Why Biocompatibility Cares about Preclinical: NAMSA and APS Discuss

In this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices.

This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh.

“We have expanded the possibilities of people who can join us now.” – Sheri Krajewski-Bibins

“We are very excited. We firmly believe that both companies share the same goals to provide high-quality, comprehensive services for medical device development.” – Dr. Chen

“Companies are beginning to think about biocompatibility when they should early-on with studies like these. These [preclinical] studies can be so powerful in so many ways.” – Don Pohl

“The local tissue response is the most commonly used (biocomp endpoint) used in the preclinical study. Sometimes you want a clinically relevant implant site. That is something to keep in mind to combine (preclinical and biocomp) studies.” – Dr. Chen

Discussion points include:

• The importance of preclinical testing to the biological evaluation
• Early-stage preclinical studies vs. GLP studies and the value they bring to medical device regulatory submissions
• The challenges of combining preclinical and biocomp studies

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.

Meet the Speakers

Yan Chen, PhD; Senior Director of Biocompatibility Services, APS

Dr. Chen is the Sr. Director of Biocompatibility Services at American Preclinical Services (APS). She received her Ph.D. in Pharmacology from the University of Illinois and has more than 18 years of experience in preclinical testing in both pharmacology and biocompatibility. Dr. Chen serves as the primary voting member on multiple ISO/TC194 working groups.

Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the U.S. FDA and other global regulatory bodies in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.