ACoP13 Programming

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

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