Today, biospecimen collections are used by multiple research groups for various research aims, from basic research through clinical trials. Useful biosamples must be collected to maintain their molecular integrity for specific (or unknown) downstream analysis. Thus, the proper collection, processing, storage and tracking of biospecimens are critical components allowing researchers to better link molecular and clinical information. Cambridge Healthtech Institute’s 8th International Leaders in Biobanking Congress: Applying Biospecimen Science to Advance Biomedical Research and Patient Care addresses biospecimen science, management, and applications, bringing together 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.

WEDNESDAY, SEPTEMBER 7

Pre-Conference | Day 1 | Day 2 | Day 3 | Speaker Biographies

9:00 am Short Course Registration

9:30 am-12:30 pm Pre-Conference Short Course*

SC1: Managing a Viable Biobank

* Separate registration required.

12:30 pm Enjoy Lunch on Your Own

1:30 Main Conference Registration 

Conference Venue and Hotel:
Hilton Baltimore
401 West Pratt St.
Baltimore, MD 21201

2:00 Complimentary Shuttle Bus to Afternoon Programs

Keynote Presentation

Location at Johns Hopkins, East Baltimore Campus:
Tilghman Auditorium
720 Rutland Avenue
Baltimore, MD 21205

The Tilghman Auditorium is located on the Ground level of the Turner Concourse. Take the Ross elevators to the ground floor, and the Tilghman Auditorium is in the center of the concourse.

Visitor Parking Garages

Rutland Avenue Garage

(Madison Street at Rutland Avenue)
The entrance to the Rutland Garage is located at 1800 Madison Street

Washington Street Garage

Address: 701 N Washington St, Baltimore, MD 21205

Click Here For More Info

3:00 Welcome Remarks by Johns Hopkins University

Daniel E. Ford, M.D., MPH, David M. Levine Professor of Medicine; Director, Institute for Clinical and Translational Research; Vice Dean, Clinical Investigation, Johns Hopkins School of Medicine

3:15 The NIH Precision Medicine Initiative: The Potential of a Million

Eric Dishman, Director, Precision Medicine Initiative Cohort Program, National Institutes of Health

Precision medicine is an emerging approach for disease treatment and prevention that seeks to maximize effectiveness of prevention and treatment strategies by accounting for individual differences in genes, environment, and lifestyle. As part of the President’s Precision Medicine Initiative (PMI), NIH is building an unprecedented national research cohort of one million or more people from across the U.S. This cohort will take 3-4 years to assemble and will be followed over many years. Speaker Video: Health Care Should Be a Team Sport

 

 

THURSDAY, SEPTEMBER 8

Pre-Conference | Day 1 | Day 2 | Day 3 | Speaker Biographies

8:00 am Morning Coffee

It Takes a Village

8:30 Organizer’s Remarks

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

8:35 Chairperson’s Remarks

Homayoon Farzadegan, Ph.D., MSc, Professor, Epidemiology & Molecular Microbiology and Immunology; Director, JHBR and Core Laboratories, Johns Hopkins Bloomberg School of Public Health

8:40 Biobanking in the 21st Century: Opportunities and Challenges

Stella Somiari, Ph.D., Senior Director, Biobank and Biospecimen Science Research, Chan Soon-Shiong Institute of Molecular Medicine at Windber

Biobanks will face greater specimen demand as genomics, post-genomic and personalized medicine research increases. New technological platforms will drive new specifications for biospecimen collection and processing. Personalized medicine will require easily accessible specimens to diagnose disease, determine treatment and monitor response. Specimen scarcity due to disease rarity and size restrictions of surgical material are new issues. Future biobanks must address these challenges to remain relevant.

9:10 Modern Biorepository Informatics Infrastructure: A Data-Driven, Service-Oriented Modular Approach to Operation and Discovery

Alex S. Felmeister, Supervisor, Data Integration – Enterprise Informatics, Translational Informatics Unit, Department of Biomedical and Health Informatics, The Children’s Hospital of Philadelphia

With the increase in high-throughput sequencing based on a growing infrastructure to collect a variety of biospecimens, challenges have arisen in the informatics infrastructure required to support this type of research. This talk focuses on utilization of modern web technologies to implement connected applications to facilitate biospecimen banking operationally and scientifically while protecting patient privacy.

