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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


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