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Denver, CO

François Vallée, Vice-President, Bioanalytical, Anapharm;

Saleh Hussain, Director, Bioanalytical Operations, Anapharm;

Samuel Gu, RI Research Scientist, Anapharm; and

Nuno Santos, Bioanalytical Investigator, Anapharm

“Automated Liquid-Liquid Extraction Method for High-Throughput Analysis of Tolterodine and 5-Hydroxymethyl Tolterodine in Human EDTA Plasma by LC-MS/MS”

Aimin Tan, PhD, Bioanalytical Project Coordinator, Anapharm;

Jacky Lee, RI Quality Assurance Auditor, Anapharm;

Saleh Hussain, Director, Bioanalytical Operations, Anapharm; and

François Vallée, Vice-President, Bioanalytical, Anapharm

“Sensitive LC-MS/MS Method for the Determination of Diclofenac in Human EDTA Plasma”

Aimin Tan, PhD, Bioanalytical Project Coordinator, Anapharm:

Saleh Hussain, Director, Bioanalytical Operations, Anapharm; and

François Vallée, Vice-President, Bioanalytical, Anapharm

“IS Response Variations in Incurred Sample Analysis by LC-MS/MS: Case by Case Trouble-Shooting”

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London, United Kingdom

Myrthe Rijswijk-Trompert, Associate Director, Business Development

“Overcoming R&D Contractual Issues within Global Projects”

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Langhorne, PA

Duu-Gong Wu, PhD, Executive Director, PharmaNet Consulting

“Overview of Follow-on Biologics Regulatory Issues in US”

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Speaker:

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Boston, MA

Vijay R. Prabhakar, MD, Medical Director

"Outsourcing Strategies and Trial Management in Asia"

"Outsourcing Strategies in Asia from a CRO Perspective"

Christophe Tournerie, MD, Executive Director, Clinical Research

"Letters from the Front: Experiences with Clinical Trials in Asia"

"Meeting Challenges in Clinical Research in Asia Pacific"

Betty Kuhnert, PhD, MBA, Executive Director, Training Services

“Generations in the Workplace: Battlefield or Playground?”

“Learning Style Diversity”

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Speaker:

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Toronto, Canada

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

“Regulatory Challenges for Gene Therapy”

Speaker:

Topic:

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

“Regulation of Combination Products”

Location:

Speaker:

Topic:

Dublin, Ireland

Duu-Gong Wu, PhD, Executive Director, PharmaNet Consulting

“Overview of Follow-on Biologics Regulatory Issues in the US”

Location:

Speaker:

Topic:

Monterey, CA

Bengt Danielsson, MD, PhD, Vice President, PharmaNet Consulting

“Pharmacologically-Induced Hypoxia: A Common Teratogenic Mechanism for Drugs with Potential to Cause Embryonic Cardiac Arrhythmia”

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Quebec, Canada

Mario Tanguay, PhD, B. Pharm, Vice Preisdent, Scientific and Regulatory Affairs, Anapharm

“Drug-Drug Interaction Studies”

Pierre Olivier Tremblay, M.Sc, Senior Pharmacokineticist, Anapharm

Modeling and Simulations in Product Development”

Richard Larouche, MD, Director, Medical Affairs, Anapharm

“Phase I Studies: Clinical and Study Design Issues”

Robert Dodge, PhD, Laboratory Director, Immunochemistry, Taylor Technology

“Immunogenicity: Clinical and Bioanalytical Issues”

Location:

Presenter:

Topic:

Quebec, Canada

Jacqueline Montalibet, Bionalytical Scientific Advisor, Anapharm

“Pharmacokinetic Characterization of Mycophenolate Mofetil and its Metabolite, Mycophenolic Acid in Normal Healthy Volunteers”

Location:

Chair:

Topic:

Cambridge, MA

William M. Egan, PhD, Vice President, PharmaNet Consulting

" Vaccine Adjuvants”

Location:

Co-Moderator:

Title:

Copenhagen, Denmark

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“The Spectrum of Anti-Infectives”

