Plants are given the special abilities to regrow their organs. Some animals, such as lizards, can regrow their tail. Talking about human beings, the liver is the only internal organ that can regenerate. But blessed with intelligence, we are inventing new technologies every day to achieve better health. The advancement of medical science has eased human life significantly, and the next chapter is regenerative medicines.
Regenerative medicine and tissue engineering have emerged as essential therapy options for a wide range of human disorders, with the goal of replacing, repairing, or improving the biological function of damaged tissues and organs. Though the research is in its early stages, it has some promising results.
Hence, many companies are investing in the research of regenerative medicines. One of the leading names in that list is RepliCel Life Sciences, Inc. which provides tailor-made cell therapy products for aesthetics and orthopedics.
In an interview with Insights Care, Lee Buckler, the CEO of RepliCel, shares the journey of his company, its role in the development of regenerative medicines, and the future aspects of the medical sector. Below are the highlights of the interview:
Please brief our audience about RepliCel, its USPs, and the aspects that make it a leading name in the regenerative medicine space.
RepliCel Life Sciences is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, male and female pattern baldness due to androgenetic alopecia, and chronic tendinopathies such as Achilles’ tendinosis, Patellar Tendinosis (‘Jumper’s Knee’), Lateral Epicondylitis (‘Tennis Elbow’), Golfer’s Elbow, etc.
The company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are manufactured using RepliCel’s innovative technology, starting with cell populations isolated from a patient’s healthy hair follicles.
RDH-01, having successfully met the endpoints in two completed clinical studies, is currently the subject of a third clinical study in Japan being funded by Shiseido Company. RepliCel owns the unfettered rights to the product outside of Asia. RCT-01 and RCS-01 are the subject of a co-development and commercialization agreement in Greater China to YOFOTO (China) Health Company. RepliCel maintains the rights to these products outside of Greater China.
No other regenerative medicine company has a manufactured and regulated product as far along in clinical development for the treatment of hair loss as RepliCel’s RCH-01. Similarly, no other regenerative medicine company has a manufactured and regulated product in clinical development with clinical data showing as much promise as RepliCel’s RCS-01 to regenerate the extra-cellular matrix under aging or sun-damaged skin, which is currently the target of the >2-billion-dollar dermal filler market.
RepliCel’s RCT-01 is one of the leading cell-based regenerative medicines in clinical development for the treatment of tendinopathies which is a significant and large unmet medical need.
What other solutions and services does RepliCel offer that gives it a leading edge over its competitors?
RepliCel is one of the few regenerative medicine companies developing a proprietary delivery system (DermaPreciseTM) optimized for local delivery of cells into the skin and underlying tissue, and this platform will be available for other companies to use in the delivery of their injectable products ranging from other cell therapies to drugs, enzymes, toxins, antibodies, etc.
RepliCel’s proprietary injection system and related consumables are expected to improve the administration of its cell therapy products and any other injectable product being injected into the dermis or subcutaneous region of the skin and for which precision of depth, dose, and/or delivery is important for safety and/or efficacy.
YOFOTO has exclusively licensed the commercial rights for the DermaPreciseTM device and consumables for dermatology applications in Greater China and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. RepliCel maintains all global rights to manufacturing and further development and maintains commercial rights outside of Greater China. MainPointe Pharmaceuticals holds the exclusive distribution rights for the DermaPreciseTM device and consumables for a limited time in the United States.
With constant development in medical technologies, in your opinion, what could be the future of the regenerative medicine space?
The life sciences sector is now in a position where we understand the genetic or cellular causes of many human conditions. Once we understand the genetic or cellular deficits or dysfunction underlying acute and chronic conditions, we can develop genetic or cellular therapeutic approaches which do not target palliative solutions but rather aim to be curative.
Matching cellular or genetic deficits with cellular or genetic solutions address the underlying condition in a way that few if any, predecessor therapeutic modalities accomplish. This is the promise of regenerative medicine, and it is clearly now well-entrenched as a future pillar of healthcare.
As an established leader, what would be your advice to the budding professionals aspiring to venture into the biotech industry?
My advice to all budding professionals, regardless of the industry, is to let their career follow their interests regardless of what education they took, or they think they ‘should’ do. If they’re doing what they love, they’ll be good at it, and their career will reward them. For those loving change and always being on the cutting edge of discovery and technology, biotechnology is one of the most rewarding industries.
How do you envision scaling RepliCel’s operations and offerings in 2022 and beyond?
RepliCel’s three cell therapy products have now been tested in over 100 patients in four countries on three continents. RepliCel now has key strategic partners in the United States, China, and Japan, each of which is now investing heavily in the further clinical testing and development of RepliCel’s products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
Specifically, in Japan, where regulators have created two very unique commercialization pathways for regenerative medicine products, RepliCel is one of the leading foreign companies actively engaged in regulatory review, clinical development, and partnering to position its products for early commercialization. Finally, we expect to bring our dermal injector technology across the development and testing line culminating in a submission for marketing approval to the FDA.
About the Leader
RepliCel’s CEO, Lee Buckler, has been in the regenerative medicine space since 2000, having served executive roles in contract manufacturing, non-profit, consulting, technology services, and cell therapy product development organizations. He has continued RepliCel’s early direction of securing regional co-development and commercialization partners and been instrumental in positioning RepliCel as one of the most active foreign cell therapy companies in Japan.
