Cambridge Healthtech Institute’s 11th International
Leaders in Biobanking Congress
Innovations to Maintain Integrity and Maximize Investment in Biospecimens
October 30–November 1, 2019
Human biospecimens (tissues and fluids) are an essential foundation for effective translational and genomics-based research and have proven to be critical for the development of personalized medicine. The demand for high quality and clinically annotated
biospecimens and the challenge of finding them to conduct clinical research or validation studies has grown rapidly, primarily due to an unprecedented level of genomic, post-genomic and personalized medicine research. The increased complexity of biospecimen
requests in terms of linked pre-clinical variables, biospecimen types, and multidimensional longitudinal clinical follow-up data has created new challenges but also opportunities for adapting collection and annotation strategies to meet the biospecimen
supply needs of the future.
Final Agenda
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WEDNESDAY, OCTOBER 30
9:30 am Short Course Registration
10:00 am - 1:00 pm Pre-Conference Short Course*
SC1: Research Electronic Data Capture (REDCap): A Crash Course on Building Web-Based Data Collection Forms
Instructor:
Sean Banks, PhD, Data Scientist, Data Governance, Ascension Clinical Research Institute
*Separate registration required.
1:00 - 1:30 pm Lunch Provided for Short Course Participants
1:30 - 4:30 Pre-Conference Short Course*
SC2: CAP Biorepository Accreditation Program: Overview and Lessons from the First Five Years
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
4:30 Shuttle Bus from Conference Hotel to Welcome Reception and Laboratory Tour
5:30 - 7:30 Welcome Reception and Laboratory Tour hosted by Miami Cancer Institute/Baptist Health South Florida
7:30 Close of Laboratory Tour and Shuttle Bus to Conference Hotel
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THURSDAY, OCTOBER 31
7:30 am Registration and Morning Coffee
8:30 Organizer’s Remarks
Mary Ann Brown, Executive Director, Cambridge Healthtech Institute
8:35 Chairperson’s Welcoming Remarks: Biobanking in 2020: Cyclic and Dynamic Strategy to Maximize Value
Zuanel Diaz, PhD, Director, Protocol Support Laboratory and Biospecimen Research Facility, Baptist Health South Florida, Miami Cancer Institute
8:45 Biobanking for Clinical and Translational Research Programs: An Integrated and Innovative Model for a Hybrid Academic-Community Cancer Center
Jeff Boyd, PhD, Associate Deputy Director, Translational Research and Genomic Medicine, Miami Cancer Institute, Baptist Health South Florida
As cancer research moves increasingly toward translational science and clinical trials require patient biospecimens, it becomes essential for hybrid academic-community cancer centers (Miami Cancer Institute) to develop a robust and comprehensive
biobanking and distribution infrastructure. We developed a model that includes a Biospecimen Repository Facility, supporting translational science in the region, and a Protocol Support Laboratory, supporting clinical trials. Comprehensive
IT integration includes linkage to the EMR and a LIMS.
9:30 Serial Biobanking in the Context of Specific Therapies for Metastatic Cancer: Clinical and Scientific Rewards of a Complex Multi-Disciplinary Team Effort
Gerald Batist, MD, Director, Segal Cancer Centre, Jewish General Hospital; Director, McGill University Centre for Translational Research in Cancer, McGill University
Large atlases of tumor sequencing, based on biobanked tumor, have been important in describing cancers and have yielded invaluable information about genomic variants. We have established a program of serial biopsy-based studies to explore tumor
evolution and mechanisms of therapeutic resistance. This presentation will discuss the complex logistics and multi-disciplinary team requirements in serial biopsy-based studies of metastatic disease and of molecular profiling that includes
the proteome.
10:15 Digital Pathology: The Promise and the Problems
Rajiv Dhir, MD, MBA, Vice Chair, Department of Pathology, University of Pittsburgh Health Systems
The advent of Digital Pathology and the plethora of tools provided by it brings opportunities and challenges. The impact and utility of these new resources touch all aspects of biobanking and associated research support. This ranges from sample
selection, processing, QA/QC, data generation, and visualization. The associated challenges encompass a plethora of issues, including standardization, rapid workflow, storage issues, and data security, to name a few. This talk will focus on
some of the key aspects of Digital Pathology implementation with specific examples.
11:00 Coffee Break with Exhibit and Poster Viewing
11:30 Biospecimens, AI, and Big Data: The Perfect Mix
Speaker to be Announced
12:15 pm Many Villages, Many Hands. The Nomadic Lifecycle of Clinical Trial Biospecimens
Melissa Rawley-Payne, MS, Executive Director, Biospecimen Operations, Celgene
As biospecimens move from location to location in a clinical trial, there are many potential road bumps that can occur along the way. Given the scope and diversity of the road bumps that can arise (e.g. shipping delays due to weather, barcodes
not adhering properly, etc.), each of the villages and hands plays a crucial role in ensuring an optimal chain of custody over the course of the biospecimen’s nomadic lifecycle.
