Date: April 23, 2014 (2 PM EST)
In February of 2014 the FDA released a draft guidance document related to the development of drugs for analgesic indications. A previous version of this document was released 22 years ago; during the George H.W. Bush era. Obviously much has changed. The importance of this document cannot be over emphasized in that it speaks to the current mindset of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products (DAAAP). A multitude of topics are covered in it, including specific information regarding the following:
- The development of new molecular entities versus reformulations
- Requisite paths to specific analgesic indications
- Early phase requirements
- Appropriate endpoint selection
- Recommended strategies for administration of rescue medication
- Data imputation guidelines
- Acceptable patient reported outcomes etc.
Many of the topics that drug developers have been guessing about for years are now to some degree spelled out. Of course every line is subject to interpretation, but the document is a great starting point. In this webinar, Dr. Singla will discuss the draft guidance document and highlight issues relevant to the analgesic drug development community.
ABOUT THE PRESENTER:
Dr. Neil Singla is the founder and Chief Scientific Officer for Lotus Clinical Research, an analgesic research site and CRO located in Pasadena California. Established in 2001 Lotus has: 40 employees, a 40 bed phase 1 unit, the ability to run phase 2/3 analgesic programs on a site and/or CRO level, full CRO capabilities and most importantly therapeutic expertise in pain.
Dr. Singla currently chairs the Analgesic Clinical Trials Special Interest Group at both the American Pain Society (APS) and the International Association for the Study of Pain (IASP). The main focus of Dr. Singla’s academic endeavors has been to analyze and understand how the inherent variability in analgesic clinical trials can be minimized. He has developed novel techniques for patient education designed to minimize variability, reduce placebo response and increase effect size. Dr. Singla’s affiliation with Lotus provides a unique opportunity not only to develop novel methodological techniques, but also implement and test them. Dr. Singla has frequent regulatory correspondence with the FDA's analgesics division on behalf of Lotus's pharmaceutical clients.