Scientific Program · ISBER 2016 Regional Meeting Quality Biobanking for Precision Research and Medicine: Overcoming Scientific, Information Technology and Policy Challenges November

November 7-8, 2016BETHESDA, MD, USA

Regional Meeting

Scientific Program

leading since 1999

International Society for Biological and Environmental RepositoriesSuite 301 – 750 West Pender Street Vancouver BC V6C 2T7 Canada | T 604.484.5693 | F 604.874.4378 | E [email protected]

Regional Meeting2016 NOVEMBER 7-8, 2016

BETHESDA, MD, USA

2www.bsisystems.com

[email protected]

301-628-1BSIComplete Biospecimen management

CUSTOMIZABLE WEB-BASED BIOSPECIMEN TRACKING SOLUTION

ISBER 2016 Regional Meeting Quality Biobanking for Precision Research and Medicine:

Overcoming Scientific, Information Technology and Policy Challenges

November 7-8, 2016 Bethesda, MD, USA

International Society for Biological and Environmental Repositories Head Office: Suite 301 – 750 West Pender Street, Vancouver BC V6C 2T7, Canada

T: 1-604-484-5693 • F: 1-604-874-4378 • E: [email protected]

www.isber.org

ISBER Mission

ISBER is a global organization which creates opportunities for sharing ideas and innovations in biobanking and harmonizes approaches to evolving challenges for biological and environmental repositories.

ISBER Vision

ISBER will be the leading global forum for promoting harmonized high quality standards, ethical principles, and innovation in the science and management of biorepositories.



BETHESDA, MD, USA

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ISBER 2016 Corporate PartnersISBER gratefully acknowledges the generous support of our Corporate Partners:

Platinum Corporate Partners

Gold Corporate Partners

Silver Corporate Partner


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Table of ContentsISBER 2016 Corporate Partners ................................................................... 4

Message from Regional Scientific Program Committee and President .............. 6

ISBER 2016-2017 Board of Directors ............................................................ 8

ISBER Committee Chairs ............................................................................ 8

ISBER Committees, Working Groups & Special Interest Groups ...................... 8

General Information .................................................................................10

Venue Map ............................................................................................. 12

Exhibit Floor Plan ..................................................................................... 13

Exhibitor Listing ....................................................................................... 13

Scientific Program at a Glance ...................................................................14

Scientific Program .................................................................................... 17

Presentation Summaries .......................................................................... 23

ISBER Education and Training Workshop Summaries ................................... 29

Poster Index ............................................................................................31

Exhibitors .............................................................................................. 33



BETHESDA, MD, USA

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Message from Regional Scientific Program Committee and President

Dear Friends and Colleagues,

On behalf of the International Society for Biological and Environmental Repositories (ISBER) Board of Directors and the 2016 Regional Meeting & Exhibits Leadership, we welcome you to Bethesda, Maryland, USA.

We are excited to be a part of ISBER’s first Regional Meeting with a focus on the Americas. The theme of this first Regional Meeting is “Quality Biobanking for Precision Research and Medicine: Overcoming Scientific, Information Technology, and Policy Changes.” The location in Bethesda, MD, near the U.S. National Institutes of Health (NIH), the nation’s medical research agency, has made it easy for the Regional Scientific Program Committee to integrate discussions of policy and science issues important within the United States.

The Regional Meeting opens on Monday morning with our keynote speaker, Dr. Stephen Thibodeau. Dr. Thibodeau, Professor of Laboratory Medicine at the Mayo Clinic, will address biobanking and the United States Precision Medicine Initiative (PMI). The PMI is a new research program that was initiated by President Obama to improve health through research, technology, and policies. This program will bring together patients, researchers, and providers to work together toward the goal of individualized care. Dr. Thibodeau’s address will set the stage for the next 2 days of presentations and workshops that will address how the biobanking community will be an integral part of the PMI as well as address how the ethical, legal, and social issues (ELSI) are related to biobanking in the United States and beyond.

Symposium 1 will focus on ELSI and policy issues within the evolving regulatory landscape, with special attention to current questions about the adequacy of existing regulations and policies governing biobank research and the need to engage and educate participants and the public about the use of specimens in research. Symposium 2 will address real-world challenges to improving biospecimen processes and accompanying data challenges, whether for personalized medicine, clinical trials, or research purposes.

Two concurrent sessions will run in the early afternoon on Monday. Information management is an important element of the meeting’s theme and an area where leaders in biobanking can greatly contribute to precision research and medicine. An educational workshop, “Current Topics in Biobanking Informatics: Standards, Security, and Other Discussions,” will engage meeting participants on these important topics. Symposium 3, “A Bit of Berlin in Bethesda,” will run concurrently and will highlight some of the major discussions from the 2016 ISBER Annual Meeting in Berlin and the progress that has been made since April.

Later on Monday afternoon, two contributed papers sessions will run concurrently, “Optimizing Quality Procedures in Clinical Biobanking” (Session 1) and “Enhancing Efficient Biobanking Operations” (Session 2). A poster discussion session will follow the contributed paper sessions and will bring to light specific like-themed posters that either complement or contradict one another or raise a common issue for discussion. This session will get the discussion started as everyone heads to the Welcome Reception so the conversation can continue in the Exhibit Hall where the posters will be displayed and the exhibitors will be present. We encourage everyone to spend time in the vendor exhibition.


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On Tuesday, November 8th, there are two concurrent sessions planned for the morning. Symposium 4A will focus on biospecimen science with particular emphasis on ‘omic’ analysis, while Symposium 4B will focus on improving the sharing of biospecimens between institutions and researchers to enable translational research. Two late-morning sessions will run concurrently, one an educational workshop on the ISBER Best Practices, and one a late-breaking topics session covering timely issues relevant to the biobanking world.

The final session of the meeting on Tuesday afternoon will be devoted to reports on the results of an NCI research initiative examining the effects of major pre-analytical factors on molecular analysis of formalin-fixed, paraffin embedded (FFPE) tissues. As FFPE is increasingly utilized in biomedical research and molecular diagnostic assays, it is important to better understand how pre-analytical variation in FFPE may affect research results and patient care, and to take steps as possible to mitigate pre-analytical effects. A third educational workshop on the ISBER Best Practices will run concurrently to this session, with special attention to ethical and legal issues.

We welcome you to Bethesda and thank all those involved in planning and executing this exciting meeting.

Sincerely,

Rebecca Pugh, MS

ISBER 2016 Regional Scientific Program Committee Co-Chair

Katheryn Shea, BS


Helen Moore, PhD


Brent Schacter, MD FRCPC

ISBER President 2016-2017



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ISBER 2016-2017 Board of DirectorsPresidentApril 2016-May 2017Brent Schacter, MD FRCPCWinnipeg, MB, CanadaPresident-ElectApril 2016-May 2017Zisis Kozlakidis, PhD, AKC, MBA, FLSLondon, United KingdomPast PresidentApril 2016-May 2017Jim Vaught, PhDKensington, MD, United States

TreasurerMay 2014-May 2017Heather Siefers, MSRockville, MD, United StatesSecretaryMay 2014-May 2017Katherine Sexton, MBABirmingham, AL, United StatesDirector-at-Large – AmericasMay 2015-May 2018Piper Mullins, MSWashington DC, United States

Director-at-Large – ChinaMay 2015-May 2018Xiaomin Wang, MD, PhDBeijing, ChinaDirector-at-Large – Europe, Middle East, AfricaMay 2014-May 2017Rita LawlorVerona, Italy

Director-at-Large – Indo-Pacific RimMay 2011-May 2017Jane Carpenter, MAppSci, FIBMSWestmead, AustraliaISBER Executive DirectorAna Torres, BA (Hon), MPubVancouver, BC, Canada

ISBER Committees, Working Groups & Special Interest Groups

Education and Training Advisory CommitteeChair:Sheila O’DonoghueVice-Chair:Sara Nussbeck

Members:Candace CarterMarta CastelhanoKristina HillErin HorneDiane McGarveyMaimuna Mendy

Cheryl MichelsKatherine SextonTamsin Tarling

Finance CommitteeChair: Heather Siefers

Members:Debra GarciaScott JewellZisis KozlakidisKaj RydmanBrent SchacterKatherine SextonJim Vaught

ISBER Committee Chairs

Education and Training Advisory Committee ChairSheila O’Donoghue Vancouver, BC, Canada

Membership and Marketing Advisory Committee ChairDebra Garcia, MPA San Francisco, CA, United States

Organizing Advisory Committee ChairMarianne K. Henderson, MS Bethesda, MD, United States

Publications Advisory Committee ChairBrian Clark, BSc, MBChB, FRCPath Måløv, Denmark

Regional Scientific Program Committee Co-ChairsRebecca Pugh, MS Charleston, SC, United StatesKatheryn Shea, BSIndianapolis, IN, United StatesHelen Moore, PhD Bethesda, MD, United States

Science Policy Advisory Committee ChairMarianna Bledsoe, MA Silver Spring, MD, United States

Scientific Program Advisory Committee Co-ChairsMonique Albert Toronto, ON, CanadaAlison Parry-Jones Cardiff, United Kingdom


