Biopharma's Needs And Focus Of Small Sponsors

By Jonathan Lee, VP of development operations and Deborah Bisio Dwyer, leads the outsourcing group, Cerexa

In this day and age of preferred service provider relationships and/or functional service providers, small pharmaceutical and biotechnology companies present a unique challenge to service providers vying for their business. The resource constraints (both money and people) and time lines are critical, given a narrow or single product development pipeline, little to no revenue stream, and a hyperfocused management team. While these issues may not be unique to small companies, oftentimes the viability of a project, and possibly the company, may lie within two critical aspects — the people and on-time delivery of the project.

The Importance Of Identifying The Right Project Leads
Small companies spend a significant amount of time during the interview process screening potential employees to ensure they have a sense of urgency, a broad base of experience, and the ability to forge collaborative relationships. The expectations of a service provider’s project lead are very similar. This necessitates the service provider’s project leads to act with a sense of urgency and to take action before issues escalate into problems. As no one likes surprises, the small companies value an early “headsup” on potential issues, with the knowledge of what is being done to monitor or mitigate them. The intention would not be that the sponsor would vigorously engage at this time, but allow the service provider time to manage the issue at hand. Moreover, if the issue escalates to a challenge, the sponsor is already aware and can quickly engage to jointly determine a course of action. Project leads should constantly be considering if there are additional resources or pockets of expertise within their organization which could be solicited as advisors or engaged formally.

Breadth and depth of experience are critical to the success of the project lead. These traits enable them to be knowledgeable, manage all aspects of the project, and act as a single point of contact. The project may encompass various functional areas such as medical writing, protocol development, site contracts, site start-up, data management, site management, monitoring, etc. Thus, the service provider’s project lead would need breadth of expertise to be able to understand the interdependencies of the various departmental processes. They would also need depth to assess and prioritize potential risks and recommend to the sponsor appropriate mitigations.

Not to be overlooked is the service provider’s project lead’s ability to forge a strong and collaborative working relationship with the sponsor’s project lead. Underlying this ability would be the communication skills needed to convey the right message at the right time in a collaborative manner. Just as important as their communication skills is their ability to build trust. This entails the sponsor believing the project lead understands the program and is able to assess and prioritize the risk, provide potential solutions, and then execute with the sponsor’s best interest in mind. Having these skillsets in a project lead significantly enhances the joint team’s ability to deliver the project on time, which for a small company is crucial.

Execution Tactics
To assess these various characteristics, we have employed an approach which we call “Speed Dating.” This entails a series of three 20-minute targeted interviews with either an individual or panels of people, immediately following each bid defense meeting. Each interviewer or panel is assigned a competency (e.g. conflict resolution, leadership style, influence management) to probe and garner examples during their interview. If the team is not comfortable with the outcome of the interviews, we have asked to assess other potential project lead candidates as part of our consideration. We have found that by employing the speed dating process, we have increased our satisfaction with the project leads. Realizing that we must continue to build these relationships, we continue to invest time, money, and effort after selection with periodic structured faceto- face meetings for the project leads throughout the course of the project.

We recognize that the project leads are only as good as their team. Thus, we acknowledge and celebrate the successes and milestones each service provider contributes to the project. For example, as a service provider achieves their first patient enrolled, we send a small token of our appreciation for the service provider’s team to recognize the effort in support of that milestone. We have found that this small token of appreciation goes a long way to highlight our commitment to the team.

In summary, for service providers who recognize the unique nature of small companies’ needs and can select the appropriate people, these projects can be some of the most rewarding.

Jonathan Lee is VP of development operations for Cerexa, a subsidiary of Forest Research Institute. His 23 years in the pharma industry include stints at companies such as Nektar Therapeutics/ Inhale Therapeutic Systems, Gilead Sciences, and Genentech.

Deborah Bisio Dwyer leads the outsourcing group at Cerexa. She previously worked for Genentech and Chiron Corp.