Examining 2023 & 2024: Looking Back with President & CEO, Mark Sawicki
2023 was a year of highs and lows for the cell and gene therapy (CGT) market. The Alliance for Regenerative Medicine reported in their August 2023 sector snapshot that the FDA is set to approve nine CGT therapies in total this year, compared to In Vivo’s predictions of 13 total approvals at the beginning of 2023. While nine new therapies being brought to market is a huge win, 2023 also brought forth many challenges that will persist into the coming year.
We sat down with Mark Sawicki, Cryoport Systems’ President & CEO, to look back on the cell and gene therapy market in 2023 and his predictions for the industry in 2024. In this first installment of a two-part blog series, Sawicki answered five questions and described how Cryoport Systems has helped the industry advance.
1. Were you surprised by the amount of CGT therapy approvals in 2023?
“Former FDA Commissioner, Scott Gottlieb, stipulated back in 2019 that the market would see 10-20 approvals a year by 2023/2024. We’re obviously getting close to that prediction. The growth and innovation within the industry has been a topic for so long that it’s refreshing now to see rapid growth in a relatively short amount of time, a reflection of the hard work the industry has put in over the last 10 years.”
2. Were there any noticeable challenges facing the industry this past year?
“Patient access continues to be a major issue and will continue to be a struggle for many organizations and people. Right now, the lack of reach into new regions beyond large hospitals limits clinical opportunities to find patients for trials, and patients aren’t able to access clinics and hospitals where these life-saving therapies are accessible. This issue isn’t restrictive to the cell and gene therapy space but to the life sciences market at large.”
3. How has Cryoport Systems made strides to combat those challenges?
“Our IntegriCell™ solution is aimed at solving aspects of the patient access problem over time with standardized cryopreservation and distribution services. IntegriCell™ combines our organization’s global leadership in temperature-controlled supply chain solutions with our domestic and international cryopreservation, transportation, and storage capabilities. This service provides the optimization of cellular viability via cryopreservation so that our clients can extend their reach to patients in need in remote areas around the world.”
4. How was Cryoport Systems able to support the life sciences in 2023?
“There were many wins within the industry for our organization this year, but three newly approved commercial launches from Cryoport Systems’ clients stand out. First is Sarepta’s newly FDA-approved gene therapy to treat Duchenne Muscular Dystrophy, ELEVIDYS. The second would be the approval of an allogenic T-cell immunotherapy from Atara Biotherapeutics, Ebvallo. Third is the first regulatory authorization of a CRISPR-based gene-editing therapy, CASGEVY, from Vertex and CRISPR Therapeutics. Cryoport Systems has and is supporting these launches to help reach patients around the world. Our clients are constantly evolving the future of health and medicine, and we’re proud to support wins like these three.”
5. What company accomplishments are you most proud of this year?
“I’m always proud of this company and the fact that we have a zero-defect policy. Cryoport Systems continues to support life and health by improving the ways we can support not only the cell and gene industry but the life sciences at large. This year, the launch of Cryoportal® 2 and the Elite™ Ultra Cold shipper furthered our ability to provide new solutions and added certainty to our clients’ operations. The innovation and evolution of our services and solutions will always be our priority and an aspect of pride for our organization.”
Cryoport Systems is delighted to mark 2023 as a year of innovation and growth despite industry challenges. To learn more about our performance within the life sciences market this year, check out our quarterly results webpage.