Pharmaceutical & BioScience Society, PBSS

Webcast

[Free Online by PBSS-San Diego] 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: 8:30-12:00 Pacific Time
Registration fee: Free
Location: Webcast from PBSS SD.
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

Major Sponsors: Veloxity, and RedDrop Dx

Regular Sponsors: Altasciences, Alturas Analytics, Celerion, Tasso, and Q² Solutions.

Time (PST)	Topic	Presenter(s)
8:30-8:35am	PBSS Welcome	Robyn Rourick, MSc, Genentech
8:35-9:00am	Introduction to PCS	Neil Spooner, PhD, Patient Centric Sampling Interest Group
9:00-9:35am	FDA Challenges with PCS	Brian Booth, PhD, FDA
9:35-10:10am	Evaluating the Tasso Device for Pediatric Blood Sampling in Muscular Dystrophy	Mitch Johnson, PhD, Veloxity Labs, LLC Jeff Silverman, PhD, Edgewise Therapeutics
10:10-10:15am	Major Sponsor Presentation I	RedDrop Dx
10:15-10:20am	Major Sponsor Presentation II	Veloxity Labs, LLC
10:20-10:30am	Break	-
10:30-11:05am	Patient Centric Sampling for PK: Implementation Considerations	Katty Wan, PhD, Pfizer, Inc.
11:05-11:40am	A Strategic Approach to Microsampling Device Selection and Associated Workflows Supporting Regulated Bioanalysis	Jeff Plomley, MSc, Bioanalysis, Altasciences
11:40am-12:15pm	Evaluation of Patient Centric Sampling Technologies for Pharmacokinetic Assessment of Large and Small Molecules	Sally Fischer, PhD, Genentech, Inc.
12:15-12:45pm	Panel Discussion	All Presenters
12:45-12:50pm	Wrap-up	Robyn Rourick & Neil Spooner

About the Speakers

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

Other Events of PBSS-San Diego:

2024-12-10, [In-Person] Antibody-Drug Conjugates from Discovery to Development: Chemistry, Engineering, Characterization, CMC, PK/Tox, Clinical Design and Intellectual Property