Medical Device Preclinical Bootcamp

March 30, 2018 | 9:30am - 2:30pm Massachusetts Biotechnology Council (MassBio) 300 Technology Square, 8th Floor Cambridge, MA 02139

Featured Speakers

Bootcamp Coverage

Rosalyn Año Laurence Lister Kevin Connor, Ph.D., DABT

Stephen Doherty, Ph.D.

Russell Sloboda

• 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 10993 and ISO 18562

• Tips for a Successful Sponsor-Laboratory Partnership

www.toxikon.com

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a9:30 – 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 10993 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.

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 10993 and ISO

18562 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.

Medical Device Preclinical Bootcamp

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. Bootca

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Medical Device Preclinical Bootcamp

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 Doherty, Ph.D. Director of Analytical Chemistry

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.

Rosalyn Año Business Development Manager

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.

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 10993-17 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.

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 10993-17. 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.

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Medical Device Preclinical Bootcamp

Registration Information: Online: http://go.toxikon.com/medical-device-preclinical-bootcamp

Venue Information:

Directions / Parking:

Massachusetts Biotechnology Council (MassBio)

300 Technology Square, 8th Floor

Cambridge, MA 02139

Accessible via the MBTA at the Kendall Square stop, Red Line.

Parking available at Technology Square Garage, 595 Technology Square, Cambridge, MA 02139

www.toxikon.com

Email: info@toxikon.com

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