Cambridge Healthtech Institute’s 10^th International

Leaders in Biobanking Congress

Innovations to Maintain Integrity and Maximize Investment in Biospecimens

October 14-16, 2018

Today, biospecimen collections are used by multiple research groups for various aims, from basic research through clinical trials. Useful biosamples must be collected to maintain their molecular integrity for specific (or unknown) downstream analysis. Thus, during research, biobanks are key infrastructures because at one time or another, these biospecimens have been stored in a biobank. Cambridge Healthtech Institute’s Tenth International Leaders in Biobanking Congress addresses innovations in biospecimen science and infrastructure to support expanding applications. Maintaining the integrity of biospecimens allows biomedical and biopharmaceutical researchers, regulators, biorepository managers, and practitioners to investigate the best strategies for effective use of biospecimens within today’s cutting-edge biomedical research.

Final Agenda

Day 1 | Day 2 | Day 3 | Download Brochure | Speaker Biographies

Sunday, October 14

9:30 am Short Course Registration

10:00 am - 1:00 pm Pre-Conference Short Course*

SC1: Lean Six Sigma and the Biorepository

Instructors:

Kerry R. Wiles, Program Director, CHTN Western Division Coordinator, Vanderbilt University Medical Center

Taylor B. Daughrity, Research Assistant I, Core, CHTN Western Division, Vanderbilt University Medical Center

*Separate registration required.

1:00 - 1:30 Lunch Provided for Participants of Both Short Courses

1:30 - 4:30 Pre-Conference Short Course*

SC2: CAP Biorepository Accreditation Program

Instructor:

Shannon J. McCall, MD, Associate Professor of Pathology, Duke University School of Medicine; Director, BioRepository & Precision Pathology Center; Vice Chair, College of American Pathologists’ Biorepository Accreditation Program Committee

*Separate registration required.

4:00 Conference Registration

5:00 Shuttle Bus from Conference Hotel to Welcome Reception and Laboratory Tour

Tour participants will be dropped off at 6700 Euclid Avenue.

5:30 Welcome Reception and Laboratory Tour at Eversight

7:00 Close of Laboratory Tour and Shuttle Bus to Conference Hotel

Tour participants will be picked up at 6700 Euclid Avenue.

To reserve your place, please visit the registration page.

7:00 Close of Day

Day 1 | Day 2 | Day 3 | Download Brochure | Speaker Biographies

Monday, October 15

7:30 am Registration and Morning Coffee

Keynote Session: It Takes a Village

8:30 Organizer’s Remarks

Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute

8:35 Chairperson’s Opening Remarks and Welcome to Cleveland

Charles Modlin, MD, Department of Urology, Cleveland Clinic

8:45 Optimizing Research through Collaboration with Your Organ Procurement Organization

Julie Caldro, CTBS, CEBT, Director, Tissue and Donor Referral Services, Lifebanc

9:20 Transforming Biobanking: From Precision Diagnostics and Big Data Analytics to Tailored Drug Development

Michael Roehrl, MD, PhD, Director, Precision Pathology Biobanking Center, Memorial Sloan Kettering Cancer Center

9:55 Samples to Biomarkers – Software Tools Supporting Biomarker Discovery*

Diane Leong, PhD, Director, Biobanking and Sample Management, Biomarker Sciences, Gilead Sciences, Inc. (*Speaker at the Inaugural Science of BioBanking meeting)

Unlocking the potential of biological samples requires tracking of samples and associated data across the span of the sample lifecycle. Samples used for biomarker research in biopharmaceutical companies are handled by a number of different functional groups over time, and storage of sample and assay information in databases and other software tools is essential to maximizing their value. An overview of one approach for managing sample inventory and associated informed consent and storing and visualizing biomarker assay results will be presented.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Leveraging Multi-Institutional Collaborations for Novel Health Discoveries – Biobanking and Beyond!

