- Tuesday, May 14, 2024
8:30 AM – 9:30 AM PT
AAPS Bioanalytical Community Membership Meeting
8:30 AM – 9:30 AM PT
AAPS Bioanalytical Community Membership MeetingLocation:Yosemite ACommunity Leader: – Merck Research Laboratories
Daniel S. Spellman, PhD – Merck Research Laboratories ### 1286023###Community Leader###Distinguished Scientist###Merck Research Laboratories###Community Leader: – Merck Research Laboratories
### 8:30 AM – 3:30 PM PT
Registration Hours
8:30 AM – 3:30 PM PT
Registration Hours
Location:Yosemite Foyer
8:30 AM – 3:30 PM PT
Speaker Ready Room
8:30 AM – 3:30 PM PT
Speaker Ready Room
Location:Executive Boardroom
9:30 AM – 11:00 AM PT
Executive Track - Cell and Gene Therapies at the Intersection of Business
9:30 AM – 11:00 AM PT
Executive Track - Cell and Gene Therapies at the Intersection of Business and Science Location:Franciscan A&BModerator: – Potens Pharmaceuticals
Executive Education Speaker: – CTMC
Executive Education Speaker: – QPS
Executive Education Speaker: – iXCells Biotechnologies
Executive Education Speaker: – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics
Executive Track
Praveen Tyle, PhD – Potens Pharmaceuticals ### 2277761###Moderator###Founder & CEO###Potens Pharmaceuticals###Moderator: – Potens Pharmaceuticals
### @@@ Jason Bock, Ph.D. – CTMC ### 2277760###Executive Education Speaker###Co-Founder + CEO###CTMC###Executive Education Speaker: – CTMC
### @@@ Kimberley Buytaert-Hoefen, Ph.D. – QPS ### 2288256###Executive Education Speaker###Executive Director and Global Head of Regulatory Affairs###QPS###Executive Education Speaker: – QPS
### @@@ Nianwei Lin, PhD (he/him/his) – iXCells Biotechnologies ### 2296275###Executive Education Speaker###President###iXCells Biotechnologies###Executive Education Speaker: – iXCells Biotechnologies
### he/him/his @@@ Hari Pujar, Ph.D. – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics ### 2242482###Executive Education Speaker######Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics###Executive Education Speaker: – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics
### 9:30 AM – 11:00 AM PT
Symposium: Development Strategy for Novel Targeted Therapeutic DeliveryModerator: – BioAgilytix Labs
Novel Strategies to Advance Biotherapeutic Development
9:30 AM – 11:00 AM PT
Symposium: Development Strategy for Novel Targeted Therapeutic DeliveryLocation:Plaza AModerator: – BioAgilytix Labs
Novel Strategies to Advance Biotherapeutic Development
Lynn Kamen, PhD – BioAgilytix Labs ### 1680382###Moderator###Scientific Officer###BioAgilytix Labs###Moderator: – BioAgilytix Labs
### 9:30 AM – 10:00 AM PT
An Ultra-Sensitive Human pS413 Tau Assay in Cerebrospinal FluidLocation:Plaza ANovel Strategies to Advance Biotherapeutic Development
Xuemei Zhao, PhD – Merck ### 2173997###Speaker###Senior Principal Scientist###Merck###Speaker: – Merck
### 10:00 AM – 10:30 AM PT
The Advancement of High-Plex Bioanalytical Technology and its Data IntegrationLocation:Plaza ASpeaker: – Takeda Pharmaceutical Company Limited
Novel Strategies to Advance Biotherapeutic Development
Tomoki Yamashita, PhD (he/him/his) – Takeda Pharmaceutical Company Limited ### 2173998###Speaker###Associate Scientist###Takeda Pharmaceutical Company Limited###Speaker: – Takeda Pharmaceutical Company Limited
