A Blended Solution–How Midsize Pharmaceutical and Biotech Companies Can Optimize the Delivery of Their Clinical Trials
Contributed Commentary by John Barry, ICON plc
August 12, 2022 | Traditionally, biopharma companies use two outsourcing models to deliver their clinical trial portfolios. First, the Contract Research Organization (CRO) model creates a 1:1 relationship between a project and a project contract. Second, the Functional Service Provider (FSP) model leverages economies of scale, allowing the company to outsource portfolio functions. Large pharma is usually attracted to the FSP model because it better addresses their everchanging needs.
But what about mid-sized companies? Through their developmental and commercial success, coupled with their desire to remain an independent company, they experience significant growth as the number of studies in their development portfolio increases. The question then becomes: Have their operating models grown with them?
Recently, mid-size pharma and biotech companies have demonstrated increasing interest in finding solutions that ease their growing pains. While the strategic growth objectives for each company may vary, a customizable solution that adopts the advantages of both models can meet most of the industry’s needs. These advantages have emerged as critical elements and include:
Regaining accountability to deliver projects
Consistent quality management
Reducing the cost of clinical trial delivery
Ensuring synchrony between the variable trial portfolio and the portfolio workforce
Improving cycle times for site activations
Improving patient recruitment
Proactive and real-time status reporting
Mid-size pharma companies have clinical development demands that emulate large pharma in some functions while mimicking a small or virtual company in others. Additionally, new study starts in smaller countries are often inconsistent–which can be challenging to manage in an FSP model but is well suited for project-based sourcing common for a CRO.
The needs of mid-size pharma companies offer an opportunity to create a blended model that combines FSP scale and CRO project-based sourcing. This new model would consider the customer’s needs to design a clinical trial portfolio delivery solution that evolves with their goals and objectives. The proposed “embedded blended solution” is the optimal economic model because it introduces unitized services to offset staff's underutilization due to workload fluctuations. In addition, it can be offered across clinical trial functions, companies, and countries.
This embedded blended solution can support:
The customer's unique goals: Different sponsors will be at different stages in the development, and their commercialization goals will be based on their current position within the market. The embedded blended model removes limitations and enables the portfolio solution design that best benefits the company.
The economic benefit of clinical trial portfolio development: In the past, sponsors have used their resources, along with FSP and CRO model staff, to deliver their portfolio of studies. However, a more optimal solution can be developed using one supplier to access both sourcing models. Then, companies can consider a single operating infrastructure and platform while taking advantage of both models.
Enterprise flexibility: Deciding the right path for growth, when to include a country in a clinical trial, or which legal entity to establish are essential choices for sponsors. An embedded blended model allows companies to use the CRO’s legal entity and office presence while deferring the company presence until later in the growth phase. This option postpones the fixed costs of establishing and managing a physical infrastructure until the development presence warrants it.
A focus on productivity: As sourcing models evolve, sponsors will turn away from a fixed number of resources to fixed production blocks. The embedded blended model would allow innovative CROs to include productivity targets in the contract. Tying the contract to output ensures the model is efficient, productive, and one that enables sponsors to achieve maximum value.
The needs, functions, and locations of mid-size pharma and biotech companies will change over time. As dynamic organizations, they need flexible and customer-centric CRO support. The “embedded blended solution” offers the flexibility and support to deliver quality and effective clinical trial portfolios.
John Barry is the SVP and Chief Strategy Officer for ICON’s Strategic Solutions Division. He manages the division’s consulting practice and provides strategic oversight on critical opportunities and customer models. John has extensive experience in the drug development industry and has worked as an executive leader in various functions, including alliance management, business development, clinical operations, contracts, proposals, and legal. Before joining ICON, Mr. Barry was the Chief Operating Officer at a mid-size CRO and a member of the senior leadership team for Merck Research Laboratories’ Global Clinical Trials Organization. He can be reached at JD.Barry@iconplc.com.