Integrated first-in-human services for bioavailability-challenged molecules (SimpliFiH®)
The pharmaceutical industry is focusing on accelerating all aspects of drug discovery and development. This focus makes it critical to reduce the timeline from the initial idea to first-in-human (FIH) clinical safety and efficacy data for proof of concept. Aligning with a single service partner can reduce timelines, complexities, risks and costs associated with reaching FIH milestones.
Bioavailability hurdles, which are often a challenge in advancing new molecules and require enabling technologies even for phase I studies, must be factored into the choice of development partners. Another factor that can further accelerate your pathway is phase-appropriate processing for API, particle engineering and specialized finished drug products.
We can help you address these challenges and simplify the pathway to FIH verification.
Access our proven first-in-human expertise
Access the flexibility required to fit your molecule and drug program:
- API to OEB5: dedicated kilo-labs and teams in place to provide the quantities necessary for preclinical and early clinical trials
- Solid-state characterization: API physicochemical characterization, aqueous solubility, salt and polymorph screening services
- Solubility and dissolution rate enhancement: proprietary modelling/technology selection services and manufacture of enabled phase I drug product with required dissolution rate and/or aqueous solubility
- Drug product in the phase-appropriate format: powder-in-capsule, powder-in-bottle or tablets
SimpliFiH® Solutions center on a rapid technology selection methodology that requires a single gram of API to identify a phase I appropriate approach.
The Lonza team works in an open and collaborative way, with good understanding of client requirements, from forecasting and project planning to delivery.
Stephan Bulat, Head CMC, Grünenthal
Take your BA-challenged molecule to Phase I in 32 weeks or less
Our first-in-human SimpliFiH® Solutions package is designed to meet the needs of the vast majority of phase I programs, and provides integrated drug substance and drug product solutions in 32 weeks, incorporating:
- Single project manager for ease of communication
- Simple and phase-appropriate service agreements, terms & conditions
- Fit-for-purpose process development
- Phase I qualified drug product methods
- GMP documentation, including batch records and CoA
- Suitable drug product stability package
Options for program customization regulatory services can include:
- Provide regulatory guidance for the drug substance and drug product development
- Draft briefing books and support scientific advice meetings with regulatory authorities
- Write and review IND CMC and IMPD sections in support of FIH clinical trial global applications
- Provide advice for regulatory strategy for phase II/III and commercialization