September 12, 2013
11:30 am to 12:30 pm EDT

Precision for Medicine focuses on Bioservices for the preservation of biological samples and on the delivery of Companion Diagnostics. The rigor needed in both areas of focus requires the organization to think broadly about the delivery of both science and service as it relates to Precision Medicine.

Symposium Course Description:

This topic will describe the current understanding of biobanking and the standards needed for successful development and execution of a Precision Medicine Strategy. We will explore how to develop best practices and drive consensus on Standard Operating Procedures (SOPs) that ensure the pre-analytical factors associated with the collection, processing, storage and transport of specimens are not altering the profile for the biomarker of interest. These SOPs must be developed in a manner that is logistically feasible across multiple sites to ensure that they will have clinical utility after the launch of the CDX. This presentation will provide an understanding of two core elements of Precision Medicine: the starting point, the specimen, and the end game, the testing and treatment of patients whereby drug eligibility is indicated through a test (Companion Diagnostic).

Learning Objectives:

• Current understanding of current biobanking environment
• Best practices on SOPs for collection, processing, storage and transport of specimens
• How to prepare your specimen strategy to ensure clinical utility after the launch of the CDx
• Providing an understanding of Precision Medicine Strategy

Who Should Attend:

• Industry (Pharma and DX) R&D
• Developmental Therapeutics
• Companion Diagnostic Developer
• Assay/content Developers

Program Agenda :

• Intro of PHC
• Intro to the Development of CDX
• Biobanking in the context of PHC
• Biobanking in the context of CDX
• Quality Measures and Standards
• Q&A

PIA MARIA GARGIULO

Managing Director, Companion Diagnostics

Pia Maria Gargiulo, PhD joined Precision for Medicine in the Fall of 2012 as the Managing Director of Companion Diagnostic Solutions. Dr. Gargiulo leads the team in the novel delivery of companion programs focusing on the broad utility and uptake of commercialization models for both the pharmaceutical and diagnostic sectors.

Before joining Precision, Dr. Gargiulo was the Vice President of the companion diagnostic partnership team at Qiagen. There she worked with pharmaceutical companies to establish drug-diagnostic collaborations and co-development programs, consulting on the novel technology, regulatory, clinical, and commercial requirements for bringing a companion diagnostic to market.

Prior to Qiagen, Dr. Gargiulo was a Therapeutic Brand Leader and Senior Regional Scientific Manager in the medical affairs/oncology department of AstraZeneca working in breast, lung, colorectal, and prostate cancer pipelines. Dr. Gargiulo has also worked with Oncor and Vysis to support the European development of their respective Her2 companion diagnostics.

Dr. Gargiulo earned a PhD in cytogenetics from the Northwestern Medical School. She is also a regional member of the American Cancer Society, I-Bio, and World Business Chicago and was recently appointed to the Governor’s Commission on Women’s Health.

KATHERYN SHEA

Vice President, Bioservices

Katheryn Shea is the Vice President of Bioservices at Precision Bioservices Inc., a subsidiary of Precision for Medicine. For over 20 years, Ms. Shea has led repository programs, helping clients build and manage biological collections from design through implementation, maintenance, and closeout stages. She is the current President of the International Society of Biological and Environmental Repositories (ISBER) and has served on its council for seven of the last twelve years.

Ms. Shea has served as principal investigator for several large repository initiatives sponsored by the National Institutes of Health and also acts as a scientific reviewer for repository applications. In addition, Ms. Shea advises on the design of various research studies and clinical trials that utilize anywhere from hundreds to millions of biospecimens. She also serves on the advisory working group that designed the Biorepository Accreditation Program for the College of American Pathologists and is the Biorepository Director for the CAP Biorepository Accreditation held by her company.

Ms. Shea received her undergraduate degree in biology from Mount Saint Mary’s College in Maryland.