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Governance CommitteeChair:Katherine SextonMembers:Jane CarpenterRita LawlorKatheryn SheaHeather SiefersNicole Sieffert

Membership and Marketing Advisory CommitteeChair:Debra GarciaVice-Chair:Piper MullinsMembers:Luke BradshawAlex EsmonJohnny GreeneMarianne HendersonDavid LewandowskiRick MichelsAlison Parry-JonesShonali PaulMelanie PietrasAyat SalmanCathy SeilerHeather SiefersDaniel Simeon-DubachRichard TsaiAndy ZaayengaXuexun Zhou

Nominating CommitteeChair:Jim VaughtMembers:Koh FurutaElaine GunterRita LawlorAndy PazahanickBrent Schacter

Organizing Advisory CommitteeChair:Marianne HendersonVice-Chairs:Cheryl MichelsDaniel Simeon-Dubach

Members:Monique AlbertKristina HillZisis KozlakidisDavid LewandowskiJacqueline Mackenzie-DoddsDiane McGarveyAlison Parry-JonesAndy PazahanickPamela Saunders Brent SchacterKatherine SextonRoman SiddiquiHeather SiefersMenghong Sun

Publications Advisory CommitteeChair:Brian ClarkVice-Chair:Jim VaughtMembers:Marianna BledsoeLori CampbellKoh FurutaWilliam GrizzleAllison HubelScott JewellAnna MeredithRick MichelsPeter RiegmanBrent Schacter Daniel Simeon-DubachPeter Watson

Regional Scientific Program CommitteeCo-Chairs:Helen MooreRebecca PughKatheryn SheaMembers:Lokesh AgrawalRebecca BarnesHugo BarreraJohn BartlettMarianna BledsoeLaura CosentinoHelena EllisDebra GarciaPing GuanMarianne HendersonKristina Hill

Zisis KozlakidisCari LichtmanCheryl MichelsPiper MullinsSheila O’DonoghuePedro Rondat RadíoBrent SchacterKatherine SextonRoman SiddiquiHeather SiefersDavid StokesPeter Watson

Scientific Program Advisory CommitteeCo-Chairs:Monique AlbertAlison Parry-JonesMembers:Catherine Alix-PanabièresJonas AstrinMarianna BledsoeNigel BrocktonHugo CamposDianne ChadwickBonginkosi DumaJudith GiriLotte GlückClive GreenMarianne HendersonKristina HillCatherine KennedyZisis KozlakidisDominik LermenDavid LewandowskiDiane McGarveyMaimuna MendyPiper MullinsSheila O’DonoghueKlaus PantelBrent SchacterTeresa SelanderKatherine SextonHeather SiefersDaniel Simeon-DubachTatsuaki Tsuruyama

Science Policy Advisory CommitteeChair:Marianna BledsoeVice-Chair:Helen MorrinMembers:

Brian ClarkJoe GalbraithLisa GilbertWilliam GrizzleTyron HooverPaula KimJacqueline Mackenzie-DoddsTohru MasuiHelen MooreAnita NelsonPedro Rondat RadíoElena SalvaterraHeather SiefersNicole SieffertAnne-Marie TasséAmelia WarnerNikolajs Zeps

ISBER Working Groups• Biospecimen Science• Environmental Biospecimens• Informatics• Integrated Biobanking

Workflows• International Repository

Locator• Pharma• Proficiency Testing• Rare Diseases• Regulatory and Ethics• Trans-Omics

Special Interest Groups• Automated repositories• CSF biobanking• Hospital-Integrated

Biorepositories• Management of Investigator-

Returned Research Results



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General Information

VenueBethesda North Marriott Hotel & Conference Center5701 Marinelli Rd,North Bethesda, MD 20852United StatesMeeting Dates: November 7-8, 2016

Conference RegistrationFoyer

Sunday, November 6 1:00pm – 7:30pmMonday, November 7 6:30am – 5:30pmTuesday, November 8 8:00am – 4:00pm

Speaker ServicesSeneca

Sunday, November 6 1:00pm – 7:30pmMonday, November 7 6:30am – 5:30pmTuesday, November 8 8:00am – 4:00pm

ExhibitsSalon A-D

Exhibit Installation:Sunday, November 6 1:00pm – 5:00pm

Exhibit Takedown:Tuesday, November 8 4:45pm – 8:00pm

Exhibit Hours:Monday, November 7 10:00am – 7:00pmTuesday, November 8 10:30am – 4:15pm

Annual Meeting Registration (Prices in USD)

On-Site Rate

Member $445

Non-Member $545

Technician/Student $345

Exhibit Hall Pass $150

One Day Pass $340


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Full Conference Registration:Full conference registration includes access to scientific sessions, Exhibit Hall, delegate materials, food and beverage offered during lunch and breaks, and the Welcome Reception.

Exhibit Hall Pass:Exhibit hall pass includes access to the Exhibit Hall, food and beverage served in the Exhibit Hall, and access to the Welcome Reception.

Certificates of Attendance:All attendees will receive instructions by email on how to access the Certificate of Attendance after the meeting.

WifiMeeting attendees can access WiFi in the meeting areas with the following information:

Network: MARRIOTT_CONFERENCEPassword: ISBERMEETING

Password is case sensitive.

Symposium Session RecordingsPlease note that symposium sessions may be audio recorded.

Poster Presentation InstructionsPoster Set up: Sunday November 6 5:00pm – 6:00pm

Presentation: Monday November 7 10:00am – 7:00pmTuesday November 8 10:30am – 4:15pm

Poster Takedown:Tuesday November 8 4:00pm – 4:45pm



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Venue Map


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Exhibit Floor Plan

Exhibitor Booth #

ATCC 208

BioLife Solutions, Inc 205

Biosero 204

Bluechiip 407

Brooks Life Science Systems 401

BSI Systems 202

CryoXtract Instruments 302

Exhibitor Booth #

Fisher BioServices, a Thermo Fisher Scientific brand 213

Freezerworks 306

GA International Inc. 304

Hamilton Storage 314

International Society for Biological and Environmental Repositories (ISBER)

413

LabVantage Solutions, Inc. 206

Exhibitor Booth #

Liconic Instruments 214

Longhorn Vaccines and Diagnostics LLC 207

Panasonic Healthcare 403

RURO, Inc. 203

Stirling Ultracold 405

Worthington Industries 201

Z-SC1 Biomedical 308

POSTERS

POSTERS

Exhibitor Listing



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Scientific Program at a Glance

MONDAY, NOVEMBER 7, 2016

TIME SESSION ROOM

8:00am – 9:00am Welcome and Keynote Address Salon E

9:00am – 10:15am Symposium 1 – Biobanking for Research toward Precision Medicine: The Evolving Ethical, Legal, Social and Policy Issues Salon E

10:45am – 11:45am Symposium 2 – Getting Real: Addressing Challenges and Obstacles to Achieving Next-Generation Biobanking Salon E

1:15pm – 3:00pm Symposium 3 – ICYMI: A Bit of Berlin in Bethesda (Concurrent) Salon E

1:15pm – 3:00pm Educational Workshop 1 (Concurrent) – Current Topics in Biobanking Informatics: Standards, Security and Other Discussions Salon G-H

3:30pm – 4:30pm Contributed Paper Session 1 (Concurrent) – Optimizing Quality Procedures in Clinical Biobanking Salon E

3:30pm – 4:30pm Contributed Paper Session 2 (Concurrent) – Enhancing Efficient Biobanking Operations Salon G-H

4:30pm – 5:00pm Poster Discussion Session Salon E

5:15pm – 7:00pm Welcome Reception in the Exhibit Hall with Posters Salon A-D

TUESDAY, NOVEMBER 8, 2016

TIME SESSION ROOM

9:00am – 10:45am Symposium 4A – Biospecimen Science (Concurrent) Salon E

9:00am – 10:45am Symposium 4B – Facilitating Sharing of Biospecimens and Associated Data for Translational Research (Concurrent) Salon G-H

11:15am – 12:30pm Late Breaking Session: Global and Regional Quality Standardization and Harmonization Efforts (Concurrent) Salon E

11:15am – 12:30pm Educational Workshop 2 (Concurrent) – ISBER Best Practices Workshop: Repository Planning Considerations Salon G-H

12:45pm – 1:15pm Roundtable Discussions Salon A-D

1:30pm – 3:30pm Educational Workshop 3 (Concurrent) – ISBER Best Practices Workshop: Legal and Ethical Issues for Biospecimens Salon G-H

1:30pm – 5:30pm Research Findings on FFPE Tissue from the Biospecimen Preanalytical Variables (BPV) Program Salon E

Your biobanking solution provider has a new name

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The portfolio of autofill freezers,

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available from Worthington

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Your biobanking solution provider has a new name

Worthington Industries acquired

the assets of the global

CryoScience business of

Taylor-Wharton, including

the manufacturing facility in

Theodore, Alabama, USA in

December 2015.

The portfolio of autofill freezers,

cryogenic refrigerators, dewars

and dry shippers are now

available from Worthington

Industries, a leading global

manufacturer of high pressure

cylinders, cryogenic and related

products.