9:40 Investigator Experiences and Attitudes about Research with Biospecimens

Suzanne M. Rivera, Ph.D., Vice President, Research and Technology Management, Case Western Reserve University

To advance knowledge about human diseases and treatments, investigators need access to human biospecimens and associated data. However, regulatory and procedural requirements may impede investigators’ efforts to share biospecimens and data within and across institutions. We conducted a survey of practicing scientists to learn about investigators’ experiences and attitudes about research with biospecimens. I share our findings.

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

10:45 The Importance of Centralized and Harmonized Biobanking to Support Precision Medicine Initiatives across Government, Academic and Industrial Initiatives

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University

11:15 Roles of Biospecimens in in vitro Diagnostics (IVD) Product Development

Thomas Li, Ph.D., FAAAAI, FACB, CTO, Diagnostic Development Hub, ETPL, Agency for Science, Technology and Research

This presentation begins with an overview of the IVD product development process, followed by the roles biospecimens play in diagnostics development. The challenges of biospecimens acquisition for diagnostics assay development will then be described. Finally, the partnership engagement model of the Diagnostics Development Hub of Singapore with an overseas technology partner will also be discussed.

11:45 Panel Discussion with Speakers

Moderator:
Homayoon Farzadegan, Ph.D., MSc, Professor, Epidemiology & Molecular Microbiology and Immunology; Director, JHBR and Core Laboratories, Johns Hopkins Bloomberg School of Public Health

 

 

Panelists:

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University

 

 

 

 

Laura Elnitski, Ph.D., Principal Investigator, Translational and Functional Genomics Branch, National Human Genome Research Institute (NHGRI), National Institutes of Health

 

 

 

 

Alex S. Felmeister, Supervisor, Data Integration – Enterprise Informatics, Translational Informatics Unit, Department of Biomedical and Health Informatics, The Children’s Hospital of Philadelphia

 

 

 

Victoria Haggerson, Ph.D., Group Lead, Global Biological Assets, Discovery Supply, GlaxoSmithKline

 

 

 

 

Thomas Li, Ph.D., FAAAAI, FACB, CTO, Diagnostic Development Hub, ETPL, Agency for Science, Technology and Research

 

 

 

 

Stella Somiari, Ph.D., Senior Director, Biobank and Biospecimen Science Research, Chan Soon-Shiong Institute of Molecular Medicine at Windber

 

 

 

 

Diverse experts consider the link between clinically relevant genomic research and reliable biorepositories, sharing experiences from and insights into biobank management, biopreservation and fit-for-purpose sample strategies, data integration and the ethics of biospecimen use.

12:15 pm Session Break

12:30 Enjoy Lunch on Your Own

Biospecimens Link Cancer Molecular Markers to Clinical Information

2:00 Chairperson’s Remarks

Anton Wellstein, M.D., Ph.D., Professor, Oncology, Pharmacology and Medicine; Associate Director, Basic Science, Lombardi Comprehensive Cancer Center, Georgetown University Medical School

2:05 Assessing ZNF154 Hypermethylation from Circulating Tumor DNA in Pan-Cancer Diagnostics

Laura Elnitski, Ph.D., Principal Investigator, Translational and Functional Genomics Branch, National Human Genome Research Institute (NHGRI), National Institutes of Health

Aberrant DNA methylation in cancer represents a potential biomarker for diagnostics. We identified hypermethylation at the ZNF154 CpG island in 15 epithelial tumor types from 13 different organs. We further assessed the magnitude and pattern of differential methylation across colon, lung, breast, stomach, and endometrial tumors. Our findings strongly support this epigenetic signature as a biomarker in circulating tumor DNA.

2:35 Circulating Nucleic Acids in Cancer Treatment Monitoring

Anton Wellstein, M.D., Ph.D., Professor, Oncology, Pharmacology and Medicine; Associate Director, Basic Science, Lombardi Comprehensive Cancer Center, Georgetown University Medical School

Improvements in nucleic acid sequencing and detection can use serially collected blood samples and assess the mutational status and altered gene expression patterns in cancer patients. The analysis of circulating tumor-derived mutant DNA and the expression patterns of RNAs (e.g., microRNAs) can provide a profile reflecting the responses of the host and the disease to treatments.

