Cambridge Healthtech Institute's Inaugural 

Sample & Biospecimen Management in Clinical Trials 

Biospecimen Collection, Transport and Quality from Protocol to Analysis and Banking
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL 


About the Conference 

The availability of high quality biological specimens is of utmost importance for clinical trials and future research. Regulations exist to provide direction in many aspects of clinical research conduct, however more formal regulations that direct the collection and management of biospecimens is needed. The 2014 Sample & Biospecimen Management in Clinical Trials conference brings together leading experts, representing clinical trial sites and sponsors, to discuss challenges and identify actions to improve biospecimen collection, storage, operations, biobanking, and the resulting data for both the clinical trial at hand and future use.


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Mon February 3 See all Short Courses 

TUESDAY, FEBRUARY 4

7:00 am Registration and Morning Coffee

8:00 Organizer’s Welcome

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

 

Opening Plenary Keynotes And Panel: Keeping The Patient In Mind  

8:05 Chairperson’s Opening Remarks

Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP

8:15 Plenary Keynote Introduction 

Nancy Mulligan, Senior Director, Operations, Patient & Physician Services,
United BioSource Corporation

 

8:20 Plenary Keynotes and Panel 

What Does a Trial Mean in the Era of Real-Time Measurement?

Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe

The Silent Partners and Their Role in Clinical Research: Improving Trial Design and Management by Understanding the Real “Customer”

Christine Pierre, President, The Society for Clinical Research Sites (SCRS) 

PANEL: Perspectives from a Cast of Characters Needed for Any Successful Study Execution

 

Keynote Details 


9:45 Grand Opening Coffee Break in the Exhibit Hall

 

 

Biospecimen Collection & Management - In An Era Of Precision Medicine & Biomarker-Based Trials 

10:45 Chairperson’s Remarks

Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer

10:55 Operationalizing Precision Medicine through Biospecimen Management Strategy

Brenda YaaaakBrenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer

Quality biospecimens are the foundation of precision medicine. This talk will discuss the use of a specimen management framework to operationalize Precision Medicine.

  

11:20 Mandatory Exploratory Sample Collection in Clinical Trials

AndreaRenningerAndrea Renninger, Head, BioBank Operations; Senior Manager, Clinical Coordination, Eisai, Inc.

The purpose of this talk is to highlight the current barriers in mandatory sample collection with the intention of banking. Topics will include internal and external resistance, informed consent, sample permissions, and the use and reporting of data.

 

Precision Bioservices11:45 Building Future Use Collections

Shea_KathiKatheryn E Shea, Vice President, BioServices, Precision Bioservices, Inc.
Building high quality collections that will be useful for future research requires the well annotated and standardized processes. This talk will focus on the lifecycle of a biospecimen and the critical elements that must be incorporated into the design of future use collections. 


 

Sample Minded

12:10 pm Will Your LIS Handle a Million Tests a Year? From Trials to Launching a Validated, High-Throughput Screening Operation

Steenblik_DanDaniel Steenblik, Vice President, Technology and Operations, sampleminded

Challenges faced transitioning our clinical trial sample tracking system into a simple and sleek LIS that employs tablets, monitoring, workflow metrics, captures quality indicators and maintains traditional LIMS functionality. How supporting the needs of a new lab led us to a new collaborative SAAS model - sampleminded: Service As A Service.


12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:15 End of Morning Session 

 

Biospecimen Collection & Management - In an Era of Precision Medicine & Biomarker-Based Trials (continued) 

1:25 Chairperson’s Remarks
Ball_LoriLori Ball, COO, BioStorage Technologies 


 

 

1:35 Managing the Biospecimen Lifecycle: From Collection to Biomarker Discovery

NancieDeckardNancie Deckard, Biomarker CRA, Clinical Operations, Duke Clinical Research Institute (DCRI)

The DCRI has firsthand experience as an Academic Research Organization (ARO) in sample management for trials varying in size and scope from international, multicenter randomized clinical trials. In addition, we have trial experience across multiple therapeutic areas and with a variety of stakeholders. The Duke Clinical Research Institute (DCRI) created a cross functional group with representation from Informatics, Data Management, Clinical Operations and Statistics to facilitate successful implementation of sample collection in clinical trials.

2:00 Standardizing the Biospecimen Life-Cycle from Procurement to Release via SOPs, Policies, and Processes

TyHooverTy Hoover, M.D., J.D., FCLM, FCAP, Director, Biorepository Regulatory Support, University of Texas MD Anderson Cancer Center

This talk will focus on practical tips, lessons learned and the importance of controlling the processes involved the provision of human tissue for clinical trials at a large academic cancer center including pitfalls, SOPs, guidances, and regulatory and administrative obligations.

 

2:25 Impact of Regulation on Future Biomedical Research in Multinational Clinical Trials?

Amelia Wall WarnerAmelia Wall Warner, President, Board of Directors, Gentris Corporation; former, Head Clinical Pharmacogenomics and Clinical Specimen Management, Merck

 

2:50 Megatrends Impacting the Future of Biospecimen Management

Ken WilkeKenneth A. Wilke, Consultant; former Director, Clinical Pharmacogenomics and Clinical Specimen Management, Merck

 

3:05 Refreshment Break in the Exhibit Hall

 

4:05 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

CLICK HERE to view the current topics and moderators


5:15 Welcome Reception in the Exhibit Hall

6:15 End of Day



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