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Training the Translational Reseacher

Date: 05/2009

Clinical investigators are able to see the full picture: With firsthand exposure to patients, they understand the human side of disease. And with skilled laboratory training, they have the necessary tools to develop therapies to manage disease.

Today's growing emphasis on translational research means that the need for clinical investigators has never been greater. And that's where the  Clinical Investigator Training Program (CITP) comes in. A two-year fellowship housed at Beth Israel Deaconess Medical Center (BIDMC) and the Division of Science and Technology (HST) at Harvard Medical School, the CITP has helped launch the careers of an impressive array of translational researchers during its 16-year history. Since 1993, more than 146 CITP graduates have gone on to assume a wide variety of positions throughout academia and industry, including 36 faculty members at BIDMC. On June 2, 12 graduates of CITP's Class of 2009 will join this number.

The Program's History

Founded by Alan Moses, MD, of the former Beth Israel Hospital and Robert Rubin, MD, of the Harvard-MIT Division of Harvard Science and Technology, the CITP, since its inception, has been supported by a grant from Pfizer, Inc.; in 2004, Merck & Co. joined Pfizer in supporting the program. The CITP is one of only a few such specialized training programs nationwide, according to Hollenberg, who joined Rubin as codirector in 2004. Linda Bard serves as the program's administrator.

"At a time when relationships between academic medicine and industry - pharmaceutical companies, in particular - has come under intense scrutiny, it's important to remember that these partnerships can be valuable," says Hollenberg. "With the current lull in funding for translational researchers, the CITP is of particular value, providing participants with two years' salary, giving them the freedom and focus to be able to get their research projects off the ground."

The program is based on a specialized curriculum that enables trainees to gain direct experience in clinical investigation and, at the same time, acquire the solid academic foundation necessary to carry out patient-oriented research. Course work includes classes in computational and statistical sciences, biomedical ethics, principles of clinical pharmacology, and in vitro and in vivo measurement techniques. During the course of the program, fellows must complete 24 months of laboratory and/or clinical investigation. At the end of the program, participants who have successfully met the degree requirements are awarded a Masters in Medical Science from Harvard Medical School.

"Our goal is for these fellows to have built the foundation necessary for carrying out patient-oriented research," he adds. By applying contemporary research tools to clinically relevant areas of investigation, the participants are poised to compete for careers in academic medicine, industry and regulatory affairs."

Trudy Pang: Helping Epilepsy Patients Gain Control

"With the CITP fellowship, I've learned about research by conducting research," explains neurologist Trudy Pang, a member of this year's graduating class. "Just as I was in the process of recruiting patients for a clinical study to test a new means of detecting seizure onset in patients with epilepsy, I was learning about study design and statistics through CITP. The timing was ideal."

Trudy PangPang had completed her neurology residency training as well as a fellowship in BIDMC's Epilepsy Program. With Steven Schachter, MD, as her research mentor, she decided to apply for CITP. "I think the field of epilepsy still has tremendous potential for clinical research, both in terms of diagnosis and management," she explains.

The dedicated research time provided by the fellowship enabled Pang to continue her work with Schachter, together with engineers from the Massachusetts Institute of Technology, to develop a system that combines a computer algorithm to detect seizures seconds after onset, and a vagus nerve stimulator in order to offer patients an acute treatment - at the very beginning of a seizure. "Uncontrolled seizures are a major cause of disability, morbidity and mortality for one in four patients with epilepsy," explains Pang. "If we are successful, this technology will represent the first non-invasive closed-loop detect-and-treat system," she explains.

"At a time when grants are especially hard to come by - both as a result of our economic climate and because I'm still in the early stage of my career - the CITP provided a valuable opportunity to enable me to pursue this work by providing protected research time," she notes. "At the end of the program, I hope to have obtained preliminary data, which would better position me for additional grants to further our work. CITP has also provided me a wonderful opportunity to meet - and learn from - researchers in other fields."

As it turns out, Pang's CITP experience has already paid off: Last month she was notified that she was among the first group of investigators to receive a Harvard Catalyst Pilot Grant. The one-year grant will focus on the development of a prototype for a non-invasive wearable seizure-detection system equipped with an alarm that patients with uncontrolled seizures could potentially use at home to improve epilepsy control and safety.

