How MHA helped a young clinical-stage biotechnology company navigate potentially critical risks during an important phase II clinical trial

Introduction

Our client was in a startup phase, a clinical-stage biotechnology company developing personalised whole tumour-derived immunotherapies.

What was the challenge?

The company was in the early stages of its first company-sponsored clinical phase II trial in treating an aggressive form of solid tumour 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 tumour treatments, so they were additionally 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 another year; the organization was focusing on strengthening key areas such as clinical, research and development and technical operations. Equally important, the company was confronted with the issue of raising funds and financing its operations as they planned a public listing.

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 the while focusing on a capital raise and potential initial public offering.

What was our 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 over a three-year period. Our programmes of work included the following:

Enterprise risk and needs assessment planning

We 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

We 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

We 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.

What did we achieve?

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 plan and prepare for the commercialization of the organization. This assessment included upgrading systems that were starting 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 in governance and oversight of key processes and related controls to allow the organization to partner with key opinion leaders (KOLs) in a compliant way to further their clinical programs and strengthen third-party oversight practices to ensure that obligations and key performance indicators (KPIs) were consistently met.