Cell Based Bioassays in Biological Drug Development and Lot Release
Industrial Short Course
November 3, 2009
Doubletree Somerset Hotel & Executive Meeting Center
200 Atrium Drive
Somerset, NJ
Short Courses for the Pharmaceutical Industry
Registration
Your registration options are as follows:
The registration is $950.00 and Early bird discounts ($750) are offered to individuals registering prior to October 18, 2009.
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Register Online. Login in using your user account. If you don't have a user account creating one is free & easy. |
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Download the registration form, complete & mail to: Pharmacy Short Courses |
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By phone at 608.262.3130 or toll-free at 877-947-4255 using a credit card for payment. |
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Download the registration form, complete & fax to 608.262.2431 using a credit card for payment. |
Goals & Objectives
Goals and Objectives
This University of Wisconsin-Madison professional development course is designed as a practical workshop on design issues that impact the quality of Bioassays for biological drugs. The content is designed to provide an intermediate level training that will survey the state of the art in cell based bioassay technology and current regulatory environment. The focus will be on practical issues that can arise when developing new bioassays and how to use appropriate method development to ensure a robust assay is created. Upon completion of the course, the attendee should be able to:
- describe the key FDA regulatory expectations for a lot release bioassays for biological drugs;
- select the appropriate cell based bioassay technology for a given biological drug;
- list the key assays parameters that introduce variability into cell based bioassays and how to minimize that variability and
- understand how cell based bioassays can be used to describe biosimilars relative to the non-generic drug.
Short Course Program General Information
Who should attend
Bench scientists, regulatory managers, and technical managers who are (or may become) responsible for developing, or interpreting, cell based bioassays for biological drugs. The course will be at a post-graduate level and should be useful to those just starting bioassays or scientists looking to get an update on current cell based bioassay design technologies. In addition, the course will help managers who rely on bioassay data for regulatory submissions, product development, or product lot release to better understand how assay design can impact the statistical validity of the results. The statistical curricula will not assume an advanced understanding of statistical mathematics..
Location
Doubletree Somerset Hotel & Executive Meeting Center
200 Atrium Drive
Somerset, NJ 08873
(732) 469-2600
The day begins (8:00am) with a continental breakfast and includes lunch and break service throughout the day. All classes will begin at 8:30am and end at approximately 5:00pm.
Accommodations
Blocks of hotel rooms have been reserved at the DoubleTree Hotel at the rate of $99.00 per night. Reservations should be made directly with the hotel at (800) 222-TREE and request University of Wisconsin Short Courses block. To guarantee this special room rate, reservations must be made by October 16.
Enrollment & Fees
One-day Short Course (any of the six other programs) $ 950
Payment received prior to October 18, 2009: $ 750
Contents
1) History of bioassay technologies and regulations
2) Cell based bioassay technology options
3) Optimization of cell culture parameters
4) Assay design optimization
5) Selecting appropriate statistical methods
6) Current regulatory expectations
7) Case study using anti-TNF antibodies
Instructors
Frank Fan Ph.D.
Senior R&D Manager
Promega Corporation, Madison, WI
Dr. Fan has experience in the development of anti-microbial therapeutics at GSK and now heads the bioassay R&D program at Promega Corporation. His approach to the course curriculum will apply his practical experience in the pharmaceutical development process to the expanding area of cell based bioassays for monitoring the activity of biological drugs.
John Watson, Ph.D.
Director, Cellular Analysis
Promega Corporation, Madison, WI
Dr. Watson has been responsible for developing bioassay tools at Vertex, Invitrogen and Promega. He currently manages the development of new cell based technologies for bioassay applications at Promega.
For More Information
James E. De Muth, Ph.D., Conference Director
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705
(608) 262-3130
FAX (608) 262-2431
Send Email
Special Offer for Academic Institutions
Extension Services in Pharmacy at the University of Wisconsin School of Pharmacy has instituted a new policy for industrial professional development programs to encourage greater participation by faculty, graduate students and post doctoral students at academic institutions. Programs will be offered at a significantly reduced price, based on space availability. For information about any specific course please contact Dr. James E. De Muth by email.
