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One partner, one path. Get to First-in-Human—faster.
Unlike traditional CDMOs that stitch services together, Thermo Fisher Scientific connects our capabilities to streamline biologics development through Path to First-in-Human.
Clearing the path: Your journey from preclinical candidate to first-in-human (FiH) trials and beyond demands speed, precision, and confidence at every milestone. Whether you’re advancing toxicology studies, securing your IND/IMPD, or running early-phase clinical research, Path to First-in-Human delivers an integrated, end-to-end solution—uniting development, manufacturing, and clinical execution across one global network in as little as 12 months.*
Key completion milestones for Path to FiH for biologics
| Timeline (months) | |||||||||||||
| Clinical trial consulting services | X | ||||||||||||
| Transfection | X | ||||||||||||
| Stable pool | |||||||||||||
| Final clone | |||||||||||||
| Pre-IND meeting | |||||||||||||
| Toxicology study | |||||||||||||
| DS transferred to DP | |||||||||||||
| GMP DP manufacturing | |||||||||||||
| Clinical pack and label | |||||||||||||
| Clinical protocol | |||||||||||||
| IND submission | |||||||||||||
| Clinical trial material transferred to clinical sites | |||||||||||||
| Clinical plan development | |||||||||||||
| Clinical trial enrollment | |||||||||||||
| Phase I clinical trial initiation and follow-up |
- Completed
- Start
Table 1. Timeline for combined early-phase biologics development services, all completed in-house through Thermo Fisher’s global network, from transfection to Phase I first-in-human clinical trials. * Services shown may be purchased as a combined, integrated offering or individually, based on client preference.
Key benefits of partnering with us for FiH:
- Reduced risk and flexibility: Combined or standalone services, as well as process platforms and custom solutions tailored to your needs
- Integrated services: Thermo Fisher is uniquely positioned to offer bioprocessing, CDMO, and CRO services through a single partner
- Supply security: Raw materials are sourced in-house by leveraging Thermo Fisher’s inventory of high-quality, proven products
- Global expertise: Access to industry experts with deep experience in drug substance and drug product manufacturing, as well as clinical trial management
- Thermo Fisher Financial Solutions: Flexible financing options to support your development and commercialization goals
Why CDMO and CRO integration matters:
- Reduces handoffs and delays by aligning development functions, which can shorten timelines by up to 12 months.1
- Improves coordination and decision-making across teams
- Mitigates risk by proactively identifying roadblocks and enabling greater flexibility to adapt to evolving development needs
View references
1. DiMasi, Joseph, Dirks, Abigail, Getz, Kenneth. “The Net Financial Benefits of Single Vendor Integrated CDMO and CRO Drug Development Services.” (2025) Manuscript submitted for peer review and publication. Tufts Center for the Study of Drug Development, Tufts University.
Did you know?
A recent study showed that single-supplier models can help bring molecules to market 34 months sooner than multi-supplier models . 1 By harnessing the integrated capabilities of our first-in-human framework, Thermo Fisher meets you where you are in your therapeutic journey and helps speed up your progress to the next phase.
Can’t afford to wait?
Frequently asked questions (FAQs)
Thermo Fisher Scientific does not conduct toxicology studies; however, we can support protocol development and third-party lab selection based on client needs.
Both. We can provide either a templated platform or a pathway customized to your needs.
We’re more than just a drug development partner—we’re here to support your innovation from every angle. Thermo Fisher Financial Solutions help speed up your journey from molecule to medicine, whether you’re developing a drug, conducting clinical trials, scaling manufacturing, or navigating new challenges.
Apply now or get more details by emailing us at financialservices@thermofisher.com
Learn more about our flexible financial solutions at thermofisher.com/financialsolutions
A global network of 60+ state-of-the-art CDMO and CRO facilities ready to support your integrated approach to biologics manufacturing.
Thermo Fisher Scientific's biologics facility in St. Louis, MO is a center of excellence in single-use bioreactor technology that specializes in mammalian cell development, process development, analytics, and end-to-end cGMP manufacturing services.
Explore our facility in St. Louis, MO
Thermo Fisher Scientific’s site in Brisbane, Australia is a state-of-the-art facility, specializing in clinical and commercial manufacturing services, including clinical cGMP manufacturing.
Explore our facility in Brisbane, Australia
Thermo Fisher Scientific’s site in Groningen, Netherlands specializes in preclinical and commercial cGMP manufacturing and scale-up of mammalian cell culture, recombinant proteins, and monoclonal antibodies.
Explore our site in Groningen, Netherlands
Thermo Fisher Scientific’s facility in Lengnau, Switzerland specializes in highly flexible bioproduction technologies, including single-use bioreactors up to 5,000 L and stainless steel bioreactors up to 12,500 L, providing a pathway from development to large-scale production as your manufacturing needs evolve.
Explore our site in Lengnau, Switzerland
Featured resources
eBook
Accelerate drug development with innovative 360˚ CDMO and CRO solutions: A comprehensive guide to streamlining drug development and reducing time to market
This eBook outlines solutions to help maximize resources and minimize risks across all phases of drug development, supporting each biotech or pharma company’s unique journey to market.
*Timelines are provided as good-faith estimates that reflect Thermo Fisher’s current expectations regarding the Path to FiH milestones and may vary depending on various factors, including, but not limited to, the starting molecule, project complexity, the integrated services included in the final agreement, regulatory approval, and terms included in the MSA.