The document summarizes an upcoming conference on biobanking in the Americas from June 7-9, 2011 in Boston. It will bring together experts from biobanks, pharmaceutical companies, biotech firms, and regulatory agencies to discuss strategic approaches to biosample management and using biobanks to enable next-generation drug discovery and personalized medicine. Speakers will provide practical knowledge on new biobanking models, address ethical and legal challenges, and explore how to leverage biospecimen resources to support biomarker research. Attendees will learn best practices for biorepository management and implementation, applications of genome sequencing, and strategies for building biomarker discovery pipelines. The conference aims to facilitate networking and enable confident decision making through benchmarking against
1. Biobanking
Americas
The future for next generation drug discovery and personalised medicines
7th - 9th June 2011, Boston, USA BOOK NOW!
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
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 Biosolutions
Dr Nicolas Goffard, Bioinformatician - Functional Analysis, Almac Diagnostics
Jim Chinitz, Chief Executive Officer, Population Diagnostics
Pre-conference Workshop, 7th June 2011
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
Associate Sponsor
Driving the Industry Forward | www.futurepharmaus.com
Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biobankingamericas
2. Conference Introduction
Biobanking Americas
7th - 9th June 2011, Boston, USA
An estimated $1bn has been invested in the biobanking industry Associate Sponsor:
within the last ten years. At least 179 biobanks with 345,000 Nexus Biosystems provides high-integrity solutions for
donors exist in the US, most of which were established in the last demanding Life Science applications. From Sample
10 years. (Source: Business Insights, March 2009) Storage to Sample Analysis, Nexus provides high-
performance products and services to high-value discovery
Dear Colleague, laboratories. Nexus provides the Universal Store line of Automated Biological
IME Magazine highlighted biobanking as one of “10 Ideas Changing the World Right
T and Chemical Compound Sample Storage, for highly-modular and expandable
Now.” Biobanking is rapidly growing and thriving to change approaches to target- systems from -80°C, -20°C and ambient environments. Nexus manufactures
finding, drug development and patient treatment. It is being viewed as a key driver for and sells its’ XPeel Automated Seal-Removal Systems enabling highly-
next generation biomarker and drug discovery. automated systems to run unattended. Nexus markets the Aurora Microplate
he substantial advancement of research on the human genome has led to the creation
T Products for sensitive fluorescence and cellular-imaging applications in the
of biobanks, which has brought a paradigm shift in drug testing and development. world’s leading assay development and screening settings.
Recognizing the potential benefits from biobanks, pharma and biotech across the world
are investing in infrastructure and biobank development. For further information please email: www.nexusbio.com
iobanking Americas reflects the broad spectrum of strategic approaches in biosample
B Media Partners:
management. Visiongain is proud to be hosting this important conference, which will PharmiWeb.com is the leading industry-sponsored portal
bring together a panel of experts, comprising scientists, regulators, researchers who
for the pharmaceutical sector. Supported by most of the
will provide you with practical knowledge and strategic advice on new models and
theoretical frameworks of biobanking. In addition to this, the conference will enable leading pharmaceutical corporations, PharmiWeb.com provides dynamic
participants to identify and overcome the ethical, legal and social challenges. real-time news, features, events listings and international jobs to industry
professionals across Europe and the US.
Reasons to register today: For further information please email: corporate@pharmiweb.com
• Learn how to develop the best practices to leverage biospecimen resources BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
• Analyse major challenges for biorepository management and implementation WORLD. It is based and located in Warsaw, Poland.
