Audrey Turley

Nelson Laboratories’ Experts Receive SOT Award

During the annual Society of Toxicology (SOT) meeting in Baltimore, Maryland, Michelle Lee and Audrey Turley from Nelson Laboratories were two of eleven authors awarded Best Overall Abstract for “Round Robin Study to Evaluate the Reconstructed Human Epidermis (RHE) Model as In Vitro Skin Irritation Test for Detection of Irritant Activity in Medical Device Extracts”. This abstract resulted in a poster presentation on the results of a worldwide collaboration to demonstrate the application of an in vitro skin irritation method for medical devices.

SOT_AwardThe acceptance of this method could significantly reduce the animal testing needed when determining the biocompatibility of medical devices. The initiative to reduce animal testing has primarily been led by Europe, but US regulatory bodies are adopting the initiative as well.

The irritation test is based on exposing RHE to device or material extracts, then performing a viability assay (using an MTT assay) where limits have been established to determine irritation potential based on an adopted method for chemicals from OECD 439: In Vitro Irritation: Reconstructed Human Epidermis Test Method.

Nelson Laboratories has been involved with this project long before it came to SOT, through our membership on the ISO working group for irritation. We have worked in conjunction with medical device manufacturers for this round robin. Look for a review of the official publication for this groundbreaking work in the near future.

LIVE Webinar: How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance

Register HERE for the three-day live webinar series “How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance” presented by Nelson Laboratories’ experts: Thor Rollins, Sarah Campbell, and Audrey Turley.

This three-day webinar will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the webinar will cover each step in developing a BSE in detail. This webinar will provide insight into regulatory expectations when it comes to evaluating device safety.

The presenters for this three day webinar provide a combined 50 years of experience in their field of expertise. Thor Rollins is a leading biocompatibility expert and has worked closely with medical device companies and the FDA for over 15 years. Dr. Sarah Campbell is a board certified Toxicologist with an extensive 17 year background in practicing and using analytical chemistry for toxicological evaluation. This combination of expertise is important to in order to handle the important aspects of material/chemical characterization and toxicological risk assessment. Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry.

DAY 1: DEVELOP A BIOLOGICAL EVALUATION PLAN (BEP)

The new FDA guidance document for ISO 10993-1 focuses on a risk based approach to biocompatibility. The first step is to develop a BEP. This webinar will go over the thought process and information needed to develop a useful testing plan.

Date: August 30, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Thor S. Rollins, B.S., RM (NRCM)
Senior Scientist

 DAY 2: UNDERSTANDING TEST OPTIONS

Justifying out of testing using chemical characterization vs performing full biocompatibility testing. The first important step in determining the risk of a medical device to a patient is to know and understand your materials and processes. This webinar will go over the steps in evaluating device materials and an extractable/leachable chemical testing needed to demonstrate biocompatibility.

Date: August 31, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Sarah Campbell, PhD, DABT
Toxicologist

DAY 3: SUMMARIZE ALL YOUR FINDINGS IN A BIOLOGICAL EVALUATION REPORT (BER)

The ISO 10993-1 and new FDA guidance document asks you to write a BER to demonstrate that the identified risks have been mitigated. We will go over the information needed and the important points that should be included in the report.

Date: September 1, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Audrey Turley, B.S., RM (NRCM), CBA (ASQ)
Research Scientist

U.S. ISO Certified Experts Announced

 

Thor Rollins, Michelle Lee, and Audrey Turley have been accepted as U.S. experts to four working groups in the Biological Evaluation ISO Technical Committee 194: WG5 (Cytotoxicity – Thor), WG8 (Sensitization and Irritation – Michelle), WG9 (Effects on blood – Michelle), and WG6 (Genotoxicity, Carcinogenicity, and Reproductive Toxicity – Audrey). This placement allows participation in the annual ISO meetings to discuss changes to the ISO 10993 and movements surrounding the approach to biocompatibility of medical devices. These meetings have recently been closed, and only those that are nominated and accepted by the co-chair of the respective working groups are allowed to attend and participate in the international annual meeting. Meet the experts:

Thor Rollins started his career at Nelson Laboratories as the study director over cytotoxicity testing. He is familiar with the test procedure and can speak to its application to medical devices providing a deep knowledge of all the complexities that can occur in cytotoxicity testing. Thor frequently works with clients who run into issues with cytotoxicity and need help mitigating patient risk.

