An article published this month in New York Magazine highlights the recent advancements to the regenerative medicine and medical device fields. While legislation is struggling to keep up with such advancements, various sources report that the regenerative medicine industry is growing and attracting increasing investor interest.
Regenerative medicine focuses on stimulating the body’s repair mechanisms to heal damaged tissues and organs, and growing these tissues and organs so that they may eventually be safe to transplant. The field includes cell therapy (CT), gene therapy (GT), tissue engineering (TE), and biologics and small molecules. Essentially, regenerative medicine can change the mechanisms behind certain diseases, altering their progress and providing a potential cure, whereas most current treatments simply delay disease progression and relieve or prevent symptoms.
Regenerative medicine is not a new field, but this growing interest is perhaps due to the increase in legislative guidance and support for therapies that treat serious, life-threatening, and rare diseases. A recent report noted that approximately seven cell therapy products were approved worldwide in 2012, compared to five between 2009 and 2011, and zero between 2002 and 2008. Of the regenerative medicine products that are currently commercially available, most involve cell therapy or tissue engineering. However, of the thousands of regenerative medicine clinical trials occurring globally, the report estimates that only 15 percent are sponsored by industry players – the remainder are sponsored by academic institutions.
The Safety and Innovation Act improved the accelerated approval process, specifically requiring FDA to expedite the review and development of therapies that treat serious or life-threatening conditions or diseases which also have the potential to address unmet medical needs. The Act also places additional weight on the rarity and severity of diseases, particularly in the area of pediatrics, instructing FDA to take into consideration the research and development hurdles that may arise when developing orphan therapies. The most recent legislation, introduced in the House on April 28, 2014, H. R. 4494 aims “to launch a national strategy to support regenerative medicine through funding for research and commercial development of regenerative medicine products and development of a regulatory environment that enables rapid approval of safe and effective products, and for other purposes.”
Particularly within the United States, regenerative medicine could not only improve healthcare for millions of citizens, but could alleviate the financial burden on the healthcare system. Focusing solely on the aging population, regenerative medicine can offer treatments for some of the more onerous (and costly) conditions and diseases, such as stroke and cardiovascular disease, neurodegenerative disorders (e.g., Parkinson’s, Alzheimer’s, and ALS), and diabetes. Additionally, with the advent of 3D printing, pharmaceutical and biotech companies have the opportunity to perform toxicology and efficacy testing on 3D bioprinted, functional human tissues, which could dramatically accelerate the drug discovery process.
While interest in the field is on the rise, there is much debate about how these therapies should be regulated, with conflicting views among patients, researchers, legislators, and industry advocates. Regenerative medicine could undeniably improve the quality of life for many; but, even with positive legislative progress and industry innovation, companies must continuously monitor the long-term efficacy and quality of their therapies, while demonstrating their value to the market and to the patients they serve.