Perspectives Blog

Clinical Development Oncology & Hematology

Bringing an Oncology Asset to Market: In-House vs Outsource?

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During the multifaceted journey of bringing a promising therapeutic to market, sponsors are faced with a critical choice—whether to manage asset development in-house or to outsource to a clinical research organization (CRO) partner. This decision can influence timelines, costs, control over the development process, and the likelihood of success. Understanding the pros and cons of each approach is essential for determining which strategy is best suited to the unique needs of both the program and the sponsor organization. 

In this blog, we compare in-house management with outsourcing to a CRO partner and explore the benefits of integrating regulatory, clinical, and medical expertise to propel asset development forward. 

A tale of two management strategies  

For companies with sufficient resources, in-house management offers several advantages, including: 

  • Greater control and oversight. Managing development internally allows for direct supervision of every aspect of the program, ensuring alignment with the overall vision of the sponsor. 
  • Confidentiality. Keeping projects in-house reduces the risk of intellectual property (IP) exposure and enhances the security of proprietary technologies and data. 
  • Convenient communication. Proximity of team members facilitates timely communication and decision-making, reducing the likelihood of misunderstandings. 
  • Development of internal expertise. Building in-house capabilities contributes to the development of specialized skills and institutional knowledge that may benefit future programs. 
  • Agility. Internal teams may be able to adapt more quickly to changes in program scope or direction without the need for contract renegotiation. 

However, in-house management requires significant investment in infrastructure, equipment, and personnel, leading to increased overhead. Resource constraints may lead to bottlenecks and developing internal expertise can be time-consuming. Further, managing all facets of development adds layers of complexity in areas that may be outside of a sponsor’s core competencies. 

Working with a dedicated CRO, on the other hand, provides substantial benefits that support a more seamless asset development experience. Some of these benefits include: 

  • Access to existing expertise. CROs bring specialized knowledge and experience that can support formulation of an effective regulatory strategy and streamline trial design and execution. 
  • Resource flexibility. CROs can adapt to changing needs by scaling resources up or down, right-sizing the team for the tasks at hand without long-term commitments. 
  • Cost efficiency. Utilizing a CRO can be more cost-effective than maintaining an extensive in-house team, allowing for better budget allocation. For example, rather than hiring full-time employees with market access and commercialization expertise during the early stages of clinical development, a sponsor can outsource that function to a CRO that provides the necessary expertise with a just-in-time resource, converting a fixed cost into a variable one. 
  • Faster timelines. CROs often have established processes and resources that can expedite the development timeline and facilitate transitions if the sponsor experiences turnover. 

Access to integrated expertise when you need it 

Partnering with the right CRO provides a sponsor with access to extensive experience gained from working with many companies across many therapeutic areas and interacting with regulatory bodies around the world, which ensures all development activities comply with local and international regulations. In particular, CROs can ensure development plans factor in new regulatory initiatives or guidelines such as Project Optimus, which aims to reform dose selection and optimization in oncology drug development, earlier collection of patient reported outcome (PRO) data, and the need for a Diversity Action Plan.   

It is important for development plans to map out early and frequent engagements with regulatory bodies to ensure deployment of the most efficient strategies for obtaining marketing authorization. These strategies include use of adaptive study designs, patient-centric approaches and real-world evidence to improve and enhance outcomes, as well as development of a robust plan for post-market surveillance, continued real-world evidence generation and potential label expansion.   

Beyond regulatory expertise, the right CRO can help a sponsor begin planning for and deploying medical science or clinical pipeline liaisons to bridge the gap between clinical development and market access. These roles are critical in providing valuable insights into patient needs and clinical practice that can feed into the commercialization strategy.  

A CRO partner as an extension of the sponsor team 

While certain disciplines will scale up and down throughout the course of a clinical program, there are three core CRO roles that should serve as an extension of the sponsor team at every stage of development: 

  1. Regulatory strategy lead who oversees and facilitates all stages of the development plan and guides the team to adjust based on regulatory feedback or other unexpected hurdles. 
  1. Operations strategy lead who translates the protocols into practice by outlining the operational delivery strategy, navigates the competitive treatment landscape to ensure the right country and site mix, defines evidence-based recruitment rates, and deploys patient-centric methods, as necessary. This individual stays engaged with the study teams throughout delivery and makes recommendations for adjustments based on the data, which could include the addition of a new country, additional sites, or alternative patient recruitment tactics, while also staying aligned with the overall regulatory strategy and timeline. 
  1. Medical monitor or clinical pipeline liaison who informs the delivery strategy through knowledge of the patient treatment journey. This individual also fosters relationships with the medical community to build awareness of the asset, drive recruitment and support data quality by keeping a study top of mind with participating investigators

Making the decision for your asset 

Partnering with a CRO can improve the efficiency, quality, and success of asset development. The right partner will offer integrated expertise and flexible, adaptable solutions tailored to the needs of an asset development program, scaling services to ensure all stages of delivery remain on track.  

To learn more about how Premier Research can help propel asset development, contact us

ABOUT PREMIER RESEARCH:  

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.    

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.    

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.