Cell and gene therapies have the potential to change countless lives. These therapies are also transforming patients’ role in the supply chain.

Take Chimeric Antigen Receptor (CAR) -T cell therapy, which is being used to treat cancer and other diseases. With this therapy, a provider collects a patient’s T-cells in a process called apheresis. The T-cells are then reengineered in a lab to attack cancerous cells. The manufacturer ships the CAR-T cells in a cryogenic dewar back to the site of care. The provider then reintroduces the cells back into the patient.

Groundbreaking CAR-T therapies offer a potential “one-time cure” for diseases like pediatric acute lymphoblastic lymphoma and adult DLBCL. They could also transform disease categories including oncology, neurology and ophthalmology, giving hope to patients who need it most.

But CAR-T therapies also bring challenges, including:

  • Their immune toxicity
  • Their high cost
  • Their complicated logistics needs
How Biopharmaceutical Manufacturers Can Support CAR-T Therapy Patients

With CAR-T therapies, there is no room for inefficiency in the supply chain. After all, each treatment is only manufactured once, with no backup. Given these high stakes, your biopharma company needs to support your CAR-T therapy differently to ensure its clinical and commercial success.

Challenges for CAR-T providers and patients

CAR-T therapies hold a lot of promise. But to help meet that promise, case managers, providers, nurses, biopharmaceutical manufacturers, patients, pharmacies, and other stakeholders need to communicate effectively.

Coordination among hospital staff is essential, starting with the apheresis process. The need grows as the patient receives lymphodepleting chemotherapy and waits for his or her treatment to be manufactured. After the T-cell infusion, hospital staff need to keep a close eye on potential toxicities. If these appear, it may require coordination with an ICU, ER, or neuro unit.

Finding the right partner for your CAR-T offering

Everything I’ve covered so far shows the need for a partner who can manage this complex process. After all, you need to focus on supporting providers as they focus on caring for their patients.

Your partner should have deep clinical subject-matter expertise, through its network of providers, in areas such as oncology, neurology and ophthalmology. This will help them understand and manage the complexities of CAR-T therapy.

Once you’ve found the right provider partner, you can work together on a process map. This will help you deliver the best treatment to patients.

Process mapping helps you and your partner understand CAR-T therapy’s challenges and helps reduce risks. It can cover:

  • The patient journey
  • Stakeholder touchpoints
  • Technology needs

Here are some tips that can help you and your provider give a seamless experience for patients.

Early education is key for CAR-T

For years, scientists have been working to improve outcomes in pediatric and young adult patients with r/r B-cell acute lymphoblastic leukemia (ALL). CAR-T therapy meets that need, and providers are excited about its potential. The challenge now is to help them fully understand the complex logistics, high cost and potentially life-threatening adverse events that can affect patients and caretakers.

Offering high-touch CAR-T therapy education to patients, caregivers and providers is one way you can help this therapy meet its potential. To do that, you must understand where these potential patients may be referred from and where they are being treated.

The first part of the education is making sure patients know how your CAR-T therapy works and what is required for the treatment to be effective. Patients should understand each step in the therapy process. This includes everything from the first blood draw to post-treatment monitoring. They should understand how long it will take before they get treatment. And they should be properly prepared before they begin a treatment that requires a great deal of precision.

Educating caretakers and providers is critical

Informing patients is not enough. Caregivers should also be part of your patient education program. Most patients who receive CAR-T therapy are seriously ill. They might have relapsed or might not be responding to other treatments.

Caregivers need to know how to care for their patients before leukapheresis even begins. Their education should start as early as the clinic consultation and pathology review of the patient. And they need to be kept informed all the way through post-infusion, including detecting signs of potential complications like a cytokine storm or neurotoxicities.

Providers need to be informed, too. Each CAR-T therapy has a different care protocol. Your education program should include any provider who cares for a patient during the entire treatment process.

Providers should know:

  • How your therapy works
  • How to administer your therapy
  • What potential side effects to watch for
  • The medical care that should be available at any point in the process
Create a distribution and logistics checklist

The treatment itself is not the only complex part of the process. Making the patient-specific treatment and then getting the treatment back to the patient is also a challenge.

You need to move the patient tissue safely through your supply chain and manufacturing process to the eventual point of reintroducing it back into the patient. These are high-value patient samples that are being shipped and stored at cryogenic temperatures—that’s negative 150 degrees.

This means your usual distribution and logistics approach won’t work. You need a partner who offers specialty distribution and cryogeniclogistics services for your CAR-T therapy.

Given the cost and clinical stakes, your biopharma company, patients and providers all have a huge interest in making sure your distribution partner is up to the job.

Your checklist of requirements for your distribution partner should include:

  • Sets up existing accounts for easy onboarding and financial tracking
  • Stores and transports your product at the right temperature range
  • Provides storage logistics during your product’s entire lifecycle
  • Educates receiving providers about your product
  • Maintains product viability from thawing to infusion

The clinical and commercial success of your biopharma company’s new CAR-T therapy isn’t a guarantee after your clinical trial is over. To improve your odds, you need to find a partner that:

  • Understands the patient and provider challenges
  • Can educate all stakeholders as they navigate through the complex CAR-T therapy process
  • Has the infrastructure to manage the financial flow of a high-cost therapy

By taking control of the supply chain, you’re not just taking control of your own business outcomes. You’re taking control of the patient experience. And if done right, that can lead to life-saving drug therapies for patients who need them most.

Related: Learn more about McKesson’s specialty drug distribution services for biopharma companies.

Top requirements for your distribution partner
  • Sets up existing accounts for easy onboarding and financial tracking
  • Stores and transports your product at the right temperature range
  • Provides storage logistics during your product’s entire lifecycle
  • Educates receiving providers about your product
  • Maintains product viability from thawing to infusion
 
Layne Martin

About the author

Layne Martin is the Vice President/General Manager of Supply Chain Solutions, which has responsibility for McKesson Specialty Health’s core distribution services, title 3PL and non-title 3PL services.  Layne’s manufacturer relations team partners with pharmaceutical and biotech manufacturers to create distribution models tailored to drive value to key stakeholders in the evolving specialty marketplace. Over the past 16 years at McKesson he has held a number of roles in manufacturer services, business development, finance and M&A. Layne holds a BA degree from Luther College and a MBA from the University of Michigan Stephen M. Ross School of Business.

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