Academic scientists at institutions like Stanford University excel at basic science research and innovative out-of-the box discoveries. Creative and novel ideas have been discovered and explored. However, a barrier exists in translational and clinical research: far too many of these breakthrough ideas never make it to patients.

These failures to translate promising discoveries result from a lack of knowledge and expertise required to advance and de-risk future medical products so they become attractive for commercialization. Academics are generally not trained in industry concepts. Therefore, academics are often unable to navigate drug optimization, clinical trials, regulatory hurdles, securing intellectual property, and commercial challenges that accompany the long drug development process.

The SPARK program was founded at Stanford by Daria Mochly-Rosen in 2006 to address these problems.

Dr. Mochly-Rosen experienced these very challenges in her own work developing a therapy and starting a company. In 2000, her lab discovered a novel inhibitor that can reduce infarct size by more than 50% after heart attack or stroke in animal models. Dr. Mochly-Rosen tried to bring the potential therapeutic to pharmaceutical companies, but none showed interest. With her student, she then founded a biotech company, KAI Pharmaceuticals, to develop the drug.

“At KAI, surrounded by industry people, I realized I knew very little about drug development. Nothing in my own years as a student and researcher prepared me with the knowledge required for drug development.” Dr. Mochly-Rosen said.

To bridge the gap between the innovative discovery machine of academia and industry’s sophisticated drug development machine, Dr. Mochly-Rosen realized academia and industry need to work more closely together to share knowledge.

SPARK brings together academics with promising discoveries with many volunteer industry experts who provide education and mentorship to advance these research discoveries from bench to bedside. The program combines weekly updates by project teams with educational sessions taught by industry advisors, plus additional sessions for personalized project feedback.

Why SPARK is unique

SPARK’s ecosystem deviates from the common ‘academic incubator’ system to a team science-based, design thinking approach. SPARK’s design thinking approach brings the needs of the user early into the innovation process to influence the solution - 'beginning with the end in mind” to design a Target Product Profile, defining the essential features of the final product. Participants must understand the unmet medical need - a problem that involves an intricate interplay of molecular, clinical, financial and regulatory components - requiring input from many stakeholders in a variety of disciplines. Therefore, SPARK offers multiple opportunities for engagement and learning together as a team.

SPARK scholars are the university’s faculty members and their postdocs and trainees. While translational research courses are usually offered to students only, here at SPARK we ‘educate the educators’ as well.

SPARK’s volunteer advisors bring immeasurable expertise from years of working in industry. Each week at SPARK's evening sessions, advisors listen to presentations from SPARK scholars and offer feedback and suggestions. Often an advisor will suggest an option the academic hadn’t even considered.

The SPARK program is unique in that it has nurtured an entire learning ecosystem with multiple players to advance academic translational research. Too often academia and industry is divided, but here at SPARK academics and industry collaborate in a non-hierarchal community, learning to respect each other’s skills and working together towards a single goal – addressing unmet clinical needs.

A successful translational research ecosystem de-risks projects for future investment while training the future workforce. De-risking projects increases their attractiveness for industry and weeds out bugs and failures that, again, often were not considered by the academic researcher until an expert who has experienced these very failures calls attention to them. And the SPARK scholars are introduced to the varied career paths they can follow from these experts in many disciplines.

What’s next for SPARK

SPARK is now expanding its translational research ecosystem. Early this year, SPARK published the second edition of its trusted book on drug development in academia. First published in 2014, the book has been updated with the latest developments in the drug discovery and development space. "A Practical Guide to Drug Development in Academia: The SPARK Approach" is written by SPARK's industry advisors and edited by SPARK co-directors Daria Mochly-Rosen and Kevin Grimes. Each chapter broadly discusses an important topic in drug development, from discovery, optimization and preclinical studies through clinical trial design, regulatory issues and marketing assessment. The book is peppered with real-life anecdotes emphasizing that drug development is not necessarily intuitive and demonstrating how mistakes of the uninitiated can lead to failure.

SPARK is developing a comprehensive online learning system to teach academics every step of the drug discovery, development and commercialization process. This online learning system will provide academics with the tools and knowledge necessary to navigate the complex path of product development through subject-specific instruction, real-life case studies, and advice from experts in multiple fields. Content will be presented in multiple engaging methods such as visual images, written text, animated videos, interactive components, and resources to provide application-based teaching.

The ultimate success and scalability of translational research is dependent on the ecosystem being greater than the sum of its parts: namely, the knowledge exchange and collaborations amongst individuals, teams and stakeholders within the translational research community. In our paper, we describe SPARK’s goals, methods and metrics in more detail. SPARK offers a model that can be adopted by other academic institutions to bridge the gap between bench and bedside and help develop solutions for patients in need.