Outsourcing Early Development Operations

BioPharm International spoke with Marybeth Reynoso, senior director, early development strategic operations at PPD about the direction the industry is taking regarding the outsourcing of early development operations to contract research organizations (CROs).

Investing in early development

BioPharm: Are CROs investing in early development services more than in the past?

Reynoso (PPD): In our recent experience, yes. There was a period over the last decade where we saw a number of global CROs actually contract their early-phase operations, including divesting their clinical research units (CRUs). However, today, we find that CROs, including PPD, are recognizing the evolving nature of early-phase trials and are investing in innovative ways to deliver in the early development space. As early-phase trials increase in complexity, we have seen pharma and biotech outsource much of their early development to CROs in full-service or single-service (functional service provider) models. Sponsors have the desire to see if their drug produces a signal in the intended patient as quickly as possible. Early development CROs have taken on this challenge in various ways with a variety of solutions that all require some level of investment.

BioPharm: What kind of early development services are CROs investing in?

Reynoso (PPD): CROs are leveraging and investing in new innovations, technology, and increased global capabilities to deliver trials faster enabling a more efficient drug development process. They have established resources, teams, and processes that are able to adapt and deliver early development studies seamlessly to proof of concept (POC). Often the CROs transition the compound through the drug development process internally and occasionally to another provider. By developing models that accommodate healthy subjects in complex studies while investing in the ability to access select patient populations, CRUs maintain greater control with regard to enrollment, and speed of execution in a limited number of locations.

Investing in fit-for-purpose staff ensures a streamlined operating model. Upon successful completion of the studies, provided the molecule is safe, the study can be transferred seamlessly to late-stage development teams.

Such investments give sponsors the ability to accelerate from healthy subjects to patient populations in the early phase spaces. Investment in unique recruitment models for healthy and patient populations allows CRUs to provide clients unique solutions with complex studies. While leveraging dedicated early phase staff and processes, CROs can facilitate the client’s desire of getting data for good go/no go decisions expeditiously.

Overall, early development CROs are investing in those elements that get sponsors access to patients as safely and cost effectively as possible.

The benefits of outsourcing early development

BioPharm: What are the benefits of contracting out early development?

Reynoso (PPD): Maintaining a CRU and resources for early development is quite expensive. Some sponsors had their own early-phase CRUs, but over the past decade the studies increased in complexity, including multiple arms into a single protocol. Also, they tended not to have access to the patients in a confined manner. The sponsor CRUs did not have the ability to evolve their operating models to adapt to the new complex protocols nor could they include access to patients. Bio/pharmaceutical companies are better positioned to put their resources toward the larger late-stage trials while choosing a global CRO like PPD as their early development preferred provider.

BioPharm: What are some best practices for using a CRO for early development?

Reynoso (PPD): There are numerous best practices that sponsors should employ when identifying CROs as their partners for early phase delivery: utilize CROs that have new drug early development expertise and proven access to patients; ensure the CRO has an efficient safety review process and perhaps a medical safety board; identify CROs with their own CRUs ensuring the highest degree of oversight, quality, and safety; and verify that the resources are truly early development experienced resources and not repositioned later stage resources.

Employing a CRO’s ability to leverage internal processes, experienced resources, facilities, and patient populations and be more efficient and innovative as the industry evolves and the landscape changes, is a good practice to engage in.

Article Details

BioPharm International
Vol. 32, No. 10
October 209
Page: 48