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Pre-Conference Programming

Pre-Conference Programming

Please note that all Pre-Conferences are taking place at the Marriott Marquis.
WEDNESDAY, MARCH 18, 2020 | 8:00 AM – 5:00 PM.
Chairs:

Sandra Visser, PhD

GlaxoSmithKline

Sriram Krishnaswami, PhD

Pfizer


Why You Should Attend!

Welcome and step aboard the Model-informed Drug Discovery and Development (MID3) Rollercoaster Workshop where you will experience the highs and lows of (hyper) accelerated drug development. Ten teams of ten participants each will take a small molecule from first in human through to Phase 3 (maybe) with real-time trial execution! This unique workshop will offer attendees an opportunity to submerse themselves in developing a drug and decision-making around this. Participants will gain learnings with respect to decision-making around trial design, dose and schedule selection, therapeutic benefit vision relative to standard of care, changing competitive landscape, and go/no go decisions.

Format:
  • The format would be new, interactive, various scenarios, dynamic with real time simulations 
  • At each decision point, some key concepts around interpretation, extrapolation, and decision-making tools will be laid out and discussed in addition to each team rationalizing their decisions.
  • Clinical pharmacology understanding is critical to the determination of the optimal dose. 
  • Emerging external data from competitors and backup compounds will be added to the mix. 
  • Semi-competitive element by keeping a score on decisions that have impact on costs and time.
High Level Summary of Workshop
  • Teams will start with the following 
    • Background on molecule, endpoints, indication, medicine vision
    • Nominal time and a nominal budget

  • Simulated Phase 1 results for PK + Biomarker for single and repeated dose will be distributed 
    • Decision point 1
      • What dose(s)/schedule(s) to take into a POC trial? (increased N comes with cost penalty)
      • What duration should the POC trial be?  (longer or shorter duration than standard option will come with time penalty or gain)

  • Distribute Phase 2a (POC) results for PK + Biomarker + clinical endpoint + safety info
    • Decision point 2
      • Go / no go for the molecule
      • Potential to bring in back-up molecule (time penalty) or external compound (cost penalty)
      • Design of dose-ranging trial and primary method of analysis (selection of number of doses, sample size and duration will come with both cost and time consequences)

  • Distribute Phase 2b (dose ranging) results for PK + Biomarker + clinical endpoint + safety info
    • In addition, results of E/R analysis and emerging competitor information will be shared
    • Decision point 3
      • Go / no go for the molecule
      • Potential to co-develop with other team (cost penalty)
      • Design of Ph 3 confirmatory trial (selection of number of dose and duration will come with both cost and time consequences)

  • Distribute Phase 3 results for Efficacy and Safety
    • Comparison of compound results for each team
      • Integrate cost / time penalties to create the full landscape across teams
Attendance for the Pre-Conference is limited to 100 attendees. Registration opens in early September, register early to secure your seat!

WEDNESDAY, MARCH 18, 2029 | 8:00 AM – 5:00 PM

Co-sponsored by International Society of Anti-Infective Pharmacology (ISAP) and Society of Infectious Diseases Pharmacists (SIDP)

Chairs:

Matthew Rizk, PhD

Merck

Melanie Nicol, PharmD, PhD

University of Minnesota


Why You should Attend!
This Pre-Conference will focus on the role of translational approaches in anti-infective development and clinical pharmacology considerations. The aim is to bring together individuals interested in anti-infective translational approaches, QSP models, and clinical characterization of special populations. 

This Pre-Conference will feature a poster session! 
Tentative Agenda:
  • 8:00 AM— 8:30 AM – Opening remarks and introductions
  • 8:30 AM — 9:15AM – Keynote #1: the pivotal role of translation in anti-infective development 
  • 9:15 AM — 9:40 AM – Speaker #1: current practices in the design and interpretation of in vitro and animal models for anti-infective PK/PD
  • 9:40 AM —10:05 AM – Novel approaches in mechanistic and QSP models in anti-infective development
  • 10:05 AM — 10:20 AM – Break
  • 10:20 AM — 10:45 AM –Assessing combination drug products
  • 10:45 AM — 11:30 AM – Panel discussion on translational approaches and the growing role of systems models
  • 11:30 AM — 12:00 PM – Trainee and/or early career presentations 
  • 12:00 PM — 1:30 PM – Networking lunch and Poster Session
  • 1:30 PM — 2:15 PM – Special populations and novel clinical methodologies for anti-infectives
  • 2:15 PM — 2:40 PM – Use of innovative trial designs in anti-infective development
  • 2:40 PM — 3:05 PM – Regulatory considerations and streamlined pathways for anti-infectives
  • 3:05 PM — 3:20 PM – Break
  • 3:20 PM — 3:45 PM – Understanding patient characteristics and impact on PK/PD
  • 3:45 PM — 4:10 PM – The role of therapeutic drug monitoring and personalized dosing in anti-infectives
  • 4:10 PM — 5:00 PM– Panel discussion on clinical development of anti-infectives and ensuring a robust data package
Registration opens in early September. Plan now to secure your seat!

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