Clinical Pharmacology Podcast with Nathan Teuscher

Latest Episodes:

Project Optimus (Ep. 21) Mar 11, 2024

Show notes

Today’s episode was about Project Optimus, the FDA initiative to improve dose selection and optimization for oncology products. Julie Bullock was a guest on this episode and shared her expertise as a former oncology clinical pharmacology reviewer at the FDA and as a current consultant in the pharmaceutical industry.

Links discussed in the show:

Project Optimus FDA
List of FDA guidances and publications for Project Optimus
May 2022 FDA-ASCO workshop: Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology
Sept 2023 Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right (this one focused on combinations)
Feb 2024 FDA/AACR Public Workshop: Optimizing Dosages for Oncology Drugs
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Tackling TMDD Models (Ep. 20) Feb 26, 2024

Show notes

Today’s show is about TMDD or target-mediated drug disposition models. I review the scientific and physiologic basis for TMDD models, how to review data and determine if a TMDD model is needed. I review the various modeling approaches along with my recommendations for specific TMDD models. I hope this information helps you understand how to recognize TMDD behaviors and the options for modeling that data.

Links discussed in the show:

Communication for scientists (Ep. 19) Feb 12, 2024

Show notes

Today’s episode is about communication for scientists. I believe that improvements in communication skills can have a greater impact on your career and work than technical skills. Michael Piperno, an expert in communication and leadership skills joins me to discuss communication challenges and solutions for clinical pharmacologists and pharmacometricians.

Links discussed in the show:

You can connect with Michael

On his website
On LinkedIn
On his blog
On his podcast
Subscribe to Michael’s newsletter
View upcoming leadership and communication workshops

You can connect with me

You can connect with me on ⁠LinkedIn and send me a message⁠⁠
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Cell Therapy and Clinical Pharmacology (Ep. 18) Jan 22, 2024

Show notes

Today’s episode is about cell therapies, including CAR T-cell theraphy for cancer. I give an overview of cell therapy and the challenges of clinical pharmacology in this new area of research.

Links discussed in the show:

CAR T-cell Therapy Image

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Allometry in Pediatrics and First in Human Studies (Ep. 17) Jan 08, 2024

Show notes

Happy New Year! Today’s episode is all about allometric scaling in pharmacokinetic and pharmacodynamics. In particular, I’ll discuss how to use it for scaling from adults to pediatrics and for selection of first in human doses.

Links discussed in the show:

Boxenbaum manuscript
FDA guidance on First in Human doses
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Computer System Validation for Pharmacometrics (Ep. 16) Dec 25, 2023

Show notes

This is the last podcast for 2023. Thank you for listening throughout the year! In today’s episode I talk about computer system validation for pharmacometrics. I review my experience with validation in multiple companies over 20 years and discuss what auditors and FDA inspectors want to see.

Links discussed in the show:

QSP, PBPK, PKPD, PopPK … analysis abbreviation soup! (Ep. 15) Dec 11, 2023

Show notes

In today’s episode I cover 4 different modeling approaches: QSP, PBPK, PopPK, and PKPD. All of these are methods for analyzing data to predict either drug concentrations, or a response variable. But each method is developed in a different way and has different assumptions and limitations.

Links discussed in the show:

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Handling BLQ samples (Ep. 13) Nov 27, 2023

Show notes

In today’s episode I discuss BLQ handing for both non-compartmental and modeling analysis approaches. I discuss how BLQ samples are defined, methods for analyzing them, and situations when you should use different analysis approaches.

Links discussed in the show:

Clinical Drug Interaction Studies (Ep. 14) Nov 27, 2023

Show notes

In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the guidance. Then I will review recommendations for both stand-alone clinical drug interaction studies, as well as nested drug interaction studies. I’ll finish with recommended approaches for interpreting drug interaction study results and expressing that information in drug labeling.

Links discussed in the show:

PK in patients with impaired renal function (Ep. 12) Oct 23, 2023

Show notes

In today’s episode I discuss the evaluation of pharmacokinetics in patients with impaired renal function. I include information from both the US FDA and EMA guidance documents linked below. I discuss the determination of when a dedicated renal impairment study is needed, characteristics of the study design and how to analyze and interpret the results.

Links discussed in the show:

• FDA guidance on PK in patients with impaired renal function

• EMA guidance on Evaluation of PK in patients with decreased renal function

• You can connect with me on LinkedIn and send me a message.

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• Sign up for my newsletter