Non-clinical / Pre-clinical Development
Venn provides Non-clinical Development through its wholly owned subsidiary Kinesis Pharma BV.
Non-clinical testing is conducted throughout all phases of drug development in order to assess the safety profile and pharmacokinetic and toxicokinetic (PK/TK) characteristics of candidate medicinal products. If the non-clinical (or pre-clinical) development is performed well, it can maximize the chances of success in the clinical development phases. Strategies for the non-clinical development of products follow general regulatory guidelines, but are also designed on a case-by-case basis according to the specifics of the drug. It is of key importance to design an optimal pre-clinical development program that allows the drug to be taken forward into the clinic (“e.g. IND package”), or a more extended non-clinical development plan allowing the drug to be taken into the next clinical phase, or to product registration (e.g. including 6 months tox, carcinogenicity study, reproductive toxicity etc). The project managers of Venn/Kinesis-Pharma BV can guide the client though all these phases of drug development.
The non-clinical experts of Venn/Kinesis-Pharma BV have a broad experience and hands-on drug development expertise with respect to design, monitoring, issue management and overall consultancy for PK/TK, metabolism, safety pharmacology and toxicology studies. Questions that are handled by the Kinesis expert 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). Also for obtaining a second opinion on any pre-clinical or non-clinical research issue/question, the Kinesis experts can be consulted.
The non-clinical experts work in close collaboration with the Venn/Kinesis-Pharma BV project managers CMC, regulatory, QA and clinical specialists to ensure that non-clinical (or pre-clinical) development plans provide the most time-efficient and cost-effective strategy for clients.
- Pharmacokinetics and Toxicokinetics (PK/TK)
- Non-clinical / Pre-clinical Project Management
- Preparation of Non-clinical Regulatory Documentation and Reports
- Non-clinical (Pre-clinical) Consultancy
“In non-clinical development you must always expect the unexpected!”
Ilonka van Hoof, Ph.D.,
Director Non-Clinical Development
Tel: +31 76 54 80 660
Mob: +31 6 27 24 70 93