Our drug product consulting services span CMC, Clinical Pharmacology and DMPK. This ranges from input at the pre-clinical / discovery phase, through first-in-human (FiH) and early clinical trials (CTs) and onwards to product approval.
Chemistry Manufacturing and Controls (CMC)
Our CMC capability covers both drug substance and drug product development. Specific activities include:
- Drug substance project strategy development and integration with drug product, safety and clinical planning
- Expertise in chemical development at the Discovery interface, Preclinical and Clinical Development, including synthetic route design, process design, solid form selection and analytical method development
- Definition of drug product (formulation strategy) through FiH/early CTs, Phase 2, Phase 3 and Launch, using rapid prototyping, in-silico formulation tools and product design thinking
- Management and delivery of pharmaceutical development elements of drug development programs (including estimation of costs, timings and resource requirements)
- Design of CMC programs based on the latest Quality by Design thinking
- Definition of Quality Target Product Profile (QTPP) and Quality Risk Assessment (QRA) as per ICH Q9
- Sourcing and management of Drug Substance and Drug Product activities from third party contract service providers
- Authoring and review of the CMC technical elements of regulatory dossiers to ensure authorization for clinical trials and marketing
- Representation of client companies in interactions with Health Agencies
- Conduct of Due Diligence review on prospective asset purchases
Clinical Pharmacology and DMPK
Our DMPK and Clinical Pharmacology Project Leaders can provide expertise to support the following activities:
- DMPK profiling, problem solving and compound selection / progression at all stages of drug discovery
- Design of molecules to avoid DMPK liabilities
- Prediction of human pharmacokinetic (PK) profiles and therapeutic doses
- Selection and justification of FiH dose
- Authoring and review of the DMPK and Clinical Pharmacology technical elements of regulatory dossiers (including label) to ensure authorization for clinical trials and marketing
- Design of the pharmacokinetics elements of FiH Clinical Studies (with a focus on FiH studies in Cancer Patients) and Clinical Study Protocol writing e.g.
– PK sampling time points
– Inclusion and exclusion criteria
– Concomitant medications - Interpretation of clinical PK and PD (pharmacodynamic) data and justification of clinical dose
- Design of drug-drug interaction studies
All of the above can be provided as an individual offering or as a fully integrated drug substance and drug product consulting service.