Home Events CATO Webinar: Regulatory Strategies for Stem Cell–based Therapies

CATO Webinar: Regulatory Strategies for Stem Cell–based Therapies

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

Click link below to register.
Even if you will not be able to attend please register and we will send you a recording of the webinar once it’s available.

Regulatory Strategies for Stem Cell–based Therapies
Date: Thursday, August 1, 2019
Time: 10:00am (EST)
Click this link to register: https://zoom.us/webinar/register/WN_HJTmqH8QQNCQpreEwxRyHA

Register Now

 

Presenter Biographies

Lynda Sutton, President

Ms. Sutton has more than 35 years of experience in the drug development industry, specializing in the development of regulatory strategies for drugs and biologics. Ms. Sutton has been involved in the development of new clinical entities; has overseen the preparation of FDA pre-meeting submissions; and has ensured that regulatory requirements necessary for the approval and launch of new products have been satisfied.

She has served as the primary regulatory contact for more than 200 sponsors over the last 20 years. As the primary regulatory contact at Cato Research, she develops and coordinates strategies for regulatory agency meetings, and serves as the moderator at these meetings.

She has expertise in the development of biological products, with emphasis on gene therapy and blood products, and in the development of oncological, anti-infective, and neuropharmacological products.

Will T. Lee, Ph.D., R.A.C., Vice President of Regulatory Affairs

Dr. Lee has more than 30 years’ research and industrial experience in gene therapy, cellular immunology, and therapeutic vaccines, including 11 years in regulatory affairs. He has experience in the writing of patents and in the design and execution of preclinical studies, and he currently participates in the preparation and submission of various INDs, NDAs, and FDA meeting packages.

Dr. Lee has experience in pharmacogenetics and the therapeutic areas of infectious diseases and oncology. Dr. Lee is regulatory affairs certified by the Regulatory Affairs Professionals Society.

 

About Cato Research

Cato Research is a mid-sized Contract Research Organization (CRO) with over thirty years of acquired knowledge and experience. With more than fifty (50) marketing approvals obtained, 800 clinical trials completed and 400 annual regulatory submissions made per year, Cato Research has the expertise and experience in Regulatory Strategy, Clinical Trial Operations, and Chemistry, Manufacturing, and Controls (CMC) to support your projects.

In the event that you will not be able to attend our Webinar this month:
let’s schedule a time to introduce you to Cato Research and our expertise that would be most relevant to your drug development program needs.
Send Us A Message

Date

Aug 01 2019

Time

10:00 am - 11:00 am