9th Annual Biomarkers Congress
DIA’s 8th Annual Canadian Meeting: “Keeping Canada on the Map: Fostering Innovation and Access to Drugs in Canada�
Westin Ottawa Hotel
11 Colonel By Drive
Ottawa, Ontario
http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23405&eventType=Meeting
 CALL FOR ABSTRACTS
   for Presentations (details on page 3)
   for Posters (details on page 2)
   All abstracts are due by October 18, 2010 PROGRAM OVERVIEW The
   biopharmaceutical community is experiencing a paradigm shift in drug
   development. Important global changes are occurring with respect to
   regulatory oversight to clinical trial design and execution. Several
   factors infl uencing these changes include: new scientifi c
   approaches; biomarkers and individualized medicine; healthcare reform
   and the interplay between safety pharmacovigilance and eff ectiveness
   research. In order to remain competitive, Canada will need to foster
   innovation in these areas and facilitate market access to medicines.
   World market dynamics have led to increased opportunities for both
   industry and regulators to share information while at the same time,
   introducing new challenges regarding privacy and/or confi dentiality
   and clinical trial competitiveness. The program will highlight
   information on improving effi ciency in the running of clinical
   trials; discussion of streamlining federal and provincial regulatory
   and formulary approvals; and advice on strategies to overcome
   obstacles. TUTORIAL Wednesday, November 3: Primer on Reimbursement
   Preregistration required. Event Code: 10019 EXHIBIT INFORMATION
   Attendees may visit the exhibits during the event and receptions.
   Contact Jeff Korn, Exhibits Associate, Phone +1.215.442.6184 Fax
   +1.215.293.5924, email Jeff.Korn@diahome.org


   11 Colonel By Drive , Ottawa, ON, K1N 9H4 , Canada

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Schedule of Presentations:

Wednesday, November 3, 2010
08:00:00 Registration
Thursday, November 4, 2010
08:30:00 Opening Plenary Session Paul Karamanoukian, Robert G. Peterson, Karen Feltmate, Kimby N. Barton, Paul Pomerantz
09:00:00 Keynote Address Paul Karamanoukian, Robert G. Peterson
13:30:00 TRACK 1 – Clinical Development - Globalization of Clinical Trials: How Can Canada Stay Competitive? Russell Clarke
13:35:00 Trends in the Globalization of Clinical Trials Lesley Ann Barnett
13:45:00 Canada: Your Location of Choice for Clinical Trials Brad Millson
13:50:00 Clinical Trial Competitiveness Mark Ferdinand
14:00:00 TRACK 2 – Reimbursement - Clinical Trial Design Wayne Critchley, Vijay Shukla, Kostas Trakas
14:30:00 TRACK 3 – Regulatory - Distributing Drugs in Today’s Global Environment: Regulatory Impact Daniela Decina
14:35:00 Establishment Licensing Renewal: Fostering a Safe Drug Supply Chain in Canada Merry J. Bujaki
14:45:00 The Critical Role of Regulatory Affairs in Business Development Activities Stephanie L Sherman
15:00:00 Globalization of Supply Chain – Pro’s and Con’s, Making Manufacturing Changes on a Global Scale, Regulatory Hurdles and Impacts on Product Availability Dean Callaghan
15:30:00 TRACK 1 – Clinical Development - Streamlining the Clinical Trial Process: Technology and Productivity Measures Joanne Watson
15:35:00 FDA: Regulatory Considerations of ePRO and Other Technologies, Update on FDA Guidance Issued in December, 2009
15:45:00 Maximizing the Benefit of the ePRO Tool with EDC Serge Bodart
16:00:00 Social Media and Its Impact on Clinical Trials Deirdre Cozier
16:10:00 TRACK 2 - Methodological/Data Challenges in Reimbursement Decision Making – Meta-analyses: Drawing insights and value from combining across studies Lesia Babiak
16:15:00 Methodologic Challenges in the Use of Meta-analysis in Comparative Effectiveness Research Jesse A. Berlin
16:30:00 Academic Perspective Karen Lee, George Wells
16:40:00 TRACK 3 – Regulatory - Emerging Scientific Advances in Pharmacogenomics, Biomarkers, and Companion Diagnostics: Academic, Industry, and Regulatory Progress, Challenges, and Roadmap for Success Maria Klapka
16:45:00 The Personalized Medicine Landscape Clarissa Desjardins
16:50:00 A Case Study of Crizotinib with a Dx and Its Contribution, Promise, and Challenge toPersonalized Medicine Hakan Sakul
16:55:00 Canada’s Perspective on Developing Regulatory Requirements for Products in Emerging Scientific Fields Elwyn Griffiths
Friday, November 5, 2010
08:30:00 TRACK 1 – Clinical Development - Ethical Considerations in Clinical Trials Russell Clarke
08:35:00 Ethical Reflection on Clinical Trials in a Global Environment Gordon DuVal
08:45:00 Independent or Institutional REBs: Potential Conflicts of Interest Involving REBs, Investigators, and Institutions Denis Cournoyer
08:55:00 Patient Retention Strategies in Long Term Clinical Trials: Challenges and Ethical Considerations Sandra Smyth
09:00:00 TRACK 2 – Reimbursement - Postmarketing: More Than Just Safety – Effectiveness Matters George Wyatt
09:05:00 Post Marketing – More than Just Safety – Effectiveness Matters: Industry Perspective Judith Glennie
09:15:00 Understanding the Challenges Faced by the Represented Party Olaf Koester
09:25:00 TRACK 3 – Regulatory - International Collaboration: Use of Foreign Reviews in Canadian Regulatory Decisions, MRAs, and Confidentiality Agreements Alice Hui
09:30:00 Implementation of International Joint Review Karen Reynolds
09:40:00 International Collaboration: An Industry Perspective Neerja Goyal
09:50:00 Consideration of other Regulators' Decisions: Legal Basis and Practice at Swissmedic Petra Doerr
10:00:00 Break
10:30:00 TRACK 1 – Clinical Development - Innovations in Clinical Development Diane Colizza
10:35:00 Adaptive Clinical Trial Designs: Where Is Industry with Respect to Adaptive Design? Jeffrey Maca
10:45:00 Personalized Medicine: Impact on Clinical Trial Design and Patient Recruitment? Brian Foster
10:55:00 Adaptive Clinical Trials Designs: Issues and Considerations – A Regulatory Perspective Celia Lourenco
11:00:00 TRACKS 2 and 3 – Reimbursement/Regulatory - Common Drug Review Pre-NOC Alain Boisvert, Alice Hui
11:10:00 Common Drug Review Pre-NOC Pilot Project for Xarelto Kory McDonald
11:20:00 Pre-NOC Submissions to CDR Sandy Pagotto
11:40:00 Patient Perspective on Drug Access Katharina Kovacs-Burns
12:00:00 Lunch
13:30:00 Panel Discussion: “Ask the Regulators” Diana Dowthwaite, Nancy Richards, Elwyn Griffiths, Christopher E Turner, Supriya Sharma, Karen Feltmate
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