After initial concerns and disappointing studies in the 1980s to early 2000s, cell and gene therapies are now at the forefront of medicine, displaying unprecedented efficacy in a number of clinical trials. As more trials occur, the patient success stories are growing, and an increasing number of manufacturers are investing or partnering to develop more of these next-wave cancer medicines. In 2015, close to 100 clinical trials involving CAR (chimeric antigen receptor) T-cell therapies were under development, according to the Journal of Immunology Research.

To date, manufacturers, scientists and clinicians have been focused on enabling the development of these personalized medicines and addressing the complex nature of cancer in each individual patient, and now manufacturers are shifting their focus to bringing these innovative therapies to market. The question is, how can manufacturers navigate the complex healthcare ecosystem to bring these patients the innovative medicine that they need?

Commercializing cell therapies such as CAR-T goes beyond the traditional diagnosis and treatment process that we’re used to in oncology today. Rather, it includes a multistep process including apheresis, cryopreservation, transport, reprogramming, quality controls, cryopreservation and re-transport, some type of chemotherapy or preparation for the infusion, infusion, and acute and ongoing monitoring for short- and long-term side effects, which oftentimes can be quite dramatic. One can imagine that the customer service model here truly needs to evolve to ensure that manufacturers successfully navigate this multistep journey to get the medicine safely to the patients who need it.

Here are three key strategies—and tips for implementing them—that manufacturers should keep in mind when commercializing cell therapies.

  1. Ensure that the customer-facing model is different.
  • Think beyond the patient and customer journey to the cell journey to capture all of the stakeholders involved. Then design a service model rather than a commercial model to handle the multiple steps and stakeholders in the cell journey.
  • Focus on a few key centers of excellence and ensure a high degree of service and quality in the first sets of patients treated. Make sure to build a strong referral network from community-based oncologists to drive patients to these centers of excellence.
  • Create and hire for truly differentiated customer-facing roles, with the appropriate skills to meet the unique needs of these therapies. You’ll need to explore the bounds of medical and commercial collaboration with compliance teams to enable seamless customer service.
  • Ensure that the reimbursement strategy is well thought out and optimized for in-patient and out-patient dynamics.
  1. Use sales operations and back-end systems as a competitive advantage.
  • Construct a robust, accurate forecasting process to plan for manufacturing capacity requirements. (Planning for lab capacity requires much more detail than traditional sales forecasting.)
  • Think about how technology and platforms can provide a competitive advantage in your service model.
  1. Don’t reinvent the wheel. Work within the existing healthcare ecosystem.
  • Consider partnering with existing players in the cell journey versus building from scratch to enable high utilization of your therapy (or, at the very least, prevent barriers to utilization).
  • Work with governmental and regulatory bodies to overcome cross-border treatment hurdles.

While life sciences companies are just now beginning to address these topics, the stakes are high to get it right. With the competition intensifying, the manufacturers that think beyond the science to help patients in need gain access to these curative medicines will win the day. And that will be a win for cancer patients everywhere.


Topics: Innovation, Namita Kalyan, oncology, CAR-T, next-wave cancer medicine