Past EventNMBio May Meeting – An Insider’s Guide to Navigating the FDA IND Process and Initiating Human Clinical Trials
For those who have never before been involved in drug or device development, the regulatory process is often complex and mysterious. The FDA can appear to be an inscrutable organization and it is not intuitively obvious which guidelines and regulations might apply to a new drug or device.
Dr. Sara McKenzie, with over 30 year’s experience in the pharmaceutical and biotech industries, has successfully navigated this process numerous times. Her expertise spans the range of experimental design, data analysis, manufacturing, pre-clinical testing, clinical operations, regulatory affairs and the business of science. Dr. McKenzie holds a B.S. in chemistry, a PhD in biochemistry and an MBA in General Management. http://www.linkedin.com/in/saramckenzie/
She will share her insights on how to approach the Investigational New Drug (IND) process. The topics covered will include how to nominate a drug candidate, an overview of the IND-enabling requirements, and how to work with FDA for a successful submission.
A case study involving Senior Scientific, a company developing a novel early detection and non-invasive cancer diagnostic instrument, will be included. Robert Proulx, President and COO of the medical device firm, will provide his company’s perspective on mastering the early stages of the regulatory process.