• Get the latest updates on the applications on genome sequencing Biotechnology World was founded in 2007 to provide the world’s biotech and
• nvestigate the future of biobanks, regulation, ethics, investment and the humanization
I
pharma information and market to make it universally accessible and useful
of drug discovery in the Americas for scientific and business processes. Its first step to fulfilling that mission
was building the BIOTECHNOLOGY EUROPE platform that will allow a quick
• Determine how to implement virtual biorepository
spread of information in different channels. BIOTECHNOLOGY EUROPE offers
• Understand the importance of quality management in biobanking companies completed internet public relations, publication and marketing
• ain an insight into the bioprospecting of tissues, DNA, protein or genetic
G solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to
information integrate the Biotech and Pharma Sector in Europe to global biotechnology,
• nable confident decision making by benchmarking yourself against other leaders in
E pharmaceutical and life science activities.
the field For further information please visit www.biotechnology-europe.com
I look forward to meeting you at the conference Future Pharmaceuticals has forged powerful relationships
Driving the Industry Forward | www.futurepharmaus.com
Best regards with key industry leaders to provide a platform for
successful brand recognition, and for senior decision-makers to have the
means to procure and plan implementation strategies based on the topics
covered. Positioned to be an authoritative resource within top pharma
Pranita Nangia companies as well as small, specialty, and biotech, Future Pharmaceuticals
Head of Conferences magazine is geared to create a deep penetration into a highly targeted and
responsive audience, bridging the gap between the industries’ top issues and
the solutions top-tier vendors can provide.
For further information please visit: www.futurepharmaus.com
Who should attend? InPharm is the online platform for exclusive pharmaceutical
VPs, Directors, Heads, Managers of: news, comment, contracts, services, jobs and events and is
home to InPharmjobs.com, Pharmafile and Pharmafocus.
• Biobank
• Tissue bank For further information please visit: www.In-Pharm.com
• Biorepository/BioSample
• Molecular Diagnostics
• Clinical Genetics, Pathology
• Genomics
Sponsorship and exhibition opportunities:
• Privacy/Protection/Security
• Scientific and Quality This event offers a unique opportunity to meet and do business with some
• Laboratory and Inventory
• R&D of the key players in the pharmaceutical and biotech industries. If you have a
• Quality Control
• Strategic Outsourcing service or product to promote, you can do so at this event by:
• Clinical Research • Hosting a networking drinks reception
• Translational Medicine
• Personalized Medicine • Taking an exhibition space at the conference
• Bioanalytical Chemistry
• Pharmacogenomics • Advertising in the delegate documentation pack
• Proteomics
• Business development • Providing branded bags, pens, gifts, etc.
• Strategic alliances
If you would like more information on the range of sponsorship or exhibition
Others:
possibilities for visiongain's Biobanking Americas Conference, please contact us:
Consultants& Academics
Regulatory bodies
Researchers Ronald Magali, +44 (0)20 7549 9934
Biorepository Vendors ronald.magali@visiongainglobal.com
Government Officials
3. Pre-Conference Interactive Workshop
Biobanking Americas
Tuesday 7th June 2011
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 Timings: 9:30 - 10:00 Coffee & Registration
0
Vice President, Strategic Alliances and 10:00 - 15:00 Workshop
International Biobank Relations
T
iming includes lunch and refreshment breaks
Trans-Hit Biomarkers
About the workshop: About your workshop leader:
Many consider biobanks to be the crucial cornerstone of
biomedical research through their provision of expertise and Lisa B Miranda
procurement of high quality samples and well annotated
data to foster research. One’s ability to develop high utility, With over 20 years of experience, Ms. Miranda
impactful, yet quality biobanking collections lies in the has a vast range of expertise in all aspects of
biospecimen resource’s success in implementing current best Biospecimen Resource Research Management and
practice as well as the foresight to incorporate evidence Development. After 14 years in research at the University
based practice into daily operations. The role of the of Pennsylvania, Ms. Miranda attained international
