From innovation to impact: How to get further, faster
The expertise and end-to-end support needed to bring oncology therapies to market
Every delay faced while bringing an oncology therapy to market represents a critical challenge—whether it’s navigating regulatory hurdles, securing insurance coverage, or managing complex logistics.
“We’ve seen an explosion in innovation in cancer care, and the science is accelerating fast. That is wonderful, but it also brings challenges for the healthcare system, like clinical care, patient access, reimbursement, and logistical considerations,” said Joanna Stevens, Vice President, Enterprise Strategy and Solutions, for Cencora.
- Regulatory complexities like tumor-agnostic approvals.
- Market access challenges associated with crowded therapeutic spaces.
- Evidence generation and data utilization requirements for diverse indications.
- Clinical trial design that satisfies both regulatory requirements and clinical relevance.
- Integration of new therapies with specialized pharmacovigilance systems.
- Stakeholder engagement like connections with regulatory bodies, healthcare professionals, and patient advocacy groups.
Leveraging end-to-end support
For example, each new vendor requires ramp-up time to learn new systems and ways of working. A biopharma also assumes the burden of coordinating work between vendors and must manage the sharing of proprietary information. Increasingly, biopharma companies are recognizing the value of reducing vendor complexity that adds unnecessary internal strain by choosing a single, integrated commercialization partner like Cencora. Whether seeking fully integrated services or simply aiming to minimize the number of vendors across multiple needs, Cencora offers flexible solutions tailored to each client. With expertise spanning regulatory, clinical, market access, and distribution, Cencora provides support throughout the entire product development and commercialization journey, helping oncology therapies reach patients.
Having guided biopharma companies of all sizes through the commercialization journey, Cencora understands the challenges of bringing a product to market. “As a partner across the access continuum, we help smooth out the friction points that can arise,” Stevens said. Capable of providing both strategic and tactical support, Cencora can help biopharma companies avoid missteps that could delay the product launch, impacting manufacturers’ commercial operations and, ultimately, the health of patients.
Launching globally
As an example, when it comes to supporting the patient, a biopharma company would need three different engagements if it were to use separate vendors for developing a patient kit, arranging nursing services, and creating instructional videos. That is not the case with Cencora, however. “Clients like the fact that although we’re not quite a one-stop shop, we’re close to it,” Stevens said. With local market access support in 28 countries, more than 12,000 regulatory submissions annually, and over 1,500 successful brand launches spanning 45 years, Cencora possesses the necessary depth and breadth of expertise and capabilities to support biopharma companies throughout their entire product journey, helping their breakthrough oncology products break through.
“Most of our partners launch first in the United States, but we've been able to communicate the knowledge from the US launch team to our global team. Typically, the client would have to do that,” Stevens said. “So, stringing the strategy together when going into a new market is easier and more efficient for the client because they don’t have to start from scratch.”
Examples of Cencora’s expertise in action include:
- Navigating complex regulatory environments. Cencora led the development of the first-ever tumor-agnostic dossier submission through the Health Technology Assessment (HTA) framework. HTA bodies were not prepared for such broad indications, highlighting the significance of Cencora’s leadership in this space.
- Facilitating market access and commercialization. Cencora helped a large biopharma company differentiate its lymphoma therapy and clear pricing and reimbursement hurdles by developing an effective market access strategy amidst a crowded therapeutic space.
- Coordinating and integrating services. Cencora helped a small biopharma company launch its first product by creating and implementing a cohesive commercial strategy, integrating services across pharmacovigilance, regulatory, and distribution.
- Engaging healthcare professionals at launch. Cencora overcame a biopharma company’s post-acquisition challenges with effective contract design, marketing, and targeted educational outreach. These efforts were curated by an effective group purchasing organization (GPO) engagement strategy for its oncology product launch.
As a trusted end-to-end partner, Cencora helps biopharma companies reach patients every step of the way in their oncology treatment journey. With the breadth and depth of expertise and capabilities necessary to tackle challenges, from common to complex, Cencora supports the patient and product journey by partnering with biopharma companies along the access continuum.
Overcoming barriers for oncology products
- Comparative data requirements. Traditional randomized control trials may not always be feasible or ethical for oncology products. Instead, they often require innovative approaches to generate comparative data, such as external control arms.
- Payer and reimbursement concerns. Establishing an innovative therapy’s value to payers is vital, particularly in terms of cost-effectiveness and therapeutic benefit, given that oncology drugs often carry high price tags.
- Real-world evidence (RWE). Post-marketing studies and RWE are critical for continuously assessing an oncology drug’s safety and effectiveness in broader patient populations.
- Advanced therapies. Integrating advanced therapies, such as cell and gene therapies, into existing treatment paradigms requires careful planning and regulatory strategy to ensure compliance and efficacy.
- Oncology networks and relationships. Connections with key stakeholders, such as regulatory bodies, healthcare professionals, and patient advocacy groups, are crucial to navigating the oncology landscape effectively.
At Cencora, we address oncology-specific challenges comprehensively, and catalyze integration and efficiency within biopharma companies, applying a collaborative model that dismantles silos and unites teams.
People, processes, and technology work together around a cohesive strategy addressing regulatory, clinical, and market access considerations. Factors contributing to bringing oncology therapies to market efficiently include:
- Cencora has seven board-certified oncology pharmacists (BCOPs) who conduct Health Economics and Outcomes Research (HEOR) engagements, reviewing global value dossiers, and formulary kits, and participating in advisory boards.
- Cencora is the largest specialty pharmaceutical distributor for oncology and supportive care products. Our comprehensive distribution capabilities— servicing 95% of US hospitals and other sites of care— support the entire product journey and ensure reliable, efficient, and safe supply chain management for life-saving therapies.
- With decades of oncology experience and expertise, Cencora enhances the patient’s ability to start, stay on, and navigate coverage for prescribed therapies. We work closely with providers and their staff, helping them resolve access and reimbursement issues so patients benefit from therapy sooner.
Bringing innovative oncology therapies to market
- Regulatory
- Market access
- Pharmacovigilance
- Quality
- Specialty distribution and logistics
Cencora supports every step in the process of bringing an oncology therapy to market, saving biopharma companies both time and financial resources. With each milestone having cost implications, avoiding delays allows a biopharma company to launch its product more efficiently and seize market opportunities sooner.
“The skills of the people and the services of the organization make us a great partner for biopharma companies,” Stevens said. “All of us at Cencora chose to come here because we believe in the vision that we're united in our responsibility to create healthier futures.”
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