Expedited Development: Qualifying for Breakthrough Therapy or Fast Track Designation

As science has rapidly progressed, more and more therapies targeting an unmet medical need in the treatment of serious or life-threatening conditions have been introduced. To assist patients with life-threatening conditions and shorten timelines between the development of these new therapies and patients receiving treatment, the FDA has introduced an expedited review program. But, how can you know if you are qualified for an expedited review program and, if it is always the best path for your development?

Join Cato Research in our upcoming webinar to learn how to qualify for this new program, better understand both advantages and risk of an expedited development, and get answers from experts to your questions.

Greg Hileman, Ph.D., VP of Regulatory Strategy, Cato Research, will guide you through the process of expedited development and Will Lee, Ph.D., R.A.C., VP of Regulatory Affairs, Cato Research, will be in attendance for questions and answers.

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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.

Qualifying for Breakthrough Therapy or Fast Track Designation
Date: Wednesday, August 28, 2019
Time: 10:00am (EST) | 7pm (PST) | 3pm (CET)


About the Presenters

Greg Hileman, Ph.D., Vice President of Regulatory Strategy

Dr. Hileman more than 35 years’ research and industrial experience, including 25 years in strategic regulatory affairs. He has led drug development meetings with most FDA divisions and contributed to submission of multiple fast track designation requests, breakthrough therapy designation requests, FDA meeting packages, INDs, NDAs, and BLAs. Dr Hileman currently leads Cato’s regulatory strategy group and serves as primary FDA contact for multiple sponsors.

Dr. Hileman has clinical and product development experience in neurology, psychiatry, oncology, gastroenterology, cardiology  and women’s health.


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

Dr. Lee has more than 25 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.


We look forward to introducing you to Cato Research and the solutions-oriented expertise we provide.