Have Regulatory Authorities Finally Eased off on the Regenerative Medicine Frontier?


Scientific advancements in the field of medicine and molecular biology have been exceptional, to an extent where even regulatory authorities have struggled to keep up. The first hurdle to any company operating in the regenerative medicine space is that of the regulatory framework. Just like all biological substances, the use of regenerative medicine involves several health risks. With severe health risks such as functional loss of infused cells and potential neoplastic transformations, strict regulatory compliances were imposed. Having said that recent updates in rules and regulations for development of regenerative medicines may just have exhibited massive potential.

The United States recently overtook Japan as the region with most number of companies involved in development of regenerative medicine. The United States Food and Drug Administration (USFDA or simply FDA) announced an upgrade in the regulatory guidelines that were laid down for regenerative medicine and stem cell theories. Firstly, the FDA comprehensively discussed the existing rules, which will prove beneficial for the researchers and healthcare authorities, engaged in this field. Secondly, the FDA stated that it will be allowing a ‘grace period’ for certain medicine manufacturers for obtaining investigational new drug applications (IND) for the premarket approval (PMA) of their respective products. FDA’s latest update provides a huge opportunity for some major companies, who seem to have amped up their research methodologies.

An Investor’s Dream’: Regenerative Medicine Companies Are Racking Up Huge Funding

From scientific discoveries, compatible studies, successful clinical trials, and now backed by regulatory giants such as the FDA, the regenerative medicine space is set to witness a gush of product launches in the coming years. The possibilities and evidential backing for regenerative medicines have caught the eye of investors from around the world. The recent surge in investment will emerge as the final piece of the puzzle. In recent years, major healthcare companies have been encouraged by the promise and potential showcased in their financial stand, from which external investors have emerged at the fore. Besides investments from external firms, big name companies are acquiring small-scale enterprises. Medtronic’s US$ 123 Mn acquisition of Osteotech depicts a non-hesitant pattern towards regenerative medicine. Other leading companies haven’t held back either, with the likes of Novartis and Integra LifeSciences showcasing tremendous growth in regenerative medicines in 2018. The Alliance for Regenerative Medicine (ARM) states in its 2018 annual report that the global investment in regenerative medicine increased by around 73% from 2017. Altogether, the amount of money vested in research and development of regenerative medicine will lay strong foundations for the companies operating in the healthcare industry.

Is Regenerative Medicine the Best Hope for ‘Failed’ Body Parts?

Health risks have raised several debates regarding the use of regenerative medicines. The question of resurging failed body parts also raises several ethical issues. Although several platforms have been built for practical advancements, nothing will really kick off until the coast is completely cleared. Although regenerative medicines have shown signs of tissue regeneration abilities as well as some potential to fix failed body parts, the practical use of these medicines have raised minor speculations. Nonetheless, recent strides taken in the form of hefty budget allocations and molecular development in accordance with regulatory compliances look promising and it won’t be long until stem cell therapies will be in practical use.