Next Generation Dx Summit

Short Course 6
Clinical Trials to Establish the Value of Diagnostic Tests: Design and Management
Monday, August 18 | 2:00pm - 5:00pm | Capital Hilton Hotel | Washington DC

Instructors:

Adrienne Bambach, Ph.D., Manager, Clinical Affairs; Acting Director, Clinical Affairs, Nanosphere, Inc.

Anita Borek, Senior Manager, Clinical Affairs and Specimen Management, Nanosphere, Inc.

Scott Powell, Clinical Marketing Manager, Nanosphere, Inc.

 

This workshop will share best practices and case examples outlining the similarities and differences between diagnostic and pharmaceutical clinical trials. Diagnostic test clinical studies follow many of the same operating principals and standards as pharmaceutical trials. We will start with the processes needed to manage and conduct both sponsor and supported studies and then move into specimen acquisition and management and end with study publication planning and execution. This workshop will present tools and tips to take diagnostic clinical trials from concept through initiation, execution, and publication.

 

Topics will be addressed:


  • Sponsored- and Investigator-Initiated-Study clinical diagnostics processes for successful, compliant and timely execution.
  • Specimen Acquisition and Management—Who from, how to acquire, when to acquire, what to acquire and management best practices.
  • Clinical study publication planning and execution—Microbiology molecular diagnostic test case presented from market development studies through clinical outcomes/cost-effectiveness studies.

Faculty Biographies:

 AdrienneBambach Adrienne Bambach, Ph.D., Manager, Scientific Affairs; Acting Director, Clinical Affairs, Nanosphere, Inc. 

Dr Adrienne Bambach currently serves as Manager of Scientific Affairs and Acting Director of Clinical Affairs at Nanosphere, Inc. In this position, her responsibilities include managing sponsored and investigator initiated studies as well as providing clinical and scientific support for Nanosphere's portfolio of molecular diagnostic tests. She was previously a Field Application Scientist at Focus Diagnostics, where she assisted customers in assay verification and validation as well as scientific studies. Dr. Bambach received her Ph.D. in Microbiology and Immunology from Georgetown University and her B.S. in Honors Biology and German from Doane College. She completed an ASM/CPEP-approved Postdoctoral Training Fellowship in Medical and Public Health Laboratory Microbiology at University of Rochester Medical Center in Rochester, NY.      

 

 

Anita BorekAnita Borek, Senior Manager, Clinical Affairs and Specimen Management, Nanosphere, Inc.

Anita Borek is the Senior Manager of Clinical Affairs at Nanosphere. In this role, Anita is applying her knowledge of laboratory work flow, studies, and technical support to translate the Company’s Clinical Affairs and Principle Investigator needs for successful collaboration. Her research is focused on the clinical and economic impact of clinical microbiology methods. Prior to joining Nanosphere, Anita held several positions in which she was responsible for translating the needs of her customers, including an IT project manager role at Johns Hopkins where she translated laboratory requirements and as manager of Molecular Technical Support at Roche Diagnostics. Anita began her career at the bedside as a phlebotomist, shortly after became a generalist medical technologist, specialized in microbiology and moved into laboratory leadership, all before PCR was discovered. Anita received her MBA from Johns Hopkins while participating in sponsored and supported trials at Johns Hopkins, preparing her for her career in Clinical Affairs. Anita gets a kick out of helping different people understand each other and has extended her relationships across cultures, both professionally and personally when she moved with her husband from their suburban home to the inner city of Indianapolis where they mentor families in need. Anita’s career connected her to the experts, conferences, committees, and hidden resources to find rare specimens required for success. “Your trash is my treasure” has risen to an entirely new level in Anita’s world! When Anita’s not searching the ends of the earth for a rare find she enjoys books, bicycling, and board games.

Scott Powell, Clinical Marketing Manager, Nanosphere, Inc.

Scott Powell is the Clinical Marketing Manager at Nanosphere. In this role, Scott is defining where applications of multiplexed diagnostic testing will best benefit clinical outcomes and healthcare economics. In order to do so, Scott spends a large part of his time interacting with key stakeholders throughout the hospital and translating their feedback into new product designs and current product improvements. On the back end of product development, Scott works with the Clinical Affairs department to define, initiate, and manage clinical and economic outcomes studies that best capture the data necessary to effectively prove the value of a particular test to drive adoption. Prior to joining Nanosphere, Scott received a full fellowship to the doctorate program in biomedical engineering at Northwestern University. During his time at Northwestern, Scott’s research focused on the development of novel applications of magnetic resonance imaging (MRI) to non-invasively assess coronary artery health. Specifically, Scott developed new software and image processing tools to assess and quantify blood flow in the coronary arteries in order to determine coronary arteries at risk of developing debilitating plaque build-ups associated with coronary artery disease. After 3 years in the graduate program and conducting research at both Northwestern University Hospital and Cedars-Sinai Medical Center, Scott chose to leave with his Masters of Science and pursue a career where his work would have a more tangible impact on patient care and well-being. Scott received his Bachelors of Science in biomedical engineering from the Georgia Institute of Technology, where his research focused on the benefits of novel heart valve repair techniques versus artificial valve replacement, particularly with the mitral valve. This work was heavily influenced by fluid mechanics principles and focused on creating an in vitro diagnostics tool to effectively simulate the pressure and flow conditions present in the left side of the heart in order to develop and best characterize improvements offered through surgical repair of the heart valve.



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