More Commercial Activity, More Commercial Filings: Good News Ahead for Regenerative Medicine

Fri, Feb 12, 2021 | By Cryoport Team

While the pandemic continues to disrupt many industries, including regenerative medicineit’s not all bad news -- in fact, there are likely some bright spots ahead for the industry this year. 

In a recent article for Technology NetworksCryoport Systems CEO Mark Sawicki, Ph.D outlines expectations for 2021, including:  

Up to 21 BLA/MLA Filings 

The pandemic will continue to affect the start of some clinical trials as well as patient enrollment, but ample progress has already been achieved on the development of several cell and gene therapies. We can expect up to 21 Biologics Licensing Applications or Marketing Licensing Applications to be filed with the FDA this year.  

Five (or More) Approved Commercial Products 

“We anticipate 2021 being a record year for commercial launches, which will further cement regenerative medicine as the third pillar in the pharmaceutical market in conjunction with small molecules and biologics for the foreseeable future,” Sawicki explains. We are hopeful for approvals for Orchard Therapeutics, Bristol Myers Squibb and Mesoblast, as well as several othersAtara Biotherapeutics, IovanceSanBioPoseida and Audentes Therapeutics. 

Improved Transportation Safety Standards for Regenerative Medicine Products: ISO 21973 Awareness 

Clear-cut standards for transportation of cell and gene therapies have been hard to come by for this relatively young and fast-growing industry. ISO 21973 is the first standard to specifically address, in detail, the requirements for the cell and gene therapy supply chain, with a focus on transportation, recognizing that these products are significantly more fragile and valuable than most small molecule and biological medicines,” Sawicki writes.  

In an effort to educate the industry on the importance of this development, Cryoport Systems has released a new white paper. “ISO 21973: A Leap Forward in Standardizing the Regenerative Medicine Supply Chain” is free and available for download here. 

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