Devendra Mishra
Executive Director,

The innovative therapy of Cell and Gene Therapy has imposed Draconian demands on the supply chain of the embryonic industry in terms of production batch of one, sixteen day vein to vein lead time, cryogenic preservation and cold-chain logistics, chain of custody, real-time patient care and cost of treatment.

Commercialization of the therapy faces the challenges of raw material supply, supplier QA, apheresis, scale up of clinical operations, manufacturing productivity, distribution and logistics, information systems, digitalization, data analytics, governmental compliance and efficacy of treatment.

Apheresis remains the weakest link of the supply chain and the supply chain is only as strong as its weakest link. First, apheresis has an unprecedented ecosystem that traditional pharma does not have. It involves Hospitals, Blood Collection Labs, Material Suppliers, Clinical Service Providers, Manufacturers, Specialty Distributors, System and Network Enablers, Research Organizations, Academia, Regulatory Government and Standard Bodies, to name the major ones. While the Standards are being set by ASFA, FACT, SCB PDA and others, it is imperative that a systems view be taken to address Best Practices where stakeholders, Therapy Manufacturers, Technology Enablers and Service Providers collaborate. And this is the scope of BSMA whose members represent all aspects of the supply chain of the Cell and Gene Therapy supply chain, from end to end. BSMA is that unique organization which is addressing the business problems of CGT in an industry-specific manner.

BSMA’s Steering Committee for Cell and Gene is committed to promoting collaboration to advance the commercialization of Cell & Gene Therapy for it believes that we must collaborate to compete, particularly when the required infrastructure is not in place for an embryonic industry. Under the leadership of supply chain management heads of the major Cell and Gene Therapy companies on its Steering Committee (Atara Biotherapeutics, Allogene, Bluebird Bio, Bristol-Myers Squibb, Celgene, Gritstone Oncology, Gilead Sciences, Johnson and Johnson, Kite Pharma, Novartis, Orchard Therapeutics, Sangamo, Seattle Genomics and Ultragenyx), BSMA is strategically moving ahead to organize conferences, webinars, continuing education programs and publications in the US and Europe. It is also collaborating with Standards Agencies for Cell and Gene Therapy.                     

Given that cell and gene therapies are in their infancy, no single company has the wherewithal to upgrade and improve the capabilities and performance of the entire ecosystem. Collectively, the industry should collaborate in areas which are not competitive threats, examples of organizations where manufacturers can continue to collaborate further is with center of excellence focused organizations like the Bio Supply Management Alliance and UK’s Cell & Gene Therapy Catapult. These organizations have created the opportunity for those working on CAR-T supply chains to come together and share their success and failures for the community to learn from and move forward quickly.

The Bio Supply Management Alliance (BSMA) was established 13 years ago to address the challenge of transforming Biotech from being a Science to a Business. A holistic Supply Chain Management perspective was taken to promote collaboration among the stakeholders of the Biotech industry in order to achieve the objectives of efficiency, lead time reduction, quality assurance, governmental compliance and patient care. Conferences, steering committees, publications and continuing education programs have been its hallmark in the USA, Europe and India. The mission of BSMA has been advanced by an advisory board of the supply chain management heads of all the major biotech companies and academic institutions. Today there are over 5,000 participants and 500 companies in the global activities of BSMA.

Email Devendra Mishra to join the Steering Committee of Cell and Gene Therapy, or call 818-224-1552