Chris Cappello is Chief Technology Officer for PharmaJet, where he has overall responsibility over product development, quality, regulatory, clinical and intellectual property. Chris has a Bachelor of Science degree in Mechanical Engineering from Colorado State University and my PMP certification. Chris has over 10 years of Project/Program Management experience and experiential Medical Device development. He has managed multiple cross functional teams and departments in the successful design, development, clearance and launch of both reusable & high volume disposable medical devices. Chris has driven the development of disruptive medical device technologies at companies such as AlloSource and Applied Medical.
Purpose: In the growing field of vaccine development, it is often the delivery device that can provide a differentiation in the market place and drive innovation for critical formulations. PharmaJet Inc. offers this differentiation in the form of its novel Needle-Free Injection Systems. Through its ingenuity and commitment to world class manufacturing, PharmaJet has been able to develop a platform of delivery systems that have shown to be preferred by both patient and caregivers alike. Method: Through a combination of clinical studies, most notably the non-inferiority study performed with bioCSL, and post market evaluations, PharmaJet Inc. has been able to show that its technology is safe, effective and preferred in the marketplace. This data spans from early Phase I (first in human) vaccine studies to Phase IV and post market user evaluations. Results: Through a combination of both regulatory clearances (FDA, CE, WHO/PQS etc), publications (Lancet etc) and strategic collaborations; PharmaJet has compiled a dossier of data that bolters the safe and effective use of its technology. In addition, recent market place evaluations have shown a >90% satisfaction rating for the technology for both patients and caregivers. Conclusions: PharmaJet’s Needle-Free Injection Systems have shown to be safe, effective and to provide a critical differentiation in the market place that is preferred by patients and caregivers