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Tuesday, Jul 23rd
8:00 AM – 10:05 AM CST
Nitrosamine Analysis and Control
Location: Salon III
Moderator: Sachin Lohani, Ph.D. – Merck & Co., Inc.
Pharmaceutical Analysis
Tuesday, Jul 23rd
8:05 AM – 8:35 AM CST
Perspectives on Acceptable Intakes for Nitrosamines
Location: Salon III
Speaker: Leonardo Allain, PhD (he/him/his) – Merck & Co., Inc.
Pharmaceutical Analysis
Tuesday, Jul 23rd
8:35 AM – 9:05 AM CST
Predicting Nitrosamine Formation in Drug Products
Location: Salon III
Speaker: Eric J. Munson, PhD, FAAPS – Purdue University/Industrial and Physical Pharmacy
Pharmaceutical Analysis
Tuesday, Jul 23rd
9:05 AM – 9:35 AM CST
Accuracy Challenges in Nitrosamine Analysis
Location: Salon III
Speaker: Qiyao Li, PhD (she/her/hers) – United States Pharmacopeia
Pharmaceutical Analysis
Tuesday, Jul 23rd
9:35 AM – 10:05 AM CST
Navigating the Complexity of LC-MS Method Development for NDSRI Analysis - Case Studies
Location: Salon III
Speaker: Jan Yang, PhD – US FDA
Pharmaceutical Analysis
Tuesday, Jul 23rd
10:25 AM – 11:30 AM CST
Nitrosamine Analysis and Control - Continued
Location: Salon III
Moderator: Sachin Lohani, Ph.D. – Merck & Co., Inc.
Pharmaceutical Analysis
Tuesday, Jul 23rd
10:25 AM – 10:55 AM CST
Application of Structure-Activity Relationship (SAR) Modeling to Nitrosamine Impurities in Pharmaceuticals
Location: Salon III
Speaker: Naomi Kruhlak, PhD (she/her/hers) – US Food and Drug Administration
Pharmaceutical Analysis
Tuesday, Jul 23rd
10:55 AM – 11:25 AM CST
Nitrosamine Analysis and Control Panel Discussion
Location: Salon III
Speaker: Leonardo Allain, PhD (he/him/his) – Merck & Co., Inc.
Speaker: Eric J. Munson, Ph.D. – Purdue University
Speaker: Qiyao Li, PhD (she/her/hers) – United States Pharmacopeia
Speaker: Jan Yang, PhD – US FDA
Speaker: Naomi Kruhlak, PhD (she/her/hers) – US Food and Drug Administration
Pharmaceutical Analysis
Tuesday, Jul 23rd
11:30 AM – 12:00 PM CST
Practical Approaches to Characterizing Charged Variants
Location: Salon III
Partner Presenter: Shawn Fitzgibbons, MS Chemistry (he/him/his) – Catalent Pharma Solutions
Pharmaceutical Analysis
Sponsored By
Tuesday, Jul 23rd
1:30 PM – 3:10 PM CST
Stuck in the Middle - Methodologies for Oligonucleotides, Peptides and Other Medium-Sized Molecules
Location: Salon III
Moderator: Eric J. Munson, PhD, FAAPS – Purdue University/Industrial and Physical Pharmacy
Pharmaceutical Analysis
Tuesday, Jul 23rd
1:35 PM – 2:05 PM CST
Expanding the Characterization Capability of Therapeutic LNPs
Location: Salon III
Speaker: Jiawei Gong, PhD (she/her/hers) – Bristol Myers Squibb
Pharmaceutical Analysis
Tuesday, Jul 23rd
2:05 PM – 2:35 PM CST
Design and Implementation of a Platform Analytical Characterization Strategy for Rapid Candidate Screening and the study of Degradation Mechanism Pathways of Synthetic Macrocyclic Peptide Therapeutics
Location: Salon III
Speaker: Sam Yang
Pharmaceutical Analysis
Tuesday, Jul 23rd
2:35 PM – 3:05 PM CST
Analytical Comparability of a Complex Medium-Sized Biotherapeutic
Location: Salon III
Speaker: Mark Chipley, MS – Pfizer
Pharmaceutical Analysis
Tuesday, Jul 23rd
3:30 PM – 4:15 PM CST
Rapid Fire Presentations: Pharmaceutical Analysis
Location: Salon III
Rapid Fire Moderator: Jeff Patrick, PhD – BioAgilytix Labs
Pharmaceutical Analysis
Tuesday, Jul 23rd
3:30 PM – 3:45 PM CST
Advancing Quality Control for CRISPR-Cas9 Systems: Separation of CRISPR Components using Ion Exchange Chromatography
Location: Salon III
