Enterprise risk and needs assessment creates implementation roadmap for biotech startup

Client background

A startup, clinical-stage biotechnology company that develops personalized whole tumor-derived immunotherapies.

The business challenge

The biotech company was in the early stages of initiating its first company-sponsored clinical phase II trial in treating an aggressive form of solid tumor cancer. The phase II trials had proven to be a significant undertaking for the young organization, especially with the therapy being the company’s leading asset. In addition to primary cancer type, the company observed positive preclinical signals in other solid tumor treatments, so they were secondarily focused on developing the tool into a platform technology to treat an array of cancers. Finally, the company had experienced tremendous growth, growing from five employees to 40 within two years and with another expected increase to 80 employees within an additional year; the organization is focusing on strengthening key areas such as clinical, research and development (R&D), and technical operations. Equally important, the company is confronted with the issue of raising money and financing its operations, especially since they intend to go public in the next 12 months.

Navigating the path from a single asset to a platform technology brings many challenges. Our client was facing the daunting task of managing the phase II clinical trial of its leading asset and transitioning preclinical assets into the clinical stage to phase I trials of other solid tumor cancers, all while focusing on a capital raise and potential initial public offering. 

The Baker Tilly approach

Our client asked us to complete an enterprise-wide risk and needs assessment and develop an implementation roadmap to help them achieve their key organizational milestones throughout the next one to three years.

• Enterprise risk and needs assessment planning: Baker Tilly met with the client’s project sponsor and other key members of the leadership team during the planning phase to discuss the project scope and timing, and identified the leaders across each functional area that we would interview. Based on our initial review document review, and drawing from our experiences with similar organizations in the life sciences industry, we developed tailored interview guides for the engagement.  
• Enterprise risk and needs assessment administration: Baker Tilly conducted interviews with leaders from multiple departments, including clinical development and research, regulatory affairs, operations, infrastructure and manufacturing, legal and compliance, information technology, finance and human resources. From these interviews, our team identified risks to organizational milestones associated with the current and planned business activities. Our recommendations were organized into a heat map that listed out the potential impacts of meeting the organization’s business goals/objectives based on inherent and residual risk.  
• Implementation roadmap development: Baker Tilly developed an implementation roadmap for our client that outlined the tactical action steps needed to mitigate the identified enterprise risks. The roadmap included prioritized recommendations across key organizational milestones with suggested timing and estimated resource requirements, including human capital and other operational expenses. 

The business impact

The risk assessment ultimately enabled our client to prioritize resources, both capital and headcount. This helped the company operate more efficiently as a pre-commercial organization in the short-term and allowed the organization to more intentionally plan and prepare for the commercialization of the organization. 

This assessment included upgrading systems that were beginning to be outgrown and implementing new software, such as an enterprise resourcing planning (ERP) system. The identification of these needs in the engagement allowed for adequate lead time for the sourcing and implementation of key systems.  

The assessment also allowed for improvements into governance and oversight of key processes and related controls, such as the standup of compliance processes to allow the organization to compliantly partner with key opinion leaders (KOLs) to further their clinical programs and the need for stronger third-party oversight practices to ensure that obligations and key performance indicators (KPIs) are consistently met.   

For more information on this topic or to learn how Baker Tilly’s team of Value Architects™  can help, contact our team.