### he/him/his10:30 AM – 11:00 AM PT
Hybrid LBA LC-MS Assay: Does One Size Fit All?Location:Plaza ASpeaker: – US Food and Drug Administration
Novel Strategies to Advance Biotherapeutic Development
Jinhui Zhang, PhD (he/him/his) – US Food and Drug Administration ### 603101###Speaker###Chemist###US Food and Drug Administration###Speaker: – US Food and Drug Administration
### he/him/his9:30 AM – 11:00 AM PT
Symposium: Preformulation and Formulation Approaches for Biologics and New ModalitiesModerator: – Teva Pharmaceuticals
Advances in Discovery, Formulation, and Delivery of New Modalities
9:30 AM – 11:00 AM PT
Symposium: Preformulation and Formulation Approaches for Biologics and New ModalitiesLocation:Yosemite BCModerator: – Teva Pharmaceuticals
Advances in Discovery, Formulation, and Delivery of New Modalities
Haichen Nie, PhD – Teva Pharmaceuticals ### 1976730###Moderator###Associate Director###Teva Pharmaceuticals###Moderator: – Teva Pharmaceuticals
### 9:30 AM – 10:00 AM PT
Novel Approaches to Cancer Immunotherapy: a Strategic OverviewLocation:Yosemite BCSpeaker: – Teva Pharmaceuticals
Advances in Discovery, Formulation, and Delivery of New Modalities
Steffen Nock, PhD (he/him/his) – Teva Pharmaceuticals ### 2173967###Speaker###Chief Science Officer, Head of Global Discovery, Early Development & CMC###Teva Pharmaceuticals###Speaker: – Teva Pharmaceuticals
### he/him/his10:00 AM – 10:30 AM PT
High-Throughput Screening and Structural Characterization for Oligonucleotide LNPLocation:Yosemite BCSpeaker: – Genentech, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Chunwan Yen, PhD (she/her/hers) – Genentech, Inc. ### 1768341###Speaker###Sr. Principal Scientist###Genentech, Inc.###Speaker: – Genentech, Inc.
### she/her/hers10:30 AM – 11:00 AM PT
Structure-Function Relationships in Lyophilized Biologics for Stability PredictionLocation:Yosemite BCSpeaker: – Purdue University/Industrial and Physical Pharmacy
Advances in Discovery, Formulation, and Delivery of New Modalities
Eric J. Munson, PhD, FAAPS – Purdue University/Industrial and Physical Pharmacy ### 856795###Speaker###Dane O. Kildsig Chair and Head###Purdue University/Industrial and Physical Pharmacy###Speaker: – Purdue University/Industrial and Physical Pharmacy
### 10:00 AM – 11:00 AM PT
Coffee Break in the Solution Center
10:00 AM – 11:00 AM PT
Coffee Break in the Solution CenterLocation:Grand Ballroom AB
10:00 AM – 11:00 AM PT
Hot Topic: Particle Safety and Size Threshold for Particle Visibility RevisitedHot Topic Moderator: – Takeda
Advances in Discovery, Formulation, and Delivery of New Modalities
10:00 AM – 11:00 AM PT
Hot Topic: Particle Safety and Size Threshold for Particle Visibility RevisitedLocation:Yosemite AHot Topic Moderator: – Takeda
Advances in Discovery, Formulation, and Delivery of New Modalities
Nazila Miller, PhD (she/her/hers) – Takeda ### 2204972###Hot Topic Moderator###Director###Takeda###Hot Topic Moderator: – Takeda
### she/her/hers10:00 AM – 10:20 AM PT
Reassessing Size Threshold and Other Particle Characteristics that Define Particle VisibilityLocation:Yosemite AHot Topic Speaker: – Genentech
Advances in Discovery, Formulation, and Delivery of New Modalities
Miguel Saggu, PhD (he/him/his) – Genentech ### 2173969###Hot Topic Speaker###Sr. Principal Scientist###Genentech###Hot Topic Speaker: – Genentech
