Meet our Subject Matter Experts

Adrian Keene

Associate VP, Global Biological Safety & Validation and EMEA Consulting Services

Biological Safety, Clinical, EU IVDR, EU MDR, Regulatory

Alexander Hermann, PhD

Supervisor, Study Director Group

Biological Safety, Chemical Characterization, FDA

Alfred Dibao-Dina, PhD, DABT, ERT

Biological Safety Scientist

Biocompatibility, Biological Safety

Andy J. Wyen, MS, DABT, LAT

Principal Toxicologist

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Toxicology

Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting Services, Europe

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Regulatory, Toxicology

Céline Furne, PhD

Biological Safety Scientist

Biological Safety

Chikako Kitayama, PhD, DABT

Senior Biological Safety Scientist

Biocompatibility, Biological Safety

Cindy Dingee, DVM

Histopathology Operations Manager and Veterinary Pathologist

Biocompatibility, Biological Safety, FDA, Preclinical, Regulatory

Don Pohl, BS

Principal Strategy Consultant, Biocompatibility

Biocompatibility, Biological Safety, EU MDR, FDA, Regulatory

Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

Biological Safety, EU MDR, FDA, Medical Writing, Preclinical, Product Development, Regulatory

Marie-Charlotte Notargiacomo

Senior Biological Safety Scientist

Biocompatibility, Biological Safety, EU MDR, Medical Writing, Regulatory

Marie-Eve Cluzel-Valentin

Principal Biological Safety and Validation Scientist

Biocompatibility, Biological Safety, Clinical, EU IVDR, FDA, IVD, Medical Writing, Microbiology, Regulatory, Validation

Michelle Kelly, BSc, MSc, ERT

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, Notified Body Expertise, Toxicology

Phillip Smiraldo, PhD, DABT

Principal Toxicologist

Biocompatibility, Biological Safety, Preclinical, Toxicology

Sandi Schaible

Executive Director, Analytical Chemistry and Regulatory Toxicology

Biocompatibility, Biological Safety, Chemical Characterization, FDA, Preclinical, Regulatory

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