Speakers: Brian Booth, FDA; Jeff Silverman, Edgewise Therapeutics; Mitch Johnson, Veloxity Labs, LLC; Sally Fischer, Genentech, Inc.; Katty Wan, Pfizer; Jeff Plomley, Altasciences
Organizers: Robyn Rourick, Genentech; Neil Spooner, Spooner Bioanalytical Solutions
Date: 2024-10-17
Time: 8:30-12:00 Pacific Time
Registration fee: Free
Location: Zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2024-10-16  (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:

• Overview of  Patient Centric Sampling - technologies, applications and benefits

• Regulatory considerations for including PCS approaches in clinical trials

• Implications and considerations for clinical operations, PK/ClinPharm, bioanalytical, etc.

• Case studies highlighting how PCS has been used for clinical trials

Brian 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