Rapid Fire Presenter: Rachel Ginther, PhD (she/her/hers) – MRIGlobal
Pharmaceutical Analysis
Tuesday, Jul 23rd
3:45 PM – 4:00 PM CST
Size Exclusion Chromatography for LNP Analysis: Strategies for Dealing with Method Development Challenges
Location: Salon III
Rapid Fire Presenter: Abraham S. Finny, PhD, PChem – Waters Corporation
Pharmaceutical Analysis
Tuesday, Jul 23rd
4:00 PM – 4:15 PM CST
Implications of Draft FDA Guidance on Potency Assays for G&CT
Location: Salon III
Rapid Fire Presenter: Manoj Baskaran, MS (he/him/his) – BioAgilytix Labs
Pharmaceutical Analysis
Wednesday, Jul 24th
8:00 AM – 10:05 AM CST
Analytical Methods for Complex and Novel Formulations
Location: Salon III
Moderator: Nathan Contrella, PhD (he/him/his) – Merck Research Laboratories
Pharmaceutical Analysis
Wednesday, Jul 24th
8:05 AM – 8:35 AM CST
Detecting Crystallinity at Extremely Low Levels by Nonlinear Optical Spectroscopy
Location: Salon III
Speaker: Garth Simpson, PhD – Purdue University
Pharmaceutical Analysis
Wednesday, Jul 24th
8:35 AM – 9:05 AM CST
Challenges of Gel-Based Formulation Analysis
Location: Salon III
Speaker: Adam Socia, PhD – Organon
Pharmaceutical Analysis
Wednesday, Jul 24th
9:05 AM – 9:35 AM CST
Characterization of Complex Drug Product using Asymmetrical Flow Field Flow Fractionation (AF4): Challenges and Opportunities
Location: Salon III
Speaker: Haiou Qu, PhD (he/him/his) – US Food and Drug Administration
Pharmaceutical Analysis
Wednesday, Jul 24th
9:35 AM – 10:05 AM CST
New Analytical Frameworks to Accelerate Method Development of Vaccine Adjuvants across Complex Formulations
Location: Salon III
Speaker: Caleb Kinsey (he/him/his) – Merck
Pharmaceutical Analysis
Wednesday, Jul 24th
10:25 AM – 11:30 AM CST
Analytical Methods for Complex and Novel Formulations - Continued
Location: Salon III
Moderator: Nathan Contrella, PhD (he/him/his) – Merck Research Laboratories
Pharmaceutical Analysis
Wednesday, Jul 24th
10:25 AM – 10:55 AM CST
Dissolution Method Development of a Parenteral Formulation
Location: Salon III
Speaker: Limin Zhang, MS (she/her/hers) – Bristol-Myers Squibb
Pharmaceutical Analysis
Wednesday, Jul 24th
10:55 AM – 11:25 AM CST
New USP General Chapters for the Complex Injectables (Microspheres and Iron Colloidals) and Drug-Device Combination Products
Location: Salon III
Speaker: Prabhakar R. Gruddanti, MS, PhD (he/him/his) – United States Pharmacopeia
Pharmaceutical Analysis
Wednesday, Jul 24th
1:30 PM – 3:10 PM CST
Challenges in Analytical Method Validations and Transfers
Location: Salon III
Moderator: Landon Greene, PhD (he/him/his) – Vertex Pharmaceuticals
Pharmaceutical Analysis
Wednesday, Jul 24th
1:35 PM – 2:05 PM CST
Pitfalls in Underpowered and Poorly Designed Validation Studies
Location: Salon III
Speaker: Steven Walfish, MA MBA (he/him/his) – Statistical Outsourcing Services
Pharmaceutical Analysis
Wednesday, Jul 24th
2:05 PM – 2:35 PM CST
Transferring an AAV Genome Titer Method - Lessons and Keys to Success
Location: Salon III
Speaker: Sabine Wenzel, PhD (she/her/hers) – Eli Lilly
Pharmaceutical Analysis
Wednesday, Jul 24th
2:35 PM – 3:05 PM CST
Transfer of Analytical Procedures as Part of the Method Lifecycle: USP Chapters <1224> and <1220>
Location: Salon III
Speaker: Margareth R. Marques, MS, PhD (she/her/hers) – U. S. Pharmacopeia
Pharmaceutical Analysis
Wednesday, Jul 24th
3:30 PM – 4:15 PM CST
Rapid Fire Presentations: Pharmaceutical Analysis
Location: Salon III
Moderator: Sachin Lohani, Ph.D. – Merck & Co., Inc.
