2020 IADR/AADR/CADR GENERAL SESSION

The 98th General Session & Exhibition of the IADR was to be held in conjunction with the 49th Annual Meeting of the American Association for Dental Research and the 44th Annual Meeting of the Canadian Association for Dental Research, from March 18-21, 2020 in Washington, D.C., USA. Due to COVID 19 and the world pandemic, the meeting had to be canceled, but we were able to collect some of the science that was planned for presentation to be available to our members as part of an on demand meeting.

The recordings in this library are a selection of the science that was to be presented onsite at the General Session. These recordings give you the opportunity to participate in the meeting and hear from leading researchers. The recordings include IADR Distinguished Lecture Series speakers, IADR Centennial Plenaries and symposia from a collection of scientific groups and networks.

This session can be purchased as part of the full meeting recordings within the product bundles

SESSION DESCRIPTION

In order to familiarize dental researchers with the New Drug Application (NDA) or Biologic Licensing Application (BLA) process we have chosen Sjogrens syndrome as a model and have brought together the following speakers.

Kathy Hammitt will speak from the patient’s perspective. Currently, no biological therapies are FDA-approved for Sjogren’s, yet Sjogren’s is the second most common autoimmune disease affecting 4 million Americans and many more worldwide. This session will illustrate the devastating effects Sjogren’s can have on patients’ lives will include results from the Sjogren’s Foundation Living with Sjogren’s national survey conducted by Harris Poll and showing the physical, emotional and financial burden of the disease. It also will increase attendees’ understanding of why there is a critical need for more research and better management tools and will highlight key areas in which research is needed.

Dr Vivino will speak about conducting a Phase III clinical trial on sialogogues and regulatory process followed during a trial. The importance of following a protocol and documenting findings.

Dr.Papas will speak about her experience conducting Phase II trials on biologics.
Currently, no therapies are FDA-approved for Sjogren’s, yet Sjogren’s is the second most common autoimmune disease affecting 4 million Americans and many more worldwide. This session will illustrate the devastating effects Sjogren’s can have on patients’ lives will include results from the Sjogren’s Foundation Living with Sjogren’s national survey conducted by Harris Poll and showing the physical, emotional and financial burden of the disease. It also will increase attendees’ understanding of why there is a critical need for more research and better management tools and will highlight key areas in which research is needed.

Dr. Chalmers will discuss:
The New Drug Application (NDA) or Biologic Licensing Application (BLA) process is the formal regulatory vehicle through which drug sponsors request that the FDA approves their proposed drug products for sale and marketing in the U.S. This session will provide information regarding the regulatory pathways to market new drugs in the U.S., required components of an NDA/BLA submission and the review process, including congressionally mandated policies and regulations, post-marketing surveillance, and other regulatory actions. She with Dr Hyman's help will review the labeling requirements for prescription and nonprescription drug products. The historical context will be provided based on the approval of two marketed drugs that treat symptoms of dry mouth in patients with Sjögren’s syndrome, Salagen (pilocarpine) and Evoxac.
A Panel discussion will follow.


Organizer: Athena S. Papas, DMD PhD – Tufts University

Learning Objectives:

• To familiarize researchers with the clinical trials co- development process with the FDA and the steps that are necessary in a successful drug application. Examples of trials will be given by participants.
• CDER Regulation of Drugs to Treat or Prevent Oral Pathology
• Patient perspective on Clinical Trial Development will be addressed