WASHINGTON, D.C.—Womble Bond Dickinson attorney Dan Orr and regulatory scientist Heather Hatcher will teach two sections of the Food & Drug Law Institute course Introduction to Biologics and Biosimilars Law and Regulation.
The course will take place in Washington, D.C. on April 2-3. Orr will teach a section concerning how FDA reviews biological products and makes its approval decisions. Dr. Hatcher’s section will focus on how FDA regulates new regenerative medicine products and advanced therapies, such as gene therapies, stem cell therapies, and immunotherapies.
Dan Orr is a Partner in the Washington, D.C. office of Womble Bond Dickinson. He advises clients concerning regulatory and patent issues in the pharmaceutical, biotech, and medical device sectors. Before joining WBD in January 2018, Orr was a Regulatory Counsel in FDA’s Center for Drug Evaluation & Research where he solved regulatory problems in a portfolio of drugs and biologics with combined annual sales of more than $37 billion.
Heather Hatcher is a Regulatory Scientist in the Winston Salem, N.C. office of Womble Bond Dickinson. Her extensive background as a basic and clinical research scientist, as well as Regulatory Affairs, has enabled her to effectively guide clients through the complex FDA regulatory landscape. Before joining Womble Bond Dickinson, Dr. Hatcher worked in academic research and research administration at Wake Forest Baptist Medical Center for 12 years. Dr. Hatcher’s 20+-year research career spans a number of fields including endocrinology, cancer biology and regenerative medicine; and her research has been published in numerous peer-reviewed journals.