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California Clinical Laboratory Association 2016 Annual Conference

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Presentation on theme: "California Clinical Laboratory Association 2016 Annual Conference"— Presentation transcript:

1 California Clinical Laboratory Association 2016 Annual Conference
Reaping New Revenue: Leveraging Specimens, Data, and Patient Access to Drive Research and Lab Income Christopher Ianelli, MD, PhD CEO California Clinical Laboratory Association 2016 Annual Conference November 3, 2016

2 iSpecimen Introduction & Background
Who is iSpecimen? Founded in 2009 to build the first true biospecimen marketplace to serve both clinical labs and life science researchers Use proprietary technology to watch the flow of patients, specimens, and data through numerous healthcare settings Match available samples – based on de-identified data – to a growing number of research studies across academia and industry. Our Growing Network 250+ hospitals & labs 1000+ clinics & practice groups 10+ biorepositories 1 large blood center (emerging area)

3 What We Do iSpecimen provides a technology-based, turnkey solution to make it easy to capture the full value of the specimens flowing your clinical labs and biorepositories to promote medical research and increase both revenue & profitability. No up-front investment required Non-disruptive to laboratory operations Minimal IT support required Ensures full protection of patient privacy

4 Our Vision WA OR ID CA NV UT AZ NM CO WY MT ND SD NE KS OK TX AR LA MO IA WI MI IL IN OH PA NY VT MN NH ME KY WV VA NC TN SC GA AL MS FL MA CT RI NJ MD DE AK To broadly enable research sampling of any patient population based on specimen- and patient-level data, using the clinical & pathology laboratory. Discussion of the partners in the venture, the type of model, and the current market share and/or revenue growth over time Hawaii

5 The Typical flow of specimens…
Waste Pathology Lab Clinical Lab Clinical Research Biorepository Patients Clinical Operations Research Operations Researchers

6 New revenue opportunities from specimens
Pathology Lab Clinical Lab Clinical Research Biorepository Patients $$ Clinical Operations Research Operations $$$

7 Enabling on-demand specimen & data access
Pathology Lab Clinical Lab Sponsored Programs Biorepository Industry Academia Government Clinical DATA Research

8 THE need is real for annotated biospecimens
Biospecimen demand growing at rates of 15+% per year Driven by personalized medicine and precision medicine initiatives – heavily engaged in biomarker discovery and validation Source: Visiongain 2014

9 Driven By Wide Variety of Industry Players

10 THE R&D need for biospecimens
Target Validation Lead Selection & Optimization ADMET Phase I Phase II Phase III Marketing Phase IV Surveillance FDA Approval Discovery Diagnostic Assay Development Analytical Clinical CLIA Laboratory Acceptance (Dx) FDA Approval (Rx-Dx) Instrument Validation Therapeutic Development Pathway Biomarkers & Diagnostic Development Pathway Basic & Preclinical Research Post-Marketing

11 Enabling on-demand specimen & data access
Sales & Marketing Client Contracting Client & Project Management Order Management Specimen Monitoring Invoicing De-identification Data Harmonization Specimen Selection Annotation Fulfilment Compliance Pathology Lab Clinical Lab Sponsored Programs Biorepository Industry Academia Government Clinical DATA Research

12 The iSpecimen Technology and Process
Researcher Inquiry Management iSpecimen develops the market and works with researchers to define the criteria (e.g. sex, age, medical conditions) for patient and specimen selection. Feasibility Assessments iSpecimen’s technology manages the FA process, either using data and predictive analysis to assess feasibility or managing FA-related communications between labs and iSpecimen. Order Management The technology either generates a picklist (if data provided) or order requirements (if data not provided) and distributes these to selected labs and biorepositories. Specimen Fulfilment iSpecimen’s technology manages the specimen collection, annotation, and shipping processes at each lab or biorepository. The technology manages compliance across the process- tracking IRB oversight by institution, consent by patient, and Material and Data Use Agreements by researcher.

13 Ispecimen provider network map – Q3 2016
WA OR ID CA NV UT AZ NM CO WY MT ND SD NE KS OK TX AR LA MO IA WI MI IL IN OH PA NY VT MN NH ME KY WV VA NC TN SC GA AL MS FL MA CT RI NJ MD DE AK iSpecimen provider hubs Discussion of the partners in the venture, the type of model, and the current market share and/or revenue growth over time Hawaii

14 Considerations – regulations & compliance
THE COMMON RULE (45 CFR, Subpart A) Clinical specimens that have been de-identified can be used for research – once they are no longer needed for clinical care – without IRB approval and without patient consent – since the use of them is considered Non-Human Subjects Research. 21 CFR (Parts 50 & 56) However, if the research will be submitted to the FDA, it generally requires IRB approval and consent – with exceptions* made for in vitro diagnostic research and development. HIPAA (PRIVACY RULE) Proper de-identification includes removal of all Protected Health Information, including 18 specific identifiers.

15 Considerations – PATIENTS Attitudes
Studies show support from the patient community: Across a collection of studies gathered by Public Responsibility & Medicine in Research, % of patients were willing to allow use of their clinical discards for research. A separate study from Biopreservation & Biobanking found that 90% of tissue donors felt they were “contributing,” supporting a “good cause,” helping “find a cure,” and that it “feels good to help.” A new population-based study by iSpecimen shows 83% of the general population support repurposing of their remnant specimens into research and 66% would give an extra tube of blood for research.

16 considerations – Disclosure & consent
iSpecimen has tools and experience to support any information dissemination and consent processes required by your organization IRB-approved consent language for disclosure, opt-in/out permission, informed consent IRB-reviewed brochures and FAQs for registration areas Web content Media talking points and FAQs Regular reports on the types of research into which specimens are going

17 CONSIDERATIONS – LAB OPERATIONS
Technology-driven process increases quality / reduces errors Daily instructions for specimen picking, processing, packing and shipping Fully barcoded specimen handling Automated creation of log sheets, data files, labels, packing lists Integrates seamlessly into lab workflow and send-out processes

18 iSPECIMEN PARTNERSHIP OPTIONS
Remnant Sample Marketplace Generate new revenue stream for the lab by offering remnant clinical and anatomic specimens and data sets to researchers. Biorepository Marketplace Monetize specimens collected and stored within your institution’s biorepository – increasing liquidity through your biobank and revenue from the effort. RUO Sample Marketplace Drive additional research endeavors by engaging in custom sample collection programs under protocols provided by iSpecimen.

19 Revenue Plans A Revenue Share Plan B A Revenue Share Plan B C
Remnant Sample Marketplace Fee Schedule Plan B Revenue Share Plan A Biorepository Marketplace Fee Schedule Plan B Revenue Share Plan A RUO Sample Marketplace Per Project Pricing Plan C

20 Questions


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