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Tuesday, November 11, 2025
7:00 AM - 8:30 AM
CT
Mentor Breakfast
7:00 AM - 8:30 AM
CT
Mentor Breakfast
Location: Stars at Night Prefunction
Career Development
Sponsored By
7:30 AM - 5:00 PM
CT
Speaker Ready Room
7:30 AM - 5:00 PM
CT
Speaker Ready Room
Location: 305
8:00 AM - 2:30 PM
CT
Industry Tour: BioConnect San Antonio Industry Immersion Experience (additional fee required)
8:00 AM - 2:30 PM
CT
Industry Tour: BioConnect San Antonio Industry Immersion Experience (additional fee required)
Location: Meet at the Henry B. Gonzalez Convention Center at 7:30 am
8:00 AM - 5:00 PM
CT
Registration Hours
8:00 AM - 5:00 PM
CT
Registration Hours
Location: Lobby Registration
8:30 AM - 4:30 PM
CT
Free Professional Headshots
8:30 AM - 4:30 PM
CT
Free Professional Headshots
Location: Careers 360, Exhibit Hall
Career Development
Sponsored By
8:30 AM - 4:30 PM
CT
LinkedIn Profile Critiques & Resume Reviews
8:30 AM - 4:30 PM
CT
LinkedIn Profile Critiques & Resume Reviews
Location: Careers 360, Exhibit Hall
Career Development
Sponsored By
8:30 AM - 4:30 PM
CT
Mock Interviews
8:30 AM - 4:30 PM
CT
Mock Interviews
Location: Careers 360, Exhibit Hall
Career Development
8:30 AM - 5:00 PM
CT
Solution Center Hours & Poster Presentations
8:30 AM - 5:00 PM
CT
Solution Center Hours & Poster Presentations
Location: Exhibit Halls 2-4
9:00 AM - 10:00 AM
CT
Complex Complexities: Insights into the Method Development and Binding Tendencies of Hemoproteins and their Heme-Bound Complexes.
9:00 AM - 10:00 AM
CT
Complex Complexities: Insights into the Method Development and Binding Tendencies of Hemoproteins and their Heme-Bound Complexes.
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker:
Joseph Campbell, Ph.D.
– Prolytix
Bioanalytics
Sponsored By
9:00 AM - 10:00 AM
CT
Hot Topic: Predictive Scale-Up/Scale-Down for Pharmaceuticals/Biopharmaceuticals
Hot Topic Moderator:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Hot Topic Speaker:
Kirk Roffi, M.S.
– Pfizer
Hot Topic Speaker:
Nima Yazdanpanah, PhD (he/him/his)
– Procegence
Hot Topic Speaker:
Mahaveer Satra
Hot Topic Speaker:
Ehab Moussa, PhD
– AbbVie Inc.
Manufacturing & Analytical Characterization
9:00 AM - 10:00 AM
CT
Hot Topic: Predictive Scale-Up/Scale-Down for Pharmaceuticals/Biopharmaceuticals
Location: 220
Hot Topic Moderator:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Hot Topic Speaker:
Kirk Roffi, M.S.
– Pfizer
Hot Topic Speaker:
Nima Yazdanpanah, PhD (he/him/his)
– Procegence
Hot Topic Speaker:
Mahaveer Satra
Hot Topic Speaker:
Ehab Moussa, PhD
– AbbVie Inc.
Manufacturing & Analytical Characterization
9:00 AM - 10:00 AM
CT
Negotiating Your Contract -- Ask Me Anything
Career Development
9:00 AM - 10:00 AM
CT
Negotiating Your Contract -- Ask Me Anything
Location: Careers 360, Exhibit Hall
Career Development
9:00 AM - 11:00 AM
CT
Symposium: Biomarker, Platform and Support
Moderator:
Shoshana Oberstein (she/her/hers)
– Takeda
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Biomarker, Platform and Support
Location: 221 AB
Moderator:
Shoshana Oberstein (she/her/hers)
– Takeda
Bioanalytics
9:00 AM - 9:30 AM
CT
Bioanalytical Assays for Gene Therapy Shedding Studies: Platforms and Validation
Location: 221 AB
Speaker:
Amanda L. Hays, PhD
– BioAgilytix
Bioanalytics
9:30 AM - 10:00 AM
CT
Composite Non-Invasive Testing Biomarker Enrichment in HBV-aHCC with Poor Prognosis
Location: 221 AB
Speaker:
Bin Ye, PhD.
– Huahui Health Biotech
Bioanalytics
10:00 AM - 10:30 AM
CT
Best Practice of Regulated Flow Cytometry by Chinese Bioanalysis Forum
Location: 221 AB
Speaker:
Jing Shi, PhD
– InnoStar
Bioanalytics
10:30 AM - 11:00 AM
CT
Advancing AAV Standards in Gene Therapy
Location: 221 AB
Speaker:
Ben Clarke, PhD
– United States Pharmacopeia
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Clinical Trials for Pediatric Populations
Moderator:
Sesha Rajeswari Talluri, M Pharm
– Ernest Mario School of Pharmacy
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Clinical Trials for Pediatric Populations
Location: 225 CD
Moderator:
Sesha Rajeswari Talluri, M Pharm
– Ernest Mario School of Pharmacy
Preclinical, Clinical, and Translational Sciences
9:00 AM - 9:30 AM
CT
Model-Informed Drug-Drug Interaction Assessment in Pediatric Populations
Location: 225 CD
Speaker:
Valvanera Vozmediano, PhD
– CTI Laboratories
Preclinical, Clinical, and Translational Sciences
9:30 AM - 10:00 AM
CT
Clinical Study Design and Effective Study in Pediatric Population
Location: 225 CD
Speaker:
Daniel A. Morgenstern, MBBChir PhD (he/him/his)
– Hospital for Sick Children
Preclinical, Clinical, and Translational Sciences
10:00 AM - 10:30 AM
CT
What Should Consider for the Drug Development in Pediatric Populations
Location: 225 CD
Speaker:
Lanyan Fang, Ph.D.
