Share page on Facebook Share page on Twitter Share page on LinkedIn Home Sectors Biotech Helping emerging biopharma meet their milestones to market. 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. An integrated partnership model for biotech: Tailored clinical development Small highly experienced team and program leadership Single point of contact and accountability Faster executions through streamlined S.O.P.s Senior management tactical involvement Certainty of cost Consulting & advisory services Robust asset development and funding consulting Regulatory and quality assurance strategies, submissions management and ongoing global compliance Integrated commercial positioning to demonstrate the value of your product Therapeutic expertise Proven experience across an extensive range of therapeutics including novel therapies such as Cell and Gene therapies, first-in-class immunotherapies and others Early phase and preclinical services to prove asset viability Factsheet: Biotech services at ICON Transformative therapies start with transformative approaches Whitepaper: Early engagement and regulatory considerations for biotech Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. 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 Media article: Europe’s emerging biotechs Challenges, opportunities and funding Media article: Moving beyond a buzzword How small to mid-sized biotechs can adopt patient centricity in their oncology trials FSP solution helps China based biotech drive high quality in clinical drug development Learn how we increased quality and grew our client's team by over 200% while increasing retention to 90% in the highly competitive Chinese market 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. IN THIS SECTION Biosimilars Biotech Emerging biotech funding Externalised development for biotechs Biotech and early engagement considerations Regulatory considerations for biotech Government & Public Health Solutions Medical Device Pharmaceuticals Connect with us Contact us Submit proposal request Update Email Preferences Global office locator ICON on social media Related information BLOG Exploring the benefits of biotech partnerships CASE STUDY Virtual Development Model MEDIA ARTICLE How biotechs can adopt patient centricity in their oncology trials Next 1 2 3 4 Contact About ICON Results & Reports For Clients Therapeutics Services Insights Innovation Content Preferences Office locations ICON For Patients Volunteers Investigators Jobs & Careers Investors Suppliers News & Events Press Releases Mediakit Events Social Media Dashboard LinkedIn Twitter Facebook Youtube © 2021 ICON plc Disclaimer Privacy Site Cookies