8:35 Chairperson’s Recap Of Day 1

8:45 Reaching Real Solutions For Today’s Patients: Will Our BioBanks Stand Up To The Challenge?

When the rubber meets the road and we access our DNA biobank samples and EMR’s for conducting biomarker discovery and validation, will molecular diagnostics / personalized medicine firms get the content and quality of data they need to successfully translate research to medicine. The actual genetic causes (not to be confused with genetic risk or predisposition factors) of common diseases as well as the genetics that dictate one’s response to a drug, have continued to elude medical researchers despite the unveiling of the first human genome sequence 10 years ago. However, the most sought after answers to addressing unmet medical needs can be had given the right strategic alliance between a biobank and a discovery company.

Topics to be discussed include:

• In a biobank / discovery alliance, what does “win win” mean?
• Returning value back to the biobank’s patient population.
• Beyond GWAS for complex diseases; common and rare variants and the medical relevance of structural variation.
• Dissecting phenotypes into genotypes to define disease heterogeneity.
• Will the paradigm shifts behind nextgen discovery methods change the demand for biobanks?
• Distinguishing between causative associated biomarkers and risk factors to establish a new standard for molecular diagnostics, companion tests and drug discovery.

Jim Chinitz
Chief Executive Officer
Population Diagnostics Inc.

9:30 Creating A Vision And Strategy For Building A World-Class Repository

To support the high volumes of patient samples needed for research and testing of potential new drugs and therapies, biobanks need to consistently challenge existing standards for collection and management of samples. Corporate biorepositories are today working with researchers to optimize biobanking strategies to enhance drug development. Banks are becoming strategic. Biobank managers are building successful partnerships internally and externally to capitalize on the unlimited potential behind better use of biospecimens. Topics to be discussed include:

• Ensuring timely access to high quality biosamples
• Capturing the value in a repository investment through effective sample annotation and evolution of best practices
• Raising sample quality standards
• Facilitating successful partnerships between repositories

Diane Leong
Associate Director, Sample Repository
Genentech, Inc

11:00PANEL DISCUSSION: Validation On A Budget

How samples are collected, processed and stored has a major impact on their future usefulness. Validation studies can be used to test the robustness of initial sample handling and storage protocols. Topics to be discussed include:

• Basic methods and standard sample sizes
• Judging degradation of samples
• Validation project expectations: time, funds, and reporting

Mark Mense
DMV, PhD, MBA, Head, Global Pathology
MedImmune, LLC

1:30 Panel Discussion: Standards In Pre-Storage Sample Analytics

Pre-storage analytics of a sample involve events within the preacquisition and acquisition phases. Prior to sample acquisition there can be circumstances, such as treatment with certain drugs, that can influence the final quality status of the sample upon retrieval. Development of quality control tools for assessing variations in samples as they are acquired is thus very useful to assess conformity of samples. When the specimen comes under the supervision and control of the biobank personnel the search for biomarkers, molecular targets and profiles becomes a focus. Topics to be discussed include:

• Research done to define quality factors associated with the pre-acquisition phase
• Process changes in the pre-acquisition phase that present themselves as barriers to implementation of desired strategies
• Impacts of lag times time between tissues being without a blood supply and freezing
• Recommended analytics for repository samples upon initial acceptance

George Tokiwa
Leader of Integration Team, Biorepository Practices and Specimen Collection
Merck

2:15 Best Practices In Assuring Sample Integrity Over The Long Term In Cancer Stem Cells

When it comes to research coming out of the doors of biobanks, garbage in produces garbage out. The high-power genomic analyses of current interest, and that have significant market potential, require pristine biospecimens over the long term. Topics to be discussed include:

• Current consensus on cryopreservation
• Effective use of cryo-, ambient, liquid nitrogen and mechanical freezer options
• Biological integrity of cancer stem cells under cryopreservation
• Assurance of downstream analysis capabilities based on a comparison of storage techniques

Feridoun Karimi-Busheri, PhD
Senior Investigator, Stem Cell Program
NovaRx Corporation

3:30 Amplifying Solutions Provided Through Breakthrough Discoveries

Translating lab discoveries into proofs of concept in clinics can take up to 4-5 years and cost $25 million+. The time and cost of reaching these critical clinic-based milestones can be reduced significantly by an efficient research plan and a carefully designed risk-leveraged development strategy. Opportunities to accelerate clinical proofs of concepts exist through: exploratory INDs, relaxed GMP requirements for Phase 1 clinical trial materials, adaptive clinical trial design, and the use of fit for purpose biomarkers to select patients uniquely able to respond to treatment. Topics to be discussed include:

• Selecting patients in ways to get to important milestones sooner
• Which accelerator techniques to use when
• Establishing and running a lean, flexible organization that minimizes fixed costs

Martin Latterick
CEO
Proteogenomics Research Institute for Systems Medicine

4:15 Chairperson’s Closing Remarks & End Of Conference