Date: Thursday, April 23, 2026
Time: 3-4pm (JST) and 10-11am (CET)
Products: Certara IQ™, Phoenix®, Simcyp® PBPK Simulator
Summary
In the development of antibody–drug conjugates (ADCs), selecting a starting dose is only the first step. Sustained success depends on refining dose regimens that appropriately balance efficacy, safety, and regulatory requirements as programs progress from early clinical studies to registrational planning. This process relies on the integration of quantitative methods to ensure dose and regimen strategies are robust, well supported, and aligned with overall development goals.
In this webinar, Certara experts Khaled Benkali, Eline van Maanen, Armin Sepp, and Felix Stader will explore how population pharmacokinetics (PopPK), exposure–response (E-R), toxicology, and mechanistic modeling approaches, including PBPK and QSP, can be combined to guide dose regimen optimization throughout development.
The session will address the design of informative early regimens, the selection of expansion and backfill strategies that balance signal detection and risk, and the development of Phase 3 and BLA and MAA dose rationales that clearly support an optimal risk–benefit profile. Participants will also gain practical perspective on common challenges and applied solutions for constructing regulator-ready dose optimization strategies.
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Felix Stader
Senior Research Scientist at Certara UK Limited, Simcyp DivisionFelix studied biology and pharmaceutical science in Muenster (Germany) and did his PhD in Basel (Switzerland) about HIV drug pharmacokinetics and drug-drug interaction magnitudes in the elderly by using a Matlab model. At Certara UK, he worked extensively on the biologics models of the Simulator including subcutaneous absorption, antibody-drug conjugates and the possibility to simulate therapeutic protein disposition in paediatrics. Additionally, Felix has broad experience in developing population and compound files.
Khaled Benkali, PhD, MBA
Senior Director, Team Lead, Clinical PharmacologyDr. Khaled Benkali joined Certara as a Director, Clinical Pharmacology in February 2020. He is a pharmacist and completed his training with a Master of Science and a PhD in pharmacology and holds an executive MBA. Khaled brings a strong business acumen and strategic perspective acquired through 10 years in the pharmaceutical industry, at Galderma and Pierre Fabre, successively. During this period, he participated actively in the development and successful approval of several dermatological drugs. Khaled participated to the development of new chemical entities and monoclonal antibodies. He had also an extensive exposure to in-licensing opportunities and interactions with regulatory bodies, a good understanding of M&S (popPK, PBPK) and their applications to support drug development.
Armin Sepp
Senior Principal Scientist, Certara SimcypArmin Sepp is a Senior Principal Scientist in Certara’s Simcyp Science team, specializing in biologics. Before joining Certara, he was a Scientific Leader and Fellow at the DMPK Modelling group at GlaxoSmithKline where he provided pre-clinical to Phase I PK/PD support for mAbs, antibody fragments, and other engineered proteins. His background is in bio-organic chemistry with post-doctoral training in protein engineering and in vitro evolution at the MRC Immunochemistry Unit in Oxford and MRC Laboratory of Molecular Biology in Cambridge, UK.
Eline van Maanen
Director ConsultingDr. 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.
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