The goal of personalized medicine has ushered in the transition from empirical medicine to molecular medicine. Thus during research, biobanks are key infrastructures for biomedical R&D because at one time or another, these biospecimens have been stored in a biobank. Well-annotated biospecimens and their associated clinical data accelerate translational and clinical research discoveries. However, high-throughput molecular sequencing and increased biosample variety have introduced significant informatics challenges for biobanking infrastructures. Meanwhile, the lack of high-quality biospecimens both stalls projects and limits research advances.

Cambridge Healthtech Institute’s Ninth International Leaders in Biobanking Congress 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, leading to the goal of personalized medicine.

Final Agenda

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Wednesday, October 25

8:00 am Short Course Registration

8:30 - 11:30 Pre-Conference Short Course*

SC1: From Donor to Discovery - Post-Mortem Sample Biobanking

* Separate registration required.

11:30 Bridging Luncheon for Short Course Participants

12:30 - 3:30 pm Pre-Conference Short Course*

SC2: Lean Six Sigma and the Biorepository - Synchronicity in the Simplest Form

* Separate registration required.

3:00 Conference Registration

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Thursday, October 26

7:00 am Registration and Morning Coffee

It Takes a Village

8:30 Organizer’s Welcome Remarks

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

8:35 Chairperson’s Opening Remarks

Mary Kay Washington, M.D., Ph.D., Professor, Pathology, Vanderbilt University Medical Center

8:45 KEYNOTE PRESENTATION: A Brief Introduction to the All of Us Research Program

Joshua C. Denny, M.D., MS, Professor, Biomedical Informatics & Medicine; Director, Vanderbilt Center for Precision Medicine; Vice President, Personalized Medicine, Vanderbilt University Medical Center

The Precision Medicine Initiative All of Us Research Program’s goal is to sustainably improve the health of individuals and populations. PMI will collect comprehensive data from a diverse cohort of more than 1 million individuals through the application of new precision medicine knowledge obtained from rigorous research studies. All data will be housed in a secure cloud with diverse tools to easily access the data.

9:30 The Pathologists’ Perspectives on Biobanking

Sarah M. Dry, M.D., Vice Chair, Biobanking and Research Services; Director, Anatomic and Surgical Pathology; Director, Center for Pathology Research Services; Director, Pathology Research Portal; Director, Translational Pathology Core Laboratory; Department of Pathology, UCLA David Geffen School of Medicine

In today’s -omic environment, biosample acquisition, storage and testing are critical for inclusion in clinical trials, selection of optimal therapies and proper diagnosis. High-quality biobanking operations are essential to accurate testing. This talk summarizes developments in biobank quality standards and accreditation, reviews continuing challenges faced by pathologists in their role as caretakers of biosamples, discusses inclusion of donor/patient perspectives into biobanking practice and considers some emerging developments.

10:00 Ensuring Sample Integrity through Genetic Fingerprinting & Quality Screening

Robin Everts, Ph.D., Staff Scientist, Scientific Affairs, Agena Bioscience

It is estimated that 1 in 200 specimens is misidentified. Many mistakes occur outside a facility's chain of custody and traditional checks will not detect them. Downstream, DNA quality can cause even pre-qualified samples to fail analysis. Learn techniques to prevent incorrect results and avoid wasting time and money.

10:15 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Management of Specimens Collected in Complex Biomarker-Driven Clinical Trials: Integration of Patient, Molecular, and Specimen Information to Drive Precision Medicine

Michael Tanen, Director, Clinical Biomarker Specimen Management, Translational Medicine, Merck Research Laboratories

Recent advances in translational and personalized medicine initiatives have led to a marked increase in biomarker-driven research objectives within clinical trials. These advances will require innovative mechanisms and best practices to manage collected biomarker specimens. Improved capabilities are necessary to develop integrated data sources that will inform the selection and use of clinical specimens based on clinical and scientific insight relevant to human disease.

