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From Site to Sample: Considerations for Effective Minimal Risk Diagnostic Research

May 3, 2012
11:30am to 12:30pm Eastern Time

Featured speakers: Kathleen Mandziuk & Cathy Michael, PRA & BioStorage Technologies

*PRA will be sponsoring this event, making it complimentary for all translation professionals. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately. Don't miss this learning opportunity, take advantage today


You can register for this webinar at: http://www.fxconferences.com/From-Site-to-Sample-Considerations-for-Effective-Minimal-Risk-Diagnostic-Research-P876.aspx

Webinar highlights:

The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.

This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.

This webinar covers:

-Strategic site selection

-Proactive and effective site training for sample collection and processing

-Integrated sample management processes and flow (chain of custody)

-Robust and compliant data management and statistical techniques

-Transition of the program though each phase of development

-International considerations

-Pricing difference from other types of clinical research

About the speakers:

Kathleen Mandziuk, M.P.H., R.N., Sr. has almost exclusively focused her professional research career in the area of minimal risk research and late phase services development. Following her nursing training, she joined the pharmaceutical industry as a clinical data coordinator and enjoyed a variety of management positions. In these roles, she managed the data aspects of several large global minimal risk and post-approval projects from planning to analysis. Her responsibilities included overall strategic planning, daily operational supervision, executive level communications, and mentoring activities to several departments/units. Following her success in data management, Ms. Mandziuk transitioned into a project manager position and was responsible for the overall management of minimal risk and observational projects specializing in large national and international programs. She has directly managed programs ranging in size from 60 - 18,000 patients in a number of countries (the United States, Canada, Europe, Central/South America, and Asia) and therapeutic areas (CNS, dermatology, GI, infectious disease, ophthalmology, women's health, men’s health, and oncology).

In her current role as Scientific Affairs Director at PRA, Ms. Mandziuk assists sponsors and study teams with protocol development, strategic design and implementation methods that blend robust scientific rigor with proven operational techniques. Specific to minimal risk biomarker and diagnostic research, Ms. Mandziuk has designed and supported several types and phases of development including discovery, validation, submission and commercialization across many regions and therapeutic areas.

Cathy Michael is responsible for creating and implementing unique sample management solutions for strategic partnerships with laboratories, CROs, emerging pharma companies and in newly discovered business markets as Senior Director of Comprehensive Solutions at BioStorage Technologies. In her first 2 years at BioStorage Technologies, Michael was the global head of sample management operations accountable for the global policies and procedures of the sample storage management services. She led day-to-day tactical activities associated with receiving, registering and retrieving samples, and initiated the new 2011 services of sample preparatory services and clinical trial project management.

Prior to joining BioStorage Technologies, Michael was executive director of global project and data management at PPD Global Central Labs. There, she led two departments and was responsible for all service and data deliverables to the company’s pharmaceutical clients, including trial definition, conduct and closeout. As part of the executive committee, Michael defined and led strategic initiatives regarding process and technology, as well as supported financial and operational obligations for all markets. Michael holds a B.A. in Education from Purdue University, West Lafayette, Ind. She also studied pharmacy through Purdue University.

You can register for this webinar at: http://www.fxconferences.com/From-Site-to-Sample-Considerations-for-Effective-Minimal-Risk-Diagnostic-Research-P876.aspx

If you have any questions about this event, please send an email to acsupport@fxtrans.com

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FX Conferences
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Newton, MA 02465