1:00 Session Break
1:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
2:30 Chairperson’s Remarks
Harold Alvarez, MD, Medical Director, Stem Cell Processing & Immunotherapy Laboratory, Miami Cancer Institute.
2:35 Tools to Automate the Isolation of Peripheral Blood Mononuclear Cells (PBMC)
Carlos Aparicio, PhD, CEO, ImmunoSite Technologies
The worldwide use of PBMC in clinical trials continues to increase every year. However, these studies often conclude with mixed results due to poor reproducibility amongst testing sites caused, in part, to the laborious and time-dependent processes
for PBMC isolation leading to varying ranges of cell yields and viability. New tools and devices discussed herein facilitate the use of automation to increase reproducibility and reduce hands-on time to isolate PBMC.
3:05 Peripheral Blood Mononuclear Cells: Challenges in Using PBMC for Monitoring Immunotherapies
Robyn Osborne, MS, Research Project Manager, Surgery, Duke University
Immune monitoring utilizing PBMCs collected from study subjects is a critical component of immunotherapeutic research. This process is complicated by a variety of factors. These include not only the logistics of PBMC collection, processing and
storage, but are also impacted by the normal variance observed in PBMCs across the population being studied.
3:35 Sponsored Presentation (Opportunities Available)
4:05 Refreshment Break with Exhibit and Poster Viewing
4:45 Tissue Print Biobanking of Biopsy Specimens from Clinical Trials
Sandra Gaston, PhD, Director, Molecular Biomarker Analytic Laboratory, Radiation Oncology,
University of Miami, Miller School of Medicine
Tissue biopsies provide critical information about the molecular status of a patient’s cancer, but obtaining these valuable specimens from clinical trials is often challenging. Tissue prints provide a practical approach to obtaining high-quality
RNA, DNA, and protein samples from biopsy tissues for molecular biomarker analyses without compromising the specimen for diagnostic H&E and immunohistochemistry. For clinical trials, tissue prints support molecular biomarker studies of
valuable specimens that may otherwise be significantly limited or entirely unavailable for research.
5:15 CASE STUDY CO-PRESENTATION: Perfecting the Art of Prospective Tissue Collection in the Nick of Time
Zasha M. Pou, MPH, Supervisor, Biospecimen Repository Facility, Miami Cancer Institute
Jeremy W. Chambers, PhD, Associate Professor, Department of Cellular Biology and Pharmacology, Department of Neuroscience, Herbert Wertheim College of Medicine, Florida International University
Today’s cancer research pursues biomarker-driven and personalized interventions to improve patient outcomes. For this, high-quality human tissues collected and managed with a fit-for-purpose model must be readily accessible. Preemptive and
logistical orchestration is needed to provide investigators with tissues within a precise physiological window. Experimental considerations for initial and secondary tissue use are key to expand the scientific project scope.
6:00 Welcome Reception with Exhibit and Poster Viewing
7:00 Close of Day
FRIDAY, NOVEMBER 1
7:30 am Brainstorming Breakfast Discussion Groups
8:30 Close of Discussion Groups
8:45 Chairperson’s Remarks
Louis T. Gidel, MD, PhD, Chief Medical Informatics Officer, Baptist Health South Florida
8:50 Implementing a Data Framework for Research and Analytics: Perspectives from the Community Hospital Setting
Don Parris, PhD, MPH, CCRC, Assistant Vice President, Center for Advanced Analytics, Baptist Health South Florida
This presentation describes the data framework implemented for research and analytics at Baptist Health South Florida, the largest healthcare organization in the region. Topics covered include Baptist Health’s current data and research infrastructure
and studies that involve biobanking, including the Miami Heart Study, a 2,500-person observational study designed to identify new and novel relationships between risk factors, genetics, lifestyle behaviors, and cardiovascular disease.
9:20 Enabling Scientific Discovery and Innovation Using Biomarker Specimens by Means of Advanced Informatics
Lynn Wetherwax, Senior Manager, Biological Sample Management & Biobank, Research Operations, Amgen
Biomarker specimens may be collected with a specific purpose in mind or they may be stored until that “a-ha” moment when scientific discovery hinges on biomarker investigation. This presentation will provide an overview of biomarker
specimen management strategy using informatics to track, confirm consent, and search clinical data attributes related to available specimens.
9:50 Longitudinal, Event-Based, Same-Day Sample Collection: The Implications for Biomarker Development
Brian Neman, CEO, Sanguine Biosciences
Sanguine partners with patients and leverages their health data to accelerate your research for their condition. By working together with patients directly, Sanguine is able to perform home visits and to easily retrieve medical records on their
behalf. 500+ completed studies. 20/40 top pharma. 30,000+ patients.
10:05 Sponsored Presentation (Opportunities Available)
10:20 Coffee Break. Last chance for Exhibit and Poster Viewing.