11:30 The Role of Biobanks in Moving Precision Medicine Forward

Nazneen Aziz, Ph.D., Executive Director, Kaiser Permanente Research Bank

Kaiser Permanente Research Bank (KPRB) is the second largest biobank in the U.S. with goals of enrolling 500,000 participants representing membership in all seven Kaiser Permanente regions. KPRB is one of the largest and most diverse repositories of biospecimens, genetic, EMR and health survey data. The KPRB was created to impact the healthcare of KP members and is using precision medicine approaches to accomplish that goal.

12:00 pm How Biobanking Changed My Bereavement

Sarah Gray, Director, Communications, American Association of Tissue Banks; Author, A Life Everlasting: The Extraordinary Story of One Boy’s Gift to Medical Science

Gray shares the now world-famous story of how she anonymously donated her infant son’s post-mortem tissue for research, then years later, tracked down each donation to learn about the impact. She discusses her surprising findings and shares her unique perspective on biobanking and biospecimen donation.

12:30 Book Signing with Sarah Gray

A Life Everlasting: The Extraordinary Story of One Boy’s Gift to Medical Science

*Book will be available for purchase onsite

1:00 Enjoy Lunch on Your Own

Biospecimen Science

2:15 Chairperson’s Remarks

Mary Kay Washington, M.D., Ph.D., Professor, Pathology, Vanderbilt University Medical Center

2:20 FEATURED PRESENTATION: Factors Affecting the Use of Human Tissues in Research: What the Literature Should Tell Biorepositories

William E. Grizzle, M.D., Ph.D., Professor, Pathology, University of Alabama at Birmingham

This presentation discusses why specimens from biorepositories may not meet the needs of investigators and may fail to produce reproducible results. Topics include patient variables, bias, fixation and tissue processing, storage, quality control, and warm and cold ischemia. How biorepositories can optimally meet investigator needs is a major theme.

2:50 Next-Level Biobanking: Increasing Medical Value with New Tools for Tissue Preservation

Abbey Theiss, MS, Senior Scientist, tRED Research and Early Development, Ventana Medical Systems, Inc.

Cancer diagnostics is rapidly moving to advanced assays to determine drivers of disease. Current non-standardized pre-analytic techniques are inadequate to keep up with the demands of advanced assays. We have investigated formalin chemistry to standardize tissue collection, allowing rapid preservation of an increased number and class of biomarkers. This enables biobanks to create elite tissue sets based on molecular integrity, medical value and verified collection parameters.

3:20 Selected Poster Presentation: Quality Evaluation for Biobanking Human Granulosa Cells

Sahar Jahangiri, MSc, Biobank Manager, CReATe Program, Inc.

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

4:00 Conditional Reprogramming (CR): Bringing Biobanks to Life

Xuefeng Liu, M.D., Associate Professor, Pathology, Georgetown University

To date, it has not been possible to expand and indefinitely propagate cells derived from adult tissues while retaining lineage-commitment, normal growth control and differentiation potential. Indeed, many primary cells (e.g., prostate, liver, lung and pancreas) are incapable of being passaged for significant periods in vitro. We now describe conditional reprogramming (CR) that rapidly expands both normal and malignant epithelial cells from diverse anatomic sites and mammalian species and does not require transfection with exogenous viral or cellular genes. Establishment of cell cultures from both normal and tumor tissue is highly efficient. Perhaps most important, cell cultures can be generated readily from core biopsies as well as frozen tissue. The robust nature of the technique is exemplified by the ability to produce 2 x 106 cells in 5 days from a core biopsy of rat breast tumor. Normal breast and prostate cultures retain a normal karyotype and differentiation potential and cell lines derived from tumors retain their tumorigenic phenotype. The ability to produce inexhaustible cell populations from small biopsies and frozen tissue has the potential to transform biobanking repositories by enabling genetic, biochemical, metabolomic, proteomic, and biological assays, including chemosensitivity testing.

4:30 Steps of Research and Development - “Live Biobank”

Zdenka Prodanovic, Biobank Manager, Pathology, Monash Health

We discuss managing a biobank to facilitate translational research in pioneering efforts toward precision medicine by establishing a “live biobank”. We share latest diagnostic molecular developments and the ongoing impact on patient treatments, which call for a “live biobank” setup. Organoid cultures could hold an answer. A “live biobank” may prove to be, among other uses, one of the most important research tools in cancer/other diseases. How far its impact may reach is yet to be seen.