– FDA
Preclinical, Clinical, and Translational Sciences
10:30 AM - 11:00 AM
CT
The Effect of Formulation Excipients for Oral Absorption in Pediatrics
Location: 225 CD
Speaker:
Kazuki Matsui, PhD (he/him/his)
– Ono Pharmaceutical
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Emerging Technology as a Game Changer in Drug Discovery
Moderator:
Juan Guan, PhD
– University Of Texas At Austin
Discovery and Basic Research
9:00 AM - 11:00 AM
CT
Symposium: Emerging Technology as a Game Changer in Drug Discovery
Location: 303 AB
Moderator:
Juan Guan, PhD
– University Of Texas At Austin
Discovery and Basic Research
9:00 AM - 9:30 AM
CT
Circular Single-Stranded DNA-Mediated Genomic Integration
Location: 303 AB
Speaker:
Hao Wu, PhD
– Full Circles Therapeutics
Discovery and Basic Research
9:30 AM - 10:00 AM
CT
Organoid-Derived Small Intestinal Monolayers as a Novel Lymphatic Transport Model
Location: 303 AB
Speaker:
Rebecca L. Carrier, Ph.D.
– Northeastern University
Discovery and Basic Research
10:00 AM - 10:30 AM
CT
GEMclear Elevates Accuracy of Spatial Proteomics for Drug Target Discovery
Location: 303 AB
Speaker:
Xiaoyu Shi, PhD (she/her/hers)
– University of California, Irvine
Discovery and Basic Research
10:30 AM - 11:00 AM
CT
The Airway Revolution: Proteins and Probiotics in Pulmonary Drug Delivery
Location: 303 AB
Speaker:
Francesca Buttini, MPharm, PhD (she/her/hers)
– University of Parma
Discovery and Basic Research
9:00 AM - 11:00 AM
CT
Symposium: Enabling Technologies and Materials for Formulation Innovation 1
Moderator:
Haichen Nie, PhD
– Teva Pharmaceuticals
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Enabling Technologies and Materials for Formulation Innovation 1
Location: Stars at Night B1
Moderator:
Haichen Nie, PhD
– Teva Pharmaceuticals
Formulation and Delivery
9:00 AM - 9:30 AM
CT
Carbohydrate-Driven Control of Respirable Protein Powder Surfaces and Performance
Location: Stars at Night B1
Speaker:
Ashlee D. Brunaugh, PharmD, PhD (she/her/hers)
– University of Michigan
Formulation and Delivery
9:30 AM - 10:00 AM
CT
How to Resolve Dilemma of Selecting Excipients for Pediatric Products?
Location: Stars at Night B1
Speaker:
Anjali Agrawal, PhD (she/her/hers)
– Novo Nordisk
Formulation and Delivery
10:00 AM - 10:30 AM
CT
H-Bonded Organic Frameworks as Ultrasound-Programmable Delivery Platform
Location: Stars at Night B1
Speaker:
Huiliang (Evan) Wang, PhD
– University of Texas At Austin
Formulation and Delivery
10:30 AM - 11:00 AM
CT
Innovative Pathways: Trends in IND Studies for Nanomedicines
Location: Stars at Night B1
Hot Topic Speaker:
Robert D. Arnold, PhD (he/him/his)
– Auburn University, Dept Drug Disocvery and Development
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Enabling Technologies and Materials for Formulation Innovation 2
Moderator:
Pengbo Guo, PhD (he/him/his)
– Cybernax Bio
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Enabling Technologies and Materials for Formulation Innovation 2
Location: Stars at Night B2/B3
Moderator:
Pengbo Guo, PhD (he/him/his)
– Cybernax Bio
Formulation and Delivery
9:00 AM - 9:30 AM
CT
Lipids Evaluation in RNA-LNPs: Enhancing Endosomal Escape and Extrahepatic Delivery
Location: Stars at Night B2/B3
Speaker:
Aishwarya Saraswat, Ph.D.
– Regeneron Pharmaceuticals
Formulation and Delivery
9:30 AM - 10:00 AM
CT
Novel Biodegradable Class of Ionizable Lipids for Efficient RNA Delivery
Location: Stars at Night B2/B3
Speaker:
Raquib Hasan, PhD
– Millennium: The Takeda Oncology Company
Formulation and Delivery
10:00 AM - 10:30 AM
CT
Designing Lipid Nanoparticle Formulations for Pulmonary Delivery of Nucleic Acids
Location: Stars at Night B2/B3
Speaker:
Debadyuti Ghosh, Ph.D.
