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- Common Practices for Analytical Methods Transfer
Roberto Rodriguez-Diaz, Principal Scientist Kevin Bullock, Ph.D., Sr. Principal Scientist Steve Durban, Assoc. Research Fellow Tim Sullivan, Ph.D., Assoc. Research Fellow Pfizer BioTherapeutics Research and Development
- Cold Chain Management – A Strategic Quality Approach
Arminda Montero Distribution Quality Assurance Program Manager Global Pharmaceutical Products Division Abbott Laboratories, Inc.
- Unique Challenges and Opportunities for Enabling and Supporting Preclinical and Translational Areas of Biologic Development in India - A Perspective
Ashwin Datt, Dir., Development Sciences Sara Kenkare-Mitra, Ph.D., VP of Development Sciences Genentech, Inc.
- Monoclonal Antibody Manufacturing Strategies for the 21st Century
James Blackwell, Ph.D., MBA Sr. Consultant Thomas Ransohoff, VP and Sr. Consultant Howard L. Levine, Ph.D., President and Principal Consultant BioProcess Technology Consultants
- Where Do Consultants Fit in to the Early Development API Supply Chain?
Alan Harris Partner Alacrity Pharma Associates
- A Silent Epidemic: Protecting the Safety and Security of Drugs
David Howard Director of Product Protection for the Global Brand Integrity Group of Johnson & Johnson Medical Device and Diagnostics Chair of the International Authentication Association (IAA)
- Alliance Management and Project Management – Working Together as a Team
Kendra B. Eager, Ph.D., Assistant Vice President, Alliance Management Wyeth Pharmaceuticals
- Informed Consent for Optimal Usage of Samples Collected for Future Use in Global Clinical Trials
Amelia Wall Warner, PharmD, RPh, Associate Director, Experimental Medicine Head, Global Clinical Pharmacogenomics Merck Research Laboratories
- What’s Unique about Ligand Binding Assay Bioanalysis and What Have We Learned from Outsourcing?
Huifen Faye Wang, Ph.D. Director, Clinical Pharmacology, Emerging Markets Business Unit, Pfizer, Inc.
- Early Stage API and Intermediate Sourcing - Building Effective Partnerships
Richard B. Toupence, Sr. Sourcing Analyst, Process Research Merck Sharp & Dohme Corp.
- Looking at Clinical Trial Developments
Sally Shorthose Intellectual Property and Life Sciences Partner Bird & Bird
- Survival Strategies for Successful Pharmacovigilance Inspections
Patricia Moore GCP/ GPvP Operations Manager and Senior Pharmacovigilance Inspector Medicines and Healthcare Products Regulatory Agency
- The Landscape for Pharmaceutical Innovation: Drivers of Cost-Effective Clinical Research
Kenneth I. Kaitin, Ph.D. Director & Professor of Medicine Tufts Center for the Study of Drug Development Tufts University
- Drug Supply Modelling in Clinical Trials (Statistical Methodology)
Prof. Dr. Vladimir V. Anisimov, Director, Research Statistics Unit, GlaxoSmithKline
- The Changing Outsourcing Landscape
Joost Quaadgras Research Fellow, Pharm Sciences Arindam Bose, Ph.D., Executive Director, Biologics Strategy & Outsourcing, Worldwide Pharmaceutical Sciences Pfizer, Inc.
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