Jill Barnholtz-Sloan, PhD, Professor and Associate Director, Bioinformatics/Translational Informatics;

Sally S. Morley Designated Professor in Brain Tumor Research, School of Medicine, Case Western Reserve University

Utilization of robust biobanks coupled with updated clinical data from multi-institutional efforts in Cleveland, Ohio and internationally will be discussed in the context of brain tumors. Efforts to make available data on clinical data coupled with biospecimens accessible to researchers in Cleveland will also be showcased.

11:35 My Greatest Teacher Went to Vanderbilt

Rose Vinci, Business Consultant, Mother, Advocate

Glory Vinci was the first Neonatal Organ Donor at The Cleveland Clinic, Fairview. Her donations live on as a part of her legacy in multiple institutions for research. Her pancreas went to Vanderbilt for research. My understanding of love and life has deepened to a level no scholar could teach but instead was from a mighty little girl, my daughter, Glory.

12:10 pm Session Break

12:25 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:55 Close of Morning Session

Innovations in Biospecimen Science – Benchtop

2:00 Chairperson’s Remarks

Gregory H. Grossman, PhD, BCMAS, CEBT, CCRP, Director, Research Programs, Eversight

2:05 Preparing Research Samples for Future Use*

Andrew Brooks, PhD, COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University (*Speaker at the Inaugural Science of BioBanking meeting)

2:35 Presentation to be Announced

3:05 Sponsored Presentation (Opportunity Available)

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

4:05 PBMCs: The Good, the Bad, and the Ugly, and Why You Should Store Them Anyway

Robyn Osborne, MS, Research Project Manager, Substrate Service Core & Research Support, Department of Surgery, Duke University Medical Center

Research involving the use of peripheral blood mononuclear cells (PBMC) is increasing across translational research, aiding in the discovery of biomarkers and utilized for immune monitoring of immunotherapies. As more and more investigators turn to PBMCs for answers, the demand for quality, cryopreserved cells is growing. But cryopreservation and long-term storage of PBMCs are not without their challenges.

4:35 Development of Tissue Print Technologies for Biopsy-Based Molecular Biomarker Studies

Sandra Gaston, PhD, Director, Molecular Biomarker Research Laboratory, Department of Pathology and Laboratory Medicine, Tufts Medical Center

Biopsies are a critical source of biospecimens for both biomarker discovery and molecular testing, but access to these specimens is often limited. We have developed and fully implemented a practical, cost-effective technology that allows these valuable specimens to be utilized more effectively without compromising the tissue for pathology diagnosis. We want to share our experience with others whose work depends on biopsy-based molecular testing.

5:05 Ultra-Fast Vitrification of Patient-Derived Circulating Tumor Cell Lines

Rebecca Sandlin, PhD, Instructor, Surgery, Harvard Medical School and Massachusetts General Hospital

Emerging technologies have enabled the isolation and characterization of rare circulating tumor cells (CTCs) from the blood of metastatic cancer patients. As CTCs are fragile and difficult to expand in vitro, molecular characterization must be performed immediately following isolation. To ease experimental timelines and enable biobanking, we have developed a method to cryopreserve CTCs by ultra-rapid vitrification.

5:35 Welcome Reception in the Exhibit Hall with Poster Viewing

6:30 Close of Day

Day 1 | Day 2 | Day 3 | Download Brochure | Speaker Biographies

Tuesday, October 16

7:30 am Biobanking Brainstorming Breakfast Discussion Groups

Grab a cup of coffee and join a discussion group. These are moderated discussions with brainstorming and interactive problem solving, allowing conference participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.

Next-Generation Biospecimens for Precision Medicine

Moderator: Dianne Chadwick, PhD, Operations Director, UHN Biobank, University Health Network, Toronto, Canada

• Types of biospecimens and timepoints: collection opportunities during clinical care
• Biospecimen processing: tissue microdissection, cryopreservation, patient-derived xenografts, organoids
• Quality assurance: timely processing from diverse collection sites, treatment effects
• Share your experience

ISO 9001:2015 Certification for Biobanks

Moderator: Sameer Kalghatgi, PhD, Assistant Director, Cell and Molecular Biology Laboratory, Laboratory Operations, Coriell Institute for Medical Research

