Convincing Stakeholders

In order for PCS technologies to gain broader acceptance, many stakeholders require solid evidence of the benefits of the technologies and their application. One particular area where PCS technologies are thought to bring particular benefit is through their use in clinical trials for the development of new pharmaceutical drugs. However, applications reach much further into the diagnostic marketplace. The idea of unscheduled and unsupervised sampling. It is considered that this approach to blood sampling, particularly if performed in the home rather than in a clinical setting, helps generate more information through easier recruitment of patients onto clinical trials and minimizes their dropout rate. This in turn will facilitate shorter clinical trials with fewer subjects being required for recruitment, hence bringing valuable new medicines to patients more quickly. The PCSIG are designing and implementing a clinical study to generate data to support this suggested benefit of the technology.

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The team responsible for this activity includes:

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Melanie Anderson (Merck), George Atiee (Worldwide Clinical Trials), Matthew Barfield (Roche), Kevin Bateman (Merck), Erwin Berthier (Tasso), Stephanie Cape (Covance), Wendy Comisar (Merck), Sally Fischer (Genentech), Arkady Gusev (Novartis), Thijs van Iersel (PRA), Remco Koster (PRA), Anahita Keyhani (Altasciences), Remco Koster (PRA), Florian Lapierre (Trajan Scientific & Medical), Mike Lee (Milestone Development Services), Thomas Lloyd (Worldwide Clinical Trials), Julie Milojevic (Novartis), Sara Naseri (Qurasense), Ricardo Neto (University of South Australia), Jeff Plomley (Altasciences), Jenny Royle (Rekaryo Health and digitalECMT), James Rudge (Neoteryx), David Sciberras (Consultant Clinical Pharmacologist), Neil Spooner (Spooner Bioanalytical Solutions), Christophe Stove (Ghent University), Soren Therkelsen (Qurasense), Mike Walker (Consultant), Emily Welch (Tasso), Jinming Xing (Novartis)

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Tasso are responsible for funding aspects of this clinical study.

 

Communicating the value of patient centric sampling

The PCSIG group is developing a website to facilitate the broader understanding and acceptance of patient centric sampling technologies and so contribute towards their routine implementation. The website aims to communicate in plain english to the general public, the scientific and medical communities, Legislators, Payers, Regulators, Media, etc. The website also serves as a source of information for the above to better understand the PCS values and be aware of the key stakeholder

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The team responsible for this activity includes:

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Phil Garner (Future Science), Florian Lapierre (Trajan Scientific and Medical), Sarah Mayes (Future Science), Kayte Parlevliet (Trajan Scientific and Medical), Tim Richards (Seventh Sense Biosystems), Neil Spooner (Spooner Bioanalytical Solutions), Jinming Xing (Novartis)

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Future Science are responsible for the funding of the building and maintenance of this website.

 

Standardisation

To enable patient centric sampling technologies to be integrated into current and future workflows, certain information such as patient identifier, sample details, shipping details, etc., need to be standardized across different devices and manufacturers. A PCSIG team are building an industry standard to enable this and are working with established bodies for industrial standardization, including;

• CLSI

• IVD Industry Connectivity Consortium

• Fast Healthcare Interoperability Resources – FHIR

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The team responsible for this activity responsible for this includes:

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Florian Lapierre (Trajan Scientific and Medical), Søren Therkelsen (Qurasense), Neil Spooner (Spooner Bioanalytical Solutions), Greg Nagy (Drawbridge Health), Tim Richards (Seventh Sense Biosystems), Enaksha Wickremsinhe (Lilly), Pawanbir Singh (Trajan Scientific and Medical), Cory Zuehlsdorf (CoreMedica)