Calabassas, July 17, 2018 . Since the birth of the Biotech industry in 1976 with the launch of Genentech , today we are noticing the promise of the next revolution in Life Sciences where “ science is moving away from a one-size-fits-all, trial-and-error approach toward a targeted approach that uses patients’ molecular information to inform health care decisions”. CAR-T therapy has been hailed as a cure for cancer, but what will it take to successfully commercialize the “ miraculous technology ” and build a robust supply chain over the next decade?

Novartis AG and Gilead , the latter which acquired Kite last October, own the first and second U.S. approvals of CAR-T cell therapies. The treatment discovered takes a patient's T cells (a type of immune system cell) from the blood and adds a gene for a special receptor that binds to a certain protein on the patient’s cancer cells in the laboratory. Large numbers of the chimeric antigen receptor (CAR) cells are grown in the laboratory and given to the patient by infusion. The combined CAR-T cells fight the cancer.

BSMA realizes there is an unprecedented necessity and opportunity to shape and scale the nascent supply chain of immunotherapy for commercialization. Science delivers the right treatment to the right patient at the right time . The overall lead time for this therapy is 16 to 18 days vein to vein. This Direct to Patient (DTP) delivery of the treatment shrinks the supply chain to being as short as imaginable. The resultant challenges to the supply chain of this emerging therapy are myriads and overwhelming.
Meet Our 6 Founding Members
Neil Ackerman, Senior Director, Global Supply Chain Enterprise Planning and Innovation, Johnson and Johnson  
Jayant Aphale , Executive Vice President of Technical Operations, Gritstone 
Kimberly Lounds Foster , Corporate Vice President and Head of Global Commercial Supply, Celgene
Jian Irish , Senior Vice President, Supply Chain, Kite Pharma
Devendra Mishra, Executive Director & Co-Founder, BSMA
Shankar Suryanarayanan, Global Operations Leader, Pharmaceuticals and Medical Devices, Baxter International
Devendra Mishra , Executive Director, BSMA , observed " The value chain of CAR-T Cell Therapy, from therapy discovery to patient care, faces the formidable challenge of management of cell product, process, quality, delivery, customer service, field administration, and compliance across the internal functional silos of an enterprise, external partners and governmental regulatory agencies. There is an extraordinary need to develop materials and supplies, process engineering, equipment, packaging, cold chain logistics, systems, monitoring, customer service and educational training. The premise of BSMA’s initiative is that the required innovation can be accelerated only through collaboration among all the stakeholders of the emerging ecosystem. "
Areas of Focus
The Pharmaceutical manufacturing historically consists of large volume batch production using 1000 L vessels, generally considered a fairly simple process. On the other hand, these new personalized therapies are exponentially more complex than more traditional medicines. The traditional characteristics of scale, speed, reliability, and traceability required for the efficacy and safety of the treatment are non-existent in immunotherapy.

It is envisioned to bring the stakeholders of this expanding industry to address the following issues in a Steering Committee, Webinars, Workshops and Conferences to be organized by BSMA in the US and overseas.

  • Sourcing of Raw Materials and Supplies
  • Clinical Trials Management
  • Laboratory Operations and Interface
  • Demand Planning and Scheduling
  • CAR-T Manufacturing
  • Process Control (Machine and Environment)
  • Cold Storage Packaging
  • Logistics
  • Chain of Custody and Monitoring end-to-end
  • Information Systems
  • Quality Assurance
  • Regulatory Compliance
  • Administration of Immunotherapy in the Field
  • SCM Metrics
  • Next Generation Technology

A systematic and holistic approach will be adopted by the Steering Committee to meet the challenges enumerated above.
BSMA - Driving Innovation in the Life Sciences Supply Chain

Since its inception in 2007, BSMA is a global organization that fosters Innovation and Adoption of disruptive technologies within the end-to-end supply chain of the Life Sciences industry. With offices in California (USA), Brussels (Belgium) and Mumbai (India), BSMA promotes collaboration and networking between professionals of the biotech, pharmaceutical, academic and medical diagnostics enterprises. The Alliance partners with industry, academia, foundations, suppliers, technology enablers, research institutions, trade organizations and the government to improve productivity, quality, product and service integrity, risk mitigation, managerial talent development and patient care globally. It is also the home of start-up companies engaged in business development and scale up.      

CONTACT: Devendra Mishra