Pharmaceutical Analysis
Wednesday, Jul 24th
3:30 PM – 3:45 PM CST
Global Harmonization of PCR: An Initial Study with Six World Health Organization Reference Strains
Location: Salon III
Rapid Fire Presenter: Sharon J. Manley, PhD – Eurofins Viracor Biopharma Services
Pharmaceutical Analysis
Wednesday, Jul 24th
3:45 PM – 4:00 PM CST
Transfer and Validation of Flow Cytometry Assay Across Platforms and Labs
Location: Salon III
Rapid Fire Presenter: Manoj Baskaran, MS (he/him/his) – BioAgilytix Labs
Pharmaceutical Analysis
Wednesday, Jul 24th
4:00 PM – 4:15 PM CST
Stability Study and Beyond-Use Date Determination of a Compounded Labetalol Suspension
Location: Salon III
Rapid Fire Presenter: Busayo O. Akodu, Bpharm. (he/him/his) – School of Pharmacy, Southern Illinois University, Edwardsville.
Pharmaceutical Analysis
Thursday, Jul 25th
8:00 AM – 10:40 AM CST
Challenges in Analytical Method Validations and Transfers: Bio and Pharm Joint Session
Location: Salon II
Moderator: Sachin Lohani, Ph.D. – Merck & Co., Inc.
BioanalyticalPharmaceutical Analysis
Thursday, Jul 25th
8:05 AM – 8:35 AM CST
Strategies for Overcoming Challenges with Bioanalytical Method Transfers
Location: Salon II
Speaker: Amanda L. Hays, PhD – BioAgilytix
BioanalyticalPharmaceutical Analysis
Thursday, Jul 25th
8:35 AM – 9:05 AM CST
Strategies for the Modernization of Legacy Transfer Methods
Location: Salon II
Speaker: Erik Jerks, B.S. – Eurofins Pharma Bioanalytics Services, LLC
BioanalyticalPharmaceutical Analysis
Thursday, Jul 25th
9:05 AM – 9:35 AM CST
Risk Assessment for Lab Training and Readiness Prior to Method Transfer
Location: Salon II
Speaker: Joselito Gonzalez, MS Quality Engineering (he/him/his) – Organon
BioanalyticalPharmaceutical Analysis
Thursday, Jul 25th
9:35 AM – 10:05 AM CST
Lessons Learned from Registrational Analytical Methods Transfer and Validation at External CMOs in Support of Drug Substance Processes
Location: Salon II
Speaker: Peter I. Tattersall, PhD (he/him/his) – Analytical Strategy & Operations / Bristol Myers Squibb
BioanalyticalPharmaceutical Analysis
Thursday, Jul 25th
10:05 AM – 10:35 AM CST
Joint Session: Panel Discussion
Location: Salon II
Speaker: Amanda L. Hays, PhD – BioAgilytix
Speaker: Erik Jerks, B.S. – Eurofins Pharma Bioanalytics Services, LLC
Speaker: Joselito Gonzalez, MS Quality Engineering (he/him/his) – Organon
Speaker: Peter I. Tattersall, PhD (he/him/his) – Analytical Strategy & Operations / Bristol Myers Squibb
Moderator: Sachin Lohani, Ph.D. – Merck & Co., Inc.
BioanalyticalPharmaceutical Analysis
Thursday, Jul 25th
10:35 AM – 10:40 AM CST
Closing Remarks
Location: Salon II
Moderator: Lynn Kamen, PhD – BioAgilytix Labs
BioanalyticalPharmaceutical Analysis