Road to University of Cincinnati’s Online Pharmacogenomics Degree Program

Heart Center Meditation v0.1

Are you an Early Career member who’s interested in applying for ASCPT’s Leadership Accelerator? Join Drs. Anu Ramamoorthy and Toni Ajavon-Hartmann as they discuss this exciting new learning and networking opportunity. If you’d like even more information about the Leadership Accelerator, visit the ASCPT website.

The deadline for applications to this unique program has been extended to June 23, 2023, so take advantage and submit your application soon!

Early Career Members: Apply for ASCPT’s Leadership Accelerator!

On behalf of the ASCPT PMK (pharmacometrics and pharmacokinetics) community, in this ASCPT Catalyst Podcast Dr. Neeraj Gupta interviews Dr. Hao Zhu regarding his expertise in MIDD and his visions for the future of pharmacometrics. Join us to hear important lessons Dr. Zhu has learned in his career and his advice for early-career scientists and students.

Journeys and Visions of Leaders in Clinical Pharmacology

In this podcast, Biologics Steering Committee member Tu Mai, PhD (Genentech), will be interviewing Monica Susilo, PhD (Genentech). Monica Susilo is a senior scientist at Genentech in the CP department, specialized in QSP modeling. She is supporting a variety of TDB oncology programs. On the podcast, Monica will share with us her experience in utilizing QSP models to support early clinical development.

Supporting Clinical Development from the Lens of a QSP Modeler

This episode is part of a multi-episode series regarding the impact of organ impairment on pharmacokinetics of therapeutic proteins and peptides, hosted by ASCPT Biologics Community and ASCPT Regulatory Science Community. Regarding the impact of organ impairment on therapeutic peptides, their impact has been inconsistently studied. This is likely due to an expectation of a lower likelihood of impact due to alternate pathways of metabolism compared to the small molecules and the larger size of peptides. In general, elimination pathways differ for small molecules and peptides. Peptides can exhibit adsorption, distribution, metabolism, and elimination (ADME) characteristics that are, in some cases, similar to small molecules, while in some cases to therapeutic proteins. In addition, the complexity of peptides has increased over the years with a goal of increasing stability and improving the ADME characteristics, e.g., the use of modified or synthetic AAs. Series 2 podcast will provide expert opinions about mechanisms, interesting examples, and scientific considerations for evaluating the impact of renal and hepatic impairment on PK of therapeutic peptides. The knowledge will help facilitate the development of therapeutic peptides and enhance rational dose recommendation in patients with renal and hepatic impairment.

Impact of Organ Impairment on Pharmacokinetics of Therapeutic Peptides

This episode is part of a multi-episode series regarding the impact of organ impairment on pharmacokinetics of therapeutic proteins and peptides, hosted by ASCPT Biologics Community and ASCPT Regulatory Science Community. Regarding the impact of organ impairment on therapeutic proteins, the current FDA guidance has some recommendation for renal impairment, but limited information for hepatic impairment. The mechanism and the impact of organ impairment on the PK of therapeutic proteins could be very different compared to small molecules, especially for hepatic impairment which could lead to decreased exposure of therapeutic proteins compared to increased exposure of small molecules. In addition, there are lots of unique considerations for a specific type of therapeutic proteins (e.g., mAb, ADC, growth hormone). This podcast will provide expert opinions about mechanisms, examples, and scientific considerations for evaluating the impact of renal and hepatic impairment on PK of therapeutic proteins. The knowledge will help facilitate the development of therapeutic proteins and enhance rational dose recommendation in patients with renal and hepatic impairment.

Impact of Organ Impairment on Pharmacokinetics of Therapeutic Proteins

Physiologically Based Pharmacokinetic Modeling and Simulation (PBPK) of absorption-related issues is an area of great present and future potential. Drug interactions with modulators of gastric potential of hydrogen (pH), also called as acid-reducing agents (ARAs, such as PPIs, H2 blockers, antacids), is of concern for orally administered drugs having a pH sensitive solubility. PBPK simulations could be used to inform internal decision making on allowed comeds in clinical studies. It could also be used in regulatory applications, either alone or combined with other data/analysis in totality of evidence approaches. The recently finalized US Food & Drug Administration guidance on gastric pH change-mediated drug-drug interactions (DDI) (i.e., pH-DDI) when used with ascending reticular activating systems (ARAs) mentions PBPK as an alternative approach and encourages consultation with the agency. This webinar will include two presentations, one weak acid and one weak base, exploring the applications of this methodology and lessons learned.

Impact of Organ Impairment on Pharmacokinetics of Therapeutic Proteins

ASCPT Catalyst

Related tracks