Case Studies in Human Clinical Specimen Outsourcing The move toward targeted therapies and targeting

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Case Studies in Human Clinical Specimen
OutsourcingThe move toward targeted therapies
and targeting patients30 September 2009
www.conversanthcs.com
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A few quick comments about my company first
www.conversanthcs.com

• Founded in 2007 and headquartered in Huntsville,
  Alabama
• 19 Collection Sites approved, all U.S.
• Western IRB-approved Protocol, HIPAA Compliant,
  Informed Consent
• Run studies in Cancer, Hematology, Inflammation,
  Cardiology
• Consent Patients gt Collect Data Clinical
  Samples such as
• Diseased Tissues
• Human Cells, plasma, and serum
• Fresh Peripheral Blood and Bone Marrow
• Special Projects
• More about us online
• Website Blog www.conversanthcs.com
• www.facebook.com/conversant
• www.linkedin.com/companies/conversant-healthca
  re-systems-inc
• www.twitter.com/conversanthcs.com

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I will start by talking about a fewIssues to
Consider when Sourcing Human SpecimensthenOff
er a few Case Studies illustrating these issues
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Be clear upfront about Informed Consent
Regulatory Matters

• Informed Consent and Regulatory
• Intellectual Property Reach Through
• Commercial Use
• Can the DNA be sequencing are other uses
  specified?
• Process of Consent
• Who conducted consent, were they trained in FDA
  Good Clinical Practices?
• IRB Oversight
• Is there an Independent IRB?
• Data Collection
• Can you collect historical data on patients?
• Is this HIPAA compliant?
• Emerging Topics
• Xenografts is patient aware of potential animal
  testing?
• Human Tissue Act UK legislation
• Collaborators who can use the samples for what
  purpose?

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Be sure to ask how specimens were collected and
where

• Collection Sites
• Where are the collection sites?
• Can patients be followed longitudinally (surgery
  site 1, treatment site 2, etc)
• Can you request additional specimens?
• Quality Assurance and Quality Control
• Can you customize the sample collection,
  processing, storage, shipping?
• Is there a chain of custody of the sample?
• Is each sample collected the same way at each
  site? Site-to-site variability
• Emerging Topics
• Timing increasingly researchers need fresh
  (within 24 hours) material
• Customization most researchers have
  study-specific SOPs can they be used?
• Targeting knowing stage, treatment history,
  drugs on board is critical to targeting

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Different types of Sources for Clinical Samples

• Academic CentersLong established and effective
  model
• Pros deep patient access, world-class P.I.s,
  credibility
• Cons often very slow, IP issues, publication
  rights, often very expensive indirectly
• Non-Profit Disease FoundationsEffective in
  narrow disease categories
• Pros highly motivated groups, willing donors,
  alignment of interests
• Cons disease focus makes multiple
  collaborations difficult, consent narrow,
  expectations high
• Commercial CompaniesA good option for speed and
  ease-of-use
• Pros often faster, fewer IP issues, motivated
• Cons can be expensive, few one-stop shops
• Emerging Topics
• Drug Resistant Patients often requires
  significant logistics coordination
• Use of Specimens important to resolve
  who-does-what on the front end

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Now to a few Case Studies Illustrating these
Issues
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Case 1 Non-Small Cell Lung Cancer

• Overview In this case, the researchers wanted
  to match tumor size by CT scan between benign
  lung nodules and malignant tumors
• Request
• Disease NSCLC
• Patients 25 Stage I, 25 Stage II, 25 Stage
  III, 25 Stage IV 50 Benign Lung
• Data Treatment, Path, CT Scans
• Samples Serum, Plasma
• Purpose develop diagnostics test to replace CT
  scan

What this example shows Having the right
information helps target the right patients
Once a patient is consented, it is important to
be able to access old records
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Case 1 Non-Small Cell Lung Cancer Data
example 1
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Case 1 Non-Small Cell Lung Cancer Data
example 2
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Case 2 Chronic Lymphoid Leukemia

• Overview In this case, the researchers wanted
  to collect matched fresh bone marrow and
  peripheral blood, process the samples, and send
  them same day to multiple collaborators
• Request
• Disease CLL
• Patients 30 Patients
• Data Treatment, Path, Flow Cytometry
• Samples Fresh bone marrow, PBMCs
• Purpose Various flow cytometry, in vitro, and
  colony forming assays

What this example shows It is important to be
able to create and execute customized SOPs
Collecting several different specimen types from
a patient is important If collaborators require
fresh material, look for clinics that can ship 24
hours
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Case 3 Circulating Tumor Cells (CTCs)

• Overview In this case, the researchers wanted
  to collect fresh blood from patients likely to
  have elevated CTCs
• Request
• Disease Various Solid Tumors
• Patients 50 Patients
• Data Treatment, Stage, CTC Counts or clinical
  treatment
• Samples Fresh whole blood
• Purpose Assay development and validation

What this example shows Targeting patients by
Stage, Treatment, and previous CTC counts is
important In this case, it was important to
collect additional specimens from a patient
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Case 3 CTCs Data Example 1
www.conversanthcs.com

• EXAMPLE CUSTOM REQUEST
• Stage IV (metastatic) prostate cancers
• Demographic and Clinical Information should
  include (as available) for each patient
• Stage and differentiation of primary tumor
• Serum PSA (baseline, 6 weeks and 12 weeks after
  treatments)
• Metastatic sites
• Androgen response status (sensitive/independent)
• Summary of previous treatment including local,
  adjuvant and metastatic disease
• Summary of response on current treatment (if
  available)

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Case 4 Lung Cancer Solid Tumors

• Overview In this case, the researchers wanted
  to collect various samples over time as a patient
  was treated in hospital, then in clinic
• Request
• Disease Lung Cancer
• Patients 35 Patients
• Data Extensive
• Samples Tumor Blood Sputum (Time 1), Blood
  Sputum (Time 2 and 3)
• Purpose Various flow cytometry, in vitro, and
  colony forming assays

What this example shows A community-based
approach is needed with longitudinal samples
Good working relationships w surgeons, path, and
med/onc helps
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Please contact me any time for more info
www.conversanthcs.com
Luke Doiron Managing Partner, Business
Development Conversant Healthcare Systems 1
256.705.6001 (office) 1 214.437.2938
(mobile) luke.doiron_at_conversanthcs.com
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Thank you very much

• Any questions?