Built with the heritage of CryoScience by Taylor-Wharton

Phone: 844-273-7517 / +43 7485 606 286CustomerService@WorthingtonIndustries.comWorthingtonIndustries.com/LifeSciences

CryoScience-Ad_092616_8.5x11.indd 1 9/26/2016 10:57:04 AM

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SUNDAY, NOVEMBER 6, 2016

1:00pm – 5:00pm Exhibitor Installation Salon A-D

1:00pm – 7:30pm Registration Open Foyer

1:00pm – 7:30pm Speaker Services Open Seneca

5:00pm – 6:00pm Poster Installation Salon A-D


6:30am – 5:30pm Registration Open Foyer

6:30am – 5:30pm Speaker Services Open Seneca

7:00am – 8:00am Coffee/Tea and Pastries in Foyer Foyer

8:00am – 9:00am WELCOME AND KEYNOTE ADDRESSChairpersons: Rebecca Pugh (USA), Katheryn Shea (USA), Helen Moore (USA)

Salon E

8:00am – 8:15am ISBER Welcome and Opening RemarksBrent Schacter (Canada), ISBER President, 2016-2017

8:15am – 9:00am Keynote Address – Biobanking for the Precision Medicine InitiativeStephen Thibodeau (USA)

9:00am – 10:15am SYMPOSIUM 1 – BIOBANKING FOR RESEARCH TOWARD PRECISION MEDICINE: THE EVOLVING ETHICAL, LEGAL, SOCIAL AND POLICY ISSUESChairpersons: Marianna Bledsoe (USA) and Marianne Henderson (USA)

Salon E

Successful research leading to the ability to conduct precision medicine depends on the availability and sharing of high-quality specimens and associated data, especially genomics data. However, the uncertainty about how already-banked specimens may be used in the future and the privacy and confidentiality issues raised by broad sharing of genotypic and phenotypic data raises numerous ethical, legal and social issues (ELSI). These issues include questions about the most appropriate models of informed consent and governance and the need to engage and educate participants and the public about the use of specimens in research. In addition, these issues have raised questions about the adequacy of existing regulations and policies governing biobank research and have led to new regulatory and policy developments. This session will address these evolving issues and challenges in a series of short presentations followed by an interactive audience discussion period.

9:00am – 9:15am Participants as Partners in the Precision Medicine InitiativeKathy Hudson (USA)

9:15am – 9:30am ELSI in Population Biobanks: High and LowMa’n Zawati (Canada)

9:30am – 9:45am Permission to contact: An Integrated Strategy for Enrollment and Engagement in Biobanking and Clinical ResearchPeter Watson (Canada)

9:45am – 10:15am Panel Discussion

10:00am – 7:00pm Exhibit Hall and Posters Open Salon A-D

10:15am – 10:45am Coffee Break in Exhibit Hall Salon A-D

Scientific Program



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10:45am – 11:45am SYMPOSIUM 2 – GETTING REAL: ADDRESSING CHALLENGES AND OBSTACLES TO ACHIEVING NEXT-GENERATION BIOBANKINGChairpersons: Helen Moore (USA), Sheila O’Donoghue (Canada), Debra Garcia (USA)

Salon E

In this session, speakers will address real world challenges to improving biospecimen processes, whether for precision medicine, clinical trials, or research purposes – and how medical institutions can work to overcome these challenges. What are some of the obstacles in getting the fit-for-purpose biospecimens needed for molecular analyses? How can you “get around” some of these obstacles? What obstacles seem to be non-negotiable? In addition, this session will cover real-world challenges to improving the availability of the clinical data needed to accompany research biospecimens – and how researchers and institutions are working to overcome these challenges.

10:45am – 11:15am Delivering Fit-for-Purpose Biospecimens: A Cumulative ExperienceMichael Roehrl (USA)

11:15am – 11:45am Maximizing the Value of Research BiospecimensLincoln Stein (Canada)

12:00pm – 1:00pm General Lunch in Exhibit Hall with Posters Salon A-D

1:15pm – 3:00pm SYMPOSIUM 3 – ICYMI: A BIT OF BERLIN IN BETHESDA (CONCURRENT)Chairpersons: Roman Siddiqui (Germany) and Cari Lichtman (USA)

Salon E

This session will highlight topics from the 2016 ISBER Annual Meeting held in Berlin and the pre-conference National Biobanking Day hosted by TMF which showcased efforts in Germany. This meeting addressed the unique contributions human, zoological, model organism, and environmental biobanks make with regard to research and policy making. In addition to a brief synopsis of the meeting, this session will feature diverse presentations from three of the extraordinary speakers from Berlin.

1:15pm – 1:30pm ISBER Annual 2016 in a NutshellRoman Siddiqui (Germany), Cari Lichtman (USA)

1:30pm – 2:00pm AABB Standards & Accreditation Process for Hematopoietic Stem Cell Banks Naynesh Kamani (USA)

2:00pm – 2:30pm The Munich MIDY Pig Biobank – A Unique Resource to Gain Insight into Systemic Consequences of Chronic HyperglycemiaEckhard Wolf (Germany)

2:30pm – 3:00pm Challenges in Protein Based Companion Diagnostics – from Tissue Quality to Quality ControlVeronique Neumeister (USA)

1:15pm – 3:00pm EDUCATIONAL WORKSHOP 1 (CONCURRENT) – CURRENT TOPICS IN BIOBANKING INFORMATICS: STANDARDS, SECURITY AND OTHER DISCUSSIONSPresenters: Piper Mullins (USA), Kevin Meagher (USA), Cheryl Michels (USA), Helena Ellis (USA), Jie Zheng (USA)

Salon G-H

The ISBER Informatics Working Group will discuss current issues and ongoing considerations in Biobank Informatics. The topics for this workshop are: Biobanking Ontologies; ISBER Best Practices; IT Security for Biobanks; and Guidelines for Software Selection. The presentations will be followed by a group-led discussion on these topics.

3:00pm – 3:30pm Coffee Break in Exhibit Hall Salon A-D


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3:30pm – 4:30pm CONTRIBUTED PAPER SESSION 1 (CONCURRENT) – OPTIMIZING QUALITY PROCEDURES IN CLINICAL BIOBANKINGChairpersons: Kristina Hill (USA) and Laura Cosentino (USA)

Salon E

3:30pm – 3:45pm Integrating Surgical Pathology (SP) and Biorepository (BR) Resources, Essential in Optimal Quality Control (QC) and Validation of Tumor Specimens for Precision Medicine Diagnostic, Therapeutic and Research Applications. A Vision for Efficiency, Protocols and Strategies at Children’s HospitalsHector Monforte (USA)

3:45pm – 4:00pm Progress Toward a Unified Institution-Wide Human Specimen Repository at an Academic Medical CenterJames Lagowski (USA)

4:00pm – 4:15pm Regulatory Compliance in Hospital Pathology-based Patient Consenting, Biospecimen and Annotation, and Distribution of Materials in Support of Translational and Clinical ResearchStephen Schmechel (USA)

4:15pm – 4:30pm An Institutional Commitment to the Return of Clinically Actionable Genomic Results Positively Impacts Recruitment for Geisinger’s MyCode® BiobankWilliam Faucett (USA)

3:30pm – 4:30pm CONTRIBUTED PAPER SESSION 2 (CONCURRENT) – ENHANCING EFFICIENT BIOBANKING OPERATIONSChairpersons: Pedro Rondot Radío (Argentina) and David Stokes (USA)

Salon G-H

3:30pm – 3:45pm México’s National Biobank ProjectHugo Barrera-Saldaña (Mexico)

3:45pm – 4:00pm Biospecimen Culling: Temporal RNA Integrity Analysis Across Spaceflight Missions Dating From 1985 to 2011Jon Rask (USA)

4:00pm – 4:15pm ISBER Pharma Working Group Survey on Use of Academic Biobanks by IndustryJean Cavallo (USA)

4:15pm – 4:30pm Use of Mobile Technology to Enhance Biospecimen Quality and Biobank EfficiencyJames V. Lacey, Jr. (USA)

4:30pm – 5:00pm POSTER DISCUSSION SESSIONChairpersons: Peter Watson (Canada) and Rebecca Pugh (USA)

Salon E

The Poster Discussion Session will begin just before the opening of the Welcome Reception and all poster authors are required to attend. The chair person(s) of the session will bring to light specific like-themed posters that may complement or contradict one another or raise a common issue for discussion. The authors of these previously chosen posters will be notified in advance and asked to provide an electronic version of their poster, which summarizes the key relevant findings or addresses the common issue (this will be dependent on how many like-themed posters are submitted and accepted; there may be 1-3 different rounds of discussions during this time period). This will be followed by a structured discussion and guided by the chair person(s) and involving the authors and audience.

5:15pm – 7:00pm Welcome Reception in the Exhibit Hall with Posters Salon A-D



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8:00am – 4:00pm Registration Open Foyer

8:00am – 4:00pm Speaker Services Open Seneca

8:30am – 9:30am Coffee/Tea and Pastries in Foyer Foyer

9:00am – 10:45am SYMPOSIUM 4A – BIOSPECIMEN SCIENCE (CONCURRENT)Chairpersons: Katheryn Shea (USA), John Bartlett (Canada), Lokesh Agrawal (USA)

Salon E

This session will cover biospecimen issues for molecular (“omic”) characterization for developing personalized precision medicine. This includes microRNA expression, isolation of DNA.RNA Biomarkers and pre-analytical variability surrounding detection of circulating tumor cells (CTC’s) and circulating free-DNA (cf-DNA) that are gaining clinical relevance for genomically informed precision health care. Biospecimen issues around these analytes can provide biological insight, informing drug and diagnostic development, and guiding therapeutic intervention.

