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Tuesday, July 15, 2025
7:00 AM – 8:00 AM
ET
Continental Breakfast
7:00 AM – 8:00 AM
ET
Continental Breakfast
Location: London
7:00 AM – 3:30 PM
ET
Exhibit Hall Open
7:00 AM – 3:30 PM
ET
Exhibit Hall Open
Location: West Foyer
7:00 AM – 3:30 PM
ET
Registration
7:00 AM – 3:30 PM
ET
Registration
Location: West Foyer
8:00 AM – 12:00 PM
ET
Beyond the Analysis: Immunogenicity and Beyond
Moderator:
Mark Wissel
– Eurofins Viracor BioPharma Services
Bioanalytical Track
8:00 AM – 12:00 PM
ET
Beyond the Analysis: Immunogenicity and Beyond
Location: Vienna Ballroom: South, East + West
Moderator:
Mark Wissel
– Eurofins Viracor BioPharma Services
Bioanalytical Track
8:05 AM – 8:35 AM
ET
Evaluating the Immunogenicity of Peptides form the Clinical Pharmacology Perspective
Location: Vienna Ballroom: South, East + West
Speaker:
Mohsen Rajabi, PhD
– Novartis
Bioanalytical Track
8:35 AM – 9:05 AM
ET
Systematic Assessment of S/N Ratios as Alternative for ADA Titers
Location: Vienna Ballroom: South, East + West
Speaker:
HISANORI HARA, MSc
– B2S Life Sciences
Bioanalytical Track
9:05 AM – 9:35 AM
ET
ADA Interference for a Ligand Binding Drug Concentration Assay
Location: Vienna Ballroom: South, East + West
Speaker:
Karen Liao, MD
– Merck
Bioanalytical Track
10:05 AM – 10:35 AM
ET
Insights into Non-Bridging Assay Designs for Detection of Anti-Drug Antibodies
Location: Vienna Ballroom: South, East + West
Speaker:
Ronald R. Bowsher, PhD, FAAPS
– B2S Life Sciences
Bioanalytical Track
10:35 AM – 11:05 AM
ET
Bioanalytical Chicken Immunoglobulins as Better Immunogenicity Assay Reagents for Biotherapeutics
Location: Vienna Ballroom: South, East + West
Speaker:
JOHN P. PIRRO, n/a
– Sword Bio
Bioanalytical Track
11:05 AM – 11:55 AM
ET
Beyond the Analysis: Immunogenicity and Beyond: Panel Discussion
Location: Vienna Ballroom: South, East + West
Moderator:
Mark Wissel, PhD
– Eurofins Viracor BioPharma Services
Speaker:
Linlin Luo, Ph.D.
– Merck
Speaker:
HISANORI HARA, MSc
– B2S Life Sciences
Speaker:
Karen Liao, MD
– Merck
Speaker:
Ronald R. Bowsher, PhD, FAAPS
– B2S Life Sciences
Speaker:
JOHN P. PIRRO, n/a
– Sword Bio
Bioanalytical Track
11:55 AM – 12:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: South, East + West
Moderator:
Mark Wissel
– Eurofins Viracor BioPharma Services
Bioanalytical Track
8:00 AM – 12:00 PM
ET
Ensuring Patient Safety through Analytical Control of Impurities Across Modalities
Moderator:
Eric Munson, Ph.D.
Pharmaceutical Analysis Track
8:00 AM – 12:00 PM
ET
Ensuring Patient Safety through Analytical Control of Impurities Across Modalities
Location: Vienna Ballroom: North
Moderator:
Eric Munson, Ph.D.
Pharmaceutical Analysis Track
8:05 AM – 8:35 AM
ET
Extractables and Leachables: Analytical Strategies for Patient Safety
Location: Vienna Ballroom: North
Speaker:
Subathra Ramamoorthy, MS, RPh
– Veranova
Pharmaceutical Analysis Track
8:35 AM – 9:05 AM
ET
Characterization of Oxidation as a Non-Critical Quality Attribute
Location: Vienna Ballroom: North
Speaker:
Benjamin K. Wheat, MS (he/him/his)
– Pfizer
Pharmaceutical Analysis Track
9:05 AM – 9:35 AM
ET
Identifying and Quantifying Elemental Impurities Using X-Ray Fluorescence
Location: Vienna Ballroom: North
Speaker:
Dylan Lundgren, MS
– Malvern Panalytical
Pharmaceutical Analysis Track
10:05 AM – 10:35 AM
ET
Deconvolution and Identification of a Packaging Component Leachable from Blister Packed Tablets on Stability – A Case Study
Location: Vienna Ballroom: North
Speaker:
Adam Socia, PhD
– Organon
Pharmaceutical Analysis Track
10:35 AM – 11:05 AM
ET
A Unified Approach to Mass Balance in Pharmaceutical Stress Testing
Location: Vienna Ballroom: North
Speaker:
Stacey Marden, PhD (she/her/hers)
– AstraZeneca Pharmaceuticals
Pharmaceutical Analysis Track
11:05 AM – 11:55 AM
ET
Ensuring Patient Safety through Analytical Control of Impurities Across Modalities: Panel Discussion
Location: Vienna Ballroom: North
Moderator:
Eric Munson, Ph.D.