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Amsterdam, The Netherlands

Philippa Smit-Marshall, MD, Vice President, Medical Affairs

Modern Clinical Development Outsourcing Strategies

Jeffrey P. McMullen, President & CEO

“Models for Outsourcing in Clinical Research”

Location:

Speaker:

Topic:

Boston, MA

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

"Regulatory Challenges for Biologic/Drug Combination Products”

Location:

Instructor:

Topic:

Philadelphia, PA

William Egan, PhD, Vice President, PharmaNet Consulting

“Stability and Specifications for Biological and Biotechnology Derived Products”

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Speaker:

Topic:

Dallas, TX

Zia Haque, Associate Director, Data Management

“Project Management in Clinical Data Management – What is the Need?”

Bernadette Brown, Manager, Data Management

“When Coding Counts: Creating a Conscious Coding Environment”

Location:

Speaker:

Topic:

Philadelphia, PA

Peggy Schrammel, Vice President, Clinical Research (Phase IV Development)

“Strategies for Effective Sponsor/CRO Collaborations for Post Approval Studies – Creating a Long Term Partnership”

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Chair:

Topic:

Wilmington, DE

William Egan, PhD, Vice President, PharmaNet Consulting

“Regulatory Issues Specific to New Substrates”

Location:

Chair:

Topic:

Speaker:

Topic:

Buenos Aires, Argentina

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance

“Pharmacovigilance in Hospitals”

Jan Willem van der Velden, MD, FFPM, FISPE, Senior Vice President, Global Safety and Pharmacovigilance
Topic: “Pharmacovigilance from an Industry Perspective”

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Speaker:

Topic:

Houston, TX

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

“Potency Assays: What are the Requirements and Why”

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Speaker:

Topic:

Princeton, NJ

Pierre Olivier Tremblay, M.Sc, Senior Pharmacokineticist, Anapharm

“Modeling and Simulations in Product Development”

Location:

Speaker:

Topic:

Melbourne, Australia

Joyce Frey-Vasconcells, PhD, Executive Director, PharmaNet Consulting

“Biologic/Device Combination Products – A Regulatory Perspective”

Location:

Speaker:

Topic:

Barcelona, Spain

Kris Davé, Director, Clinical Trials Supply Management

“Regulatory and Risk Management in Drug Device Development”

Location:

Speaker:

Title:

San Diego, CA

Gary Fishbein, MD, MPH, Senior Medical Director

“Proving Clinical Effectiveness in Oncology – How are Alternatives to Mainstream Pathways and Endpoints Evolving and With What Impact on Clinical Trial Design and Approval”

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Chair:

Topic:

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Berlin, Germany

Andrew Fleming, Executive Director, Business Development

“Strategic Expansion into Emerging Economies – Tapping into cost-Effective Resources Together”

Philippa Smit-Marshall, Vice President, Medical Affairs

“Paediatric Investigation Plans – Challenges for the Outsourcing Department”

Location:

Speaker:

Topic:

Reston, VA

Andrew C. Chang, PhD, Executive Director, PharmaNet Consulting

"Efforts to Improve Methodologies/Analytics for Plasma-Derived Products during the Characterization of Approved Products"

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Speaker:

Topic 1:

Topic 2:

Poster
Presenters:

Topic:

Atlanta, GA

Saleh Hussain, Director, Bioanalytical Operations, Anapharm

“Dealing with Contamination and Carry-Over in Analytical Research”

“Root Cause Analysis During Out of Specification Investigation: A Step-By-Step Procedure”

Samuel Gu, RI Research Scientist;

Nuno Santos, Bioanalytical Investigator;

Aimin Tan, RI Coordinator;

Sharmila Van Heer, RI Coordinator; and

Saleh Hussain, Director, Bioanalytical Operations -- Anapharm

"Evaporation-Free and Automated Method for Determination of Diacerein (Rhein) in Human EDTA Plasma by LC-MS/MS"

Location:

Speaker:

Topic 1:

Topic 2:

Vienna, Austria

William M. Egan, PhD, Vice President, PharmaNet Consulting

“Stability Testing for Biologics: A Lifecycle Approach”

“WHO Guidance for Stability Testing of Vaccines”