Webinar Resources

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An ASCPT Journal Family presented by Clinical Translational Science
Title: Reviewer Readiness: How to Be an Effective Reviewer for ASCPT Journals
Date and Time: Wednesday, January 29, 2020, 12:00 pm ET
Speakers: Valentina Shakhnovich, MD, and Deanna Kroetz, PhD
Moderators: Mark Dresser, PhD
Description: This interactive discussion with editors of Clinical and Translational Science will provide information to current and prospective reviewers for all ASCPT journals on the editorial process and the critical role of reviewers in this process. The distinct roles of journal staff, editors and reviewers will be discussed. A large portion of the webinar will be devoted to providing guidance on how to provide effective reviews.
Registration Link: https://zoom.us/webinar/register/WN_IozOz4ElSJiq_3hNQ464XQ

ASCPT Members-Only Webinar presented by the Systems Pharmacology (SP) and Early Career (EC) Communities
Title: Next Generation Pharmacometricians – Examples from Early Career Modelers on MID3 Implementation
Date and Time: Thursday, January 30, 2020, 1:00 pm ET
Speakers: Lulu Chu, and Songmao Zheng
Moderator: Aline Barth and Michael Block
Description: By means of using case studies, early career modelers will demonstrate how they developed the technical and soft skills to successfully implement modeling approaches and to impact discovery and drug development strategies. The presenters will reflect on the questions that had to be addressed during the modeling, the challenges they experienced, and how they successfully advocated, communicated and implemented MID3 at an early stage of their careers.
Registration Link: 

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.
Registration Link: https://zoom.us/webinar/register/WN_47YxyKgAQ6qPQMtM5LfyTw

Please note this webinar will not be recorded. In addition, no slides will be available.

ASCPT Members-Only Webinar presented by the Pharmacogenomics (PGx) Community
Title:  Therapeutic Impact and Detection of Membrane Transporter Polymorphisms
Date and Time: Thursday, February 6, 2020, 12:00 pm ET
Speakers: Kathy Giacomini, PhD, Sook Wah Yee, PhD, and Alex Galetin, PhD
Moderators: Jason Sprowl, PhD
Description: In this webinar, we will provide an overview of transporter polymorphisms that are important in drug disposition and response.  We will focus on transporter polymorphisms that have a high level of evidence that they should be genotyped in drug development programs and in precision medicine.   In addition, we will describe the discovery of metabolomic biomarkers for transporters and how these biomarkers are being used in combination with modeling and simulation to predict interindividual variation in the activity of transporters due to genetic polymorphisms and drug-drug interactions. 
Registration Link: 

ASCPT Members-Only Webinar presented by the Biologics Community, Pharmacometrics & Pharmacokinetics Community (PMK), Systems Pharmacology Community (SP), and Biomarkers & Translational Tools (BTT) Communities
Title: Clinical Pharmacology Considerations in Development of siRNA Therapeutics: Case Study of Givosiran
Date and Time: Tuesday, April 21, 2020, 1:00 pm ET
Speakers: Sagar Agarwal, PhD and Varun Goel, PhD
Moderator: Sagar Agarwal, PhD
Description: Small interfering RNAs (siRNAs) are a promising type of RNA-based therapeutic oligonucleotide drugs that can inactivate several target RNA molecules in a sequence-specific manner. Since the discovery of RNA interference (RNAi), a significant progress has been made in the development of therapeutic siRNAs including approval of the first ever siRNA therapy. Givosiran is a FDA approved siRNA therapeutic for the treatment of acute hepatic porphyria. Givosiran which is administered subcutaneously utilizes a GalNAc conjugate technology to enable targeted delivery to liver, the site of action. This presentation will give an overview of the clinical pharmacology program of givosiran, that included characterization of the PK and PD of givosiran, the impact of extrinsic and intrinsic factors, as well as special populations. Modeling and simulation analysis that enabled dose selection will be discussed.
Registration Link: 

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, April 30, 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.
Registration Link: https://zoom.us/webinar/register/WN_ZziZ45ahSci1dMlOumy0bA 

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