– University of Texas at Austin
Formulation and Delivery
10:30 AM - 11:00 AM
CT
AI-Driven Development of Next Generation Lipid Nanoparticles for mRNA Delivery
Location: Stars at Night B2/B3
Speaker:
Bowen Li, PhD
– University of Toronto/Department of Pharmaceutical Sciences
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 1
Moderator:
Carl Allenspach, PhD
– Bristol Myers Squibb
Manufacturing & Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 1
Location: 301 ABC
Moderator:
Carl Allenspach, PhD
– Bristol Myers Squibb
Manufacturing & Analytical Characterization
9:00 AM - 9:30 AM
CT
Analytical Insights into Bispecific Antibodies Manufactured Through Co-Culture/Column-based Redox
Location: 301 ABC
Speaker:
Jay (Jukyung) Kang, PhD (she/her/hers)
– Pfizer
Manufacturing & Analytical Characterization
9:30 AM - 10:00 AM
CT
Navigating Challenges of High Concentration Protein Therapeutics: Advanced Analytical Approaches
Location: 301 ABC
Speaker:
Hanmi Xi, PhD (she/her/hers)
– Merck and Co Inc
Manufacturing & Analytical Characterization
10:00 AM - 10:30 AM
CT
Recommendations for Biosimilar Manufacturers on Analytical and Functional Comparability Assessments
Location: 301 ABC
Speaker:
Anurag S. Rathore, PhD
– Indian Insitute of Technology Delhi
Manufacturing & Analytical Characterization
10:30 AM - 11:00 AM
CT
Overcoming Challenges in Characterizing (Degraded) Surfactants through Advanced Chromatographic Methods
Location: 301 ABC
Speaker:
Simon Eisele, PhD (he/him/his)
– Coriolis Pharma Research GmbH
Manufacturing & Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 2
Moderator:
Zack Zhiqiang Guo, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 2
Location: 302 ABC
Moderator:
Zack Zhiqiang Guo, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
9:00 AM - 9:30 AM
CT
Extrusion-Based 3D Printing Approaches for Rapid Prototyping of Orodispersible Films
Location: 302 ABC
Speaker:
R Jayachandra Babu Babu, Ph.D. (he/him/his)
– Auburn University
Manufacturing & Analytical Characterization
9:30 AM - 10:00 AM
CT
A Novel Laboratory-Scale Pneumatic Tube System (PTS) to Assess the Impact of Hospital PTS Transportation on the Product Quality of Therapeutic Monoclonal Antibodies
Location: 302 ABC
Speaker:
Kashappa Goud Desai, PhD
– GSK
Manufacturing & Analytical Characterization
10:00 AM - 10:30 AM
CT
Case Study on Manufacturing Scalability: Gelation Impact on Lyophilization
Location: 302 ABC
Speaker:
Hima Bindu Gottam, MS, MBA, RAC (US) (she/her/hers)
– University of Iowa, Pharmaceuticals
Manufacturing & Analytical Characterization
10:30 AM - 11:00 AM
CT
Analytical Control Strategy for Half-Life Extension Features of Biotherapeutics
Location: 302 ABC
Speaker:
Kevin Gurney, PhD (he/him/his)
– Merck Research Laboratories
Manufacturing & Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Special Considerations for Patient Populations in Clinical Trials
Moderator:
Viera Lukacova, PhD
– Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Special Considerations for Patient Populations in Clinical Trials
Location: 225 AB
Moderator:
Viera Lukacova, PhD
– Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
9:00 AM - 9:30 AM
CT
Hepatic Impairment and the Differential Effects on Drug Clearance Mechanisms
Location: 225 AB
Speaker:
Manthena V. Varma, PhD
– Pfizer Inc
Preclinical, Clinical, and Translational Sciences
9:30 AM - 10:00 AM
CT
AI in Designing and Delivering Clinical Trials for Specific Populations
Location: 225 AB
Speaker:
Raja B. Velagapudi, PhD (he/him/his)
– Tolmar Inc
Preclinical, Clinical, and Translational Sciences
10:00 AM - 10:30 AM
CT
Trial Design for Obese: Right Compound, Right Dose, Right Patient
Location: 225 AB
Speaker:
Maxime Le Merdy, Ph.D.
– Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
10:30 AM - 11:00 AM
CT
Model-Informed Design of Clinical Trial in Patients with Renal Impairment
Location: 225 AB
Speaker:
Viera Lukacova, PhD
– Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Using Mass Spec to Support PD/PK
Moderator:
Jennifer Cunliffe, PhD (she/her/hers)
– Novartis Institutes for BioMedical Research, Inc.
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Using Mass Spec to Support PD/PK
Location: 221 CD
Moderator:
Jennifer Cunliffe, PhD (she/her/hers)
– Novartis Institutes for BioMedical Research, Inc.
