Bioscience Americas Senior Scientific Advisor Presents at Major FDA Public HearingAngie Godinez
Bioscience Americas Senior Scientific Advisor Dr. Leslie Miller participated as a recognized expert in the field of stem cell biology at a major U.S. Food and Drug Administration (FDA) public hearing held recently at the National Institutes of Health in Bethesda, Maryland.
The public hearing, attended in-person and on-line by more than 1,000 stem cell researchers and medical professionals, addressed the issue of FDA regulation of human cells, tissues, and cellular and tissue-based products and the FDA’s related draft Guidelines for Cell Therapy.
Dr. Miller is a practicing cardiologist and clinical trialist with experience in over 100 FDA approved clinical trials, including four current actively enrolling cell therapy trials. In addition to his work with Bioscience Americas, he serves as Chairman of the Executive Committee of the Alliance for the Advancement of Cell Therapy. This organization is composed of patients, clinicians, and scientists interested in not only the advancement of this field, but the responsible use of cell therapy.
In his presentation, Dr. Miller noted that there is “very significant interest in the proposed Guidelines largely because they involve the biggest problem in U.S. health care, the treatment of chronic disease. More money is spent on chronic disease care than any other single item in Federal or private health care, and accounts for the greatest disability and loss of productivity.”
Dr. Miller added that “unlike drugs, which only treat symptoms of a disease, cell therapy attempts to harness the body’s native repair mechanisms to actually repair and regenerate damaged tissue and organs, with a goal of not only stabilizing, but reversing disease progression, and hopefully move toward cures. As such, it represents one of the most promising treatment options for most chronic diseases.”
He went on to say that the FDA is facing a “very significant challenge in how to optimize the many rapid advances taking place with many diverse uses and types of cell therapy, while maintaining the health and the safety of products.”
He indicated that “we share this commitment to safety and to the highest standards for cell therapy. However, under the current regulations, research has become slow and almost prohibitively expensive, leading to trials that have often been under-powered to answer critical questions on efficacy, which delays and impedes progress in the field. We believe that the very pressing health problem of chronic disease warrants new approaches to regulation to meet this challenge, and provide benefit for the millions of patients in need.”
Dr. Miller called for the creation of a Registry of Cell Therapy to address valid concerns regarding the unrestricted use of cell therapy including cell quality, treatment strategies, therapy expectations, and the reliability of data.
In a related development, and in response to Bioscience Americas CEO Eric Stoffers’ and Dr. Miller’s call for passage of the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Act (the REGROW Act), Bioscience Americas President Bill Deegan will be interacting with the U.S. Senate’s Committee on Health, Education, Labor, and Pensions to encourage passage of the Act. Introduced by Illinois Senator Mark Kirk, the legislation is designed to reduce barriers to medical innovation and accelerate the development of new medical treatments.
Mr. Deegan noted that “these new treatments have the potential to restore or establish normal function in damaged human cells, tissues and organs. Virtually any disease that results from malfunctioning, damaged or failing tissues may potentially be alleviated through regenerative medicine.”
Bioscience Americas is a leading international developer of autologous stem cell wellness centers. Its science partner is the San Diego, California based Global Institute of Stem Cell Therapy and Research.