Research Triangle Park Chapter Upcoming Event

The Research Triangle Park Chapter of the Licensing Executives Society invites you to join us for our upcoming June lunch meeting.

DATE:
Tuesday June 12, 2007

TIME: 
11:45 a.m. – 12:00 p.m.   Registration, Networking and Appetizers
12:00 p.m. – 1:30 p.m.     Lunch and Speaker

LOCATION:
Maggiano’s Restaurant – Streets of SouthPoint Mall, Durham

TITLE: 
"Bridging the Gap Between Drug and Diagnostic Development:  A Novel Approach to Rapid Commercialization of Companion Diagnostics."

SPEAKER: 
Dr. David Johnston - Vice President and Chief Scientific Officer for Esoterix Clinical Trials Services

LabCorp is one of the world’s largest clinical reference laboratories; Esoterix Clinical Trials Services provides specialized and routine laboratory analyses for pharmaceutical and diagnostic product development worldwide.

Dr. Johnston earned his Ph.D. from the University of North Carolina at Chapel Hill School of Medicine in Microbiology and Immunology, and has been involved in clinical research for over 15 years.  Dr. Johnston studied gene regulation and surface virulence determinants in the pathogenic Neisseriae, and developed a novel mutagenesis strategy to engineer genetically modified bacteria without the introduction of antibiotic resistance.  In postdoctoral studies, Dr. Johnston studied drug resistance mutations in HIV and HCV, and worked on the first clinical assays to detect HIV drug resistance mutations. 

As CSO, Dr. Johnston is responsible for laboratory testing to support clinical and pre-clinical studies in over 15 laboratories worldwide, including facilities on 5 continents.  The scientific affairs department oversees a global proficiency assessment program, inter-laboratory technology transfer procedures, and strategic technology acquisition initiatives through in-licensing and M&A.

Previously Dr. Johnston served as Assistant Director of Research and Development for LabCorp, where he participated in the development of several novel clinical genotyping assays in the areas of infectious disease, genetics and pharmacogenomics.  He also previously directed the clinical quality assurance department.   He is an authority on ICH GCP, GLP, cGTP and CAP/CLIA regulations.  The QA department under his leadership supported hundreds of clinical and non-clinical research studies leading to IND, NDA, PMA, and 510(k) regulatory submissions to FDA and international regulatory authorities.  Dr. Johnston participated in the DIA/FDA Workshops on Pharmacogenomics Data Submissions and Drug/Diagnostic Co-Development, and served on the AACC Advisory Committee on Pharmacogenomic Assay Validation. 

In addition to his current role in clinical trials, Dr. Johnston is the National Discipline Director for Clinical Trials and Infectious Diseases.  He serves on several internal committees at LabCorp, including the Scientific Management and Strategy Committee, the National Office of Quality and Science, and Discipline Committees for Genetics/Genomics and Automation/Diagnostics Assessment.  He is a member of the American Association for the Advancement of Science, the Drug Information Association, the American Association for Clinical Chemistry, and American Society for Microbiology. 

ADMISSION:
Early registration fee of $25.00 through June 12th.  Registration fee increases to $30.00 for registrations received after June 12th.  Seating is limited and will be on a first come, first serve basis.  Registration fee includes lunch.  To reserve a space, please register online by June 8, 2007 at https://www.usa-canada.les.org/registration.asp?ID=348

QUESTIONS: 
Any questions or concerns may be directed to: jackie.quay@duke.edu. 

DIRECTIONS:
Take I-40 to exit 276, Fayetteville Rd.  Follow signs to Streets of SouthPoint Mall.  Maggiano’s is located on the outside portion of the mall at 8030 Renaissance Parkway, Suite 890.  Phone: 919-572-0070.

CANCELLATIONS: 
LES is required to provide the number of registrants to the meeting venue at the time of the registration deadline and guarantee payment for each registrant.  For this reason, refunds or credits can only be provided to registrants who provide notice of cancellation prior to the registration deadline stated above.  This policy applies to registrants requesting delayed payment at the door (by check) as well as those registered online in advance.

LES Research Triangle Park is a local chapter of the Licensing Executives Society (LES).  We gather together professionals who engage in managing, valuing and licensing technology.  You may participate in our chapter’s meeting without joining LES.  Feel free to pass this invitation on to your colleagues.