Speaker:
Subathra Ramamoorthy, MS, RPh
– Veranova
Speaker:
Benjamin K. Wheat, MS (he/him/his)
– Pfizer
Speaker:
Dylan Lundgren, MS
– Malvern Panalytical
Speaker:
Adam Socia, PhD
– Organon
Pharmaceutical Analysis Track
11:55 AM – 12:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: North
Pharmaceutical Analysis Track
9:35 AM – 10:05 AM
ET
Networking Break
9:35 AM – 10:05 AM
ET
Networking Break
Location: West Foyer
12:30 PM – 1:30 PM
ET
Networking Lunch
12:30 PM – 1:30 PM
ET
Networking Lunch
Location: ArtsGarden
Sponsored By
1:30 PM – 3:00 PM
ET
Beyond the Analysis: Pre-Analytics and Logistics
Moderator:
Indiwari Gopallawa, PhD
– AstraZeneca
Bioanalytical Track
1:30 PM – 3:00 PM
ET
Beyond the Analysis: Pre-Analytics and Logistics
Location: Vienna Ballroom: South, East + West
Moderator:
Indiwari Gopallawa, PhD
– AstraZeneca
Bioanalytical Track
1:35 PM – 2:00 PM
ET
Controlling Pre-Analytical Variables: Strategies, Insights, and Case Studies
Location: Vienna Ballroom: South, East + West
Speaker:
Clarinda D. Islam, MBA, MT(ASCP)
– Somru BioScience Inc
Bioanalytical Track
2:00 PM – 2:25 PM
ET
Improving Standard LC-MS Bioanalysis Approaches of siRNA Therapeutics from Tissues
Location: Vienna Ballroom: South, East + West
Speaker:
Douglas Carhuff
– Labcorp
Bioanalytical Track
2:25 PM – 2:50 PM
ET
Learnings from the External Implementation of Liquid Chromatography – Mass Spectrometry Analytical Methods for the Bioanalysis of Antibody Oligonucleotide Conjugates
Location: Vienna Ballroom: South, East + West
Speaker:
Sowjanya Garapati, MS
– Eli Lilly and Company
Bioanalytical Track
2:50 PM – 3:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: South, East + West
Moderator:
Indiwari Gopallawa, PhD
– AstraZeneca
Bioanalytical Track
1:30 PM – 3:00 PM
ET
Transferring Analytical Methods - Challenges and Opportunities
Moderator:
Xiuli Li, PhD (she/her/hers)
– Eli Lilly and Company
Pharmaceutical Analysis Track
1:30 PM – 3:00 PM
ET
Transferring Analytical Methods - Challenges and Opportunities
Location: Vienna Ballroom: North
Moderator:
Xiuli Li, PhD (she/her/hers)
– Eli Lilly and Company
Pharmaceutical Analysis Track
1:35 PM – 2:00 PM
ET
Streamlining Global Analytical Transfers While Maximizing Method Knowledge and Monitoring
Location: Vienna Ballroom: North
Speaker:
Amy R. Barker, PhD
– Eli Lilly & Company
Pharmaceutical Analysis Track
2:00 PM – 2:25 PM
ET
Risk Assessment to Facilitate and Structure Method Knowledge Transfer to a Receiving Lab
Location: Vienna Ballroom: North
Speaker:
Joselito Gonzalez, MS Quality Engineering (he/him/his)
– Organon
Pharmaceutical Analysis Track
2:25 PM – 2:50 PM
ET
Ensuring Consistency in Bioassay Method Transfer: Strategies for Overcoming Variability
Location: Vienna Ballroom: North
Speaker:
Andrew R. Taylor, MS (he/him/his)
– BioAgilytix
Pharmaceutical Analysis Track
2:50 PM – 3:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: North
Moderator:
Xiuli Li, PhD (she/her/hers)
– Eli Lilly and Company
Pharmaceutical Analysis Track
4:00 PM – 6:00 PM
ET
Networking Reception off-site at Eli Lilly Corporate Center
4:00 PM – 6:00 PM
ET
Networking Reception off-site at Eli Lilly Corporate Center
Location: Eli Lilly Corporate Center: 893 S Delaware St, Indianapolis, IN 46285
Sponsored By