CVG LC-MS Discussion Group Meeting Feedbacks from the 50th ASMS Conference Presented by: Dr.Fabio Garofolo Eli Lilly

1. CVG LC-MS Discussion Group Meeting�Feedbacks from the 50th ASMS Conference�Presented by: Dr.Fabio GarofoloEli Lilly Canada Inc. June 20th 2002Toronto, Canada

2. SPONSORS Agilent Technologies Applied Biosystems/MDS Sciex Micromass ThermoFinnigan Waters Calibration and Validation Group

3. MEETING Agenda: Dinner: 6:30pm -8:00pm � 6:30-8:00pm � Oral presentations 6:30-6:45pm � CVG LC-MS Group Introduction (Fabio Garofolo) 6:45-7:00pm � Agilent Technologies (Richard Smith) 7:00-7:15pm � AB/MDS Sciex (Yves LeBlanc) 7:15-7:30pm � Micromass (David Heywood) 7:30-7:45pm � ThermoFinnigan (Steve Hassan) 7:45-8:00pm � Waters (John Vukovic) � 6:00-9:00pm � Poster session. (Authors present from 8pm to 9pm). Adjourn �

4. Agenda: CVG Discussion Groups LC-MS Discussion Group Review of the minutes from previous Meetings 1st on Jan 24th 2001 2nd on March 21st 2001 3rd : �Feedbacks from the 50th ASMS� Next meeting at the �CVG/TPD International Convention on Quality of Pharmaceutical� on Sept. 19- 20, 2002. Q & A

5. Background Based upon the success of the CVG Pharmacopoeial Discussion Group Four CVG Discussion Groups Pharmacopoeial Impurity Dissolution LC/MS

6. Objectives provide a forum for free exchange of scientific information solicit feedback on best practices discuss proposed guidelines from different regulatory agencies

7. Scope of the LC-MS discussion group Only in the GTA there are more than 800 scientists involved in LC-MS Bioanalytical (pharmacokinetics, pharmacology, Toxicology, Metabolism) Analytical (pharmaceutical and environmental ) Proteomics

8. How to achieve our goals? All personal information will be kept strictly confidential, and this information will NOT be documented in the minutes. All opinions are those of the individual, and do not reflect that of their company. The membership of each discussion group will be kept below 60. This is to ensure each member will have the chance to participate actively in the discussion. In each discussion group, there will be not more than 5 members from the same company. This is to ensure we will receive opinion from many different companies.

9. How can you help? Encourage your colleagues to join Participate actively in the discussion Suggest discussion topics Facilitate some discussions in upcoming meetings Provide feedback about the effectiveness of the discussion

10. Plan for upcoming meetings One meeting every ~2 months Meeting duration: 6pm-9pm Location: hotel, convention centre or company Each meeting will schedule 3 discussion topics (Bioanalytical, Analytical and Proteomics) Agenda will be sent in advance Minutes will be published Jan., Mar., Nov.: 1 sponsor per meeting June: Special Meeting after ASMS meeting Sept.: Special meeting at CVG convention

11. Role and responsibility Coordinators: For LC-MS Dr.Fabio Garofolo (Eli Lilly) For CVG Dr. Chung Chow Chan (Eli Lilly) Dr. Herman C. Lam (GlaxoSmithKline) Area Topic Leaders: Bioanalytical Dr. Henrianna Pang (Eli Lilly) Dr. Adan Effio (Novopharm) Analytical Dr. Nick Toltl (Eli Lilly) Proteomics Dr. Bev Incledon (Eli Lilly) Prof. Michael Siu (York University)

12. Jan. and Mar. meetingsCompanies represented: Agilent Technologies, Apotex AB/MDS Sciex, Biovail Contract Res. Bodycote Canada Inc., Eli Lilly Canada, Novopharm, 8. Patheon, 9. Pharma Medica, 10. Ray &Berndtson Inc. 11. ThermoFinnigan 12. Unilever Canada 13. York University

13. TOPICS discussed: BIOANALYTICAL Atmospheric Pressure Ionization LC-MS/MS: short run times and high sample throughput Impact of Biotransformation in Bioanalytical Assays ANALYTICAL Data Dependent Experiment PROTEOMICS Nanospray vs MicroESI in Proteomics

14. �Feedbacks from the 50th ASMS Conference� The purpose of the meeting is to share and collect feedbacks from the 50th ASMS conference. There are posters presented by Canadian scientists and sponsoring LC-MS manufacturers and leading companies, which were introduced at the ASMS Conference in Florida

15. Next meeting: Joint CVG/Therapeutic Products Directorate (TPD)�International Convention on the Quality of� Pharmaceuticals and Exhibitions� (Toronto, Canada, September 19 & 20) SESSION 4 LC-MS applications Carry-over in Bioanalytical Methods Protein in Mass Spectrometry and Proteomics Validation of Bioanalytical Methods LC-MS in Environmental Analysis

16. Next meeting: �International Convention on the Quality of� Pharmaceuticals and Exhibitions� Registration fees: Includes Continental Breakfast, Lunch and Refreshments It is free for all LC-MS Discussion Group registered members (if you have already paid the fee for the LC-MS discussion group you don�t need to pay the convention registration fee)

17. For More Information: About CVG activities and discussion groups,and training, check: www.cvg.ca About LC-MS discussion group & LC-MS training courses check: www.cvg.ca www.csms.inter.ab.ca

18. CVG LC-MS Discussion Group Meeting�Feedbacks from the 50th ASMS Conference�Presented by: Dr.Fabio GarofoloEli Lilly Canada Inc. June 20th 2002Toronto, Canada