3:05 Selected Oral Poster Presentation: The Gundersen Medical Foundation Cancer Biobank, a Multi-Decade Resource for Cancer Research

Steven Cash, HT-ASCP, Supervisor, Kabara Cancer Research Laboratory, Gundersen Medical Foundation

The CAP-accredited Gundersen Cancer Biobank consists of over 10,000 samples in two major collections: formalin-fixed paraffin embedded specimens (1983-1995), and prospectively collected minimally ischemic flash-frozen matched tumor and normal specimens, with serum and cryopreserved whole blood and/or buffy coats (2009-present). All samples are de-identified. Biobank samples are used for oncology research within the Gundersen Medical Foundation and are made available to qualified investigators and consortia such as TCGA.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Precision Medicine Begins with Biospecimens

Michael Roehrl, M.D., Ph.D., Director, Precision Pathology Biobanking Center, Memorial Sloan Kettering Cancer Center

We discuss the creation of the brand-new Precision Pathology Biobanking Center at MSKCC and the five key pillars on which it is being built: (1) Next Gen Biobanking; (2) Big Data Analytics and Precision Pathology Informatics; (3) New Disruptive Pathology Technologies; (4) Creation of a Pathology Hub for Precision Clinical Trials; and (5) R&D and Commercialization Partnerships with Biotech and Pharma. Examples for each of these areas will be discussed and the key role of Pathology as a driver discipline for Precision Health Care will be emphasized.

4:30 High-Throughput qRT-PCR Validation of Blood MicroRNAs in Non-Small Cell Lung Cancer

Mustafa Kahraman, MSc, Bioinformatician & Research Scientist of the Chair for Clinical Bioinformatics, Center for Bioinformatics, Saarland University

MicroRNAs from body fluids have increasingly become recognized as potential novel biomarker candidates, though few could be reproduced in follow-up studies. We report validation of a known miRNA signature on an independent platform and cohort distinguishing patients with NSCLC, COPD and healthy controls. This study highlights the diagnostic potential of minimal-invasive blood-based miRNA signatures as valuable biomarkers for early disease detection and personalized medicine.

5:00 A Nanotechnology Approach to Nucleic Acid Biomarker Assessment

Adam R. Hall, Ph.D., Assistant Professor, Biomedical Engineering, Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest University School of Medicine

Circulating nucleic acids present a route to diagnostic analysis, but issues that range from target scarcity and size to measurement speed and cost present challenges. Nanotechnology offers a possible solution. Here, I present a novel solid-state nanopore assay and describe how it can be used to assess two types of nucleic acid biomarkers with specific relevance to cancer diagnostics: epigenetic modifications and short sequences, including miRNAs.

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

6:30 Close of Day

FRIDAY, SEPTEMBER 9

Pre-Conference | Day 1 | Day 2 | Day 3 | Speaker Biographies

7:45 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.

Table 1: Biobanking Practices and Evidence-Based Guidance

Moderator: Kelly B. Engel, Ph.D., Lead Curator, Biospecimen Research Database, Biorepositories and Biospecimen Research Branch, National Cancer Institute, National Institutes of Health

• What steps/processes in biobanking could benefit from procedural guidelines developed using literature evidence?
• Would your biobank consider them during SOP development or revision?
• Experimental- versus evidence-based validation: Is one enough? How to handle conflicting evidence?
• How can inter-institution SOPs be developed given differences in equipment and resources?
• Which area in biobanking needs guidance the most?

Table 2: Models of Discovery and Clinical Biobanking in Pharma

Moderator: Victoria Haggerson, Ph.D., Group Lead, Global Biological Assets, Discovery Supply, GlaxoSmithKline

 

• Central vs. decentralized models
• Crossing the discovery-clinical spaces
• Managing samples for reuse in discovery
• Standardization of technology, best practices

Table 3: Emerging Techniques for Nucleic Acid Analysis

Moderator: Adam R. Hall, Ph.D., Assistant Professor, Biomedical Engineering, Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest University School of Medicine

• What shortcomings of current technologies need to be addressed and why?
• What experimental approaches are particularly promising as emerging analytical tools for nucleic acids?
• Discuss the most important targets of emerging nucleic acid analysis techniques
• What are the most critical challenges remaining to push new technologies from the laboratory to the clinic?

Table 4: Fast, Cheap or Good: Choose Any Two

Moderator: Jeffrey M. Otto, Ph.D., MBA, Founder and CEO, Otto Consulting Group

• Discuss the relationship between speed of acquisition and cost
• Discuss the relationship between a lockdown process and cost
• Discuss the complex relationship between ease, flexibility, process control, speed and cost
• Discuss how these factors impact biorepository sustainability

Table 5: Consenting for In-Depth Genetic Analysis (e.g., WGS)

Moderator: Jane Rogan, Business Manager, Manchester Cancer Research Centre (MCRC) Biobank, The Christie NHS Foundation Trust

• How much information is too much?
• Can we use communication aids to increase understanding?
• How do we deal with incidental findings?
• What about risks to patient anonymity?

