Webinar Resources

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ASCPT Members-Only Webinar presented by the Early Development & Drug Safety and Systems Pharmacology Community
Title:  Model-Informed Drug Discovery and Development (MID3): Current Industry Good Practice, Regulatory Expectations and Future Perspectives
Date and Time: Wednesday, December 4, 2019, 10:00 am ET
Speakers: Scott Marshall, PhD, Efthymios Manolis, MS, and Rajnikanth Madabushi, PhD
Moderator: Lakshmi Vasist, PharmD
Description: Good practices around model-informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within drug development and regulatory review. Furthermore, these model-informed approaches continue to have an increased focus within future guideline development such as in the EMA extrapolation concept paper, PDUFA 6 that aims at advancing model-informed drug development, and ICH E11. In this special presentation, the following learning objectives will be discussed:
  • Do the recently documented industry good practices match with regulatory expectations?
  • How do these practices fit with future viewpoints from both industry and regulatory perspectives of the role of MID3 in making R&D and regulatory review more efficient?
  • What are the gaps and opportunities in the Pharma-Regulatory alignment, technical aspects and documentation, and how should these gaps be addressed?
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ASCPT Members-Only Webinar presented by the Translational Informatics (TI) Community
Title: Advancing High-Fidelity, Personalized Pharmacogenomics Education Through the Test2Learn Platform
Date and Time: Thursday, December 5, 2019, 12:00 pm ET
Speaker: Philip Empey, PharmD, PhD
Moderator: Sonal Singh, PhD
Description: This special webinar presentation will review consensus pharmacogenomic educational competencies promulgated by the genomics/genetics competency center (G2C2) and describe contemporary challenges in delivering genomics education broadly. Participatory education, defined as employing learner personal genomic testing, will be introduced as a solution. A critical review of the literature will provide evidence supporting its value. Ethical challenges to generating, storing, and distributing genetic data in educational environments will be discussed. Finally, the Test2Learn platform (free-license for noncommercial use) which mitigates these risks will be introduced with a description of how informatics and real-world data can be combined to deliver high fidelity education that increases learning outcomes.
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ASCPT Members-Only Webinar presented by the Pharmacometrics & Pharmacokinetics (PMK) Community
Title:  Tisagenlecleucel Modelā€Based Cellular Kinetic Analysis of Chimeric Antigen Receptor–T Cells
Date and Time: Tuesday, December 10, 2019, 1:00 pm ET
Speakers: Andy Stein, PhD, and Edward Waldron, MSc, PhD
Moderator: Neeraj Gupta, PhD
Description: Novel modalities of immuno-oncology agents such as CAR-T therapies have now started to take main stage in the era of post immune checkpoint agents. With the approval of two CAR-T therapies and several hundred ongoing clinical trials, clinical pharmacology and pharmacometrics considerations have not only become important to understand the mechanism of action, but also to support development and registrational questions such as dose and impact of various intrinsic and extrinsic factors. This special presentation will focus on kinetics of Tisagenlecleucel, an approved CD19 directed CAR-T therapy, and assess the impact of intrinsic and extrinsic factors, with a focus on comedications used for treating cytokine release syndrome.
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ASCPT Members-Only Webinar presented by the Special Populations Community
TitleRecent Advances in Neonatal Clinical Pharmacology
Date and Time: Wednesday, December 11, 2019, 11:00 am ET
Speakers and Panelists: David Taft, PhD, and Khaled Abduljalil, PhD
Moderator: Farzaneh Salem, PharmD, PhD
Description: Neonates are one of the most challenging groups of patients when optimizing pharmacotherapy. This is partially due to the rapid physiological and maturational changes that occur in this population, as well as our limited knowledge of the impact of these changes on the pharmacokinetics and pharmacodynamics of drugs in neonates. Prematurity adds another layer of complexity. Clinical trials are seldom performed to establish appropriate dosing in this population. Modeling and simulation techniques and, more recently, physiologically based pharmacokinetic (PBPK) modeling have opened new prospects in the clinical management and dose selection for neonates. The major advances and challenges in modeling and simulations that enable prediction of pharmacokinetic and pharmacodynamics in neonates will be presented in this webinar. This presentation will include an overview of physiological changes in preterm neonates required to develop a PBPK model for preterm population as well as application of preterm PBPK models to predict pharmacokinetics and pharmacodynamics. Discussion will include the potential role of modeling and simulations in improving our understanding and dose optimization in this population. Lastly, a case study will be presented with the antibiotic medication gentamicin that illustrates how PBPK modeling can provide practitioners with a scientific rationale for dosage regimen selection in preterms, thereby promoting safe and effective therapeutic interventions in this patient population.
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ASCPT Members-Only Webinar presented by the Early Career (EC) Community
Title: Clinical Pharmacology Considerations in the Development of Immune-Oncology Drugs
Date and Time: Thursday, January 23, 2020, 1:00 pm ET
Speaker: Nidal Al-Huniti, PhD
Moderator: Malek Okour, PhD, and Nithya Srinivas, PhD
Description: Building on the success of PD-1 (or PD-L1) inhibitors, a wave of next generation immunotherapies with different mechanisms of action (e.g., LAG3, CD40, ICOS, TIM-3, IDO1, GITR, STING, OX40, TIGIT) are being developed across multiple oncology indications. A key characteristic of immune-oncology programs is the assessment of clinical pharmacology information in patients within safety and efficacy studies, rather than through the use of healthy volunteer studies. As a result of this condensed trajectory of development, unique opportunities exist for the use of modeling and simulation strategies to address several important questions in immune-oncology development - from translation of pre-clinical data into first-in-human studies, to the characterization of relationships between exposure and safety/efficacy in pivotal clinical trials. This webinar will focus on strategies to optimize and highlight immuno-oncology drug development and expand on pharmacometrics, clinical pharmacology and statistical strategies to optimize clinical trial design and development of immune-oncology drugs.
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ASCPT Members-Only Webinar presented by the Infectious Diseases (INF) Community
Title: Clinical Pharmacology and Modeling and Simulation Applications in Neglected and/or Tropical Diseases
Date and Time: Wednesday, February 5, 2020, 1:00 pm ET
Speakers: Melanie Nicol, PharmD, PhD, and Luning (Ada) Zhuang, PhD
Moderators: Philip Sabato, MSc, PharmD
Description: This presentation will focus on applications and obstacles to clinical pharmacology research in tropical and neglected diseases. The unique opportunities and limitations to clinical pharmacology research in a resource limited setting will be discussed. Additionally, examples of drug repurposing to address neglected diseases and how clinical pharmacology can support these initiatives will be explored. A focus of the second speaker will be on Chagas disease- a neglected, tropical disease. Efficacy and safety data will be shared to provide context of dose recommendations in pediatric patients with Chagas Disease based on a model-informed approach.
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