Heejin Lee, PhDPrincipal Engineering Innovation Lead, Final Product Technologies Early DevelopmentAmgen, Inc.Host: Professor Guillermo Ameer

VALUE CREATION THROUGH INNOVATIVE COMBINATION PRODUCTS: CHALLENGES AND OPPORTUNITIES

FDA defines combination products as therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Some of the key elements for the successful development of innovative combination products include unmet needs finding and team building through strong and weak ties in healthcare and innovation ecosystem, cross-disciplinary thinking and practice, and cross-functional and cross-industry collaboration to take ideas from inception to product launch. The first part of the presentation will highlight an example of a drug-device combination product, a urological drug delivery device platform targeted to treat patients with bladder diseases including painful bladder syndrome, bladder cancer, and overactive bladder. The second part of the talk will cover some lessons learned firsthand from combination product R&D experiences in academia and industry.