This is the fifth colloquium of a series presented by the Society of Toxicology in conjunction with US FDA Center for Food Safety and Applied Nutrition.
New data types, primarily from in vitro tests, and an ever-increasing plethora of computational tools for in silico modeling have ushered in the era of “big data” in investigative toxicology. Practitioners in the field of human health assessments are transitioning rapidly away from lamenting a lack of data to drowning in a deluge of information. There is a clear opportunity for a paradigm shift toward high-throughput risk assessment and non-traditional data-based regulatory decision-making; however, only very recently has the information from rapid screening, in silico modeling, and prioritization efforts begun to make inroads into human health decisions. This colloquium is following up on the “Contemporary Issues in Risk Assessment” (June 17, 2015) colloquium and extends the discussion to the use of new computational and in vitro science, approaches, and technologies for risk assessment and regulatory decision-making.
Specifically, this session will cover (1) an overview of risk- and hazard-based decision contexts at the US FDA; (2) a case study of replacement of an animal test with a battery of in vitro tests; (3) examples of how in vitro and in silico data aid in developing category and analogue read-across; and (4) the use of in vitro data to fill in data gaps in a traditional cancer hazard assessment. Overall, the learning objective for this session is to demonstrate recent examples of the implementation of the novel information streams from computational and in vitro methods into the practice of risk assessment across a wide array of decision contexts.
(all times are Eastern US, GMT-5)
|8:00 AM–8:30 AM||Badge Pick Up|
|8:30 AM–8:40 AM||US FDA Welcome and Overview—Suzanne Fitzpatrick, US FDA, College Park, MD|
|8:40 AM–8:45 AM||Welcome from SOT—Peter Goering, PhD, SOT President, US FDA, Silver Spring, MD|
|8:45 AM–9:10 AM||
Development of In Silico Tools at OFAS CFSAN FDA
|9:10 AM–9:55 AM||Gaining Confidence in Replacing Animal Tests: A Case Study of the Endocrine Disruption Program at the US EPA—Richard Judson, US EPA/NCCT, Research Triangle Park, NC|
|9:55 AM–10:10 AM||Break|
|10:10 AM–10:55 AM||Read-Across with Computational and In Vitro Data—Elisabet Berggren (by webinar), Joint Research Centre, European Commission, Ispra, Italy|
|10:55 AM–11:40 PM||Use of Computational and In Vitro Data in Cancer Hazard Assessment of Data Rich Chemicals: Examples of IARC Monographs—Ivan Rusyn, Texas A&M University, College Station, TX|
|11:40 PM–12:40 PM||Roundtable Discussion
Ivan Rusyn, Moderator
|12:45 PM–1:45 PM||
Informal lunch for speakers and FDA employees Room 1A-001 (Bring your own lunch)
FDA employees are welcome up to the capacity of the room
Registration to participate on-site is now closed.
On-site seating is limited and has no cost. Note that there will be no onsite registration for those who are not US FDA employees.
A cafeteria is available outside the security entrance to the facility.
Register for webcast.
Webcast participants can submit questions online during the event. These will be answered as time allows.
Questions about the SOT FDA Colloquia?
Contact Rachel Woodson or 703.438.3115 Ext. 1602.
Harvey W. Wiley Federal Building
US FDA, Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway, College Park, Maryland 20740
We strongly encourage visitors to take the Metro via the Green Line to the College Park-University of Maryland station stop, which is across the street from the Wiley Building.
Directions from the Capital Beltway (I-495) to CFSAN
For those who must drive, there is limited public parking at CFSAN which must be reserved in advance by indicating the parking request on the registration form. Alternatively, paid parking is available at the College Park Metro Station across the street from the campus.
Wiley Auditorium is a secured space. All on-site participants will pass through security, which will require a photo ID for those who are not FDA employees. In addition, anyone who is not a US citizen or permanent resident will be required to complete a Foreign Visitor Form to submit to SOT by October 25, 2014.