Lori Ball leads BioStorage Technologies global and domestic operations, including strategic business development, the implementation of global growth strategies, and overseeing the company’s North American and European facilities. She also maintains senior management responsibilities for sales, marketing, logistics and information technology.

Formerly at Covance, Inc., she served as global head of sales/business development and global head of supply chain management and logistics. While there, Ball had a proven track record of sales and revenue growth and was responsible for overseeing multiple lines of management. She holds Six Sigma Green Belt credentials and has completed Six Sigma Executive and Champion training. Additionally, she is a known industry speaker and an expert on specimen transportation.

Strategies for Evaluating and Selecting a Sample Management Outsourcing Model

Kristina Robson, Scientific Director, Bioscience Division, EMD Millipore

Dr. Robson is a Scientific Director in EMD Millipore’s Discovery & Development Solutions organization based in St. Charles, MO. Dr. Robson has years of experience from the Biotechnology/ Pharmaceutical industry in the fields of biomarkers, GMP and pharmacokinetics/toxicokinetics. She has led teams that developed and validated assays for the quality control environment in support of GMP lot release testing while at Amgen Inc, in Thousand Oaks, CA. While at Amgen she also held a position in the Molecular Sciences department where she was responsible for biomarker strategy for various programs in oncology, neuroscience and metabolic disorders. She also led a development, validation and large scale sample analysis team responsible for supporting the clinical trials of various programs and therapeutic indications. Her expertise also extended to the establishment of numerous quality standards and she is well versed in the regulatory requirements for the use and application of biomarkers in clinical trials. Subsequently, Dr. Robson also worked as a principal scientist at Pfizer, where she was responsible for developing and evaluating regulated bioanalytical quantitative analysis for test compounds. Dr. Robson also served as an undergraduate instructor at the University of Kansas before her entry into the pharmaceutical industry.

Offsite Management of Research Samples:
Generating Research Efficiencies and Cost-Savings

Mary Rose Keller, Vice-President Clinical Operations, Sangart

Mary Rose Keller is Vice President, Clinical Operations for Sangart. She has proven success in global execution of preclinical through post-marketing stages for drug, biologic, and diagnostic products across multiple therapeutic areas. She began in academic research with UC Davis and San Francisco and broadened her experience working with a niche CRO that supported multiple regulatory filings. She held leadership positions at Pfizer, Shire, and Agouron, overseeing successful clinical programs. She served on the Partnerships Advisory Board for over 5 years and is Chair of the Corporate Advisory Board for the SoCal Chapter of the HBA.

Onsite Management of Research Samples:
Leveraging Technology to Advance Research

Steve Sweeney, Head of Clinical Information Systems, Infinity Pharmaceuticals, Inc.

Steven Sweeney has worked in clinical research operations for 15 years. His experience spans Phase I through IIIb CNS, Inflammation, Oncology and Cardiovascular/Metabolic Disease studies. Since he began his career in research he has led or participated in a variety of technology initiatives encompassing Electronic Data Capture (EDC), Clinical Trial Management, Customer Relationship Management and Knowledge Management.

One of his primary goals is to revolutionize the way we use technology in the management of clinical trials. By making information easier to find, automating processes and reducing duplication he hopes to improve decision making, speed communication and make the work of study teams and investigative sites easier and more productive.

Steve is currently the Head of Clinical Operations at Infinity Pharmaceuticals, a small company of 190 Citizen-Owners that is focused on small molecule, targeted therapies in oncology, pain and inflammation.

Utilizing a Hybrid Sample Management Model:
Improving Asset Utilization

Jay Schiestle, Senior Director of Operations, Exact Sciences, Inc.

Jay Schiestle joined Exact Sciences as Senior Director of Operations in October, 2010. Jay previously served as Vice President of Operations at Roche NimbleGen, and led Process Development and Manufacturing for Roche Diagnostics’ Diabetes Care business in Indianapolis, IN. Prior to joining Roche, Jay held positions of increasing responsibility in Engineering, Quality, IT, Materials Management and Production at Corning Cable Systems. Jay earned a Bachelor’s Degree in Biomedical Engineering from Marquette University and an MBA from Duke University’s Fuqua School of Business. Jay also served 5 years in the U.S. Navy Submarine Service.