Unlocking Insights: Strategic Positioning of the PK Package

Join D2V Clinical’s Chief Development Officer, Jill Loftiss MHS, as she shares valuable insights on strategically positioning PK packages within NDAs. With 22+ years of drug development experience, Jill provides expert guidance on leveraging the timing of your PK package to enhance the likelihood of successful submissions.

Hi, I’m Jill Loftiss, and I work for D2V Clinical, a CRO handling early-phase oncology and hematology programs. Today let’s talk about the positioning of our pharmacokinetic (PK) package within our New Drug Application (NDA).

There is a lot of difference between oncology and non-oncology programs. Often, with non-oncology programs, we can start with healthy volunteer studies where we establish a full pharmacokinetic/pharmacodynamic (PK/PD) and safety analysis upfront in our first-time-in-human (FTIH) trial before we move to populations of special interest. With oncology trials, we establish the safety of where we want to begin our dosing based on our animal trials in our pre-clinical package, and we move directly into patients.

With our FTIH, we will do an initial PK draw to see if the dosing is at the levels we expect it to be at. We’ll save the full comprehensive package until proof of concept is shown because that will reduce unnecessary risk and prevent premature investments. The full PK package for oncology studies can include drug-drug interaction studies and studies of patient special populations with patients with dysfunctional kidneys or livers. We can also go into food effects with high-fat and low-fat meals. We may also do a definitive QT study, depending on what the pre-clinical work showed.

If you have any questions about how to build your PK package or where you should start with your dosing, please feel free to contact D2V Clinical today.

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Jill brings more than 22 years of experience as an R&D Clinical Operations Leader in pharma, managing clinical operations specialists and clinical scientists. Over those two decades, Jill built a flexible, scalable outsource model with leading CROs to meet internal project demands and led teams to multiple successful BLAs, NDAs, and sNDAs in oncology. She specializes in patient-centric, quality-focused and innovative approaches to accelerate drug development.