bit.bio is a leading biotech firm producing artificial human cells for drug discovery and research. This pioneering company is dedicated to advancing medical research through innovative cell technologies. They aspire to be the world’s leading synthetic biology company that provides human cells for research, drug discovery, and cell therapy. They are driven by a bold vision: empowering biomedical innovation and a new generation of cures through precision-programmed human cells. Bit.bio approached Freeman Clarke with a number of issues concerning security, compliance, and IPO readiness.
Challenges
- Bit.bio faced multiple challenges related to their IT readiness and compliance:
- Identifying quick wins for enhancing cyber security and compliance.
- Pinpointing gaps for public market readiness.
- Creating a comprehensive data strategy and infrastructure to leverage existing data for machine learning across various functions (discovery, research, bioinformatics, manufacturing, and clinical data).
- Understanding gaps in IT readiness, including team capabilities, organisational structure, and delineation of internal versus external responsibilities.
- Determining the best Information Security Management System (ISMS) framework for their needs.
- Evaluating data integrity, software, systems acquisition, and alignment with quality controls like CAPA, documentation control, data quality, and continuous improvement.
- Assessing internal and external factors influencing the scope of the ISMS framework.
- Ensuring compliance with UK/EU and US regulations, specifically for ISO 27001.
- Measuring the effectiveness of the ISMS framework.
Collectively, these challenges were preventing the business from innovating quickly, leveraging the huge volume of data being generated, and having confidence to move to the next level of global regulatory compliance.
Solutions provided
To address these challenges, we implemented a multifaceted approach:
1. Gap Analysis and Discovery Phase
- Conducted a thorough gap analysis to identify IT readiness and compliance gaps. The whole IT estate, both onsite and remote working, were reviewed, including infrastructure, desktop apps, productivity suite, cloud providers and incumbent MSP.
- Developed detailed IT and data roadmaps for the year ahead to help prioritise tactical decision-making.
2. Board Executive Alignment
- Presented findings and strategic options to the Board, highlighting pros and cons, and prioritising urgency versus importance.
3. IT Security Assessment
- Performed a comprehensive IT security assessment. A RAG (red, amber, green) review against pharmaceutical industry standard criteria to create readiness for procurement by big pharmaceutical companies.
- Updated the corporate risk register. We reviewed the register and added IT risks such as key-person dependencies, costly/less-than-scalable architecture, lack of in-house security expertise, and finding a new owner in quality and compliance.
4. Vendor Management and Policy Updates
- Improved the vendor management process. Suggested a Technology Steering Group to make future selections and reduce suppliers.
- Updated policies and processes to align with best practices. For example, BYOD (Bring Your Own Device) policy, access control policy, security policy, along with recommendations on policies to include to provide an ISMS for ISO 27001.
5. Recruitment Support
- Created job descriptions for key IT roles: DevOps Data Engineer, Director of Data Management, Director of IT Operations, Director of IT Project Management & Architecture, VP of IT
- Assisted in recruiting a new VP of IT. Helped with sourcing search terms (done by internal HR through LinkedIn), triaged initial scoring grid and carried out first interviews to check for technical competence and communication skills.
Outcomes and benefits
The solutions provided led to significant improvements for the client:
ISO 27001 Audit Readiness
- • Bit.bio is now well-prepared to pursue ISO 27001 certification.
Data Strategy Implementation
- • Bit.bio developed and initiated a robust data strategy enhancing the company’s ability to leverage data for machine learning. The discovery platform combines genetic screening, big data, machine learning and large-scale experimentation to find the combination of transcription factor codes for every human cell type.
IT Recruitment and Planning
- • Provided assurance and clarity on IT recruitment planning and role specifications.
- • Successfully supported the recruitment of a new VP of IT.
Conclusion
Through targeted interventions and strategic guidance, Freeman Clarke has helped bit.bio significantly enhance its IT readiness, compliance, and data strategy. These improvements have positioned them for continued innovation and growth in the biotech sector, ensuring robust cyber security and compliance as they prepare for public market readiness.
We are very pleased with the Principal’s work to date. He is extremely professional, knowledgeable, and thoughtful as he interacts with all levels of the company to best understand the gaps and opportunities to define our IT roadmap. He is very effective, and I appreciate his expertise.