersonal skills.
2006-present Biotechnology Startup
Vice President, Product Development & Manufacturing
" Clinical phase startup. Implantable medical devices. Hemostatic putties & drug delivery combination product for post-surgical pain. Revenues: $2.5MM.
" Technical presenter for successful series B fund raising road show: $25MM.
" Six 510(k) clearances.
" Product launches Feb 2010, July 2011, February 2012, February 2013.
" 4 product launches
" ISO 13485 certification, CE mark, Health Canada clearance.
" Established and managed GMP aseptic processing operation.
02/01-03/03 Established Orthopedic Company
Senior Director, Research and Development
Director, Research and Development
" Implantable medical devices. Polymer composite biomaterials and human allograft R&D. Revenues: $100 MM.
" Direct report to CSO, managed R&D staff of 20 for R&D and product development.
" Four 510K clearances covering 7 products.
" Five product launches
" Technical market support and clinician think tank presentations.
" Developed and launched novel implantable bone substitute under design control in 11 months.
" Developed novel high biological activity tissue-polymer composite biomaterial.
" Managed collaborations for polymer development, cartilage tissue engineering, and growth factor delivery.
1996- 2001 Biotechnology Startup
Director, Product Development
" Early stage orthopedic biomaterials startup marketing injectable/settable bone substitute.
" R&D manager for implantable orthopedic biomaterials, bone substitutes, peptide and small molecule delivery devices.
" Regulatory filings, product launch and post market activities in the U.S., Canada, and Europe. ISO registration, Quality System and Design Control implementation.
" Supported private placement, IPO registration, 510K and IDE submissions.
" New technology in-licensing, academic and industrial partnership, and IP management responsibilities.
1991 - 1996 Tissue Engineering Startup
03/91-05/94 Program Development Manager
Research Manager Diabetes
Manager: Intellectual Property
" Discovery stage startup developing cell-based for Diabetes and neurodegeneration.
" Managed the development of insulin cell-based delivery system.
" Established the world's first genetically engineered, phenotypically stable, correctly glucose responsive, pancreatic beta cell line.
" Managed pre-clinical development for encapsulated cell therapy combination product for Parkinson's disease with a $5M budget and approximately 25 FTEs.
" Supervised preparation of European ethical committee submission for Parkinson's disease cell therapeutic clinical trials.
" Managed research collaborations with Brown University and Washington University.
" Established project teams, developed program plans, planned and assisted in market research and business development activities.
" Intellectual property manager and advisor to senior staff for corporate partnering endeavors, strategic planning etc.
1989-1991 Biotechnology Research Boutique
Scientific Patent Liaison
" Managed patent portfolio consisting of 50 pending and issued U.S. patents with 15-20 new patent filings per year in technology ranging from plants and microbiology to engineered genes and diagnostics.
1986-1989 Harvard Medical School, Department of Cardiology, Brookline, Massachusetts
" Molecular biology of mRNA splicing.
1984-1986 Cornell University, Department of Neurobiology and Behavior
Ithaca, New York
" Molecular biology of receptor biosynthesis in skeletal muscle.
Cornell University, Ithaca, New York.
Ph.D. Molecular Neurobiology.
St. Lawrence University, Canton, New York.
B. Sci. Multi-field, Chemistry-Biology-Geology
Howard Hughes research fellowship at Harvard Medical School.
NIH predoctoral traineeship at Cornell University.
NIH predoctoral traineeship at Boston Univ. School of Medicine.
American Association of Tissue Banks August 2004
Pittsburgh Bone Symposium August 2003
Swiss Spine Institute
Bone Substitutes in Spinal Fusion October 2001
Portland Bone Symposium August 1997,1999
Materials Research Society
Cues and Organic/inorganic hybrids December 1998
Strategic Research Institute
Neurodegeneration in Alzheimer's Disease,
Parkinson's Disease and Acute Stroke.
New York Academy of Science
Third International Congress on Vitamin C. October 1986
Association of University Technology Managers
American Society for Bone and Mineral Research
Society for Biomaterials
American Association for the Advancement of Science
(OVER 40 PAPERS ABSTRACTS AND PATENTS AVAILABLE ON REQUEST)