Preliminary Program

Clinical Pharmacometrics: Bringing Models to Patients

Co-chairs: Navin Goyal (GlaxoSmithKline) and Elizabeth Lakota (Vertex)
October 20th 2019

The annual ACoP Preconference aims to provide an in-depth coverage on a specific theme or topic(s) of impact and interest to our community. This year’s Preconference theme is “Clinical Pharmacometrics: Bringing Models to Patients”, which will focus on the application of pharmacometrics to direct patient care.  The planned program is intended to bring together pharmacometricians with clinical interests and clinicians with an interest in pharmacometrics.  Given the scope, this year’s Preconference is has been developed in close collaboration with the Clinical Pharmacometrics Special Interest Group.

 The day will start with a keynote address introducing the audience to bedside pharmacometric tools, an overviewing of the development and regulatory approval of a bedside pharmacometric tool used to treat patients with hemophilia, and highlighting the challenges to widespread use of the tool in clinical practice.  Following this introduction, there will be two talks on recent advancements in the field, both in clinical practice and in drug development.  The final morning session will consist of four speakers of varying backgrounds, each highlighting a challenge in this space followed by a potential solution.  Topics will include pharmacokinetic model validation, special populations, electronic-medical record integration, and software development standards.

 The afternoon will feature a poster session, a hands-on session showcasing bedside pharmacometric tools across various therapeutic areas, and a regulatory session highlighting the various requirements for approval of bedside pharmacometric tools.  The pre-conference will wrap up with a panel discussion on moving this field forward.  Following the event, the proceedings from the pre-conference will be summarized and a plan to continue discussions will be formed.

Preliminary Agenda for the pre-conference is as follows:
7:00–
8:00 AM
Continental Breakfast and Preconference Registration
8:00–
8:15 AM
Welcome and Introductions 
Navin Goyal, GSK, and Liz Lakota, Vertex
8:15–
9:00 AM
Keynote Lecture 
Chairs: Navin Goyal, GSK, and Liz Lakota, Vertex

Martin Wolfsegger, Takeda -
Some Likely Useful Thoughts on Prescription Drug-Use-Related
Software Supporting Personalized Dosing Regimens
 
9:00-
9:40 AM
Morning Session 1
Recent Developments 
Chair: Michael Neely, USC
9:45–
10:05 AM
Coffee Break
10:05–
11:45 AM
Morning Session 2
Implementation Challenges and Opportunities: Various Perspectives 
Chair: Seth Berry, IQVIA
11:45 AM –
12:45 PM
Lunch and Poster Session
12:45 –
2:00 PM
Hands-On Session
Demonstrations of Current Tools/Technology
2:00–
3:30 PM
Afternoon Session 1
Regulatory Considerations Challenges and Practice
Chair: Diane Mould, Projections Research
3:30 –
3:50 PM
Coffee Break
3:50–
4:50 PM
Afternoon Session 2
A Path Forward: Moving the Math from Manuscripts to the Bedside
Chair: Raj Madabushi, FDA
4:50–
4:55 PM
Closing 
Navin Goyal, GSK, and Liz Lakota, Vertex

 

Additional Details for Hands-On Session

The hands-on session will feature interactive demonstrations by individuals/groups.  There will be 8-12 tables with screens set up around the perimeter of the room (one table + screen per presenter).  All presenters will have a tool currently being used in clinical practice.  Presenters will be selected from a call for presenters (below). This session will run following the poster/lunch break. Attendees will be able to hop from table to table to see presenters demonstrate the applications and tools relevant to the pre-conference theme.

 

Call for ACoP10 Pre-Conference Hands-On Session Presenters

 The pre-conference will include multiple sessions providing comprehensive coverage of various aspects in this area with representation from industry, CROs, academia, FDA and clinicians. The ACoP10 pre-conference will provide an opportunity for individuals/groups with a bedside pharmacometric tool currently being used in clinical practice to demonstrate the tool in an interactive hands-on setting. Each presenter will be able to demonstrate their application/tool to pre-conference attendees, while answering audience questions. ACoP will provide tables and display monitors. Presenters are required to bring their own laptops and/or devices they may need for the demo. The session will be approximately 60-75 minutes in duration.

Interested individuals are requested to submit a one page description of their tool to [email protected] .  In the description, please include details on number and geographical location of current users (patients, providers), brief description about the model/software qualification process, regulatory status (if applicable) and relevant information to allow pre-conference organizers to make an informed selection.  Selection will be based on diversity of tools and unique elements that highlight use of pharmacometric tools at the patient bedside.