Editor’s note: The 16th annual Biotech conference put on by the Council for Entrepreneurial Development opens today and runs through Tuesday at the Durham Mariott hotel.
Among the speakers in Dr. Anthony Atala, who is a pioneer in the search to develop replacement organs. Joe Sollee, a lead attorney with law firm Kennedy Covington’s Life Sciences Group, recently talked with Atala about his research efforts. Kennedy Covington is a sponsor of the conference.
Dr. Atala is W.H. Boyce Professor and Director of the globally renowned Wake Forest Institute for Regenerative Medicine (WFIRM), which is based in the Biomedical Research Campus in downtown Winston-Salem, a part of the 280-acre biotechnology Piedmont Triad Research Park initiative. WFIRM applies the principles of regenerative medicine to treat human diseases and disabilities, and is an international leader in the translation of scientific discovery to clinical therapies. The former director of Tissue Engineering and Cellular Therapeutics at Children’s Hospital and Harvard Medical School in Boston, Mass., Dr. Atala joined Wake Forest University in early 2004.
The discussion:
Thank you for taking the time to meet with me today Dr. Atala. During a tour of your research facilities last year, I was struck by the wide range of ongoing activities – with clinicians studying gene regulation sitting across from bio-engineers tinkering with inkjet printers to re-task them for cellular imprinting. The entrepreneurial atmosphere at WFIRM was contagious.
Many visitors to our Institute have the same reaction. While regenerative medicine involves a great deal of traditional bench work, it is more accurately characterized as a composite field that involves the application, from the bench to the bedside, of many scientific and medical disciplines. The Wake Forest Institute for Regenerative Medicine includes scientists and physicians in the fields of biomedical and chemical engineering, cell and molecular biology, biochemistry, physiology, materials science, nanotechnology, genomics, proteomics, drug delivery, surgery and medicine.
These and other specialists will play essential roles in creating a successful regenerative medicine program, as we push forward in our efforts to develop more efficient ways to enhance cell growth and function in vitro and fabricate biomaterial scaffolds for tissue generation in three-dimensions. We have made a concerted effort at the Institute to bring together all the components necessary to foster multidisciplinary collaboration and, most importantly, facilitate the transfer of technologies emerging from this research to the patients who need them.
Your focus on translational research appears to be producing ground-breaking results, with your report last year of the successful human transplantation of engineered bladders, and your report earlier this year on the discovery of pluripotent stem cells in amniotic fluid and placenta. Could you describe these breakthroughs for us and their broader implications?
I would be happy to.
The bladder study represents the culmination of over 17 years of research and development in engineered bladders. Starting in 1999, we transplanted the first laboratory-grown organs into patients with poor bladder function due to birth defects. To avoid rejection by the patient’s immune systems, the engineered bladders were grown from autologous tissues (from the same patient). Prior to publishing results, we followed the patients for a number of years to verify that the new bladders were both functional and durable.
Earlier this year we reported the discovery of amniotic fluid-derived stem (AFS) cells, which we believe may represent a valuable intermediate stage between embryonic stem cells and adult stem cells. These AFS cells exhibit a high degree of flexibility and growth potential, similar to that of human embryonic stem cells, which are believed capable of generating every type of adult cell. Moreover, the AFS cells remain stable for years without forming tumors, unlike other stem cells, which are often tumorigenic due to uncontrolled growth.
Taken together, these studies represent valuable steps in the search for potential solutions to help reduce or end the critical shortage of transplantable organs and tissues around the world. One death occurs every 30 seconds as a result of organ failure. The number of patients awaiting transplants of all types increases by 20% each year, yet the number of donors has remained small, at under 4% of potential donors. Regenerative medicine seeks to harness, in the laboratory, the body’s natural healing process – by coaxing cells to grow, divide and differentiate into organs and other tissues for implantation.
You and your team have accomplished a great deal since you opened the Wake Forest Institute for Regenerative Medicine three years ago. Can you give us an indication as to what you will be focusing on over the next three years?
We have numerous ongoing and planned projects that represent the next phases of advancement toward the clinic as well as expansion into an increasing array of tissue types, ranging from organs such as kidneys, livers and heart valves, to tissues and cells for therapy, such as cartilage, bones and nerve cells.
I would, however, recommend cautious optimism in this complex and nascent field of regenerative medicine. Our team, together with renowned scientists from other institutions, have been working on these or similar projects for almost two decades, and it could be years before commercial-scale production of engineered organs is viable.
Given the extended window before general clinical acceptance, what opportunities are there, if any, in the near term for commercial organizations in the field of regenerative medicine?
One of our most important missions at the Institute is to share our technologies with scientific and industrial communities worldwide to further accelerate clinical translation to patients in need. Toward this goal, we continuously pursue extramural collaborative research efforts, together with education and training in regenerative medicine for motivated young scientists from around the world.
In your upcoming keynote address for Biotechnology 2007 in Durham, N.C., do you plan to raise any themes that are particular to North Carolina and/or the Southeast?
Yes I do, and thank you for raising that topic. When I decided to move to this area from Boston in 2004, I was drawn by the commitment that the public, academic and private communities were making to invest in and nurture cutting-edge life sciences, both at the local, state and regional levels.
I believe that regenerative medicine will play a critical role in the continued expansion and development of the life sciences corridor in North Carolina. With the national cost of caring for persons who might benefit from engineered tissues or organs exceeding $600 billion annually, regenerative medicine promises to be one of the most pervasive influences on public health in the modern era. I believe that the wide range of technologies and services that will be required to support the multidisciplinary field of regenerative medicine will help to spawn many new enterprises in North Carolina and the region.
Though we may be years away from implantation of engineered organs becoming standard of care, we are developing new, breakthrough technologies today that will have immediate impact in the fields of research and development. A number of companies operating in the field of regenerative medicine have already established operations in the region, and I get inquiries weekly proposing new business ideas and collaborations. One of our primary goals at WFIRM is to serve as an incubator for new biotech businesses generated from the transfer of technologies discovered in our laboratories.
