Foreward

I cannot foresee a situation in my life for which I am more thankful and humble than the one that is presented by the completion of this e-book. That my vision has matured and been translated into valuable and substantive educational materials has surpassed my expectations.

After completing my training in internal medicine, cardiology, and interventional cardiology, I spent extra years studying investigational devices and obtaining an epidemiology degree in public health with a concentration on clinical effectiveness. Many years of training occurred in prestigious universities such as Boston University, Tufts University, University of Wisconsin, Harvard University, and Harvard School of Public Health. Despite this training, I discovered that my curriculum was deficient in helping me to develop a stem cell line to treat patients. I found myself lacking in depth knowledge of how to optimally employ an animal model, perform an adequate toxicology study, or design a definitive clinical trial. I did not have a firm understanding of the nature of intellectual property, and more importantly, the regulatory pathway, and reimbursement strategy necessary for introduction of a new product.

It was only after deep reflection that I realized that the medical school curriculum did not provide the knowledge that was critical for the clinical scientist to advance a new discovery to patients. After years of practice it has become even more obvious to me that the collaboration of regulatory authorities, industry, scientists and reimbursement agencies is critical to achieve the research objective of providing benefit to patients. This is the goal of translational research.

My first attempt to address translational research was a smaller scale book published in 2006 entitled ”Stem Cell Therapy and Tissue Engineering for Cardiovascular Repair from Bench to Bedside”. The current e-book involved the worldwide collaboration and efforts of many people from different backgrounds and with different expertise. All have come together to nurture this vision and make it a reality. I believe that this e-book is the most comprehensive exposition of the skills necessary for effective translational research that has been produced. We hope it will provide a usable tool to advance future science and educate the next generation in ways to expedite and translate science to patients.