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The Business of BioBanking - Day 1


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Key Features

  • PRESENTATIONS
    Gain insight from biobanking managers and biopreservation scientists and delve into the molecular advances in biomedical science.
  • PANEL DISCUSSIONS
    Determine best practices in biopreservation protocols.
  • CASE STUDIES
    Analyze ongoing biobanking partnerships.
  • NETWORKING OPPORTUNITIES
    Join discussion groups and dedicated exhibit hall and poster viewing hours.
  • SHORT COURSES
    Attend interactive courses designed as a great introduction for those who are new to a particular discipline or as a refresher for those who want to brush up on their knowledge or expand their horizons.

Today, biospecimen collections are used by multiple research groups for varying research aims from basic research through clinical trials. A well managed biobank is a critical prerequisite for high-quality biological research. Proper collection, processing, storage, and tracking of biospecimens are critical components allowing researchers to better link molecular and clinical information. Thus, by necessity, biobanking is both a science and a business. Cambridge Healthtech Institute’s Third International Leaders in Biobanking Congress addresses both the business and science angles of biobanking, bringing together biomedical and biopharmaceutical researchers, regulators, biorepository managers, and practitioners to investigate the best tactics for effective use of biospecimens within today’s cutting edge research.

Sunday, November 6 Pre-Conference Events

1:00 pm Pre-Conference Short Course Registration

Short Course One*

1:30 - 3:30 pm
Information Management: Conquering the Complexity of Biobanking

Biobanks provide the resource for researchers to increase our understanding of complex disease. Biosample resources come together through a complex chain of cooperation across collection, preservation, storage, retrieval, and research. The value of these biosamples lies not only in the samples themselves but with the metadata associated with each specimen. Information Management (IM) helps simplify data from inventory management to database integration through to data analysis. Learn from biobank managers and IT professionals as they share their experience of conquering the complexity of biobanking.

Designing the IM system to meet and adjust to growth:

  • Inventory management
  • Data capture and data tracking
  • Quality control
  • Chain-of-custody
  • Integration of instrumentation and automation systems
  • Improving operations
  • Data sharing
  • Data mining

Instructors:

Pedro Rondot Radío, Executive Director, Public National Oncologic Serum Biobank, University of Buenos Aires

Rao Mulpuri, Director, Center for Translational Research, CIRI, Catholic Health Initiatives

 

*Separate registration required.  

Short Course Two*

3:30 - 5:30 pm
Lab Automation: Hands-On through Hands-Off Biobanking

How Do You Invest in the Future?

A well managed biobank is an investment that pays dividends. Biobanks create repositories of biological specimens for further biomolecular investigations. The sample types collected, preserved, stored, and distributed can be extremely diverse. Thus, laboratory automation is a critical component for handling ever increasing demands.

Where does it make fiscal and scientific sense to automate the process?

  • Laboratory design
  • Workflow implementation
  • Maintaining compliance
  • Developing SOPs
  • Quality control
  • ROI

Learn from the experiences of managers, technicians, and equipment providers as they share their experience of hands-on through hands-off biobanking.

Short course will include an on-site tour and hands-on laboratory experience at the Rutgers University Cell and DNA Repository.

Instructors to be Announced.

 

*Separate registration required. 

5:30 Main Conference Registration

6:00 Opening Reception

Join your peers and colleagues for an evening of networking at Rutgers University Cell and DNA Repository.
Enjoy a tour of the facility and complimentary cocktails and hors d’oeuvres.
Roundtrip shuttle service will be provided for all conference delegates.

7:30 Close of Day

Monday, November 7

7:30 am Conference Registration and Morning Coffee

Plenary Session – It Takes a Village

(Combined Session)

8:15 Chairperson’s Opening Remarks

8:30 Tissue Banking, Specimen Evaluation, and Scientific Advancement: The Pathologist’s Point of View

Sandra A. McDonald, M.D., Associate Director, Laboratory for Translational Pathology, Washington University School of Medicine

Pathologists play key roles in the operation of research tissue banks, whether academic or industrial. Recognition of these roles by the user community is crucial to the full utilization of the resource. Besides interpreting studies that are performed on banked samples, pathologists conduct quality assurance programs, assist with resource allocations, educate investigators who use the tissue resource, and evaluate tissue samples for their potential utility in research. Interaction and communication initiatives are critical to the success of these roles.