5:00 The Importance of Centralized and Harmonized Biobanking to Support Precision Medicine Initiatives

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

This presentation describes how to standardize biobanking efforts in a manner commensurate with both academic and industrial partnerships. Data will be presented on the governance of biosample collections, standardization efforts, and quality control harmonization for biosamples and global best practices for the regulatory oversight of national biobank resources.

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

6:45 Close of Day

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Friday, October 27

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.

Issues Around Return of Individual Research Results

Moderator: Helena Ellis, Founder and Managing Director, Biobanking Without Borders, LLC

• Objective vs. subjective issues regarding returning individual biomarker results to participants: clinical validity, clinical utility, and actionability
• Return of Results vs. Return of Value - What does it mean and what do participants really want?
• What are the ethical and legal issues for the institution, the participant and their families?
• Share your institution’s approach and success stories

How to Leverage Support from Patient Groups in IRB/EC’s Review of Exploratory/Future Research

Moderator: Feng Hong, Ph.D., Associate Director, Clinical Biospecimen Management, BioMarin Pharmaceutical, Inc.

• Review of sponsor ICF by patient advocacy group prior to submission to IRB/EC
• Review of early trial results or proposed protocol endpoints by patient advocacy group to help design better trials
• Potential attendance of IRB/EC review meeting by member of patient advocacy group

How Does Virtual Biobanking Facilitate Implementation of Best-in-Class Sample Lifecycle Management?

Moderator: Jun Luo, Director of Projects Management, Brooks Life Science Systems

• Employing virtual network of sample assets in labs across global regions to proactively manage samples and affiliated data
• Improving data collection and reconciliation efficiency from different sources
• Timely and faster resolution of day-to-day operational challenges

Can Biobanks Keep Up with New Demands?

Moderator: Zdenka Prodanovic, Biobank Manager, Pathology, Monash Health

• Biobanks of the past – longitudinal collection, minimal processing; improving validation processes. Was this a feasible model?
• Biobank engagement in research – provision of samples – mainly blood, tissue, bone marrow, but occasional pleural fluid, ascites, CSF
• Are all these collections part of your standard collections? If not, what process do you have in place in adopting new sample collections and how do you approach developing SOPs for the new collections?
• Would you say a researcher provides more detail to their request for samples – asking specifically for samples narrowing their specifications? If so, why would you say yes? If no, why would you say no?
• How is translational research affecting your biobank workflow?
• Which new activities (if any) have you had to introduce following these requests?
• Is your biobank at forte in molecular biology or not? If not, what do you think you need to do to make it a viable and worthwhile process for your biobank?
• Live biobank – can we do it within current resources? If yes, how would you set it up? What does it take to have “live” biobank? And how long do you estimate your “live” biobank is going to last in terms of storage? Is there an adequate option available now?

Will There Ever Be an Academic Biorepository That Is Sustainable?

Moderator: Kerry R. Wiles, Program Director, Cooperative Human Tissue Network and Vanderbilt University Medical Center Tissue Repository, Vanderbilt University

• What really is sustainability and what does it mean to the biobank directors and institutions?
• Is there a "degree" of sustainability that can ever be achieved and what type of institutional support would there need to be?
• How does the academic biobank organize work in order to progress towards achieving sustainability?

8:45 Close of Discussion Groups

Applying Biospecimens for Translational Research

9:00 Chairperson’s Remarks

James R. Goldenring, M.D., Ph.D., AGAF, Paul W. Sanger Professor of Surgery, Professor of Cell and Developmental Biology, Vice Chairman for Research, Surgical Sciences, Vanderbilt University School of Medicine

9:05 The Fibrotic Microenvironment in Pancreatic Cancer and Chronic Pancreatitis

Anna L. Means, Ph.D., Associate Professor, Department of Surgery, Vanderbilt University Medical Center

Pancreatic cancer and chronic pancreatitis involve large fibrotic responses with variable functions in benign and malignant disease. Using biobanked tissues, we have identified similar and unique fibrotic elements occurring in pancreatic cancer and in benign disease. We are using freshly acquired tissue to identify regulatory pathways specific to the pro-tumor functions of the microenvironment that don’t weaken constraints on tumor dissemination.

