Day One: Tuesday, September 21

12:00 -1:00    Registration, Poster Setup and Coffee

Company Perspectives and Challenges

1:00-1:30    Opening Remarks by Dr. Adam Brockman, Principal Scientist, Millennium

Why Build an Internal Lab:
   • The Integration Movement 
   • Value Capture vs. Value Creation
   • Valuation by Stage
   • The True Life of a Drug
   • Capturing Value No Matter the Stage with the Same FTE
   • Deciding What to Integrate
   • How Bioanalysis Fits into All of This
   • The Insourcing Phenomenon
   • The Quality/Price Relationship
   • The Challenges of GLP Bioanalytical

1:30    Interpretation of the FDA Guidelines
Dr. Ajai Chaudhary, Head, Drug Disposition, Lilly Research Labs

2:00    Maintaining Regulatory Compliance & Streamlining Bioanalytical Work Processes at the Same Time
Dr. Tom Huggins, Senior Staff Scientist, Procter and Gamble Pharmaceuticals
A Bioanalytical Chemist is intimately involved in turning a promising drug candidate into a marketable product. This involvement starts very early in the Drug Discovery Process and typically lasts long after the filing of an NDA. With the increased demands from shareholders and management to develop breakthrough technologies and blockbuster drugs in shorter cycle times and with less headcount the pressure on Pharmaceutical Scientists to produce has never been greater. Couple that with the increased scrutiny and mandates from Regulatory Agencies and there exists a situation where hard work alone does not cut it ­ You have to work smarter. The goal of today's presentation will be to highlight how the Bioanalytical Lab at P&GP has adapted to this new environment and what steps we have taken to increase our productivity as well as regulatory compliance.

2:30    Poster and Exhibit Viewing and Refreshment Break

3:30    The Millennium Experience of Building a GLP Bioanalytical Laboratory
Dr. Jing-Tao Wu, Associate Director, DMPK, Millennium
A GLP bioanalytical laboratory was built from scratch in less than five months at Millennium Pharmaceuticals. A systematic approach was established at the beginning to prioritize and map out strategies to perform software and hardware validation, establish SOPs and the documentation system, and etc. The work was accomplished by close teamwork with people from informatics/IT, QA, documentation, facility, external consultants, and bioanalytical scientists. The experience and lessons learned from this process will be presented.

4:00    Balancing Productivity with Compliance
Dr. Min Chang, Section Manager, Drug Analysis Department Abbott

4:30    Ensuring Data Integrity
Dr. Julie Zalikowski, AstraZeneca
The integrity of your analytical data at the time of collection as well as long term is an equally important aspect of building a GXP compliant analytical system. The ability to defend your analytical data is required by both 21 CFR Part 58 and 21 CFR Part 11. Ensuring data integrity requires qualification of the analytical instruments and laboratory personnel, validation of the algorithms used in data calculations, complete audit trails of all electronic data and finally documentation of all of these efforts. There are systems and tests that need to be designed and executed to demonstrate data integrity. The first step is usually the Analytical Instrument Qualification (AIQ) process, which has been detailed in a recent publication. The AIQ provides documented evidence that the analytical instrument performs suitably for its intended purpose. This presentation will outline the key components of an AIQ process. In addition to the AIQ process, ensuring data integrity also requires processes to protect and store the raw data. In the current electronic age this means that user accounts, access levels, password protections, regular data backups and data archiving systems all need to be established. The creation of these various systems will require testing and documenting of their effectiveness. Again, this presentation will describe in general terms the process of establishing and documenting such systems. 

5:00- 6:00    Networking Wine and Cheese Reception

6:00    Close of First Day

Call for Sponsors and Exhibitors
Showcase your company’s expertise, brand your solutions and develop revenue opportunites with qualified decision-makers by becoming an Exhibitor or Sponsor of GLP BioAnalysis 2004! Contract exhibit booth space by July 16, 2004 and you will save $300! If you want to discuss sponsoring or exhibiting at GLP BioAnalysis 2004, please contact Carol Dinerstein at 781-972-5471 or dinerstein@healthtech.com.