2024 ACCP STEP & ESP Webinar: Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies - LIVE

2024 ACCP STEP & ESP Webinar: Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies

Live webinar: October 2, 2024 from 12:00 - 1:00 PM ET 

On-demand webinar recording: October 2, 2024 to October 2, 2027

Target audience:

Interprofessional team of MDs, PhDs, PharmDs including Students, Trainees and all levels of professionals seeking an introduction the biological principles and clinical pharmacology considerations for antibody-drug conjugates and bispecific antibodies.

Learning Objectives

After completing this activity, the learner will be able to:

1. Understand the mechanism of actions of ADCs and bispecific antibodies;
2. Apply clinical pharmacology principles in different stages of the development of novel therapeutics;
3. Leverage model-informed drug development approaches in the dose optimization of novel therapeutics;
4. Identify the opportunities and challenges for dose optimization trials.

Description:

Attendees of all experience levels will receive a practical introduction to the exciting modalities of antibody-drug conjugates (ADCs) and bispecific antibodies. ADCs and bispecifics represent new frontiers in immunotherapy and are generating massive interest from prescribers and pharmaceutical companies alike. This webinar, presented by two experts in the spaces of ADCs and bispecifics, will provide a conceptual foundation of the two modalities and how they differ from traditional antibody therapeutics. In the meantime,  ADCs and bispecifics also bring novel challenges in drug development. The clinical pharmacology considerations for evaluating the two modalities, including model-informed approaches and dose optimization, will be discussed and illustrated with case studies.


Suzette Girgis

Vice President, Head of Global Clinical Pharmacology & Pharmacometrics

Jazz Pharmaceuticals Inc

Dr. Girgis is a passionate, patient centric, strategic drug developer with over 20 years of experience in small molecules, biologics and cell therapy, ranging from discovery to commercialization, with a particular emphasis on oncology. She joined Jazz Pharmaceuticals Inc in October 2022 as the Vice President and Head of Global Clinical Pharmacology and Pharmacometrics. She currently serves as the Industry Representative on the US FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee. Dr. Girgis is recognized as an expert in dose selection for First-in-Human and Proof of Concept studies. Over the years, she has made significant contributions to the development of several approved compounds [including abatacept (Orencia®), belatacept (Nulojix®), bortezomib (Velcade®), decitabine (Dacogen®), daratumumab (Darzalex®), ciltacabtagene autoleucel (Carvykti®), teclistamab (Tecvayli®), Talquetamab (Talvey®), and asparaginase Erwinia chrysanthemi (Rylaze®)]. Suzette has a strong commitment to mentoring and talent development and is a strong advocate of rotation programs.

Dr. Girgis earned her BPharm Degree from Cairo Univ (Egypt) and her MS and PhD in Pharmaceutical Sciences, specializing in PK/PD modeling, from the Univ of Rhode Island. After completing her studies, she began her career as a Postdoctoral Research Fellow in Clinical Pharmacokinetics at Johnson & Johnson. She later joined the Drug Metabolism and Pharmacokinetics Department of Schering-Plough (currently Merck), where she worked on early development compounds in neuroscience, cardiovascular and virology. Subsequently, she joined the clinical pharmacology department at Bristol Myers Squibb, where she worked on oncology and immunology compounds and later oversaw the clinical pharmacology activities for the Immunology Therapeutic Area. She has also directed many clinical pharmacology studies in oncology, immunology, neuroscience, cardiovascular and metabolic diseases. In 2008, Dr. Girgis rejoined Johnson & Johnson as a director in Global Clinical Pharmacology, where she took on increasing roles and responsibilities, including the US Head of Scientific and Technical Operations in the Clinical Pharmacology Department. Prior to joining Jazz, Dr. Girgis served as the Clinical Pharmacology Head of Hematologic Malignancies at Johnson & Johnson, where she developed multiple immuno-oncology compounds (including bispecifics, trispecifics and CAR-T), implemented model-informed drug development principles and oversaw the clinical pharmacology strategy of heme pipeline.

Dr. Girgis has published many manuscripts in prestigious journals including the New England Journal of Medicine and Lancet. She has presented at many scientific conferences such as ASH, ASCO, EHA, ESH, IMW, ACoP and AAPS. When not working, she enjoys spending time with her family, painting and hiking. She is also active in her Coptic church, where she volunteers her time to serve the local community.

Li Li

Senior Director, Quantitative Clinical Pharmacology

Daiichi Sankyo Inc

Dr. Li is a Senior Director in Quantitative Clinical Pharmacology Department at Daiichi Sankyo Inc. She had worked on trastuzumab deruxtecan (T-DXd) and now is working with a team of clinical pharmacologists on patritumab deruxtecan (HER3-DXd).

Before joining DSI, Dr. Li has worked on both early phase and late phase programs in Eli Lilly and BMS. She was responsible for all PK/PD activities of neurodegeneration molecules in preclinical phases and supported progression into clinical of over 10 drug candidates and more than 5 First-in-Human studies. She has made significant contributions to more than 10 late phase clinical projects in immunology, neuroscience and oncology, including baricitinib, ixekizumab, donanemab and nivolumab. Her areas of expertise encompass both biologics and small molecule development. In addition, she led cross-functional initiatives such as establishing data/model repository, internal guidelines/practices and job aids.

Dr. Li received her BS in biology from Wuhan Univ, China; MS in Horticultural Sciences and PhD in Pharmaceutical Sciences from the Univ of Florida. She possesses a broad knowledge in biochemistry and molecule biology, and bioanalytical and mathematical mechanistic modeling.  

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2024 ACCP STEP & ESP Webinar: Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies - Live
10/02/2024 at 12:00 PM (EDT)  |  60 minutes
10/02/2024 at 12:00 PM (EDT)  |  60 minutes
2024 ACCP STEP & ESP Webinar: Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies-Evaluation - LIVE
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