Maximizing the Impact of Antibody–Drug Conjugates (ADCs): Model-Informed Labeling, Expansion, and Market Access

Ananth has more than 20 years’ experience in pharmaceutical consulting across a variety of disciplines, including quantitative systems pharmacology modeling, health economic modeling, systemic literature reviews, indirect treatment comparisons, and complex statistical analyses of clinical and real-world databases required to support regulatory, payer and HTA submissions worldwide.

Dr. Cheung has more than 20 years of experience in modeling and simulation, as well as clinical pharmacology, with expertise in PBPK/PD mechanistic modelling, special populations (e.g., pediatrics, maternal, and geriatrics), extrapolation, model-based meta-analysis, vaccines, infections, HIV, complex biologics, and different therapeutic areas across early, late-phase and post marketing drug development. She is an honorary professor at the School of Engineering at the University of Warwick, UK. She is leading the EU funding project, ERAMET (grant agreement number 101137141), in work package 5, championing the enhancement and utilization of extrapolation in pediatric populations and for rare diseases.

Before joining Certara, Amy was a Senior Pharmacometrician and Scientific and Project Leader at the AstraZeneca Pediatric Working Group, which included 22+ cross-functional pediatric experts. During this time, she also served as the company representative on the IMI DDMoRe initiative and co-led work packages (e.g., PMX-workflow, cardiovascular training) and IQ consortium CPLG Pediatric Working Group. Dr Cheung has been a member of the EFPIA MID3 workgroup since the 2011 EMA M&S workshop, which resulted in several white papers. Currently, she is contributing her expertise to various professional societies, such as the IQ Consortium, EFGCP, ASCPT, and EU Horizon-funded projects. She has published over 50 papers on MIDD methodology/applications, reviews, and white papers in peer-reviewed journals.

As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the global market access, HEOR and real-world evidence context related to product value demonstration and has deep experience in both formal and informal exchanges with payers and HTA bodies.

Isabelle Deprez is a Clinical Pharmacology director and a professional with 20+ years of experience in clinical studies and clinical pharmacokinetics, combined with a background in pharmacology. She has expertise in conducting clinical pharmacology studies, including DDI, and likes to share knowledge and experience on clinical pharmacology topics, and has recently been part of workshops dedicated to DDI. She is used to managing project teams with multiple deliverables in various therapeutic areas (infectious diseases, cardiology, oncology, neurology, diabetes), in early and late development both for small molecules and biologics in adult and pediatric populations.

Isabelle is a pharmacist, has a Master in Sciences of Metabolism and Mechanism of Action of Drugs and a PhD in Cellular and Molecular Biology from Inserm U492, France.