Accelerating the development of discoveries from bench to bedside
A new drug’s path from promising idea in a research lab to FDA approval is a long, complex process that can take more than a decade to complete. Often, the biggest obstacle between the lab and the marketplace is a financial one.
“The gap in funding between basic research and clinical trials is often referred to in medical literature as the ‘valley of death,’” said Frank Grassler, Vice President for Technology Development at UT Southwestern. “Government entities are great at funding basic research. Pharma and biotech companies are good at funding clinical trials. Preclinical discovery is where the gap is. It’s highly risky and it’s where most failures occur. It’s expensive and can be demoralizing.”
In response to this need, UT Southwestern’s Office for Technology Development (OTD) created a Director of Biopharmaceutical Product Development position – a role that is unique to the field of academic technology development nationwide. It is intended to build a bridge between the worlds of discovery and commercialization, and assist in lowering the level of risk in the preclinical trials phase.
OTD’s mission is to protect and license a full spectrum of UTSW discoveries, ideas, and inventions. That includes medical devices – ranging from surgical instruments to new smartphone apps. Some of the most successful examples of discoveries that have passed through the OTD include the development of Citracal, a supplement used worldwide for the prevention of osteoporosis, and the most widely prescribed version of tissue plasminogen activator, an effective clot-busting drug for stroke victims.
The potential to achieve additional lifesaving advances in medicine is enormous – UT Southwestern has more than 200 research labs working toward discoveries in a wide variety of areas.
Leading one of those labs is Dr. Marc Diamond, Director of the Center for Alzheimer’s and Neurodegenerative Diseases and holder of the Distinguished Chair in Basic Brain Injury and Repair. His mission is to halt the advancement of neurodegenerative diseases in patients before brain damage occurs.
When Dr. Diamond and other UTSW researchers make significant discoveries, they work with the OTD in hopes of achieving three milestones: protection of the discovery through a patent, funding for clinical research and trials, and then commercialization and licensing. It’s the critical financial part that can slow down the advancement of a promising discovery. The excitement can dissolve if an investor perceives the risk for failure in the preclinical period is too high.
“In some regards, searching for new drug compounds is like drilling for oil,” Mr. Grassler said. “You’d rather know that the well being drilled is going to be a dry hole when you’ve reached 100 feet, instead of finding out after you’ve drilled to 1,000 feet. You can cut your expenses earlier and move on to the next exploration. Pharmaceutical industry development programs usually end in failure.”
Mr. Grassler wants to identify such failures earlier so that capital and energy can be preserved for other promising programs at UTSW. OTD staff use their expertise in drug discovery and in development and training in medicinal and synthetic chemistry to leverage relationships with pharmaceutical companies to reduce costs – and perceived risks in the preclinical phase.
By assisting UT Southwestern researchers with planning and negotiating; advising and reviewing discoveries in their nascent stages; helping to advance experiments and projects that lead to discoveries; and devising strategy for UTSW drug development, Mr. Grassler’s goal is to work with researchers to ensure that discoveries are better prepared for late preclinical and clinical development and that their valuations are increased.