Nov 22 2019

WINSTON-SALEM, NC— The weekly Venture Café Winston-Salem Thursday Gathering serves as a physical nexus for helping innovators and entrepreneurs find one another and collaborate to bring their dreams to reality. Womble Bond Dickinson is proud to be a Thought Leader sponsor of Venture Café Winston-Salem and was delighted to lead sessions to educate North Carolina Piedmont innovators, entrepreneurs and local businesses on how to navigate The Food and Drug Administration (“FDA”), a mission-critical step in taking new products to market.

On Thursday, November 14, Martika Harper and Dr. Heather Hatcher along with Rolf Garcia-Gallont and Mark Vaders presented two informative sessions on FDA-related topics:

  • I Didn’t Know that FDA Regulated THAT!” - Presented by Martika Harper, MS, Regulatory Affairs Analyst, Womble Bond Dickinson
    • Misbranding, False Claims, and Product Recalls can be avoided simply by knowing what and how certain products are regulated by FDA. 
    • Martika Harper is an integral part of Womble Bond Dickinson’s in-house Regulatory Affairs team. She has experience preparing regulatory submissions to FDA for drugs, biologics, and medical devices including: Investigational New Drug applications, Investigational Device Exemption applications and meeting requests. Before joining Womble Bond Dickinson, Martika worked as a research regulatory specialist in clinical and translational research at Wake Forest Baptist Medical Center. She also has experience with reviewing clinical study protocols.
  • Beyond the Fairytale – How to Talk to the FDA” - Presented by Dr. Heather Hatcher, Regulatory Scientist, Womble Bond Dickinson
    • Now that you understand what the FDA regulates, learn the right way to talk to regulators about your promising medical devices and drug candidates. Rather than entertain, the purpose is to streamline the FDA regulatory process, which is infamous for being confusing, time consuming and costly.
    • 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.

Heather Hatcher is leading the firm’s participation in the Venture Café. The Thursday Gatherings take place in Winston-Salem’s Bailey Power Plant, a former industrial facility that has been refurbished as a multi-use space.

Stay tuned for more Womble Bond Dickinson programming at the January 16, 2020 Venture Café Thursday Gathering session.

Venture Café Winston-Salem helps enhance and accelerate the growth of innovation and entrepreneurship in our city through high-impact programming and events and by creating intentional spaces for individuals and organizations to gather, connect, and build relationships.

Womble Bond Dickinson’s FDA Regulatory Affairs Team has years of experience at the FDA as well as scientific and technical knowledge to provide strategic regulatory guidance to clients in the pharmaceutical, biotechnology, and medical device industries. We offer scalable solutions to the full range of issues facing regulated medical products, including cutting-edge products like biosimilars, cell and gene therapies, 3D printed combination products, precision medicine and in vitro diagnostics. We also have regulatory experience with dietary supplements, food, cosmetics, and veterinary products.

Heather Hatcher and Martika Harper

Rolf Garcia-Gallont