The Office of Technology Commercialization
Invention 2 Innovation (I2I)
Moving from the Lab to the Clinic:
Early-Stage Interactions with the FDA
Wed., September 11, 2019
12:00 pm - 1:30 pm
Leavey Program Room #1606 at the Leavey Center
Mr. Dan Orr, Esq., Partner, Womble Bond Dickinson LLP
Dan Orr is a Partner in the Washington, DC office of Womble Bond Dickinson. He helps clients ranging from start-ups to Fortune 500 corporations obtain FDA approval for medical products and navigate the agency’s regulations. Dan was previously a Regulatory Counsel at the FDA where he solved regulatory problems in a portfolio of drugs and biologics with combined annual sales of over $37 billion.
Dan will discuss when and how sponsors of early-stage medical products should begin talking with FDA. The seminar will cover small business support available from the agency, special product designations (such as orphan and regenerative medicine designations), early-stage development meetings, data expectations, and related topics.
Lunch will be provided, space is limited.
Please RSVP by Monday, September 9, 2019
to Jeremy S. Alexander at firstname.lastname@example.org or 202.687.7424.
Interested faculty, staff, and clinicians, undergraduate and graduate students, and entrepreneurs should attend.