CMTI Seminar Series: Balakrishna Haridas, Ph.D.
Development & Commercialization of Synthetic Scaffolds for Soft Tissue Repair & Regeneration: A Case Study in Innovation of a New Biomaterial Platform Technology
Co-Director & Associate Professor, Program in Medical Device Innovation & Entrepreneurship, University of Cincinnati
Significant basic research has been done the past few decades on implantable biomaterials for soft tissue repair and reconstruction, including more recently in the last 10 years an increasing focus on three-dimensional synthetic as well as biologic porous scaffolding materials. However, successful results in the laboratory do not always translate into commercialized products given the tremendous challenges in product development, regulatory approval, and market adoption. In this presentation, we will review approaches that universities and companies can adopt to strategically organize the development of a portfolio of products based on one single novel biomaterial platform. Using a real case study on Biomerix Corporation's Polycarbonate-Polyurethane Urea (PCPU) scaffold platform technology, we will review the entire translational research, product innovation, and commercialization path to FDA approved products for soft tissue repair. Future pipeline development strategies for new products including conventional tissue repair, stem cell based therapeutics, drug and bioactive agent delivery will also be discussed.