Regulatory Strategies for Stem Cell–based Therapies
Stem cell–based therapies have shown great promise in recent years with many exciting advancements in research. Nonetheless, the further we advance, the greater the challenges are, not only in the scientific front but in the regulatory front as well. It is of high importance to understand and strategize the regulatory pathway in order to build a strong route towards a marketing approval.
As the FDA released a comprehensive policy for the development and oversight of new cell–based therapies, it is essential to fully understand the regulation involved and identify the most appropriate strategies for your program in order to successfully and optimally navigate towards the desired outcome.
In this upcoming webinar, Key Thought Leader, Will Lee, Ph.D., R.A.C., VP of Regulatory Affairs Cato Research will be giving a brief presentation on creating and identifying regulatory strategies for stem cell–based therapies. Lynda Sutton, President of Cato Research, will join and answer questions along with Dr. Lee.
What will you benefit from this webinar:
- Gain a better understanding of the regulatory framework for stem cell–based therapies
- Identify a strategic framework to benefit your program
- Get a chance to “pick the regulation professionals’ brains” and get some answers to questions you might have
- Draw inspiration from case studies based on real sponsors’ issues