• How to make your biobank ready for ISO certification: Key issues, quality systems, risk assessment and changing the way of doing things
• SIPOC (Suppliers, Inputs, Processes, Outputs, and Customers) and risk registers; importance of buy-in from all stakeholders
• How to get ready for ISO audit: Importance of tracking key metrics (production, quality, non-conformances, turnaround times, preventative and corrective action reports, etc.)
• Importance of implementing regular competency training and creation of and adhering to SOPs and work instructions across all processes in all departments
• Involvement of management throughout the process of applying for ISO certification and continuous involvement during the implementation

Biorepository Best Practices

Moderator: Shana Lamers, MSc, Laboratory Manager, Clinical Research Laboratory and Biobank, Hamilton Health Sciences

• Identifying what “Best Practices” means and what are the key categories or areas to address
• Resources and assessment tools to monitor and review your biorepository’s practices
• Challenges of implementing and maintaining these “Best Practices”
• Discuss new considerations due to changes in technology, regulations, and accreditation

Impact of European Union General Data Protection Regulations

Moderator: Diane Leong, PhD, Director, Biobanking and Sample Management, Biomarker Sciences, Gilead Sciences, Inc. (*Speaker at the Inaugural Science of BioBanking meeting)

• Relevance of GDPR to your activities
• Informed consent changes needed for GDPR compliance
• Process changes needed for GDPR compliance
• Effect on rate of consent for donor data use

Eye Banks, Biorepositories of Human Donor Eye Tissue, Isolation and Storage of Stem Cells, Cell Lines

Moderator: Zala Luznik, MD, PhD, Postdoctoral Fellow, Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School

• Biorepositoring of human donor eye tissue: Why, how, and where to do it?
• A new opportunity to develop advanced and accessible therapy medicinal products; the ethical and legal issues behind it
• Strengthening collaboration between eye banks and research institutions – share your institution’s practice and views

Topic to be Announced

Moderator: Sureyah Nassimbwa, Head, Biorepository, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Research Unit, Uganda

Additional Discussion Groups to be Announced

8:45 Close of Discussion Groups

Innovations in Biospecimen Management – Desktop

9:00 Chairperson’s Remarks

Abby Statler, MPH, MA, CCRP, Research Regulatory QA Coordinator, Taussig Cancer Institute, Cleveland Clinic

9:05 Revisions to the Common Rule – What You Need to Know

Abby Statler, MPH, MA, CCRP, Research Regulatory QA Coordinator, Taussig Cancer Institute, Cleveland Clinic

The revisions to the Common Rule published on January 19, 2018 by the U.S. Department of Health and Human Services are set to take effect in July 2018. The objective of this presentation is to outline the major revisions, specifically focusing on the new and revised definitions, informed consent, and secondary research with identifiable information and biospecimens.

9:35 Managing Change in a Biorepository: Challenges of Moving an Active Biorepository

Shana Lamers, MSc, Laboratory Manager, Clinical Research Laboratory and Biobank, Hamilton Health Sciences

At >12,000 square feet and currently storing 3.5 million biospecimens, some for more than 25 years, we are one of Canada’s largest biobanks. When our biorepository required significant renovations, we were challenged to relocate 59 liquid nitrogen and 23 mechanical freezers, redesign nitrogen pipelines, and manage/monitor freezer failures and variable renovation timelines—all while maintaining normal day-to-day operations.

10:05 Sponsored Presentation (Opportunity Available)

10:35 Coffee Break in the Exhibit Hall with Poster Viewing

11:05 Managing Workflows to Meet Deliverables

Sameer Kalghatgi, PhD, Assistant Director, Cell and Molecular Biology Laboratory, Laboratory Operations, Coriell Institute for Medical Research

Biobanks play a critical role in providing researchers with high-quality biospecimens as reference material to validate the reliability and quality of their assays. Laboratories have struggled to achieve consistent results. For researchers studying complex diseases and for clinical laboratories sequencing patients’ genomes for healthcare decisions, the reliability of biospecimens is crucial. This talk focuses on good practices in biobanking operations.

