Veteran leader in drug-device development, regulatory strategy, and global standards partners with EdgeOne to strengthen expertise as combination product complexity grows
WHEELING, Ill.–(BUSINESS WIRE)–EdgeOne Medical, an integrated development partner for drug-device combination products, today announced that Lee Leichter, a pioneer in the combination product field and long-time contributor to global device and regulatory standards, is partnering with the company as a Senior Advisor.
Drug-device combination products bring together pharmaceutical science, device engineering, regulatory strategy, and quality systems. This creates a level of technical and regulatory complexity that continues to increase across the industry. Leichter has spent decades helping pharmaceutical, biotechnology, and medical device organizations navigate these challenges while advancing the development and commercialization of innovative drug delivery technologies.
Over the course of his career, Leichter has worked across a broad range of combination product platforms including autoinjectors, wearable delivery systems, inhalers, and other advanced drug delivery technologies. His experience spans regulatory strategy, device engineering, risk management, and product lifecycle considerations. This breadth of experience provides a uniquely comprehensive perspective on the challenges companies face when developing complex drug-device systems.
Leichter has also played an important role in shaping the broader combination product ecosystem through leadership and participation in organizations including Parenteral Drug Association (PDA), International Standards Organization (ISO), Association for the Advancement of Medical Instrumentation (AAMI), Combination Product Coalition (CPC), Human Factors and Ergonomics Society (HFES), and Regulatory Affairs Professionals Society (RAPS). Through this work he has contributed to standards development, regulatory dialogue, and technical education across the global life sciences community.
In his role as Senior Advisor, Leichter will work closely with EdgeOne’s internal teams to provide perspective on evolving combination product regulations, emerging industry trends, and developments in relevant technical standards. His guidance will help strengthen EdgeOne’s ability to address regulatory and technical changes while continuing to refine the capabilities the company brings to its clients.
“Lee is one of the most respected experts in the combination product field,” said Lilli Zakarija, CEO of EdgeOne Medical. “His experience across regulatory strategy, engineering realities, and global standards development is incredibly valuable for our team. We are thrilled to have him working alongside EdgeOne as we continue to help companies navigate the growing complexity of drug-device development.”
“Combination products continue to evolve as therapies become more advanced and delivery technologies grow more sophisticated,” said Lee Leichter. “EdgeOne has built a strong reputation for technical depth and collaborative problem solving, and I look forward to supporting the team as they continue helping companies address the challenges of modern drug-device development.”
About EdgeOne Medical
EdgeOne Medical is a device development professional services organization supporting the biopharmaceutical industry across the full lifecycle of drug-device combination products. The company provides integrated engineering, testing, and consulting services that help clients navigate the development and commercialization pathway for drug-device delivery systems.
Backed by seasoned industry experts and a deeply collaborative, client-first mindset, EdgeOne Medical has supported more than 135 clients across a wide range of device modalities including pre-filled syringes, autoinjectors and pen injectors, inhalers, on-body delivery systems, vial access devices, custom drug delivery platforms, connected devices, and other advanced medical technologies.
EdgeOne Medical is the industry’s leading Integrated Partner for Combination Products, combining a cross-functional device development team with in-house FDA-inspected device testing laboratories operated by experienced device engineers. This integrated model enables biopharma teams to move from development uncertainty to Combination Product Confidence™, helping ensure therapies reach patients safely, effectively, and on schedule.
Founded in 2012, EdgeOne Medical is headquartered in Wheeling, Illinois.
Contacts
Media Contact
June Lau
EdgeOne Medical
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