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Orchestra BioMed, Inc. today announced the appointment of Bob Laughner, an expert in global regulatory affairs for combination products, as Vice President, Regulatory Affairs. Mr. Laughner will play a lead role in advancing Orchestra BioMed’s Virtue® Sirolimus AngioInfusion Balloon (SAB) through global regulatory approvals.

“Bob has successfully spearheaded combination product development and regulatory efforts for a number of global medical device and biopharmaceutical companies, where he ultimately secured approvals and implemented life-cycle management strategies for their respective technologies,” said Darren R. Sherman, president, chief operating officer and co-founder of Orchestra BioMed. “We welcome Bob to our leadership team and look forward to his guidance as we work with our partner Terumo to advance Virtue SAB for the treatment of artery disease. We believe that Bob will also add value in advancing BackBeat CNT™ and other pipeline product candidates based on SirolimusEFR™, our extended focal release sirolimus formulation used in Virtue SAB.”

Mr. Laughner brings over a decade of leadership experience in combination product development and successful implementation of regulatory strategies for global medical device and biopharmaceutical companies. Before joining Orchestra BioMed, he served as the Regulatory Director, Medical Device and Combination Products at AstraZeneca, where he drove combination product regulatory strategies across the product portfolio. In this role, Mr. Laughner managed combination product regulatory submissions and meetings with the FDA and other global regulatory agencies, while also evaluating new technologies and implementing guidelines for their development, regulatory approval and life-cycle management. Prior to that, Mr. Laughner served as the Associate Director, Combination Products at MedImmune, an AstraZeneca company, where he developed regulatory strategies and submissions for combination products in their biologic portfolio and developed strategies to evaluate the safety and effectiveness of drug delivery systems, including novel and wearable technologies. Prior to MedImmune, Mr. Laughner was a regulatory scientist at Cook Medical, where he provided regulatory and scientific support in the development, testing, and regulatory approval for combination products and medical devices, including many novel technologies. Mr. Laughner has been involved in the development of international standards for drug delivery devices as an expert for various ISO committees, and is currently Co-Chair of the Association for the Advancement of Medical Instrumentation’s committee on Devices for Administration of Medicinal Products and Catheters.  Mr. Laughner holds an M.S. in pharmacology and a B.A. in biology from Indiana University-Bloomington and holds certification in regulatory affairs from the Regulatory Affairs Professional Society.

“I share Orchestra BioMed’s commitment to providing high-impact solutions that address large unmet patient needs in procedure-based medicine. The Company’s innovative therapies, Virtue SAB and BackBeat CNT, have the potential to significantly improve treatment of artery disease and hypertension, respectively,” said Bob Laughner. “I’m delighted to be a part of the Orchestra BioMed team and look forward to advancing these important new therapies through the regulatory process.”



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