Expert Details
orthopedic R&D, regulated (GLP) nonclinical trials, large animal models, surgery, vet med
ID: 727255
Pennsylvania, USA
He has guided several nucleus pulposus replacement technologies through the preclinical phases, of which all have started clinical trials.He has managed a multitude of pivotal regulatory preclinical trials which required model development and validation prior to the pivotal study of which >80% have been successfully introduced in clinical practice.He has advised various entities in development of clinically relevant animal models to meet scientific and regulatory metrics
Education
Year | Degree | Subject | Institution |
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Year: 1996 | Degree: VMD | Subject: Veterinary Medicine | Institution: U of Penn |
Work History
Years | Employer | Title | Department |
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Years: 2004 to Present | Employer: Undisclosed | Title: Staff Veterinarian | Department: Vet Med Department of Clinical Studies New Bolton Center |
Responsibilities:Dir Translational Orthopaedic Research Penn Vet CORL.He directs the daily activities and functions as a Study Director for regulated and non-regulated nonclinical studies. He has trained numerous fellows, residents, veterinary students and pre-vet students in translational orthopaedic research and has raised close to US$10 million in research funding through biotech industry and foundations. He is a consulting surgeon with various industry-led ventures in orthopaedic trauma, spine and sports medicine. |
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Years | Employer | Title | Department |
Years: 2000 to 2004 | Employer: U of Penn | Title: Lecturer in Surgery | Department: Department of Clinical Studies New Bolton Center |
Responsibilities:He was a member of the surgery staff at the George D. Widener Hospital for Large Animals seeing both elective and emergency large animal patients. |
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Years | Employer | Title | Department |
Years: 1997 to 2000 | Employer: U of Penn | Title: Surgery Resident | Department: Department of Clinical Studies New Bolton Center |
Responsibilities:House officer of the section of surgery seeing elective and emergency patients with senior clinicians of the George D. Widener Hospital for Large Animals |
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Years | Employer | Title | Department |
Years: 1996 to 1997 | Employer: Rood and Riddel Equine Hospital | Title: Hospital Intern in Medicine and Surgery | Department: |
Responsibilities:Intern in surgery, anesthesia and medicine seeing elective and emergency patients with senior clinicians of the Rood and Riddle Equine Hospital Lexington, KY |
International Experience
Years | Country / Region | Summary |
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Years: 2004 to Present | Country / Region: Switzerland | Summary: Collaboration on spine research at the University of Zuerich. |
Years: 2005 to Present | Country / Region: Italy | Summary: Collaboration in spine research at the University of Milan and Ospedale Reuniti Bergamo |
Years: 2009 to 2011 | Country / Region: Netherlands | Summary: Advisor in nonclinical trials for ACL / meniscus technologies to meet regulatory objectives (FDA). |
Years: 2011 to 2011 | Country / Region: USA-EU | Summary: Due diligence analysis / technology evaluation of orthopedic therapies (sports medicine) |
Career Accomplishments
Associations / Societies |
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AAEP, ORS, SFBM, OARSI, Spine Arthroplasty Society, Academy for Surgical Research |
Licenses / Certifications |
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PA |
Professional Appointments |
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Voting member UPENN IACUC (Philadelphia) Voting member Association for the Study of Internal Fixation Veterinary Care Commission (AOVAC Davos) |
Publications and Patents Summary |
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Extensively published in the field of orthopedics 2 Patents (Spine) 1 Patent application (Anti-infective Technology) |
Additional Experience
Training / Seminars |
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AO/ASIF Courses for Large Animals. Regulatory courses with emphasis on 21CFR part 58 and part 11 compliance. Initiated and directed GLP due diligence analyses FDA Clinical Investigator Training Courses Wharton Executive Education 2011- |
Vendor Selection |
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Sourcing of study material to GLP compliant entities for bioanalytical, histopathological and histomorphometrical analyses |
Marketing Experience |
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Surgeon Consultant for orthopedic device R&D using Large Animal Models. Critical path study design, execution and management for regulated nonclinical trials. Leading cross-disciplinary teams in orthopedic device R&D |
Language Skills
Language | Proficiency |
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German | |
French | |
Italian |
Fields of Expertise
veterinary orthopedics, fracture fixation, orthopedic implant, medical device product development, translational medicine, Good Laboratory Practice, regulatory organization, maxillofacial prosthesis implantation, invertebral disk chemolysis, bioabsorbable material, anterior cruciate ligament, artificial joint, spine surgery, prosthetic intervertebral disk, musculoskeletal disease