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Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Speaker:
Stacey Marden, PhD (she/her/hers)
– AstraZeneca Pharmaceuticals
Pharmaceutical Analysis Track
Tuesday, Jul 15th
11:55 AM - 12:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: North
Pharmaceutical Analysis Track
Tuesday, Jul 15th
12:00 PM - 12:30 PM
ET
Automated Viscosity Testing for Drug Formulation, Injectability and Cluster Size Analysis
Location: Vienna Ballroom: North
Partner Presenter:
Soheila Shabaniverki
Pharmaceutical Analysis Track
Sponsored By
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
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
Tuesday, Jul 15th
3:00 PM - 3:30 PM
ET
PBMC Sample Quality for Immune Monitoring
Location: Vienna Ballroom: North
Partner Presenter:
Virginia Litwin, PhD (she/her/hers)
– Eurofins Clinical Trial Solutions
Pharmaceutical Analysis Track
Sponsored By
Wednesday, Jul 16th
8:00 AM - 12:00 PM
ET
Recent Developments in Techniques for Pharmaceutical Analysis
Location: Vienna Ballroom: North
Moderator:
Beata Sweryda-Krawiec, PhD
– Boehringer Ingelheim
Pharmaceutical Analysis Track
Wednesday, Jul 16th
8:05 AM - 9:00 AM
ET
Enzyme-Powered API Manufacturing: Analytical Strategies for Ensuring Drug Quality
Location: Vienna Ballroom: North
Speaker:
Funing Yan, PhD
– Boehringer Ingelheim Pharma
Pharmaceutical Analysis Track
Wednesday, Jul 16th
9:00 AM - 9:30 AM
ET
Detecting and Controlling Residual Enzymes in the Production of Islatravir
Location: Vienna Ballroom: North
Speaker:
Gregory Hughes, PhD
– Merck & Co.
Pharmaceutical Analysis Track
Wednesday, Jul 16th
10:05 AM - 10:35 AM
ET
Broad-Shear, low-volume viscometry for the whole drug lifecycle with nanovisQ™
Location: Vienna Ballroom: North
Speaker:
Daniel French, PhD
– Qatch Technologies
Pharmaceutical Analysis Track
Wednesday, Jul 16th
10:35 AM - 10:50 AM
ET
Automated High-Throughput Solutions for Residual DNA Quantitation: Implementation and Outcomes.
Location: Vienna Ballroom: North
Rapid Fire Presenter:
Shruti B. Patel, MS
– Merck & Co., Inc.
Pharmaceutical Analysis Track
Wednesday, Jul 16th
10:50 AM - 11:55 AM
ET
Recent Developments in Techniques for Pharmaceutical Analysis: Panel Discussion
Location: Vienna Ballroom: North
Speaker:
Daniel French, PhD
– Qatch Technologies
Rapid Fire Presenter:
Shruti B. Patel, MS
– Merck & Co., Inc.
Speaker:
Funing Yan, PhD
– Boehringer Ingelheim Pharma
Speaker:
Gregory Hughes, PhD
– Merck & Co.
Moderator:
Beata Sweryda-Krawiec, PhD
– Boehringer Ingelheim
Pharmaceutical Analysis Track
Wednesday, Jul 16th
11:55 AM - 12:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: North
Moderator:
Beata Sweryda-Krawiec, PhD
– Boehringer Ingelheim
Pharmaceutical Analysis Track
Wednesday, Jul 16th
12:00 PM - 12:30 PM
ET
Derivatization Procedures in Analysis of Drug Substances
Location: Vienna Ballroom: North
Partner Presenter:
Rafail Usatinsky, PhD
– Siegfried Grafton Inc., d/b/a “Siegfried Acceleration Hub”
Pharmaceutical Analysis Track
Sponsored By
Wednesday, Jul 16th
1:30 PM - 3:00 PM
ET
Accelerating Analytical Development: Strategies and Case Studies
Location: Vienna Ballroom: North
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Pharmaceutical Analysis Track
Wednesday, Jul 16th
1:35 PM - 2:00 PM
ET
LCMS-based analytical methods for detecting genotoxic nitrosamine impurities.
