Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

×

Expert Details

orthopedic R&D, regulated (GLP) nonclinical trials, large animal models, surgery, vet med

ID: 727255 Pennsylvania, USA

Request Expert

Expert is the Director of the Comparative Orthopaedic Research Laboratory in the Department of Clinical Studies at the University Of Pennsylvania School Of Veterinary Medicine. Expert trained in both human and veterinary medicine, and completed an internship, residency and lectureship in large animal/equine surgery. He is a member of the UPENN ULAR Veterinary Care Advisory Board as well as the UPENN IACUC, and is very involved in animal welfare and regulatory issues at the University level. His primary interests are in clinical orthopaedic trauma, joints, spine, and CMF with a particular interest in the application of novel materials for functional restoration of the musculoskeletal system. In 2005 he started to develop a training program to provide an incubator environment across traditional academic boundaries for undergraduate and graduate education in orthopedic translational and regulatory R&D. He has developed an expertise in large animal surgical models for device development and evaluation, musculoskeletal tissue replacement and repair. These animal models have been developed through numerous funding sources, including both private industry and federal funding agencies. He has a significant amount of experience with developing animal models through discussions with cross-functional groups in the orthopedic biotech arena. Expert continues to develop and refine large animal models to improve the predictability of clinical outcome in orthopedic large animal models as novel therapies are being translated from bench-to-bedside. He has worked as a study director/project manager for over six years, designing and writing preclinical protocols to match the requirements of multidisciplinary core teams. He has interfaced with regulatory colleagues in the submission of GLP (21CFR58 & 21CFR11)/Pivotal studies to the FDA and coordinated the preclinical requirements of these submissions in GLP/Pivotal studies.

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
Year: 1996 Degree: VMD Subject: Veterinary Medicine Institution: U of Penn

Work History

Years Employer Title Department
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.
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.
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
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
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
AAEP, ORS, SFBM, OARSI, Spine Arthroplasty Society, Academy for Surgical Research
Licenses / Certifications
PA
Professional Appointments
Voting member UPENN IACUC (Philadelphia)
Voting member Association for the Study of Internal Fixation Veterinary Care Commission (AOVAC Davos)
Publications and Patents Summary
Extensively published in the field of orthopedics
2 Patents (Spine)
1 Patent application (Anti-infective Technology)

Additional Experience

Training / Seminars
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
Sourcing of study material to GLP compliant entities for bioanalytical, histopathological and histomorphometrical analyses
Marketing Experience
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
German
French
Italian

Fields of Expertise

Request Expert

Dev Tool:

Request: expert/orthopedic-rd-regulated-glp-nonclinical-trials-large-animal-models-surgery-vet-med
Matched Rewrite Rule: expert/([^/]+)(?:/([0-9]+))?/?$
Matched Rewrite Query: experts=orthopedic-rd-regulated-glp-nonclinical-trials-large-animal-models-surgery-vet-med&page=
Loaded Template: single-experts.php