### he/him/his10:20 AM – 10:40 AM PT
Silicone Oil Particles in Protein Drug Product – Are These a Significant Immunogenicity Risk Factor? Location:Yosemite AHot Topic Speaker: – Amgen
Advances in Discovery, Formulation, and Delivery of New Modalities
Kimya Nourbakhsh, PhD (she/her/hers) – Amgen ### 2204974###Hot Topic Speaker###Principal Scientist###Amgen###Hot Topic Speaker: – Amgen
### she/her/hers10:40 AM – 11:00 AM PT
Panel DiscussionLocation:Yosemite AHot Topic Speaker: – Genentech
Hot Topic Speaker: – Spyre Therapeutics
Hot Topic Speaker: – Amgen
Hot Topic Moderator: – Takeda
Advances in Discovery, Formulation, and Delivery of New Modalities
Miguel Saggu, PhD (he/him/his) – Genentech ### 2173969###Hot Topic Speaker###Sr. Principal Scientist###Genentech###Hot Topic Speaker: – Genentech
### he/him/his @@@ Tapan K. Das, PhD, FAAPS – Spyre Therapeutics ### 2173968###Hot Topic Speaker###Executive Director###Spyre Therapeutics###Hot Topic Speaker: – Spyre Therapeutics
### @@@ Kimya Nourbakhsh, PhD (she/her/hers) – Amgen ### 2204974###Hot Topic Speaker###Principal Scientist###Amgen###Hot Topic Speaker: – Amgen
### she/her/hers @@@ Nazila Miller, PhD (she/her/hers) – Takeda ### 2204972###Hot Topic Moderator###Director###Takeda###Hot Topic Moderator: – Takeda
### she/her/hers10:00 AM – 4:30 PM PT
Solution Center Hours & Poster Presentations
10:00 AM – 4:30 PM PT
Solution Center Hours & Poster PresentationsLocation:Grand Ballroom AB
10:15 AM – 11:00 AM PT
High Resolution Accurate Mass Analysis: Addressing Sensitivity and Specificity
10:15 AM – 11:00 AM PT
High Resolution Accurate Mass Analysis: Addressing Sensitivity and SpecificityLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Q Squared Solutions
Novel Strategies to Advance Biotherapeutic Development
Prakash Bhosale, PhD – Q Squared Solutions ### 2300468###Partner Presentation Speaker###Director of Discovery ADME Services###Q Squared Solutions###Partner Presentation Speaker: – Q Squared Solutions
### 11:00 AM – 1:00 PM PT
Dedicated Solution Center Hours
11:00 AM – 1:00 PM PT
Dedicated Solution Center Hours
Location:Grand Ballroom AB
11:15 AM – 12:00 PM PT
High-Speed Microdroplet Reactions for Faster Therapeutic Protein Analysis
11:15 AM – 12:00 PM PT
High-Speed Microdroplet Reactions for Faster Therapeutic Protein AnalysisLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Gilead Sciences
Novel Strategies to Advance Biotherapeutic Development
Krishna D.B Anapindi, PhD (he/him/his) – Gilead Sciences ### 2300470###Partner Presentation Speaker###Research Scientist###Gilead Sciences###Partner Presentation Speaker: – Gilead Sciences
### he/him/his11:30 AM – 12:30 PM PT
Special Poster Collection
11:30 AM – 12:30 PM PT
Special Poster CollectionLocation:Grand Ballroom AB, Poster Forum 1Poster Collection Host: – BioAgilytix
Advances in Discovery, Formulation, and Delivery of New Modalities
Amanda L. Hays, PhD – BioAgilytix ### 1529523###Poster Collection Host###Scientific Officer###BioAgilytix###Poster Collection Host: – BioAgilytix
### 11:30 AM – 1:00 PM PT
Light Lunch in the Solution Center
11:30 AM – 1:00 PM PT
Light Lunch in the Solution Center
Location:Grand Ballroom AB
12:15 PM – 1:00 PM PT
Mass Photometry – an Analytical Technology for Biomolecular Characterization
12:15 PM – 1:00 PM PT
Mass Photometry – an Analytical Technology for Biomolecular CharacterizationLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Refeyn Inc.
