From Bench to Bedside: Understanding How Cancer Research Becomes Cancer Treatment

Drug Development Boot Camp

Groundbreaking discoveries are made in the labs of the world-class cancer researchers of The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC – James). But moving this research from the bench to the bedside, through the long and grueling process of preclinical development, clinical trials and then federal approval, is something many scientists struggle to understand and navigate. It can be daunting.

“We think it’s important to help (OSUCCC – James researchers) gain an understanding of the entire process of taking a drug from discovery to development and how ultimately they can leverage the DDI partnership to accomplish these complex steps,” said Jeffrey Patrick, PharmD, who was named director of the OSUCCC – James Drug Development Institute (DDI) in February.

As one of the many steps it is taking to help its scientists get through this process, the DDI recently hosted a Drug Development Symposium: Practical Aspects of Positioning Your Research. About 100 scientists from the OSUCCC – James attended the conference, which included presentations, practical advice and a panel discussion from some of the top executives of Charles River Laboratories, Inc., a Massachusetts-based company providing preclinical research services to the pharmaceutical industry, and a co-sponsor of the seminar.

The DDI continually reviews compounds in the early stages of development at the OSUCCC – James that have the potential to become novel anticancer agents. The DDI, which is supported by Pelotonia and other philanthropic organizations, currently has seven projects in its portfolio that receive funding and technical guidance from the DDI team of scientists.

Charles River is one of the many external partners the DDI and the OSUCCC – James could work with in the long and expensive process of bringing a new drug to market. Among other services, they have expertise in the preclinical and clinical development required for pharmaceutical products and can help scientists “navigate the complex and challenging journey of identifying new therapies and bringing them to market,” according to Charles River.

This process can take as long as ten years, costs hundreds of millions of dollars and requires expertise in a lot of areas.

The secret to success, said Joe Cornicelli, PhD, of Charles River is “to identify a good target, put together your best and brightest team.”

Cornicelli’s talk was titled “Case Study: Difference Between Tool Compound and Clinical Candidate.” Understanding the toxicity level of a new drug early on is important, he said.

Sharing information among members of the team is another key, said Adrian Sheldon, PhD, of Charles River. And sometimes, you have to know when to move on to another potential drug. “You can fall in love with a molecule and go to heroic measures to keep that molecule going,” Dr. Sheldon said. “You have to be ruthless and if you have to go to heroic measures every step of the way, you probably won’t be successful.”

The Charles River scientists also discussed understanding the off-target effects of a drug, deciding on the optimal tests, understanding the regulations in other countries and when to use an outside lab.

Erandi De Silva, PhD, Director of Biology at the DDI and Symposium host, touched on the importance of understanding the process of drug approval.

“Our goal is to show you, as academic researchers, how industry can help you think about your own drug development, the biology of it and what makes a good candidate,” she said in her opening remarks. “And we want you to think in this way so you’ll know what you’ll encounter when you look for investors and industry partners to move your research along.”

Patrick said “as a researcher, the earlier you incorporate this type of information into your planning, the better chance you’ll have of advancing your research and all of that work leading to the development of a new drug.”

The new director of the DDI has almost 20 years of experience in the pharmaceutical industry. Most recently, Patrick served as global vice president of professional affairs at Mallinckrodt Pharmaceuticals and field director for medical sciences at Myogen/Gilead Sciences.

While the OSUCCC – James is not the only university-based cancer center with an entity such as the DDI, it is at the forefront of this type of support for academic scientists.

“We were on the early side of pharmaceutical product research,” Patrick said. “And what we have that sets us apart is we can leverage being part of one of the world’s top comprehensive cancer centers and cancer hospitals and having our top leaders, such as Dr. Michael Caligiuri (the director of the OSUCCC and CEO of The James), supporting us.”

Other backing for this endeavor, he noted, comes from “the support of Pelotonia, the Mangurian Foundation and other philanthropic organizations, enabling us to capitalize on the innovative research, vast expertise and collaborative environment at our comprehensive cancer center to speed cures to cancer patients.”