Phil is a Principal Toxicologist in the Biological Safety Department at NAMSA. His experiences in the medical device field encompass toxicology, biological safety, preclinical study design, and extensive preparation of biological and toxicological risk assessments. Prior to his role in the Biological Safety Department, he was a Study Director overseeing special/custom preclinical functional studies, preclinical safety studies, and simulated-use chemistry studies.

Before joining NAMSA in 2013, Phil was a Staff Toxicologist at WIL Research, where he was a Study Director of preclinical safety studies for pharmaceutical and chemical-based products.  He holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center where he was awarded two grants to support his research, authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications.

CORE COMPETENCIES

• Preparing risk assessments, evaluation plans, gap analyses, and reports in compliance with ISO 10993-1, ISO 10993-17, ISO 18562-1, and ISO 14971, for submissions to FDA, EU Notified Bodies, and other regulatory agencies
• Evaluating and summarizing biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards
• Performing toxicological risk assessments of extractable and leachable chemicals from medical devices (literature search and calculating tolerable intake/exposure, margin of safety, and cancer risk values)
• Working knowledge of FDA, EU MDD/MDR, and other global medical device regulations
• Advising clients on technical issues related to biocompatibility and material characterization
• Group subject matter expert for the ISO 18562 series of standards (Biocompatibility evaluation of breathing gas pathways in healthcare applications) (respiratory devices)
• Co-Instructor for the four-day training course: Biocompatibility of Medical Devices, NAMSA Training Series
  • 2023: San Francisco, California
  • 2022: San Diego, California, Virtual (June); Minneapolis, Minnesota
  • 2021: Virtual (January, March, and June); Boston, Massachusetts
  • 2020: San Diego, California; Virtual (October)
  • 2019: Salt Lake City, Utah; Austin, Texas; and Philadelphia, Pennsylvania
  • 2018: Boston, Massachusetts
• Supporting device manufacturers when deficiencies related to biocompatibility are identified by US FDA and EU Notified Bodies (for example, participating in teleconferences and/or preparing written responses)
• Mentoring new Associates that join the Biological Safety Department
• Providing technical support to laboratory staff, especially for extractable and leachable studies (ISO 10993-18)
• Evaluating and determining biological relevance of unexpected results

RECENT PROJECTS

• Author of a Biological Evaluation Report for a nasal mask (to be used for continuous positive airway pressure, CPAP, therapy)
  • Document evaluated the safety of the device, including a toxicological risk assessment of chemicals released from the device, in alignment with ISO 18562 (all parts), ISO 10993-1, ISO 10993-17, 2023 FDA Biocompatibility Guidance, and relevant sections of the EU MDR
• Author of a Biological Evaluation Plan for a cardiovascular (venous) stent
  • Document presented a testing plan for the stent and delivery system, in alignment with ISO 10993 (all parts) and 2023 FDA Biocompatibility Guidance
• Author of a Biological Evaluation Report for an absorbable embolic device
  • Document evaluated the safety of the device, including a toxicological risk assessment of chemicals released from the device and degradation products, in alignment with ISO 10993 (all parts), 2023 FDA Biocompatibility Guidance, ISO 22442 (all parts), ISO/TS 37137, and relevant sections of the EU MDR

PUBLICATIONS

• Blog: Understanding the ISO 18562:2024 Standards Update for Medical Devices.  Co-Author.  https://namsa.com/understanding-the-iso-185622024-standards-update-for-medical-devices/
• Blog: ISO 10993-17:2023 Update: Key Changes and FDA Recognition.  https://namsa.com/iso-10993-172023-update-key-changes-and-fda-recognition/
• Luniwal A, Fusby B, Kent DR, Hendershot MD, and Smiraldo P. Particulates in Preclinical Testing:  Understanding the Implact on Overall Device Biological Safety (White Paper).  North American Science Associates, Inc. (NAMSA).  February 2019.
• Wyatt MD, Reilly NM, Patel S, Rajesh P, Schools GP, Smiraldo PG, Pittman DL. Thiopurine-induced mitotic catastrophe in Rad51d-deficient mammalian cells.  Environ Mol Mutagen. 2017 Sep 25. doi: 10.1002/em.22138.
• Phillip G. Smiraldo, Jun Tang, Jerry W. Shay, and Woodring E. Wright. Cellular Senescence, Telomerase, and Cancer in Human Cells.  Book Chapter Appearing in ‘Telomerases: Chemistry, Biology, and Clinical Applications’.  John Wiley & Sons, Inc., 2012.
• Phillip G. Smiraldo, Aaron M. Gruver, Joshua C. Osborn, and Douglas L. Pittman. Extensive Chromosomal Instability in Rad51d-Deficient Mouse Cells.  Cancer Research 65(6): 2089-2096, 2005.  Highlighted cover article.
• Aaron M. Gruver, Kristi A. Miller, Changanamkandat Rajesh, Phillip G. Smiraldo, Saravanan Kaliyaperumal, Rachel Balder, Katie M. Stiles, Joanna S. Albala, and Douglas L. Pittman. The ATPase motif in RAD51D is required for resistance to DNA interstrand crosslinking agents and interaction with RAD51C.  Mutagenesis, 20:433-440, 2005.
• Phillip G. Smiraldo. Telomerase, A Mystery By Name Alone.  (Invited Commentary).  IUBMB Life, 56: 573-574, 2004.
• Madalena Tarsounas, Purificacíon Muñoz, Andreas Claas, Phillip G. Smiraldo, Douglas L. Pittman, María A. Blasco, and Stephen C. West. Telomere Maintenance Requires the RAD51D Recombination/Repair Protein.  Cell, 117: 337-347, 2004.  Highlighted article.