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Cell and gene therapy are some of the most exciting scientific advances in the pharmaceutical industry, but they are not always commercially successful.
One of the biggest barriers to implementation is cost, with each new gene therapy outperforming previous treatments. in terms of price. For a successful launch, radical innovation alone is not always enough. Even if a treatment is in development, it is important to develop a sound commercial strategy.
Executives from Bayer, Kite Pharmaceuticals and Orca Bio said internal coordination across the organization during clinical development and agility during the growth phase should be a top priority, in a previous ThinkLive Cell and Gene Therapy Best practices were shared during a virtual discussion at Summit 2024. week.
Commercial considerations from the top
In recent years, Bayer has been one of the first to enter the field of cell and gene therapy. 600 million dollars We acquired BlueRock Therapeutics in 2019 and plan to acquire Asklepios BioPharmaceutical. $4 billion deal In 2020.
“We are focused on Parkinson’s disease and chronic heart failure,” Doug Danison, commercial head of cell and gene therapy, said during the panel discussion. “And as you can imagine, these are relatively large indications for a large number of patients. So that impacts how we think about preparing our commercial strategy.”
Bayer’s focus is on treatments that are “life-changing” where treatments are available that provide “reasonable results.”
“We need to understand these patients, consider current outcomes, and design robust evidence generation packages that are centered around sales both within and outside of clinical trials,” he said.
He said it’s best to focus on the business model early, understanding the costs, profit potential and value proposition against the larger metrics.
Payer and provider engagement
Orca Bio is currently conducting mid- to late-stage research on cell therapy for blood cancers, and is concentrating on designing clinical trials with commercialization in mind. So Dan Kirby, chief commercial officer for a biotech company, is taking a more hands-on approach. He reached out to his Orca external stakeholders and asked for feedback on the most valuable endpoints in a randomized trial to ensure patient coverage. The commercial team also asked doctors what it would take from a clinical perspective to justify cell therapy over standard treatment.
“We incorporated all of that feedback as we renegotiated the trial design with the FDA,” Kirby said. “When you think about registration testing, it’s important to prove the point on that test because when you get to the other side of commercialization, that’s what will make for a successful launch.”
The company is currently balancing its Phase 3 leukemia candidate, Orca T, with new assets within the academic community. Obtaining feedback from the academic community and other stakeholders is also important to understanding provider capabilities.
“I feel like we’ve been around for a while, but you’re introducing changes into their systems, and no two cells or gene products are the same,” he said. “But we need to get early feedback from the perspective of health care providers and, of course, payers, advocacy groups, and physicians.”
Danison reiterated the importance of connecting with payers and understanding how care is delivered.
“We all interact differently with payment centers based on what we need for our product…to understand how that treatment is performed in the treatment center,” Danison said. Ta. This is your chance to capture the market in a better environment where you know how things work. ”
The leadership of Kite Pharmaceuticals, a Gilead Sciences company with a pipeline of CAR T cell therapies in oncology, is putting science at the forefront of commercial discussions.
“We recommend leveraging scientific advice as early as possible so that you can approach your discussions with payers with a dispassionate eye,” said Vice President of Global Commercial Strategy, Value and Access at Kite Pharma. Ted Slocombe said at a press conference. discussion.
Internal best practices
At Orca Bio, in addition to long-term planning meetings, internal alignment focused on quarterly goal setting with management was essential. As we grew from a small, close-knit group, our meetings covered the functions of our growing leadership team, tracked progress on goals, and remained agile.
“In this market, and being a smaller company, you always have to make trade-offs and manage your cash burn,” Kirby said. “This really helps us realize across the organization that we are not spending as much money on commercial, but at the expense of operations. It’s a really good way… to adjust our priorities. , to ensure we have the resources we need to bring these products to patients.”
Orca not only brings business leaders closer together, but also differentiates them.
“If you look at the number of startups and what they’re doing, you see there’s tremendous technology out there,” Kirby said. “And we need to focus on what we’re doing to commercialize, what’s in front of us.”
Managing a wholly owned subsidiary is a different ball game for a company like Bayer, Danison said, and identifying which decision-makers are needed to ensure commercial input is reflected in treatment plans and clinical trial plans. It is said that there is The goal is to create consensus among Bayer and its subsidiaries.
“In large companies, everything tends to be functionally driven,” he said. “For us, we’re always looking to bring together cell therapy teams and gene therapy teams cross-functionally to provide a unified view of what needs to happen in medical marketing, market access, and indeed gene therapy sales. do my best.”
In addition, Danison said his job is to allow the team to “make decisions within the team” while allocating resources within the budget.
“If[product teams]don’t get that funding early on, they’re not going to be set up for success in the future,” he said.
Kite has found that cell therapy is best initiated using a team approach. The company has two approved therapies to treat lymphoma, Yescarta and Tecartus, in addition to drug candidates in the pipeline.
“We like to say that cell therapy is a team sport,” Slocombe said. “It is very important that sales and medical personnel work well together.”
