The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization representing the engineered cell therapy and genetic medicines sector, announced the promotion of Michael Lehmicke to Senior Vice President, Science & Industry Affairs, effective immediately.
Mr. Lehmicke has led several strategic initiatives at the intersection of scientific, technical, and regulatory policy to advance the cell and gene therapy sector. These include ARM’s A-Gene and A-Cell projects, two multistakeholder collaborations that provide best practices and standard methodologies for Chemistry, Manufacturing and Controls (CMC) in the field, as well as a significant 2022 meeting with the US Food & Drug Administration, biotechnology companies, and other concerned parties regarding CMC potency assay development and validation for cell and gene therapies. A report responding to the findings of the CMC potency assay meeting is live on ARM’s website.
“The rapid advance of the cell and gene therapy sector requires that we modernize global healthcare systems, including regulatory policy and CMC approaches, to keep pace with scientific innovation,” said ARM Chief Executive Officer Tim Hunt. “Mike leverages his strong leadership style, technical expertise, and passion for innovative medicines to drive unique solutions on behalf of ARM’s membership and the broader field. With the promotion to Senior Vice President, we look forward to Mike’s continued leadership, with all of us working toward the ultimate goal of ensuring patient access to these durable and potentially curative treatments.”
Mr. Lehmicke joined ARM in 2019 as its first Director of Science and Industry Affairs and was subsequently promoted to Senior Director and Vice President, Science and Industry Affairs. He has over 20 years of R&D experience in biomaterials, medical devices, and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple U.S. patents to his name. Mr. Lehmicke has an MSc in Biomedical Engineering, with a focus on tissue engineering, from Drexel University. His areas of expertise include cell-based tissue engineering, bioceramics, biodegradable polymers, project management, strategic pipeline development, and business development. Mr. Lehmicke serves on the Board of Directors of the Standards Coordinating Body and on the Steering Committee of the Foundation for the National Institutes of Health’s Bespoke Gene Therapy Consortium.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. As a community, ARM builds the future of medicine by convening the sector, facilitating influential exchanges on policies and practices, and advancing the narrative with data and analysis. We actively engage key stakeholders to enable the development of advanced therapies and to modernize healthcare systems so that patients benefit from durable, potentially curative treatments. As the global voice of the sector, we represent more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organizations.
