If you’ve been reading my blog, you’ve heard a lot about clinical trials. They’re the last series of steps in the testing process that potential treatments – whether drug, gene therapy or stem-cell – must go through before they can be approved by the U.S. Food and Drug Administration, or FDA. Clinical trials are experiments, and you can’t conduct a sound experiment without the right subjects – in this case, human beings. But identifying trial participants with rare inherited retinal diseases, such as those targeted by the Foundation, can be a major challenge. This is especially true because there often isn’t a large population of retinal disease patients living within a specific geographic area.
Then, of course, the team running the trial has to ensure that the participants comply with the trial parameters and receive the proper dosing – whether it’s the potential treatment or standard of care. In addition, patient follow-up is crucial, including collecting all the data necessary to win FDA approval.
What you need, in other words, is a team with a team leader who works well with people. One clinician-researcher who does all of these things extremely well is Dr. David Birch.
It’s no coincidence that, last week, David received one of FFB’s Visionary Awards at a special dinner event in Dallas, Texas. At dinners across the country, we give the award to honorees who’ve committed their undivided attention, time and resources to our cause of finding treatments and cures for retinal diseases. And David certainly qualifies.
David’s base of operations is the Retina Foundation of the Southwest (RFSW), where, since the early 1980s, he’s developed a very special cohort of patients – more than 3,000 at last count – which allows him to track disease progression, symptoms and inheritance in ways that only a small cadre of other researchers can. This enables David to pay extremely close attention to each patient while holding clinical trials with a large pool of potential recruits.
Lately, he’s served as a principal investigator in several landmark clinical trials for treatments – including those for Neurotech (RP and dry AMD), docosahexaenoic acid (X-linked RP) and valproic acid (dominant RP). As such, he ensures that the recruitment goes as smoothly as possible, and that trial participants stick with the process till the end, which can sometimes take years.
At last week’s dinner, Gordon Gund, FFB’s chairman and co-founder, said of David: “Simply put, David is a thought leader. He is not only an experienced clinical researcher, but he has also pioneered new and better methods for ERG [electroretinography] and other testing that has led to a better understanding of inherited eye diseases and useful markers for response to treatment.”
Appropriately enough, David completed his postdoctoral fellowship at the Berman-Gund Laboratory at Harvard Medical School, an FFB-funded research center that was the first in the world dedicated exclusively to studying retinal diseases. Then, in 1982, he landed in Dallas, where he became research director of the RFSW and went on to develop a team of outstanding basic and translational researchers as well as clinician-scientists, and build an infrastructure comprised of resources and personnel that can perform clinical research and trials without a hitch.
David, by the way, is no slouch when it comes to the science. Since 1985, he’s served as scientific advisor to the Foundation’s Dallas/Fort Worth chapter. In 1988, he received the first of only a few research grants from FFB. In 1994, he was appointed to our Scientific Advisory Board, and in 1999, he helped establish the Foundation’s Southwest Regional Research Center in Dallas, for which he’s served as co-director ever since.
But it’s as head of the RFSW that David reminds me of an orchestra conductor – a maestro, if you will. He has his own “musical” (read: scientific) talents, but he also has a deep understanding of, and appreciation for, the role each “musician” (researcher, clinician, ophthalmologist) plays in a performance. First, he makes sure they’re all in tune; then, with baton in hand, he helps them make beautiful music.