Paola Blanco: Investigating the Source of Chronic Pancreatitis

Paola Blanco had been a member of Steve Freedman's lab for six years, studying the origins of cystic fibrosis and chronic pancreatitis, when she applied for the CITP program in 2007.

Paola Blanco"I knew about cell cultures, mouse models and hands-on benchwork," explains Blanco, an investigator in the Division of Gastroenterology. "I had learned basic science, how to run experiments and how to test hypotheses. So I already knew what I wanted to investigate from our lab work. But being in the clinic with Steve and seeing patients with chronic pancreatitis made me want to play a larger role as a clinical investigator."

The CITP provided her with a breadth of experience that enhanced her laboratory skills, including valuable exposure to the numerous aspects of the drug development process.

"During a recent trip to Pfizer's headquarters, we spent a day being taken through the drug development process," says Blanco. "We learned how Cox-2 inhibitors were developed, how it went through the Phase 1 and Phase 2 testing, and how the drug's marketing plan was developed. It's very interesting and useful to be able to get industry's point of view." A one-week course in Clinical Pharmacology, jointly taught by faculty from Harvard Medical School, Merck and Pfizer, further enhances the fellows' experience.

Similarly, she adds, a separate trip to the U.S. Food and Drug Administration (FDA) provided CITP fellows with a firsthand look at government's role in the drug development process, including regulatory steps that have to occur before a new therapy is launched.

Blanco is currently investigating how primary sclerosing cloangitis (PSC) - a painful digestive disease that can lead to liver damage- is associated with mutations the CFTR gene (the same gene responsible for cystic fibrosis), and hopes to expand her work to find new treatment options for PSC.

"It's amazing just how many people are involved in a successful study," she adds. "It's by no means a one-person operation. I've had lots of help with my work and I feel very fortunate."

Aaron Cypess: Brown Fat is Good Fat

Aaron Cypess, Class of 2008, puts it succinctly: "CITP was the real reason this study happened. Without the support of CITP, I wouldn't have been able to conduct this research."

Aaron Cypess being interviewed by NBC Science Correspondent, Robert BazellThe research he's referring to is his work identifying and understanding the importance of brown fat, a type of "good fat," that holds promise for the future development of treatments for obesity. Published in the April 9, 2009 issue of The New England Journal of Medicine (NEJM), the findings garnered world wide media attention, including a report on "NBC Nightly News" for which Cypess was interviewed by NBC science correspondent Robert Bazell.

"I applied for the CITP fellowship because I wanted the opportunity to apply what I already knew to an area of research that would more directly impact patients," explains Cypess. "CITP really taught me the nuts and bolts of translational research - how you take information from the laboratory and apply it to human subjects - and then bring it back to the lab."

It was one morning as Cypess was sitting in a BIDMC endocrinology fellowship lecture by  Nuclear Medicine staff physician J. Anthony Parker, that an idea began to crystallize. "Dr. Parker showed us a PET scan and pointed out an area that he said was brown fat, noting that it often got in the way of identifying and treating tumors," remembers Cypess. "I had been working in the lab of Ronald Kahn, MD, and was studying brown fat's metabolic properties." Known for its important role in infancy - but assumed to no longer be in existence by adulthood - Cypess seized on this opportunity to find out if adults might still harbor brown fat - and could, therefore, make use of its metabolically active nature to help manage weight.

And, you might say that the rest of the story is summarized in the NEJM paper.

The CITP is rich in experiences, says Cypess, adding, "Among other things I got a lot of exposure to the ethics of clinical studies. What happens, for example, if you see a tumor during a PET scan you're conducting as part of your research project?" asks Cypess. "How do you tell the volunteer? You're still a clinician, so what is your obligation?" These types of issues, he adds, may be routine but often go unexplored in medical training.

"Ultimately, the CITP fellowship bought me time. When my first K grant [from the National Institutes of Health] was not funded in 2008, it could have meant the end of my research. But because I still had my CITP salary and support, I could keep moving ahead with the brown fat experiments."

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Beth Israel Deaconess Medical Center
330 Brookline Ave, GZ 811
Boston, MA 02215

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