Moving from the Lab to the Clinic: Early-Stage Interactions with the FDA

The Office of Technology Commercialization

Presents

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

Presented By

                                    Dan                           

                    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 jsa28@georgetown.edu or 202.687.7424.

Interested faculty, staff, and clinicians, undergraduate and graduate students, and entrepreneurs should attend.