Conference on Biobanking Americas

Conference on Biobanking Americas ( Conference and Workshop Only )
The future for next generation drug discovery and personalised medicines
To be held at 9th - 11th November 2010, Boston, USA

Key Speakers
• Dr. Marc Allard, Research Microbiologist, Center for Food Safety and Applied Nutrition, FDA
• Dr. Adel Laoui, Director, Healthcare Technologies Aging Therapeutic Strategic Unit, Sanofi-aventis
• Brenda Yanak, West Point IT Site Head and Account Manager, Franchise Biology, siRNA, Imaging, and GeM, Merck
• Jeff Milton, Bioinformatics & Computational Biology, Genentech
• Dr. John G. Baust, UNESCO Chair & Professor, Director, Institute of Biomedical Technology, State University of New York
• Elaine W. Gunter, Founder and President, Specimen Solutions, LLC, National Cancer Institute
• Dr. Hartmut Juhl, CEO, Indivumed
• James Eliason, Director, Stem Cell Commercialization Center
• Dr. Michael Hehenberger, Business Development Executive, Life Sciences, IBM Thomas J. Watson Research Center
• Kristen Rosati, Partner, Coppersmith Schermer & Brockelman
• Dr. Richard J. Maguire, Director of Business Development – LIMS, Ocimum

An estimated $1bn has been invested in the biobanking industry within the last ten years. At least 179 biobanks with 345,000 donors exist in the US, most of which were established in the last 10 years. (Source: Business Insights, March 2009)

TIME Magazine highlighted biobanking as one of "10 Ideas Changing the World Right Now." Biobanking is rapidly growing and thriving to change approaches to target-finding, drug development and patient treatment. It is being viewed as a key driver for next generation biomarker and drug discovery.

The substantial advancement of research on the human genome has led to the creation of biobanks, which has brought a paradigm shift in drug testing and development. Recognizing the potential benefits from biobanks, pharma and biotech across the world are investing in infrastructure and biobank development.

Reasons to register today:
• Learn how to develop the best practices to leverage biospecimen resources
• Analyse major challenges for biorepository management and implementation
• Get the latest updates on the applications on genome sequencing
• Investigate the future of biobanks, regulation, ethics, investment and the humanization of drug discovery in the Americas
• Determine how to implement virtual biorepository
• Understand the importance of quality management in biobanking
• Gain an insight into the bioprospecting of tissues, DNA, protein or genetic information
• Enable confident decision making by benchmarking yourself against other leaders in the field

Who should attend?

VPs, Directors, Heads, Managers of:
• Biobank
• Tissue bank
• Biorepository/BioSample
• Molecular Diagnostics
• Clinical Genetics, Pathology
• Genomics
• Privacy/Protection/Security
• Scientific and Quality
• Laboratory and Inventory
• R&D
• Quality Control
• Strategic Outsourcing
• Clinical Research
• Translational Medicine
• Personalized Medicine
• Bioanalytical Chemistry
• Pharmacogenomics
• Proteomics
• Business development
• Strategic alliances

Others:
Consultants& Academics
Regulatory bodies
Researchers
Biorepository Vendors
Government Officials

Workshop
Pre-conference Workshop, Tuesday 9th November 2010

The role of best and evidence based practice in promoting quality sample and data collection to support biomarker research and development

Led by: Lisa B Miranda, Vice President, Strategic Alliances and International Biobank Relations, Trans-Hit Biomarkers

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks

About the workshop:

Many consider biobanks to be the crucial cornerstone of biomedical research through their provision of expertise and procurement of high quality samples and well annotated data to foster research. One’s ability to develop high utility, impactful, yet quality biobanking collections lies in the biospecimen resource’s success in implementing current best practice as well as the foresight to incorporate evidence based practice into daily operations. The role of the biobanker is now expanding to include proactive pipeline planning which incorporates these considerations to ensure successful “proof of concept” in translational research efforts such as biomarker research and development.

