Day Two: Wednesday, September 22

8:30-9:00    Morning Coffee

How to Build a GLP Lab: 
Strategies, Services and Qualifications

9:00    Remarks by Session Chair

9:10    Engineering the Bioanalytical Laboratory
Dr. Howard Hill, Director of Pharmaceutical Services, Huntingdon Life Sciences 
Success, in terms of delivery, quality and cost effectiveness depends on ensuring your facility is “fit for purpose”, it should be neither over nor underengineered. A prerequisite is to define quality standards and customer requirements. The size of the operation will dictate the staffing levels – do I need a software system manager, do I need an instrument specialist, do I need sample control clerk - if not how do I distribute the functions amongst the analysts? How much and what do you automate – how much value is there in automating small batch sizes and multiple analytes? What skill mix do you need? All of these will impact upon the type of LIMS system, documentation processes, instrumentation and automation choices that you need to make. What is right for a group of 6 may not be right for a group of 50 or 150. The relative merits and requirements of the small through to large labs will be discussed

9:40    Lower Your Bottom Line: In House In Vitro GLP Testing Benefits
Dr. Ann Wright, Lead Professional, Cell Biology/Toxicology, Ciba Vision, Novartis
Topic for discussion would be simple steps and methods to stream-line an in-house operation to be both cost- and time-efficient performing GLP studies. How a lab proceeds from data to submission efficiently? Our group has implemented numerous SOP’s, protocols, templates, QA systems, validation of operations and tracking policies which enable us to be extremely efficient as an in-house GLP lab. We are able to perform the USP or ISO testing required for EU/FDA or Japan submissions quickly for our customers without out-sourcing. I also have a developed a relationship with outside contract labs to out-source our in-vivo work and higher level testing. For the last 10 years, I have worked in a GLP Cell Biology/Toxicology /Microbiology lab and am also a Regulatory Affairs Certified (RAC, by the Regulatory Affairs Professional Society).

10:10    GLP Bioanalysis - A QAU Perspective
Mr. Subru Bhat, Scios, Johnson and Johnson 
My presenttaion will incldue a step-by-step approach in building a GLP Bioanalytical laboratory from inside out. This presentation is based on my first-hand experience. My expertise is in the areas of GLPs, GMPs and GCP (or GXP). I have been in the industry for over 32 years.

10:40    Poster and Exhibit Viewing and Coffee Break

11:20    Building a Biomarker Laboratory in a GLP Environment
Dr. Deborah Kinch, Senior Scientist, Biomarker Development and Validation, Biogen Idec
The successful development and validation of biomarkers for utility in the clinic requires the application of traditionally research-based technologies in a GLP environment. These technologies, such as microarray based transcriptional profiling and genotyping, present unique challenges for meeting regulatory guidelines. In this presentation, we will discuss the development of a GLP and 21 CFR Part 11 compliant biomarker laboratory. Topics to be discussed include development of GLP compliant laboratoryoperations, including LIMS, as well as an approach to the development of SOPs, protocol and report templates, data analysis workflows, and decision matrices.

11:50    Sample Handling and Tracking in the GLP Lab
Mrs. Brenda Emerzian, Manager, Lab Operations, Biogen Idec
I would like to relate the methods our lab has used over the years to maintain chain of custody for GLP study samples. I have been involved in this process for 11 years, both as an analyst and now as a Laboratory Manager. Our methods have survived numerous outside audits and the sample management department was declared a ‘center of excellence’.

12:20    Panel Discussion
• What regulatory pitfalls can be avoided when building a lab from the ground up?
• What staffing issues must a new lab overcome?
• Which key systems are most critical to the success of a new bioanalytical lab?

12:50    Lunch on your own (Technology Workshop Sponsorship Available)

Leveraging Resources for Maximal Results: Insourcing and the Role of the CRO

2:20    Remarks by Session Chair

2:25    When Should GLP Bioanalytical Support Be insourced and When Should it be Outsourced? 
Dr. Scott Wright, Director, Chromatographic Sciences Department, PPD Development
This question can be vexing unless the costs of operating a GLP laboratory are carefully identified and evaluated. These costs will be reviewed with particular reference to the type and size of study requiring bioanalytical support. Pros and cons of insourcing and outsourcing GLP bioanalysis will also be addressed. Dr. Wright has over 15 years of experience in managing bioanalysis laboratories in big Pharma, Biotech, and CROs

2:55    Trends and Demand in Bioanalysis Outsourcing
Dr. Farhad Sayyarpour, Associate Director, Developmental Bioanalysis, Charles River Labs

3:25    A Validation Case Study as Per the Requirements for 21 CFR Part 11
Ms. Victoria Lander, Development Manager, NuGenesis Technologies
A case study of how a medium-sized biotech company validated their systems for generating electronic records in a GLP environment will be presented. A validated electronic records management system was implemented including a process for long-term archiving of high-risk GLP records. The study will cover the steps required to generate a validation plan, user requirements document, system qualification (IQ, OQ, PQ) and managing validation documentation.

3:55    A New Approach to System Qualification
Ms. Virginia Corbin, Manager Corporate Compliance, Waters Corporation
Assuring government agencies that the data supporting production of regulated products meets quality and consistency requirements is a time consuming and expensive laboratory challenge. We take the manual labor out of qualification, freeing up your chemists for more science! There is a better way than the paper workbook that allows for greater consistency, less human error and meets the requirements of GLPs and GMPs. Connections QT for Systems will help you meet the constantly evolving regulatory challenge and you will spend less time on IQ,OQ and PQ for systems.

4:25    Poster and Exhibit Viewing and Refreshment Break

Interpreting Regulations and Forming the Recommendation

6:00    Close of Conference

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.