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What does the Clinical Pharmacology Plan for a Biologic Look Like?

September 21, 2021
On-Demand Webinar

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and safe therapeutic solutions for patients. Due to their molecular and biological specificities, their clinical and pharmaceutical development present some particularities and challenges in comparison to the development of new molecular entities.

Thanks to three decades of experience in the development and approval of monoclonal antibodies, it is now possible to leverage prior knowledge and to establish a typical standard plan to address the common regulatory and scientific questions. This webinar will provide an overview of monoclonal antibodies’ properties and their clinical development program, including the investigation of pharmacokinetics (PK), immunogenicity, and the potential impact of organ impairment. Examples of specific clinical pharmacology studies investigating the drug-drug interaction (DDI) potential or manufacturing changes will be presented and discussed. This webinar will also present and discuss a potential clinical pharmacology development plan for monoclonal antibodies.


Dr. Khaled Benkali

Dr. 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.