Main Conference Day 1

Agenda Day One

Tuesday, September 9, 2008

7:30

Registration and Morning Coffeef

8:00f

Chairperson’s Welcome and Opening Remarks

Joseph Kessler, Associate Director, Vaccine & Biologics Research, MERCK RESEARCH LABORATORIES

8:15 -- KEYNOTE ADDRESS:

Leverage Your Biorepository as a Strategic Asset to Uncover New Biomarkers and Advance Translational Medicine

We are on the brink of monumental scientific developments with the discovery and utilization of biomarkers in modern medicine. But, how can we best utilize the wealth of information that is at our fingertips? Today, doctors are learning to tailor treatments to individuals more effectively. What does this mean for today’s biorepositories? During this cutting edge keynote session you will hear from the top pharmaceutical companies on what strategies they have implemented at their biorepositories to facilitate scientific discovery today and lay the groundwork for tomorrow’s road to translational medicine.

Nadine Cohen, Ph.D, Head of Pharmacogenomics and Senior Research Fellow, JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT

Richard Deane Hockett, Medical Fellow II, Director of Genomic Medicine at Eli Lilly and Company, ELI LILLY & COMPANY

9:30

45 Minute Networking Break

10:15

Anticipating The Future: Why Your Biorepository is So Critical Today

The transformation of healthcare, as we know it today, is dependent on our ability to better predict, diagnose and treat human disease. Biorepositories will play a key role in our search as they provide the substrate for studies to investigate genomic and proteomic factors which influence each of these biological measurements described above. Once such factors have been identified, the integration of these biomarkers into clinical development becomes dependent on effective biobanking. Finally new technologies, including whole genome sequencing, point to an new era in genomic studies aimed at unraveling the complexity of human disease. Each of these concepts will be explored during this presentation.

Biobanks coupled with emerging technologies open new opportunities to investigate human disease.
Biological specimens are critical for the effective integration of biomarkers into drug development.
When will we have a complete understanding of the human transcriptome and it’s role in human disease?
When will an individuals genome sequence be an integral part of drug development?

Patrice M. Milos, PhD, Vice President and Chief Scientific Officer, HELICOS BIOSCIENCES CORPORATION

11:00

Standardization in Biorepositories to Guarantee Accurate Information for Future Sample Usage and Compliance with Current Guidelines

Compliant operating procedures for collecting, storing, and testing samples are essential to new drug development. Hear from the National Cancer Institute’s Office of Biorepositories and Biospecimen Research on their set of guidelines for the Biorepository Industry. Learn what they recommend in terms of consistency of storage standards for studies that are handled across a large number of investigator sites. NCI officials discuss standard operating procedures to collect and store.

Is the right data collected with the samples and is it consistent with the rest of the industry?
What do you do with the information you have collected?
How do you store your samples?
Utilizing biorepository samples for the prediction of adverse events prior to the approval and marketing of a product
Expedite your approval process through the testing of viable samples and submission of quality data
How can standardization ensure sample integrity to comply with current guidelines?
What research is needed to address pre-analytical variables in sample handling that may affect assay results?

Helen M. Moore, PhD, Biospecimen Research Network Program Manager Office of the Director, NATIONAL CANCER INSTITUTE

Karen Pitt, PhD, Special Assistant for Biological Resources, NATIONAL CANCER INSTITUTE

11:45

Innovative Cold Storage Designs That Lower the Operating Cost of a BIOREPOSITORY and Assure Product Safety and Stability.

As facility design, construction and operating costs continue to increase in the foreseeable future, Environmental Specialties (ES) has responded repeatedly to industry with design build products for critical high volume cold storage from 4°C down to -80°C. This presentation and discussion will focus on innovation in the following areas which directly affect the facility upfront and operating costs.

Sizes that reduce the actual chamber number by offering increased unitary capacity for an overall facility volume increase.
Central refrigeration concept with redundant systems to maintain uniform product temperatures continuously.
Efficient LN2 safety systems.
Central control systems and corresponding monitoring point reduction.
Condensor designs matched to the building for remote heat removal.
Extensive IQ/OQ/PQ experience resulting in efficient project turnover.

