eciding to join a company like Virpax Pharmaceuticals is both exciting and daunting. The authors have both worked for other small biopharmaceutical companies in the past, but with just six full-time employees, Virpax is decidedly one of the smallest companies either author has worked for.

To manage these challenges, it was essential for us to identify and partner with vendors who had suitable expertise who could advance our company’s assets at the appropriate stage of clinical development and who were able to examine different aspects to resolve issues as soon as possible. The key was to form strong strategic partnerships to help mitigate risks. However, given bandwidth limitations, we found it essential that we manage the vendor resources in an effective manner. This required a balance between fostering a collegial relationship and the establishment of clear expectations.

Identifying partners with the appropriate expertise who could provide a competitive budget was a crucial factor in our decision-making process. The fundamental strategy we employed included establishing clear goals and creating a playbook that could serve as a template to structuring a deal, conducting robust financial evaluations of partnership proposals, and identifying contingencies to address unforeseen circumstances. These strategies helped us to create sustainable relationships for our company as well as for our vendor partners.

The following summary details strategies we have found effective for achieving program goals including capabilities, capacity, and cultural fit. Our paradigm includes the following approaches:

1. Culture Fit. Selected vendors should be a good cultural fit with the biopharmaceutical sponsor company. Companies with aligned cultures tend to share a significant proportion of core values and collective behaviors that lead to more frictionless interactions and better collaboration. One example of a good cultural fit would be a shared emphasis on consensus building to solve issues. Conversely, a vendor that utilizes an empowered individual contributor model would be a less ideal fit with the consensus-building sponsor model. The consideration of cultural fit should carry more weight than the cost of a vendor’s proposal alone. A marginal cost saving could provide less value than a strong company fit. Ideally, the assessment of cultural fit should be made jointly by senior leadership and the operations teams.
2. Clear Expectations. The biopharmaceutical sponsor should always set clear expectations in writing that have been agreed upon by both parties. This can be effectively established in a single-page governance charter that defines the shared program goals, Key Performance Indicators (KPIs) that can be reasonably measured to ensure that stated goals are satisfactorily met, and appropriate escalation pathways within the respective organizations. Work by Norton and Sussman (2009) provides a robust overview of the advantages of the early adoption of such charters. Although Governance Charters are typically associated with larger pharmaceutical companies, simplified versions are an effective tool for clearly documenting shared objectives and commitments. It is important that vendors have an opportunity to register feedback and to “buy-in” on the goals and expectations of a project. Even with the advantages of a strategic partnership, there are many factors that can derail the plan, such as changes in a company’s priorities.
3. Plan for Delivery. The sponsor should establish a “deliverables management plan,” which should include an estimated timeline for all expected deliverables and establish expectations for adjustments over the lifecycle of a project, at the initiation of any new contract. The parties should have a clear understanding of which deliverables are critical path, which deliverables are immutable, and when updating deliverable dates is warranted and appropriate. These should not be strictly top-down decisions. Vendors should have input into this process to help maintain effective relationships.
4. Transparency. Small biopharmaceutical companies are often dynamic organizations which pivot quickly and change priorities on short notice. The playbook should examine the amount of flexibility a company needs to make last-minute changes while being mindful of the vendor’s obligation to meet other customers’ needs. Vendors should have, within reason, insight into decisions that affect the priorities of a project. Although a biotech sponsor may not be at liberty to share details of certain decisions, it is critical to be as transparent as reasonably possible with partners. This permits effective resource management at the vendor and prevents misunderstandings related to vendor invoices.
5. Tracking Systems. A system should be established to effectively track and close action items. With limited internal resources, a small biopharmaceutical sponsor must be aware of the status of all vendor partner tasks. An effective mechanism to ensure follow-up will allow all parties to document that assigned tasks have been appropriately closed in a timely manner. These systems can be as simple as an Action Item log kept in a shared drive and can use the reminder functionality found in most e-mail programs. It is important that these follow-ups are not presented in a punitive manner, but rather are part of a system to which all parties agree.

These guidelines are primarily intended to ensure the quality delivery of tasks that both our company and our vendors desire. Furthermore, they provide a valuable line of defense as having clear and excellent documentation of vendor management plans, decisions made, and timeline management conversations are considered essential elements of vendor oversight expected by regulators.

Additionally, we would advise caution that the implementation of these structures not be reduced to a “checklist exercise” that imposes a burden on program managers or vendor staff. Used correctly, they will reduce work by ensuring all resources are appropriately aligned with the most critical tasks. Research performed by Mathieu and Rapp (2009) demonstrated a measurable positive long-term benefit that supports the correlation between early implementation of high-quality charters and high-quality performance strategies with overall team effectiveness. This connection provides multiple benefits including the prevention of rework and reduction in billing errors.

Conclusion