HCB News: How is Cardinal Health’s partnership with TrakCel intended to solve those infrastructure challenges?
FG: Cardinal Health is the leading provider of comprehensive services for cell and gene therapies. We are proud of the clinical, regulatory, logistic, and patient-focused value that we offer to healthcare providers and pharmaceutical manufacturers. Partnering with TrakCel allows Cardinal Health to offer sophisticated and reliable tracking and tracing services for these critical therapies. TrakCel offers chain of identity, chain of custody, location and patient journey information throughout the process of product delivery and administration. As partners, Cardinal and TrakCel offer industry leading visibility and transparency to healthcare providers, manufacturers and case managers working with these important medications.

HCB News: Are there other bottlenecks that are preventing widespread development of gene and cell therapies?

FG: Several challenges still exist in the development and widespread availability of cell and gene therapies. Starting from the beginning is patient identification- identifying a very small population of people with a very rare disease can be challenging for manufacturers designing and enrolling patients in clinical trials.

FDA approval is also a required but often lengthy process. The patient-by-patient manufacturing processes are yet another barrier to broader reach for these treatments, as these processes are individualized and take time and extreme diligence. The cost of these medications is another significant barrier to broader uptake and use. These are some of the most expensive medications in the world, and developing payment models for a sustainable future is an area of great focus. A final challenge that I will address is that the final product is often volatile, requiring special handling and extreme temperature controls, tracking and tracing capabilities and often limited stability.

Cardinal Health is in the unique position to help mitigate several of these challenges, but much work is to come to ensure that these therapies are scalable and that they are available to patients who need them.

HCB News: Looking ahead, what are some of the genetic diseases that you believe gene and cell therapies could be game changers for?
FG: Looking at phase II and phase III clinical trials can give us a good idea of what conditions gene and cell therapies might be able to impact. Phase III trials are those that are nearest to FDA filing. Phase III trials are underway for diseases such as pulmonary hypertension, diabetic neuropathy, Parkinson’s disease, chronic heart failure, vision loss disorders, and additional cancer types. Although those are not yet approved, it is apparent that cell and gene therapies are here to stay and will continue to have an important impact on patients who need these life-changing treatments.

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