Originally published Oct. 15.
The University of Pennsylvania took a major step toward growing its presence in personalized medicine last week by hiring a former pharmaceutical executive to take charge of spearheading its efforts in this space.
Gary Gilliland, former head of cancer research at Merck, is now PennMedicine's VP for precision medicine. In this newly created position, Gilliland will be in charge of research efforts across all disciplines, starting with oncology, and will be responsible for putting in place the infrastructure for delivering precision medicine to patients treated at the university's school of medicine and other affiliated hospitals and medical centers.
Gilliland brings to PennMedicine not only his industry experience launching numerous targeted treatments at Merck but also genetics expertise, a combination of skills critical for the job. While at Harvard University, he advanced the genetic understanding of leukemias and other hematologic malignancies.
Gilliland had stepped into his new post only 10 days prior to speaking with PGx Reporter about his responsibilities at PennMedicine and his plan to advance precision medicine within the university's research programs and throughout its healthcare system. He said that he would help propel forward a number of key research efforts at PennMedicine already underway looking at the genetic underpinnings of cancer, cardiovascular conditions, and neurodegenerative diseases. Setting up the infrastructure needed to deliver precision medicine within a large healthcare system would be a big challenge, he acknowledged, but one that Gilliland feels prepared for after his experience leading a research division at a large pharma company.
Below is an edited transcript of the interview.
Why does PennMedicine need a VP for precision medicine?
[Precision medicine] is where all of medicine in this country is going to need to move toward in the coming years. It's a real challenge to implement this effectively across a large healthcare system. But the notion is that we need to be able to identify patients who are most likely to benefit from treatments that we have and we would also like to identify those patients who are most likely to have adverse events from treatments we may employ. If we were able to do that using modern molecular profiling techniques and imaging techniques … then we have something of incredible value to patients, most importantly. But it's also of value to our healthcare system as we think about the most efficient way to address the rising cost of healthcare.
The leading edge for applying this, although it's challenging, is in oncology, where we now understand that there are certain kinds of genetic defects that occur in tumors that have a very high predictive value in terms of telling us who's going to respond to therapies.
In which specific patient populations at PennMedicine are you planning to offer precision medicine programs?
Our plans for launching this are ultimately across all therapeutic areas in PennMedicine. We're going to begin with oncology … but we will attempt to bring this into cardiovascular disease, into endocrinology and diabetes, [and] into neurodegenerative disease … [such as] Alzheimer's.
The vision that Larry Jameson, [dean of the Perelman School of Medicine,] and Ralph Muller, [CEO of the UPenn Health System,] have is that if we can have a unified front, and bring this all together …so that every therapeutic area has its own [focus] on precision medicine, then we're going to have a very powerful tool. This is something that's going to have to happen across all healthcare systems in the US. It's a wave that's coming … but it's very challenging to implement these initiatives.
To that point, the implementation of personalized medicine requires certain types of infrastructure, such as processes for sample collection, electronic medical records, and data analysis capabilities. To what extent does PennMedicine have access to these types of resources?
We have a lot of parts here. Profiling platforms, sample acquisition, tissue repositories – a lot of these exist, but they're not united entities. Part of the goal and my task is to put all this together so we have a whole. This requires … bringing together the EMR system. Of course, there are issues around patient confidentiality, so if we're collecting patients' blood for example through a test … we need to have the appropriate consent for that … And we need the appropriate consent so that if we find any mutations [that will impact patients' health], we can re-contact them. This will also require staggering informatics capabilities to analyze data … from whole-genome sequencing or exome sequencing.
We need to build that infrastructure and make sure it's all integrated. We need to integrate pathology efforts around many of the platforms for molecular profiling and histopathology with radiology and imaging capabilities.
This is a large university and integrating all this will be a challenge. But all the pieces are there.
You said that oncology was a low-hanging fruit and the area where you'll first focus precision medicine efforts on. Are there any projects already underway at PennMedicine that you'll be overseeing?
