Effective Method Transfer of Complex Bioassays

Why Should You Attend:

50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis.Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline; skills and planning required to successfully transferring these assays. Naiveté in this area causes loss of precious time and money during development.

Participants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay.

Areas Covered in the seminar:

This seminar systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. Topics to be addressed are:

• Setting a realistic timeline for your assay transfer
• Issues that need to be addressed in preliminary discussions between the labs
• Proper method writing
• Parameters to be evaluated during transfer - the transfer protocol
• Transfer report

Who Will Benefit:

Participants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay.

• Bioassay and Analytical Scientists
• Pharmacokinetic/Pharmacodynamic Scientists
• Outsourcing Professionals
• Project Management
• Regulatory Staff
• QA/QC
• Consultants

Instructor Profile:

Ana T. Menendez, is Senior Director of Biotechnology at Catalent, a full-service solution provider to the pharmaceutical industry. Dr. Menendez implemented biotesting at Catalent with the following services: Cellular Technologies, Molecular Technologies and Virology. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers.

Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. As the head of the Cancer Cell Biology department Dr. Menendez identified and/or optimized several compounds currently in clinical trials, including second-generation taxanes and inhibitors of the ras and src oncogenes. Her seminal apoptosis research (programmed cell death) was critical to the incorporation of a drug’s pro-apoptotic potential into the BMS decision pathway for oncology drug generation. While Associate Director of Regulatory Sciences she assisted the transition of Oncology and Infectious Diseases leads from the lab bench to the clinic. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.

Dr. Menendez obtained her Ph.D. in Microbiology/Immunology in 1995 from NY Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She teaches courses and leads workshops on Bioassay Method Development and Validation and is a frequent speaker at biopharmaceutical conferences.

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