The presentation will delve into early planning for a high volume BIOREPOSITORY and discuss the main facility differences from standard "freezer farms" currently in operation.

Mr. Thomas (Tom) A. Herdman, Director of Engineering & Product Development, ENVIRONMENTAL SPECIALTIES (A LUWA GROUP COMPANY)

Mr. Edward (Ed) Paul Frantz, Jr., Director of National Sales, ENVIRONMENTAL SPECIALTIES (A LUWA GROUP COMPANY)

12:15

Luncheon for Delegates and Speakers

Choose between two concurrent tracks:

TRACK A Operational Strategies for Biorepositories	TRACK B Legal and Regulatory Issues Surrounding Biorepositories
1:30
Establishment of Standard Collection Practices for Sample Viability Global biobanking is essential in providing answers that matter to patients and translational medicine. One of the challenges with global biobanking is maintaining a high level of integrity for both samples and data during the collection process. This presentation will describe an approach to establishing best practices for sample collection and patient privacy. Collecting and using samples and clinical data Informed Consent: understanding the differences between limited use, stored, and banked samples Establishing a process for ensuring patient privacy Utilizing biobank samples in a regulated environment Crystal Dotson, Banking Process Expert/Diagnostic and Experimental Medicine, ELI LILLY & COMPANY	Obtain Appropriate Informed Consent for Optimal Usage of Biorepository Samples Industry Perspective: Obtaining appropriate informed consent for stored biosamples begins with creation of an appropriate template with adequate disclosure of processes and procedures for patients. Changes to the template made by individual sites participating in global studies must be monitored and managed to identify sample permission changes. Finally, an auditable informed consent/sample permissions system is essential for ensuring informed consent permissions are enforced on banked samples for the entire course of sample banking and analysis. Amelia Wall Warner, PharmD, RPh, Senior Principal Scientist, SCHERING-PLOUGH CORPORATION Academic Perspective: Informed Consent is a requirement for collection of biospecimens and their associated data. Fully annotated biospecimens are a precious resource for the advancement of molecular medicine. Often availability to these resources is limited by highly complex clinical and research interactions coupled with extensive operations of the biorepository environment. For repositories who do not obtain their own consent, their ability to confirm consent is often inhibited by end users who sometimes misunderstand the repository’s need to document consent. This talk will clarify the role, responsibilities and challenges for the biorepository in recruitment, procurement, documentation, tracking and regulation of informed consent as well as how one may appropriately and efficiently engage in this educational process. Additionally, this talk will demonstrate how you can utilize your informatics platform, database and software tools to increase consent adherence, facilitate tracking, enhance operations, and establish an audit trail. Lisa B. Miranda, Technical Director, Tumor Tissue and Biospecimen Bank, UNIVERSITY OF PENNSYLVANIA, Biospecimen Resource Consultant, USA and Europe
2:15
Biorepository Storage and Handling Practices to Optimize the Long-Term Value of Samples in Biomarkers Research Differences in current bio-sample and storage practices across the pharmaceutical industry are attributable to different assumptions being applied about their value and long term viability. In this session we’ll discuss how processing and storage decisions may be limiting the value, use and long term viability of the samples. Holding Short or Long term? Months, years or decades? Single vs. Multiple Access (aliquots vs. freeze/thaws) Up and Down sides of assay miniaturization and automated sample processing Storage temperature and its stability; key determinates of sample viability Lessons from the chemical liquid storage and handling world James B. Matthew, PhD, JB MATTHEW CONSULTING LLC, formerly Executive Director of Exploratory Medicinal Science, PFIZER	Perspectives for Ethical Establishment of Biorepositories and Sample Handling to Ensure Patient Rights and Further Research Research for the sake of research no longer holds the mystique it once did for patients/subjects; the bioethics controversy over ownership of biomaterials is in the mainstream media and the stuff on which bestsellers are based (e.g., Michael Creighton’s Next). Individuals impacted by disease who are interested in research participation also are well-informed advocates. Patient rights, comprehensive yet clearly