biobanker is now expanding to include proactive pipeline prominence as Technical Director of the Tumor Tissue and
planning which incorporates these considerations to ensure Biospecimen Bank (TTAB) Core Facility. She served as the
successful “proof of concept” in translational research prime architect of the centralized biospecimen resource
efforts such as biomarker research and development. and led TTAB’s collaborative efforts in development of the
NCI’s CaTissue Suite inventory management system and a
This interactive workshop will include discussion of: National Mesothelioma Virtual Bank with the University of
• An overview of related best and evidence based practice Pittsburgh and the CDC. In 2006, she was recognized for her
issues development of a Sustainable Cost Recovery Model which
• The role and current implications of best and evidence was acknowledged as the gold standard by the United
based practice in the biobanking workspace that relate to States National Cancer Institute’s Office of Biorepositories
pipeline planning and Biospecimen Research (NCI OBBR). Since then she has
• Strategies for how to navigate the R&D pathway and continued to establish and develop best practices for the
build a biomarker discovery pipeline for your biobank that biobanking community through her role as a NIH Contractor
integrates evidence based practice 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
About Trans-Hit Biomarkers Inc: Hub, which is aimed at developing a common biorepository
infrastructure that promotes resource sharing and team
Trans-Hit Biomarkers is a privately held company whose science, in order to facilitate multi-institutional, high
mission is to advance innovative biomarkers into more throughput genomic and proteomic studies, Ms. Miranda
valuable and competitive products. Trans-Hit Biomarkers recently authored a new chapter for the NCI Best Practices
is collaborative research organization forging strong focusing on Technical Considerations for Management and
partnerships between human biobanks, preclinical CROs, Operations of Biospecimen Resources. In her role as member
diagnostic companies and technology transfer offices. of the Ca Hub Acquisition of Normal Tissues Working
For further information, please visit: http://www.trans-hit.com/ 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
About visiongain: of Biobusiness Consulting Inc., which serves the global
Visiongain is a specialist business information company focused on providing cutting biobanking research communities in government, academia,
edge products and services across the Pharmaceutical/Biotech, Telecommunications, pharmaceuticals, biotech and related industry.
Defence and Finance sectors, which include reports, conferences, online daily news and
offline news analysis and bespoke consultancy. With a commitment to innovation and Ms. Miranda is also active in numerous professional
excellence, visiongain offers flexible solutions to meet our clients’ business intelligence societies and committees and has gained recognition as
needs, providing the right information at the right time to facilitate the commercial an international speaker and an expert in Biobanking.
decision-making process. Our pharmaceutical products include Pharma Business Daily, Her current roles include: Councilor on the ISBER Board of
the leading daily email newsletter for the pharmaceutical, biotech and healthcare Directors, membership in the global “think tank” known
industries, and a range of independent, high-quality, in-depth reports covering focused
as the “Marble Arch International Working Group on
and topical areas of concern. Our pharmaceutical conferences address the hottest
commercial, regulatory and technical topics and provide an ideal forum for debate and Biobanking for Biomedical Research”, as well as P3G Society
networking for pharmaceutical professionals from around the world. (Public Population Project in Genomics), LRIG and the NIH
Biospecimens Special Interest Group.
For further information, please visit: www.visiongain.com
4. Day 1
Biobanking Americas
Wednesday 8th June 2011
09:00 Registration and refreshments 13:40 Science guided biobanking: A prerequisite for the
development of individualized cancer therapies
09:30 Opening address from the chair • issues are under tremendous biological stress when surgically separated
T
from the body and, subsequently, significantly change gene and protein
expression profile and, possibly, also growth regulating factors that might
09:40 NCI’s Cancer Human Biobank (caHUB): Raising the
serve as targets or stratification markers for new drugs.
