Having recognized that the education of healthcare professionals is critical to the adoption of genomic medicine, Baylor College of Medicine is building a teaching hospital focused solely on personalized medicine.
With a scheduled opening date of April 2011, the hospital is being built under the aegis of the college's Personalized Medicine Alliance and will offer a residency program that will allow doctors to attain genomics training in certain specialties. According to David Tweardy, interim chair of the department of medicine at Baylor College of Medicine, Baylor's Genomic Leadership Residency is the first program of its kind in the US.
BCM’s Personalized Medicine Alliance is also introducing a predictive chip in January 2009, priced at between $500 and $1,000, to help guide treatments for women in its health clinic.
Tweardy discussed the college’s projects and their focus on personalized medicine with Pharmacogenomics Reporter last week. Below is an edited transcript of the interview.
Could you discuss the Personalized Medicine Alliance BCM is implementing?
If you look around at academic institutions in terms of how they are implementing and how they are pursuing from an educational, research, and clinical perspective, personalized medicine at their institution at this point, some have instituted centers or institutes for personalized medicine. So, those are somewhat free-standing structures, if you will, separate from the department, but certainly under the umbrella of the university, but still a free-standing structure with a director, a secretarial staff, and also a physical plant, where there [is] a building with physicians and investigators.
Baylor looked at that model and thought that was a bit too restrictive for what we hoped to accomplish. We have a new building of sorts, which is our new hospital and clinic. In terms of the research and educational missions, they are going to focus there but they are going to be more broadly based throughout the whole college. So, rather than establish an institute, we thought an alliance idea was a better one for our organization and for implementation. So, the alliance is a more broadly based virtual center, but it facilitates our implementation of personalized medicine at Baylor College of Medicine.
What are some immediate projects under this alliance?
As it turns out the very first real implementation is the Baylor chip. That is kind of our first entry into the clinical arena. And we’re just rolling out the rest of it. We’re going to have an advisory council that will meet and we’re planning to do that in the next month or so.
Could you give me some details on the Baylor chip that you are developing?
The chip really covers five general areas, and all of it is Illumina based. There are 32 genes. The categories are pharmacogenetics testing; SNP testing for common diseases; a SNP-based assessment of HLA transplantation antigen; single-gene disorder testing for mutations in 99 genes that predispose adults to certain diseases; and a SNP profile to assess genetic or ethnic background.
Could you elaborate on the last category, SNP profiling to assess ethnic background?
The HapMap Project, which took 30 individuals from Western European background in Utah and 30 individuals from Africa, and 30 individuals from the Pacific Rim, demonstrate[s] clearly that there are SNP differences that are just based on the ethnic background. In order to interpret SNP results that you get for the other four categories, particularly the common risk diseases and the HLA transplantation antigen, which are SNP-based assessments, you need to put those into an ethnic context in order to interpret them correctly. That’s an important component of that chip now. It’s somewhat controversial because ethnic profiling is not something that you can enter into lightly. You have to be careful what you do with that information and all of that. But it turns out it’s critically important to interpret the SNP analysis for the other tests that we’re doing.
You have said you plan to introduce the chip first in your women’s health clinic. How will you use the chip in the clinic?
We’re going to use the chip to put together a prevention and management plan for those individuals who come into the women’s health clinic. It will be used for research but in fact the immediate benefit to the patient will be that we’ll be able to help manage their healthcare better with the information we get from the chip. It will be immediately beneficial in terms of alleviating patient worry, changing lifestyle, and also managing medications they are on. The plan would be to offer it to these women for the purposes of helping to manage their healthcare.
In the way that you describe the chip, it doesn’t seem particularly specific for women’s diseases. Why are you introducing it in the women’s clinic first and are there other populations you intend to introduce the chip in?
We’re targeting it to the women’s health clinic because we have a very interested and probably a little more financially well-off population that would like to have a level of care and would be willing to pay for that additional level of care. As you know, these chips are not reimbursable for general use. So, that partly influenced our decision with where to go. We wanted to go into an interested subpopulation of patients that would see the benefit, the worth of it, and who could also pay for it. And the group that we have set up right now in that category is those in our women’s health clinic.
Could you discuss this hospital you’re building at BCM solely for personalized medicine? How unique is a teaching hospital that focuses specifically on personalized medicine?
In terms of the clinic and hospital it will be state-of-the-art, fully integrated with an electronic medical record [system], clinic, and hospital. Because of its size it will not be completely full service. We’re going to focus on five service lines. In each of those services lines – cardiovascular medicine, oncology, neuroscience, transplantation, and advanced surgical and medical interventions – we plan to have a personalized genomic medicine component in the care that we provide from the hospital, to the clinic, and to the community.
In many respects, the uniqueness of our clinic and hospital is that we’re building it now and that we’re building it with this concept in mind, as opposed to other institutions that have existing facilities to which they’re going to layer on a personalized medicine component. So, we’re thinking of this as we’re building the building.
Another thing that is unique is that we’re planning to have residents who are trained in a variety of specialties there, and they will participate in a new residency program, called the Genomic Leadership Residency. That is unique. We are one of five programs that the [Accreditation Council for Graduate Medical Education] has been in contact with. They’re interested in us and we’re interested in communicating with [ACGME] to develop this program. This will be the first program of its kind in the country. That perhaps is the most unique aspect of this clinic and hospital, is that it will house a new residency training program.
To what extent will pharmacogenomics be a part of the interventions or treatments that you will be implementing and how do you plan to get reimbursement for such treatments delivered at the hospital?
Some of our payor mix is out of pocket and for those we will be able to implement as personalized genomic medicine as soon as it becomes validated. We won’t have to wait for the regulatory agencies to move through the process, for instance, to approve a test. We’re not going to be ahead of the curve in terms of the science; we’re not going to implement in our care of patients there sort of speculative genomic interventions, but rather proven genomic interventions. We hope to participate in a lot of the research that moves forward to establish he medical actionability of a lot of the medical information that we’re able to collect on our patients. We will implement those in patients who are out-of-pocket payors, as soon as the data is validated. For instance, abacavir testing can be implemented now. I don’t know, for instance, what [the Centers for Medicare and Medicaid Services’] position is on reimbursement of that test at this time. It probably is in the process of being approved, but as soon as we see the science supports the test we will move forward and implement it in our patients who can pay for it.
We’ll have to be careful in that in some respects. Physicians don’t always know what the insurance status or the payment status of our patients is. Like we’re implementing the Baylor chip in our women’s clinic where they can pay for it, we’ll use the same model for some of our other tests. We’ll be very careful in implementing this.
Through this residency program, can you foresee that personalized medicine would be something doctors can specialize in or can personalized medicine be a stand-alone specialty?
I think what will happen is that personalized medicine will be integrated into all of the care that we provide in this country. I think what we anticipate this program at the residency level generating are individuals who will be leaders in moving that forward. I don’t anticipate there will be programs that will be standalone in personalized genomic care either in service care or patient care. The medical community moves forward quickly and there will be graded implementation of personalized medicine into the practices of physicians, groups, and institutions. But I don’t think it will become so distinct and separate that there will be programs that practice personalized genomic medicine and others that don’t. I think you’ll see a gradation of that as we move forward.
When will the hospital open?
The hospital will open in … April 2011.