9:05 Stem Cell Banking: The Perspective of an iPS Donor Family

Chris Hempel, Founder, Addi and Cassi Fund

9:40 A Trial Lawyer’s Perspective on Biobank and Medical Research Litigation

Daniel D. Harshman, Lawyer, Cozen O’Connor

The rising tide of biotechnology has resulted in an increasing number of lawsuits concerning medical research, clinical trials or experimental medical treatments. When lawsuits involve cutting-edge, scientific methods or experiments, courts struggle to apply statutes and traditional legal principles to these disputes. This presentation offers a trial lawyer’s perspective of how researchers or biobanks may become involved in lawsuits, how judges or juries decide complicated issues and suggestions to help you understand, avoid or prepare for such lawsuits.

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

11:00 Commercial Biobanking in an Academic Setting: Exploring the Scientific and Fiscal Boundaries of Biosample Resources

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

11:35 Challenges in Sampling and Storage of DNA: A Pharmacogenetics Perspective

Terrye DelMonte, Senior Research Scientist II, Bristol Myers Squibb

Generating laboratory data is typically considered a straightforward part of most clinical trials; however, getting patients to submit samples for genetic testing is another issue. In today’s world, there are numerous concerns over privacy and long term storage of DNA samples which can lead to low patient enrollment. The purpose of this presentation will be to discuss topics specifically relating to pharmacogenetic sampling: acquiring adequate patient enrollment, concerns of long term storage of DNA, unique challenges which Pharma companies face versus academic institutions and country specific sampling issues.

12:10 pm Close of Session

12:15 Luncheon Presentation (Sponsorship Opportunity Available) 

The BUSINESS of Biobanking

IT: Infrastructure

2:00 Chairperson’s Remarks

2:05 Proposed Virtual BioRepository Platform for Distributed Research Networks

Alexander Sherman, Director, System, Institute for NeuroTherapeutic Investigational Trials, Massachusetts General Hospital

Research network of 90+ academic institutions has multiple member BioBanks. A Web-based platform was designed and built for managing distributed biological samples. This is a unique approach in managing multiple biobanks at multiple locations while knowing the inventory across the research network and being able to search for samples based on the data from heterogeneous data sources such as clinical trials, biomarker studies and patients records. This is the first virtual network to “cover” a major neurological disease, Amyotrophic Lateral Sclerosis (Lou Gehrig’s Disease), and may serve as a model for academic and industry collaboration in biomarkers discovery and validation.

2:35 Streamlining the Scientific Review

Elizabeth Wagner, Scientific Program Coordinator, Transfusion Medicine & Cellular Therapeutics, NIH NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) is the custodian of multiple historical and contemporary biospecimen collections from NHLBI funded research and clinical studies. All biospecimen requests are reviewed for the significance and appropriateness of the proposed research, study design, the qualifications of the investigators to do the research, the availability of research funding, the availability of biospecimens, and the ethical and legal considerations. The BioLINCC IT infrastructure that was developed to streamline the scientific review of biospecimen requests will be presented.

3:05 Pan-Institutional Biospecimen Collection: Developing a Central Biospecimen Research Infrastructure

Christopher J. Ianelli, M.D., Ph.D., CEO, iSpecimen Inc.

Across the life science industry, there is a need for a central biospecimen research infrastructure. This presentation lays out the basis for this need along with the elements necessary to consider in building it. The focus of the talk will be on iSpecimen’s plans and progress in developing such an infrastructure that serves the needs of industry, academia, and government research programs.

3:35 Sponsored Presentation (Opportunity Available)

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

IT: Informatics Tools

4:30 Development and Applications of Informatics Tools to Enhance Biobanking and Translational Research

Anil V. Parwani, M.D., Ph.D., Division Director, Pathology Informatics, Staff Pathologist, Shadyside Hospital, University of Pittsburgh Medical Center Biomarkers

Successful biobanking requires not only the collection and timely delivery of high quality biospecimens for researchers but also simultaneous annotation and de identification of these biospecimens which can be easily accessible to the research community. The focus of this talk will be on the development and use of disease specific databases and new and emerging technologies such as digital imaging to enhance biobanking to support translational research.

5:00 Talk Title to be Announced

Iman Osman, M.D., Associate Director, Cancer Institute Director, Interdisciplinary Melanoma Program; Associate Professor, Dermatology, Oncology and Urology, New York University School of Medicine

The SCIENCE of Biobanking

Workflows/Automation

2:00 Chairperson’s Remarks

2:05 Biobanking: The Past, Present and the Future

Stella Somiari, Ph.D., Senior Director, Windber Research Institute; Director, Windber Research Institute Tissue Bank

There are now well established and emerging institutional core biobanks and commercial biobanks that are changing the way biospecimens are acquired, stored and distributed. Unfortunately, it remains a challenge to obtain enough good quality, well annotated and certain types of biospecimens on demand, and within budget, an indication that demand exceeds supply or the current biobanking workflow process does not satisfy the needs of all researchers. To be well positioned to meet the anticipated increase in demand and future needs of researchers, biospecimen banks will have to re-examine the way biospecimens are collected, stored and distributed.

