Innovations to Maintain Integrity and Maximize Investment in Biospecimens
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.
View Final Agenda
Final Agenda
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
Instructor:
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
Participants will have the opportunity to tour our biorepository as well as the reading center that we partner with that grades our disease states for the tissues in our biorepository. We also have a small cocktail reception with locally made beer,
wine, and made charcuterie. Members from our board and partners will speak on what it means to be a part of the biorepository and how it impacts Northeast Ohio and the world.
5:00 - 5:30 Shuttle Bus from Conference Hotel to Welcome Reception and Laboratory Tour
Tour participants will be dropped off at 6700 Euclid Avenue.
Dress code: Business casual.
Networking, Drinks, and Food
5:30 - 6:00 Introduction and Short Speeches
6:00 - 6:15 Group A to Reading Center and Group B to Biorepository
6:15 - 6:30 Group B to Reading Center and Group A to Biorepository
6:30 - 7:00 Networking and Ending Remarks
7:00 Close of Laboratory Tour and Shuttle Bus to Conference Hotel
Tour participants will be picked up at 6700 Euclid Avenue.
7:00 Close of Day
Monday, October 15
7:30 am Registration and Morning Coffee
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, MBA, Kidney Transplant Surgeon & Urologist, Department of Urology; Founder & Director, Minority Men's Health Center, Cleveland Clinic
8:45 Optimizing Research through Collaboration with Your Organ Procurement Organization
Julie R. Schneider Caldro, CTBS, CEBT, COT, Director, Tissue Services, Lifebanc
Organ procurement organizations (OPOs) are charged with the responsibility of identifying individuals who can save and heal lives through the donation of precious gifts, including organs, tissues, eyes, and in some cases the entire body. This can
be accomplished through transplantation, research, and education. For many families the opportunity to donate for research has an even greater impact because it can help countless individuals. By working with your local organ procurement organization,
you can establish protocols to assist in providing tissues, including eyes, for research.
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
2:00 Chairperson’s Remarks
Gregory H. Grossman, PhD, BCMAS, CEBT, CCRP, Director, Research Programs, Eversight
2:05 Setting Up a Minority Biobank
Charles Modlin, MD, MBA, Kidney Transplant Surgeon & Urologist, Department of Urology; Founder & Director, Minority Men's Health Center, Cleveland Clinic
2:40 An Academic Approach to Next-Generation Biobanking
Rohit Gupta, Executive Director, Stanford Biobank; Executive Director, Clinical Research
Services (CTRU)
While individual academic researchers continue to proliferate their independent biorepositories, they often lack infrastructure to support large-scale sample and data management solutions interfaced with rich and diverse clinical (EHR) and molecular
(‘omics’) annotations related to the biospecimen collected. The Stanford Biobank is a first-of-its-kind academic center that aims to develop the next generation of biobanking tools and platforms in order to catalyze collaboration
amongst the siloed biobanks, improve biospecimen utility, and accelerate in silico research.
3:15 Refreshment Break in the Exhibit Hall with Poster Viewing
3:45 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.
4:20 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.
4:55 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.
5:30 Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
Tuesday, October 16
8:00 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
9:15 Close of Discussion Groups
9:30 Chairperson’s Remarks
Abby Statler, MPH, MA, CCRP, Research Regulatory QA Coordinator, Taussig Cancer Institute, Cleveland Clinic
9:35 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 January 2019. 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.
10:05 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.
10:35 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 Enrichment of Pancreatic Ductal Adenocarcinoma (PDAC) Cells by Laser Capture Microdissection (LCM): Increased Detection of Molecular Alterations towards Improving Patient Care
Dianne Chadwick, PhD, Operations Director, UHN Biobank, University Health
Network, Toronto, Canada
PDAC is a rapidly fatal disease with limited treatment success. Despite decades of research, the biological basis of PDAC remains poorly understood. This is due in part to tumor fibrosis that limits molecular analysis. We propose that microdissection
of PDAC prior to whole genome and RNA sequencing will enhance the detection of somatic alterations towards the development of more personalized treatment and improved patient outcomes.
12:05 pm Session Break
12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
12:50 Close of Morning Session
1:45 Chairperson’s Remarks
Kayla Gray, CCRP, Innovations Operations Supervisor, Eversight
1:50 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.
2:20 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.
2:50 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.
3:20 CASE STUDY PRESENTATION: Cleveland Clinic BioRepository
Jennifer Ko, MD, PhD, Medical Director, Central Biorepository Cleveland Clinic
Dr. Jennifer Ko will share details of planning and strategy for the new Cleveland Clinic Biorepository.
3:50 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.
4:35 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
4:45 Close of Conference