The Juvenile Diabetes Research Foundation (JDRF), the world’s largest charitable funder of type 1 diabetes research, has teamed up with global contract research organization (CRO) PPD in a unique partnership designed to improve clinical research for type 1 diabetes.
As JDRF’s preferred provider for translational clinical development services, PPD will help JDRF overcome the often sluggish rate by which experimental type 1 diabetes drugs move through the drug development process.
“JDRF has for most of its 38 years of existence been doing preclinical research and only over the past five years or so have treatments reached the stage where they were ready for clinical development,” said Randy Anderson, PPD’s vice president of development. “JDRF has discovered that there’s sort of a struggle in making the translational development between preclinical and clinical development, and they saw a number of promising treatments tend to have a slower progress in that transition.”
PPD was selected as JDRF’s preferred provider from among five clinical research organizations that submitted proposals to the foundation. Neither PPD nor JDRF would release specific details about the preferred provider agreement, but, according to JDRF vice president and chief medical officer, Paul Strumph, the agreement is for PPD to provide services for an expected number of projects per year.
“By relieving clinical investigators of non value-added work such as optimizing and writing protocols, JDRF allows the investigators to do what they do best—innovate—while allowing those who optimize and write protocols for a living do the work that is burdensome to investigators,” Strumph said.
PPD’s designation as JDRF’s preferred provider is a unique twist in foundationfunded clinical research.While investment into drug development research by disease foundations has become increasingly common in the past few years, few foundations have signed on with an exclusive CRO. Typically, a foundation awards a grant to a biotech company or an academic investigator and the grantee initiates and manages that work. It may be easier to carry out preclinical testing, but, without the appropriate resources, the move to clinical testing can significantly delay drug development.
“If you’re doing an animal study, it’s easy for one investigator to be able to carry out that work…but when you go to clinical development, if you need to enroll 10 subjects a year and they need to be newly diagnosed type 1 diabetes, a single investigator has a great challenge to get an adequate number of subjects within a short time,”Anderson explained. “Biotech companies know who to go to…to get a multicenter trial designed and executed, but I still think JDRF saw a need to further resource that translational period. By coming to us with our expertise in translational development and full clinical development, we know what needs to get done to put together a protocol to be able to do a multicenter trial and then be able to execute that trial.”
PPD has done a significant amount of work in diabetes research. Up until recently, however, much of the drug industry’s diabetes research has been focused on type 2 diabetes, a condition that affects many more people than type 1. Type 1 diabetes research, however, has seen significant growth in the past five years, and Anderson hopes an improvement in the process by which type 1 treatments move through drug development will increase the amount of type 1 diabetes research.
“I think the dynamic changes as potential treatments become available without a lot of preclinical development work. Once that works been done, facilitated by things like JDRF funding, then commercial development sees a shorter opportunity horizon to get those products through clinical development and to the market,”Anderson said.