communicated informed consent documents, and transparent communications are essential to establishing and maintaining biorepositories that can help bring bench science to translational research and complement the drug development process. Partnership between patients/subjects and scientific and/or clinical researchers is key to establishing biorepositories; mutually beneficial objectives can help reach research project timelines Including the patient perspective in protocol, informed consent documents and outline of patient rights in biorepository documentation development and review Consideration of yet unanticipated or unrelated use of biorepository samples, need for future communication with patient (direct or indirect), patient/subject ability to redact biorepository participation and return or destruction of samples. Patient/community advisory to biorepository development process and ongoing management to ensure perspective as above Eureka! Therapeutic discovery is great, but what is your obligation to those who gave the samples to make it possible? The more upfront thinking, planning and scenario imagining and case studies explored, the more consensus there will be in building your biorepository. Jayne C Gershkowitz, Director of Patient Advocacy and Public Policy, AMICUS THERAPEUTICS Jon Merz, MBA, JD, PhD, Associate Professor, CENTER FOR BIOETHICS, UNIVERSITY OF PENNSYLVANIA
3:00
30 Minute Networking Break
3:30
Transfer of Samples from one Biorepository to Another: How do you do it? Where do you start? The decision has been made to transfer all biological samples from one biorepository to another. Now you must create and implement a plan to pack and transfer all biological samples. You will be moving from one Vendor to another, the loss of your business will likely not be well received especially if you are a key client. What supplies are required? How many people do I need to accomplish this task? If this is a multiple day move, what must I accomplish each day? How many samples will be moved? Marylee Garvey, Senior Supervisor, Sample Management, BIOGEN IDEC	Establish a Chain of Custody for Your Samples to Guarantee Quality Regulatory agencies are requesting more and more data and information as part of the approval process for new pharmaceuticals. New testing methodologies are developed daily and may be relevant for samples collected 5-10 years ago. You must be able to guarantee the integrity of your sample throughout the collection process and storage in order for analysis to be meaningful and accurate. Implementing an audit trail Maintaining 21 CFR Part 11 Compliance Linking the sample to the subject, test, data points Managing the samples moves and current location Appropriate sample handling Proof of storage at correct temperatures Jennifer Benner, Manager of Quality Systems, BIOSTORAGE TECHNOLOGIES, INC. Lisa Fey BS, LATG, RQAP-GLP, Scientific Investigator, Bioanalytical Chemistry, AMYLIN PHARMACEUTICALS
4:15
Understanding Global Sample Management and Customers Needs This program will discuss the benefits of “one-stop shopping” your biological specimen management needs with Fisher BioServices (FBS); The “how and why”. As a Global Leader in the biosample market, Fisher BioServices has the most comprehensive portfolio of products and services with respect to Sample Collection, Processing, Testing, Storage, and Transportation and Relocation. This program will share how FBS manages all aspects with respect to the management and chain of custody of your valuable samples at our state of the art facilities globally located. There are multiple steps in the “chain of custody” of your samples, and Fisher BioServices can provide expert guidance to be sure your needs are met every step of the way. This program will cover how FBS meets customer needs on every level with respect to the “continuum of a sample” from collection kitting, receipt, handling, lab processing and repository needs and doing so with international expertise. In addition, this discussion will cover how FBS’s highly qualified staff and “real-time” state of the art inventory tracking system makes connectivity and visibility all seem simple. Learning Objectives: Why collection kits should start and return at the same location Reasoning behind having a state of the art molecular laboratory with repository The importance of IT, and how IT and chain of custody need to be perfect The importance of Project Managers, and why this role has become “global” Support systems behind producing quality samples Bob Goodman, Director of Business Development and Sales, FISHER BIOSERVICES
4:45
Day One Concludes

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Agenda Day One

Agenda Day One