This interactive workshop will include discussion of:
• An overview of related best and evidence based practice issues
• The role and current implications of best and evidence based practice in the biobanking workspace that relate to pipeline planning
• Strategies for how to navigate the R&D pathway and build a biomarker discovery pipeline for your biobank that integrates evidence based practice

About your workshop leader

With over 20 years of experience, Ms. Miranda has a vast range of expertise in all aspects of Biospecimen Resource Research Management and Development. After 14 years in research at the University of Pennsylvania, Ms. Miranda attained international prominence as Technical Director of the Tumor Tissue and Biospecimen Bank (TTAB) Core Facility. She served as the prime architect of the centralized biospecimen resource and led TTAB’s collaborative efforts in development of the NCI’s CaTissue Suite inventory management system and a National Mesothelioma Virtual Bank with the University of Pittsburgh and the CDC. In 2006, she was recognized for her development of a Sustainable Cost Recovery Model which was acknowledged as the gold standard by the United States National Cancer Institute’s Office of Biorepositories and Biospecimen Research (NCI OBBR). Since then she has continued to establish and develop best practices for the biobanking community through her role as a NIH Contractor and Consultant for NCI OBBR and the Biospecimen Research for Molecular Medicine Offices, as well as current work on cost recovery for the ISBER Best Practices (2010 version).

In addition to collaborating on development of the Ca Hub, which is aimed at developing a common biorepository infrastructure that promotes resource sharing and team science, in order to facilitate multi-institutional, high throughput genomic and proteomic studies, Ms. Miranda recently authored a new chapter for the NCI Best Practices focusing on Technical Considerations for Management and Operations of Biospecimen Resources. In her role as member of the Ca Hub Acquisition of Normal Tissues Working Group, she collaborated with her ANTWG colleagues on development of an additional best practice document focusing on procurement of post mortem tissues. In 2008, she expanded her consultancy with the incorporation of Biobusiness Consulting Inc., which serves the global biobanking research communities in government, academia, pharmaceuticals, biotech and related industry.

Ms. Miranda is also active in numerous professional societies and committees and has gained recognition as an international speaker and an expert in Biobanking. Her current roles include: Councilor on the ISBER Board of Directors, membership in the global “think tank” known as the “Marble Arch International Working Group on Biobanking for Biomedical Research”, as well as P3G Society (Public Population Project in Genomics), LRIG and the NIH Biospecimens Special Interest Group.

Day 1
Biobanking Americas
Wednesday 10th November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 NCI's Cancer Human Biobank (caHUB): Raising the level of excellence for research biorepositories
• The vision for caHUB
• Planning process for caHUB
• caHUB as a national reference repository
• Challenges in bioethics and IP
• White papers available on caHUB operations

Elaine W. Gunter
Founder and President
Specimen Solutions, LLC, National Cancer Institute

10:20 The institutional virtual biobank
• Discuss strategies, tools and techniques used for institutional federation and curation of large volumes of disparate data, and present a case-study for a workflow from repositories to data analysis
• Developing a cost-effective workflow to permit computational analysis will become essential to scientific investigations
• High-throughput experimental techniques threaten to dump mountains of new data onto bioinformatics teams already struggling with the diversity, complexity and enormity of existing resources

Jeff Milton
Bioinformatics & Computational Biology
Genentech

11:00 Morning refreshments

11:20 The importance of an Honest Broker function for clinical data associated with biospecimens
• What is an Honest Broker in biobanking?
• Why is it needed for research?
• What types of research does it support?
• How does it work?

James Eliason
Director
Stem Cell Commercialisation Center

12:00 Biobanking in the post-genomic era: methodological challenges

Dr. John G. Baust
UNESCO Chair & Professor, Director
Institute of Biomedical Technology, State University of New York

12:40 Networking lunch

13:40 Science guided biobanking: A prerequisite for the development of individualized cancer therapies
• Tissues are under tremendous biological stress when surgically separated from the body and, subsequently, significantly change gene and protein expression profile and, possibly, also growth regulating factors that might serve as targets or stratification markers for new drugs.
• Several factors have been identified that affect tissue research data, including:
- drug treatment and anesthesia of patients before surgical tissue removal
- intrasurgical ischemia by ligation of main arteries (warm ischemia)
- “cold” ischemia, i.e. the time interval between surgical removal and fixation of tissue
- location of tumor biopsy within a given tumor
- processing of tissue and fixation protocols
• Consequently, biobanks for target discovery and drug development have to be based on fully controlled, well-documented processes that start already presurgery and include rapid and standardized tissue preparation in the surgery unit

Dr. Hartmut Juhl,
CEO, Indivumed and Inostics
Adjunct Professor, Georgetown University
Adjunct Professor, University of Hamburg

14:20 Recent Legal Developments in Biobanking
• The HITECH Act, the HIPAA Privacy Rule amendments, and their impact on biobanking
• The affect of the Genetic Information Nondiscrimination Act on informed consent for biobanking
• And more!

