AAPS Workshop on Stress Testing and Degradation Chemistry
November 10, 2007
San Diego Convention Center
San Diego, CA
ACPE #073-999-07-591-L04
Background Information
Stress testing is recognized as an important part of the drug development process. Recent efforts by the ICH with regard to impurity and photostability guidance has brought increased regulatory scrutiny of impurities and the need to identify and qualify impurities at lower levels. Coupled with the fact that the pharmaceutical industry is making major efforts to reduce the time and resource that it takes to get products to market, the potential for stability and impurity issues that affect the development timeline has increased dramatically. For these reasons, an AAPS workshop dedicated to stress testing has been developed. Stress testing is the main tool that is used to predict problems, develop methods, and identify degradation products/pathways. Since there are no detailed regulatory guidelines that direct how stress testing is performed, stress testing has evolved into an artful science that is highly variable based on the company and/or scientist performing the studies. This course will provide a benchmark of current best practices of experienced pharmaceutical and academic scientists. Questions like "how hot, how long, what conditions are appropriate?" and topics such as mass balance, photostability, oxidative susceptibility, regulatory filing data package guidance, the chemistry of drug degradation and case studies will be addressed.
Goals and Objectives
During the course of this workshop we will cover
- Regulatory perspectives on drug degradation and stress testing
- Fundamentals of photochemistry and oxidative degradation
- Practical aspects of oxidative and photostability stress testing
- Current strategies and protocols for stress testing of pharmaceuticals and industry best practices
- Chemistry of drug degradation and degradation case studies
- Packaging-induced and excipient-induced degradation
- Examples of degradation data in regulatory submissions for mono therapy and combination products
Planning Committee Members
Steven W. Baertschi, Ph.D., Eli Lilly and Company, Co-Chair
Karen M. Alsante, Ph.D., Pfizer, Co-Chair
Kim Huynh-Ba, M.S.
Bob Kirsch, Ph.D.
Saji Thomas
Geoff Carr, Ph.D., BSc, CChem, FRSC(UK)
Eric Nelson, Ph.D.
Continuing Education
The University of Wisconsin, an approved provider of continuing pharmaceutical education, offers continuing education credits. The fee must be paid at the time of registration or on-site. Continuing education credits will not be available after the meeting has occurred.
Earn: 0.7 CEUs (7 credit hours)
Program Number: 073-999-07-591-L04
Fee: $30, payable with registration
Workshop Agenda
Saturday, November 10
8:15 am
Introductory Remarks
Karen M. Alsante, Ph.D.
Pfizer, Inc.
Steven W. Baertschi, Ph.D.
Eli Lilly and Company
8:30 am
Regulatory Perspective on Drug Degradation and Stress Testing
Linda Ng, Ph.D.
U.S. Food and Drug Administration
9:15 am
Fundamentals of Photochemistry
Guilherme L. Indig, Ph.D.
University of Wisconsin, Milwaukee
10:00 am
Coffee Break
10:20 am
Practical Aspects of Photostability Testing
Allen C. Templeton, Ph.D.
Merck and Company, Inc.
10:50 am
Fundamentals of Oxidative Degradation
Karen M. Alsante, Ph.D.
Pfizer, Inc.
Steve Baertschi, Ph.D.
Eli Lilly and Company
11:20 am
Practical Aspects of Oxidative Susceptibility Testing
Paul A. Harmon, Ph.D.
Merck and Company, Inc.
11:50 am – 1:05 pm
Lunch
1:05 pm
Overview of Stress Testing Protocols: Industry Best Practices
Karen M. Alsante, Ph.D.
Pfizer, Inc.
Steven W. Baertschi, Ph.D.
Eli Lilly and Company
1:35 pm
Drug Degradation Case Studies
Valentino J. Stella, Ph.D.
University of Kansas
2:20 pm
Accelerated Forced Degradation Studies Using Microwaves
Dinos Santafianos, Ph.D.
Pfizer, Inc.
2:50 pm
Coffee Break
3:10 pm
Excipient-induced Chemical Photochemical Degradation
Robert A. Reed, Ph.D.
Xenoport, Inc.
3:40 pm
Packaging-induced Degradation
Mark D. Argentine, Ph.D.
Eli Lilly and Company
Patrick J. Jansen, B.S.
Eli Lilly and Company
4:10 pm
Degradation Chemistry in Regulatory Submission
Dan W. Reynolds, Ph.D.
