Symposium 3 – ICYMI: A Bit of Berlin in Bethesda

Chairpersons: Roman Siddiqui (Germany) and Cari Lichtman (USA)

Pre-Symposium, April 5, 2016 – National Biobanking Day

http://www.tmf-ev.de/EnglishSite/AboutUs.aspx

non-profit umbrella organization for academic research consortia and institutions

established by the Federal Ministry for Education and Research (BMBF) in 1999

funded by three federal ministries: BMBF (Education & Research), BMG (Health), BMWT (Economy & Technology)

supported by several funding bodies (e.g. DFG)

engaged in EU-funded projects (FP7, ESFRI, Innovative Medicine Initiative)

TMF Profile

TMF - 12 Years a Platform for Biobanking in Germany: https://www.tmf-ev.de/EnglishSite/WorkingGroups/Biobankingworkinggroup.aspx

Germany’s way towards excellence in Biobanking

• TMF - 12 Years a Platform for Biobanking in Germany - Michael Krawczak

• Biobanking in the German Centers for Health Research - Peter Schirmacher

• The German Biobank Registry - Vision and Lessons Learned - Roman Siddiqui

• The German Biobank Node: National Coordination and Central Point of Contact for BBMRI-ERIC - Michael Hummel

• Biobanking as Part of the German National Cohort- Annette Peters

• Success Model of Centralizing Biobank-Sites - Roland Jahns

• Clinical Biobanking for Research in the Field of Congenital Heart Disease in Germany - Thomas Pickardt

• Biobanking for Successful Translational Oncology - Esther Herpel

• Moving Toward Evidence-Based Biobanking - Helen Moore (USA)

National Biobanking Day | www.tmf-ev.de/englishsite/news/2986

Symposium 1 – HUMAN & ENVIRON. BIOBANKS CONFRONT GLOBAL HEALTH CHALLENGES

Chairpersons: Dominik Lermen (Germany) & Peter Schirmacher (Germany) • ISBER Welcome and Opening Remarks - Jim Vaught (USA) • BBMRI-ERIC: European Gateway for Health - Jan-Eric Litton (Sweden) • Future Health Challenges - The Role of Biobanking and Related Collaboration in Preparing for Public Health

Emergencies Keynote - Cathy Roth (Switzerland) • The German Environmental Specimen Bank - Science to Support Policy - Lilian Busse (Germany) • Eur. Biob.: Joining Population Based Studies to Meet Grand Challenges - Ronald Stolk (Netherlands) • Large-Scale Cryobanking of Biodiversity to Avert Mass Extinctions - Stephen Blair Hedges (USA)

Message & Conclusion: High quality biobanking to counteract emerging diseases, e. g. Zika / Ebola Environmental Biobanking supports policy - tackles health challenges due to

pollution Use existing biobanking (huge data/samples) rather than initiate new studies Large scale cryobiobanking to preserve biodiversity (example of Haiti)

Symposium 2 A – BIOBANKS AND INDUSTRY TO ADVANCE PRECISION MEDICINE

Chairpersons: Arndt Schmitz (Germany) & Judith Giri (USA) • Diagnostics Industry Working with the Biobank Community Towards Better Precision Medicine Assays - Mike

Burgess (UK) • Examining the Role of Host and Nasal Microbiome in Staphylococcus Aureus Nasal Carriage through a Twin Study - Cindy Liu (USA) • Personalized Therapy of Refractory Leukemia - Kimmo Porkka (Finland) • Panel Discussion - with speakers and chairpersons

Message & Conclusion: Need for open information about biospecimens available for sharing Be persistent to create a win-win situation between academia and industry Understand each partner´s perspective, e. g. importance of peer-reviewed

publication for academia vs. IP interests of industry / pharma Be realistic - pragmatic - patient with regard to mutual schedules

Symposium 2 B – STRATEGIES FOR BIOBANK COLLABORATIVE DATA MANAGEMENT

Chairpersons: Jonas Astrin (Germany), Zisis Kozlakidis (UK), Piper Mullins (USA) • Streamlining the German Barcode of Life Dataflow - Peter Grobe (Germany) • Global Catalogue of Microorganisms (GCM): A Global Information Platform for Accessing, Tracking,

Monitoring and Benefit Sharing of Microbial Resources - Juncai Ma (China) • GGBN – A Virtual Assembly of the Tree of Life - Ole Seberg (Denmark) • Reducing False Positive Somatic Mutation Calls in Next Generation Sequencing of Cancer Samples - Sangsoo Kim (Republic of Korea) • Panel Discussion - with speakers and chairpersons

Message & Conclusion: The absolute scale of data- impossible to handle 5-10 years ago Pressure on biobank informatics/technology to keep pace managing big data Open access & free data sharing = heart of scientific progress

ISBER 5K Run/Walk/Sleep 2016 Große Tiergarten

Winner: Scott Kerns in 18 minutes, 53 Travel Award Winner: Plebeian B. Medina

Symposium 3A – SUSTAINABILITY: TARGETING UTILIZATION THROUGH PLANNING, MARKETING AND ACCESS

Chairpersons: Kirstin Goldring (UK), Marianne Henderson (USA) & Daniel Simeon-Dubach (Switzerland) • Sustainability through Optimized Sample Management – Suenne Orth (Switzerland)

• Biobanking for Birth Cohort Study – Shoji Nakayama (Japan)

• Marine Plankton Bioresource Centre – Willie Wilson (UK)

• Sustainability & Marketing Tools for a Viable Biobank – Rajiv Dhir (USA) • Interactive Presentation & Panel Discussion - with speakers and chairpersons

