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Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
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  • Contains 3 Component(s) Includes a Live Web Event on 11/12/2024 at 9:00 AM (EST)

    In this webinar we will discuss efforts for improving the global underrepresentation of African genetics in science. We will further explore the current landscape and challenges in realizing an African hepatic modeling platform - with a specific focus on the development of hiPSC models that can better recapitulate hepatic function.

    The African continent harbors unparalleled genetic diversity yet remains largely underrepresented in  pharmaceutical  research  and  development.  Pharmacogenomics  is  fundamental  to  precision medicine strategies, and although to date largely absent from implementation, representing the genetic diversity of the African population within the laboratory is critical to the democratization of stratified  and  effective  healthcare  in  Africa.  Afrocentric  preclinical  resources  could  support precision  medicine on  the  continent  and  reshape  the  global  underrepresentation  of  African genetics  in  science. Models  which  could  begin  to  address  this  include  primary  human hepatocytes,  immortalized  hepatic  cell  lines,  and human induced  pluripotent  stem  cell  (hiPSC)derived hepatocyte-like cells – derived from individuals of African genetic ancestry. The feasibility of an African hepatic modeling platform is slowly being realized due to the convergence of several technologies and methodologies which have traditionally been siloed on the continent.

  • Contains 3 Component(s) Includes a Live Web Event on 04/09/2024 at 11:00 AM (EDT)

    Selective inhibitors of drug metabolizing enzymes are critical for reaction phenotyping to characterize clearance pathways. New selective inhibitors have been identified to enable more effective understanding of mechanisms involved in metabolism and drug-drug interactions. Learning the characteristics of these new selective inhibitors will allow researchers to apply them readily to characterize new drug candidates.

    Selective chemical inhibitors are critical for reaction phenotyping to identify drug-metabolizing enzymes that are involved in the elimination of drug candidates. Although relatively selective inhibitors are available for the major cytochrome P450 enzymes (CYP), they are quite limited for the less common CYPs and non-CYPs. To address this gap, we developed a multiplexed high throughput screening (HTS) assay using 20 substrate reactions of multiple enzymes to simultaneously monitor the inhibition of enzymes in a 384-well format. Four 384-well assay plates can be run at the same time to maximize throughput. This is the first multiplexed HTS assay for drug-metabolizing enzymes reported. The HTS assay is technologically enabled with state-of-the-art robotic systems and highly sensitive modern LC-MS/MS instrumentation. Virtual screening is utilized to identify inhibitors for HTS based on known inhibitors and enzyme structures. Screening of ~4000 compounds generated many hits for many drug-metabolizing enzymes. This webinar will highlight the characterization of selective inhibitors of CYP3A5 (loteprednol etabonate) and AO (erlotinib and dibenzothiophene). We encourage colleagues from other organizations to explore their proprietary libraries using a similar approach to identify better inhibitors that can be used across the industry.

  • Contains 3 Product(s)

    This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years.

    This workshop is organized through the efforts of the ISSX Transporters Focus Group and is organized by Drs. Aleksandra Galetin, Xinning Yang, Bhagwat Prasad, Xiaoyan Chu, Hong Shen, Pei Feng Shawn Tan (student member), Mitesh Patel, Eva Gil Berglund, and Chitra Saran.

    This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years. 

    The three-day workshop will cover several important topics in these areas: 

    -application of transporter biomarker in drug development,
    -understanding transporter function changes in specific populations facilitated by biomarker assessment, 
    -methods to identify transporter biomarkers, and 
    -emerging biomarkers of efflux transporters.  

    Each session of the workshop consists of presentations from several expert speakers followed by roundtable discussions, with case study presentations incorporated into one session to showcase the experience and advances in using transporter endogenous biomarkers during drug development. In addition, there will be an interactive virtual poster session, which will be selected from the pool of abstracts from trainees and industry attendees.

    Your workshop registration includes access to all presentation slides and recordings.

  • Contains 3 Component(s)

    This webinar is intended to highlight and discuss: The Process of Drug Discovery to Clinic.

    Drug discovery and development can be described as the sum of multiple steps taken by biotech and pharmaceutical companies to identify and study new chemical or biological entities and convert these into approved marketed medical products. The entire process takes, on average, more than 10 years and over $1-2B, to bring a product to market.

    During this process the attrition rate at all stages of drug discovery and early development are high; hence, sponsors are seeking ways to conduct early-stage drug development studies in the most cost-effective manner. The other consideration is the timeline needed to reach first in human (FIH) studies– the faster we can conduct these studies, the better it is for companies seeking to advance these leads further into development or sell the promising assets to potential buyers who are prepared to conduct additional clinical trials beyond Phase 1 studies. 

