Two significant milestones for treating and curing diseases were reached this year as the FDA approved CAR-T therapies from Novartis, Kymriah, in August followed by Gilead Science unit Kite Pharma’s cancer gene therapy treatment Yescarta this week. Expected to reach more than $50 billion by 2025, the market for cell and gene therapies is poised to bring hope for the future of medicine.
However, challenges arise as manufacturers must carefully consider the integrated logistics required to bring therapies like Kymriah and Yescarta to market — a process requiring more coordination than the commercialization for traditional therapies.
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Integrating patients as a part of the supply chain
Because their own cells are used for these therapies, patients must be considered throughout all stages of the process. Specifically, therapies must be transported on time and in pristine condition both to and from the manufacturer and ultimately to the treatment site for patient administration. Delays and inconsistent temperatures can reduce the viability of the therapy, which can be costly and detrimental to patients who look to these therapies as a final opportunity for treatment.
As manufacturers move to commercialize cell and gene therapies, they must have detailed knowledge of the supply cycle required to design a logistics strategy tailored to a specific therapy. Often times, it is advantageous for therapy owners to partner with a logistics company that can support the steps necessary to move from the clinical trial setting to a commercialized product by integrating different elements of the supply chain together into one cohesive plan.
Finding partners with experience to support logistics of innovative therapies
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The approval of Kymriah and Yescarta helps set the stage for manufacturers looking to commercialize cell and gene therapies. At the same time, though, regulators are paying increasing attention to logistics as part of their approval – a trend that is likely to continue – making selecting the right partner critical for clinical, regulatory and commercial success.
Manufacturers should look to align themselves with a partner who has experience within highly complex therapeutic areas that require uniquely designed, high-touch, and integrated solutions. A trusted and experienced partner would give therapy owners more flexibility in other aspects of their commercialization plans. Manufacturers should look for partners who will be able to offer:
- Expertise on how to take the processes in place from clinical trials and scale them up to support the product in the commercial market.
- Global reach and local knowledge to support logistics. With the regulatory landscape continuing to develop, it will be critical to have a partner who can work proactively with other stakeholders to ensure therapies get to patients counting on them.
- Actionable and integrated data that enable effective communication across all stakeholders and reduce barriers to access. Logistics partners who use data to complement their knowledge and experience give therapy owners additional confidence in the safety of their products.
- Strategic counsel to help think through the unique considerations that will result in innovations beyond the therapies themselves. Logistics partners can have a role in designing and testing innovative solutions to meet the logistics needs of these therapies – like temperature controlled or real-time reporting packaging options.
As therapies like Kymriah and Yescarta move into the market, a logistics partner can provide the infrastructure and proven methodologies and processes these unique therapies require, allowing therapy owners to continue to focus on innovation rather than diverting resources to build additional infrastructure. Supporting cell and gene therapies will also require a coordinated approach to payment. An integrated logistics partner can offer an established and comprehensive accounts receivable management service, which includes account set-up, invoicing, collection and cash application efforts. Throughout the process, a partner can customize and manage warehousing, customer service and back-office functions – to meet a business’s needs and to reduce manufacturers’ financial risks and administrative burdens.
While these are only some of the offerings a manufacturer should look for in a partner to support their logistics, they should strongly be considered as factors when commercializing new therapies.
As more cell and gene therapies are reviewed and approved by the FDA, manufacturers will need to be proactive in selecting partners that can help them navigate the complex path to the commercialization of these therapies. Integrated partners offer manufacturers the ability to streamline tracking, monitor performance, and ensure there is a fully coordinated patient-centric process for each and every stage of the treatment journey. The right partner will eliminate barriers to access, allowing patients to receive the potentially life-saving treatment they need.
Photo: Filograph, Getty Images