level of excellence for research biorepositories • everal factors have been identified that affect tissue research
S
• The vision for caHUB data, including:
• Planning process for caHUB - rug treatment and anesthesia of patients before surgical tissue removal
d
- intrasurgical ischemia by ligation of main arteries (warm ischemia)
• caHUB as a national reference repository
- cold” ischemia, i.e. the time interval between surgical removal and
“
• Challenges in bioethics and IP fixation of tissue
• White papers available on caHUB operations - location of tumor biopsy within a given tumor
Elaine W. Gunter - processing of tissue and fixation protocols
Founder and President • onsequently, biobanks for target discovery and drug development have
C
Specimen Solutions, LLC to be based on fully controlled, well-documented processes that start
already presurgery and include rapid and standardized tissue preparation
in the surgery unit
10:20 The institutional virtual biobank
Dr. Hartmut Juhl
• iscuss strategies, tools and techniques used for institutional federation
D CEO, Indivumed and Inostics
and curation of large volumes of disparate data, and present a case-study Adjunct Professor, Georgetown University
for a workflow from repositories to data analysis Adjunct Professor, University of Hamburg
• eveloping a cost-effective workflow to permit computational analysis will
D
become essential to scientific investigations 14:20 Recent Legal Developments in Biobanking
• he HITECH Act, the HIPAA Privacy Rule amendments, and their impact
T
• igh-throughput experimental techniques threaten to dump mountains
H
on biobanking
of new data onto bioinformatics teams already struggling with the
• he affect of the Genetic Information Nondiscrimination Act on informed
T
diversity, complexity and enormity of existing resources
consent for biobanking
Jeff Milton • nd more!
A
Bioinformatics & Computational Biology Kristen Rosati
Genentech Partner
Coppersmith Schermer & Brockelman
11:00 Morning refreshments
15:00 Afternoon Refreshments
11:20 The importance of an Honest Broker function
for clinical data associated with biospecimens 15:20 Sponsor Spotlight Session
• hat is an Honest Broker in biobanking?
W T
ake this unique opportunity to be a part of our conference theme, network
and provide an overview of your product/services to the audience.
• hy is it needed for research?
W
F
or more information please contact ronald.magali@visiongainglobal.com
• hat types of research does it support?
W
• ow does it work?
H
16:00 Biobanking: A key resource for deciphering the
James Eliason
molecular basis of cancer subtypes
Director
• hallenges for data mining and integration of clinical information with
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Stem Cell Commercialisation Center
functional genomics data
• ecent developments of effective strategies
R
12:00 Biobanking in the Post-genomic Era: • pplication to prostate cancer subtypes
A
Methodological Challenges Dr Nicolas Goffard
• Can current cryopreservation practices be defined as “best practices?” Bioinformatician - Functional Analysis
Almac Diagnostics
• an mitigation of cell stress molecular pathways improve biobanked
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cellular products? 16.40 Cardiovascular Sample Repositories for the Human
• ow does the end-user objective influence issues of “structural”
H Cardiovascular Proteome
versus “functional” cryopreservation? Dr. Mario Hugo Genero
• Is biomarker integrity impacted by sub-optimal cryopreservation? Cardiovascular Initiative
Human Proteome Organisation’s (HUPO)
Dr. John G. Baust
UNESCO Chair & Professor, Director 17.20 Closing remarks from the chair
Institute of Biomedical Technology,
State University of New York
17.30 Networking drinks
12:40 Networking lunch Take your discussions further and build new
relationships in a relaxed and informal setting
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
5. Day 2
Biobanking Americas
Thursday 9th June 2011
09:00 Registration and refreshments 14:20 The Gene Partnership: Implementing the ‘Informed
Cohort’ model for the ethical recruitment and
09:30 Opening address from the chair
engagement of participant into genomic research
• Description of the project at Children’s Hospital Boston
09:40 Next Generation sequencing at the FDA Center for • Return of research results through a personally controlled health record
Food Safety and Applied Nutrition. Trace back and
• versight of return of research results: the “Informed Cohort
O
testing of foodborne pathogens Oversight Board (ICOB)”
• he milestones for this project included: the ability to provide all of the
T
• Implications for personalized medicine
data generated from analysis of Salmonella enterica genomes
Dr. Ingrid A. Holm
• eveloped software that will provide full contig assembly of 454
D
CASE STUDY
Director Phenotyping Core, Program in Genomics
genomic data, annotation of those contigs and then generate lists of
Divisions of Genetics and Endocrinology,
genes present in each Salmonella genome based on annotation analysis.
