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PCSIG Webinar On Demand

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

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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.

Moderator
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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.​​​​​​​

Speakers
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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.

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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.

IN ASSOCIATION WITH
EvidenceBase

OUR SPONSORS

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Altasciences: Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

Capitainer: Dried blood spots (DBS) is now quantitative with volumetric control through our microfluidic qDBS technology solution. Precision, accuracy, sample protection and ease of use both at sampling and in the lab are key features for us in all product development.

CoreMedica: Blood Testing Made Simple. Micro Blood Sample Collection and Analysis. Our innovations in capillary blood analysis provides the best of both, a venipuncture like test menu from a fingerstick collection.

Drawbridge Health: Drawbridge Health is a healthcare technology company founded by partnership with GE Healthcare in 2015. Its revolutionary OneDraw Blood Collection System has re-invented the blood draw experience, enabling comfortable convenient blood sample collection. By integrating engineering, chemistries, and modular design, Drawbridge Health has developed a people-friendly system for collecting and stabilizing blood samples, opening new doors to enable access to important health information.

ICON: ICON manages the laboratory, investigator and logistical support requirements for thousands of clients in virtually every phase and therapeutic area of clinical development. We are working in partnership with our clients to continually optimize the provision of agile patient-centric solutions that facilitate the inclusion of patients with diverse needs via our strategically positioned bioanalytical and clinical central laboratories. Recent advances with microsampling devices and self-collection approaches provide opportunities to greatly enhance the clinical trial experience of numerous groups, and, in particular, pediatrics and their parents. To find out more visit iconplc.com/labs.

Jana Care: Jana Care, Inc. is a medical technology company that develops patient-centric, self-administered point-of care diagnostics for the screening and management of chronic diseases such as heart failure, chronic kidney disease and diabetes. Jana Care’s digitally connected at-home blood testing platform has the potential to improve the effectiveness of and access to care and the metrics associated with mortality, morbidity or rates of complications and cost. The CDC estimates that six in ten adults in the US currently live with a chronic disease – a leading cause of death and disability, and leading driver of the Nation’s $4.1 Trillion annual healthcare costs. Within this population, distance to healthcare providers and socioeconomic barriers impede adequate and timely detection and monitoring of disease progression and the adjustment of therapies.

Labcorp Drug Development: Labcorp Drug Development (formerly Covance) is a leading clinical research organization that provides pharmaceutical and biotech clients with vital information to accelerate innovations and improve patient health through our unparalleled drug development capabilities. Learn more about Labcorp Drug Development at www.drugdevelopment.labcorp.com or follow us on LinkedIn and Twitter @LabcorpDrugDev.

Loop Medical: Loop Medical is developing a painless and easy-to-use blood collection technology that collects a 1 mL capillary whole blood sample in a tube that is directly compatible with existing lab workflows – allowing the reinvention of blood collection without requiring reinvention of the laboratory.

Neoteryx: Neoteryx, the microsampling brand of Trajan Scientific and Medical, provides remote microsampling devices and tools that enable easy, minimally invasive sample collection for the comfort and convenience of both adult and pediatric subjects. To ease stress for children who may fear needles, finger-stick microsampling at home can often replace venipuncture blood collection in pediatric clinical trials.

Q2 Solutions: Q2 Solutions, a wholly owned subsidiary and laboratory division of IQVIA, is a leading global clinical trial laboratory services organization providing comprehensive testing, project management, supply chain, biorepository and specimen management, and clinical trial sample and consent tracking solutions. Through its Decentralized Clinical Trials group, Q2 Solutions is at the forefront of patient-centric sampling, offering a variety of self-collection methodologies and is validating multiple assays using micro-samples that are self-collected by study participants.

Rhinostics: Rhinostics is revolutionizing sample collection, providing a growing platform of purpose-built collection devices that combine easy, patient-centric collection with efficiencies for the laboratories that do the testing through automated solutions. By focusing on these two design areas, the company’s solutions for automated swabs, microsample blood collection, DNA collection, and in the future urine/fecal collection enable in-home testing and low-cost testing.

Sanquin: Sanquin Pharma & Biotech Services (PBS) supports bioanalysis for biotech and pharma companies. Sanquin has a long-standing experiences and an academic department that is skilled in services for blood transfusions and immune disorders and monitors immune system modulating therapies. The combination of knowledge on disease mechanisms associated with access to human bio specimens and state-of-the-art technology is a unique asset assisting clients in early drug-development and diagnostic challenges. We have published numerous papers on capillary blood sampling and we advocate TDM of biologics and clinical trials by capillary blood sampling at home.

Tasso: Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time.

Veloxity Labs: Veloxity Labs is a CRO focused on LC-MS bioanalysis. Our company is employee owned and operated, and offers start-up times and turn-around times in days by maintaining 80% capacity.

YourBio Health: YourBio Health, makers of the TAP® device, was founded by Flagship Pioneering in 2007. TAP® is the world’s first push button collection device. Our technology allows a patient blood sample to be collected from any location without the pain of a fingerstick or need for traditional phlebotomy. We enable the decentralization of clinical trials and access to companies who offer wellness testing to consumers. Our patient-centric device is virtually painless, easy-to-use, and enables the collection of a blood specimen from any setting – clinical or in-home. We eliminate barriers to blood collection.

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