The state of Wisconsin has tremendous capacity for scientific discovery, transformative research advances, and technological innovation in biomanufacturing. Wisconsin’s research institutions are among the largest in the world in terms of total research scope and intellectual property generation. A driving force behind our success is the vibrant spirit of collaboration between leading scientists and clinicians from multiple disciplines. Building on this foundation, the Forward BIO Institute was created to catalyze innovation in biomanufacturing research through transdisciplinary collaboration, with the goal of “catapulting” technologies out of universities and into the private sector though a series of supportive initiatives.

Catapult Program

The Institute has established a program to support the effective translation of new discoveries into innovative technologies with commercial impact. Our Catapult Program identifies high value technologies, and creates value propositions and preliminary business cases for these breakthroughs. Business cases are pre-incorporation, and we will connect investigators with entrepreneurs and investors to accelerate research innovations on the path to commercial impact. Through collaboration with our Forward BIO Initiative partner, Forward BIOLABS, we will assist in converting valuable technologies into start-up companies.

Pathways Program

Lacking an early and complete understanding of key issues related to both clinical and commercial developmental has proven to be one of the primary obstacles to successful translation of discoveries into products. With support in part through a Novel Methods award through ICTR, the Institute is establishing a program to support investigators developing biomanufacturing technologies for the treatment of human diseases. In this program, investigators will be directly connected with Regulatory and Clinical Key Opinion Leaders to develop a pathway to first-in-human trials, as well as industry experts for guidance on the dynamics of the commercial path. This program will accelerate the path toward clinical/commercial impact of new discoveries and avoid blind alleys that often limit forward progress.

Novel Methods Award

A Systems Approach to Expediting Preclinical Therapeutic Development

The translation of cutting-edge technologies from research applications to meaningful therapeutics is inherently complex and requires substantial planning and knowledge that is difficult to obtain in the absence of hands-on experience. Additionally, academics are generally not familiar with many industry best practices, requirements for manufacturing at scale, and/or commercial pressures inherent to commercial therapeutic production. To bridge this knowledge gap, we propose to develop a robust, innovative process that supports navigation of the regulatory landscape for academic innovators working on therapies in early-to-mid-stage development. First, we will leverage our team’s experience and connections within the clinical arena to conduct a survey of industry professionals from three groups based on their familiarity with preclinical development: naïve, familiar, and experts. We will then use this information to construct a process map that outlines the interdependent steps involved in navigating the complex preclinical process, identifying critical points for de-risking therapeutic technology. Finally, this process map will enable our team to disseminate this milestone-driven approach to researchers using an interactive, centralized, online resource, which can be easily updated and disseminated as the field advances. Successful completion of these Aims will result in an effective decision-making process that will be refined in an iterative process for implementation in larger test groups, adapting to the requirements of preclinical development as they expand.
William Murphy, PhD, College of Engineering
Collaborators: Christian Capitini, SMPH; Philip Keegan, Cathy Rasmussen, COE