• ecent Next gen experience in building a comparative genomics lab
R Children’sHospital Boston
that is directly testing the applications of these methods for foodborne
pathogen outbreak detection and analysis 15:00 Afternoon refreshments
Dr. Marc Allard
Research Microbiologist, Microbiology 15:20 Biobanking: The Lynchpin for Translational Research
FDA-CFSAN-ORS
• So, what’s an imperative for the Biobank?
- he Quality of the specimens, diseased and normal, must be
T
10:20 Presentation to be announced absolutely maintained
Brenda Yanak - he real value of a Biobank, in either context, is the Meta data (patient
T
West Point IT Site Head and Account Manager, Franchise Biology, demographics, diagnosis, cohorts, environmental exposure, behavior
siRNA, Imaging, and GeM (smoker/non-smoker), etc.
Merck
- Whether de-identified or anonymized, or with PHI (Patient Health
11:00 Morning refreshments Information), the intrinsic value of biospecimens is in how well and
how thoroughly the specimens are annotated
11:20 Integrated Healthcare Technologies Solutions for - n the Pharma context, it is also an imperative to validate the biomarker
I
an Aging Society information via SNP Genotyping, Gene Expression, Flow Cytometry or
• harmaceutical company moving towards global healthcare corporation
P Mass Spectrometry.
• ealthcare paradigm shift from traditional inpatient care towards
H - n Medical Research, it essential to track the genealogy of child samples
I
home-based care downstream form the Biobank with a referential link to the parent
• evelop solutions that span from Wellness to Illness care
D specimen, as that is where the patient Meta data is stored.
• ole of Informatics to enable a consumer healthcare business model
R Dr. Richard J. Maguire
• ision-Gain from a true integrated and diversified healthcare system
V Director of Business Development – LIMS
Adel Laoui Ocimum Biosolutions
Director, Healthcare Technologies Aging Therapeutic Strategic Unit
Sanofi-aventis 16:00 Biobanking : New Developments in Genomics That
May Impact Biobanks
12:00 Sponsor Spotlight Session • he extent of human genetic variation is much greater than anyone
T
imagined. How does this alter gene discovery approaches and the patient
T
ake this unique opportunity to be a part of our conference theme, network
samples required?
and provide an overview of your product/services to the audience.
• he importance of normal human variation and the use of samples from
T
F
or more information please contact ronald.magali@visiongainglobal.com
apparently healthy people.
• ther paradigm shifts around disease heterogeneity such as rare varants
O
12:40 Networking lunch vs common variants and the how the impact to discovery and validation
design alters biobank requirements.
13:40 IT Solutions to support Biobanking • WAS produced fodder mostly for the DTC market segment, but what’s the
G
• iobanks are essential for the transformation of Healthcare, as we move
B next generation of approaches to translate medicine that doctors can use.
towards “translational science”, preventive care and personalized medicine.
Jim Chinitz
• T Solutions supporting Biobanks must address privacy and security concerns
I Chief Executive Officer
and should accommodate new data types such as genomic and imaging data Population Diagnostics
• o provide value to the medical research community, IT solutions must
T
be capable of query and analysis and enable the creation of disease 16:40 Chair’s closing remarks
specific repositories
• xamples to be discussed will include Oncology and Neuroscience
E
16:50 End of Conference
Dr. Michael Hehenberger
Business Development Executive, Life Sciences
IBM Thomas J. Watson Research Center
6. Registration Form
Biobanking Americas
7th - 9th June 2011, Boston, USA
For multiple bookings
Photocopy this form Conf. code VG
Standard Prices Biobanking Americas
Conference and workshop Fee: £1699 (USD* 2629)
Conference only Fee: £1299 (USD* 2010) 7th - 9th June 2011
Workshop only Fee: £599 (USD* 927)
Boston, USA
*USD price is estimate only
Promotional Literature Distribution
Distribution of your company’s promotional literature to all conference attendees
Fee: £999 VAT: £199.80 Total: £1198.80
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