Jack Frautschi, Ph.D. ---------------------------------------------------------------------------------------- 6270 Sherwood Dr. Athens, TX 75752 903-677-3556 [email_address] Director of R&D / Medical Consulting Summary Once employed I will bring your company highly innovative products, that exceed the customers requirements, employees that are highly productive, along with an internal drive to succeed. I can reduce the normal device development time with time-efficient techniques that will provide a more favorable price structure. - Program Manager, Directed R&D, 20 years experience in medical device; Leader in Biomaterials and the Biological response to Biomaterials, Managed Polymer Laboratory, Expert Witness. - Major Projects: Coated Antimicrobial Multilumen Central Venous Catheter, Steerable Hydrophilic Guidewires , a surface modified Polymeric Heart Valve and Drug Delivery Cardiovascular Stent (experienced in reducing development time). - Expert in Polymer Chemistry, Technology and Processing, Surface Modifications & Coatings, Polymer Biocompatibility & Polymer Adhesion, Knowledge in Medical Research and Chemistry (polymer synthesis) Clinical Experience; Regulatory Submissions; Patented IP; Leader in Biomaterials-Biocompatibility; Start-ups; Author of Books, Patents and Journal Articles.
Experience and Education
THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL SCHOOL
Ph.D. Biomedical Engineering, December, 1994. Concentration in Biomaterials.
THE UNIVERSITY OF TEXAS AT AUSTIN
M.S. in Chemical Engineering, December, 1982.
WESTERN SCIENCE CONSULTANTS ( www.westernscienceconsultants.com/) , Lead Consultant/Program Manager (3/04 to date)
Product development expert; hired by physicians to help take concepts to products (see Selected Achievements and Skills).
Sunscreen Soap - 3 yr project; Developed mechanism in which the soap would clean the skin, while depositing a sunscreen; SPF of 18 is retained after washing; patent pending; production ready; Phase II clinical written & completed; 3 patents pending.
Wound Healing Ointment - 2 yr project; tissue engineered to reduce scar formation; Phase I clinical written & running; patent pending.
Expert Witness – Current Project; Hired to describe the clinical effect of Drug Eluting Cardiovascular Stents on tissue.
WESTERN LIFE SCIENCES, Science Officer/Director R&D (3/02 to 3/04)
Start-up company; created drug delivery polymer coatings that were chemically bonded to metal; significantly better than those currently on the market (target product was drug delivery coating for Cardiovascular Stent).
Visiting professor at Univ. of TX at Dallas; 3 graduate assistants; successful coatings; patent pending; marketing coatings.
MAXXIM MEDICAL , Senior Staff Scientist (5/97 to 3/02)
Managed new development projects and R & D; project leader for 3 FDA approved products;
Antimicrobial Coated Multilumen Central Venous Catheter (developed blood compatible/drug delivery coating); Cut 18 mo. development to 12 mo.; preclinical, Phase III clinical, patent pending; IDE, 510K submitted.
Polymer-cladded Hydrophilic Guidewires (steerable) – Cut 12 mo. development to 9 mo.; patent pending; 2-510Ks approved.
SULZERMEDICA CARBOMEDICS , Staff Scientist (2/89 to 7/96)
Managed the Polymer Department and Project Leader; annual budget of $800,000; synthesized polymers, evaluated resorbable polymers and surface modified polymers (blood compatible) for use in heart valves, vascular grafts and indwelling catheters.
Surface Modified Polymer Heart Valve – Preclinical testing in 70 animals, which outperformed market leaders in Flow Characteristics and Blood Compatibility; 2 patents.
Polymer Vascular Graft – Developed polymers, optimized for mechanical characteristics & blood compatibility;
Intermedics Pacemaker - Instituted a replacement for Pellethane lead insulation that significantly improved the Biostability;
Intermedics Orthopedics - Recommended surface treatment to reduce friction of knee prosthesis, patent; work on new Bone Cement, patent.
