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:
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:
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:
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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
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
2024-04-30, [In-Person] Small Molecule Preclinical Development and IND Filing: Nuts, Bolts and Best Practices
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2024-10-17, [Free Online] Patient Centric Blood Sampling for Facilitating De-centralized Clinical Trials: Implications for ClinOps, PK/ClinPharm, Bioanalytical and Biomarkers
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