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

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 Analytics Manager, Ascension - Data Governance

*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 Updates

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

THURSDAY, OCTOBER 31

7:30 am Registration and Morning Coffee

IT TAKES A VILLAGE PLENARY KEYNOTE SESSION

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 Biobanking for a “Mega Cohort”: Informatics for Operationalization at Scale

Saiju Pyarajan, PhD, Director, Center for Data and Computational Sciences, VA Boston Healthcare System; Faculty, Harvard Medical School

Multiple initiatives are currently underway for setting up large biobanks with associated clinical and molecular data. We in the Million Veteran Program (MVP) have developed a comprehensive informatics infrastructure to enable collection, storage, processing and management of biospecimens. This infrastructure facilitates genomic research in a secure environment with appropriate privacy protections.   

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: Biobanking Today - How AI, Social Media and Crypto Currency Impact Patient Data

Brian Neman, MHA, CEO, Sanguine 

What do Artificial Intelligence, Social Media and Crypto Currency have in common?  Learn how each of these will influence access to patient data and the gathering and sharing of information in 2020 and beyond.

BIOSPECIMEN SCIENCE

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.

3:10 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.

3:45 Selected Poster Presentation: Facilitating Rare Cancer Biobanking in Manchester, UK

Jane Rogan, MCRC Biobank Coordinator, The Christie NHS Foundation Trust

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

8:00 am Brainstorming Breakfast Discussion Groups

9:00 Close of Discussion Groups

BIOSPECIMEN ANNOTATION, DATA ARCHITECTURE, & ANALYTICS

9:15 Chairperson’s Remarks

Louis T. Gidel, MD, PhD, Chief Medical Informatics Officer, Baptist Health South Florida

9:25 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.

10:00 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.

10:35 Coffee Break.  Last chance for Exhibit and Poster Viewing.

11:05 Selected Poster Presentation: Kaiser Permanente Research Bank: Core Resource for Collaborative Research

Alexander Lituev, MD, Practice Leader, Biorepository Head, Kaiser Permanente Research Bank

11:25 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 CO-PRESENTATION: 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

Julie L. Gorman, Supervisor, Oncology Data Analytics, Clinical Informatics, Miami Cancer Institute

Michelle Keller, MS, Oncology Data Architect, Clinical Business Systems, Baptist Health South Florida, Miami Cancer Institute

Peter McGranaghan, PhD, Business Intelligence Consultant, 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.

12:45 Enjoy Lunch on Your Own

BIOBANKING MANAGEMENT

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