Bioanalytics
9:00 AM - 9:30 AM
CT
Measuring Receptor Occupancy in Peripheral Blood Cells Using Mass Spectrometry
Location: 221 CD
Speaker:
Joseph M. Eckenrode, PhD
– Merck & Co, Inc - Rahway, NJ
Bioanalytics
9:30 AM - 10:00 AM
CT
Uncover the Power of Mass Spectrometry Imaging (MSI) for Spatially Resolved Analysis of Biological Tissues
Location: 221 CD
Speaker:
Erin H. Seeley, PhD (she/her/hers)
– University of Texas at Austin
Bioanalytics
10:00 AM - 10:30 AM
CT
MS and Stable-Isotope Kinetic Methods for Target Biology & Biomarker Strategies
Location: 221 CD
Speaker:
Stephen F. Previs, PhD
– PharmaCadence Analytical Services, LLC
Bioanalytics
10:30 AM - 11:00 AM
CT
Innovative Mass Spectrometry Strategies for Clinical Bioanalysis and Monitoring
Location: 221 CD
Speaker:
Robin Kemperman, PhD (he/him/his)
– Children's Hospital of Philadelphia
Bioanalytics
9:00 AM - 4:00 PM
CT
Career Connections
9:00 AM - 4:00 PM
CT
Career Connections
Location: Careers 360, Exhibit Hall
Career Development
9:30 AM - 10:00 AM
CT
Coffee Break in the Solution Center
9:30 AM - 10:00 AM
CT
Coffee Break in the Solution Center
Location: Exhibit Halls 2-4
10:30 AM - 11:30 AM
CT
Bridging Science and Business: Essential knowledge for the Modern Scientist
Career Center Moderator:
Kim Huynh-Ba, M.S., PMP, FAAPS (she/her/hers)
– Pharmalytik
Career Center Speaker:
Honglue (Holly) Shen, PhD
– Merck
Career Development
10:30 AM - 11:30 AM
CT
Bridging Science and Business: Essential Knowledge for the Modern Scientist
Location: Careers 360, Exhibit Hall
Career Center Moderator:
Kim Huynh-Ba, M.S., PMP, FAAPS (she/her/hers)
– Pharmalytik
Career Center Speaker:
Honglue (Holly) Shen, PhD
– Merck
Career Development
10:30 AM - 11:30 AM
CT
Hot Topic: 2025 FDA Guidance BMV for Biomarkers: Impact and Path Forward
Hot Topic Speaker:
Steven P. Piccoli, PhD (he/him/his)
– SPARC
Hot Topic Speaker:
Lauren Stevenson, PhD (she/her/hers)
– Immunologix
Hot Topic Speaker:
Karen J. Quadrini, PhD
– Prothena Biosciences
Hot Topic Moderator:
Carmen Fernandez-Metzler, PhD
– PharmaCadence
Hot Topic Speaker:
Lakshmi Amaravadi, PhD (she/her/hers)
– AstraZeneca
Bioanalytics
10:30 AM - 11:30 AM
CT
Hot Topic: 2025 FDA Guidance BMV for Biomarkers: Impact and Path Forward
Location: 220
Hot Topic Speaker:
Steven P. Piccoli, PhD (he/him/his)
– SPARC
Hot Topic Speaker:
Lauren Stevenson, PhD (she/her/hers)
– Immunologix
Hot Topic Speaker:
Karen J. Quadrini, PhD
– Prothena Biosciences
Hot Topic Moderator:
Carmen Fernandez-Metzler, PhD
– PharmaCadence
Hot Topic Speaker:
Lakshmi Amaravadi, PhD (she/her/hers)
– AstraZeneca
Bioanalytics
11:00 AM - 1:30 PM
CT
Dedicated Solution Center Hours
11:00 AM - 1:30 PM
CT
Dedicated Solution Center Hours
Location: Exhibit Halls 2-4
12:00 PM - 1:00 PM
CT
Elevating Analytical Excellence: RNA Extraction and Singlicate use in LBA
12:00 PM - 1:00 PM
CT
Elevating Analytical Excellence: RNA Extraction and Singlicate use in LBA
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker:
Ruwini D. Rajapaksha, PhD, PMP (she/her/hers)
– Lovelace Biomedical
Bioanalytics
Sponsored By
12:00 PM - 1:00 PM
CT
Know Your IP and How to Protect It
Career Center Speaker:
Katrina Rogers, ASQ-Certified Manager of Quality and Organizational Excellence; ASQ-Certified Pharmaceutical GMP Professional (she/her/hers)
– KATRINA ROGERS CONSULTING LLC
Career Development
12:00 PM - 1:00 PM
CT
Know Your IP and How to Protect It
Location: Careers 360, Exhibit Hall
Career Center Speaker:
Katrina Rogers, ASQ-Certified Manager of Quality and Organizational Excellence; ASQ-Certified Pharmaceutical GMP Professional (she/her/hers)
– KATRINA ROGERS CONSULTING LLC
Career Development
1:00 PM - 3:00 PM
CT
Smoothie Station Sponsored by Eurofins Clinical Trial Solutions
1:00 PM - 3:00 PM
CT
Smoothie Station Sponsored by Eurofins Clinical Trial Solutions
Location: Booth #2729
Sponsored By
1:30 PM - 2:30 PM
CT
Keynote: Creating Community Connections to Enhance Clinical Research
Keynote Speaker:
J. Nikki McKoy, MPH, MBA (she/her/hers)
– RTI International
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Creating Community Connections to Enhance Clinical Research
Location: 225 CD
Keynote Speaker:
J. Nikki McKoy, MPH, MBA (she/her/hers)
– RTI International
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Designing, Formulating, and Manufacturing Molecules for Long-Acting Therapies
Keynote Speaker:
William Rowe, BS, PhD (he/him/his)
– Gilead Sciences
Moderator:
Pallavi P. Pawar
– Gilead Sciences
Manufacturing & Analytical Characterization
1:30 PM - 2:30 PM
CT
Keynote: Designing, Formulating, and Manufacturing Molecules for Long-Acting Therapies
Location: 302 ABC
Keynote Speaker:
William Rowe, BS, PhD (he/him/his)
– Gilead Sciences
Moderator:
Pallavi P. Pawar
– Gilead Sciences
Manufacturing & Analytical Characterization
1:30 PM - 2:30 PM
CT
Keynote: Evolving Decentralized Clinical Research: Lessons from Five Years of Progress
Keynote Speaker:
Jean Branttie, PhD (she/her/hers)
– Eli Lilly and Company
Moderator:
Amita Datta-Mannan, PhD
– Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Evolving Decentralized Clinical Research: Lessons from Five Years of Progress
Location: 225 AB
Keynote Speaker:
Jean Branttie, PhD (she/her/hers)
– Eli Lilly and Company
Moderator:
Amita Datta-Mannan, PhD
– Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Excipient Phase Behavior in Frozen and Freeze-Dried Systems – Potential Implications on Drug Stability
Keynote Speaker:
Raj Suryanarayanan, PhD
– University of Minnesota
Moderator:
Jayasree Srinivasan, PhD (she/her/hers)
– Simtra BioPharma Solutions
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: Excipient Phase Behavior in Frozen and Freeze-Dried Systems – Potential Implications on Drug Stability
Location: Stars at Night B1
Keynote Speaker:
Raj Suryanarayanan, PhD
– University of Minnesota
Moderator:
Jayasree Srinivasan, PhD (she/her/hers)
– Simtra BioPharma Solutions
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: Harnessing MALDI Mass Spectrometry Imaging for Biomarker Development in Hepatocellular Carcinoma Diagnosis and Prognosis
Keynote Speaker:
Anand Mehta
Moderator:
Ryan De Palma
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Harnessing MALDI Mass Spectrometry Imaging for Biomarker Development in Hepatocellular Carcinoma Diagnosis and Prognosis
Location: 221 CD
Keynote Speaker:
Anand Mehta
Moderator:
Ryan De Palma
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Illuminating Dynamic Architecture of Living Systems to Discover Biology and Identify Therapeutics
Keynote Speaker:
Xiaokun Shu, PhD
– University of California, San Francisco
Moderator:
Juan Guan, PhD
– University Of Texas At Austin
Discovery and Basic Research
1:30 PM - 2:30 PM
CT
Keynote: Illuminating Dynamic Architecture of Living Systems to Discover Biology and Identify Therapeutics
Location: 303 AB
Keynote Speaker:
Xiaokun Shu, PhD
– University of California, San Francisco
Moderator:
Juan Guan, PhD
– University Of Texas At Austin
Discovery and Basic Research
1:30 PM - 2:30 PM
CT
Keynote: Lipid Nanoparticles-Based mRNA Delivery for the Treatment of Genetic Diseases
Keynote Speaker:
Gaurav Sahay, PhD
– Oregon State University
Moderator:
Bowen Li, PhD
– University of Toronto/Department of Pharmaceutical Sciences
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: Lipid Nanoparticles-Based mRNA Delivery for the Treatment of Genetic Diseases
Location: Stars at Night B2/B3
Keynote Speaker:
Gaurav Sahay, PhD
– Oregon State University
Moderator:
Bowen Li, PhD
– University of Toronto/Department of Pharmaceutical Sciences
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: Navigating the Biomarker Spectrum: From Pharmacokinetics to Companion Diagnostics in a Complex Regulatory World
Keynote Speaker:
Sarah Hersey
Moderator:
Lina Luo, MS (she/her/hers)
– Bristol Myers Squibb
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Navigating the Biomarker Spectrum: From Pharmacokinetics to Companion Diagnostics in a Complex Regulatory World
Location: 221 AB
Keynote Speaker:
Sarah Hersey
Moderator:
Lina Luo, MS (she/her/hers)
– Bristol Myers Squibb
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Pharmaceutical Novel Modalities: Opportunities and Challenges
Keynote Speaker:
Otilia M. Koo, PhD, FAAPS (she/her/hers)
– Novo Nordisk
Moderator:
Carl Allenspach, PhD
– Bristol Myers Squibb
Manufacturing & Analytical Characterization
1:30 PM - 2:30 PM
CT
Keynote: Pharmaceutical Novel Modalities: Opportunities and Challenges
Location: 301 ABC
Keynote Speaker:
Otilia M. Koo, PhD, FAAPS (she/her/hers)
– Novo Nordisk
Moderator:
Carl Allenspach, PhD
– Bristol Myers Squibb
Manufacturing & Analytical Characterization
1:30 PM - 2:30 PM
CT
The Changing Landscape of the Pharmaceutical Industry
Career Center Speaker:
Carl Allenspach, PhD
– Bristol Myers Squibb
Career Center Speaker:
Amit Desai, PhD
– Astellas Pharma
Career Development
1:30 PM - 2:30 PM
CT
The Changing Landscape of the Pharmaceutical Industry
Location: Careers 360, Exhibit Hall
Career Center Speaker:
Carl Allenspach, PhD
– Bristol Myers Squibb
Career Center Speaker:
Amit Desai, PhD
– Astellas Pharma
Career Development
2:30 PM - 3:00 PM
CT
Coffee Break in the Solution Center
2:30 PM - 3:00 PM
CT
Coffee Break in the Solution Center
Location: Exhibit Halls 2-4
2:30 PM - 3:30 PM
CT
2025 AAPS High Impact Manuscript Award Rapid Fire Presentations
2:30 PM - 3:30 PM
CT
2025 AAPS High Impact Manuscript Award Rapid Fire Presentations
Location: Spotlight Stage A, Aisle 2500, Exhibit Hall
2:30 PM - 3:30 PM
CT
Hot Topic: New Technologies and Approaches for Translation to Clinical Practice
Hot Topic Moderator:
Seeprarani P. Rath, Ph.D.
– Rutgers - The State University of New Jersey
Hot Topic Speaker:
Colin W. Castleberry, PhD (he/him/his)
– Amgen
Hot Topic Speaker:
Rodrigo Cristofoletti, PhD (he/him/his)
– University of Florida
Preclinical, Clinical, and Translational Sciences
2:30 PM - 3:30 PM
CT
Hot Topic: New Technologies and Approaches for Translation to Clinical Practice
Location: 220
Hot Topic Moderator:
Seeprarani P. Rath, Ph.D.
