Why Cell Therapy Innovation Can Only Be Sustained By Rapid Commercialization And Commitment To Diversity
By Sophia Ononye-Onyia, PhD, MPH, MBA, Founder and CEO, The Sophia Consulting Firm
A landscape overview of the cell and gene therapy space with a focus on the need for more diverse founders and leaders that can help to sustain therapeutic and talent innovation.
There is no doubt that we are experiencing a period of transformational growth in the cell therapy space and life science industry at large. Over 20 cell and gene therapies (CGTs) have been approved by the FDA to date, and it is estimated that the agency will approve 10 to 20 CGT products annually based on strong pipelines and favorable clinical success rates. In addition, regulatory policies such as the FDA’s Regenerative Medicine Advanced Therapy Designation (RMAT), which was conceived by the 21st Century Act, has fostered innovation in the cell therapy space by expediting the approval of regenerative medicine products in the US.
Consequently, cell therapy biotech companies are sprouting at increasingly high rates across most the U.S. But the cell therapy revolution is truly global as showcased by China, which has experienced a 61% rise in the number of cell therapy clinical trials since 2014. In particular, allogeneic or off-the-shelf cell therapies hold great promise because by design, they rely on a single source of cells to treat many patients thus enabling quicker delivery to patients with progressive diseases all over the world.
Bridging the Commercialization Gap
Intersecting with this transformational growth in cell therapies is the democratization of innovation that is showcased by rapid inventions at academic medical centers around the world. Remarkably, many of these research-focused institutions are looking for commercialization partners to help bring these medicines to patients. One example of a company that is meeting this gap in commercialization is Cellevolve, a cell therapy development and commercialization company, founded on the premise that patients can only benefit from the discovery of novel cell therapeutics if these innovations are commercially available. The startup biotech is partnering with small biotech and academic medical centers to bring innovations through late-stage development and into commercialization. Cellevolve’s founder and CEO, Dr. Derrell Porter is a physician-entrepreneur with over two decades of experience in the business of medicine. A California native and San Francisco resident, Dr. Porter spent some of his formative years in Philadelphia while studying for his dual MD/MBA at the University of Pennsylvania.
Coincidently, San Francisco and Philadelphia are both leading hubs for cell therapy innovations. Cellevolve is headquartered in South San Francisco, which is considered the “Birthplace of Biotechnology and the hub of the biotech industry.” Conversely, Philadelphia, which is affectionately nicknamed, ‘Cellicon Valley,’ is uniquely posed to become a leading cell and gene therapy hub. Notably, the first FDA-approved gene therapy, Kymriah, was discovered at Children’s Hospital of Philadelphia (CHOP), and its huge commercial success has enabled the development of additional cell and gene therapies for the treatment of grievous illnesses.
Biotech Must Embrace and Implement a Commitment to Diversity
In parallel to the transformational growth in cell therapy, we are also witnessing a long overdue change in how companies are viewing the importance of diversity. The lack of diversity in senior leadership roles and Boards at large has prompted states like California to issue mandates that can boost the number of underrepresented groups. In particular, there is a paucity of leaders of color in biopharmaceutical companies. As one of the few Black biotech leaders, Dr. Porter inherently recognizes the importance of diversity in sustaining innovation. He has reinforced his company’s commitment to diversity in several recent podcasts and other media engagements, including the Cell & Gene podcast where he stated, “One of our statements is diversity and inclusion as norm. What that means is that we embrace the diversity and inclusion of the people we work with as a positive differentiator.”
Diversity is also being addressed by prominent advocacy groups in the industry. For example, Dr. Michelle McMurry-Heath, President and CEO of BIO, the world’s largest science and public advocacy organization, has also emphasized the importance of diversity in facilitating innovation in the life science industry. On a guest appearance on the Amplifying Scientific Innovation® Video Podcast, Dr. McMurry-Heath said, “Innovation is the perfect place to really demonstrate the power of diversity because it works.” Additionally, the Alliance for Regenerative Medicine (ARM) is also making an impact in the cell therapy space through its Summer 2021 launch of the GROW RegenMed program that provides Black students with crucial early-career paid opportunities in the regenerative medicine space with the ultimate goal of increasing the representation of African Americans and other minorities in cell and gene therapy companies.
Despite the uncertainty rampant amid the COVID-19 pandemic, there is still palpable excitement about cell therapies and its impact on grievous illnesses. A concerted focus on rapid commercialization of novel cell therapies will help facilitate access and therapeutic options for the approximate one in 10 Americans who live with a rare disease. Founders and leaders of color in the life science industry are also showcasing that diversity of thought, made possible through building diverse talent pipelines, will pave the way for sustained innovation in cell therapies. In turn, faster delivery of life-saving medicines will enhance the patient experience globally.
Dr. Sophia Ononye-Onyia is the founder and CEO of The Sophia Consulting Firm, a WBENC-certified New York City life sciences marketing and communications consultancy. She is also the creator, host and producer of her company's Amplifying Scientific Innovation® Video Podcast.