Role at ICON:

 

I joined ICON Clinical Research three years ago after a long career in the practice of general, vascular and solid organ transplant surgery. Since joining ICON I have been the Global Medical Lead Monitor for several solid organ transplant clinical trials. My responsibilities include protocol development; investigator, site, and patient recruitment strategies. I coordinate internal and external training, consulting, as well as monitoring studies from a medical perspective around the globe. I am also the transplant TAG (therapeutic area group) leader here at ICON.

 

Background:

 

I grew up in the Philadelphia area and was graduated from Villanova University. I received my medical degree from Temple University School of Medicine in Philadelphia. After completing a residency in general, vascular and organ transplant surgery I settled into private practice in West Palm Beach, Florida. I was invited to become a faculty member at the University of Miami School of Medicine in the Department of Organ Transplantation in 1981, the year the department was founded. I held the title of Clinical Associate Professor of Surgery until 2000. In 2005, I returned to the Philadelphia area to become Senior Medical Director at ICON. I am a Fellow of the Philadelphia College of Physicians, American Society of Abdominal Surgeons, American Society of Transplantation and member of the Alumni Advisory Board of Temple University School of Medicine.

 

Career highlights and challenges:

 

One of the highlights of my surgical career that I am most proud of was the opportunity to be part of an organ transplant program that was newly-developed at the University of Miami in the early 1980’s. I had the privilege of being involved in the first surgical procedure to harvest organs for transplantation in south Florida. Being a part of one of the fastest-growing transplant programs in the US was a real highlight for me.

One of the greatest personal challenges for me has been making the transition from performing surgery to performing my duties as global medical monitor for newly developing compounds and molecules. Fortunately, my surgical and patient care experience has given me the tools to better interact with principal investigators and sponsors. I closely identify with the day to day challenges facing transplant physicians in caring for these complex patients.

 

My career as a surgeon allowed me to help one patient at a time, whereas, now my role at ICON allows me to help thousands of patients live better, more normal lives after their organ transplanta tion. Working with a talented group of team members at ICON allows me the opportunity to become involved in the latest, most advanced ideas in the treatment of organ rejection and opportunistic infections, which are; two major obstacles facing all transplant recipients.

 

What are the most challenging factors in conducting clinical trials in your field?

 

The most challenging issue in conducting clinical trials in the field of organ transplantation is the complexity of the patient population. These patients usually have a multitude of medical problems simul taneously, which present challenges to the study enrollment as well as long-term retention. There is always a fine line between tolerance and rejection of the transplanted organ that must be maintained in order to successfully complete a clinical trial.

Do you have any advice that would benefit sponsors considering drug development in transplant & immunology?

 

Sponsors considering drug development in the area of transplant immunology should consider the potential new added value that their product brings to the patient. Drugs that offer little in the way of increased efficacy and/or safety have brought little value in this therapeutic area, because of the very small number of transplant patients available to enroll in clinical trials and the intense competi tion for those patients. Me too products that offer little or no improvement over existing therapies are very unlikely to succeed.

 

What new advances do you see happening in this field that promise a better future for organ transplant patients?

 

The most significant new advance in the field of organ transplanta tion that is likely to improve the quality of life in transplant patients is the development of new molecules to prevent acute and chronic allograft rejection. Promising new therapies currently in clinical trials and in the later stages of development may be proven safer and more efficacious. These new entities may allow patients to discontinue toxic therapies that are currently the standard of care and provide a very bright future for organ transplant recipients.