Non-clinical / Pre-clinical Development
In non-clinical development you must always expect the unexpected!
Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic and toxicokinetic (PK/TK) characteristics of candidate medicinal products. Optimised non-clinical (or preclinical) development can maximize the chances of success in clinical development.
Strategies for the non-clinical development of products follow general regulatory guidelines and can also be developed on a case-by-case basis depending on the specifics of the drug. It is of key importance to design an optimal preclinical development program that enables the drug candidate to be progressed into the clinic (“e.g. IND package”), or a more extended non-clinical development plan enabling the drug to be taken to the next clinical phase, or to product registration. The project managers at Venn can guide the client though all these phases of drug development.
Venn’s non-clinical experts have a broad experience and hands-on drug development expertise including study/project design, monitoring, issue management and overall consultancy for PK/TK, metabolism, safety pharmacology and toxicology studies. Issues that are handled by the Venn experts range from writing responses to questions obtained from authorities (FDA/EMA) to calculating a safe starting dose for a first-in-man study (NOAEL/MABEL) and from advising on specific study findings (e.g QTc prolongation, or unexpected deaths in a study) to proposing a strategy on how to deal with high levels of metabolites (MIST guideline).
Regarding non-clinical PK/TK, a team of well-trained data analysts and report writers, supervised by experienced consultants with a solid background in PK/TK, is committed to delivering optimal quality within agreed timeframes for each PK/TK analysis. Noncompartmental PK/TK analyses have been performed for all types of non-clinical development studies (GLP & non-GLP), including toxicology studies, ADME studies, bioequivalence and bioavailability studies.
- Non-clinical (Preclinical) Consultancy
- Due Diligence of Non-Clinical related topics/parties
- Preparation of Drug Development Plans
- Non-clinical / Preclinical Project Management
- Design, management and reporting of non-clinical programs, projects, studies (GLP) e.g ADME, PK/TK & Tox, including CRO selection and management
- Pharmacokinetics and Toxicokinetics (PK/TK) (GLP)
- Preparation of Non-clinical Regulatory Documentation and Reports (IND, IMPD, IB)
Venn’s non-clinical experts work in close collaboration with the project managers in CMC, regulatory, QA and the clinical specialists to ensure that non-clinical (or preclinical) development plans provide the most time-efficient and cost-effective strategy for clients.