– Rutgers - The State University of New Jersey
Hot Topic Speaker:
Colin W. Castleberry, PhD (he/him/his)
– Amgen
Hot Topic Speaker:
Rodrigo Cristofoletti, PhD (he/him/his)
– University of Florida
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
How to Become A Successful Consultant
Career Center Speaker:
Stacey J. Tannenbaum, PhD, FISoP
– SJTPharm LLC
Career Center Speaker:
Shingai Majuru, BPharm, MBA, PhD (he/him/his)
– JSM Pharmaceutical Consulting, LLC
Career Center Speaker:
Katy Moore, PharmD, RPh
– Allucent
Career Center Moderator:
Dave Watson
Career Development
3:00 PM - 4:00 PM
CT
How to Become A Successful Consultant
Location: Careers 360, Exhibit Hall
Career Center Speaker:
Stacey J. Tannenbaum, PhD, FISoP
– SJTPharm LLC
Career Center Speaker:
Shingai Majuru, BPharm, MBA, PhD (he/him/his)
– JSM Pharmaceutical Consulting, LLC
Career Center Speaker:
Katy Moore, PharmD, RPh
– Allucent
Career Center Moderator:
Dave Watson
Career Development
3:00 PM - 4:00 PM
CT
Rapid Fires: Biomarker, Platform and Support
Rapid Fire Moderator:
Chris Sucato
Bioanalytics
3:00 PM - 4:00 PM
CT
Rapid Fires: Biomarker, Platform and Support
Location: 221 AB
Rapid Fire Moderator:
Chris Sucato
Bioanalytics
3:00 PM - 3:15 PM
CT
Biomarker Challenges: Spiked Quality Controls, Can They Bias your Results?
Location: 221 AB
Rapid Fire Speaker:
Marc-Olivier Pepin, BSc
– Charles River
Bioanalytics
3:15 PM - 3:30 PM
CT
Practical Management of Conjugates for ADA and NAb Assays
Location: 221 AB
Rapid Fire Speaker:
Kuiyi Xing, Ph.D. (he/him/his)
– Celerion
Bioanalytics
3:30 PM - 3:45 PM
CT
Innovative Approaches to Micro-Sampling/Patient-Centric Sampling in Regulated Bioanalysis
Location: 221 AB
Rapid Fire Speaker:
Lina Luo, MS (she/her/hers)
– Bristol Myers Squibb
Bioanalytics
3:45 PM - 4:00 PM
CT
A Validated Assay for LC-MS/MS Analysis of an siRNA Therapeutic Drug Using Microsampling Devices
Location: 221 AB
Rapid Fire Speaker:
Todd Lusk, BS
– IQVIA Laboratories
Bioanalytics
3:00 PM - 4:00 PM
CT
Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 1
Rapid Fire Moderator:
Shoshana Oberstein (she/her/hers)
– Takeda
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 1
Location: 225 AB
Rapid Fire Moderator:
Shoshana Oberstein (she/her/hers)
– Takeda
Preclinical, Clinical, and Translational Sciences
3:00 PM - 3:15 PM
CT
Emerging Trends for FIH Studies Over the Last 4 Years
Location: 225 AB
Rapid Fire Speaker:
Vanessa A. Zann, BSc, PhD (she/her/hers)
– Quotient Sciences
Preclinical, Clinical, and Translational Sciences
3:15 PM - 3:30 PM
CT
Translational Pharmaceutics to Support Clinical Trials for Orphan/ Rare Diseases
Location: 225 AB
Rapid Fire Speaker:
Robert Cornog (he/him/his)
– Quotient Sciences
Preclinical, Clinical, and Translational Sciences
3:30 PM - 3:45 PM
CT
Advancing Inclusive Research: Thinking End-to-End and Starting Early in Development
Location: 225 AB
Rapid Fire Speaker:
Thierry Lave, PhD (he/him/his)
– Roche
Preclinical, Clinical, and Translational Sciences
3:45 PM - 4:00 PM
CT
Nemolizumab: Pediatric Extrapolation to Waive Placebo-Controlled Studies in Atopic Dermatitis
Location: 225 AB
Rapid Fire Speaker:
Nathalie Wagner, MSc (she/her/hers)
– Galderma R&D
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 2
Rapid Fire Moderator:
Hiroshi Sugimoto, PhD
– Takeda
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 2
Location: 225 CD
Rapid Fire Moderator:
Hiroshi Sugimoto, PhD
– Takeda
Preclinical, Clinical, and Translational Sciences
3:00 PM - 3:15 PM
CT
Multiplexed Targeted Proteomics for Translating Research Discoveries into Clinical Utility
Location: 225 CD
Rapid Fire Speaker:
Sudhir Putty Reddy, PhD (he/him/his)
– Bristol Myers Squibb
Preclinical, Clinical, and Translational Sciences
3:15 PM - 3:30 PM
CT
Iberdomide Biopharmaceutical Risk Assessment Using Model Informed Drug Development Approach
Location: 225 CD
Rapid Fire Speaker:
Ajay Saxena, PhD
– Bristol Myers Squibb
Preclinical, Clinical, and Translational Sciences
3:30 PM - 3:45 PM
CT
Novel Oral Molecules: Preclinical to Clinical Translation of Absorption-Disposition
Location: 225 CD
Rapid Fire Speaker:
Sandhya Mandlekar, PhD
– Genentech, Inc.