GlaxoSmithKline
4:40 pm
Panel Discussion
5:00 pm
Adjournment
Registration Fees
| Early-Bird Registration Received on or before September 7, 2007 |
Advanced Registration Received by October 5, 2007 |
On-Site Registration Received October 5 ? on-site |
|
| Stress Testing and Degradation Chemistry Workshop AAPS/CRS Member | $890 |
$890 |
$1,075 |
| Stress Testing and Degradation Chemistry Workshop Non-member | $1,245 |
$1,245 |
$1,380 |
| Stress Testing and Degradation Chemistry Workshop Government | $450 |
$450 |
$525 |
| Stress Testing and Degradation Chemistry Workshop Government, Non-member | $500 |
$500 |
$575 |
| Stress Testing and Degradation Chemistry Workshop AAPS Member, Student | $70 |
$70 |
$80 |
| Stress Testing and Degradation Chemistry Workshop Academic Member | $510 |
$510 |
$640 |
Cancellation Policy
All written refund requests received by October 12, 2007 will be issued minus an administrative fee ($180 for registrants/$50 government registrants/$15 student registrants). Refund requests received after this date will not be accepted. Registrant substitutions submitted in writing are accepted at any time without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge may apply.
Fax: (703) 243-5582
Email: registration@aaps.org
Deadline: October 12, 2007
All refunds will be issued after December 21, 2007.
Until you receive a confirmation letter, your registration is not complete. You should receive a confirmation letter by fax or email 5 to 10 business days after payment is received. If not, call (301) 694-5243.
Become an AAPS Member and Save
Save money on this AAPS workshop by taking advantage of AAPS membership. Membership gives you the competitive edge you need to advance your career and keeps you up-todate on the latest in pharmaceutical research. Continue your professional development and take advantage of AAPS membership! Use the registration form to indicate your membership choice and send in payment with your registration fees.
Phone: (703) 243-2800
Email: membership@aaps.org
Regular Membership Fee: $135
Student/Post-doc Membership Fee: $30
Hotel Accommodations
The San Diego Marriott Hotel & Marina is the headquarter hotel for the 2007 AAPS Annual Meeting and Exposition. AAPS is also holding additional room blocks at other hotels. Please visit www.aapspharmaceutica.com/annualmeet/housing.
Registrants are responsible for making hotel reservations. Contact the AAPS Housing Bureau using one of the following options:
Reserve your room online at www.aapspharmaceutica.com/annualmeet/housing.
Fax the Housing Reservation Form using the fax number listed on the form
Phone: (800) 967-4590 US & Canada; International: (847) 282-2529
*Please note: there is a 10 room limit per company at the San Diego Marriott Hotel
Reserve Your Space Early!
Rooms are assigned on a first-come, first-served basis. Reservations should be made by October 12, 2007. After October 12, 2007, all reservations will be accepted on a space- and rate-available basis.
Room Deposit Required to Secure Reservation
All San Diego hotels require a credit card guarantee or a one night?s deposit via check with each reservation request. Requests received without a credit card guarantee or check deposit will be returned. Complete the Hotel Reservation Form with credit card information, or mail the form with a check made payable to the AAPS Housing Bureau.
Travel & Transportation
Discounted air fares are available for attendees traveling to/from San Diego for the 2007 AAPS Annual Meeting and Exposition. To take advantage of these discounts, call the official AAPS travel agency, Carlson Wagonlit, and mention this meeting. You may also call the airlines directly. Certain restrictions apply and seats are limited. Times are listed as Eastern Standard Time (EST).
Carlson Wagonlit
PH: (866) 412-7957 in the U.S.
PH: (304) 876-8635 outside the U.S.
EM: sismith@carlsonwagonlit.com
9:00 am ? 5:30 pm, Monday ? Thursday
9:30 am ? 4:00 pm, Friday
American Airlines
PH: (800) 433-1790
5:00 am ? 12:00 pm, Monday ? Sunday
Authorization #A60N7AA
United Airlines
PH: (800) 521-4041
8:00 am ? 10:00 pm, Monday ? Friday
8:00 am ? 8:00 pm, Saturday ? Sunday
Click here for further detailed travel information including rental car and ground transportation information.
Advertising Opportunity
Increase your visibility! Advertise in the final program and deliver your message to top pharmaceutical scientists. Limited space is available and ad space must be reserved no later than August 3, 2007.
The Townsend Group
Kim Kelemen, National Advertising Director
Phone: (301) 215-6710
Fax: (301) 215-7704
Email: advertising@aaps.org
Deadline: August 3, 2007
Questions?
Meeting Registration ? (301) 694-5243 or call toll free at (866) 229-2386 within the U.S. and Canada.
General Meeting ? (703) 243-2800, or call toll free at (877) 998-AAPS
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