ASCPT Pharmacometrics & Pharmacokinetcs (PMK) Community Members-Only Webinar
Title: Marrying Real-World Data and Modeling: A Case of Interdisciplinary MIDD to Address Changes of Bone Mineral Density in Premenopausal Women
Date and Time: Friday, August 14, 2020, 11:00 am ET
Speaker: Mohamad Shebley, PhD
Moderators: Chunze Li, PhD, and Akshanth Polepally, PhD
Description: This webinar will introduce the concept of interdisciplinary model-informed drug development (i-MIDD) in a real drug development setting. The presented work will describe how real-world data (RWD) could be linked to traditional pharmaco-statistical modeling to bridge understanding of long-term bone safety in premenopausal women. The work will highlight how the RWD could be extended to epidemiological modeling for evaluating clinical relevance of the projected changes in bone mineral density (BMD) in relation to future risk of bone fractures. For additional information, please click the registration link below.
Registration Link: https://us02web.zoom.us/webinar/register/WN_7eQ1iOZSQL6hQIHQSScsCg
ASCPT Early Career (EC) Community and Oncology (ONC) Community Members-Only Webinar:
Title: Translational and Clinical Pharmacology Considerations in the Development of Immune-Oncology Drugs
Date and Time: Friday, August 28, 2020, 2:00 pm ET
Speaker: Sree Kasichayanula, PhD
Moderators: Pooja Manchandani, PhD, and Malek Okour, PhD
Description: The presentation will highlight the hallmarks of immuno-oncology drug development and expand on pharmacometrics, clinical pharmacology and statistical strategies to optimize clinical trial design and development of immune-oncology drugs. This will be the first webinar of a three-part series on immune-oncology drug development. Highlights of this session will include:
Registration Link: https://us02web.zoom.us/webinar/register/WN_LHbb5WQqQfeRoRDSW8wwTg
- Fundamental biology underpinnings and trajectory of immune-oncology drug development and how this differs from the standard clinical development paradigm in oncology.
- Role and impact of clinical pharmacology aspects to support immune-oncology drug development for monotherapy and combination.
- Modeling and simulation strategies and clinical trial designs for early development and pivotal trials.
ASCPT Early Development & Drug Safety (EDDS) and Oncology (ONC) Communities Members-Only Webinar
Title: Using Preclinical Data in Phase I Oncology Trials: A Bayesian Decision-Theoretic Approach
Date and Time: Tuesday, September 1, 2020, 11:00 AM ET
Speaker: Haiyan Zheng, PhD
Moderator: Huiming Xia, MSc, PhD
Description: Using preclinical data to specify a prior for the human dose-toxicity model parameter(s) can improve interim dose recommendations and precision for estimating the maximum tolerated dose (MTD). Such advantages, however, must be balanced against the risk that more patients will possibly be treated with excessively toxic doses in the case of a prior-data conflict. This presentation will make a proposal for how to measure and address a prior-data conflict in a sequential study with a small sample size. For learning objectives and additional description information, please click the registration link below.
Registration Link: https://us02web.zoom.us/webinar/register/WN_Uw-PHaVcRnuDTZwa1AfNiw
ASCPT Members-Only Webinar presented by the Infectious Diseases (INF) and Oncology (ONC) Communities
Title: Convergence of Therapeutic Approaches in Oncology and HIV to Target Immune Evasion: Integrating Clinical Pharmacology Lessons Learned
Date and Time: Friday, September 25, 2020, 12:00 pm ET
Speakers: Akintunde Bello, PhD, and Islam Younis, PhD
Moderators: Daria Stypinski, PhD and Mark Dresser, PhD
Description: This special virtual session will bring together experts with experience in immuno-oncology and HIV research. They will address the major lessons learned from each therapeutic area and the goal to accelerate the pace and lesson the challenges of drug development. The participants will gain knowledge in the overlapping mechanisms in HIV and cancer that have made similar treatment strategies possible. Lessons learned will be shared from HIV combination therapy approaches on establishing contributions of regiment components to overall safety and efficacy. Immuno-oncology on dose-optimization challenges in the development of immune checkpoint inhibitors will also be explored.
Registration Link: https://us02web.zoom.us/webinar/register/WN_kkLBLp9nT26MkB_rW89UXQ