Workshop
[Free Online] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
Speakers:
Neil Spooner, Patient Centric Sampling Interest Group; Brian Booth, FDA; Mitch Johnson, Veloxity Labs, LLC; Jeff Silverman, Edgewise Therapeutics Inc.; Katty Wan, Pfizer; Jeff Plomley, Altasciences; Sally Fischer, Genentech, Inc.
Organizers:
Robyn Rourick, Genentech; Neil Spooner, Patient Centric Sampling Interest Group
Date:
2024-10-17
Time:
8:30-12:50 Pacific Time
Registration fee:
Free
Location:
Zoom
Major Sponsor:
Vendor show vendors registered to date:
(5)Altasciences; Alturas Analytics; Celerion; Q² Solutions; Tasso, Inc.
Registration: http://www.PBSS.org
Registration deadline:2024-10-15
(it will close sooner if the seating cap is reached)
About the Topic
Attendees of this half day digital workshop will learn about patient centric blood sampling and how it has been applied for decentralized clinical trials, through a number of case studies. Patient Centric Sampling (PCS) is an approach to enable the collection of high quality blood samples in a location that is more convenient to the patient, for example, at home versus a centralized clinic. Samples can be self collected, or by a caregiver and can be used for the determination of PK of administered drug and metabolites, as well as measuring concentrations of biomarkers and for the determination of clinical chemistry endpoints. PCS brings a number of advantages including the potential for increased patient recruitment and retention, the ability to expand clinical trial recruitment to rural areas and underserved communities, facilitating pediatric studies and studies with vulnerable populations.
Topics to be covered:
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Overview of Patient Centric Sampling - technologies, applications and benefits
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Regulatory considerations for including PCS approaches in clinical trials
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Implications and considerations for clinical operations, PK/ClinPharm, bioanalytical, etc.
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Case studies highlighting how PCS has been used for clinical trials
Major Sponsor: Veloxity, and RedDrop Dx
Regular Sponsors: Altasciences, Alturas Analytics, Celerion, Tasso, and Q2 Solutions.
| Time (PST) |
Topic |
Presenter(s) |
| 8:30-8:35 am |
PBSS Welcome |
Robyn Rourick, MSc, Genentech |
| 8:35-9:00 am |
Introduction to PCS |
Neil Spooner, PhD, Patient Centric Sampling Interest Group |
| 9:00-9:35 am |
FDA Challenges with PCS |
Brian Booth, PhD, FDA |
| 9:35-10:10 am |
Evaluating the Tasso Device for Pediatric Blood Sampling in Muscular Dystrophy |
Mitch Johnson, PhD, Veloxity Labs, LLC Jeff Silverman, PhD, Edgewise Therapeutics |
| 10:10-10:15 am |
Major Sponsor Presentation I |
RedDrop Dx |
| 10:15-10:20 am |
Major Sponsor Presentation II |
Veloxity Labs, LLC |
| 10:20-10:30 am |
Break |
- |
| 10:30-11:05 am |
Patient Centric Sampling for PK: Implementation Considerations |
Katty Wan, PhD, Pfizer, Inc. |
| 11:05-11:40 am |
A Strategic Approach to Microsampling Device Selection and Associated Workflows Supporting Regulated Bioanalysis |
Jeff Plomley, MSc, Bioanalysis, Altasciences |
| 11:40 am-12:15 pm |
Evaluation of Patient Centric Sampling Technologies for Pharmacokinetic Assessment of Large and Small Molecules |
Sally Fischer, PhD, Genentech, Inc. |
| 12:15-12:45 pm |
Panel Discussion |
All Presenters |
| 12:45-12:50 pm |
Wrap-up |
Robyn Rourick & Neil Spooner |
About the SpeakersBrian Booth, Director, FDA
Jeff Silverman, Senior Research Fellow, Edgewise Therapeutics
Mitch Johnson, Laboratory Director, Veloxity Labs, LLC
Sally Fischer, Sr. Director/Sr. Fellow, Genentech, Inc.
Katty Wan, Sr. Director, Pfizer
Jeff Plomley, Scientific Director, Altasciences