Dive Brief:
- The Food and Drug Administration has launched a new meeting track, dubbed INTERACT, designed to encourage earlier communication with developers of biological products.
- INTERACT will replace the Center for Biologic Evaluation and Research's current meeting process for developers that are seeking feedback even before the pre-Investigational New Drug stage of regulatory discussions. Its aim is to more clearly articulate the FDA's expectations and smooth the early development process.
- "These meetings have the potential to help streamline development by helping sponsors avoid unnecessary preclinical or other preparatory studies or plan initial clinical development strategies," said Peter Marks, director of CBER, in a June 22 statement.
Dive Insight:
The path to market is a challenging one, and as drug development costs climb, companies have a lot at stake. A failure in a late-stage study can be the beginning of the end for a biotech, or a damaging drop in stock value for larger pharmas. Regulatory authorities across the world, including the FDA, have seen the value of earlier discussions with developers to help to shape clinical trials.
"We know that academic investigators, small and medium enterprises, and sometimes even large companies can have questions regarding the path from preclinical to clinical development for biological products — particularly those that raise new regulatory questions," said Marks in prepared remarks.
The INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program gives companies that aren't yet ready for a pre-IND meeting the opportunity to receive CBER feedback.
Biopharmas can get clarification on the agency's expectations of product development programs, hopefully accelerating drug development and helping companies avoid unnecessary studies.
The benefits will also work both ways. As well as helping companies, the program gives CBER greater opportunity to learn about emerging products and technologies.
The aim of the INTERACT meetings isn't to replace the formal product-specific meetings, such as pre-IND meetings or pre-BLA meetings. These will still take place later in development.
The INTERACT program is another effort by the FDA to improve communication with developing companies and study sponsors. In December last year, the FDA unveiled two new guidances on the best practices for communication between drugmakers and regulators during development, and on formal meetings between the FDA and sponsors of PDUFA products.
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