Regulatory Science Accelerator Survey

Navigating the In Silico Alternative Methods Landscape: Where do you fit in?

In silico alternative methods are mathematical and/or computational methods and approaches that may help bring FDA-regulated products to market faster, with improved efficacy; prevent products with increased toxicological risk from reaching the market, or facilitate identification of potentially problematic substances. Additionally, these methods may harness the potential to replace, reduce, and/or refine animal testing.

FDA information on alternative methods and approaches:

· New Alternative Methods: https://www.fda.gov/science-research/about-science-research-fda/advancing-alternative-methods-fda

· New Approach Methods (foods): https://www.fda.gov/food/toxicology-research/new-approach-methods-nams

The Reagan-Udall Foundation for the FDA, in collaboration with FDA, is hosting a series of virtual working meetings on topics in regulatory science. The scope of this workstream of the Regulatory Science Accelerator is focused on in silico alternative methods. Please fill out this form to express your interest in participating in the series and share relevant information about in silico alternative methods.

1.Which in silico alternative method do you think holds the most promise for advancing regulatory science? (Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.)(Required.)

2.Which application of that in silico alternative method do you think hold the most promise in advancing regulatory science? (e.g., quantify toxicities from tobacco products, food products, and/or generate evidence about medical products)(Required.)

4.In developing a road map to address gaps in in silico advance methods, we are building a catalog of resources. Please share links to journal articles, pre-publication research, and other relevant resources that you authored.

Resource link or name

5.If it is convenient for you, please upload your CV, copies of recent articles, or other relevant resources you would like us to review. (You may email documents to regsci@reaganudall.org.)

No file chosen

6.What science gaps remain for fully harnessing in silico alternative methods to advance Regulatory Science?(Required.)

7.Enter your contact information(Required.)

Name

Company/Organization

City/Town

State/Province

Country

Email Address

8.Type of Organization (select the one you identify with most)(Required.)

Other (please specify)