Clinical Pharmacology Consultant

I’m getting out of bed and trying not to disturb my husband who is still sound asleep. Now is the perfect time to put on my running shoes and watch the sun come up over the fields outside. After a refreshing shower, breakfast and bringing my kids to school I take my cup of coffee to my home office and start up my computer.  My inbox and calendar remind me of todays schedule and to-do’s. I’m happy to see that one of my clients has sent me the draft Phase 3 protocols as well as all the needed info to map out the PK of their compound in order to be able to make a recommendation on their Phase 3 PK blood sampling scheme. Additionally, since the route of administration is not straightforward, it will require some literature digging and discussions with my pharmacometric colleagues to figure out how to best predict the target site concentration and integrating this in a PopPK(PD) model. A challenge for sure! At noontime I walk downstairs to prepare a nice salad for lunch and quickly throw in some dirty laundry in the washing machine.

After lunch, I have a video-call with one of my ClinPharm colleagues to discuss the progress of another client’s submission documents. This week’s attention is on Module 2.6.4, but we’re also developing Module 2.7.1 and 2.7.2 as well as performing the entire pharmacometric analyses for them which, taken together, need to logically build up to the recommended  dosing regimen for their patient population.

At 3 PM, the colleagues from across the pond are awake and it’s time to switch gears a little bit and attend the biweekly company-update meeting. It’s nice to see my colleagues on screen and I can hear one of their cats in the background as we discuss on the latest software update, new SOPs to read, current financial status and new client opportunities. Afterwards, I quickly call in to a client update meeting to report my status of a ClinPharm gap analysis that I had been working on the past few weeks. As the working day comes to an end, some meeting notes are written and sent and I write down some points that I should definitely not forget to do tomorrow. So what will tomorrow bring? Well, I will drive to the office to spend some ‘live’ time with my colleagues and my agenda shows me that I have a client call to discuss a few EMA Day-80 questions they received and need some help with in answering. Luckily their product is indicated for a disease that I have some past experience in. Next to a biweekly science and technology meeting, I will also try to find some time to work on the webinar that we want to set up for small start-up companies who have little or no experience in clinical pharmacology or pharmacometrics. Hence, another lovely day at the office…

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