Developing A Strategic Relationship – Amgen And PRA

By Rob Wright

Life Science Leader (LSL): Can you explain the process and timelines behind the development of a partnership such as the recently announced collaboration between Amgen and PRA?

Thoelke: When new opportunities arise and sponsor companies are vetting CROs or partners for their work, they look first to their existing relationships. Then, particularly for new development areas such as biosimilars, they look at the entire landscape for other organizations that have specific expertise in that field.

Once a subset of potential CROs/partners has been identified, they are vetted, interviewed and evaluated in order to determine which have the most appropriate and best biosimilar experience to meet the sponsor’s needs for a successful bio-similar development program moving forward.

That process can take anywhere from two to six months or longer, depending on how complicated the discussions are and the timeline of the sponsor company. In this case we were happy to be already working with Amgen and had a relationship with them over the years.

From the CRO’s perspective, it is always our preference to have more lead time than less. The role of a CRO is essentially to provide people and services that have expertise to successfully complete whatever action is being requested by the sponsor. If given adequate time, we can more fully develop plans for the outsourcing process that will give a sponsor a better picture of what we can provide. Therefore, our preference, particularly with our established partners such as Amgen, is to have as much access to pipeline information as early as possible so that we can start thinking about strategy and resourcing needs. Purely tactical decisions where an RFP goes out and we respond in ten business days and defend our bid in another week or two are routine and more standard in the industry, but are probably not the best way to utilize the breadth of expertise of potential CRO partners.