Location: Vienna Ballroom: North
Speaker:
PhanikumarReddy Satti, Pursuing a PhD in Analytical Chemistry (he/him/his)
– confidential
Pharmaceutical Analysis Track
Wednesday, Jul 16th
2:00 PM - 2:25 PM
ET
Adopting ICH Q14: A Modern Approach to Analytical Procedure Development
Location: Vienna Ballroom: North
Speaker:
Jamie T. Wasylenko, MS (she/her/hers)
– AbbVie
Pharmaceutical Analysis Track
Wednesday, Jul 16th
2:25 PM - 2:50 PM
ET
Amorphous Solid Dispersions: Water Increase Challenges and Mitigation Best Practices
Location: Vienna Ballroom: North
Speaker:
Erin Copeland Jones
– Eli Lilly and Company
Pharmaceutical Analysis Track
Wednesday, Jul 16th
2:50 PM - 3:00 PM
ET
Closing Remarks
Location: Vienna Ballroom: North
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Pharmaceutical Analysis Track
Wednesday, Jul 16th
4:00 PM - 4:45 PM
ET
Accelerating Analytical Development: Strategies and Case Studies: Rapid Fires
Location: Vienna Ballroom: North
Rapid Fire Moderator:
Gregory Sacha, PhD (he/him/his)
– Simtra BioPharma Solutions
Pharmaceutical Analysis Track
Wednesday, Jul 16th
4:00 PM - 4:15 PM
ET
Utilization of Chelators for Analyzing Oxidative Degradation of Antibody Therapeutics
Location: Vienna Ballroom: North
Rapid Fire Presenter:
Poulami Majumder, PhD (she/her/hers)
– Eli Lilly and Company
Pharmaceutical Analysis Track
Wednesday, Jul 16th
4:15 PM - 4:30 PM
ET
Addressing Challenges of Validating Quantitative Impurity Methods for Controlling Biologics
Location: Vienna Ballroom: North
Rapid Fire Presenter:
Joseph J. Tulock, II, PhD
– Labcorp
Pharmaceutical Analysis Track
Wednesday, Jul 16th
4:30 PM - 4:45 PM
ET
Comparing Peroxide Quantitation Assays: A Study on Peptide Drug Degradation
Location: Vienna Ballroom: North
Rapid Fire Presenter:
Kingshuk Dutta, PhD (he/him/his)
– Eli Lilly and Company
Pharmaceutical Analysis Track
Thursday, Jul 17th
8:00 AM - 10:35 AM
ET
Joint Session on the Relationship Between Impurities and Immunogenicity
Location: Vienna Ballroom: South, East + West
Moderator:
Lynn Kamen, PhD
– BioAgilytix
Pharmaceutical Analysis Track
Bioanalytical Track
Thursday, Jul 17th
8:05 AM - 8:35 AM
ET
Framework towards control of immunogenicity risks for impurities and contaminants
Location: Vienna Ballroom: South, East + West
Speaker:
Timothy P. Hickling, PhD
– Roche
Pharmaceutical Analysis Track
Bioanalytical Track
Thursday, Jul 17th
8:35 AM - 9:05 AM
ET
Tiered, Data-driven Approach for Assessing the Safety of Peptide-Related Impurities
Location: Vienna Ballroom: South, East + West
Speaker:
Robert Siegel, PhD (he/him/his)
– Eli Lilly and Company
Pharmaceutical Analysis Track
Bioanalytical Track
Thursday, Jul 17th
9:05 AM - 9:35 AM
ET
Case Studies Assessing Immunogenicity Risk of Recombinant Therapeutic Protein Attributes with Implications for Parenteral Drug Product Manufacturing
Location: Vienna Ballroom: South, East + West
Speaker:
Joseph R. Cohen, PhD (he/him/his)
– Amgen Inc.
Pharmaceutical Analysis Track
Bioanalytical Track
Thursday, Jul 17th
9:35 AM - 10:30 AM
ET
Joint Session on the Relationship Between Impurities and Immunogenicity: Panel Discussion
Location: Vienna Ballroom: South, East + West
Moderator:
Lynn Kamen, PhD
– BioAgilytix
Speaker:
Timothy P. Hickling, PhD
– Roche
Speaker:
Robert Siegel, PhD (he/him/his)
– Eli Lilly and Company
Speaker:
Joseph R. Cohen, PhD (he/him/his)
– Amgen Inc.
Pharmaceutical Analysis Track
Bioanalytical Track
Thursday, Jul 17th
10:30 AM - 10:35 AM
ET
Closing Remarks: 2026 SSF Program Chair
Location: Vienna Ballroom: South, East + West
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Pharmaceutical Analysis Track
Bioanalytical Track