3rd Central Labs & Diagnostics Partnerships Forum -

3rd Central Labs & Diagnostics Partnerships Forum
March 20 - 21, 2017
Philadelphia, PA

Assess diagnostic, biomarker and personalized medicine needs to strategically partner with the right central lab, accelerate patient enrollment, and pace ahead of competitors

Agenda – 3rd Central Labs & Diagnostics Partnerships Forum



Conference Day One

 Monday, March 20, 2017

8:00AM – 9:00AM

Continental Breakfast


9:00AM – 9:15AM

Chairperson’s Opening Remarks


Brenda Yanak, Former Precision Medicine Lead, Clinical Innovation and BP, Specimen Management and Imaging, PFIZER

9:15AM – 10:00AM

Challenges and Solutions in Central Lab Selection


Jonathan Reuter, Associate Director, Global Procurement R&D, Clinical Labs, BRISTOL-MYERS SQUIBB

10:00AM – 10:45AM

Best Practices for Establishing a Successful Governance Structure with Central Labs


Ly Kawaguchi, Director of Clinical Procurement and Outsourcing, ULTRAGENYX PHARMACEUTICALS

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Issue Mitigation: A Clinical Outsourcing Perspective on Successful Vendor-Sponsor Partnerships


Allyson Gunsallus, Senior Clinical Outsourcing Manager, MEDIVATION

12:00PM – 1:00PM

Lunch


1:00PM – 1:45PM

Solve Key Clinical Trial Challenges by Turning Specimen Data into Actionable Insights: Break the Data Silo Barrier with New Tools for Real-Time Data Analysis


John “JJ” Spegele, Vice President, Business Solutions and Enterprise PMO, COVANCE CENTRAL LABORATORY SERVICES (CLS)
Amelia Wall Warner, Pharm.D., R.Ph, CEO and Founder, GLOBAL SPECIMEN SOLUTIONS, INC.

1:45PM – 2:30PM

Choose a Central Lab with Access to Genomic Assays to Warrant the Right Number and Right Kind of Patients in Your Clinical Trial


Kamala Maddali, DVM, Ph.D., Vice President, Global Biopharma Market Development, Collaborations and Companion Diagnostics, CANCER GENETICS, INC.

2:30PM – 3:00PM

Networking Break


3:00PM – 3:45PM

Challenges in Cross-Validation and Transfer of Biomarker Assays: Use of Data, Compliance, Technology, Geography and Laboratory Focus


Patrick Bennett, M.S., MBA, Executive Director, Biomarker Lab, PPD LABORATORIES

4:30PM – 5:15PM

Compare and Contrast the Role of the Central Lab in Companion Diagnostics Between the Rx and Dx


Hal Mann, Director of Clinical Operations, Trial Support and Strategic Outsourcing, ROCHE MOLECULAR SOLUTIONS

5:15PM – 5:15PM

Day One Concludes



Conference Day Two

 Tuesday, March 21, 2017

8:00AM – 9:00AM

Continental Breakfast


9:00AM – 9:15AM

Chairperson’s Opening Remarks


Brenda Yanak, Former Precision Medicine Lead, Clinical Innovation and BP, Specimen Management and Imaging, PFIZER

9:15AM – 10:00AM

Best Practices in Managing Central Lab Data in Clinical Trials


Irina Wietek, Ph.D., Manager of Clinical Data, SHIRE

10:00AM – 10:45AM

Case Study: Innovative Approaches to Solving Industrywide Issues in Clinical Trials Using Advanced Technologies


Chris Clendening, Executive Director, Global Project Management and Technical Operations, PPD LABORATORIES

10:45AM – 11:15AM

Networking Break


11:15AM – 12:00PM

Consider the Site Perspective on Clinical Labs to Optimize Clinical Trials


William Smith, M.D., Professor of Medicine, UNIVERSITY OF TENNESSEE MEDICAL CENTER, KNOXVILLE, TN
President, NEW ORLEANS CENTER FOR CLINICAL RESEARCH AND VOLUNTEER RESEARCH GROUP
Chief Executive Officer, ALLIANCE FOR MULTISPECIALTY RESEARCH

12:00PM – 1:00PM

Lunch


1:00PM – 1:45PM

Optimize Delivery of Precision Medicines Through Infrastructure Planning


Brenda Yanak, Former Precision Medicine Lead, Clinical Innovation and BP, Specimen Management and Imaging, PFIZER

1:45PM – 2:30PM

Precision Medicine: Image-Based Solutions to Assure Accurate Dosing, Reduced Costs and Successful Clinical Trials 


Elias Jackson, President of Research and Development, Director of Scientific Public Relations, VYRIPHARM BIOPHARMACEUTICALS

2:30PM – 2:45PM

Chairperson's Closing Remarks


Brenda Yanak, Former Precision Medicine Lead, Clinical Innovation and BP, Specimen Management and Imaging, PFIZER

2:45PM – 2:45PM

Day Two Concludes



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