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This past year, DRI researchers focused on moving promising research into the clinical trial phase of testing, a multidisciplinary effort that requires the significant involvement of the Institute’s clinical transplant team. The BioHub pilot trial alone was a major undertaking: from preparing the transplant protocol and working with the Food and Drug Administration and other regulatory bodies for approval, to screening hundreds of people, selecting the candidates, performing the transplant procedure and managing the patients’ progress.

With the Institute’s increasing need for clinical research expertise, Dr. David Baidal, who served in the DRI’s Clinical Islet Transplant Program (CITP) as a post-doctoral fellow, re-joined the team at precisely the right moment.

Dr. Baidal had trained under Dr. Rodolfo Alejandro, director of Clinical Islet Transplantation, and DRI Director Dr. Camillo Ricordi, where his research primarily focused on identifying metabolic markers predictive of islet transplant dysfunction. In light of his clinical and research interests in type 1 diabetes, he then pursued a fellowship at Beth Deaconess Medical Center and Joslin Diabetes Center, Harvard School of Medicine. Following the completion of his fellowship, he returned to the DRI in July of 2015 to again be a part of the clinical islet transplant team and serves as assistant professor of medicine in the Division of Endocrinology, Diabetes and Metabolism at the University of Miami Miller School of Medicine.

At a time when the Institute is developing more efficient and effective methods of translating research to clinical trials, Dr. Baidal plays an integral role in this process. In recognition of his important work, Dr. Baidal was recently selected to receive the Marc S. Goodman Prize to an Outstanding Young Scientist at the DRI, a prestigious honor that carries an award of $10k to be used to advance research toward a cure for type 1 diabetes.

Having trained at the DRI, what were some of the highlights of your tenure here?

During my time with the Clinical Islet Transplant Program, I was introduced to clinical research and learned several aspects of the management of a clinical research program, as well as the medical care and evaluation of graft function of the islet transplant recipient. Under the direct supervision of Dr. Alejandro, I was trained in the use of various metabolic tests aimed at assessing the function of the transplanted pancreatic islets and focused on the identification of markers that could predict islet graft dysfunction. Without a doubt, the highlights of my time here were being able to witness the benefits that islet transplantation can bring to patients with unstable type 1 diabetes complicated by severe hypoglycemia. Experiencing the dramatic change in quality of life of patients being rendered insulin free and how this enabled them to pursue aspects of daily life that had previously been restricted due to their poor glucose control was extremely rewarding.

Why did you want to return to the DRI?

A. I wanted to pursue a career in clinical research and I remained interested in cellular therapies for type 1 diabetes. In order to achieve this goal, I needed to join a team that had a track record of excellence and innovation in diabetes research. Having worked at the DRI, I was fully aware of the outstanding team of scientists working together toward a cure for type 1 diabetes. Thus, the decision to come back to the DRI was actually a very easy one.

What is your primary role now?

I have re-joined the Clinical Cell Transplant Program and I will focus on the management of islet transplant recipients, development of new clinical trials for islet transplantation, and testing of novel therapies for the treatment of patients with new onset type 1 diabetes. I will also provide medical care to patients with endocrine diseases, in particular patients with type 1 diabetes.

Many of the DRI’s islet transplant patients, whom you have met and cared for, are enjoying long-term insulin independence. How do you feel about that progress?

A. It is both exciting and rewarding having been a part of the team that initially took care of those patients and now being able to see that those transplants have resulted in insulin independence for many years. The goal now is to identify what are the critical factors leading to long-term insulin independence so that these results are not limited to a small group of patients.

You returned to the DRI after the team received FDA approval for the BioHub clinical trial, and just a month prior to when the first transplant took place. What are your thoughts about the overall progress that’s been made?

There is an urgent need to identify an optimal transplantation site that will allow for better long-term results, minimize early islet loss, and allow for testing of novel techniques such as encapsulation of islets and/or immunomodulatory cells in order to minimize or eliminate the need for long-term immunosuppression. The DRI has been actively involved in identifying such a site and received FDA approval to test the omentum as a novel islet transplantation site. This is a huge step in moving the field forward and I feel extremely fortunate to have returned to the DRI at the time when this trial had just started. Hopefully, results from this clinical trial may allow us to demonstrate that the omentum is a safe alternative to the liver for islet transplantation.

What would you like others to know about the islet transplant program?

A. I will highlight what is already known, that this institution is a leader in diabetes research and is working tirelessly to find new therapies for type 1 diabetes with the ultimate goal of achieving a cure. Islet transplantation has demonstrated to be effective in improving glucose control and eliminating severe hypoglycemia in patients with poorly controlled type 1 and we are working to optimize long-term results and minimize risks in order to make this procedure potentially available to a wide range of patients. 

(DRIFocus Summer 2016)