Patient Centric Sampling in Pediatric Clinical Trials – Successes, Challenges and How to Overcome Them

Join Enaksha Wickremsinhe (Senior Director, Eli Lilly & Company) and Jeff Silverman (Senior Research Fellow, Edgewise Therapeutics) for this Free On Demand Webinar where they discuss the use of patient centric sampling technologies for the collection of high quality blood samples for pediatric clinical trials. Moderated by Neil Spooner (Director, Spooner Bioanalytical Solutions and Co-Founder of the PCSIG).

Agenda

  1. Welcome and introduction to patient centric sampling – Neil Spooner (download slides here)
  2. Small patients, big challenges – Enaksha Wickremsinhe (05:18) (download slides here)
  3. Patient Centric Blood Collection – Jeff Silverman (28:28) (download slides here)
  4. Introduction to the PCSIG, and a Thank you to our Sponsors – Neil Spooner (48:25) (download slides here)
  5. Q&A (50:47)

Patient centric blood sampling is an approach for the collection of high quality samples for the determination of pharmacokinetic, pharmacodynamic and clinical chemistry endpoints. The technologies offer the potential to collect high quality samples from patients away from the centralized clinical settings, such as in the home, thus putting the needs of the patient at the center. This webinar introduces the technologies available, and through the presentation of case studies, explores the benefits and challenges of implementing these technologies for pediatric clinical trials.

Speakers

Enaksha Wickremsinhe

Senior Director Eli Lilly & Company

Enaksha is a Senior Director at Eli Lilly and Company. He has over 20 years of bioanalytical experience in quantitative LC/MS/MS supporting all phases of drug development. His expertise includes microsampling for PK (preclinical and clinical) and patient centric blood sampling for decentralized clinical trials. Enaksha has also served as an ADME project leader for several oncology assets. He is the recipient of several awards from Eli Lilly and Company, including the President’s award, the Global 3Rs award, the Innovator award, and the Pediatric Excellence award. Enaksha received his Ph.D. from the Pennsylvania State University. He is the co-chair of the AAPS Microsampling and Patient Centric Sampling subgroup.

Jeff Silverman

Senior Research Fellow Edgewise Therapeutics

Dr Jeffrey Silverman is currently Senior Research Fellow at Edgewise Therapeutics. Formerly he was Vice President of Early Development at Jazz Pharmaceuticals. Previously, he held positions at Gilead Sciences, Talon Therapeutics and Sunesis Pharmaceuticals. Dr Silverman also holds an Adjunct Professor faculty position in the Department of Bioengineering and Therapeutic Sciences of the University of California in San Francisco.

Dr Silverman has had a significant role in the preclinical and clinical development of both small and large molecule therapeutics for a number of diseases, in particular in oncology and immunology. He has a passion to understand the PK/PD of novel drug candidates. He has also made significant contributions to the field of drug transporters and their role in pharmacokinetics and pharmacodynamics.

Neil Spooner

Director Spooner Bioanalytical Solutions & Chair Patient Centric Sampling Interest Group

Neil is the Founder of Spooner Bioanalytical Solutions, helping companies to integrate biological fluid microsampling, and patient centric sampling and analysis into workflows. He also works with organizations to develop technologies and introduce them to the market. Neil also assists organizations with their understanding of emerging trends in the pharmaceutical industry and bioanalysis. Neil is a Senior Visiting Research Fellow at the University of Hertfordshire, Editor in Chief of the journal, Bioanalysis, Founder of the Patient Centric Sampling Interest Group and Co-Chair of the Reid Bioanalytical Forum. He has published over 70 peer reviewed manuscripts and delivered over 50 podium presentations.​​​​​​​

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