2:35 Real Time Temperature Monitoring and Alarm System to Improve Quality Management of Biobanks

Halla Hauksdottir, Biomedical Scientist, Safety and Quality Manager, Clinical Biobanks, Diagnostic Medicine, Landspitali, University Hospital

An important feature in good biobanking practices is to monitor and log conditions of sample storing devices. Continuous temperature monitoring of biobanking freezers has been implemented using Vista Data Vision (VDV) applications in the Division of Diagnostic Medicine at Landspitali University Hospital in Reykjavik. The automatic data logging into a database and the alarm service through automated e-mail and/or text to selected staff members is most important for quality management of our Biobank, and furthermore, the easy web access to all trend lines and data and the alarm handling is of great value for monitoring freezer quality. This talk will focus on the implementation of the monitoring network and the effects of this monitoring on the overall quality management in the biobank.

3:05 Speaker to be Announced

3:35 Sponsored Presentation (Opportunity Available)

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

Biomarkers

4:30 Early Detection Biomarkers for Ovarian Cancer

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, The John Theurer Cancer Center, Hackensack University Medical Center

The mortality from ovarian cancer in the United States is greater than all gynecologic cancers combined due to late detection and complex nature of the disease. Current situation necessitates urgent need of robust biomarkers with high sensitivity and specificity for early detection of ovarian cancer for the purpose of routine screening. With combination of bioinformatics-guided approach, biobank samples and sequential screening against a library ovarian cancer cell lines and cancer patient samples, we have identified early detection biomarkers for stage I/II of ovarian cancer at the level of tissue and peripheral blood.

5:00 Exome Sequencing Reveals Comprehensive Genomic Alterations across Eight Cancer Cell Lines

Nathan Siemers, Director, R&D, Bristol Myers Squibb (invited)

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

6:30 Close of Day

Tuesday, November 8

7:30 am Breakfast Presentation (Sponsorship Opportunity Available)

8:15 Biobanking Brainstorming Breakout Discussion Groups

Grab a cup of coffee and join a table discussion. These focused groups are designed for conference participants to discuss important and interesting topics related to biospecimens from procurement, preservation, biomolecular extraction, and biomarkers. These are moderated discussions with brainstorming and interactive problem solving, allowing conference attendees from diverse areas to exchange ideas, experiences, and develop future collaborations around a focused discussion topic.

The BUSINESS of Biobanking

Consent

9:15 Chairperson’s Remarks

9:20 A Trade Secret Approach to Informed Consent for Genetic Biobanking

John M. Conley, Professor, University of North Carolina School of Law; Lawyer, Robinson, Bradshaw & Hinson

The current informed consent process faces criticism from every side. Genetic researchers claim that it is too cumbersome to provide efficient access to the vast amounts of data their work requires, ethicists and patient advocates worry that participants are misled by promises of confidentiality and anonymity that may be impossible to fulfill, and institutions sometimes find themselves caught in the middle of ill-defined notions of ownership and custodial obligation. Based on a recent study of biobank participants’ own understandings of their DNA and its use in research, this presentation argues that trade secret licensing law offers a model for biobanking that can respect participants’ autonomy, meet researchers’ needs, and clarify many of the legal ambiguities that have ended up in court.

9:50 Speaker to be Announced

10:20 Sponsored Presentation (Opportunity Available)

10:35 Networking Coffee Break in the Exhibit Hall with Poster Viewing

Population and Specialized Biobanks

11:15 The UF DBS-Brain Tissue Network

Vinata Vedam-Mai, Ph.D., Researcher, Neurosurgery, McKnight Brain Institute, University of Florida

The University of Florida Brain Tissue Network for DBS tissue was created with the idea to make available to researchers well collected, and catalogued samples for a variety of research purposes. We are striving to improve sample collection to include complete clinical data and include frozen tissue samples for molecular research purposes.

11:45 The Rewards and Perils of Biobanking in the Stem Cell Era: A Brave New World

Michael Sheldon, Ph.D., Research Assistant Professor & Assistant Managing Director, RUDCR, Rutgers

The emergence of stem cell technologies, in particular methods to “reprogram” differentiated adult cells to a pluripotent state, has opened up important new vistas for basic as well as translational research. The biobanking community will play a central role in both of these, facilitating the widest possible dissemination of resources to researchers and the assurance of sample quality. This talk will focus on the key challenges of stem cell biobanking, including consent, tissue processing, reprogramming source cells to stem cells, and all-important quality control. We will also consider the business opportunities presented, such as the types of services that are offered and the diversity of clients.