Michelle Lee has been highly involved in several ISO round robins over the last few years including a Hemolysis, Complement, and currently an in vitro irritation round robin. Nelson Laboratories have been the top testing laboratory involved providing input on sample type, sample preparation, and protocol development for these projects. Michelle is also working to develop an in vitro sensitization assay using 3D human tissues.

Audrey Turley was one of the key personnel in bringing the in vitro chromosomal aberration assay in-house at Nelson Laboratories. Once the test was validated, she stepped in as the study director for the next six years. Currently, Audrey is working as a technical consultant to help clients perform risk assessments to address carcinogenicity risks.

Celebrating Audrey Turley: 20 Years at Nelson Laboratories

By Alyessa D’Ewart

Since Audrey Turley started her career 20 years ago at Nelson Laboratories, she has worked in various departments including bioburden, biocompatibility, and technical consulting. She has cross-trained in other sections and has performed IDs, air sampling in hospitals, hydrostatic pressure, B/F, and sterility testing.

“Audrey helped develop and validate our genotoxicity chromosome aberration test,” said John Bolinder, VP of Integrated Marketing and Communications and Audrey’s current manager in her role as technical consultant. “Recently, she has been working with Daniel Olsen and Michelle Lee to develop alternative in vitro methods for biocompatibility, presenting these findings at the Society of Toxicology (SOT) and most recently at a Audrey Turleymeeting with US FDA.”

Audrey enjoys participating in the growth of the company as well as the growth of the industry. She feels Nelson Laboratories provides a great service that affects everyone on an individual level, not just in providing jobs but also in the medical attention we receive as consumers.

In her 20 years at Nelson Laboratories, Audrey has also earned a great amount of respect and admiration from all who have come to know her.

“Audrey is a brilliant scientist, but an even better person. I consider it a blessing in my life to have grown up with her at Nelson Laboratories,” said Jeff Nelson, Nelson Laboratories president. “Her loyalty, courage, and many achievements will always be an inspiration to me.”

Audrey’s favorite memory from her 20 years of working at Nelson Laboratories is seeing Dr. Nelson every day. He would walk around the halls with a diet soda and a Snickers bar, checking in on projects and helping address any problems. She also remembers coming in on weekends to help him paint the pink floors. As Nelson Laboratories continues to grow, Audrey’s contributions will surely aid in the future success of the company.

“Audrey has a great mind, a passion for science and excellent presentation skills to teach others. She is also a single mom with two beautiful twins,” Bolinder added. “We celebrate 20 years of service with Audrey and appreciate her contribution to our success at Nelson Laboratories.”

Nelson Labs Experts Invited to Present at Joint Conference

Thor Rollins, consulting manager, and Audrey Turley, research scientist, have been invited to speak at the joint conference of the Association of Analytical Communities Southern California Section (AOAC SCS) and Food and Drug Agency (FDA) 2016 Spring Conference. Rollins and Turley will be presenting the morning of Wednesday, April 27 at Chapman University, School of Pharmacy, Irvine. Click here for the full agenda.

DSC01871Rollins will be presenting on the application of chemical characteristics to medical devices. His presentation will cover how the industry is taking extractible and leachable applications and applying them to medical devices. The discussion will focus on what the challenges are, what benefits they have, where we are right now with the program and speculate about what these applications mean to the future of medical devices.

“I am excited for the opportunity to contribute to the discussion with colleagues and FDA experts about the future of the science behind biocompatibility and medical devices,” said Thor Rollins.

Turley will be presenting on in vitro alternatives to traditional animal testing. Specifically, she will be talking about in vitro irritation, sensitization and thrombogencity.

Visit the Nelson Labs website to view recent presentations by Rollins, How to Use Biocompatibility to Evaluate Changes in Medical Devices, and Turley, New Approaches to Assessing Biocompatibility for Medical Devices.