Table 6: Collection, Processing and Storage of Blood-Derived Biospecimen

Moderator: Anton Wellstein, M.D., Ph.D., Professor, Oncology, Pharmacology and Medicine; Associate Director, Basic Science, Lombardi Comprehensive Cancer Center, Georgetown University Medical School

• Processing times after blood collection: When does it matter? For which analyte?
• Collection tube recommendations for different analytes?
• Short-term storage? Shipment conditions (ambient, cold, frozen temperatures)
• Freeze-thaw cycle impact?
• Circadian variations?
• Intra-person variations?

9:00 Close of Discussion Groups

PDX Models Represent Patients
and Facilitate Research

9:05 Chairperson’s Remarks

Jeffrey M. Otto, Ph.D., MBA, Founder and CEO, Otto Consulting Group

9:10 Biobanking Brainstorming Discussion Groups Report Outs

9:20 The Evolution of a Flexible Biobanking Model

Jane Rogan, Business Manager, Manchester Cancer Research Centre (MCRC) Biobank, The Christie NHS Foundation Trust

With the advent of more readily required research techniques, e.g., the use of fresh tissue and CTCs in mice and extraction of cfDNA from blood, biobanks need to be more responsive to meet these requirements. This talk demonstrates how the MCRC Biobank has evolved a flexible model to meet these needs of researchers and facilitate high-quality cancer research.

9:50 Case Study Co-Presentation: Biobanking in Rural Maine: How a Collaboration between EMMC and The Jackson Laboratory’s PDX Consortium Engages Patients to Participate in Research

Andrey Antov, Ph.D., Program Director, Maine Cancer Genomics Initiative, The Jackson Laboratory

Jens Rueter, M.D., Medical Director, Translational Research, EMMC Oncology Research Program, EMMC Cancer Care, Eastern Maine Medical Center

The EMMC BioBank was founded to give patients the opportunity to participate in translational research. The PDX is an in vivo surrogate for the patient, offering patients the opportunity to have their tumors represented in preclinical drug development. We describe our experience in engaging patients to participate in the project as well as the success of the collaborative PDX Resource.

Biospecimen Management

10:35 Coffee Break in Exhibit Hall with Poster Viewing

11:15 Challenges and Successes of Centralizing Biosample Management for Pharmaceutical Discovery and Development

Victoria Haggerson, Ph.D., Group Lead, Global Biological Assets, Discovery Supply, GlaxoSmithKline

Creating a central function for biosample management for drug discovery and development can provide many advantages such as sample visibility and organization, increased compliance and better value from sample investment. However, the challenges are not trivial. This presentation discusses the approach taken by GlaxoSmithKline, including IT and automation infrastructure development as well as strategy for sample lifecycle management, and highlights successes including compliance and cost savings.

11:45 Big Data Integration to Facilitate Biobank Management — Case Studies and Collaboration

Douglas Last, Sales Director, BC Platforms AG

Clinical context is a challenge every Genomics researcher faces when confronted with the rapidly rising tide of sequence and genotype data. The experiences of 4 different biobanks — University of Colorado, Codigo 46 in Mexico, Monash University in Australia and the Finnish Institute for Molecular Medicine — illustrate strategies to capture, manage and analyze thousand or millions of subject genomes within a clinical context and potentially make these data globally available for subsequent, secure collaboration.

12:30 pm Luncheon Hosted by Cambridge Healthtech Institute (All Are Welcome)

Biomarkers from Biobanks

2:00 Chairperson’s Remarks

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Co-Managing Director, BioProcessing Solutions Alliance

2:05 CryoStem: Establishment of a French National Thematic Collection of Biological Samples Pre- and Post-Allogeneic Hematologic Stem Cell Transplantation for the Study of Graft-Versus-Host Disease

Emilie Robert, Ph.D., Project Manager, Governance, CryoStem

Allogeneic Hematopoietic Stem Cell Transplantation is the only curative treatment for many hematologic diseases, frequently inducing Graft-versus-Host Disease (GvHD), whose pathophysiology and long-term determinants are still largely unknown. CryoStem gathers 33 French HSCT units and 23 Biological Resources Centers contributing to a standardized, high-quality samples collection with concomitant extensive clinical data. The collection includes >3,500 patients and 1,470 related donors generating >116,000 frozen samples. CryoStem is crucial for progress in GvHD research, through call for projects, collaborative studies between French and international research organizations and fostering of technology transfer with the pharmaceutical industry. The next major issue will be to broaden the collection to all HSCT complications.