11:35 Professionalizing the MRC/UVRI and LSHTM Research Unit Biorepository to International ISBER Standards

Sureyah Nassimbwa, Head, Biorepository, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Research Unit, Uganda

Well-organized and professional biobanks play a critical role in providing reliable and quality biospecimens required in today’s translational biomedical research. Standardized biobanking practices and policies are required to harmonize all the ethical, legal, technical and scientific aspects relevant to biobanking and biorepository operations. The ISBER Best Practices provides comprehensive guidelines that have been adopted on the roadmap to professionalizing the MRC/UVRI and LSHTM biorepository.

12:05 pm Session Break

12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Close of Morning Session

Specialty Biobanks

2:00 Chairperson’s Remarks

Kayla Gray, CCRP, Innovations Operations Supervisor, Eversight

2:05 The Cancer Moonshot Biobank

Helen Moore, PhD, Branch Chief, Biorepositories and Biospecimen Research Branch, National Cancer Institute, NIH

The Cancer Moonshot aims to accelerate cancer research through increased focus on pressing questions in cancer research, including why some patients respond to a particular cancer treatment and some do not. To be able to ask such questions, researchers need access to biospecimens collected from research participants both before and after cancer treatment. The Cancer Moonshot Biobank will develop new approaches to engage with cancer patients over the course of their cancer treatment, collect longitudinal biospecimens and associated data, and distribute the biospecimens and data to qualified researchers. The presentation describes the hallmarks of this new program and highlights progress to date.

2:35 Biobanking for Interdisciplinary Clinical Research and Translational Programs: An Integrated and Innovative Operational Model

Zuanel Diaz, PhD, Director, Protocol Support Laboratory and Biospecimen Repository Facility, Miami Cancer Institute, Baptist Health South Florida

The preservation of high-quality biospecimens and associated data for research purposes is performed as part as clinical trials and biobanking initiatives. Although the collection, processing, documentation of pre-analytical variables, storage and shipment procedures are similar, the regulations and classification of these biospecimens substantially differ. The Miami Cancer Institute Protocol Support Laboratory and Biospecimen Repository Facility uses a unique operational model that fulfills both requirements. Fundamental business principles are applied to the operation of this infrastructure to ensure compliance and maximum impact.

3:05 Biobanking Applications in Translational Research for Blinding Eye Diseases

Liliana Guedez, PhD, MB(ASCP), Senior Clinical Scientist, Laboratory of Ophthalmic Pathology, National Eye Institute, NIH

Access to high-quality human tissues is one of the roadblocks for advancing clinical research. A demand for a large number of these tissues exists for studying critical eye diseases with unmet therapeutic needs. Rare genetic disorders, autoimmune/inflammatory diseases and age-related macular degeneration are among leading causes of blindness in the USA. Innovative biobanking approaches are urgently needed for advancing therapies for critical blinding diseases.

3:35 Setting Up a Minority Biobank

Charles Modlin, MD, Department of Urology, Cleveland Clinic

4:05 CASE STUDY CO-PRESENTATION: A Gift for New Sight

Zala Luznik, MD, PhD, Postdoctoral Fellow, Schepens Eye Research Institute, Massachusetts Eye and Ear, Harvard Medical School

Jessica Nash, Biorepository Technician, Eversight

The possibility of obtaining precious human donor eye tissue for research purposes has enabled significant advances in eye banking and corneal transplantation techniques. Moreover, it has enabled invaluable insights into ocular stem cell biology and culture, with new promising stem cell-based therapies being developed. Thus, research donated human donor eye tissue has a significant impact on improving ocular health.

4:50 Conference Wrap-Up

Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute

Zuanel Diaz, PhD, Director, Protocol Support Laboratory and Biospecimen Repository Facility, Miami Cancer Institute, Baptist Health South Florida

Kayla Gray, CCRP, Innovations Operations Supervisor, Eversight

5:00 Close of Conference

Day 1 | Day 2 | Day 3 | Download Brochure | Speaker Biographies