Join us for the 13th Annual APA Meeting
September 18-20, 2017

Omni Providence Hotel 
1 West Exchange Street 
Providence, RI 02903

September 17: Short Course

"Practical Considerations for Biomarker Bioanalysis: Scientific & Regulatory Perspective"

Course Moderator: Darshana Jani, Pfizer

 Speakers from the FDA

Michael Skelly, PhD, Office of Study Integrity and Surveillance, Division of Generic Drug Bioequivalence Evaluation, FDA, “Current Agency Thinking on Immunogenicity Assays and Triggers for Inspections of Immunogenicity Studies Observed During Submission Reviews”

Carol Galvis, PhD, The Center for Drug Evaluation and Research, FDA, "Achieving Adequate Drug Exposure in Nonclinical Studies: the Relevance of Bioanalytical Data - An FDA Perspective"

Bowen Cui, PhD, Regulatory Scientific Reviewer at FDA/CDRH/OIR/DMGP, "Development, Validation, and Regulatory Approval of Companion Diagnostics"

APA 2017 Plenary Speakers

	Henry Fung MD, FACP, FRCPE, Vice-Chair, Department of Hematology/Oncology, Director, Temple-Fox Chase BMT Program "The Evolving Role of Engineered T-Cells for the Treatment of Cancer"
	Hildegund C.J. Ertl, MD, Caspar Wistar Professor in Vaccine Research, Professor, The Wistar Institute Vaccine Center "Title TBA"
	F. Peter Guengerich, Tadashi Inagami Chair in Biochemistry, Vanderbilt University School of Medicine "The Importance of Cytochrome P450 Enzymes in Drug Development"
	Matthew Stanton, PhD, Vice President, Head of Chemistry, Moderna Therapeutics "Messenger RNA as a Novel Therapeutic Approach"

APA 2017 Workshops 

Regulated Bioanalysis

Regulatory Session / Guidance

Personalized Medicine - Scientific and Regulatory Aspects

Non-Traditional Applications in Bioanalysis / Biotherapeutics

Immuno-Oncology Biomarkers

Controversial Topics in Bioanalysis

Discovery

Qualification/Quantification of Large Molecules

Bioanalytical Issues with Biomarkers

New Technologies

Microbiome

Discovery DMPK Support in a Biotech or Start-Up Company

Mechanistic ADME

Applications of Isotope Labeled Compounds in Drug Development

New Guidance for DDI

Biotransformation Challenges

Biocatalysis for Metabolite Generation and Lead Diversification

Biotransformation of Large Molecules

To Print a Copy of the APA 2016 Program Guide Click Here