Novel Strategies to Advance Biotherapeutic Development
Gabriella Kiss, PhD (she/her/hers) – Refeyn Inc. ### 2300469###Partner Presentation Speaker###Director, Regulatory Strategy & Engagement###Refeyn Inc.###Partner Presentation Speaker: – Refeyn Inc.
### she/her/hers1:00 PM – 2:00 PM PT
Keynote: Crafting Complex Biologics: A Fusion of Art and Science?Keynote Speaker: – Merck & Co, Inc.
Moderator: – Merck & Co., Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
1:00 PM – 2:00 PM PT
Keynote: Crafting Complex Biologics: A Fusion of Art and Science?Location:Yosemite BCKeynote Speaker: – Merck & Co, Inc.
Moderator: – Merck & Co., Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Yongchao Su, PhD – Merck & Co, Inc. ### 1213943###Keynote Speaker###Senior Principal Scientist###Merck & Co, Inc.###Keynote Speaker: – Merck & Co, Inc.
### @@@ Elizabeth Thoryk – Merck & Co., Inc. ### 2030563###Moderator######Merck & Co., Inc.###Moderator: – Merck & Co., Inc.
### 1:00 PM – 2:00 PM PT
Keynote: Using Biomarkers to Accelerate Development of Disease Modifying Therapies for Rare DiseaseKeynote Speaker: – Ultragenyx
Moderator: – Prothena Biosciences
Novel Strategies to Advance Biotherapeutic Development
1:00 PM – 2:00 PM PT
Keynote: Using Biomarkers to Accelerate Development of Disease Modifying Therapies for Rare DiseaseLocation:Plaza AKeynote Speaker: – Ultragenyx
Moderator: – Prothena Biosciences
Novel Strategies to Advance Biotherapeutic Development
Emil Kakkis, MD, PhD (he/him/his) – Ultragenyx ### 2207050###Keynote Speaker###Chief Executive Officer and President###Ultragenyx###Keynote Speaker: – Ultragenyx
### he/him/his @@@ Karen J. Quadrini, PhD – Prothena Biosciences ### 2207101###Moderator###Director, Clinical Biomarkers###Prothena Biosciences###Moderator: – Prothena Biosciences
### 1:30 PM – 2:15 PM PT
Advances in Accelerated Quantification of Oligonucleotides with Automated, Microfluidic Methods
1:30 PM – 2:15 PM PT
Advances in Accelerated Quantification of Oligonucleotides with Automated, Microfluidic MethodsLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Gyros Protein Technologies
Novel Strategies to Advance Biotherapeutic Development
Jasmine Singh, MS – Gyros Protein Technologies ### 2266122###Partner Presentation Speaker###Field Application Scientist###Gyros Protein Technologies###Partner Presentation Speaker: – Gyros Protein Technologies
### 2:00 PM – 2:30 PM PT
Coffee Break in the Solution Center
2:00 PM – 2:30 PM PT
Coffee Break in the Solution CenterLocation:Grand Ballroom AB
2:30 PM – 3:15 PM PT
Formulation Development of sa-RNA Lipid Nanoparticles and Adjuvants for Regulating Immune Response
2:30 PM – 3:15 PM PT
Formulation Development of sa-RNA Lipid Nanoparticles and Adjuvants for Regulating Immune ResponseLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Labcorp
Advances in Discovery, Formulation, and Delivery of New Modalities
Adam R. Nasar (he/him/his) – Labcorp ### 2332755###Partner Presentation Speaker###Analytical Development Scientist###Labcorp###Partner Presentation Speaker: – Labcorp
### he/him/his2:30 PM – 3:30 PM PT
Hot Topic: Biomarkers and Accelerated Approval for Advanced Therapy
2:30 PM – 3:30 PM PT
Hot Topic: Biomarkers and Accelerated Approval for Advanced TherapyLocation:Yosemite AHot Topic Speaker: – Center for Biologics Evaluation and Research,FDA