Kristen Rosati
Partner
Coppersmith Schermer & Brockelman

15:00 Afternoon Refreshments

15:20 Sponsor Spotlight Session
Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

16:00 Biobanking: A golden cusp for tailor made personalised medicines
• Analysing the opportunities, challenges, approaches
• Discussing recent developments
• Understanding the ethical, legal guidelines

16:40 Closing remarks from the chair

16:50 Networking Drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Biobanking Americas
Thursday 11th November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Case Study: Next Generation sequencing at the FDA center for food safety and applied nutrition. Trace back and testing of foodborne pathogens
• The milestones for this project included: the ability to provide all of the data generated from analysis of Salmonella enterica genomes
• Developed software that will provide full contig assembly of 454 genomic data, annotation of those contigs and then generate lists of genes present in each Salmonella genome based on annotation analysis.
• Recent Next gen experience in building a comparative genomics lab that is directly testing the applications of these methods for foodborne pathogen outbreak detection and analysis

Dr. Marc Allard
Research Microbiologist, Microbiology
FDA-CFSAN-ORS

10:20 Biobanking: changing approaches to target-finding, drug development and patient treatment

Brenda Yanak
West Point IT Site Head and Account Manager, Franchise Biology, siRNA, Imaging, and GeM
Merck

11:00 Morning refreshments

11:20 Integrated Healthcare Technologies Solutions for an Aging Society
• Pharmaceutical company moving towards global healthcare corporation
• Healthcare paradigm shift from traditional inpatient care towards home-based care
• Develop solutions that span from Wellness to Illness care
• Role of Informatics to enable a consumer healthcare business model
• Vision-Gain from a true integrated and diversified healthcare system

Adel Laoui
Director, Healthcare Technologies Aging Therapeutic Strategic Unit
Sanofi-aventis

12:00 Sponsor Spotlight Session
Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

12:40 Networking lunch

13:40 IT Solutions to support Biobanking
• Biobanks are essential for the transformation of Healthcare, as we move towards "translational science", preventive care and personalized medicine.
• IT Solutions supporting Biobanks must address privacy and security concerns and should accommodate new data types such as genomic and imaging data
• To provide value to the medical research community, IT solutions must be capable of query and analysis and enable the creation of disease specific repositories
• Examples to be discussed will include Oncology and Neuroscience

Dr. Michael Hehenberger
Business Development Executive, Life Sciences
IBM Thomas J. Watson Research Center

14:20 Panel Discussion- Biobanking in 2010
Panellists will be analysing the recent trends and advancements in sample collection and processing. Focus will be on the challenges and opportunities involved in establishing a biobank.

15:00 Afternoon refreshments

15:20 Biobanking: The Lynchpin for Translational Research
• So, what’s an imperative for the Biobank?
- The Quality of the specimens, diseased and normal, must be absolutely maintained
- The real value of a Biobank, in either context, is the Meta data (patient demographics, diagnosis, cohorts, environmental exposure, behavior (smoker/non-smoker), etc.
- Whether de-identified or anonymized, or with PHI (Patient Health Information), the intrinsic value of biospecimens is in how well and how thoroughly the specimens are annotated
- In the Pharma context, it is also an imperative to validate the biomarker information via SNP Genotyping, Gene Expression, Flow Cytometry or Mass Spectrometry.
- In Medical Research, it essential to track the genealogy of child samples downstream form the Biobank with a referential link to the parent specimen, as that is where the patient Meta data is stored.

Dr. Richard J. Maguire
Director of Business Development – LIMS
Ocimum Biosolutions

16:00 Biobanking: A paradigm shift in drug test and development: Mouse to Man
• Assessing tools in improving drug development
• Overcoming analytical challenges in drug testing
• Implementing effective strategies

16:40 Chair’s closing remarks

16:50 End of Conference


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