Slides from the Pistoia Alliance webinar on biosample exchanges, 29th October 2015.

1. Biosample Exchanges
The past, the current and the future – how do we
make it work?
Moderator: Dr Kate Torchilin, CEO Novaseek
Panelist: John Spaull, Senior Scientific Investigator, GSK, UK
Panelist: Philip Quinlan, CTO, Advanced Data Analysis Centre, University of
Nottingham, UK.
October 29, 2015

2. This webinar is being recorded

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Panelist Background
Moderator: Dr Kate Torchilin, CEO Novaseek
Kate is an experienced life sciences executive and entrepreneur with a track record of building
innovative companies. Prior to joining Novaseek, Kate served as Vice President and General Manager of Connected
Health and Head of Global Women’s Health at Alere Inc., global leader in rapid diagnostics. Before that, Kate was CEO of
Biocell Center, stem cell technology company and biobank, and held various management positions at Thermo Fisher
Scientific. Earlier in her career, Kate worked as technology licensing specialist at Beth Israel Deaconess Medical Center,
teaching hospital for Harvard Medical School. Kate has an MBA from Harvard Business School, PhD in Biochemistry from
Tufts University and BS in Chemistry from Moscow State University, Russia.
Panelist: John Spaull, Senior Scientific Investigator, GSK, UK
John Spaull has worked for GSK for 25 years, mainly as a histologist looking at novel target validation and target
identification, using immunohistochemistry, whole slide imaging, spectral imaging and image analysis techniques. Prior to
GSK he spent 10 years in the Health Service in routine and research histology. The increasing requirement for the use of
human biological samples in target validation and other early pharmaceutical Discovery assays has led to a change in
strategy and he is now part of a small group responsible for the acquisition of human biological samples for a wide range
of assays both internally and for academic collaborators. This requires knowledge of the regulatory environments
nationally and internationally and a good understanding of sources of human biosamples, both commercial and
academic. A Biosample Exchange would simplify the task of delivering high quality samples to our research groups which
should in turn help deliver medicines to the patients who need them. John has a Biomedical Science MSc, is a Fellow of
the Institute of Biomedical Sciences and is a State Registered Biomedical Scientist.
Panelist: Philip Quinlan, CTO, Advanced Data Analysis Centre, University of
Nottingham, UK.
Dr Phil Quinlan has a over a decade of experience working on biobanking systems (such as the Breast Cancer Campaign
Tissue Bank and HCV Research UK). His current role is as the Chief Technology Officer for the Advanced Data Analysis
Centre (ADAC) and the University of Nottingham. ADAC provide leading data analytic capabilities in a range of academic
and commercial settings. One of the main projects within ADACs portfolio is the UKCRC Tissue Directory and Coordination
Centre and Phil is leading the informatics components of the UKCRC Tissue Directory and Coordination Centre.
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4. Introduction
Kate Torchilin, PhD, MBA
CEO, Novaseek Research
Boston, MA, USA

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Access to Biosamples Remains One of the
Key Bottlenecks in Pharma R&D
• Access to biosamples remains a bottleneck in pharma
R&D. Researchers need access to the right biosample from the
right patient at the right time and with the right data
• Millions of dollars have been invested both in creating biosample
repositories as well as in the collection infrastructures, by
government, academia and industry; millions in budget approvals
continue to be requested each year for acquiring biosamples for
research
• Thousands of biobanks and sample collections have been created
within various for-profit and non-for-profit entities
• We will discuss approaches that can be pursued
to increase transparency of information and
streamlined approaches to acquiring biosamples
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Existing Biobanks – Not All Samples are
Fit for Purpose
• Many of the samples in storage today were collected before the era
of genomic- and proteomic-based research
• Utilizing samples that were collected for various research or clinical
needs require specific patient consent
• Sometimes missing just one piece of data, or one clause in consent,
could make the collection obsolete
• Sometimes the quality is questionable. In one test by the Office of
Biorepository and Biospecimen Research – in Collection 1, 1,392 /
5,000 samples passed inventory review and 174 / 5,000 passed
pathology review; in Collection 2, 120 / 1,200 samples passed
inventory review and 18 /1,200 passed pathology
review (Jim Vaught, 2011.)

