Foundation Brings Knowledge and Expertise to Clinical Studies
Steve Bramer, Ph.D., chief drug development officer of the Foundation Fighting Blindness
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In the coming year, the Foundation Fighting Blindness is planning to launch as many as three clinical trials in its National Eye and Evaluation Research (NEER) Network. The first trial will be an evaluation of valproic acid for the treatment of autosomal dominant retinitis pigmentosa. That study is slated to begin in fall 2010.
In the following interview, Steve Bramer, Ph.D., chief drug development officer of the Foundation’s clinical trial organization, discusses what the NEER Network is, why it was established, and the many benefits the Foundation brings to the clinical trial process.
Why did the Foundation establish the NEER network?
A few years ago, thanks to accelerating advancements in Foundation-funded laboratories, it became clear that more and more emerging treatments would become good candidates for clinical trials. By having our own ready-to-go clinical trial network, we are better positioned to quickly move these promising therapies into human studies. With our own network, we have more control over clinical research and save a staggering amount of time in launching these human studies.
What comprises the NEER network?
The network has five core clinical trial centers: the University of Medicine & Dentistry of New Jersey; the University of Utah; The Children’s Hospital of Philadelphia; Wilmer Eye Institute at Johns Hopkins; and the Shiley Eye Center at the University of California, San Diego. However, other clinical trial centers may participate in a trial involving the NEER network through collaborations with one or several of the core sites. For example, the valproic acid study will be taking place at the University of Massachusetts Medical School and the Retina Foundation of the Southwest through collaborations with the University of Utah.
Each of the core centers has experienced clinical trial experts, state-of-the-art vision and retinal testing equipment, and information technology that can be quickly employed for a clinical trial. Because they are part of a network, the centers are easily able to share knowledge and collaborate. The NEER centers also have the luxury of tapping into the Foundation’s extensive community of retinal researchers and doctors at other leading institutions around the world.
NEER has contracted with the Oregon Health Sciences University (OHSU) Casey Eye Institute Translational Clinical Trials Reading Center in Portland, Oregon for their expertise in developing ophthalmic screening and outcome measures. To ensure consistency, OHSU will act as the central reading and evaluation center for the results of the eligibility testing and periodic assessments performed at the clinical sites. OHSU will also provide the investigators and technical staff with training and certification on the skills needed to attain the highest quality data from each test.
What value and benefit does the Foundation bring to NEER clinical trials?
You can think of the Foundation as a nucleus for NEER clinical trials. We play a big role developing the trial protocols, monitoring and overseeing the studies, and ensuring that the clinical researchers are following protocols and conducting tests and evaluations in a consistent manner. We make sure everyone is on the same page, so that there isn’t any variation in their procedures. This is critical to getting an accurate and unbiased assessment of the treatment.
We also have substantial regulatory experience, so we work with the clinical teams to ensure they are meeting FDA and review board requirements and completing the necessary documentation. There is a tremendous amount of documentation required for human studies.
Who are the Foundation’s key players in NEER clinical trials and what expertise do they offer?
The key players include me, as well as Stephen Rose, Ph.D., the Foundation’s chief research officer, and Judith Chiostri, our director of clinical development. I have 15 years of commercial industry experience, primarily in drug development and all aspects of the clinical trial process. In my 10 years with Otsuka Pharmaceuticals, I was responsible for clinical study design, clinical conduct, and analysis and reporting. Judith Chiostri has 15 years experience in monitoring and coordinating a wide variety of clinical trials. As the clinical advisor to the Congressionally Directed Medical Research Programs, she assessed day-to-day operations for a number of clinical studies. And Dr. Rose initiated, organized, and oversaw a number of clinical studies during his career at the National Institutes of Health.
While we are a strong and well-seasoned group, we are also a small team, which gives us flexibility and the ability to take action quickly when there’s a need to do so.
Overall, it’s a great team. Like the Foundation’s leadership and volunteers, we are very passionate about driving the research. In a nutshell, that’s why we are here. |
