Join us for the 12th Annual APA Meeting
September 12-14, 2016

Short Course September 11th:  Bioanalytical Considerations for the Clinical Development of ADC's

Short Course Coordinator:  Darshana Jani, Senior Manager at Pfizer, Global Assy Lead


Boston Marriott Burlington

One Burlington Mall Road

Burlington, MA 01803

Important Notice: The Applied Pharmaceutical Software 2016 meeting will be held concurrently with the APA 2016 meeting on Wednesday, September 14th at the Boston Marriot Burlington, MA.  Registering for APA 2016 will allow access for the full three day event - APA & APS - September 12-14.


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

Biomarkers and Bioanalysis -  An Evolving Paradigm


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


Regulated Bioanalysis

State of the FDA

Development and Validation of Biomarkers in Regulated Bioanalysis

Novel Drug Delivery


Cell Biology Assays/NAb



Gene Therapy / New Modalities and Delivery Systems

New Technologies that have Transitioned from Academia to Industry

Recent Advances in Assays for New Modalities

Metabolism and Catabolism of Large Molecules


Metabolism-Based Drug Optimization

Drug Transporters

Drug Interactions - Biologics and Small Molecules

New Technologies

Non-P450 Metabolism / Electron Pushing / Unusual Metabolism


To Print a Copy of the APA 2015 Program Guide Click Here 

 Join our Linkedin Group:


Regulated Bioanalysis

Discovery Bioanalysis & New Technologies



Click here to register for the APA 2016 conference online.

Conference venue:
Boston Marriott Burlington
One Burlington Mall Road, Burlington MA 01803


The Boston Society

The Boston Society (R) is an internationally-recognized NON-PROFIT organization dedicated to bringing the best scientific ideas to industrial practice through focused, timely workshops and conferences. 501(c)3


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