Clinical Pharmacometrics: Bringing Models to Patients

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

The annual ACoP Pre-Conference aims to provide an in-depth coverage on a specific theme or topic(s) of impact and interest to our community. This year’s Pre-Conference 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 ISoP/ACCP Clinical Pharmacometrics Special Interest Group.

The day will start with a keynote address overviewing 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.

Agenda for the Pre-Conference is as follows:

6:30 AM 8:00 AM Continental Breakfast and Pre-Conference Registration  
8:00 AM 8:15 AM Welcome and Introductions Navin Goyal (GSK) and Liz Lakota (Vertex)
8:15 AM 9:00 AM Keynote Lecture Hosted by Navin Goyal (GSK) and Liz Lakota (Vertex)
Some Likely Useful Thoughts on Prescription Drug-Use-Related Software Supporting Personalized Dosing Regimens Martin Wolfsegger (Baxalta Innovations GmbH, a Takeda company)
9:00 AM 9:45 AM Morning Session 1 - Recent Developments Chair: Nikolas Onufrak (ICPD)
Individualized dosing in hemophilia: the Web-Accessible Population Pharmacokinetics Service-Hemophilia (WAPPS-Hemo) Experience Andrea Edginton (University of Waterloo)
Model Informed Precision Dosing at the point of care and potential opportunities in drug development Wonkyung Byon (Pfizer)
9:45 AM 10:05 AM Coffee Break  
10:05 AM 11:45 AM Morning Session 2 - Implementation Challenges and Opportunities: Various Perspectives Chair: Seth Berry (IQVIA)
Improving the Drug Company Information to RW Patient Drug Dosing: a Rivaroxaban AF Case Study Daniel Weiner (University of North Carolina)
A Clinician’s Experience with CDS Development and Implementation Susan Abdel-Rahman (Children’s Mercy Hospital)
Scientific and Technical Considerations Behind Model-Informed Precision Dosing Sirj Goswami (InsightRX)
Considerations for Assuring Quality Tools and a Proposal for Open Software Development Standards Marc Gastonguay (Metrum Research Group)
11:45 AM 12:30 PM Lunch  
12:30 PM 2:00 PM Poster Session  
Hands-On Session (Presenters Below)  
WAPPS-Hemo Andrea Edginton (University of Waterloo)
Lixoft Tools for TKI Jonathan Chauvin (Lixoft)
NextDose Guangda Ma (University of Auckland)
InsightRX Precision Dosing Platform Jasmine Hughes (InsightRX)
DoseMeRx Kristi Kuper (DoseMe)
NeoWeight and NeoBilirubin Gilbert Koch (University Children's Hospital Basel)
2:00 PM 3:15 PM Afternoon Session 1 - Regulatory Considerations : Challenges and Practice Chair: Diane Mould (Projections Research)
Classification of Beside Pharmacometric Tools: Perspectives from a Pharmacometrician Diane Mould (Projections Research)
Evaluation and regulation of bedside pharmacometric tools-CDER Perspective Yaning Wang (FDA Center for Drug Evaluation and Research)
FDA Promotional Considerations for Pharmacometric Tools Joshua Oyster (Ropes & Gray LLP)
3:15 PM 3:30 PM Coffee Break  
3:30 PM 4:50 PM Afternoon Session 2 - A Path forward: Moving the Math from Manuscripts to the Bedside Chair: Raj Madabushi (FDA)
Panel Discussion, Comments, Q & A Brian Corrigan (Pfizer), Yaning Wang (FDA),  Sachin Sanduja (Rudraya), Susan Abdel-Rahman (Children’s Mercy Hospital), Martin Wolfsegger (Baxalta Innovations GmbH, a Takeda company)
4:50 PM 5:00 PM Closing Remarks 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 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 were selected from a call for presenters sent to ISoP members. This session will run following the lunch break concurrently with the poster session. Attendees will be able to hop from table to table to see presenters demonstrate the applications and tools relevant to the Pre-Conference theme.