Case Study 1 – Bio Tech Startup

Problem Statement

A start-up biotech company has developed a new and innovative investigational drug product. However, the initial development phase focused on manufacturing and spin up of non-clinical and phase 1 clinical development. As a result, few procedures are formalised and little or no formal oversight has been implemented.

The company is now concerned that oversight, including data and safety oversight, is lacking. As staff begin to specialise into distinct groups, stress points have appeared, including those associated with blurred responsibility and accountability. As later phase development begins there is a concern related to inspection readiness and the management of data integrity and subject safety.

Solution

Initial efforts, led by 360 Audits, involved the conduct of a gap analysis. Staff were gathered, initially in an informal setting, to gauge the roles involved and identify gaps. At this point the company was identified to have strong medical, manufacturing, regulatory and clinical research leaders. However, these individuals were not supported by operational depth, hampering execution of tasks.

It was identified that there was a need for manufacturing leadership to be supported by drug product logistics specialists. It was further identified that further operational support was needed, including that clinical research leadership required support in the form of clinical research associates to assist with the oversight of clinical trial data.

Existing regulatory support was found to be adequate. Cross over and dependencies were identified between medical, clinical research and manufacturing. As discussions progressed, formal standard operating procedures to document and facilitate roles and their dependencies were drafted.

Key Outcomes

• Development of oversight processes, formalised through controlled documents and training.
• The original gap analysis and newly drafted controlled documents were leveraged to facilitate the onboarding of contractor companies.
• This included the evaluation of which contract companies were most suitable, and which processes and procedures were to be followed (sponsor, contractor or a hybrid mix).
• An oversight structure was implemented including internal and external key performance indicators.
• A risk register and process was developed, including risk identification, measurement and mitigation approaches.
• A global audit plan was created, based on risk — processes, contractors, investigator sites and data were scheduled for oversight audits.
• Key deliverables were added to a tracker, including those related to product, regulatory reporting, data and safety.
• An inspection readiness program was implemented.