For Immediate Release
Media Contact:
Shankar Suryanarayanan
Title: Co-Chairperson, CAR-T Steering Committee, BSMA
Phone: +1.267.312.1137
CAR-T Cell Therapy Proceedings
at the BSMA Conference  
BSMA's 11 th Annual Conference brought together executives of major bio-pharma companies to address the “Commercialization and Scaling Up of CAR-T Cell Therapy Supply Chain”
October 23, 2018 , Foster City, CA . The 11 th Annual Conference of Bio Supply Management Alliance ( BSMA ) held on the 11 th of October in Foster City (CA) brought together executives of major bio-pharma companies to address the “Commercialization and Scaling Up of CAR-T Cell Therapy Supply Chain”. This unprecedented confluence was led by Dr. Jian Irish , Head of Global Manufacturing at Kite Pharma and Shankar Suryanarayanan , Former Global Operations Leader of Pharmaceuticals and Medical Devices at Baxter International. These two executives serve as the Co-Chairpersons of BSMA’s Initiative to build and advance the supply chain of this nascent medical science to deliver affordable healthcare. The consensus at the premiere gathering of over 300 executives was that while personalized medicine promises to eliminate cancer, its incorporation of agility, accountability, quality and integrity in the business end-to-end will have a game-changing impact on the traditional supply chain of Life Sciences.
Key Points of CAR-T Cell Therapy as reported by Shankar Suryanarayanan
Jian Irish , Global Head, Manufacturing, Kite Pharma , delivered the Keynote Address, “On Demand Supply Chain for Personalized Medicine” , which provided highlights of the therapy:

  • It is highly effective in saving lives even after all other treatments have failed for certain types of cancer
  • Make to order, mission critical manufacturing process takes ~3 weeks from collection of T-cells from patient to return of engineered T-cells ready for re-infusion to same patient 
  • Presents unique Operational challenges associated with personalized medicine e.g. Processing batch of 1, maintaining chain of identity and custody, ensuring real time track and trace and transportation at cryogenic temperatures
  • Kite Pharma has created an Integrated Business System with custom portals for all stake holders in the ecosystem including patients, healthcare providers, manufacturing, suppliers and payors 
  • Scale up and scale out efforts require full engagement of healthcare system at all tiers
A discussion among eminent panelists identified the following issues that have to be overcome to improve execution:
  • Need to develop industry standard processes at Apheresis centers
  • Low potency level of T-Cells and variability from patient to patient
  • Constant change in production schedule
  • Highly labor intensive process in manufacturing
  • Very expensive single and sole sourced processing and quality control materials
  • Need to upgrade GMP standards and capacity of some key suppliers
  • Comparisons were also made to Allogeneic CAR-T for execution simplification and to Dendreon for lessons learnt
Moderator: Shankar Suryanarayanan, Co-Chair CAR-T Steering Committee, BSMA
The Panel consisted of the following members, left to right: Laura Alquist, Vice President, Global Supply Chain, Kite Pharma; Reggie Foster, Director Logistics and Packaging Engineering, Kite Pharma; Jayant Aphale, Executive Vice President of Technical Operations, Gritstone Oncology; Carlo Guy, Global Head, Supply Chain - Cell and Gene Therapies, Novartis; Kenneth Locke, Head of External Manufacturing & Strategic Sourcing - Cell Therapy Dev & Operations, Celgene
Strategic Sourcing deemed to be the Achilles’’ Heel for the supply chain executives in the business, were addressed by  
Kenneth Locke , Head of External Manufacturing & Strategic Sourcing - Cell Therapy Dev & Operations, Celgene, and
Howard Bland , Sr. Director of Sourcing and Procurement, Kite Pharma
Both speakers highlighted the complex portfolio of materials and services required to deliver on the promise of CAR-T. Given the nascent stage of the industry, risk mitigation is a key priority due to sole and single sources for some of the production and quality materials. The speakers also shared key policies, processes and practices being instituted to ensure that suppliers chosen for new development programs are thoroughly vetted for GMP capabilities, financial strength and capacity availability.

Since some of the CAR-T programs started in non-cGMP environments e.g. Academia, standards at some of the key suppliers have to be upgraded before the therapies can be Commercialized. In order to ensure that academic institutions incorporate cGMP requirements early on, Stanford University held the first ‘Academic cGMP Symposium: Cellular Therapeutics & Translational Medicine’ in March 2018. The CAR-T Industry should consider collaborating with Academia on such efforts which will make it easier and faster to Commercialize future therapies.
Dan O’Donnell, President of Aquilon Consulting (formerly with Fisher BioServices) provided an in depth presentation on Logistics considerations. Based on his experience, Dan highlighted key parameters to be monitored in real time and various solutions for doing so. He also highlighted the impact of choosing the drug delivery system e.g. Bag vs. Vial on logistics requirements and cost.
Janel Firestein , Partner, Life Sciences Industry Leader, Clarkston Consulting wrapped up the day with a systematic approach to tackle the various challenges and make continuous improvements in CAR-T execution. She also suggested other areas that may provide solutions that are adaptable to CAR-T e.g. transplantation.
Given the tremendous interest and to accelerate improvements in this nascent industry, BSMA has committed to organizing additional workshops to address major areas for improvement. Key areas identified thus far for NEXT GEN CAR-T are:
  1. Improve existing processes e.g. through automation
  2. Productivity enhancements in Operations e.g. reduce cell growth time which currently accounts for nearly 50% of the lead time
  3. Make Quality control testing and release faster and cheaper
  4. To make it truly affordable and widely accessible in the long run, determine enabling technologies and Regulatory changes required to take CAR-T closer to patients.

Members of the industry are urged to join the initiative to drive innovation in CAR-T execution. Interested parties please contact Shankar Suryanarayanan .
About BSMA
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
Bio Supply Management Alliance | CA |