Hot Topic Speaker: – Passage Bio
Hot Topic Moderator: – Passage Bio
Hot Topic Speaker: – Ultragenyx
Novel Strategies to Advance Biotherapeutic Development
Celia W. Witten, MD, PhD – Center for Biologics Evaluation and Research,FDA ### 710101###Hot Topic Speaker###Deputy Director###Center for Biologics Evaluation and Research,FDA###Hot Topic Speaker: – Center for Biologics Evaluation and Research,FDA
### @@@ Yan G. Ni, PhD – Passage Bio ### 803355###Hot Topic Speaker###Executive Director###Passage Bio###Hot Topic Speaker: – Passage Bio
### @@@ Yan G. Ni, PhD – Passage Bio ### 803355###Hot Topic Moderator###Executive Director###Passage Bio###Hot Topic Moderator: – Passage Bio
### @@@ Emil Kakkis, MD, PhD (he/him/his) – Ultragenyx ### 2207050###Hot Topic Speaker###Chief Executive Officer and President###Ultragenyx###Hot Topic Speaker: – Ultragenyx
### he/him/his2:30 PM – 3:30 PM PT
Rapid Fire: Development Strategy for Novel Targeted Therapeutic DeliveryRapid Fire Moderator: – Boehringer Ingelheim
Novel Strategies to Advance Biotherapeutic Development
2:30 PM – 3:30 PM PT
Rapid Fire: Development Strategy for Novel Targeted Therapeutic DeliveryLocation:Plaza ARapid Fire Moderator: – Boehringer Ingelheim
Novel Strategies to Advance Biotherapeutic Development
Wei Wei, PhD (she/her/hers) – Boehringer Ingelheim ### 2086985###Rapid Fire Moderator###Senior Scientist###Boehringer Ingelheim###Rapid Fire Moderator: – Boehringer Ingelheim
### she/her/hers2:30 PM – 2:45 PM PT
Advanced ADA-Domain-Characterization for T-cell-Engager-Drugs to Understand Exposure and Activity ImpactLocation:Plaza ARapid Fire Speaker: – Roche Diagnostics GmbH
Novel Strategies to Advance Biotherapeutic Development
Gregor P. Lotz, PhD (he/him/his) – Roche Diagnostics GmbH ### 2173977###Rapid Fire Speaker###Principal Scientist###Roche Diagnostics GmbH###Rapid Fire Speaker: – Roche Diagnostics GmbH
### he/him/his2:45 PM – 3:00 PM PT
Spectral Unmixing Impact Comparison Across Immunophenotyping Panels and MatricesLocation:Plaza ARapid Fire Speaker: – KCAS Bio
Novel Strategies to Advance Biotherapeutic Development
Nassouh Mourabet, MS (he/him/his) – KCAS Bio ### 2245649###Rapid Fire Speaker###Scientist III###KCAS Bio###Rapid Fire Speaker: – KCAS Bio
### he/him/his3:00 PM – 3:15 PM PT
Identifying Inflammatory Biomarkers in Small-Cell Lung Cancer Using Olink AssaysLocation:Plaza ARapid Fire Speaker: – AstraZeneca
Novel Strategies to Advance Biotherapeutic Development
Jeff Chen, PhD – AstraZeneca ### 2173996###Rapid Fire Speaker###Associate Director###AstraZeneca###Rapid Fire Speaker: – AstraZeneca
### 3:15 PM – 3:30 PM PT
High-Dimensional Immunophenotyping Panel to Characterize Chimeric-Antigen-Receptor T Cells in Clinical-TrialsLocation:Plaza ARapid Fire Speaker: – Astrazeneca
Novel Strategies to Advance Biotherapeutic Development
Rohini Emani, PhD (she/her/hers) – Astrazeneca ### 2208358###Rapid Fire Speaker###Senior Scientist###Astrazeneca###Rapid Fire Speaker: – Astrazeneca
### she/her/hers2:30 PM – 3:30 PM PT
Rapid Fire: Preformulation and Formulation Approaches for Biologics and New ModalitiesRapid Fire Moderator: – SynerG Biopharma Group
Advances in Discovery, Formulation, and Delivery of New Modalities
