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Michael N. Helmus, Ph.D.
http://www.linkedin.com/pub/mike-helmus/1/3a8/9b7 http://scholar.google.com/citations?user=fX7mQJMAAAAJ
Medtech Executive, CSO, Sr. VP R&D/Innovation
Extensive experience in all phases of managing medical device development projects from inception to market
Expertise in commercializing a wide range of medical devices
Inventions and 44 US Patents for Medtech and Drug Delivery: Drug Eluting Stents, Heart Valves, Implants, Biomaterials
Over 80 publications and presentations ( http://scholar.google.com/citations?user=fX7mQJMAAAAJ)
41 Technology and Market Assessments and Commentaries
Patent Expert: Litigation, Opionions, Reexams
EXPERIENCE PROFILE
Leading and managing the R&D of medical and controlled drug delivery devices
Focus on developing commercialization strategies of potentially disruptive technology
Strong skills in assessing products, incubating emergent technologies
Deep expertise in Drug Delivery, Stents, Heart Valves, Vascular Prostheses, Implants, Biomaterials, Biocompatibility,
Nanoenabled materials
Orthopedic, cardiovascular, less invasive, wound care, opthalmic, combination and biosensor devices
Nanoenabled, magnetic nano-particle drug delivery, bioactive, biocompatible and thromboresistant coatings, electrospun
polymers, injectable polymers, therapeutic NO and statin releasing polymers, biodegradable polymers
Expert in the use of coatings, including nanoenabled coatings for drug delivery
Expert in drug eluting stent patent litigation
Managed groups up to 30 people.
White Space Innovation evaluations
Co-Chaired the review National Nanotechnology Initiative
EDUCATION
Ph.D. BIOMEDICAL ENGINEERING, CASE WESTERN RESERVE U., CLEVELAND, OH
PROFESSIONAL EXPERIENCE
2007-Present M.N. Helmus, Ph.D, Medical Devices, Drug Delivery, Tissue Engineering, Nanotechnology including VP
Biomaterials at Amulet Pharmaceuticals (a consultant contract)
2005-2007 SENIOR VICE-PRESIDENT, BIOPHARMA, Advance Nanotech, NY, NY (Participant in EU’s FLUTEST)
2000-2005 VICE PRESIDENT, ADVANCED BIOMATERIALS (2003-2005), VICE PRESIDENT, MATERIALS SCIENCE
& TECHNOLOGY (2000-2003), Boston Scientific Corporation, Natick, MA. (20 patent milestone award,
mechanistic understanding of drug elution from Taxus Drug Eluting Stent for FDA Submisson)
1995-2000 DIRECTOR R&D, MATERIALS AND TISSUE TECHNOLOGY, Edwards Lifesciences, Heart Valve Therapy,
Irvine, CA. (Managed International Joint Development Program)
DIRECTOR R&D, MATERIALS AND TISSUE TECHNOLOGY, Baxter CVS, Heart Valve Therapy Division,
R&D, Irvine, CA. (3 Baxter Technical Awards, Baxter Technical Council, Core Competency Champion, Baxter
Technical Leader )
MANAGEMENT SKILLS
Strategic Management
Functional and Project Team Leader
Matrixed Management Leader
Leading due diligence evaluation teams
Project Initiation and Management
Managing Cross-Functional and Cross Company/Institutional Teams
Innovation, Technical Strategy, Disease based strategy Teams
Initiating and managing interdisciplinary research collaborations
Budget Development and Management
Project Managment & Stage Gate Processes
Corporate Project Investment Boards
Corporate and Divisional Patent Review Boards
Initiating and managing cross-divisional projects
Collaboration with surgeons & interventionalists
