How Do You Know You Have the Right Dose? Using Exposure-Response Evidence to Justify and Defend Dose Decisions

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.

Dr. Eline van Maanen brings over 16 years of experience in pharmacometric consulting. She joined Certara in 2018. Before that, she was a PKPD consultant at LAP&P Consultants. Eline has dedicated her entire career to the field of pharmacometrics. Her expertise includes mechanistic PKPD modeling across a range of therapeutic areas, such as neurology, oncology and infectious diseases.

Eline received a PhD in Pharmacology from Leiden University in 2017, where she studied systems pharmacology of the amyloid cascade under the supervision of Prof. Meindert Danhof. Eline has a background in engineering, holding a MSc degree in Life Science and Technology from Delft University of Technology. Outside of work, Eline enjoys pilot-gig rowing.

Anna Largajolli, PhD is a Senior Director at Certara Drug Development Solutions with over 15 years of experience in pharmacometric modelling and clinical pharmacology.

She holds a B.Sc. and M.Sc. in Biomedical Engineering (cum laude) and a PhD in Pharmacometric Modelling, all from the University of Padova (Italy).

Her career spans academia and industry, including a visiting PhD studentship at the University of Cape Town, a postdoctoral fellowship at Uppsala University (Sweden), and a postdoctoral fellowship at GSK, before joining Certara in 2016 where she has progressively advanced to her current senior leadership role.

Anna has deep expertise across a broad range of modelling and simulation techniques — including population PK, PKPD, model-based meta-analysis (MBMA), and machine learning-based covariate selection — applied across multiple therapeutic areas.

She leads project teams, mentors junior associates, and contributes actively to scientific innovation through an extensive publication and conference presentation record.