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.
Day 1 | Day 2 | Track Brochure | Full Event Brochure
Mon February 3 See all 7 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)
8:05 Chairperson’s Opening Remarks
Kenneth Getz, Director, Sponsored Programs, Tufts CSDD; Chairman, CISCRP
8:15 Plenary Keynote Introduction
Abbe Steel, Vice President, 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
9:45 Grand Opening Coffee Break in the Exhibit Hall
10:45 Chairperson’s Remarks
10:55 Operationalizing Precision Medicine through Biospecimen Management Strategy
Brenda 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
Andrea 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.
11:45 Sponsored Presentation
Speaker to be Announced
12:10 pm Will Your LIS Handle a Million Tests a Year? From Trials to Launching a Validated, High-Throughput Screening Operation
Debi Koltenuk, Vice President, Products and Services, sampleminded
Daniel 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
1:25 Chairperson’s Remarks
Lori Ball, COO, BioStorage Technologies
1:35 Managing the Biospecimen Lifecycle: From Collection to Biomarker Discovery
Nancie 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
Ty 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 Warner, President, Board of Directors, Gentris Corporation; former, Head Clinical Pharmacogenomics and Clinical Specimen Management, Merck
2:50 Sponsored Presentation (Opportunity Available)
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
Day 1 | Day 2 | Track Brochure | Full Event Brochure