Translating Science into Therapy
When Paul J. Anderson, MD, PhD, became chief academic officer and senior vice president of Research at BWHC earlier this year, he took on a monumental task: developing solutions to not only address but also anticipate the needs of BWH’s entire research community – including trainees, junior faculty and senior faculty. Anderson has been tasked with building strong, proactive and collaborative relationships within BWHC and across Partners HealthCare as well as with leaders in industry, while recasting the importance of research and training within the Brigham.
Anderson serves on the Brigham Research Institute (BRI) Executive Committee, which oversees the activities of the BRI’s 10 centers and three programs. He is also leading the development of the Brigham Education Institute, an organization that will facilitate and coordinate best practices in undergraduate, graduate and post-graduate medical education.
Anderson, who started his research lab at BWH in 1990, is a senior physician in the Division of Rheumatology, Immunology and Allergy and the K. Frank Austen professor of Medicine at Harvard Medical School.
Anderson sat down with BWH Clinical & Research News to describe his goals and the future of education and research at BWH.
CRN: What’s one of the major challenges facing researchers today, especially those who are at an early stage in their careers?
PA: One of the biggest challenges comes at the point of translation. We’d like to provide an infrastructure whereby our junior faculty, who are just coming into the system, can begin launching clinical trials. We think this is an area where we could build our research business.
Take, for example, Tanya Laidlaw [MD, director of translational research in allergy in the Division of Rheumatology, Immunology and Allergy]. Tanya is a new assistant professor who just received an R01 grant. She’s doing really exciting work on aspirin-exacerbated asthma and has discovered some potential targets. She’s been approached by pharmaceutical companies who are interested in partnering on clinical trials, but she doesn’t have the infrastructure to get started. An investigator needs data management tools, bioinformatics support and a quality management system just to begin clinical trials. What we want to do is build that infrastructure to support investigators.
CRN: How are clinical trials changing and evolving?
PA: The model is beginning to change in the pre-clinical space, even before drugs are tested in clinical trials. In the old days, researchers relied on animal testing as the only way to determine and predict the effects of a drug. But we’re learning that, oftentimes, what works in a mouse model doesn’t work in humans. Instead, we’re finding that genetics can be much more predictive of a person’s response to a particular medication.
Ultimately, the proof is in the clinical trial. There’s tremendous interest in getting drugs fairly early into phase I trials – to show that a drug is safe – and phase II – to evaluate safety and how well the drug works. These are considered the “first-in-human” and “proof-of-principle” trials. And we think that this is the sweet spot that will be addressed by this new program at Brigham and Women’s. We’re very good at uncovering disease mechanisms. And we can use that knowledge to stratify patients – to identify and then enroll a subset of patients that are likely to respond to one drug rather than another. By doing so, we may be able to do clinical trials with fewer patients, with the ultimate goal of bringing safe and effective drugs through development faster. This is a personalized-medicine approach to clinical trials.
CRN: Is this personalized-medicine approach being used in certain fields?
PA: In some areas, such as oncology, it’s becoming the norm. But we suspect that the same approach can be applied to fields beyond oncology. In cardiology, for instance, we’re already moving in this direction. Christine Seidman, MD, director of the Cardiovascular Genetics Center, has identified genetic differences associated with cardiomyopathies that could help us identify a small subgroup of patients who are most likely to respond to a particular drug. As we think about the future of clinical trials, personalized medicine becomes more and more important. And the Brigham is uniquely positioned to move this concept forward, not just in oncology or cardiology but in many fields.
CRN: What is the “translational accelerator”? How did the concept of the translational accelerator come about?
PA: All of these ideas around clinical trials and infrastructure support for researchers come together in what we’re calling the translational accelerator. It’s the idea of having one central resource that provides the data management, bioinformatics, statistics and quality management tools needed to translate science into new therapies. With this in place, we can work better, faster and more efficiently.
Multiple investigators, including Calum MacRae, MD, PhD, Shalender Bhasin, MD, and Joseph Loscalzo, MD, PhD, had identified a need for a sort of one-stop shop for clinical trials. We came together to outline a common vision, and that’s when the idea for the translational accelerator began to take shape.
CRN: What’s the role of industry in this? What kinds of partnerships will help make this vision a reality?
PA: We want to interact with companies more than we have in the past – we’re changing our approach, and we want both industry and our researchers to know: the Brigham is open for business.
We want our faculty to be able to connect with industry, especially around the clinical-trials market. We have tremendous resources here to leverage. Thanks to Partners BioBank, we’re going to have 75,000 patients whose complete genomes have been sequenced. With eCare and Partners Personalized Medicine, we will have the ability to link that information to radiology data, pathology data, biomarker data and more and begin to ask probing questions that could help us design better clinical trials. In the era of personalized medicine, those resources have the potential to transform patient care, if we can find right the partners in industry to help projects move forward.
CRN: Traditionally, researchers are rewarded and recognized primarily for publishing papers in peer-reviewed journals. Does this model fit your vision for the future?
PA: Publishing in peer-reviewed journals is critically important, but we also want to expand our recognition of a researcher’s accomplishments to reward innovation and collaboration. Traditionally, we haven’t counted inventions very strongly in our academic promotions. I think we need to reexamine that. And on major publications, there can be a hundred authors on a single publication, but only the first and last author are counted. We need to think about ways to factor in the contributions of our fellows and our junior faculty in these large studies.