Emerging biotechnology companies face numerous challenges when developing immuno-oncology products. Here are some simple ways you can help clients navigate the journey from discovery to commercialization.
Despite recent successes, immuno-oncology development remains inherently challenging. Providing continuity throughout can help your clients to minimize potential risks and ensure seamless transitions across multiple stages of development.
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Plan for clinical in early development: (lead optimization, safety and preclinical efficacy). Work with your clients to identify candidates with strong in vivo anti-tumor pharmacology to assess potential combination strategies, and to determine safety. Thoroughly assessing safety and efficacy for earlier go/no-go decisions and evaluating potential risks in early development could reduce problems in later clinical stages.
Enable precision medicine through biomarkers and companion diagnostics. Pharmacodynamic biomarkers can assess if the drug is having the desired mechanism in the immune system and in the tumor, while predictive biomarkers can identify the right patients and ensure a more targeted treatment approach. Biomarkers can then be developed into companion diagnostics if a correlation is found with responses. Helping clients determine the most appropriate immuno-oncology tests, such as immuno-assays, flow cytometry or genomic technologies, in addition to cell-based or tissue-based assays can help them reach go/no-go decisions in a rapid manner for their compound.
Optimize trial design with a patient-centric and adaptive approach. Your client may want to consider adaptive trial design to improve their trial’s safety and efficiency. With proper pre-planning, an adaptive trial design can enable greater focus on critical trial parameters and a faster route to market. In addition, suggest that your client leverage informatics technologies with aggregate data. When you partner with Covance, your client’s proposed protocols are testable with our global protocol database, providing a better understanding of the impact of enrollment criteria on recruitment.
Support rapid trial enrollment in a competitive environment. With many immuno-oncology trials in progress, competition for patients is high, and speed is critical. Applying historical data modeling to identify potential investigator sites, finding investigators most likely to deliver results, and locating untapped patient populations is possible using our proprietary databases for access to diagnostics and clinical tests.
Maximize market potential. Getting to market is a major milestone, but the commercialization strategy should start as early as possible. With expanding immuno-oncology indications and a few dominant market players, our Market Access group can help your client fully understand their product’s positioning and launch strategy early in the development process to ensure its potential in the current and future therapeutic landscape.