2:35 A Large-Scale Postmortem Biospecimen Collection for Studying Genetic Variation: The Genotype-Tissue Expression (GTEx) Project

Abhi Rao, Ph.D., Program Director, Biorepositories and Biospecimen Research Branch (BBRB), Division of Cancer Treatment and Diagnosis, Cancer Diagnosis Program, National Cancer Institute, National Institutes of Health

The GTEx program examines the relationship between genotype and gene expression in multiple tissue types from 965 non-diseased postmortem donors. The program has successfully obtained quality biospecimens from which DNA/RNA has been extracted and utilized in genomic analysis. Multiple resources are available including clinical and genotype data for each donor, pathology review and gene expression data for each tissue, expression quantitative trait loci analysis, and residual biospecimens.

3:05 Case Study Co-Presentation: Gaining Scientific Insights through the Integration of Pharmacogenomics Analysis with Sample Management

Moderator: Anna O'Nan, Business Unit Controller/CFO, BioStorage Technologies

Peter Shaw, Ph.D., Head, Clinical Pharmacogenomics, Merck & Co.

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Co-Managing Director, BioProcessing Solutions Alliance

The growth in pharmacogenomics (PGx) and biomarker research is continuing at a rapid pace within the biopharmaceutical industry due to the demand for and advancement in personalized medical therapies. Now more than ever, there is a need by R&D companies for a more integrated approach to translational research and the management of biological research samples to deliver cost efficiencies which enable them to reinvest in future research endeavors. In addition, faster research decisions are an outcome of more integrated sample lifecycle management processes. Join us to learn about an integrated approach to PGx analysis and sample management which is enabling biopharmaceutical researchers to optimize sample quality and integrity in order to advance medical research decisions. This case study will discuss:

• Scientific drivers for PGx research
• Historic PGx examples that inform on the need to develop an integrated approach to deliver data for decision making
• Best practices developed through the integration of PGx and sample lifecycle management
• Strategies for integrating genomic, biomarker, informed consent, biological sample and clinical data to enhance research sample asset optimization

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:15 The Million Veteran Program: A Mega-Cohort for Precision Medicine

Sumitra Muralidhar, Ph.D., Program Director, Million Veteran Program, Office of Research & Development, Veterans Health Administration, U.S. Department of Veterans Affairs

The Million Veteran Program (MVP) is the Department of Veterans Affairs’ partnership with veterans to establish one of the world’s largest databases of genomic, clinical, lifestyle and military exposure information. Participants provide a blood sample for future, unspecified research, complete health and health-related questionnaires, provide access to their electronic health records, and agree to future contact. With the goal of enrolling one million participants, the program already has over 472,000 enrollees to date. Blood samples are processed immediately upon receipt, and DNA is sent out for characterization on a customized Affymetrix Axiom Array chip. Remaining DNA, buffy coat and plasma are stored for future use. Over 400,000 samples have been genotyped, and smaller subsets have undergone exome or genome sequencing. All data are stored in a central, secure repository and approved researchers access the data and conduct their analysis in a central, secure computing environment. A small number of alpha and beta scientific projects are currently underway. An overview of the infrastructure, data access policy and scientific projects will be presented.

4:45 Case Study Co-Presentation: BIOspecimen STOrage and REquest: How BIOSTORE & Biorepository at BMS Empowers Scientists to Exploit Our Sample Assets for Research

Karl Kammerhoff, MBA, Senior Operations Analyst, BMS Biorepository, Clinical Translational Technologies & Operations, Exploratory Clinical & Translational Research, Bristol-Myers Squibb

Christopher Nalbone, Business Capability Manager, Clinical & Translational R&D IT, Bristol-Myers Squibb

Erin Daniels, MSc, Research Scientist, Clinical Pharmacogenomics, Bristol-Myers Squibb

BIOSTORE replaced a 16-year system that performed inventory management without sample visibility. It manages samples regardless of physical location, using workflows to authorize use and facilitate tracking, and an intuitive searching mechanism to identify samples of interest. The BMS Biorepository leverages BIOSTORE to provide full chain of custody, consent tracking, additional research samples, and sample preparation services for nearly a million samples.

5:30 Close of Conference

Pre-Conference | Day 1 | Day 2 | Day 3 | Speaker Biographies