    The elements of drug development leading to IND submission and the conduct of FIH studies include: Drug Metabolism & Pharmacokinetics (DMPK), Safety/Tox, Bioanalytical (GLP/non-GLP) and CMC. With limited and dwindling resources in biotech/pharmaceutical companies, a significant portion of the task of advancing lead compounds to clinical are now conducted by Contract Research organizations (CROs) who are very well equipped to conduct these early development studies. Very often study sponsors struggle to outsource studies, often in small pieces, to reliable CROs. 

    Managing the costs and tracking timelines/samples/reports at multiple CROs often become a very inefficient and costly task. It is important to seek CROs that can provide a one stop shop option to drive cost-savings and efficiency, including accelerated timelines to reach FIH studies. Furthermore, proper project management, resolving issues with the best available science, and ability to provide proper/relevant regulatory guidance, are essential components of this one stop shop facilities. To keep the prices manageable (especially with the high attrition rate), many sponsors are also seeking more cost-effective alternatives overseas, including conducting studies in countries such as China (second largest economy in the world).

    Frontage Labs has been engaged in R & D activities over the last 20+ years, with substantial investments in facilities in both USA and China. Over the years, it has built a full-service science-driven organization that has participated in bringing products to the market for numerous clients. With its dual presence in USA and China, and being a strong science and issue driven organization, Frontage is now offering end to end services to advance clients’ lead candidates to FIH at very reasonable cost (estimated to be 50% less than what it costs to conduct these studies internally or outsource to multiple vendors) and with constricted timelines. 

    In this presentation we will describe the complete package that Frontage offers to clients seeking to advance their lead candidates to FIH and beyond.


    This webinar is sponsored by Frontage.

  • Contains 3 Component(s)

    This symposium is intended to provide perspectives on the impact that the ICH M12 guideline will have on the in vitro DDI studies required for drug development.

    In June 2022, the ICH released the first draft of its harmonized Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies' guidelines to create a single guideline that will be used across all member countries. After a review period, the guideline will be adopted in early 2024. This presentation will offer perspectives on the differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline.

    This webinar is sponsored by BioIVT.

  • Contains 3 Component(s)

    This webinar will highlight how primary human cells play a key role in the performance of Liver Tissue Chips, which are at the forefront of drug development technology. The Liver Tissue Chip, which utilizes primary cells such as human hepatocytes and non-parenchymal cells, represents a significant advancement in the field, offering a promising tool for predicting pharmacokinetic profiles, toxicodynamic assessment and drug safety evaluation in alignment with human physiology.

    Join us Tuesday, December 5, for a ISSX educational webinar presented by Dr. Chris Mathes, Chief Commercial Officer at AnaBios, and Dr. Shiny Rajan, Director of Tissue Development at Javelin. Together, they will explore the transformative potential of utilizing human primary hepatocytes and liver sinus endothelial cells (LSEC) for in revolutionizing drug development processes. They will discuss how liver tissue chips address the limitations of conventional microfluidic-based tissue chips, offering a physiologically relevant platform for better predict pharmacokinetic endpoints and improve the drug optimization process. Users will learn how Liver Tissue Chips enhance safety assessment and the implications for predicting drug-drug interactions (DDI) and drug-induced liver injury (DILI).

    This webinar is sponsored by AnaBios and Javelin Biotech.

  • Contains 3 Component(s)

    This webinar is intended to discuss a prodrug approach to target tumors. Developing tumor targeting prodrugs is highly challenging. There are not many successful examples in the field. Effective screening strategies are much needed to enable identification of successful prodrug candidates. This is a great example to spark some new ideas in the field. The enzymatic processes for prodrug cleavage are unique and the successful screening strategy is highly educational for scientists in the field.

    Many cancers change their energy metabolic requirements and become "glutamine addicted" for their growth and survival. The glutamine antagonist 6-diazo-5-oxo-l-norleucine (DON) has shown robust efficacy in both preclinical animal models and exploratory clinical studies. Although promising, clinical studies with DON were halted due to its marked dose-limiting toxicities, which were mainly gastrointestinal (GI)-related, as the GI system is highly dependent on glutamine utilization. To overcome these toxicity issues, we sought to develop a DON prodrug that could selectively deliver DON to tumor tissues while sparing normal glutamine-dependent tissues like the GI tract. We designed over 100 prodrugs by installing dual promoeities on DON that can be dislodged by the enriched milieu of esterase and protease enzymes in tumor. Using iterative chemistry and pharmacokinetic efforts, we identified various promising DON prodrugs that showed preferential tumor bioactivation and delivery. Of these, our best DON prodrug, DRP-104 is bio-activated in the tumor while bio-inactivated in gastrointestinal (GI) tissues resulting in 11-fold higher glutamine antagonist delivery to the tumor (target site) versus GI (toxicity site) resulting in robust anti-cancer activity with minimal GI-toxicities. DRP-104, is now being evaluated in Ph1/2a clinical trials in cancer patients (ClinicalTrials.gov Identifier: NCT04471415).