9:00am – 9:20am Alternatives to Cryogenic Storage of Human BiospecimensAlptekin Aksan (USA)

9:20am – 9:40am Effect of Blood Collection Tube Type and Time to Processing on the Enumeration and High-Content Characterization of CTCsAnand Kolatkar (USA)

9:40am – 10:00am Building Integrated Biobank Infrastructures in the Healthcare Sector to Map Chromosome 19 Proteins Gyorgy Marko-Varga (Sweden)

10:00am – 10:20am Pre-Analytical Effects on Breast Cancer Gene ExpressionFraser Symmans (USA)


9:00am – 10:45am SYMPOSIUM 4B – FACILITATING SHARING OF BIOSPECIMENS AND ASSOCIATED DATA FOR TRANSLATIONAL RESEARCH (CONCURRENT)Chairpersons: Ping Guan (USA) and Cheryl Michels (USA)

Salon G-H

This session will be devoted to a discussion of success stories and challenges related to sharing of biospecimens between researchers and institutions. The session will focus on three aspects: 1) social aspects of biospecimen sharing including attitudes of researchers on sharing specimens, 2) challenges to sharing data associated with specimens, and 3) tools and mechanisms to facilitate sharing biospecimens.

9:00am – 9:05am Introductory CommentsPing Guan (USA), Cheryl Michels (USA)

9:05am – 9:30am Researcher Attitudes Toward Sharing Biospecimens with Other Researchers and Other Institutions Aaron Goldenberg (USA)

9:30am – 9:55am The SEER Virtual Tissue Repository Pilot: Leveraging Population-Based Biospecimens Radim Moravec (USA)


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9:00am – 10:45am 9:55am – 10:20am Lessons from the Biospecimen Sharing Road:Sharing Biospecimen Resources – the Carrot or the Stick?Helena Ellis (USA)

USUHS/CNRM Brain Tissue Repository to Support Research on Military TBIDaniel Perl (USA)


10:30am – 4:15pm Exhibit Hall and Posters Open Salon A-D

10:45am – 11:15am Coffee break in Exhibit Hall Salon A-D

11:15am – 12:30pm LATE BREAKING SESSION: GLOBAL AND REGIONAL QUALITY STANDARDIZATION AND HARMONIZATION EFFORTS (CONCURRENT)Chairperson: Marianna Bledsoe (USA) and Helena Ellis (USA)

Salon E

Harmonization and standardization of biorepository operations are important for ensuring the quality of the specimens and data that are collected, stored, and distributed for research, promoting best practices for addressing ethical, legal and social issues, combining specimen and data sets from multiple sources and, ultimately, helping to ensure reproducibility in research. In this session, updates will be provided on ongoing standardization efforts, such as the biorepository standard development effort of the International Standards Organization (ISO TC 276), biorepository accreditation by the College of American Pathology, and certification by the Canadian Tissue Repository Network (CTRNet). [Session content subject to modification depending upon other late breaking events].

11:15am – 11:30am Setting International Standards for Biobanking - Why and how to join ISO now!Lena Krieger (Germany)

11:30am – 11:40am College of American Pathologist Biorepository Accreditation ProgramKatheryn Shea (USA)

11:40am – 11:50am CTRNet Program UpdatesPeter Watson (Canada)

11:50am – 12:30pm Panel DiscussionLena Krieger (Germany), Katheryn Shea (USA), Clare Allocca (USA), Fay Betsou (Luxembourg), Piper Mullins (USA), Brent Schacter (Canada), Peter Watson (Canada)

11:15am – 12:30pm EDUCATIONAL WORKSHOP 2 (CONCURRENT) – ISBER BEST PRACTICES WORKSHOP: REPOSITORY PLANNING CONSIDERATIONSPresenters: William Grizzle (USA) and Katherine Sexton (USA)

Salon G-H

This workshop leads the audience through issues they should consider when planning to establish a human tissue biorepository at their institution. Based on the ISBER Best Practices for Repositories (3rd Edition), the information will help them design the biorepository that is right for their needs. Repository models, financial considerations and staffing are some of the detailed topics that will be discussed.

12:30pm – 1:30pm General Lunch in Exhibit Hall with Posters Salon A-D



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12:45pm - 1:15pm ROUNDTABLE DISCUSSIONS Join us at our roundtable discussions on various hot topics relevant to biobanking during lunch in the exhibit hall! Seats are limited, please sign up at the Registration Desk on November 7th to secure your spot.

Table 1: The Public Misconceptions and the Need for Public Education Regarding Biobanking FundingFacilitator: Joseph Galbraith (USA)

Table 2: Considerations for Biobank SustainabilityFacilitator: Marianne Henderson (USA)

Table 3: Implementing the CAP Biorepository Accreditation ProgramFacilitator: Katheryn Shea (USA)

Table 4: Patient Focused Allocation of Biobanked SamplesFacilitator: Peggy Devine (USA)

Table 5: Considerations for Microbial Collections ResourcesFacilitators: Judith Giri (USA) and Piper Mullins (USA)

Table 6: Get Out of Your Own Way! Process Management and the Tension Between Scalability and AgilityFacilitator: Larson Hicks (USA)

Table 7: Public Education About BiobanksFacilitators: Sheila O’Donoghue (Canada) and Katherine Sexton (USA)

Table 8: Public Education About BiobanksFacilitators: William Grizzle (USA) and Tamsin Tarling (Canada)

Table 9: FFPE Processing Efficiency and ControlFacilitator: Tanya Krubit (USA)

Salon A-D

1:30pm – 3:30pm EDUCATIONAL WORKSHOP 3 (CONCURRENT) – ISBER BEST PRACTICES WORKSHOP: LEGAL AND ETHICAL ISSUES FOR BIOSPECIMENSPresenters: Kristina Hill (USA), Tamsin Tarling (Canada), Rebecca Pugh (USA)

Salon G-H

This workshop provides an overview of the basic Ethical, Legal and Social Issues (ELSI) that surround the activities of repositories. Based on ISBER Best Practices (3rd Edition), the workshop will provide a foundation of understanding of the issues to be considered in the collection and exchange of specimens and associated data. Key Ethical concepts, Informed Consent processes, as well as the sharing and distribution of specimens and data are some of the detailed topics that will be discussed.


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1:30pm – 5:30pm RESEARCH FINDINGS ON FFPE TISSUE FROM THE BIOSPECIMEN PREANALYTICAL VARIABLES (BPV) PROGRAMChairperson: Helen Moore (USA)

Salon E

This session will be devoted to reports on the results of an NCI research initiative examining the effects of major pre-analytical factors on molecular analysis of formalin-fixed, paraffin-embedded (FFPE) tissues. As FFPE is increasingly utilized in molecular diagnostic assays as well as in medical research, it is increasingly important to better understand how pre-analytical variation in FFPE may affect research results and patient care, and to take steps as possible to mitigate pre-analytical effects.

1:30pm – 1:35pm WelcomeHelen Moore (USA)

1:35pm – 2:00pm BPV Program: Scientific Overview and OperationsPing Guan (USA)

2:00pm – 2:30pm BPV Biospecimen Quality Assessment and Molecular Analysis OverviewRachana Agarwal (USA) and Ping Guan (USA)

2:30pm – 3:00pm Differences in Nucleic Acids Derived from Frozen vs FFPE tissues, as Revealed by NGSWendell Jones (USA)

3:00pm – 3:25pm Copy Number Variation Analysis to Evaluate the Impact of Preanalytical Variables in FFPE Tumor TissuesHabtom Ressom (USA)

3:30pm – 4:00pm Coffee Break

4:00pm – 4:30pm mRNA and miRNA in FFPE Tissues Subjected to Extended Ischemic and Formalin Fixation TimesFay Betsou (Luxembourg)

4:30pm – 5:00pm Global Proteomic and Phosphoproteomic Analysis of Case Matched Frozen and FFPE TissuesDaniel Chelsky (Canada)

5:00pm – 5:25pm Panel Discussion: Effects of FFPE Processing on Downstream Molecular AnalysisScott Jewell (USA), Therese Bocklage (USA), Ping Guan (USA), Rachana Agarwal (USA), Wendell Jones (USA), Habtom Ressom (USA), Fay Betsou (Luxembourg), Daniel Chelsky (Canada)

5:25pm – 5:30pm Closing RemarksHelen Moore (USA)

4:00pm – 4:45pm Poster Takedown Salon A-D

4:45pm – 8:00pm Exhibitor Move Out Salon A-D



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Presentation Summaries

BPV Biospecimen Quality Assessment and Molecular Analysis OverviewRachana Agrawal, Leidos Biomedical, USA

Biospecimens collected under the Biospecimen Pre-analytical Variables (BPV) Program of NCI, were thoroughly evaluated by a team of pathologist, quality managers and data managers prior to being used for downstream research. Derivatives such as RNA and DNA obtained from the BPV FFPE specimens were also evaluated for their quality using multiple methods such as NanoDrop 8000 UV-Vis spectrophotometer, Qubit 2.0 Fluorometer, Agilent Bioanalyzer and the KAPA Human Genomic DNA Quantification. Also, as the effect of a given pre-analytical factor may be dependent upon the analyte being evaluated (DNA, RNA, protein), as well as the analytical approaches and platforms used, BPV program conducted multiple, simultaneous molecular analyses to understand the impact of defined variables on the expression and detection of various analytes. This presentation will focus on providing an overview of the quality assessment, and the various molecular analysis studies conducted using BPV specimens.