Conclusions: Optimize sample management to deliver measurable value to “Customer“ Planning of resources, capacity and researcher needs Market the “brand“ to targeted researchers & exploit what you do best Regularly collect & review meaningful key performance indicators & metrics

Symposium 3B – IMPROVING BIOSPECIMEN PRACTICES & BIOMARKER RESEARCH TO FACILITATE BIG SCIENCE

Chairpersons: Lotte Gluck (Germany), Cari Lichtman (USA) & Willem Wolkers (Germany) *Joint session with Society for Cryobiology • Factors to Consider for Cryopreserving Biospecimens – John Morris (UK)

• Quality Indicators for Sample Validity & Assay Performance – Veronique Neumeister (USA)

• Detecting & Characterizing Viable Circulating Tumor Cells – Catherine Alix-Panabieres (France)

• The Munich MIDY Pig Biobank – Eckhard Wolf (Germany) • Panel Discussion - with speakers and chairpersons

Conclusions: Cutting-edge research happening across the globe Critical to improve specimen quality as well as identify methods to assess

specimen quality Emphasis on thinking from end user backwards

ISBER Gala Dinner Wasserwerk

Symposium 4A – QUALITY IS IMPORTANT FOR ALL KINDS OF BIOBANKS

Chairpersons: Michael Kiehntopf (Germany), Dominik Lermen (Germany), Cari Lichtman (USA) & Daniel Simeon-Dubach (Switzerland) • AABB Standards & Accreditation for Hematopoietic Stem cell Banks – Naynesh Kamani (USA) • Global Collaboration Experiences & Challenges with EPHect (Endometriosis Phenome & Biobanking

Harmonisation Project) – Stacey Missmer (USA) • Quality when Collecting Samples in Less than Optimal Environments – Josef Elster (Czech Republic)

• QMS and the Estonian Biobank – Andres Metspalu (Estonia) • Panel Discussion - with speakers and chairpersons

Conclusions: A good Quality Management System (QMS) is a tool to increase

transparency, reproducibility, and sustainability QMSs inform and direct internal policies, processes, and protocols All biobanks need a QMS to maintain integrity

Symposium 4B – PRECISION MEDICINE: FACILITATING ETHICAL SPECIMEN COLLECTION & USE IN INDUSTRY SPONSORED PROJECTS

Chairpersons: Marianna Bledsoe (USA), Kirstin Goldring (UK), & Elena Salvaterra (Italy) *Joint session with CAREB & PRIM&R • Overview of Challenges in Sample Collection in Academic/Industry Collaborations – Marianna Bledsoe (USA) • Ethics Board Perspective – George Browman (Canada)

• Ethics & Genome Medicine in Japan – Tohru Masui (Japan)

• Responsible Biobanking Governance in a Global Pharmaceutical Company – Brian Clark (Denmark) • Legal Challenges Sharing Biospecimens between Academia & Private Companies – Emmanuelle Rial-Sebbag

(France) • Issues Arising when Academia Share Biospecimens with Private Commercial Entities – Mark Barnes (USA) • Panel Discussion - with speakers and chairpersons

Conclusions: Transparency is best antidote to public distrust Engage in “Bioethical Partnership“ to protect participants

Special Topic – EMERGING POLICY DEVELOPMENTS: CHALLENGES TO INTERNATIONAL RESEARCH COLLABORATIONS

Chairpersons: Marianna Bledsoe (USA), Marianne Henderson (USA), & Lotte Gluck (Germany) *Joint session with CAREB & PRIM&R • International Declarations, Conventions, Guidelines of Potential Impact on the Collection & Uses of Human

Biosamples – Brian Clark (Denmark) • Overview of Proposed Changes to Biospecimen Research under US Research Regulations – Mark Barnes

(USA) • What about ELSI? The Common Service of BBMRI-ERIC – Michaela Mayrhofer (Austria) • Panel Discussion - with speakers and chairpersons

Conclusions: In 2015, US DHHS issued Notice of Proposed Rulemaking for the Common Rule

proposing major changes for specimen research & European Commission finalized General Data Protection Regulation

Common Service facilitates cross-border exchanges

Contributed Sessions • Innovative Technologies – 9 presenters

• E-consent • CryoIDs & Novel RFIDs • Cloud Based Tools

• Contributed Paper Sessions • Human Biobanks Transforming Research- 7 presenters • Biobank Sustainability in the Long-Term- 7 presenters • Emerging ELSI Issues- 6 presenters • Bioinformatics- 6 presenters

• Multimedia Biobank Education Tools • An Educational Video Showing How to Use the Cobra Guideline- Elena Bravo (Italy) • Post-Graduate Biobank Courses: A Road from the Auditorium to BOOC (Biobank Open Online Courses)- Eva Ortega Paino (Sweden) • From the Human Genome Project to Biobanking Industry, Where Are We Now?- Ahmed Samir Abdelhafiz

(Egypt) • Gamify Your Biobank: Raising Public Awareness through Social Game Play- Jessica Sims (UK) • Donating Your Tissue for Research- Carol Weil (USA)

ISBER Annual Business Meeting

• Welcomed new President - Brent Schacter (Canada) • ISBER Distinguished Leadership & Service Award – Cheryl Michels (USA) • ISBER Special Service Award – Marianna Bledsoe (USA), Piper Mullins (USA), & Nicole Sieffert (USA) • ISBER Outstanding Achievement in Biobanking Award – Rongxing Gan (China) • ISBER Founder’s Award – Sandra Wolman (USA) • ISBER Travel Award – Plebeian Bautista Medina (Philippines)