2:30 PM – 3:30 PM PT
Rapid Fire: Preformulation and Formulation Approaches for Biologics and New ModalitiesLocation:Yosemite BCRapid Fire Moderator: – SynerG Biopharma Group
Advances in Discovery, Formulation, and Delivery of New Modalities
Scott Rudge, PhD (he/him/his) – SynerG Biopharma Group ### 2204959###Rapid Fire Moderator###Founder, Principal###SynerG Biopharma Group###Rapid Fire Moderator: – SynerG Biopharma Group
### he/him/his2:30 PM – 2:45 PM PT
Atomic Level Characterization of Excipient Interactions with Monoclonal AntibodiesLocation:Yosemite BCRapid Fire Speaker: – Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland
Advances in Discovery, Formulation, and Delivery of New Modalities
Anupreet Kaur (she/her/hers) – Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland ### 2173982###Rapid Fire Speaker###Post Doctoral Associate###Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland###Rapid Fire Speaker: – Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland
### she/her/hers2:45 PM – 3:00 PM PT
Using Artificial Extracellular Matrices in Injectable Formulation DevelopmentLocation:Yosemite BCRapid Fire Speaker: – Pion Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Conor Gomes, Ph.D. (he/him/his) – Pion Inc. ### 1767840###Rapid Fire Speaker###Development Scientist###Pion Inc.###Rapid Fire Speaker: – Pion Inc.
### he/him/his3:00 PM – 3:15 PM PT
Beyond mRNA and Lipid Nanoparticles: Formulation and Process InnovationsLocation:Yosemite BCRapid Fire Speaker: – Landmark Bio
Advances in Discovery, Formulation, and Delivery of New Modalities
Rob Delong, PhD (he/him/his) – Landmark Bio ### 2173975###Rapid Fire Speaker###Director###Landmark Bio###Rapid Fire Speaker: – Landmark Bio
### he/him/his3:15 PM – 3:30 PM PT
Cell Therapy CMC Case StudiesLocation:Yosemite BCRapid Fire Speaker: – Syner-G Biopharma Group
Advances in Discovery, Formulation, and Delivery of New Modalities
Stacy Plum, PhD – Syner-G Biopharma Group ### 2173986###Rapid Fire Speaker###VP###Syner-G Biopharma Group###Rapid Fire Speaker: – Syner-G Biopharma Group
### 3:30 PM – 4:15 PM PT
Immunogenicity Assessment and Target Binding Reagents Beyond Antibodies
3:30 PM – 4:15 PM PT
Immunogenicity Assessment and Target Binding Reagents Beyond AntibodiesLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – ProImmune, Inc.
Novel Strategies to Advance Biotherapeutic Development
Emilee Knowlton, PhD (she/her/hers) – ProImmune, Inc. ### 2315937###Partner Presentation Speaker###Senior Immunology Specialist###ProImmune, Inc.###Partner Presentation Speaker: – ProImmune, Inc.
### she/her/hers3:30 PM – 4:30 PM PT
Happy Hour Sponsored by Aragen Lifesciences Ltd
3:30 PM – 4:30 PM PT
Happy Hour Sponsored by Aragen Lifesciences LtdLocation:Booth #208, Grand Ballroom AB
3:30 PM – 4:30 PM PT
Special Poster Collection
3:30 PM – 4:30 PM PT
Special Poster CollectionLocation:Grand Ballroom AB, Poster Forum 1Poster Collection Host: – Larimartx
Gopi Shankar, Ph.D., M.B.A., FAAPS – Larimartx ### 572031###Poster Collection Host######Larimartx###Poster Collection Host: – Larimartx
### 5:00 PM – 6:30 PM PT
Sustaining Partner Reception (by invitation only)
5:00 PM – 6:30 PM PT
Sustaining Partner Reception (by invitation only)Location:Vista Lounge (45th Floor)