Alternatives to Cryogenic Storage of Human BiospecimensAlptekin Aksan, University of Minnesota, USA

Freezing and thawing induce significant chemical, physical and thermal stresses on stored biospecimens. Some of these stresses are significant enough to cause damage, resulting in partial or complete loss of the molecular information contained in the specimen. Added to this complication is the financial burden imposed the rather strict cryogenic processing, transport, and storage protocols needed to ensure sample stability. In this presentation, we review ambient temperature stabilization and storage methods as an alternative to cryogenic storage. Commercially existing approaches/methods, as well as those in the developmental stages with their pros and cons, will be discussed.

mRNA and miRNA in FFPE Tissues Subjected to Extended Ischemic and Formalin Fixation TimesFay Betsou, Integrated Biobank of Luxembourg, Luxembourg

Results from two different biospecimen research projects, run in collaboration with the NCI, will be presented. First, we have studied the impact of extended formalin fixation times on global miRNA profiles in different types of tissue by high throughput qRT PCR (Wafergen) and identified targets which can be informative of extreme fixation conditions. Second, we have studied the impact of different cold ischemia times on the expression levels of 20 selected gene targets in different types of fixed tissue and identified the most unstable ones.

Global Proteomic and Phosphoproteomic Analysis of Case Matched Frozen and FFPE TissuesDaniel Chelsky, Caprion Proteomics, Canada

Using samples provided by the BPV program at the NCI, we undertook to assess the utility of FFPE samples for proteomics as well as phosphoproteomics. A direct comparison of matching FFPE and frozen samples resulted in a high overlap of peptides and proteins detected. When comparing adjacent tumor and normal samples, the proteins that were found to be differentially expressed were essentially the same whether samples were stored as FFPE or frozen. FFPE, however, appears to result in the loss of a specific class of proteins and may induce the expression of other proteins A controlled study was also performed to assess the effect of cold ischemia for up to 12 hours. Small differences in the total proteome were observed, mainly after 3 hours while changes to the phosphoproteome could be observed at the earliest time points. This work was supported by subcontract 14X127ST under NCI contract HHSN261200800001E.


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Lessons from the Biospecimen Sharing Road: Sharing Biospecimen Resources – the Carrot or the Stick?Helena Ellis, Duke University, USA

Discussion of experience at Duke using a system similar to the NCI’s Specimen Resource Locator (SRL) to facilitate sharing and leveraging of Duke’s existing biospecimen resources.

Researcher Attitudes and and Institutional Policies on Sharing Biospecimens: Ethical and Practical ImplicationsAaron Goldenberg, Case Western Reserve University, USA

As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. This presentation will report on data from a survey of Researchers and IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. These data will be used to discuss the ethical, legal, and social implications of unclear or divergent policies regarding biospecimen research and their impact genetic studies and inter-institutional collaboration.

BPV Program: Scientific Overview and OperationsPing Guan, National Cancer Institute, USA

The Biospecimen Pre-analytical Variables (BPV) Program is sponsored by National Cancer Institute to systematically study the effects of pre-analytical factors on the molecular profile of biospecimens. A robust biospecimen collection infrastructure was established to prospectively collect biospecimens at four medical centers. Rigorous standard operating procedures were implemented to control for most variables while introducing experimental conditions to study specific biospecimen handling issues, including the cold ischemic time (delay to formalin fixation), time in formalin, freezing methods, and storage temperatures and durations. The potential effects of these pre-analytical conditions on molecular integrity were investigated. Data from this study will

be used to develop evidence-based biospecimen standard operating procedures and best practices for fit-for-purpose collection, processing, and storage of biospecimens.

Participants as Partners in the Precision Medicine InitiativeKathy Hudson, National Institutes of Health, USA

Full partnership with research participants is a core principle of the Precision Medicine Cohort Program (PMI-CP). The PMI-CP will include a biobank for future research, and NIH is working to develop appropriate consent for biobanking of PMI specimens. This consent will include options for the return of information to research participants. Specific consent for recontact will be obtained from individuals to participate, with the option to set preferences for receiving information or results, or withdrawal of consent to recontact. The PMI-CP will also address privacy and security requirements for data generated through PMI, and is embracing new partnerships and approaches to encourage participation in research by underserved and minority groups.

Differences in Nucleic Acids Derived from Frozen vs FFPE tissues, as Revealed by NGSWendell Jones, Q2 Solutions - EA Genomics, USA

The NCI has completed the Biospecimen Pre-analytical Variable study of the impact of formalin preservation under several conditions on the molecular analysis of nucleic acids using NextGen Sequencing protocols. The NCI utilized large collections of tumor samples across three tissue types that were matched in preservation (fresh frozen and FFPE) with the FFPE methods further varied either related to delay-to-fixation or time-in-fixative. We examined the impact of FFPE protocols vs. snap frozen on the miRNA/RNA expression profile and the detection of SNVs in DNA. The study revealed that the formalin fixation process by itself changes the relative proportions of intronic/exonic/untranslated RNA that are captured by eluting RNA from FFPE tissue using common isolation methods and NGS library protocols such as the Illumina TruSeq Total RNA preparation protocol. Finally, SNV detection from DNA Exome Sequencing was generally robust to various FFPE preservation methods except when samples



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AABB Standards and the Accreditation Process for Hematopoietic Stem Cell BanksNaynesh Kamani, Center for Cellular Therapies and Research, AABB, USA

AABB Standards for HSC Banks are designed to promote donor and patient safety and quality. They are based on good medical practice and cGMP/CGTP and are rooted in quality systems essentials. They focus on policies, processes and procedures and emphasize the safety and quality goal of the standard rather than the method to achieve it. These Standards form the basis for AABB’s Accreditation program. To become accredited, a CBB facility must undergo a successful quality and operational systems assessment of its facility and demonstrate compliance with AABB standards. The AABB Accreditation Program and the Assessor Training Program are accredited by the International Society for Quality in Healthcare. A quality management systems approach to biorepository operations can add significant value. A crosswalk between the AABB Standards for CB Banks and ISBER best practices for biorepositories shows many similarities and common key control points.

Effect of Blood Collection Tube Type and Time to Processing on the Enumeration and High-Content Characterization of CTCsAnand Kolatkar, University of Southern California, USA

As circulating tumor cell (CTC) assays gain clinical relevance, it is essential to address pre-analytic variability and to develop standard operating procedures for sample handling in order to successfully implement genomically-informed, precision health care. Blood samples of early and advanced stage breast cancer patients were collected into Cell-free DNA (CfDNA), EDTA, acid-citrate-dextrose solution, and heparin BCTs. TTA was evaluated at 24 and 72 hours, representing the fastest possible and more routine domestic shipping intervals, respectively. We have quantified performance differences of the HD-SCA for these specific pre-analytic variables that may be used as a guide to develop best practices for implementation into patient care and/or research biorepository processes.

Setting International Standards for Biobanking – Why and how to join ISO now!Lena Krieger, DIN German Institute for Standardization, Germany

International standardization with ISO intends to provide a reference framework and universal language for suppliers and customers, facilitate trade and technology transfer, ensure that trade agreements can be successfully implemented, and to develop ISO Standards as a source of technical know-how.

ISO/TC 276 “Biotechnology” aims to improve the quality of biobanking including sample collection, handling, processing, quality control and storage procedures as well as the QM system and thus a biobank’s market acceptance.

This session will provide an insight into standardization processes within the ISO community and an overview of why standardization is relevant to every biobank and why an early involvement in the ongoing standards’ development holds numerous advantages and benefits in comparison to competitors in the market. Interested in joining the effort? This presentation will give an easy introduction to the next steps ahead.

Building Integrated Biobank Infrastuctures In Private Clinics linked to the Healthcare Sector and Academic R&D in Southern SwedenGyorgy Marko-Varga, Lund University, Sweden

Within the Human Genome Organization “HUPO”, we are championing the Chromsome 19 consortia. The aim of this project is to map cancer associated genes and its Proteins and Proteoforms on chromosome 19 using data gathered from the Nextrprot, Sanger, Waldman, GeneCards, and Cancer-index online databases.