    References:
    Leone et al., Science 366, 1013-1021 (2019)
    Rais et al., Sci. Adv. 8, eabq5925 (2022)

  • Contains 1 Component(s)

    On Wednesday, November 29, ISSX held the 2023 Member Meeting.

    The 2023 ISSX Member Meeting was online on Wednesday, November 29, 2023. You can now access the meeting recording to hear important updates from ISSX President, Scott Obach, ISSX President-Elect, Aleksandra Galetin, ISSX Treasurer, Sandy Pang, ISSX Membership Affairs Committee Chair, Marcel Hop, ISSX Transporters Focus Group Chair, Xinning Yang, and the Co-Chairs of the ISSX/JSSX 2024 Meeting, Natalie Hosea and Kiyomi Ito.

  • Contains 6 Component(s)

    This course was developed by the ISSX Modeling and Simulation Focus Group and will be moderated by Maria Posada, Ph.D., Eli Lilly and Company, USA, Oliver Hatley, Ph.D., Certara UK, United Kingdom, and Jaydeep Yadav, Ph.D. Merck, USA. This short course will focus on the fundamentals of modeling and simulation, spanning several modeling disciplines, including PBPK, QSP, PopPK and Biopharmaceutics, (small molecules, peptides, proteins, or new modalities). The course will include the fundamentals for beginners, advancement, and application, as well as case examples.

    This course was developed by the ISSX Modeling and Simulation Focus Group and was moderated by Maria Posada, Ph.D., Eli Lilly and Company, USA, Oliver Hatley, Ph.D., Certara UK, United Kingdom, and Jaydeep Yadav, Ph.D. Merck, USA.

    This short course focuses on the fundamentals of modeling and simulation, spanning several modeling disciplines, including PBPK, QSP, PopPK and Biopharmaceutics, (small molecules, peptides, proteins, or new modalities). The course includes the fundamentals for beginners, advancement, and application, as well as case examples.

    SC 1.1 Principles of Population PKPD Modeling
    Stacey Tannenbaum, Ph.D., Metrum Research Group, USA

    SC 1.2 Informing Drug Discovery and Development using Quantitative Systems Pharmacology Approaches
    Jason Chan, Ph.D., Eli Lilly and Company, USA

    SC 1.3 PBPK Modelling of Drug-Drug Interactions – Challenges and Opportunities
    Aleksandra Galetin, Ph.D., University of Manchester, United Kingdom

    SC 1.4 Physiologically Based Mechanistic Oral Absorption Modeling
    Kazuko Sagawa, Ph.D., Pfizer, USA



  • Contains 3 Component(s) Recorded On: 10/24/2023

    The webinar is intended to highlight the efforts in xenobiotic research and translatability to drug development in Africa. Learning Objectives: 1. To explore the gaps in xenobiotics research in Africa and discuss the implications for drug development and healthcare. 2. To highlight the need for comprehensive genomic data collection and representation in Africa, recognizing the continent's genetic diversity and importance in global research and healthcare initiatives.

    There is a global concern arising from contamination of the environment by xenobiotic substances. These substances cause severe damage to terrestrial and aquatic ecosystems, leading to threats to other forms of life, including animals, humans, and plants. Physical and chemical degrading methods have been introduced to mitigate the effects of these harmful substances. Though these approaches could be effective, limitations requiring appropriate changes to bioremediation techniques that would engender the necessary bioconversion of xenobiotics need special attention. Bio-friendly methods that use the metabolic potentials of microorganisms to convert toxicants into harmless products remained untapped in Africa. However, the missing link in xenobiotic research in Africa remains with the fact that most genomic datasets in use are, like most other things in Africa, foreign to the continent, from Australia, Europe, and North America. This is despite the enormous African population, evolutionary history, and genetic diversity. Is there "healthcare delivery justice" in developing therapeutic and pharmaceutical products outside Africa for treating infectious and non-infectious diseases, including clinical trials conducted on less diverse (genetic) populations, yet the effects of such investigations are meant for global use? Is there comprehensive genomic data in Africa to promote xenobiotic research? This presentation throws up these and many other issues.