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Key Issues and Need for Best Practices
PROBLEM
• Lack of availability of specimens
• Collection “silos”
• Inadequate/unknown quality
• Lack of broadly accepted
standards
• No transparency into which
samples are available and where,
and on how to access them
• Ethical & legal requirements delay
access
POTENTIAL SOLUTION
• Standardized collection approaches
• Standardized processing
• Standardized data and detailed
annotation for each sample
• Standardized and transparent
consents and MTAs
• Supporting IT systems
• Accreditation – French Norm,
Scotland biobank accreditation
scheme, CAP biobank accreditation,
Canadian tissue repository
accreditation, etc.
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Two Approaches Have Emerged for
Centralizing Biosample Resources
Hub and Spoke collections
• For example:
• the Collaborative Human Tissue
Network (CHTN), by the National
Cancer Institute (NCI) in the US,
serves as an intermediary
organization, collecting requests
from researchers and then
sourcing specimens from its
network
Catalog approach
• For example:
• BBMRI Europe – aims to improve the
accessibility and interoperability of the
existing collections of biological
samples from different populations of
Europe as well as biomolecular
resources
• ISBER – international repository locator
to identify repository managers
worldwide, and gather information about
their repositories to assist development
of content for the repository profile
webpage

9. A User Perspective
How does a Pharma user want to interact with a
Biosample Exchange?
John Spaull, GSK R&D, Stevenage, UK

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Usage ?
• Target Identification/Target Validation
– Well characterised, well annotated samples
– Likely to be archived so annotation represents that
snapshot time point
– Downstream donor data – outcome measures
– The more data is available the greater the stratification of
disease groups and the more granular the TI/TV can be
– Donor number, what is significant ?
– Add value ? TMA creation ? (Pharma have preferred
CROs)
– Timescale – project timelines are contracting, expect quick
turnaround, weeks not months
– Quality measure ?
– Ethics and Consent in place ? Sensitivities – ‘genetics’,
cross border usage
– Cost

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Usage ?
• Fresh live tissue
– Great interest in using fresh tissue as disease model
– Spontaneous mediator readout, + drug effects,
signalling intermediates, screening
– Availability ? Identification of sources within institution
– Control ischaemic delay
– Add value ? On-site preparation of fresh samples,
non-standard testing to select sample
– Regular supply, quantity, non elective surgeries ?
– Data at sample collection
– Follow up test data
– Cost

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What does the Biobank get out of the relationship?
• Cost recovery
• Potential staff funding, equipment funding (use of
your lab ?)
• (Publication)
• (Clinical Trials)
• (Access to instrumentation / feedback of results)
• Archive is a living resource (cf an end stage, dead
resource)
• Participation in drug discovery, potential benefits to
future patients
P4 Medicine –
Preventative/Predictive/Personalised/Participatory
Data driven ….. Dynamic change
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13. Current UK thinking
Explaining the work of the UKCRC Tissue Directory and
Coordination Centre
https://www.biobankinguk.org
Philip Quinlan, CTO, Advanced Data Analysis Centre, Nottingham

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Background
“Funders aim to maximise the value of human
tissue samples and resources while minimising
duplication of effort. This requires better
characterisation of tissue samples, asking for
generic consent, and increased linkage to
accurate clinical data. Sample collections must
then be made more easily discoverable and
accessible for use in high quality, ethical
research.”
http://www.ukcrc.org/research-infrastructure/experimental-
medicine/funders-vision-for-human-tissue-resources/

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Tissue Directory
Biobanks Researchers

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Phase 1
Capability
Data
Samples
• Can you collect on bespoke consent forms or using bespoke SOPs?
• Approx. how many donors do you expect in a year?
• Can you collect metastatic disease (where applicable)?
• What data can you collect and in what timeframe?
• What data can you collect and in what timeframe:
• Now?, 0-3 months, 3-6 months, 6-12 months?
• What quality information can you provide?
• Freezer logs, cold/warm ischemic time
• Approx. breakdown of donors based on:
• Disease, Age, Gender
• Percentage of samples based on:
• Material Type, Macroscopic Assessment, Preservation
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Audience Discussion
• Please submit questions through the question
box on the right.

18. info@pistoiaalliance.org @pistoiaalliance www.pistoiaalliance.org