Biotech

Biotechnology companies are at the epicenter of innovative drug development, with discoveries spanning from genomic medicines to first-in-class immunotherapies. Typically focused on a small portfolio of compounds, or just a single compound, in a particular therapeutic indication, many biotechs lack the full spectrum of resources or infrastructure required to bring these novel therapies to market.

ICON offers a flexible partnership model for biotechs, acting as a fully externalised project development team to confront challenges and facilitate integrated solutions along the development cycle – starting in the preclinical phase to clinical research to real world studies through to commercialisation – across therapeutics areas including Cell and Gene Therapies. ICON support touches on every aspect of drug development, from business development teams to tax and legal teams. Each of these functions can then be moved, as needed, based on the project or operating requirements of the sponsor company.

This nimble approach allows for the integration of the sponsor’s and ICON’s expertise, facilitating shared learning, distribution of resources, and the development of truly complementary workflows and governance.

The ICON team can assist biotechs in establishing key processes and infrastructure internally, including:

• Due diligence and asset valuation processes

• Asset development consulting

• Quality management systems and standard operating procedures

• Medical safety boards
• Protocol governance procedures and operational governances
• Good manufacturing practice services
• Flexible costing models
• Data transfer and project team site architectures
• Regulatory expertise
• Accelerated patient recruitment

ICON can help emerging biotechs meet their milestones and deliver data and evidence-based results to their investors, large pharma partners, regulatory authorities, and other stakeholders with responsiveness, accessibility, and true collaboration.