WHO WE ARE

CP Pathways’ principal consultant is Doug Mead – a highly experienced combination products regulatory expert with a diverse background in drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.  Doug has a network of experienced combination product regulatory SMEs that can be made available for specialized projects.  

Most recently, Doug was Senior Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Johnson and Johnson’s Janssen Research & Development LLC, and was responsible for establishing and implementing the worldwide regulatory strategy for the development of drug delivery systems and drug-device combination products.  In this role, he was responsible for over 40 combination products and led or authored the submissions for more than a dozen new drug device combination product that received world-wide regulatory approvals for clinical or commercial use.  These included prefilled syringes, injectors and infusion systems, microcatheters, and nasal spray devices. 

Before joining J&J in 2006, Doug was a regulatory specialist at the law firm of Hogan and Hartson (now Hogan Lovells LLP) in their medical device practice where he was responsible for the preparation of regulatory filings for client medical device companies. He specialized in highly technical product submissions, the development of innovative regulatory strategies for product approval, design control policies and practices, and general compliance issues.  Projects included Pre-IDEs, IDEs, 510(k)s, PMAs, INDs, study protocols, labeling, QSR SOPs and Warning Letter resolution.  Specialized areas included autoinjectors, disposable infusion pumps, lasers and light therapy systems, spinal implants, muscle stimulators, software products, design/QSR audits, and novel devices with complex predicates. 

Previously, he was Director of Regulatory Affairs at Elan Drug Delivery, Inc., and was a key executive for a business unit that developed sophisticated disposable devices for auto-injection and patch pumps with licensee pharmaceutical partners for commercialization as combination products.   Doug had held senior regulatory and quality positions at surgical instruments and laser system companies and led the clinical development of cross-labeled combination product photodynamic therapy laser systems.  Doug began his career at the ECRI Institute, where as Associate Director, he led multiple evaluations of infusion and injection devices for publication in their journal, Health Devices.

Doug is a frequent invited speaker on multiple topics related to delivery devices and their regulation.  Check below for some recent speaking engagements that show the breadth of his expertise.