• Pharmaceutical
• Biologics
• Combination Product
• Medical Devices
• Toxicology

Vice President of Testing and Service Development
Over 13 years’ genotoxicology experience with medical devices, small molecules and combination products • In-vivo and in-vitro expert on combination product testing with emphasis on efficacy and safety testing analysis and regulatory defense • Experienced with osteoinductive material in-vitro assay development, biologic/device testing and DMB assays for regulatory submission and approvals • U.S. Expert and Co-Chair ISO Technical Advisory Group (TAG) on Cytotoxicity; member numerous AAMI TAGs related to medical device/combination product testing and member of the ASTM F04 committee • Participated in writing/approval process for 10993 guidance standards.

Vice President and General Manager, Atlanta Operations
Over 25 years’ experience in medical device, tissue and biologics industries • Internationally recognized expert in sterilization validation testing • Member, standards board of AAMI and serves on four AAMI committees developing standards for combination products • U.S. delegate to the Micro Methods Working Group of the ISO Sterilization Standards Committee.

Director of Custom Studies
Over 25 years' experience in applied research in pathology, bioengineering, and combination products • Directs efforts in the areas of device infections and antimicrobial combination products testing • Provides expertise in the area of device study designs, regulatory consultation and data analysis for submission for device-drug combination products • Previously Instructor, Harvard Medical School, Dept. of Surgery • Ph.D. in Pathobiology; M.P.H. in Epidemiology.

Toxicologic Pathologist
Over 20 years’ experience as study director and toxicologic pathologist for medical devices and pharmaceuticals • Specific expertise in evaluation of wound healing and remodeling for multiple tissue types • Extensive experience in evaluating protein-lipid complexes and nanoparticles • Board certified by American College of Veterinary Pathologists.

Executive Director, Bioanalytical Services
Over 10 years’ experience in the area of bioanalytical services, including positions at BASF and Bristol-Myers Squibb • Extensive experience with analytical techniques and methodology development ideal for the testing of combination products • Ph.D. from Rutgers University.

Vice President, Philadelphia Operations
Over 20 years’ experience in biotech/biopharm industry, including identification and development of biotech drug candidates • Also assay development and validation, biosafety testing, mycoplasma, cell substrates, and biologics manufacturing • Authority on regulatory submissions covering in-vitro and in-vivo studies and directing regulatory-approved correlation studies for combination products, including cellular and biological-based devices • Service on multiple PDA task forces • Ph.D. in Cellular Immunology.

Vice President, Testing Services for Philadelphia Facility
Over 28 years’ experience in molecular biology, virology, and production/development of biotherapeutics • For bio-sourced materials, has particular expertise in testing recommendations and risk analyses for product safety issues • Directs implantable material device testing for lot release • Expert in combination device/biologic testing including osteoinductive and tissue-based materials • Presently Co-Chair for PDA committee on virus preparation for viral clearance studies • Ph.D. in Microbiology.

Senior Director, Toxicology
Over 20 years’ toxicology experience, including drug toxicology and drug-device combination studies ranging from ADME to safety pharmacology • Currently also Adjunct Professor of Veterinary Medicine, University of Minnesota • Diplomate, American Board of Toxicology.

Senior Director, Toxicology
Over 25 years’ experience in designing/directing studies and preparing regulatory submissions • Expert in ISO/FDA 10993 testing • Leader in the area of combination testing of devices involving toxicology and implant results testing • Member U.S. ISO Technical Advisory Group (TAG) for Biological Evaluation of Medical Devices • Ph.D. in Animal Nutrition/Toxicology; M.S. in Animal Physiology.

Technical Services, Biocompatibility
Over 40 years’ experience providing technical and quality support to medical product industries • Particular expertise in testing programs to meet ISO/FDA 10993 guidelines • Provides expert analyses and ISO 10993 part 18 summaries for regulatory submissions • Ph.D. in Physical/Organic Chemistry with Biology minor.