Medical Device Preclinical Bootcamp

Transcription

1 Medical Device Preclinical Bootcamp March 30, :30am - 2:30pm Massachusetts Biotechnology Council (MassBio) 300 Technology Square, 8th Floor Cambridge, MA Featured Speakers Rosalyn Año Laurence Lister Stephen Doherty, Ph.D. Kevin Connor, Ph.D., DABT Russell Sloboda Bootcamp Coverage The Basics of Biocompatibility Testing Chemical Characterization of Medical Devices: Strategies, Pitfalls, and Points of Consideration Toxicological Risk Assessment Based on Extractable/Leachable Data: Why, When, and How Toxicological Risk Assessment for Breathing Gas Pathway Medical Devices: ISO and ISO Tips for a Successful Sponsor-Laboratory Partnership

2 Medical Device Preclinical Bootcamp 9:30 10:00: Registration 10:00 10:15: Welcome and Introduction: The Medical Device Approval Pathway 10:15 11:45: The Basics of Biocompatibility Testing The Basics of Biocompatibility Testing Biocompatibility simply refers to the properties of materials being biologically compatible by not eliciting local or systemic responses from a living system or tissue. This presentation will discuss the basics of biocompatibility testing. This presentation will discuss the history and evaluation of biocompatibility. It will explain how to properly classify your device. Then when biological endpoints are applicable for the properly labeled device will be covered. Finally, a high level discussion of each biological evaluation and the various choices will be explained. 11:45 12:15: Lunch and Networking 12:15 1:00: Chemical Characterization of Medical Devices: Strategies, Pitfalls, and Points of Consideration Recent regulatory guidance documents have emphasized the need for chemical characterization of medical devices as part of an overall device assessment. We will examine the types of information available from a chemical characterization and how to get the information you are looking for from the testing. Strategies for study design and execution will be discussed. Common pitfalls and potential shortcomings and how to avoid them will also be presented. 1:00 2:00: Toxicological Risk Assessment Based on Extractable/Leachable Data: Why, When, and How Toxicological Risk Assessment (TRA) has been an important tool in the safety assessment of biomedical devices, providing a chemical-based approach which complements a more traditional testing program largely based on whole animal studies. The need for TRA is growing and in some cases, will be considered as a means of circumventing animal testing in the safety evaluation of devices. TRA is founded on the notion that, if all constituents of a product, including additive, impurities and contaminants, are known, then the safety (or risk) of a product can be assessed based on the toxicology of those constituents, ascertained through extractable / leachable (E/L) studies. However, the E/L analysis can face several pitfalls towards achieving the objectives of risk assessment and current regulatory guidance leaves the analyst having to make many choices based on their own judgment. However, this shortcoming of the data can be avoided with proper study design. Potential pitfalls in the E/L analysis will be discussed together some tested methods for their avoidance, which will be illustrated with case studies. 2:00 2:20: Toxicological Risk Assessment for Breathing Gas Pathway Medical Devices: ISO and ISO 1856 Breathing gas pathway medical devices such as breathing systems, ventilators, anesthesia systems, nebulizers and oxygen lines come into contact with patients at a particularly vulnerable point and time. Bootcamp Agenda

3 Bootcamp Agenda Medical Device Preclinical Bootcamp As a result, the exposure assessment for these devices is an important step in the evaluation of device safety and needs to be particularly concerned with airborne releases, especially volatile organic compound (VOCs). ISO and ISO may both apply; yet in some instances each standard recommends a very different technical approach to the measurement of releasable chemicals and different assumptions for the risk assessment. The key differences in these two methodologies will be illustrated, along with an analysis of how different risk estimates derived using these regulatory guidelines points out the need to justify the use of one over the other. 2:20 2:35: Tips for a Successful Sponsor-Laboratory Partnership With over 40 years of experience and having completed thousands of studies, Toxikon has seen the good, the bad, and the ugly of medical device safety and efficacy testing. With our customers, collectively we ve learned how proper preparation, comprehensive communication, and clear expectations on both sides creates an environment where studies are initiated efficiently and completed effectively. We will facilitate an open discussion sharing what we ve learned about creating a successful partnership between the sponsoring company and the contract laboratory, to help your next project have the best chance for success.

4 Medical Device Preclinical Bootcamp Rosalyn Año Business Development Manager Stephen Doherty, Ph.D. Director of Analytical Chemistry Workshop Faculty Rosalyn has more than 10 years of experience in guiding medical device companies through successful product safety testing strategies. As one of Toxikon s business development managers, she has a track record of controlling study costs through sound risk management techniques, reducing the probability of test failure, and streamlining product development timelines to achieve key milestones ultimately resulting in a high success rate of getting high quality and safe products to market. Rosalyn received her B.S. in Biomedical Engineering from Boston University. Laurence Lister Director of Biocompatibility Laurence has over 25 years of experience in every aspect of biocompatibility and toxicology testing. As Toxikon s head of biocompatibility, he is responsible for the direction of the staff of scientists that perform thousands of biocompatibility studies each year. Laurence has authored several papers on the specifics of biocompatibility tests, and is a member of several national and international committees that steer biocompatibility regulation and guidance. Laurence received his B.S. in Biology from Boston College. Stephen has more than 20 years of experience in chemical testing and characterization of medical devices and related products. As Toxikon s director of analytical chemistry, he develops experimental study designs to address client-specific test and regulatory requirements. Dr. Doherty is the author of a number of articles and book chapters on polymer formulation, testing, and applications, and is a frequent presenter on extractable / leachable topics at industry conferences around the country each year. Stephen received his B.A. in Chemistry from Colby College and a Ph.D. in Analytical Chemistry from the University of New Hampshire.

5 Workshop Faculty Medical Device Preclinical Bootcamp Kevin Connor, Ph.D., DABT Director of ToxSMART Consulting Practice Kevin has more than 20 years of experience in toxicology and human health risk assessment within a variety of regulatory frameworks. As head of Toxikon s risk assessment consulting division, ToxSMART, he has managed hundreds of risk assessments for medical devices and consumer products, including assessments under ISO Dr. Connor works closely with Toxikon s analytical laboratories in procuring the most relevant data from extractability leachability (E/L) analyses to best help sponsors develop methods that carefully consider the nature of consumer exposure. Russell Sloboda Study Director ToxSMART Consulting Practice Russell Sloboda is an analytical chemist and risk assessment specialist with 35 years experience. At Toxikon he is responsible for all aspects of toxicological risk assessment as per ISO and ICH M7 guidelines, which includes literature research, exposure modeling, investigation of medical device and drug product manufacturing practice and usage, application of QSAR models to screen chemical toxicity, development of toxicological profiles, and calculation of tolerable intakes based on extrapolation of animal toxicity data. He communicates effectively and provides consulting support in analytical study design, specification of AETs, and response to FDA comments.

6 Medical Device Preclinical Bootcamp Registration Information: Online: Venue Information: Massachusetts Biotechnology Council (MassBio) 300 Technology Square, 8th Floor Cambridge, MA Directions / Parking: Accessible via the MBTA at the Kendall Square stop, Red Line. Parking available at Technology Square Garage, 595 Technology Square, Cambridge, MA Registration