Chris Romeo
Principal Scientist, Device and Formulation Perfuse Therapeutics
Chris leads the design control activities for medical devices at Perfuse as well as performing formulation development, analytical testing, and method development. He has more than 10 years of experience in research and development through manufacturing supporting pharmaceuticals, drug delivery platforms and medical devices. Chris has spent the last 4 years supporting analytical and formulation development of various ocular dosage forms.
Seminars
The regulatory journey for ophthalmic drug-device products is increasingly complex, especially as innovation in delivery systems accelerates. With the FDA evolving its expectations around combination products, early-stage companies, clinical teams, and strategic partners face critical questions: Should approval start with the drug or the device? How should shifting regulatory precedents be handled? And what makes getting a device approved for the eye so uniquely difficult?
- Explore how organizations are sequencing drug and device development to meet FDA expectations without slowing down trials
- Learn how the FDA’s current stance on drug-device combinations is influencing design control, clinical strategy, and filing sequence for ophthalmic products
- Understand why ophthalmic delivery systems face higher scrutiny than systemic routes, and how preclinical modelling, sterilization, and biocompatibility are being adapted to meet ocular-specific risks
- See how early-stage teams are balancing innovation and regulatory risk by starting with basic delivery systems, then phasing in novel devices or platform technologies once clinical efficacy is validated
