More Information Coming Soon
OTSS Webinar - Regulatory Requirements for Ocular Biologics Development
Date and Time: Thursday, March 10, 2022 12:00 PM–1:30 PM
Coordinated global efforts over the last several decades have resulted in the development and adoption of alternatives to traditional animal tests for dermal hypersensitivity assessment. Following the adverse outcome pathway (AOP) framework, several new approach methodologies (NAMs) mapped to key molecular and cellular events in the AOP have been validated and combined to yield “defined approaches”, which were shown to provide superior performance to the existing animal tests when compared to human data for hazard and potency categorization. However, regulatory and industry needs extend beyond classification to deriving points of departure that will facilitate quantitative risk assessment. Next Generation Risk Assessment (NGRA) is an exposure-led, hypothesis-driven approach which integrates NAMs. This hypothetical skin allergy risk assessment case study of two consumer product exposures - 0.1% coumarin in a face cream and 1% coumarin in a deodorant – demonstrates the application of a skin allergy NGRA framework which incorporates the Skin Allergy Risk Assessment (SARA) Model. The SARA Model is a Bayesian approach which allows prediction of a human relevant point of departure (PoD) (the HRIPT dose with a 1% chance of sensitisation or ED01 [µg cm-2]) based upon any combination of HRIPT, LLNA, DPRA, KeratinoSens, h-CLAT or U-SENS data. Through incorporation of benchmark exposure information, the SARA Model can be used to calculate a risk metric for a consumer relevant exposure. This case study demonstrates how integrating a computational model and NAM data in a weight of evidence can build confidence in robust decision making.
Lighting in the Vivarium; The Spectrum and Intensity Is Crucial, The Source Is Not
Date and Time: February 23, 2022 at 2:00 PM–3:00 PM ET
The use of light-emitting diodes (LED) for vivarium lighting and in other laboratory spaces has come to the fore in the last several years, primarily driven by cost considerations, lower energy costs, and lessened environmental impact. However, as with any new technology, concerns have been raised about the light emitted from these devices, and confusion has arisen regarding the safety of their use in these environments. The purpose of this presentation is to present some fundamental information on lighting systems, the current safe lighting recommendations for vivariums, dispel the concerns for the use of LED for vivariums and provide anyone responsible for lighting to design the best systems for their vivariums or retrofit current facilities with this technology.
OTSS Reception Meeting
Date and Time: March 15, 2021, 4:15 PM–5:40 PM, EDT
Nonclinical Safety Toxicology Strategies for the Development of Novel Ocular Biotherapeutics
Date and Time: March 17, 2021, 2:45 PM–4:15 PM, EDT
OTSS/MDCPSS Virtual Career Panel—SOT Mentoring Event
Date and Time: Monday, September 21, 2020, at 12:00 Noon–1:00 PM, EDT