One year after winning the Stephen M Goodman Award at the 6th Annual Keiretsu Forum Angel Capital Expo, Carmell Therapeutics’ President, and CEO, Randy Hubbell reflects on what the honor meant to the Company and how they leveraged the award to achieve significant milestones. As a reminder, Carmell Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of regenerative medicine solutions to accelerate bone and soft tissue healing. Randy’s pitch at last year’s event earned him the votes from attending accredited investors to receive this distinguished award.
Randy Hubbell has worked in the biotech industry for more than 25 years in leadership roles at Cardiva Medical, Johnson & Johnson, Enmed and Vasca, to name a few. He has been witness to changes within the regenerative medicine industry. Today, most medical device companies will bring their product to market using the 501(k) pathway for FDA clearance. It is important to note, however, that the simplified process may no longer meet the requirements of all stakeholders. One of the key drivers in this move to more robust clinical trials in the development of devices and therapeutics is the expanding role of hospital value analysis committees.1 It is more important than ever to amass the substantial evidence and validation that will be required for regulatory approval but also to meet the requirements of physicians, patients, and the insurance payers. This trend, combined with a more stringent regulatory approach for regenerative medicine by the Federal Drug Administration (FDA), means that the familiar framework that the industry has worked with for the past 40 years will become more demanding.2
The team at Carmell Therapeutics has made substantial progress towards the ultimate goal of a BLA (Biologic License Application) with the next big milestone on the journey being an IND (Investigational New Drug) clearance for Phase III clinical trials. The success of this plan to meet key FDA milestones with comprehensive data required the funds to complete Phase II clinical trials and fully complete and validate the manufacturing of the product to be used in both the Phase III studies and commercialization upon BLA approval. . According to Randy, “the Goodman Award provided validation that we had the right team and a solid plan in place to succeed. We have been able to leverage this credibility to shorthand conversations with other investment groups and high-worth individuals that also believe in our plan.” Having strong partnerships in place with Keiretsu Forum members and Keiretsu Capital has enabled Carmell to build a funding and regulatory platform to bridge to Phase III clinical trials.
Soon the FDA will provide Carmell Therapeutics with a green light to move forward with Phase III clinical studies. Moving into the last phase of clinical trials creates an important inflection point that will further grow the value created last year. Randy reports that their current position has reduced the level of risk from previous funding rounds as they have gone through a very rigorous review by the FDA on both the clinical program and the CMC (Chemicals, Manufacturing and Controls). Having multiple interactions with FDA over the last eight months has allowed Carmell® to eliminate a number of questions that otherwise would have come up at the time of BLA submission/review. The company is now in conversations with institutional investors to provide the financial partnership to data read-out, the biggest value inflection point. Keiretsu Forum members have a unique opportunity; there is still time to invest in Carmell Therapeutics with the discounted 2018 pricing and the aforementioned reduced risk. For more information, please contact Randy Hubbell at email@example.com
1 2Pursuing a Path of Regulatory Rigor: Taking Medtech, Regenerative Medicine to the Next Level. MDDI Online in Regulatory and Compliance. August 13, 2019.