12:15 pm Luncheon Presentation (Sponsorship Opportunity Available)

The SCIENCE of Biobanking

Biopreservation

9:15 Chairperson’s Remarks

9:20 Systematic Development of Cryopreservation Strategies for Natural and Artificial Tissues

Athanassios Sambanis, Ph.D., Professor, Chemical & Biomolecular Engineering, Biomedical Engineering, Georgia Institute of Technology

Development of rigorous protocols for cryopreservation is critical, especially for three-dimensional tissues and ice-free cryopreservation (vitrification). We present guidelines on how one can measure important properties of the cells and tissues, including cryoprotectant (CPA) permeability through cell membranes, diffusivity through tissue matrix, and cytotoxicity towards cells. The development of protocols using these parameter values is then addressed. Examples discuss the application of conventional freezing and vitrification on natural and artificial tissues and their evaluation post-preservation in vitro and in vivo.

9:50 Best Practices vs. Local Practices in Biobanking: Quest for Asymptomatic Cryopreservation Outcomes

John G. Baust, UNESCO Professor & Director, Institute of Biomedical Technology, State University of New York, Binghamton University; Editor-in-Chief, Biopreservation & Biobanking

While numerous professional bodies have published comprehensive statements of biobank “Best Practices,” none have stringently addressed the critical issue of fit-for-purpose cryopreservation. Protocol variability and outcome uncertainty are the hallmarks of today’s generic cryopreservation methodologies. Critical questions remain unanswered: How do we approach the issue of standardization with the aim of creating preservation best (standard) practices guidelines? Should guidelines remain empirical and “locally” derived (specific to the operational environment) or evidence-based? This presentation will discuss this industry-wide dilemma.

10:20 Sponsored Presentation (Opportunity Available)

10:35 Networking Coffee Break in the Exhibit Hall with Poster Viewing

Enabling Technologies

11:15 Integrating Laser Capture Microdissection and Tissue Biorepository for Cancer Research

Angen Liu, M.D., Ph.D., Director, Tissue Biorepository, Hollings Cancer Center, Medical University of South Carolina

An important need of many cancer research projects is the availability of high-quality, appropriately selected tissue. Tissue biorepositories provide investigators with an invaluable resource of appropriately examined and characterized tissue specimens and linked patient information for further use in fundamental and translational cancer research. Laser capture microdissection (LCM) is a state-of-the-art technology that provides the scientific community with a rapid and reliable method to isolate a homogeneous population of cells from heterogeneous tissue specimens. The combination of LCM and a tissue biorepository offers a comprehensive means by which researchers can utilize valuable human biospecimens and cutting-edge technology to facilitate basic, translational, and clinical research.

11:45 Timeless Treasures: Preserving the Present and Future Value of Biological Samples

Joe Don Heath, Ph.D., Vice President Global Technical Services, NuGEN Technologies

Conversion of valuable RNA samples to cDNA assures their long term stability for future molecular profiling studies in drug discovery and clinical research. We will describe an efficient and flexible archiving solution requiring low nanogram amounts of total RNA that preserves and extends RNA samples for future genomic analysis on a variety of platforms and applications.

12:15 pm Luncheon Presentation (Sponsorship Opportunity Available)

Closing Plenary Session

1:30 Biopreservation Protocols Panel

All agree that biopreservation protocols can affect the biomarker (DNA, RNA, protein) of interest. However, there is no consensus. The Biopreservation Protocols Panel provides a forum to determine these effects and provide recommendations on the best protocols to preserve and store these precious biosamples. Join research scientists and managers of biobanks to start this critical dialogue.

2:30 Networking Refreshment Break, Last Chance for Exhibit and Poster Viewing

 

Case Study: Biobanker/Biouser Partnerships

This session brings together scientists who use biospecimens for research (“biousers”) with operation managers who collect, process, store, and distribute the biospecimens (“biobankers”). During a co-presentation, biobankers and biousers elaborate on the characteristics of their working partnership as they address the following issues:

  • How does the partnership work?
  • What are the bottlenecks?
  • What does each bring to the table?
  • What are the needs?
  • Ultimately, what are the scientific results?

(Sponsorship Opportunities Available)

3:00 Case Study Co-Presentation Sponsored by

Daniel Watch, AIA, NCARB, LEED AP, Global Market Sector Leader, Science + Technology, Perkins+Will

Mark Rahe, AIA, CDT, LEED AP, Associate Principal, Science + Technology, Perkins+Will

Our architects will discuss advances in the design of biobank facilities relative to advances in equipment automation. The presentation will explore in depth their latest biobank facilities in Saudi Arabia. We will examine how facility design can better support a variety of research opportunities.

3:45 Case Study Co-Presentation

4:30 Case Study Co-Presentation

5:15 Conference Wrap-Up

5:30 Close of Conference



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