David McClure, a registered patent attorney and Of Counsel to the firm, helps innovators take steps needed to advance their technologies toward market. He has done this for nearly a quarter-century, working first as a scientist and software developer. Since 2001, David has combined his work as a scientist with the practice of law, assisting companies with their general legal matters and before the U.S. Patent & Trademark Office and the U.S. Food and Drug Administration (FDA).
As Director of Regulatory Affairs for Blairex Laboratories, David oversaw manufacture and signed off on the release of every unit of the Simply Saline® line of products that went into global distribution. As consultant to Humana, he drafted standard procedures for transformation of internal innovations into consumer-facing products. As Chief Scientific Officer for PDx BioTech he led the team that launched the first-in-category OraStrip® periodontal diagnostic and as General Counsel participated in negotiations for sales, marketing, and distribution alliances with Abbott and Virbac.
David advises decision-makers early in the innovation process to enable informed strategic choices to maximize value. This approach relies heavily on his 15 years of experience in the technology commercialization industry as Senior Consultant to Foresight Science & Technology Inc., mapping path-to-market for private-sector innovations funded by various federal agencies including NIH, DOD, and EPA.
David has represented public and private companies before the Patent Office on a variety of inventions in the fields of biotechnology, pharmaceuticals, software, medical devices, and advanced materials. He counsels clients on patentability, infringement, and freedom-to-operate and assists with patent and other intellectual property litigation.
David has represented corporate clients before FDA on technologies ranging from a brain-computer interface to a smart toothbrush to pharmacogenomics software. He advises clients in FDA-regulated industry on manufacturing and labeling compliance for products including pharmaceuticals, dietary supplements, cosmetics, and foods.
A registered patent attorney since 2001 and holder of the Regulatory Affairs Certificate (RAC) since 2002, David earned degrees from Harvard (AB History; Harvard College Scholar), Louisville (MS Anatomy; Commission on Academic Excellence Thesis Award), North Texas (PhD Biochemistry; Robert A Welch Foundation Fellow), and Kentucky (JD; Dorothy Salmon Scholar).
In the community, David has served on the Board of Directors of two state affiliates of BIO, the Biotechnology Industry Organization: the Kentucky Life Sciences Organization and BIO Alabama. He and his family are active in the educational and outreach ministries of their church.