11:00 Implementing a Scalable, Self-Service Data Mart at a Hybrid Cancer Center
Paul R. Lindeman, MD, Medical Director Informatics, Miami Cancer Institute, Baptist Health South Florida
How many new patients did we see last month? How many had a diagnosis of malignancy? How Miami Cancer Institute set up a scalable, user-friendly, self-service data mart in 12 months. This presentation describes the architecture, modeling, and
utility of this approach, the benefits it confers, including biobanking support, and the challenges any such endeavor is sure to encounter along the way.
11:30 A Platform for Managing Biosample Procurement for Research
Nam Bui, Senior Associate Scientist, Biobanking & Sample Management, Gilead Sciences
Gilead’s Research Biosample Request Portal (RBRP) is a centralized web-based platform for tracking requests for samples from commercial vendors and academic collaborators. RBRP gives scientists the ability to submit and track their requests
online, anywhere and anytime with VPN access. RBRP also allows scientists to search for existing Biosample requests made by other users. Hence, it can reduce the cost and possibly shorten the time to procure samples.
12:00 pm Case Study Co-Presentation (Sponsorship Opportunity Available)
12:45 Session Break
1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
2:00 Chairperson’s Remarks
Zuanel Diaz, PhD, Director, Protocol Support Laboratory and Biospecimen Research Facility, Baptist Health South Florida, Miami Cancer Institute
2:05 Standardization for Biological Material Quality That is Fit for Purpose
Clare M. Allocca, MS, EMTM, PMP, Senior Advisor for Standardization, Standards Coordination Office, National Institute of Standards & Technology
Biobanking standards are critical for ensuring that biospecimens are fit for purpose and can support studies that are meaningful and reproducible. In 2018, ISO published ISO 20387 General requirements for biobanks. While this standard
provides multiple tools, such as quality management, explicit requirements, and conformity assessment, its implementation can be challenging. Key considerations for defining an effective path for implementation will be discussed.
2:35 Qatar Biobank: Translating Biobank Science into Evidence-Based Healthcare Interventions
Nahla Afifi, MD, PhD, Director, Qatar Biobank
Qatar Biobank (QBB) is Qatar’s National Repository Centre for biological samples and health information records, promoting medical research aiming to translate the biobank science into evidence-based healthcare interventions, and coordinating
an operational plan dedicated to bringing together multi-disciplinary stakeholders. QBB biorepository structure is unique by covering Omics data, from whole genome analysis to transcriptomics, epigenomics, proteomics, and metabolomics to clinical
diagnostic biomarkers and a variety of biological sample types to enable medical research of evidence-based healthcare interventions.
3:05 Biobanking Samples and the Need to Raise the Standards: Are Your Samples Fit for Purpose?
Sameer Kalghatgi, PhD, Director, Laboratory Operations, Coriell Institute for Medical Research
Biobanks have played a critical role in increasing understanding of genetics and genomics, paving the way for precision medicine. NGS technology advances so rapidly, laboratories have struggled to achieve consistency with results. Reference materials
are critical to alleviate the variability by providing a well-characterized reference sample to validate NGS assays. Insights into what goes on behind the scenes in making it possible to supply high-quality, well-characterized reference samples
are emphasized.
3:35 Development, Implementation, and Maintenance of a Protocol for Serial Biospecimen Collection in a Uro-Oncology Setting
Heidi Wagner, PA (ASCP), Clinical Research Manager, Surgical Oncology, Princess Margaret Cancer Centre
Genito-urinary Biobank has been collecting and storing urine, blood (and derivatives), and tissue samples for over 10 years at the University Health Network, a large tertiary health center in Toronto, Ontario. In order to maximize the value of
samples collected, a serial collection framework that reflects the stages of disease and treatments has been developed in consultation with researchers and treating physicians. Serial collection dramatically increases the scope of possible
research.
4:05 CASE STUDY CO-PRESENTATION: Empowering Collaborative Multi-Center Biobanking and Research Initiatives
Jacob L. McCauley, PhD, Associate Professor of Human Genetics & Pathology; Director, Center for Genome Technology & Biorepository Facility, John P. Hussman Institute for Human Genomics, University of Miami, Miller School of Medicine
Patrice Whitehead Gay, Biorepository Core Director, John P. Hussman Institute for Human Genomics, University of Miami, Miller School of Medicine
The academic biorepository facility within the John P. Hussman Institute for Human Genomics aids various multi-center biospecimen collections and the ongoing research those collections have enabled. We will describe the various services and
support required by these local, national, and international studies and some of the different types of research empowered by these successful collaborative team science projects.
4:50 Conference Wrap-up
Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute
Zuanel Diaz, PhD, Director, Protocol Support Laboratory and Biospecimen Research Facility, Baptist Health South Florida, Miami Cancer Institute
5:00 Close of Conference
Day 1 | Day 2 | Download Brochure