DMPK Project Support
Ensuring you implement a strategic DMPK approach at the start of your project will help you identify molecules with drug-like properties that will enable you to progress into the clinic rapidly and with confidence. Mitigating DMPK risks early will simplify and streamline your clinical development plan.
At ApconiX, our experienced DMPK scientists will collaborate with you to develop personalised DMPK strategies, ensuring that you adopt a focused approach to your drug projects, helping you to deliver drug candidates across a range of therapeutic areas and stages of R&D. We will support you to do the right studies at the right time to move your drug molecules forward as effectively as possible. We will guide you in designing the data cascades most appropriate for the stage of your project, helping you to deliver your objectives through a wide range of both in vitro and in vivo studies. Our DMPK scientists have the experience to design the studies, interpret the data, provide risk mitigation plans as required and contextualise the whole data package, ensuring that it is ready for further preclinical and clinical development.
You will benefit from a group of talented and experienced drug safety scientists who will support you to:
Rapidly progress candidates to pre-IND
Problem solve using our breadth of scientific, technical plus experimental experience and expertise
Improve safety and efficacy of drug candidates
Develop drug efficacy and safety dose for FIH
Optimise drug use for better patient outcomes
Some literature below that might be of interest:
Integration into Discovery Project Teams
We will work with you to successfully bridge the gap from laboratory to clinical trials, providing assistance that includes:
- DMPK data interpretation and analysis
- Designing of optimal, cost-effective screening cascades to identify potential liabilities, aiding informed decision making
- Determining gaps in data to improve safety and efficacy of drug candidates
- Designing in vivo PK, PKPD and tolerability studies
- Providing guidance in the selection of the most suitable CRO
Human PK Prediction
Using the following techniques, we can determine drug efficacy and safety for FIH including:
- Early dose to man (eD2M) modelling
- Predicting behaviour of a drug candidate using physiologically based pharmacokinetic (PBPK) modelling
- Evaluating dose concentration response relationships using pharmacokinetic/pharmacodynamic (PKPD) modelling
- Predicting in vivo parameters from in vitro data using IVIVC
Clinical Pharmacology Clinical Pharmacology
We can optimise drug use to improve patient outcomes by:
- Supporting informed decisions around drug approval and labelling
- Evaluating potential risks and benefits associated with a drug asset to inform investment decisions
- Providing strategic insight into the development strategy before submitting an IND application
- Providing guidance with IND submissions
Our DMPK Scientists
Ken Page
MSc
Ken has worked in the pharmaceutical industry, both in large companies (Astra Zeneca and Rhône Poulenc [now Sanofi]), small biotech (RedX), and CROs for many decades. During this time, Ken has either managed or been part of many teams including bioanalysis, P450 inhibition, in vitro permeability, metabolic stability, ADME, in vivo pharmacokinetics & PK modelling, helping identify new drugs effective in several disease areas including Oncology, Cardiovascular, Asthma & Inflammation and Anti-bacterial agents. Ken has a keen interest in human PK prediction and using it as early as possible to identify potential drug candidates. Ken has a BSc in Biochemistry and an MSc degree in Biopharmacy.
Dr Sarah Pass
PhD
Sarah is an experienced drug metabolism and pharmacokinetics (DMPK) consultant, having worked for almost 30 years in the pharmaceutical and CRO industries, providing a wide range of expertise to academia, biotechnology and pharmaceutical companies. A collaborative project leader, Sarah has broad experience ranging from lead identification though to end of Phase II clinical development. Sarah is passionate about making a difference to patients’ lives and delivering decision-making data to accelerate new drugs through the R&D pipeline.
Dr Peter Ballard
PhD
Peter is a senior drug metabolism and pharmacokinetic (DMPK) expert with extensive experience in global discovery and development projects. He has a proven track record of international project delivery from early drug discovery through to development and compound registration from over 30 years in the pharmaceutical industry and has maintained a high academic profile with more than 30 publications in peer reviewed journals and presentations at international conference.
Dr Tanya Coleman
PhD
Tanya has more than 20 years’ experience in pharmaceutical project teams as a nonclinical ADME specialist and clinical pharmacologist. She held project and team leader roles at several large pharma companies before becoming an independent consultant. In these roles, she has supported research teams as well as early and late clinical development projects, with a particular strength in oncology and infection. Tanya has also led specialist groups in in vitro metabolism and drug transporters.