ACoP13 Programming

ACoP13
Program
SxP Education Committee reviewed the ACoP program and abstracts to select content of interest for SxP
Published

October 28, 2022

Link to the ACoP13 program

Monday Oct 31

11:15-1pm Session 1A:

  • Project Optimus: Changing the Dosing Paradigm for Oncology Products
  • Dose Optimization in Early Clinical Development for Oncology: Regulatory Perspective
  • Integration of preclinical and early clinical data to inform rational oncology dose optimization strategy

11:15-1pm Session 1B:

  • Applications of MIDD for Pediatric Drug Development

2:30 - 4 pm Session 2A:

  • Regulatory perspectives on RWE guidance
  • RWE study design and analytical considerations
  • Review of Case Studies of Clin Pharm/PMx applications of RWE at Genentech

2:30 - 4 pm Session 2B:

  • MIDD on clinical development of T cell redirecting bispecific antibodies

2:30 - 4 pm Session 2C:

  • The BPCA Framework Initiative and Enhancing Pediatric Drug Development and Therapeutics
  • Utilizing pharmacometrics to support personalized therapy in pregnant and lactating women

Tuesday Nov 1

9:30 AM- 10:45 AM General Session:

  • Key Note Speaker - From mass (data) to energy (analytics) to power (decision-making), and how to shape the future of medical product development
  • Klaus Romero - Critical Path Institute

12:30 PM-2:00 PM:

  • SxP SIG Lunch - tickets are required!

2:00 PM 3:30 PM Session 3A:

  • Explainable Machine Learning for Disease Progression Modeling & Digital Twins
  • Predicting disease activity in Multiple Sclerosis patients - an explainable ML approach in Mavenclad trials
  • An Explainable Deep Learning Framework for Tumor Dynamic Modeling and Overall Survival Prediction using Neural-ODE
  • Neural ODEs for Multi-State Modeling and Cause-Specific Time-to-Event Analysis
  • Machine Learning Enables Smaller Clinical Trials

Wednesday Nov 2

9:00 AM-11:00 AM Roller Coaster sessions (note, 3 concurrent sessions):

  • From Casual to Causal: Three Fundamental Concepts to Spiff Up Your Causal Reasoning
  • Mathematical Modeling of ventilator-induced lung inflammation
  • Comparing the Applications of Machine Learning and PBPK/Pop-PK Models in Pharmacokinetic Drug-Drug Interaction Modelling
  • Dose Justification Strategies for Teclistamab, an anti-BCMA/CD3 TDB in Relapsed or Refractory Multiple Myeloma
  • Quantitative modeling to support Gene Therapy in Rare Diseases
  • Generating Model-integrated Evidence for Developing and Approving Complex Generic LAI Products
  • Rapid Decision Making: Utility of Automation and Pro-active modeling
  • Association between Immune -mediated adverse events and treatment efficacy in patients treated with immune checkpoint inhibitors
  • Regulatory experience on the application of MIDD for COVID-19
  • Establishing correlates of protection for herpes zoster infection via MBMA analysis
  • Moving beyond boundaries: utilization of continuous bounded outcome score model in drug development decision making

1:30 PM -3:00 PM:

  • Model-based extrapolation to support new pediatric formulation approval without a single pediatric study? A case study with tofacitinib

1:30 PM -3:00 PM Concurrent Session 4B:

  • An overview of joint modeling of longitudinal data and time to event data
  • Use of joint modeling in oncology drug development: Challenges and opportunities
  • Nasopharyngeal viral load reduction with early administration of anti-SARS-CoV-2 monoclonal antibodies was associated with decreased risk of disease progression in non-hospitalized patients with SARS-CoV-2

1:30 PM-5:00 PM Trainee Tutorial:

  • Pharmacometric Analysis of Categorical data
  • Lena Friberg and Andrew Hooker