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 2016WA 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