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Manufacturing Cures: Infrastructure Challenges Facing Cell And Gene Therapy Developers

To Ensure Broad Patient Access To Cell And Gene Therapies Stakeholders Must Address Manufacturing Challenges

 
• By Michael Lehmicke

As more regenerative medicine products approach clinical testing and commercialization, stakeholders in the field are increasingly pressed to address substantial challenges, including pricing and reimbursement, GMP manufacturing, and clinical availability, and patient accessibility to these life changing therapies.

regenerative-medicine
The supply chain for managing new cell and gene therapies is incredibly complex • Source: Shutterstock

Over the past decade, advanced therapies have transitioned from academic dream to a clinical reality. With the recent approval of AveXis/Novartis AG’s Zolgensma, a gene therapy for spinal muscular atrophy (SMA) Type 1, and the international approvals of Novartis’ Kymriah, Kite Pharmaceuticals/Gilead Sciences Inc.’s Yescarta, and Spark Therapeutics Inc.'s Luxturna, it is clear that increasing numbers of patients will benefit from regenerative medicine therapies in the coming years.

Though this field has the potential to dramatically transform the health care landscape and treat patients who have in the...

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