The Hottest Topics in Cell and Gene Therapy Today

August 26, 2019

 

Earlier this month, Bio Supply Management Alliance (BSMA) hosted a roundtable meeting focused on Navigating the Complex Cell and Gene Therapy Lifecycle. Archbow participated in the supply chain services discussion.  

 

Because cell and gene therapies (CGTs) have unprecedented supply chain challenges “vein-to-vein,” BSMA is bringing vested parties from around the industry together to collaborate in areas that are not competitive threats.  This “Collaborate to Compete” idea is something we’ve embraced and are committed to on behalf of our clients.

 

The roundtable was an intimate gathering of roughly 35 industry professionals; the discussion was a rich, healthy convergence of ideas, challenges, and creative, scalable solutions.  Four key topics stood out as being most pressing as we all work together to streamline the CGT lifecycle in ways that are most meaningful for patients, payers, prescribers, and pharma:

 

  1. The patient services model is changing rapidly.  Delivering care for CGT products takes an enormous amount of coordination across multiple stakeholders in the healthcare ecosystem, including patients, family caregivers, HCPs, manufacturers, suppliers, and payers before, during, and after the therapy.  Historically, the drug has been delivered to the patient, but in cell and gene therapy, we sometimes will need to deliver the patient to the drug.  Add to that the higher prevalence of caretakers in the CGT space and the increased complexity that goes along with advanced supply chain integration for greater speed, reliability, traceability, and temperature-controlled transport.  These differences present an exciting opportunity to reengineer the entire stakeholder experience.

  2. The “right” HUB model could go either way: insourced or outsourced.  With the small patient populations many CGT products expect in the near term and so many unique customer needs (see # 1), CGT manufacturers want to take the absolute best care of each and every patient with a high-touch approach. As the right balance of control (insourced) vs. scalability (outsourced) is being debated, all eyes will be watching the evolution of best practices in this space.

  3. The role of Specialty Pharmacy in CGT today is uncertain. The very nature of the CGT lifecycle conflicts with the Specialty Pharmacy model in ways that are yet to be overcome.  Should manufacturers consider having a pharmacist from an SP onsite?  Or, does it make more sense to move a dewar from location to location to fit the SP model?  With other service providers meeting the high touch needs of these patients in new ways, SPs are actively pursuing solutions to show their value and relevance in this space. 

  4. Pay-over-time models may be an option.  Curative therapies, like CGTs, come with price tags that reflect their value and also keep payers up at night.  A pay-over-time approach for these therapies makes sense, but the data collection, coordination, analysis, and sharing required to manage a long-term payment strategy effectively are unprecedented. 

 

These are just four of the pressing issues in CGT, with boundless others needing attention each and every day.  With no roadmap for CGT, it can be overwhelming to try to stay on top of all the moving parts.  That’s why we’re immersed in this space, participating in events like this roundtable, the CAR-T CR Summit, the Cell & Gene Meeting on the Mesa, and the BSMA U.S. Conference, on behalf of our clients and future clients. If you and your team need assistance navigating the CGT space, we can help.

 

 

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