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Today there are more than 500 active cell and gene therapy agents in clinical development in oncology, each bringing potential hope to physicians, patients, and caregivers fighting this complex disease.
By 2024, Evaluate Pharma estimates that oncology therapeutic sales will hit $250 billion worldwide, and the National Cancer Institute forecasts that there will be more than 22 million cancer survivors. That’s huge progress since Sidney Farber gave Actinomycin to patients with Wilms Tumors in The Emperor of All Maladies, a compelling story written by cancer physician, researcher, and award-winning science writer Siddhartha Mukherjee, Scribner, 2011.
But we must do more.
Commercializing how these critical therapies come to market to help patients hasn’t changed much in the past 20 years. We create target product profiles, identify our potential competition and create messages aligned with positioning statements. The traditional models used across both big pharma and biotech do not account for the changing, complex landscape and crowded market manufacturers face.
Factors including pressures on speed to market, access strategies, and regulatory challenges are among the reasons only 34% of launches are successful.
How can we as an industry improve these success rates while helping patients? It starts with thinking differently.
We as an industry must rethink the pre-launch planning process. We must create a system in which manufacturers can manage the financial risks needed to bring a therapy to market.
Increasingly, a manufacturer needs to validate the current patient journey as well as the changes that are occurring in the therapeutic area. Many tumors are being treated with therapies based on individual biomarkers, increasing the need for companion diagnostic development. What will the patient journey look like at launch? What support will patients need?
Manufacturers must develop programs that are unique to each patient’s journey and the form of therapy each patient community requires. We need to get the right patient the right treatment at the right time. Some patients have a more chronic journey with multiple lines of therapy, while others continue to face low rates of five-year survival (like 3% in metastatic pancreatic cancer.1
Patients have more options for screening to find lung, cervical, breast, prostate and colon cancers. Traditional cytotoxic chemotherapy remains the standard of care for many malignancies, and targeted therapies are now a component of treatment for many types of cancer, including breast, colorectal, lung and pancreatic cancers, as well as lymphoma, leukemia and multiple myeloma.2
The oncology market in the United States is becoming more controlled because patients are accessing treatment in systems that follow treatment guidelines. The NCCN Guidelines3 are used by as many as 95% of oncologists in clinical practice as well as by public and private insurers to determine insurance coverage. Manufacturers need an economic value story to submit to guideline committees for consideration.
It’s no longer enough to name a brand and launch a campaign.
Oncology developers need to know exactly how their products impact the lives of patients, caregivers, and providers. This new approach and thinking requires an interconnected system of data and experts that can bring real-world data and clinical information together and truly develop a patient-focused experience.
Is it easy? Absolutely not. It’s more complex than ever. But today we also have more resources and technology to connect this data than ever before. Oncology launch teams need to think about the patient journey and the value story throughout the development process, especially when creating a target product profile.
We can now also use real-world data and create the value story close to launch, but starting with the value a new therapy will bring to cancer patients should be the industry standard best practice. It’s an approach the oncology sector should bring to life now to help more patients and families tomorrow.
Anne Marie Robertson is Senior Vice President, Strategy & Marketing, and Ellen Cappellino is Senior Vice President, Market & Patient Access, both at EVERSANA.
For more information on EVERSANA‘s oncology commercialization services, visit https://www.eversana.com/solutions/solve-commercial-challenges/oncology-and-hematology/oncology-commercialization/
2. Kumar, Manoj, “Targeted Cancer Therapies: the future of cancer treatment,” Acta Biomed, 2012 Dec; 83(3):220-33