Clinical Biomarkers contained in patient samples provide important measures of health and disease that when combined with medical evaluation, data can aid in clinical decision making by physicians. Within the Human Proteome Organization “HUPO”, we are running Cancer studies, as five year longitudinal clinical studies with the objective to identify new disease biomarkers in blood and tissues. Completion of the Human Genome Project generated a vast database of human genetic makeup, but lacked information of protein characterization of the genome, leading to the development


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of the Chromosome Centric -Human Proteome Project (C-HPP). The purpose of this project is to gather information of proteins from protein encoding genes. At present, information about two thirds of 20,300 protein encoding genes is known. The project is a done on a global level and the consortium of C-HPP has set the guideline to keep it fairly organized. The study involves tissue localization and isoform identification of each protein. Examples will be given to the Biobank developments that form the basis for biomarker and drug development studies where protein expression patterns and drug localization have been generated from compartments within tissue sections as well as clinical studies directed to mode-of-drug-action and disease mechanisms.

The SEER Virtual Tissue Repository Pilot: Leveraging Population-Based BiospecimensRadim Moravec, National Cancer Institute, USA

The National Cancer Institute supports 18 registries across 14 states representing 30% of the US population. These Surveillance, Epidemiology and End Results (SEER) Registries report approximately 450,000 incident cancer diagnoses each year. Most pathology labs store paraffin-embedded tumors for 10 years providing an opportunity for registries to assemble biospecimens to support population-based cancer research.

The SEER Virtual Tissue Repository (VTR) Pilot will annotate biospecimens from 260 patients with pancreatic ductal adenocarcinoma who survived at least 5 years, and 526 node-negative female breast cancer patients who died within 2 years.

Histology slide images will be acquired for digital pathology research, and tissues will be used for whole genome sequencing. Specimens will be custom-annotated with information including radiation, chemotherapy,comorbidities, recurrence, and outcomes. The SEER VTR Pilot will define best practices so these efforts can be expanded in scale.

Challenges in Protein Based Companion Diagnostics – from Tissue Quality to Quality ControlVeronique Neumeister, Yale University, USA

Applied research advances the development of new clinical tests, taking new approaches and findings from bench to bedside. The rapidly evolving era of targeted and personalized medicine requires most accurate and reproducible biomarker testing in order to optimally stratify patients. This presentation will address practical issues of biospecimen collection, handling and storage in the research and clinical setting. Challenges in evaluation of FFPE tissue will be discussed, focusing on sampling and sample size, antibody validation and quality control of laboratory testing procedures.

USUHS/CNRM Brain Tissue Repository to Support Research on Military TBIDaniel Perl, Uniformed Services University of the Health Sciences, USA

Since the beginning of the war on terror in 2001, a total of over 350,000 military service members have been documented to have suffered from traumatic brain injury (TBI). Many of these TBIs have been the result of falls, motor vehicle accidents, athletic competitions, etc. and likely do not differ from similar injuries suffered by civilians. However, engagement with the enemy has exposed our service members to high explosives, primarily related to the use of improvised explosive devices (IEDs) in the field of battle. A significant percentage of individuals who are exposed to high explosives develop persistent behavioral/neurologic symptoms, such as chronic headache, problems concentrating, disordered sleep, abrupt mood swings with periods of depression and despair, often leading to suicide. The USUHS/CNRM Brain Tissue Repository has been established to support research on military TBI and identify unique features of this important consequence of participation in modern warfare.



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Copy Number Variation Analysis to Evaluate the Impact of Preanalytical Variables in FFPE Tumor TissuesHabtom Ressom, Georgetown University, USA

The suitability of FFPE-derived DNA for molecular profiling of tumor tissues using genomic methods such as array-based comparative genomic hybridization (aCGH) is underexplored. The goal of this study is to investigate how two pre‐analytical variables common in FFPE processing (cold ischemia time and time in formalin) impact copy number variation (CNV) detection in FFPE tumor tissues. We used aCGH data to evaluate the effect of variation in cold ischemia time and time in formalin on CNVs in DNA from case-matched frozen tumor tissue, FFPE, and blood from patients with renal cell carcinoma. The regions with CNVs in DNA samples from FFPE samples were compared to those detected from frozen tissues and blood samples. Also, we evaluated the changes in the number of significant regions with CNVs as time in fixative or delay to fixation increases.

Delivering Fit-for-Purpose Biospecimens: A Cumulative ExperienceMichael Roehrl, Memorial Sloan-Kettering Cancer Center, USA

The talk will discuss the opportunities (and challenges) of cutting-edge science-driven biobanking. We’ll talk about how the research use of specimens needs to inform its collection and data annotation using examples from various institutions.

The future of precision medicine depends critically on ability of human biospecimens, especially in clinical trials and companion diagnostics development.

We will also discuss the central leadership role of Pathology in biobanking.

College of American Pathologist Biorepository Accreditation ProgramKatheryn Shea, BioStorage, USA

The College of American Pathologists (CAP) has an established Biorepository Accreditation Program (BAP) that integrates guidelines and best practices from the International Society for Biological and Environmental Repositories, the National Cancer Institute, the Organisation for Economic Co-operation

and Development, the Center for Medicare & Medicaid Services and the College of American Pathologists Laboratory Accreditation Program. This program provides the means to attain and maintain standardization in biorepository processes, resulting in high quality specimens that can be used to support research, drug discovery, and personalized medicine. This talk with provide an overview of the program and a summary of common findings from Biorepositories that have been inspected as part of the CAP BAP program.

Maximizing the Value of Research BiospecimensLincoln Stein, Ontario Institute for Cancer Research, Canada

This talk will discuss the changing requirements for research biospecimens in an era of inexpensive whole genome sequencing and a focus on precision medicine.

Pre-Analytical Effects on Breast Cancer Gene ExpressionW. Fraser Symmans, MD Anderson Cancer Center, USA

The Precision Medicine Initiative BiobankStephen Thibodeau, Mayo Clinic, USA

In his State of the Union address on January 20, 2015, President Obama announced his intention to launch the Precision Medicine Initiative (PMI). The goal of the PMI Cohort Program is to enroll one million volunteers into a national cohort that broadly reflects the diversity of the U.S. population and accelerate progress toward a new era of precision medicine. A key component of the PMI program is to establish a Biobank with samples from these 1 million individuals. At Mayo Clinic, clinical and research programs are supported by the Center for Individualized Medicine Biorepositories Program, which includes a state-of-the-art, fully automated, scalable biospecimen processing core laboratory. This laboratory supports the acquisition, processing, distribution, storage, and management of all types of biospecimens for investigators both within Mayo and worldwide. In this presentation, I will provide an overview of the PMI program and the roles and responsibility of the PMI Biobank.


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Permission to Contact: An Integrated Strategy for Enrollment and Engagement in Biobanking and Clinical ResearchPeter Watson, BC Cancer Agency Vancouver Island Centre, Canada

Permission To Contact (PTC) is a method to increase patient engagement and enrollment in research by asking patients for their permission to be contacted about future research opportunities. The research consent process involves obtaining permission to contact a person, determination of interest and preferred format for interview, and then presentation of the research for discussion and consent. The first of these steps is typically a major barrier for research. Establishing an independent PTC platform within a health care center enhances patient engagement by presenting a proposition for decision and researcher access to consent broader populations through the creation of a database of potential participants that can be screened for study eligibility. I will discuss our experience with PTC platforms that have enrolled >20,000 patients and supported a spectrum of research and a PTC toolkit (available at www.biobanking.org) to assist others to establish PTC platforms.

CTRNet Program UpdatesPeter Watson, BC Cancer Agency Vancouver Island Centre, Canada

This talk will provide an update on the status of the Canadian Tissue Repository Network (CTRNet) Certification Program (accessible internationally through www.biobanking.org). This program is targeted broadly at researchers and the full spectrum of all types of biobanks. It focuses on education to promote awareness and appreciation of standards across all research biobanking.

The Munich MIDY Pig Biobank – a Unique Resource to Gain Insight into Systemic Consequences of Chronic HyperglycemiaEckhard Wolf, Gene Center, LMU Munich, Germany

The prevalence of diabetes mellitus (DM) and associated complications is steadily increasing. INSC94Y transgenic pigs are a model of mutant INS gene-induced diabetes of youth (MIDY). A cohort of two-year-old diabetic INSC94Y transgenic pigs (with suboptimal insulin treatment) and non-diabetic control animals (n= 5) was established to study long-term effects of chronic hyperglycemia. Standardized sampling protocols were developed for every organ/tissue to be examined. In total, ~2000 blood, serum, urine, liquor and synovia samples were taken, as well as ~12,000 samples from ~50 organs and tissues for quantitative and qualitative morphological analyses (cryo-histology; paraffin and plastic embedding of differentially fixed specimen, electron microscopy), and ~8000 shock-frozen samples for molecular profiling. Quantitative stereological analyses of DM relevant organ systems are currently performed, including pancreas and kidney.

ELSI in Population Biobanks: High and LowMa’n Zawati, McGill University, Canada

This presentation will examine the highs and lows of the ethical, legal and social issues (ELSI) in population biobanks. From conflation, to convergence, to interoperability and international collaboration, the ELSI of population biobanks have witnessed an important evolution in the past two decades. This presentation will discuss consent, the return of results and responsible data-sharing as case studies of such transformation.



