C2B - Mind the gap – successful bridging of QSP and PMX in drug development

Monday, November 11, 2024

3:15 PM – 4:45 PM MST

Location: Sonoran Sky Ballroom 1 - 4

Chair(s)

GK

Georgi Kapitanov, PhD

Senior Director - QSP
Certara, California, United States
Amita Joshi, PhD (she/her/hers)

Vice President, Clinical Pharmacology
Genentech, South San Francisco, CA, United States

Speaker(s)

Mirjam Trame, Ph.D (she/her/hers)

Vice President Pharmacometrics
Certara
Boston, Massachusetts, United States

PDF Slides
KG

Kapil Gadkar, PhD

Distinguished Scientist, Senior Director
Genentech

PDF Slides
Blerta Shtylla, PhD (she/her/hers)

Research Fellow
Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA, United States

PDF Slides

Panelist(s)

CM

C.J. Musante, PhD

VP & Global Head of Pharmacometrics & Systems Pharmacology
Pfizer
Jin Jin, PhD (she/her/hers)

Executive Director and Senior Fellow
Genentech, Inc.
Foster City, California, United States
JE

Justin Earp, PhD

Pharmacometrics Team Lead
United States FDA
AK

Anna Kondic, anna.kondic@bms.com

Clinical Pharmacology, Pharmacometrics & Bioanalysis
Bristol Myers Squibb

Disclosure(s):

Georgi Kapitanov, PhD: No financial relationships to disclose

Amita Joshi, PhD: No financial relationships to disclose

Mirjam Trame, Ph.D: No financial relationships to disclose

Kapil Gadkar: No financial relationships to disclose

C.J. Musante, PhD: Pfizer: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Jin Jin, PhD: Genentech, Inc.: Employment (Ongoing)

Justin C. Earp, PhD: No financial relationships to disclose

Presentations:

3:15 PM – 3:35 PM MST

Joined PMX and QSP modeling to guide step-up dosing of a bispecific antibody for prostate cancer
Speaker: Mirjam Trame, Ph.D (she/her/hers) – Certara
3:35 PM – 3:55 PM MST

Convergence of QSP and Pharmacometrics - Are we there yet?
Speaker: Kapil Gadkar, PhD – Genentech
3:55 PM – 4:15 PM MST

The best of both worlds? Integration of QSP and PMx modeling in support of MIDD in oncology
Speaker: Blerta Shtylla, PhD (she/her/hers) – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA
4:10 PM – 4:45 PM MST

Panel Discussion
Panelist: Amita Joshi, PhD (she/her/hers) – Genentech, South San Francisco, CA
Panelist: Mirjam Trame, Ph.D (she/her/hers) – Certara
Panelist: Blerta Shtylla, PhD (she/her/hers) – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA
Panelist: Kapil Gadkar, PhD – Genentech
Panelist: C.J. Musante, PhD – Pfizer
Panelist: Jin Jin, PhD (she/her/hers) – Genentech, Inc.
Panelist: Anna Kondic, anna.kondic@bms.com – Bristol Myers Squibb