Cell and gene therapies have been all the rage for some of the pharmaceutical industry's biggest players despite a wealth of manufacturing hiccups along the way. To capture that enthusiasm, a WuXi AppTec CDMO has expanded its offerings––and it's appointed as its head a Celgene veteran very familiar with those manufacturing woes.
WuXi AppTec has named David Chang, Ph.D., a veteran of Celgene's CAR-T manufacturing team, to lead its cell and gene therapy-focused CDMO, WuXi Advanced Therapies, the company said Monday.
Chang most recently worked as corporate vice president and head of cell therapy global manufacturing at Celgene––which was acquired by Bristol Myers Squibb in late 2019––where he oversaw the company's CAR-T production network, WuXi said.
One of those CAR-T offerings, Bristol's ide-cel (bb2121), was sent back to the drawing board in May after the FDA refused to review its submission based on slim manufacturing details in its filing.
Before Celgene, Chang was employed as global head of engineering and strategy at Roche after a turn as vice president and site head for Roche Shanghai Technical Operations.
"WuXi (Advanced Therapies) is at the forefront of accelerating the development of life-saving advanced therapies with even greater quality, efficiency and speed, and I look forward to further enhancing our cell and gene therapy R&D and manufacturing platform," Chang said in a release.
Chang could not be reached separately for comment.
Chang will come to WuXi during a period of manufacturing concerns for the CAR-T field––not the least of which stem from his previous employer.
RELATED: Bristol Myers Squibb in hot water after FDA rebuffs CAR-T therapy on manufacturing concerns
In May, Bristol revealed that the FDA had refused to review its submission for ide-cel, a CAR-T cell therapy for multiple myeloma co-developed with bluebird bio and acquired in the drugmaker's buyout of Celgene.
The FDA highlighted concerns about the manufacturing portion of ide-cel's filing rather than clinical or nonclinical data, Bristol said. The drugmaker expects to refile by July.
A speedy refile could go a long way toward soothing BMS investors' concerns about ide-cel's future. The contingent value rights granted to Celgene shareholders as part of the buyout—but tradeable on the open market—pay out after regulatory approvals for three assets: multiple sclerosis drug Zeposia (ozanimod), ide-cel and another CAR-T therapy, liso-cel.
Zeposia's FDA approval in March was a positive sign, but Bristol set a tight deadline of March 2021 for the ide-cel approval and an even tighter timeline for liso-cel, which needs the FDA's OK by the end of 2020.
That deadline didn't look quite as tight last month; the agency had granted liso-cel a priority review, setting it up for a potential approval in August. But last week, the FDA delayed that decision by three months. That puts the agency's new deadline in mid-November, leaving little margin for error.
RELATED: WuXi upgrades CAR-T offerings with new manufacturing platform
Bristol hasn't been the only one hit hard by CAR-T manufacturing woes.
Back in July 2018, Novartis’ Kymriah—the first CAR-T drug to hit the market—ran into manufacturing glitches, leading the Swiss drugmaker to offer doctors out-of-spec doses free of charge.
WuXi Advanced Therapies launched a closed-process CAR-T therapy platform late last month to help capture the pharmaceutical industry's spending spree in the field.
WuXi will also offer companies two modalities depending on the dose requirements they need. Each has its own set of equipment, tech and materials, which the CRO says will get new cell and gene therapies to market faster.