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ISBER Education and Training Workshop Summaries


Educational Workshop 1 – Current Topics in Biobanking Informatics: Standards, Security and Other Discussions1:15pm – 3:00pm • Salon G-HPresenters: Piper Mullins, Smithsonian Institution, USA, Kevin Meagher, Information Management Services, Inc, USA, Cheryl Michels, Freezerworks, USA, Helena Ellis, Duke University, USA, Jie Zheng, University of Pennsylvania, USA

The ISBER Informatics Working Group will discuss current issues and ongoing considerations in Biobank Informatics. The topics for this workshop are: Biobanking Ontologies; ISBER Best Practices; IT Security for Biobanks; and Guidelines for Software Selection. The presentations will be followed by a group-led discussion on these topics.

Learning Objectives:

Participants will learn about and discuss current trends, considerations, and strategies to use biobanking and informed consent ontologies, considerations for choosing software, security measures and regulations for biobank informatics, and the current biobank informatics best practices. The workshop will provide a participant-led Q&A discussion following the presentations.


Educational Workshop 2 – ISBER Best Practices Workshop: Repository Planning Considerations11:15am – 12:30pm • Salon G-HPresenters: William Grizzle, University of Alabama at Birmingham, USA, Katherine Sexton, University of Alabama at Birmingham, USA

This workshop leads the audience through issues they should consider when planning to establish a human tissue biorepository at their institution. Based on the ISBER Best Practices for Repositories (3rd Edition), the information will help them design the biorepository that is right for their needs. Repository models, financial considerations and staffing are some of the detailed topics that will be discussed.


• Gain insight about the various repository models available

• Learn what issues should be considered when designing and operating a repository

• Discuss the various types of services your repository might want to provide

• Learn how to develop an appropriate cost recovery model

• Understand the basics of operating a repository

• Identify space and resources needed to begin a repository

Educational Workshop 3 – ISBER Best Practices Workshop: Legal and Ethical Issues for Biospecimens1:30pm – 3:30pm • Salon G-HPresenters: Kristina Hill, Department of Veterans Affairs, USA, Tamsin Tarling, BC Children’s Hospital Biobank, Canada, Rebecca Pugh, National Institute of Standards & Technology, USA

This workshop provides an overview of the basic Ethical, Legal and Social Issues (ELSI) that surround the activities of repositories. Based on ISBER Best Practices (3rd Edition), the workshop will provide a foundation of understanding of the issues to be considered in the collection and exchange of specimens and associated data. Key Ethical concepts, Informed Consent processes, as well as the sharing and distribution of specimens and data are some of the detailed topics that will be discussed.


• Explain important ethical, privacy and security standards as they relate to research and biobanking

• Outline the need for ethical, privacy and security standards for biospecimen collection, storage and usage

• Explain the role of the ethics review boards in biobank operations

• Explain how a biobank ensures ethical storage and use of biospecimens

• List the key factors to consider when developing security standards related to use of information linked to biospecimens

• Apply ethical principles in developing biobanking procedures and organizational aspects of operations


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Poster IndexABSTRACT ID TITLE PRESENTER PRESENTER

COUNTRY

P-1 The Geisinger MyCode® Community Health Initiative: Integrating Genomic and EHR Data for Precision Medicine Ming Ta Michael Lee United States

P-2 The Precision Pathology Biobanking Center at Memorial Sloan Kettering Cancer Center Michael Roehrl United States

P-3 The National Children’s Study Archive Jack Moye United States

P-4 Lyophilzation: An Alternative Preservation Opportunity for Standards in Precision Medicine? Jason Kralj United States

P-6 Preliminary Assessment of Cell Viability in a Biobank by a Phosphorescence Method Svitlana Gramatiuk Ukraine

P-7 A Novel Paper Based Technology for Biosample Collection and Biobanking Bruce Jamieson United States

P-8 Towards Whole Body Whole Organ Cryopreservation Demetri Spyropoulos United States

P-9 Determining Analyte Homogeneity in Frozen Biofluids for Qualifying Frozen Aliquotting Technology in Quantitative Analytical Workflows Joseph Fraone United States

P-12 New Data from NCI’s Biospecimen Preanalytical Variables (BPV) Program Ping Guan United States

P-13 The National Cancer Institute’s 2016 Best Practices for Biospecimen Resources: Revised Recommendations Abhi Rao United States

P-14 An Online Viewer for GTEx Histological Images Abhi Rao United States

P-15 Stratification of biospecimen reporting elements by research type: evolution towards a BRISQ 2.0 Lise Matzke Canada

P-16 The Transfer of Bio-Bank Samples for Joint Research with Private Companies Tatsuaki Tsuruyama Japan

P-17 The Informative Campaign Initiative (ICI). Educating Patients and Citizens About the Donation of Samples and Data to Biobanks for Research Aims Elena Salvaterra Italy

P-20 ‘Permission to Contact’: A Strategy to Enhance Participant Recruitment and Patient Engagement in Health Research Rebecca Barnes Canada

P-21 Informed Consent Process for Participation in the eyeGENE® Clinical Research Study Yvonne Akporji United States

P-22 Importance of Biorepository Collection of Rare Genotypes in Pharmacogenomic and Neuropsychiatric Conditions Settings Sara Lazaro United States

P-23 Recruiting Biospecimen Resources to Participate in The National Cancer Institute’s Specimen Resource Locator Joanne Demchok United States

P-24 Creating an Oncology-Specific Biorepository at the Children’s Hospital of Philadelphia Miral Patel United States

P-25 Building a Biobank for the NIH’s Precision Medicine Initiative® Cohort Program Rebekah Rasooly United States

P-29Implementation of a New Informatics System across Multiple Biorespositories at an Acedemic Medical Center – The Process, The Challenges, The Advantages, and The Pitfalls. The Experience at the University of Iowa.

Joseph Galbraith United States


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ABSTRACT ID TITLE PRESENTER PRESENTER

COUNTRY

P-30 Inventory Validation and Sample Consolidation in a Large Scale Biorepository: A Process Analysis Matt Mahoney United States

P-31 UI BioShare: A Single Data Solution for Cataloging Biobank Research Specimens and Annotated Data Bridging the Gap for Wider Collaboration Laura Jacobus United States

P-33 Sample Location and Enhanced Distribution (SLED): A Research Biorepository Query and Request Tool Mary Hall United States

P-34 Overcoming Biobanking Informatics Challenges with a Purpose-Built LIMS Terry Smallmon United States

P-35 Streamlined Software for Community and Academic Biorepositories James Harrison United States

P-36 Best Practices in Precision Medicine Clinical Trial Biospecimen and Consent Tracking Steve Chen United States

P-37 An Electronic Request Ticketing System Facilitates Timely Provision of Biospecimens for Clinical Trials Enrollment Jonathan Henriksen United States

P-39 Faster is Better: Comprehensive Process Optimization at MSKCC’s New Precision Pathology Biobanking Center Michael Roehrl United States

P-40Enhancing Annotations of an Institutional Pediatric Cancer Biorepository Through Automated Association of Pathology Reports with Longitudinal Collection of Biospecimens

Edward Krause United States

P-41 Case Study of an External Liquid Nitrogen Bulk Tank Up-Grade and Product Procurement for a Revenue Neutral Core Facility Janine Neville-Golden United States

P-42 Development of a Biorepository Core Facility to Serve the Needs of a Large Pediatric Research Center David Stokes United States

P-43 Implementing Novel Virtual Biobank Model to Facilitate Biospecimens and Clinical Data Collection in Community Hospitals Kate Torchilin United States

P-44 Freezer farm HVAC failure. A case study on remedy action. Chon Boon Eng Singapore

P-45 Creating Successful Training Programs for Repository Technicians Debra Leiolani Garcia United States

P-46 Growing Pains: Quality Management Coming of Age in an Academic Biorepository Natasha Francis United States

P-47 Biospecimen Commons: A Hub for Biobanking Collections and SOPs Joseph Miceli United States

P-48 Addition of Tris-EDTA to Saliva Cell Pellets Before Extraction as a Simple Method to Improve DNA Quality Jennifer Ross-Wilkinson United States

P-49 The National Cancer Institute’s Biospecimen Research Database (BRD): a Literature and SOP Resource for the Biobanking Community Kelly Engel United States

P-50 Making a Proven Vocabulary for Biobanking Available to the Research Community Nancy Roche United States

P-51 Transition from Service-Oriented to Integrated Biobanking to Better Support Precision Medicine Amy Brankin United States

P-52 Incorporating Nylon Flocked Swabs Improves the Transfer and Purification of Compromised Whole Blood Jemma Iano-Fletcher United States



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Exhibitors

ATCC Booth 208

ATCC offers secure and reliable biological material management with temperature-controlled supply chain, 24/7 equipment monitoring, and on-call after-hours personnel. Visit the ATCC booth #208 to learn more about how we provide extensive support to customers needing cGMP and non-cGMP storage of biomaterials. With the combination of our facility expansion and service offerings, high level technical expertise in biomaterial banking, distribution, and cell characterization, as well as dedicated project management, ATCC is your one-stop service solution for all your biomaterial needs. Connect with us at www.atcc.org.

BioLife Solutions, Inc Booth 205

BioLife Solutions develops, manufactures and markets biopreservation media products and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. The Company’s proprietary HypoThermosol® and CryoStor® solutions are serum and protein-free; formulated to reduce preservation-induced cell damage and death; and are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife enables commercial companies and clinical researchers, significant improvements in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com.