Preclinical, Clinical, and Translational Sciences
3:45 PM - 4:00 PM
CT
AAV-Based Gene Therapy Shedding Study Design in Clinical Trials
Location: 225 CD
Rapid Fire Speaker:
Yi Feng, Phd (she/her/hers)
– Lilly
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fires: Emerging Technology as a Game Changer in Drug Discovery
Rapid Fire Moderator:
Shanghao Li, PhD
– WuXi AppTec
Discovery and Basic Research
3:00 PM - 4:00 PM
CT
Rapid Fires: Emerging Technology as a Game Changer in Drug Discovery
Location: 303 AB
Rapid Fire Moderator:
Shanghao Li, PhD
– WuXi AppTec
Discovery and Basic Research
3:00 PM - 3:15 PM
CT
Discovery of Ionizable Lipids for Organ-Specific Targeting Using Machine Learning
Location: 303 AB
Rapid Fire Speaker:
Aditya Sundar
– Argonne National Laboratory
Discovery and Basic Research
3:15 PM - 3:30 PM
CT
Manifold Kernelization of Molecule's Quantum Information for AI-powered Drug Discovery
Location: 303 AB
Rapid Fire Speaker:
Tonglei Li, Ph.D., FAAPS
– Purdue University
Discovery and Basic Research
3:30 PM - 3:45 PM
CT
How Artificial Intelligence Can Progress Organoid Intelligence Towards New Treatments
Location: 303 AB
Rapid Fire Speaker:
Leela Raghava Jaidev Chakka, PhD
– University of Mississippi
Discovery and Basic Research
3:45 PM - 4:00 PM
CT
Rational Discovery and Design of Membrane-Permeable Endolysins Against Gram-Negative Bacteria
Location: 303 AB
Rapid Fire Speaker:
Sharon Shui Yee Leung, PhD (she/her/hers)
– Chinese University of Hong Kong
Discovery and Basic Research
3:00 PM - 4:00 PM
CT
Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 1
Rapid Fire Moderator:
Vivek Gupta, PhD
– St. John's University
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 1
Location: Stars at Night B1
Rapid Fire Moderator:
Vivek Gupta, PhD
– St. John's University
Formulation and Delivery
3:00 PM - 3:15 PM
CT
Room Temperature Aerosol Dehydration for Innovative Thermostable Formulations of Biologics
Location: Stars at Night B1
Rapid Fire Speaker:
Zehao Pan, PhD (he/him/his)
– Inaedis, Inc.
Formulation and Delivery
3:15 PM - 3:30 PM
CT
Hydroxypropyl-ꞵ-Cyclodextrin and Trehalose for Improved Stability of Spray-Dried Monoclonal Antibody
Location: Stars at Night B1
Rapid Fire Speaker:
YuTong (Tony) Tam, PhD
– Genentech, Inc.
Formulation and Delivery
3:30 PM - 3:45 PM
CT
Protein-Surfactant Interactions at Solid-Liquid Interfaces of Primary Packaging Materials
Location: Stars at Night B1
Rapid Fire Speaker:
Felicitas Guth, PhD (she/her/hers)
– BASF Corporation
Formulation and Delivery
3:45 PM - 4:00 PM
CT
Enhancing BCS II & IV Drugs Bioavailability with Lipid Formulations
Location: Stars at Night B1
Rapid Fire Speaker:
Karunakar Sukuru, R.Ph., Ph.D.
– Catalent Pharma Solutions
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 2
Rapid Fire Moderator:
Gaia Colombo, PhD (she/her/hers)
– University of Ferrara
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 2
Location: Stars at Night B2/B3
Rapid Fire Moderator:
Gaia Colombo, PhD (she/her/hers)
– University of Ferrara
Formulation and Delivery
3:15 PM - 3:30 PM
CT
Considerations for Additional Strength Waivers of ANDA Oral Modified-Release Product
Location: Stars at Night B2/B3
Rapid Fire Speaker:
James Polli, PhD (he/him/his)
– University of Maryland
Formulation and Delivery
3:30 PM - 3:45 PM
CT
Drugs as Excipients: Colistin as Dual-Function Inhalable Excipient
Location: Stars at Night B2/B3
Rapid Fire Speaker:
Mariana Romero-Gonzalez, MS
– University of Michigan
Formulation and Delivery
3:45 PM - 4:00 PM
CT
Mitigating Alcohol Dose Dumping in Modified Release Drug Products
Location: Stars at Night B2/B3
Rapid Fire Speaker:
Nitin K. Swarnakar, PhD (he/him/his)
– BASF
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fires: Shaping Biologics: From Molecules to Manufacturing Excellence
Rapid Fire Moderator:
Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)
– CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics
Manufacturing & Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fires: Shaping Biologics: From Molecules to Manufacturing Excellence
Location: 301 ABC
Rapid Fire Moderator:
Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)
– CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics
Manufacturing & Analytical Characterization
3:15 PM - 3:30 PM
CT
ADA-SCID Manufacturing and Outcomes: Predictive Analytics Case Study
Location: 301 ABC
Rapid Fire Speaker:
Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)
– CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics
Manufacturing & Analytical Characterization
3:30 PM - 3:45 PM
CT
Strategy for Bridging Methods for an Accelerated Late-Stage mAb
