Addressing gene and cell therapy commercialization challenges
InspiroGene addresses some gene and cell therapy commercialization challenges by offering logistics programs, distribution services, a biologics specialty pharmacy and a patient hub.
Cell and gene therapy innovation has played a critical role in the healthcare system, advancing patient care and scientific discovery over the past decade. According to a recent report from McKesson, over 30 cell and gene therapies are approved in the U.S., and the FDA predicts that by 2025, 10-20 cell and gene therapies will be approved annually.
Despite rapid scientific innovation, there are several challenges in commercializing cell and gene therapies (CGT), presenting opportunities for businesses and companies to generate solutions or tools that provide services for streamlining the process.
Joe DePinto, head of cell, gene and advanced therapies at McKesson Corporation, says that some of the challenges in CGT commercialization arise from rapidly advancing science. The pipelines for these therapies are rich, and more treatments continue to be launched.
"There's significant optimism in the space because the science is really changing the delivery of products, and the outcomes for patient access are challenging. As the pipelines continue to grow, access continues to become more and more of a challenge," he explained, "Navigating the value chain because of the complexity of the delivery of the products as well as some of the payer and reimbursement challenges all come together to challenge the manufacturers as they launch these products to efficiently and effectively get these products to patients."
InspiroGene
On Oct. 1, 2024, McKesson announced the launch of InspiroGene by McKesson, a business solution focused on supporting the commercialization of CGTs.
"It's a flexible suite of services and solutions for patient access, distribution, and logistics, but we're a group of executives and personnel dedicated to the cell and gene space evolving quickly. The value of the InspiroGene group is that we help all the stakeholders in solutions for these complex decisions that need to be made to allow patients to have more access and for this space to scale so that more and more patients can access these groundbreaking therapeutics."
The company aims to help address some of the complex challenges of commercializing CGTs.
The CGT market is one of the fastest growing fields in medicine, and it's driven a lot by unbelievable innovation. Most of our clinicians said that this can significantly impact patients. The science is complex, but the outcomes are groundbreaking and never seen before.
Joe DePintoHead of cell, gene and advanced therapies, McKesson Corporation
"The need for a dedicated business at McKesson came about from the fact that the CGT marketplaces are at a tipping point conversion from clinical to the more commercial side as more and more products get approved and enter the commercial market," DePinto stated. "There was a need for us to have a dedicated focused vertical to help all the stakeholders in the value chain navigate CGT access -- everyone from manufacturers who develop these products to providers who deliver the products at the site of care to payers who hopefully will continue to engage in innovative payment opportunities to pay for the product for patients."
InspiroGene uses McKesson's assets and configures them to be better suited for CGT products as they navigate through the value chain.
"We have world-class individual assets, and we have an offering that can be integrated depending upon the needs of the companies," he explained.
InspiroGene offers multiple services, including a third-party logistics organization service that provides financial management solutions, logistics and data analytics that can allow for the seamless operational delivery of these therapeutics.
Beyond that, InspiroGene offers a specialty distribution service that homes in on high-touch logistics and advanced data analytics to help CGTs reach the appropriate patients efficiently and effectively.
"The beauty of having McKesson is we have such strong relationships with the medical centers that treat these patients," explained DePinto. "We're a known entity on the specialty distribution side, and we service many CGTs."
"A unique asset that we have is our biologic specialty pharmacy," he added. "Our biologic specialty pharmacy has a dedicated cell gene and rare disease component to it where we have developed a unique drive-by methodology to expedite the delivery of the product to patients at the site of care for CGT."
According to DePinto, InspiroGene leverages the biologics specialty pharmacy to address unique needs in the CGT landscape and deliver therapies as needed.
Another tool that InspiroGene offers is a dedicated CGT patient hub for tailored access and support services for patients, caregivers, and care sites. The hub provides tools for case management and care coordination for several stakeholders, including patients and providers.
"It's a real high-touch, white-glove approach because for these patients, there's a lot of moving parts as they navigate the healthcare system, and they need help along the way. A dedicated cell and gene patient hub allows for that intimacy of understanding and addressing the needs uniquely for individual patient populations."
DePinto explained that the hub offers a broad range of services, including benefit verification, benefit approval, travel and lodging support, copay support, and timing and appointment coordination.
"These are all world-class individual assets available through McKesson, but InspiroGene powered by McKesson allows them to have a cell and gene flavor. It also allows an integrated value offer for a smaller or mid-size company that's looking for one point to handle much of the patient distribution and logistics as well as patient access needs."
Future steps
Despite the program's just-launched status, DePinto highlights future directions and goals for InspiroGene. As mentioned, the CGT landscape is convoluted and rapidly evolving, requiring all stakeholders to adapt accordingly.
"The key for this space is it's not linear -- it's, at times, a circuitous value chain. There needs to be transparency in the value chain. So, we need to ensure that the manufacturers, the providers, and the payers understand where the patient is in the delivery of care. The digitization we use with the hub and our delivery really has to coordinate disparate systems within the healthcare system and the manufacturer at the manufacturing site. "
"The CGT market is one of the fastest growing fields in medicine, and it's driven a lot by unbelievable innovation. Most of our clinicians said that this can significantly impact patients," concluded DePinto. "The science is complex, but the outcomes are groundbreaking and never seen before."
Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.