Biosero Booth 204

Biosero addresses the daily tasks and requirements faced in laboratories by providing scientists with products and services for fields including compound management, bio-banking and sample management. Instruments and consumable solutions include scanners, tubes, seals, software and automated solutions. Products are designed to ensure laboratories the most efficient and effective solution for their process.

Bluechiip Ltd Booth 407

bluechiip has developed an IT-based temperature and identification tracking solution for biosamples in the health and life sciences industry. The system is well differentiated vs current methods such as labels (hand-written and pre-printed), barcodes (linear and 2D) and RFID (Radio Frequency Identification).

Every time a smart chiip is read, an instantaneous temperature is measured, time stamped and recorded. This allows an accurate temperature history to be recorded to provide a more complete chain of custody. The smart chiip will survive and operate in extreme temperature environments such as cryogenic storage, temperature shocks and gamma irradiation.


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Brooks Life Science Systems Booth 401

Brooks Life Science Systems, a subsidiary of Brooks Automation, is the global leader in comprehensive sample lifecycle management solutions for the bioscience industry. We provide flexible and integrated solutions for managing research samples, including industry-leading collection devices, automated storage systems, biorepository storage and management services, cryogenic automation, world-wide cold-chain logistics, genomic bioprocessing services and transformational technology solutions platform that delivers sample intelligence. Visit us at www.brooks.com/lifescience.

BSI Systems Booth 202

BSI Systems (BSI, BioShare, and SRL Advantage) is a collection of web-based specimen inventory and resource management products that provide a variety of helpful workflows, specimen inventory, and location tracking services for your facility. BSI manages your biobank with a validated software that tracks the complete life cycle of all specimens within your repository. BioShare is a platform for sharing specimens and/or datasets with others in the research community by providing a central location for researchers to search, submit requests, and track requester correspondence.SRL Advantage can aid researchers to search, locate, and request specimen resources across a biobanking network.

CryoXtract Instruments Booth 302

CryoXtract Instruments utilizes a patented coring technology to acquire frozen aliquots from a wide range of frozen samples. Samples and aliquots (cores) are maintained at -80˚C throughout the process, avoiding freeze-thaw cycling and increasing sample stability. Having previously

marketed frozen aliquotting instrumentation for molecular pathology, microbiome analysis (fecal sample processing), and biobanking, the company is beginning to focus on applications for frozen aliquotting in drug development.CryoXtract’s mission is to improve the quality of scientific data that helps advance life-science research and development by delivering solutions that preserve biospecimen integrity.

Fisher BioServices, a Thermo Booth 213 Fisher Scientific brand

Fisher BioServices, a Thermo Fisher Scientific brand, is the industry leader in the management of critical biological materials to support the advancement of cell therapy, GMP biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical customers and partners in academia and government, ensuring the integrity of their valued material from the manufacturer to the bedside.Our teams of biobanking experts follow standard operating procedures (SOPs) and offer best-in-class biospecimen and biologics management solutions, which enable our customers to accelerate and streamline their focus on science and innovation. To learn more, visit www.fisherbioservices.com.

Freezerworks Booth 306

Providing configurable sample data management and biobanking software solutions since 1985. Freezerworks tracks samples testing, reporting, billing and shipping across multiple freezers and sites while managing biobank workflow. Safeguard data with comprehensive security features, 21 CFR part 11 compliance, and cryogenic-safe bar code labeling. The Freezerworks 2015 upgrade features enhanced patient data storage with state of the art PHI security, easy to use integration tools and SQL views, and an attractive web client. The Freezerworks configurable LIMS model puts the laboratory in charge, offering adaptability at an affordable price. Freezerworks is written and tested according to the FDA General Principles of Software Validation.



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GA International Inc. Booth 304

GA International – also known as Labtag.com – is a cryogenic label manufacturer that specializes in labels for biobanks, research labs, pathology and clinical labs.

Our product lines include labels and tapes that are resistant to liquid nitrogen, dry ice, freezers, autoclave, xylene, alcohol, histological staining, etc. We provide complete printing solutions including printers, scanners, ribbons, software as well as personalized consulting. Our expertise, flexibility and quick turn-around time are unmatched in the industry. We are highly efficient in small-scale custom productions as well as in large scale industrial manufacturing. We deliver worldwide.

Hamilton Storage Booth 314

Hamilton Storage provides ultra-low temperature automated sample management solutions for the life science industries. Products include -150°C cryopreservation, -80°C biobanking and -20°C high-throughput tube and plate management systems. RackWare®, our new high-density SBS-footprint racks for tubes and cryovials, increases the storage capacity in these systems. The LabElite® line of benchtop devices includes an automated decapper, automated 2-D barcode reader and a combination of the two devices to provide flexible solutions for sample processing, tracking and security. Furthermore, our systems integrate with Hamilton Robotics’ automated liquid handling workstations for complete biobanking solutions.

LabVantage Solutions, Inc. Booth 206

LabVantage, the most configurable, web-based LIMS in the market, is trusted by industry leaders worldwide. We help customers run their labs more efficiently and with fewer errors by automating tasks and integrating with instruments and systems. Our vast experience allows us to minimize risk of

project delays or failures. Our system can adapt to changing business needs after initial implementation.With over 35 years of experience, LabVantage powers hundreds of laboratories, large and small, worldwide. LabVantage is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and biobanking.

Liconic Instruments Booth 214

LiCONiC specializes in the design and manufacture of automated plate and tube stores for storage solutions in laboratories and applications with special climate requirements. We are experts in sample management and tracking for the biorepository, blood banking, and compound storage markets. Our 20 years of leadership in this field has led to an installation base of several thousands of systems in operation worldwide. By closely working with our customers, LiCONiC continually expands its product portfolio, ensuring leading edge technology for today and tomorrow.

Longhorn Vaccines and Booth 207 Diagnostics LLC

Longhorn’s PrimeStore® Molecular Transport Medium facilitates and simplifies sample collection and non-hazardous cold chain-free transportation (long distance international shipping without dry ice) by effectively killing viral and bacterial pathogens, preserving and stabilizing naked RNA and DNA at ambient or elevated temperatures for extended periods. PrimeStore MTM® provides safe, non-hazardous human, animal, avian, environmental and other samples for molecular diagnostics, viral loads and NGS. Samples include blood/plasma/serum, fecal, urine, sputum, bodily fluids/secretions swabs, insect vectors and tissue. Sample tubes can be BioBanked for long-term studies. PrimeSuite™ products include PrimeSwabs™, PrimeXtract™ nucleic acid extraction kits and PrimeMix®


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OpenSpecimen Booth 210

OpenSpecimen is a free and open source biobanking informatics platform used by 55+ leading biobanks across 15 countries including Stanford, Johns Hopkins, Emory, University of Melbourne, University of Leicester, etc. Apart from being feature-rich and highly configurable, it is available under the most liberal and customer friendly license - namely “open source”. It means a) it’s free (b) unlimited user license (c) access to the source code (d) global community of adopters. Krishagni LLC provides commercial support for adopters with setup, configuration, data migration, integration, and annual support.

Panasonic Healthcare Booth 403

Our line of biomedical laboratory products is designed with meticulous care that has been cultivated through years of research and innovative design. Your scientific research is important to us, and we believe in providing reliable technology to help you spend less time worrying about your equipment and more time getting results.

RURO, Inc. Booth 203

Headquartered in the heart of Maryland’s biotechnology corridor, RURO develops state-of-the-art software for research, biotechnological, pharmaceutical, healthcare and government laboratories in the US and worldwide. Whether for sample management, LIMS, LIS, biobanking, or ELN, RURO solutions are the clear frontrunners.

Stirling Ultracold Booth 405

Stirling Ultracold develops and manufactures a new generation of environmentally friendly ultra-low temperature freezers which operate from -20°C to -86°C. These freezers do not use compressor-based or cascade refrigeration systems, using a patented free-piston Stirling engine technology developed for critical energy, aerospace and industrial applications. Offering unsurpassed sustainability benefits, this ULT storage solution uses less than half the power of leading cascade ultra-low freezers and uses 100% natural refrigerants. Stirling Ultracold ultra-low freezers are sold worldwide to life science, pharmaceutical, biomedical/clinical and biotechnology customers.

Worthington Industries Booth 201

Worthington Industries is a leading designer and manufacturer of cryogenic solutions for the Life Science and Healthcare markets. Products are manufactured and shipped with care to customers through our global distribution network from Theodore, AL, USA (the former manufacturing facility for CryoScience by Taylor-Wharton products).

Z-SC1 Biomedical Booth 308

Z-SC1 Biomedical manufactures high quality lab equipment, specializing in ultralow freezers. Our unique TwinCore technology utilizes two separate refrigeration systems so that each of the two compressors can maintain -82C independently and indefinitely. Along with the WiZBox proactive maintenance monitoring, the TwinCore is the safest ULT on the market for sample storage.



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2017

ANNUAL MEETING

TORONTO, CANADA

May 9 – 12, 2017

Documents

Scientific Program · ISBER 2016 Regional Meeting Quality Biobanking for Precision Research and Medicine: Overcoming Scientific, Information Technology and Policy Challenges November