8:45 Opening Remarks From The Chairperson

9:00 Keynote Presentation: Addressing Recent Developments From NCI And Best Practices To Collect And Leverage Biospecimen Resources

• Examining key challenges and requirements for biospecimen resource development
• Establishing a framework to coordinate biospecimen resource SOPs, standards, and management principles
• Coordinating international efforts to develop best practices and guidelines
• Developing a national biobank in the US: technical, policy and economic considerations
• Ensuring sample quality: lessons learned from NCI projects and developing a Biospecimen Research Network

Dr. Jim Vaught
Deputy Director, Office of Biorepositories and Biospecimen Research
National Cancer Institute

9:45 Case Study: Improving Sample Accessibility To Researchers With Virtual Biorepositories

• Creating a “virtual biorepository”
• Developing standardized policies for IRB review, informed consent, HIPAA authorization, and material transfer agreements
• Managing joint scientific review of protocols submitted to the virtual repository

Kristen Rosati
JD, Partner
Coppersmith Schermer & Brockelman PLC

11:00 Innovations In Repository Automation Technologies

• Does Automation Add Value In A Biorepository?
• Challenging Storage Requirements; Innovative Solution Outcomes
• Delicate Sample Material; Robust Storage Reliability
• Form Follows Function - Store Design And Sample Integrity
• Developing A Future-Proof Biostorage Concept

11:45 Case Study: Best Practices On Establishing And Maintaining Biological Biobanks

• Turning your biobank into a successful project: cost, time line and goal achieving
• Integrating the financial planning in the project planning phase
• Assessing and mitigating risks throughout the biobank planning and implementation
• Developing risk management and disaster recovery plan for your biobank

Edward S. Kaercher
PMP, Facility and Project Management
PPD-Vaccines and Biologics

1:30 Examining Global Regulatory Issues Affecting Specimen Collection For Industry And Non-Industry Biorepositories

• Understanding data privacy issues in EU, Asia, US
• Studying requirements for access and exporting
• Examining challenges and solutions for cross border sample exchange
• Calling for international collaborations on biospecimen collection and distribution

Amelia Wall Warner
PharmD, RPh, Head, Clinical Pharmacogenomics, Associate Director, Early Clinical Research and Experimental Medicine
Schering-Plough Research Institute

2:15 Probing Into Legal & Ethical Issues For Human Specimens

• Outlining the HHS and FDA regulations and policies as they apply to biobanking
• Highlighting the research provisions of the HIPAA Privacy Rule
• Reviewing the newest developments in privacy rules
• Understanding the key challenging legal and ethical issues

Marianna J. Bledsoe
M.A., Deputy Associate Director, Clinical Research Policy Analysis and Coordination Program (CRpac)
NIH Office of Biotechnology Activities

3:30 Developing Informed Consent Best Practice To Ensure Compliance

Informed Consent is one of the most critical practices during biosample collection, distribution and research; it’s also a very debatable topic in biobaking area. This session will present the best practices for developing informed consent for different sample purposes.

• Understanding what a broad enduring consent looks like
• Explaining from EC/IRB perspective
• Identifying the limits of the informed consent
• Understanding when additional approval or re-consent is necessary
• Rethinking and developing flexible informed consent in the nonstandard cases
• Exploring innovative practices to seek for more accurate data while protecting the patient’s privacy

Karen J. Maschke
Ph.D., Research Scholar and Editor, IRB: Ethics & Human Research
The Hastings Center

4:15 Interactive Panel Discussion: Exploring The Implications Of Ethical And Legal Issues On Biobanking Daily Practice

The presentations on the legal and regulatory frameworks for biobanking operation and informed consent considerations will be followed by an open panel discussion on what they mean for biobanks and the implications for daily practices.

• Understanding the regulatory and legal framework of biobanking and implications for daily practice
• Protecting patients’ rights through informed consent and best practices for privacy and confidentiality
• Understanding the Institutional Review Board’s (IRB) policy requirements
• Taking the discussion to the next level: what does it mean to the biobanks and research community
• What’s the role of the biobanks – giving a biobank perspective

Panelists Include:

5:00 Closing Remarks From Chairperson And End Of Day One