Panel Discussion

Wednesday, November 13, 2024

1:45 PM – 3:15 PM MST

Location: Kaibab & Lantana

Panelist(s)

Ana Ruiz, PharmD, PhD

Executive Director, Head of the Pharmacometrics Group
Gilead Sciences
Foster City, California, United States

Disclosure(s): No financial relationships to disclose
Julia Korell, PhD (she/her/hers)

Principal Scientist II
Metrum Research Group
Bethel, Connecticut, United States

Disclosure(s): Boehringer Ingelheim Pharmaceuticals, Inc.: Employment (Ongoing)
Gemma Dickinson, PhD (she/her/hers)

Vice President and Head of Global PK/PD and Pharmacometrics
Eli Lilly and Company
Indianapolis, Indiana, United States

Disclosure information not submitted.
Joga Gobburu, PhD MBA (he/him/his)

Professor
University of Maryland
Baltimore, Maryland, United States

Disclosure(s): Pumas-AI Inc: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); Vivpro Corp: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)
Peter Bonate, PhD

Executive Director
Executive Director at Astellas/ Editor-in-Chief, JPKPD
Northbrook, Illinois, United States

Disclosure(s): Astellas: Employment (Ongoing)

Disclosure(s):

Ana Ruiz, PharmD, PhD: No financial relationships to disclose

Julia Korell, PhD: Boehringer Ingelheim Pharmaceuticals, Inc.: Employment (Ongoing)

Joga Gobburu, PhD MBA: Pumas-AI Inc: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing); Vivpro Corp: Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Peter Bonate, PhD: Astellas: Employment (Ongoing)

In industry settings, the organization and structure of Pharmacometrics may vary depending on the company and its specific needs and priorities. Generally, Pharmacometrics operates under the umbrella of other functions such as Clinical Pharmacology. In this structure, pharmacometricians usually work alongside clinical pharmacologists. Integrating Pharmacometrics within Clinical Pharmacology can facilitate seamless communication and collaboration between Clinical Pharmacology and the program team. However, this set up often operates under the model where Clinical Pharmacology is acting as an intermediate player between Pharmacometrics, and the program team. This secondary seat assigned to Pharmacometrics can create some inefficiencies. Furthermore, by not having Pharmacometrics involved in strategic discussions we limit the visibility, impact, and recognition of Pharmacometrics as its own function, limiting its funding and therefore its growth. In more unique instances, pharmacometrics operates as an independent function. Independent pharmacometrics departments need to collaborate closely with Clinical Pharmacology, but also other functions such as Clinical Development, Statistics, and Regulatory Affairs among others. This setting provides more autonomy to Pharmacometrics, but other disadvantages arise.

The decision to establish Pharmacometrics as an independent function or to integrate it within Clinical Pharmacology or another function, depends on multiple factors such as the company's size, organizational culture and history, therapeutic focus, and strategic priorities. Both approaches have their advantages and challenges, and the optimal structure may vary depending on the specific context and objectives of the pharmaceutical company. But the question here is, is Pharmacometrics currently limited due to the industry settings?