Location: 301 ABC
Rapid Fire Speaker:
Mania Dorrani, PhD (she/her/hers)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
3:45 PM - 4:00 PM
CT
Molecular Modeling Assisted Critical Quality Attribute Assessment
Location: 301 ABC
Rapid Fire Speaker:
Zoey Zheng, PhD (she/her/hers)
– Amgen
Manufacturing & Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fires: Smart Science for Complex Formulation: From Nano to Manufacturing
Rapid Fire Moderator:
Andre Hermans, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fires: Smart Science for Complex Formulation: From Nano to Manufacturing
Location: 302 ABC
Rapid Fire Moderator:
Andre Hermans, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
3:00 PM - 3:15 PM
CT
TLR7-Adjuvanted Ionizable Lipid Nanoparticles for mRNA Vaccine Delivery
Location: 302 ABC
Rapid Fire Speaker:
Bishal Misra, MS (he/him/his)
– West Virginia University
Manufacturing & Analytical Characterization
3:15 PM - 3:30 PM
CT
From Milligrams to Manufacturing: Efficient Formulation Screening for Drug-Eluting Implants
Location: 302 ABC
Rapid Fire Speaker:
Andreas Bramböck, MSc (he/him/his)
– MeltPrep
Manufacturing & Analytical Characterization
3:30 PM - 3:45 PM
CT
Recent Progress in High-Throughput Formulation of Nanocrystals at Laboratory Scale
Location: 302 ABC
Rapid Fire Speaker:
Lucia Lopez Vidal (she/her/hers)
– Queen's University Belfast
Manufacturing & Analytical Characterization
3:45 PM - 4:00 PM
CT
Case Study: Viral Inactivation in Bioprocessing Using Hydroxypropyl Beta-Cyclodextrins
Location: 302 ABC
Rapid Fire Speaker:
Tao Peng, PhD
– Roquette Asia Pacific Pte Ltd
Manufacturing & Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fires: Using Mass Spec to Support PD/PK
Rapid Fire Moderator:
Qian Veronica Qin
– Amgen
Bioanalytics
3:00 PM - 4:00 PM
CT
Rapid Fires: Using Mass Spec to Support PD/PK
Location: 221 CD
Rapid Fire Moderator:
Qian Veronica Qin
– Amgen
Bioanalytics
3:00 PM - 3:15 PM
CT
Linker-Cleavage Enzyme Comparison for Hybrid LC-MS Analysis of Antibody-Drug Conjugates
Location: 221 CD
Rapid Fire Speaker:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytics
3:15 PM - 3:30 PM
CT
A Streamlined, Rapid End-to-End Workflow for Discovery Bioanalysis Laboratories
Location: 221 CD
Rapid Fire Speaker:
Nikunj Tanna, MS (he/him/his)
– Waters Corporation
Bioanalytics
3:30 PM - 3:45 PM
CT
Mass Spectrometry-Imaging to Determine Drug Disposition Using Targeted Cell-Based Carriers
Location: 221 CD
Rapid Fire Speaker:
Ishwor Poudel, PhD (he/him/his)
– University of Washington
Bioanalytics
3:45 PM - 4:00 PM
CT
LC-MS Quantification of an ASO Drug Candidate in Human Plasma
Location: 221 CD
Rapid Fire Speaker:
Xuejun Sun, PhD (she/her/hers)
– Novartis Biomedical Research
Bioanalytics
3:30 PM - 4:30 PM
CT
Happy Hour Sponsored by 10x Genomics
3:30 PM - 4:30 PM
CT
Happy Hour Sponsored by 10x Genomics
Location: Booth #2836
Sponsored By
4:00 PM - 5:00 PM
CT
Happy Hour Sponsored by Croda Pharma + Avanti Polar Lipids
4:00 PM - 5:00 PM
CT
Happy Hour Sponsored by Croda Pharma + Avanti Polar Lipids
Location: Booth #3442
Sponsored By
5:30 PM - 7:00 PM
CT
Fellows Networking Reception (by invitation only)
5:30 PM - 7:00 PM
CT
Fellows Networking Reception (by invitation only)
Location: Lone Star A, Grand Hyatt San Antonio
Sponsored By
Pfizer
5:30 PM - 7:00 PM
CT
Sustaining Sponsor Reception (by invitation only)
5:30 PM - 7:00 PM
CT
Sustaining Sponsor Reception (by invitation only)
Location: Bowie ABC, Grand Hyatt San Antonio
5:30 PM - 9:30 PM
CT
American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Banquet Meeting
5:30 PM - 9:30 PM
CT
American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Banquet Meeting
Location: India Oven Restaurant: 1031 Patricia Dr. Suite 106 San Antonio, TX 78213
6:00 PM - 7:30 PM
CT
National Institute for Pharmaceutical Technology & Education (NIPTE) 20 Year Anniversary
6:00 PM - 7:30 PM
CT
NIPTE 20th Anniversary Reception
Location: Travis AB, Grand Hyatt San Antonio
6:00 PM - 8:00 PM
CT
University of Mississippi Pharmaceutics and Drug Delivery
6:00 PM - 8:00 PM
CT
University of Mississippi Pharmaceutics and Drug Delivery
Location: Travis CD, Grand Hyatt San Antonio
6:00 PM - 9:00 PM
CT
IPEC Foundation Awards Ceremony (Invited Guests Only)
6:00 PM - 9:00 PM
CT
IPEC Foundation Awards Ceremony (Invited Guests Only)
Location: Lone Star B, Grand Hyatt San Antonio
6:00 PM - 9:00 PM
CT
Simulations Plus After Hours Event (Invited Guests Only)
6:00 PM - 9:00 PM
CT
Simulations Plus After Hours Event (Invited Guests Only)
Location: Lone Star C, Grand Hyatt San Antonio
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