General Requirements and Strategies for Successful IND Filings
Location:
Jadewin Fine McDonnell Building, McDonnell Hall A01/02, Princeton University,
76 Washington Road, Princeton NJ, 08540
Date: Saturday April 30, 2011
Organizing committee:
Dr. Handan He, email: ;
Dr. Xin Du, email:
Dr.Jane Xiang, email: ,
Dr. Charles Xie, email:
Symposium Description:
An Investigational New Drug Application (IND) is a request for a Food and Drug Administration (FDA) authorization to administer an investigational new drug (IND) for the first time to humans. Therefore, it is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only for a successful filing, but can also accelerate a promising clinical development path forward. Therefore, keeping up to date on the regulatory requirements and the industry's best practices in different aspects is paramount. Recognizing the increasing need for SAPA members to understand the pharmaceutical license application process in a constantly changing of regulatory landscape and practice in the pharmaceutical and biotechnology industry, we are hosting this one-day symposium to focus on IND filings. This Symposium has discussion topics that include preclinical and safety, DMPK, CMC clinical and biological requirements and strategy for IND filings; recommendation for successful regulatory filings from both the industrial and FDA perspectives. Also, the general requirements and application process for investigational new drug filing in China will be discussed. Following the Symposium oral presentations will be panel discussions, allowing participants to interact with expert panel members. The goal of the Symposium is to provide a comprehensive coverage for all aspects of IND filings and to promote in-depth discussions between FDA representatives, experts from the industry and the audience. This symposium will benefit scientists in academia and industry. The preliminary agenda is shown as follows:
Agenda
9:10-9:50 / Preclinical safety requirements for IND filings (Dr. Jiaqin Yao, FDA)
9:50-10:30 / DMPK requirements and strategies for IND filings and recommendations for first in human (FIH) dose selections (Dr Gregory Weber, Pfizer)
10:30-10:40 / Break
10:40-11:20 / CMC requirements and strategies for IND filings (Donna Kapple, Novartis)
11:20-12:00 / Clinical considerations for IND filings (Dr. Sally Choe, FDA)
12:00-1:00 / Lunch
1:00-1:40 / IND Submissions of Biologics: Requirements and strategies for successful filings (Dr. Xin Du, BMS)
1:40-2:20 / General requirements for investigational new drug (CTA) filings in China (Dr. Zili Li, Merck)
2:20-2:30 / Break
2:30-3:10 / Recommendations for Successful Regulatory Filings from an Industrial Perspective (Dr. Karen Habucky, Novartis)
3:10-3:50 / for Successful IND Filings from the FDA’s Perspective (Dr. Marcus.Cato, FDA)
3:50-5:00 / Panel Discussions and Q&A Session