Selected Achievements and Skills (Details on following pages)
- Wrote requirements to be included in FDA/CDRH Heart Valve Guidance Document (able to interact with FDA)
- Medical Devices Developed were Market Leaders; utilized novel techniques in encapsulation, controlled drug release, used structure/property relationships to target polymer use parameters and coatings for many different purposes; utilized many analytical techniques including NMR, HPLC, GC-MS, GPC, FTIR, UV/VIS, mechanical testing, DSC, TGA, SEM, AA, ICP and many more; different methodologies for design and manufacturing were developed/utilized: CAD/CAM design, CNC machining; pad printing, spray and dip coating; Hot Die guidewire production; injection/insert molding and extrusion of many polymer types to provide us with the best possible opportunity for success. (success is achieved by successful follow-through)
- Wrote, Set-up, and Supervised Clinical Trials; a 70 animal (Bovine & Ovis) preclinical study for the Polymer Heart Valve and 50 animal (Leporidae) study for an Antimicrobial CVC; Wrote, set-up and supervised the Phase III Clinical Study for the Antimicrobial CVC; Supervised the Phase II Clinical Study of the Sunscreen Soap; currently writing Phase I Clinical Study on Wound Healing. (clinical model and medical facility selection are critical for success)
- Considered a Leader in the Biomaterials Field and Biocompatibility; Recently interviewed by Qean Medical on “The State of Medical Device Technology”, to be published Jan. 2010. Also see Blog: http:// www.westernscienceconsultants.com /blog/ (knowledge of blood chemistry and its interactions has application in many areas)
Authored 31 Journal Publications, 15+ Presentations, a Book Chapter, 7 Patents, and 7 Patents Pending (ability to present a scientific concept to a large audience)
- Regulatory Experience: Product Submissions (IDE, 5-510k’s) and Technical Files (utilizes regulatory expertise and contacts to speed approval)
- R esults-Oriented Mind Set: Directed R&D, Projects, and Assisted physicians (KOLs) in process of taking Concepts to Products; refining & developing concept, protection of IP, regulatory, business strategies, directing & conducting R&D, smooth transition to production, along with assisting marketing and sales in product commercialization (broad knowledge and ability to push product to successful commercialization; able to interact with physicians on a scientific level)
- Successful product consultation; Developed methods to successfully engage physicians, to complete the project successfully (a project has never been delayed or derailed due to a personality conflict)
- Program Management skills: managed budgets of > $2 million with economic scrutiny, responsible for the overall direction, coordination and evaluation of personnel (17 people), good motivator and communicator, able to manage multiple projects, have managed products Class III devices and brought them to completion under budget and before the time line (achieving successful results is through successful management)
- Works well w/ other departments: interact and transmit information well with sales, marketing, quality, production and upper management (communication is the key to success)
Medical Devices Developed were Market Leaders
The Polymer Heart Valve displayed better flow characteristics, with significantly less thrombogenic events in vivo and was twice as durable as the current heart valves on market in preclinical studies (Dr. Kenton Gregory, Physician-Cardiovascular Diseases, Oregon Med Center; Dr. Anthony Furnary, Cardiothoracic Surgeon, Starr-Wood Cardiac Group; Dr. Fred Shoen, Pathologist, Brigham and Womens Hospital). In vivo preclinical polymer degradation studies (Dr. James Anderson, Pathologist, Case Western Reserve); Blood compatibility preclinical studies were performed in vivo on coated polymers for heart valve (Dr. Patrick Clagett, Vascular Surgeon, UT Southwestern Med Center). Other developed Cardiovascular products, like the Antimicrobial CVC and Steerable Hydrophilic Guidewire outperformed their competitors in side-by-side comparison studies (Dr. Robert Sherertz, Epidemiologist, Wake Forest Univ Bap Med Center; Dr. James Kirby, Cardiothoracic Surgeon, Chief of Surgery, St. Joseph Hospital); Developed a drug delivery coating for Cardiovascular Stent with Dr. Azam Anwar (Cardiologist, Baylor Hospital).
Wrote, Set-up, and Supervised Clinical Trials
Wrote, set-up and supervised a 70 animal (Bovine) preclinical study for the Polymer Heart Valve and 50 animal (Leporidae) study for an Antimicrobial CVC; Wrote, set-up and supervised the Phase III Clinical Study for the Antimicrobial CVC; Supervised the Phase II Clinical Study of the Sunscreen Soap; Currently writing a Phase I Clinical for an ointment to Reduce Scar Formation in Wound Healing.
Considered a Leader in the Biomaterials Field and Biocompatibility
Utilized knowledge of Blood Chemistry/Immunology and coatings for devices that significantly improved the blood compatibility in vivo (photos on Web Site : www.westernscienceconsultants.com/) , i.e. Blood/Material Interactions causing thrombus and immune system activation and interaction with anticoagulants; abnormal behavior of components of the immune system lead to other maladies.