There is an ability here to do a panel molecular test … that will link to targeted therapies for cancer. We want to expand that platform to not only include exome sequencing, but possibly RNASeq and other profiling tools that we can use to assess tumor genotypes.
There is an extensive effort by [professor] Dan Rader in cardiovascular medicine to identify allele variants that have an impact on cardiovascular outcomes … There's also a good team that works in neuroscience.
To be honest, I've been here for about 10 days, so I'm still getting to know the landscape here … The first part of this job is to go on a listening tour to fully understand the capabilities we have.
While PennMedicine is working to expand its presence in precision medicine, throughout the country academic centers have similar ideas and programs. How do you plan to set your program apart from those at other universities and colleges?
This is where my industry experience at Merck is going to be very valuable. A lot of the challenge here is about operations and execution. Everyone knows where we need to be but we need to figure out how to bring all the pieces together so you can develop … precision medicine.
One of the attributes of PennMedicine is that it's not a free-standing cancer center. There are a number of outstanding free-standing cancer centers that have their operating focus on oncology as they should, and there is a lot of opportunity there [for precision medicine.] But as a major medical center, PennMedicine has all the therapeutic areas encompassed. We also have … the experts who can develop a business model for this. [Implementing precision medicine] is very expensive, and there has to be a practical, sustainable business model where … you can make a case for moving this forward and persuade third-party payors that this is also in their best interest
Merck was also involved in a very large pilot program where we were working with the [M2Gen subsidiary of the] Moffitt Cancer Center in Florida, doing exactly what we're trying to do here. [Editor's Note: Under a 2006 collaboration, Merck provided $100 million over five years to M2Gen to support research initiatives to develop personalized treatment strategies in cancer.] And there are a lot of best practices from that five-year experience where we collected more than 20,000 tumor samples with appropriate informed consent. We performed clinical annotation, provided confidentiality, learned the proper way to collect samples and how to bank them, how to set up the informatics system … and we can bring those best practices here.
Given your industry experience, will your goal be to commercialize drug/diagnostic combination products or conduct early-stage research and discover biomarkers to inform care?
We'll be having more discussions around that. But our current vision is to focus on developing biomarkers that we can commercialize. The diagnostics business is a challenging one where the margins are very small, and there are a number of companies out there that are capable of bringing forward diagnostic tests that we might use, whether they are routine tests or molecular profiling tests. And [we] plan to partner with them so we can work toward developing platforms that might have commercial value, and this may be a more cost-effective way to do this. We will have a large effort in biomarker discovery as part of this engine. I'll also say that we now have predictors of outcome across therapeutic areas, so that there is more than enough for us to work with to get started.
Will you look to establish partnerships between PennMedicine and drug developers around precision medicine?
Yes. There will be a broader effort at PennMedicine to present a unified front to the pharmaceutical industry so that we can engage them. They will be the ones to use companion diagnostics, certainly in oncology, to be developed alongside drugs they are advancing.
The first companion diagnostic was approved to predict response to Herceptin for patients with breast cancer in 1998. There was not a companion diagnostic approved with a drug until 2011, when Roche's Zelboraf and Pfizer's Xalkori were approved. … So, it's safe to say that [precision medicine is] not easy to do because it was more than 10 years after the first one that the next companion test came along … I think now with those initial samples there's going to be a wave of companion diagnostics approved.
There was no program at Merck at least in oncology that didn't have a biomarker-driven patient stratification hypothesis. I think other [drug] companies are moving in that direction as well.
Most medical care, including cancer care, is delivered most readily in the community setting. The local communities where PennMedicine is located, however, could certainly benefit from your precision medicine efforts. Do you have plans to collaborate with healthcare providers in the community setting?
This is an important point and this is going to be true for every major medical center. It will be really important that whatever platforms we set up are extremely user friendly. Practicing oncologists are incredibly busy and they don't want to have 20 extra things to do for every patient, and send sample[s] to different places to have it analyzed. It's also important to provide educational outreach, and that's going to be part of our programmatic effort, not only within the university but [with] our affiliated partners …so we can ultimately translate this into clinical practice.