12th Applied Pharmaceutical Analysis Meeting
Event details
| Website: | |
| Location: | Boston Marriott Burlington, One Burlington Mall Road, Burlington MA, 01803, United States, America |
Register for this event.
See full 2015 program guide.
Click here for information about this years short courses.
Topics
Development and Validation of Biomarkers in Regulated Bioanalysis
Novel Drug Delivery
Oligonucleotides
Cell Biology Assays/NAb
Discovery
New Technologies that have Transitioned from Academia to Industry
Recent Advances in Assays for New Modalities
Metabolism and Catabolism of Large Molecules
Biotransformation
Drug Interactions – Biologics and Small Molecules
New Technologies
Non-P450 Metabolism / Electron Pushing / Unusual Metabolism
Plenary Speaker: Gerald W. Heddell, Director, Inspections Enforcement & Standards Division
Medicines and Healthcare Products Regulatory Agency, UK
Assuring the Global Supply Chain – How Bioanalysis Can Be a Weak link?
Plenary Speaker: Meena Subramanyam, Vice President, Translational Sciences and Technology, Biogen
Plenary Speaker: Linda G. Griffith, School of Engineering Teaching Innovation Professor of Biological and Mechanical Engineering and MacVicar Fellow, MIT
Move Over, Mice: How the Integration of Systems Biology with Organs on Chips is Humanizing Drug Development
Plenary Speaker: Laura Sepp-Lorenzino, Vice President, Entrepreneur in Residence, Alnylam
FDA Speakers
Carol Galvis, Ph.D, Division of Pulmonary, Allergy and Rheumatoid Products, FDA
Case Studies Based on the Relevance of Bioanalytical Guidance in Preclinical Data Review
Nilufer Tampal, Ph.D, Acting Director, Division of Bioequivalence III, FDA
Significant Bioanalytical Issues in the Review of Generic Drug Applications
Seongeun Cho, Ph.D., Acting Director, Division of Generic Drug Bioequivalence Evaluation, FDA
Recent FDA Bioanalytical Inspectorial Observations, and Impact on the Industry Applications
Lei Zhang, Ph.D., Office of Clinical Pharmacology, Senior Advisor for Regulatory Programs and Policy, FDA
Scientific Perspectives on Drug Interaction Evaluation in Drug Development