9:35 Biobank Supporting Translational Research for Rare Disease: The BioMarin Model

Feng Hong, Ph.D., Associate Director, Clinical Biospecimen Management, BioMarin Pharmaceutical, Inc.

We discuss rare disease, where unmet medical need drives expedited drug development and more extensive post-marketing assessments; smaller sample size; dearth of commercial samples; and the need to support post-marketing assessments, which lead to more scrutiny on the strategy of translational science research.

10:05 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Precision Pathology: Banking on Theranostics and Beyond

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

The talk will explain the concept of Precision Pathology and describe the new Center created at Memorial Sloan Kettering Cancer Center. Pathology plays a central and decisive role in design and execution of specimen-centered precision clinical trials, drug development, and theranostic innovation.

12:00 pm Session Break

12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:30 Dessert Break in the Exhibit Hall

Biospecimens Lead to Precise Medicine

2:00 Chairperson’s Remarks

James R. Goldenring, M.D., Ph.D., AGAF, Paul W. Sanger Professor of Surgery, Professor of Cell and Developmental Biology, Vice Chairman for Research, Surgical Sciences, Vanderbilt University School of Medicine

2:05 Use of Biospecimens in Clinical Research

Mary E. Edgerton, M.D., Ph.D., Associate Professor, Department of Pathology, University of Texas MD Anderson Cancer Center

When does clinical research involve a clinically actionable test on a biospecimen that is not a part of the clinical specimen archive? What does that mean for patient safety? How important is it for that specimen to be CLIA (Clinical Laboratory Improvements Amendment of 1988)-compliant? What steps should be taken to make a biorepository CLIA compliant? What are the pro’s and con’s of taking this approach to ensure patient safety in the use of biospecimens in clinical research? Is it always necessary? These questions will be introduced and the process for establishing a CLIA-compliant biospecimen repository will be described using the MD Anderson Institutional Tissue Bank as an example.

2:35 Enabling Systems Toxicology Assessment Studies with State-of-the-Art Biospecimen Management Systems

Sam Ansari, Ph.D., Manager, Biospecimen & LIMS, Biomedical Research, Philip Morris International R&D

Systems Toxicology is an emerging assessment approach based on a variety of high-throughput molecular measurements. These experiments often involve large sample sizes, require rich sample annotations, and cause many sample events leading to complex sample relationships. Sophisticated sample management is key to a successful experimental outcome. In a case study, we demonstrate the full lifecycle of study samples and present our technical solutions.

3:50 Co-Presentation: Vanderbilt University

Biobanker Experience: The Academic Biorepository’s Responsibility: The Ultimate Agile Resource

Mary Kay Washington, M.D., Ph.D., Professor, Pathology, Vanderbilt University Medical Center

Kerry R. Wiles, Program Director, Cooperative Human Tissue Network and Vanderbilt University Medical Center Tissue Repository, Vanderbilt University

Biouser Experience: Investing at the Biobank Will Yield Dividends: Understanding Mechanisms of Patient Response to Immunotherapy

Katy Beckermann, M.D., Ph.D., Chief Academic Fellow, Division of Hematology/Oncology, Vanderbilt University Medical Center, Vanderbilt University

The academic biorepository can be compared to a house built on shifting sands for those responsible for managing the resource. The repository managers often wear multiple hats and must be able to manage the budgets and act as business architects, process improvement managers, staff engagement and retention managers, and find ways to improve customer service and keep the resource fully staffed and operational. It requires the participation of customers, communicating current needs and scope changes of their research projects quickly and the biorepository staff to work towards streamlining processes and being agile enough to implement the changes quickly, so that there is minimal-to-no impact on the customer project. Part of the biorepositories responsibility is to work through project scope and assist with IRB submissions, which may prevent difficulties that may adversely affect the project.

4:35 Conference Wrap-Up

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

Kerry R. Wiles, Program Director, Cooperative Human Tissue Network and Vanderbilt University Medical Center Tissue Repository, Vanderbilt University

4:45 Close of Conference

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