2026 MIDD Webinar Series | Model-Based Dose Selection and Pharmacokinetic Bridging of Subcutaneous from Intravenous Pembrolizumab Across Indications

Gina Song is a Director in the Oncology Global Clinical Development organization, Quantitative Pharmacology and Pharmacometrics (QP2) function at Merck. She has over 10 years of experiences in the Pharmaceutical industry across therapeutic areas including preclinical and clinical oncology, infectious disease and pediatric development for different modalities with time spent at Hamner Institute, Labcorp and currently Merck.  She is currently leading SC pembrolizumab program for clinical pharmacology and modeling &simulation efforts across indications as well as supporting regulatory submissions in global markets.

Mallika Lala is Senior Director, Group Leader at Merck in the Oncology Global Clinical Development organization, Quantitative Pharmacology and Pharmacometrics function. She has 15 years of drug development experience across therapeutic modalities, including early and late clinical oncology, infectious diseases and CV-met. She has been involved with the clinical development of pembrolizumab across indications and regulatory submissions in several global markets, most recently MIDD for dosing regimen and SC formulation additions, as well as multiple oncology assets including ADCs and targeted therapies. Before joining Merck, in industry in India to advancing pharmacometrics and was an ORISE fellow at FDA with focus on application of innovative quantitative approaches to enhance pediatric drug development.