C2C - Integration of modelling, endogenous biomarkers, and real-world study approaches to support precision dosing in special populations

Monday, November 11, 2024

3:15 PM – 4:45 PM MST

Location: Sonoran Sky Ballroom 5 - 8

Chair and Speaker(s)

Dongyang Liu, PhD (he/him/his)

Deputy Director
Drug Clinical Trial Center, Peking University Third Hospital
Beijing, Beijing, China (People's Republic)

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Aleksandra Galetin, PhD (she/her/hers)

Professor of Translational Pharmacokinetics
University of Manchester
Manchester, England, United Kingdom

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Speaker(s)

Michael Gertz, PhD (he/him/his)

Expert Scientist
F. Hoffmann-La Roche

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Lixia Zhang, PhD

Staff Fellow
FDA

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Disclosure(s):

Dongyang Liu, PhD: No financial relationships to disclose

Aleksandra Galetin, PhD: Abbvie: Grant/Research Support (Ongoing); Bristol Myers Squibb: Grant/Research Support (Ongoing); Eli Lilly and Company: Grant/Research Support (Ongoing); EMD Serono, Merck kGa: Grant/Research Support (Ongoing); Genentech: Grant/Research Support (Ongoing); GSK: Grant/Research Support (Ongoing); Janssen Research & Development: Grant/Research Support (Ongoing); Roche: Employment (Ongoing), Grant/Research Support (Ongoing); Servier: Grant/Research Support (Ongoing); Takeda: Grant/Research Support (Ongoing)

Michael Gertz, PhD: Roche: Employment (Ongoing)

Lixia Zhang, PhD: No financial relationships to disclose

Presentations:

3:15 PM – 3:25 PM MST

The current clinical needs and gaps for precision medicine of special populations
Speaker: Dongyang Liu, PhD (he/him/his) – Drug Clinical Trial Center, Peking University Third Hospital
3:25 PM – 3:50 PM MST

Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children
Speaker: Michael Gertz, PhD (he/him/his) – F. Hoffmann-La Roche
3:50 PM – 4:15 PM MST

Application of endogenous biomarkers of drug transporters and liquid biopsy coupled with PBPK modelling to support precision dosing in renal impairment
Speaker: Aleksandra Galetin, PhD (she/her/hers) – University of Manchester
4:15 PM – 4:35 PM MST

Utilization of Real-World Data in Clinical Pharmacology – Regulatory Perspectives
Speaker: Lixia Zhang, PhD – FDA
4:35 PM – 4:45 PM MST

Panel Discussion
Speaker: Dongyang Liu, PhD (he/him/his) – Drug Clinical Trial Center, Peking University Third Hospital
Speaker: Michael Gertz, PhD (he/him/his) – F. Hoffmann-La Roche
Speaker: Aleksandra Galetin, PhD (she/her/hers) – University of Manchester
Speaker: Lixia Zhang, PhD – FDA