GLP - and GCP - regulated bioanalysis of drugs are a major component of the drug development process and an attractive opportunity for in-sourcing based on both cost savings and time-to-shelf advantages. Many pre-IND compounds are supported with small-sample-number studies, requiring very fast turnaround to choose between candidates, plan dose levels, and define parameters of next-step studies. Many contract laboratories see these small studies as unprofitable and unattractive and charge a “batch fee” to offset the cost of handling small studies. In addition, many drug candidates do not proceed to IND early development. As a result many small, mid-sized, and large pharmaceutical companies are re-investing, or increasing their investment in internal GLP. The growth in this area has driven a need to develop services for the industry that smooth the transition to in-sourcing.

Contract laboratories have a stake in supporting the growth of internal GLP laboratories to support small, unprofitable studies and in providing the variety of services that new GLP labs will require to begin in-sourcing. There are many examples to be found of such business opportunities. This opens up the opportunity for contract laboratories to demonstrate their expertise and build a strong partnership with pharmaceutical companies that facilitates their participation for later-stage large study support. 

Topics to Include:
• Drafting Standard Operating Procedures (SOPs)

• Instrument Qualification: IQ, OQ, PQ, Change Control, Documentation, and
   Philosophy

• Software Qualification: IQ, OQ, PQ, change control, Documentation, and
   Philosophy

• Laboratory Information Management Systems (LIMS): Introducing a Laboratory
   to LIMS and Successful IQ, OQ, PQ, QC, Training and Implementation

• Documentation Process: Drafting Document Templates that Facilitate
   Reconstructability, Compliance, and Archive

• Report Writing Process: Templates, Reports, Manual vs. Automated Systems,
   Quality Control

• Method Validation: Interpretation of the FDA Guidelines, Points of Divergence,    
   Successes and Shortcomings of the Recommendations

• Designing a QC Process

• Laboratory Audits: Current Trends in Periodic Laboratory Inspections

• Binder Audits: Current Trends in Bioanalytical Raw Data Audit and the Impact of
   Electronic Data

Advisors:
Dr. Adam Brockman, Principal Scientist, Millennium
Dr. Timothy Olah, Bristol-Myers Squibb
Dr. Steve Unger, Bristol-Myers Squibb
Dr. Tom Huggins, Senior Staff Scientist, Proctor & Gamble 

Speakers:
Dr. Adam Brockman, Principal Scientist, Millennium
Dr. Ajai Chaudhary, Head, Drug Disposition, Lilly Research Labs
Dr. Jing-Tao Wu, Associate Director, DMPK, Millennium
Dr. Min Chang, Section Manager, Drug Analysis Department Abbott
Dr. Julie Zalikowski, AstraZeneca
Dr. Howard Hill, Director of Pharmaceutical Services, Huntingdon Life Sciences 
Dr. Ann Wright, Lead Professional, Cell Biology/Toxicology, Ciba Vision, Novartis
Mr. Subru Bhat, Scios, Johnson & Johnson 
Dr. Tom Huggins, Senior Staff Scientist, Proctor & Gamble 
Mrs. Brenda Emerzian, Manager, Lab Operations, Biogen Idec
Dr. Scott Wright, Director, Chromatographic Sciences Department, PPD Development
Dr. Farhad Sayyarpour, Associate Director, Developmental Bioanalysis, Charles River Labs
Ms. Virginia Corbin, Manager Corporate Compliance, Waters Corporation
Dr. Deborah Kinch, Senior Scientist, Biomarker Development and Validation, Biogen Idec