Thursday, November 12, 2020

  • Test Article Conservation in Nonclinical Inhalation Programs

    • 10:00 AM–10:55 AM

    Presented by: Covance, Inc.

    Escalating development costs are driving pharmaceutical and biopharmaceutical innovators to de-risk early efficacy/toxicity programs to minimize late-stage failure risk and unnecessary expenditure on test items. This session discusses and demonstrates inhaled delivery approaches that reduce test item requirements while still providing quality data and ensuring scientific integrity.

  • The Minipig as a Model for Juvenile Toxicity Studies

    • 10:00 AM–10:55 AM

    Presented by: Sinclair Research Center, LLC

    Selection of a model for juvenile toxicology studies is essential to ensure the results will provide an appropriate understanding of safety before progressing into human juveniles. The minipig is an excellent model, as the development pathway is well known, juveniles are a good size to handle, and many of the tissues and organ systems are similar in form and function to humans.

  • Challenges to Drug Development in an Evolving International Marketplace: Managing Roadblocks to Success

    • 10:00 AM–10:55 AM

    Presented by: WuXi AppTec

    This presentation will review foundational recommendations to maximize your success in drug development, but also identify ways one can proactively mitigate potentially significant delays in meeting deadlines while assuring high-quality results.

  • Comparison of US FDA and Health Canada CTA Submission to Support First-in-Human (Healthy Normal Subjects) Phase I Clinical Trials

    • 3:00 PM–3:55 PM

    Presented by: Altasciences

    This presentation provides an overview of a foreign health authority’s differing requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada’s Clinical Trial Authorization (CTA) process to the US FDA’s Investigational New Drug (IND) submission process. The presentation highlights similarities and differences—including an overview of the receiving divisions; Health Canada and US FDA review processes, submission processes, and content; and CTA/IND review timelines.

  • Use of Duplex SequencingTM for Detection of In Vivo Mutagenesis as a New Biomarker of Cancer Risk

    • 3:00 PM–3:55 PM

    Presented by: MilliporeSigma

    Duplex SequencingTM technology is a new way to investigate mutagenesis by detecting utra-rare new mutants following exposure to drugs and chemicals. By reducing the NGS error rate 10,000-fold, DS allows for detection of genetic changes in any species, tissue, or gene/DNA sequence through changes in mutant frequency and mutational spectra.

  • Good Laboratory Practice (GLP) Training Session

    • 3:00 PM–3:55 PM

    Presented by: Society of Quality Assurance

    Experienced SQA members will present relevant information on GLP Hot Topics, recent 483s, and how landmark cases are relevant to the roles of Study Director and Testing Facility Management. ACT attendees may bring questions for discussion. GLP training certificates will be provided on request.

  • Friday, November 13, 2020

  • In Vitro Phenotypic Screening Approaches to Assess Mode of Action and Organ-Specific Toxicity

    • 10:00 AM–10:55 AM

    Presented by: Charles River

    Phenotypic screening approaches have proven to be extremely valuable tools for small molecule drug discovery. Recent technology advances are enabling development of a new range of phenotypic models for in vitro toxicity assessment, including evaluations of mode of action (MoA) and supporting the development of highly predictive organ-specific toxicity platforms.

  • New Advances in Pharmacokinetic Modeling in Safety Assessment

    • 10:00 AM–10:55 AM

    Presented by: Covance, Inc.

    Great advances have been made in computational modeling to support preclinical drug development. This program provides up-to-date advances in pharmacokinetic/pharmacodynamic/toxicity (PK/PK/tox) modeling together with cases studies where modeling assists in interpretation of toxicity and safety data, with potential to extend to prediction of safety in humans in a clinical setting.

  • Ensuring Good In Silico Practice: Supporting Regulatory Submissions and the Implementation of Protocols

    • 10:00 AM–10:55 AM

    Presented by: Leadscope, Inc.—an Instem Company

    This presentation will review Leadscope’s leading in silico products and services while outlining how their latest updates efficiently support regulatory submissions, including the ICH M7 Guideline. We will also discuss an implementation of the recently published in silico toxicology protocols to ensure results are generated, communicated, and archived in a reproducible manner.

  • Reducing the Gap Between (Q)SAR and Expert Review Outcomes

    • 3:00 PM–3:55 PM

    Presented by: MultiCASE Inc.

    Expert review incorporates insights from the human thinking process into a final decision and helps when (Q)SAR prediction fails, giving indecisive or contradictory outcomes. This presentation will discuss how enhancing the training data and the pool of expert knowledge, improving the learning algorithms, and final decision refinements using analog-based techniques play into the efforts to reduce the gap between (Q)SAR and expert review outcomes.

  • In Vitro ADME and Drug-Drug Interaction Considerations for Toxicologists

    • 3:00 PM–3:55 PM

    Presented by: Sekisui XenoTech, LLC

    In vitro ADME and drug-drug interaction investigations are important components of safety evaluation and vital addendums to toxicity assessments. This session will provide insights into regulatory drivers, investigatory objectives, and practical concerns for such studies.