Scheduled for July 23-24, 2020, "Topical Drug Development - Evolution of Science and Regulatory Policy II" is the much anticipated follow-up event to the M-CERSI 2019 workshop that focused on the assessment of dermal absorption in topical drug development.
|Important Event Information|
|Date:||July 23-24, 2020|
|Time:||8:00 a.m. - 4:30 p.m.|
|Location:||This is an online event. Information to access conference webinars will be emailed to all registrants as the conference approaches.|
|Webinar Access:||To access the webinar recordings from this conference, please use the following links:
About the Event:
In 2019, the U.S. Food and Drug Administration (FDA) and M-CERSI hosted a two-day workshop on the assessment of dermal absorption in topical drug development. Based on the enthusiastic response to that workshop, a follow-up workshop will be held on July 23-24 to focus further discussion on the evolution of in vitro and in silico methods, alongside and as an adjunct to current methods, in the drug development process for both "new" and generic topically applied drugs.
The Maximal Usage or "MUsT" paradigm has been used in the development program for every topically applied New Drug Application in the U.S. since the mid-1990s. MUsT allows for the direct observation of in vivo blood levels of topically applied drugs under labeled conditions. The evolution of MUsT itself followed improvements in analytical methodologies that allowed for the resolution of dermally absorbed drugs into systemic circulation. In a similar manner, in vitro and in silico tools have also evolved over time and have been used in the evaluation of systemically available drug products. These tools have been used to evaluate changes in dosing regimen and formulation via IV and oral routes without the need to resort to, or in other cases to supplement, the available in vivo data.
This symposium will bring together stakeholders from the FDA, academia, and industry to discuss the current status of both in vitro and in silico methods in the dermal absorption area. The first day of the workshop will focus on the in vitro and in silico methods and how they have been incorporated into current drug development programs, along with discussion on their potential application to drug development in the future. The second day of the meeting will focus specific attention on the dermal absorption of sunscreens and topical antiseptics as a significant body of data is being generated in this area that can be used to validate and inform the in vitro methods. Additional insights from both of the FDA sunscreen studies will be presented, along with how the totality of these methods (i.e., MUsT, in vitro, and in silico) can be harnessed to drive dermal drug development.
This workshop aims to:
- Facilitate discussion as to the design elements and concerns of both in vivo and in vitro methods in the new drug and over-the-counter drug space.
- Present recent advances and examples of the use of in vitro and in silico methods in the assessment of dermal absorption from both a new drugs and generic drug development perspective.
- Provide an update on the progress on the developments in the area of sunscreen and topical antiseptic absorption.
- Stimulate discussion between interested parties in the evolution of science in the area of topical drug development and dermal absorption testing.
For More Information:
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This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.