- Authored Publications : ASAIO; J of Biomaterials; J of Biomaterial Sci Polymer Edn; Surfaces in Biomaterials; J of Biomaterials Res; J of Appl Biomaterials; J Southern Biomedical Eng; Annals of NY Academy of Sciences; Biomaterials: Living System Interactions; Colloids and Surfaces B: Biointerfaces; ACS Polymeric Mat. Sci and Eng;
- Authored Book : Protein at Interfaces, Chapter 24 , Published by Amer Chem Soc;
Presented papers : Society for Biomaterials; ASAIO; World Biomaterials Congress; Southern Biomedical Eng Soc; Surfaces in Biomaterials; CarboMedics Symposium on Heart Valves; Gordon Conference on Biomaterials;
- No. 5,017,670; Methods and Compositions for Providing Articles Improved Biocompatibility Characteristics-Cellulosics. Issued May 21, 1991.
- No. 5,098,977; Methods and Compositions for Providing Articles Improved Biocompatibility Characteristics-Polyurethanes. Issued March 24, 1992.
- No. 5,098,960; Methods and Compositions for Providing Articles Improved Biocompatibility Characteristics-Cellulosics II. Issued March 24, 1992.
- No. 6,210,437; Chemical Method to Bond Silicone to Metal. Issued April 3, 2001.
- No. 6,183,516; Method for Improved Bonding of Prosthetic Devices to Bone. Issued February 6, 2001.
- No. 6,702,851; Prosthetic Heart Valve with Surface Modification. Issued March 9, 2004.
No. 6,764,509; Prosthetic Heart Valve with Surface Modification. Issued July 20, 2004.
- Prosthetic Heart Valve with Surface Modification; Biocompatible heart valves are described having incorporated therein an effective amount of coating applied thereto to render the valve resistant to in vivo pathologic thrombus formation and in vivo pathologic mineralization. Patent Pending
- Color Coding Distal Tip of Guidewires to Indicate Size; Allows the physician to distinguish between multiple guidewires in the guidewire bowl. Patent Pending
- Medical Guidewire and Method for Making; Cold forming the angled tip allows the Nitinol to retain its shape memory and thus be more flexible. Patent Pending
- Method of Forming a Polymer Layer on a Metal Surface; Method for creating a very adhesive/chemically bonded polymer coating on metal surfaces. Patent Pending
- Body Wash Having Ultra-Violet Radiation Protection; A methodology to have sunscreen retained on the skin following washing with soap. Patent Pending
- Syndet Bars Having Ultra-Violet Radiation Protection; A methodology to have sunscreen retained on the skin following washing with soap. Patent Pending
- Body Wash Having Ultra-Violet Radiation Protection-II; A methodology to have sunscreen retained on the skin following washing with soap. Patent Pending
Successful product consultation and development
- I have spent most of my career interacting with physicians, high-level scientists, academicians and medical professionals. This has involved discussing and implementing research, clinical trials, along with writing or presenting technical papers. In fact, the last 5 years has involved working directly with physicians to assist them in the process of taking their concept through to the product stage, in terms of refining the concept, IP, business strategies, directing R&D, setting up clinical trials, implementing a smooth transition to production and presenting or publishing the work. During this work I have gained considerable clinical experience designing, setting up and running clinical trials. Part of my clinical experience is derived from work in the surgical OR at Parkland Hospital in Dallas; by assisting a renowned vascular surgeon in surgery, studying platelet deposition and activation in vivo, a main component in Hemostasis and blood chemistry. Through my research and clinical experience, I have gained significant knowledge and experience in Blood Compatibility/Immunology/Hematology. In one study we evaluated electrocautery in comparison to laser cautery and its effect on tissue. Much of the research that I have been associated with has involved the study of immune components and clotting factors. During heart valve development we evaluated/studied therapeutic agents (Heparin, Warfarin, Aspirin and others) in relation to how they would affect device function. I have worked closely with Cardiologists in designing medical devices, have developed pharmaceuticals and understand the regulatory process of pharmaceutical development. I have also written and submitted several research grants to NSF and NIH.
- Specific pharmaceuticals products include therapeutic additives to soap for adherence to and in some cases absorption through the skin (Cockerell Dermatology, proprietary); therapeutics to improve Wound Healing and reduce Scar Formation (Dr. Will Posten, Mohs Surgery, proprietary).