- Pre-Recorded
Prologue: Advancements in Immuno-Oncology : mAbs to Novel ModalitiesPrologue Speaker: – Bristol Myers Squibb
Advances in Discovery, Formulation, and Delivery of New Modalities
Prologue: Advancements in Immuno-Oncology : mAbs to Novel ModalitiesLocation:Online OnlyPrologue Speaker: – Bristol Myers Squibb
Advances in Discovery, Formulation, and Delivery of New Modalities
Ankit D. Kanthe, PhD – Bristol Myers Squibb ### 1446462###Prologue Speaker###Senior Scientist###Bristol Myers Squibb###Prologue Speaker: – Bristol Myers Squibb
###
Prologue: AI/ML in Drug Manufacturing: Use Cases and Areas of ConsiderationPrologue Speaker: – US Food and Drug Administration
Advances in Discovery, Formulation, and Delivery of New Modalities
Prologue: AI/ML in Drug Manufacturing: Use Cases and Areas of ConsiderationLocation:Online OnlyPrologue Speaker: – US Food and Drug Administration
Advances in Discovery, Formulation, and Delivery of New Modalities
Thomas O'Connor, PhD (he/him/his) – US Food and Drug Administration ### 1446291###Prologue Speaker###Deputy Office Director###US Food and Drug Administration###Prologue Speaker: – US Food and Drug Administration
### he/him/his
Prologue: Opportunities and Challenges for Lipid-Based Drug Delivery Systems for BiopharmaceuticalsPrologue Speaker: – HTD Biosystems Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Prologue: Opportunities and Challenges for Lipid-Based Drug Delivery Systems for BiopharmaceuticalsLocation:Online OnlyPrologue Speaker: – HTD Biosystems Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Rajiv Nayar, PhD – HTD Biosystems Inc. ### 605167###Prologue Speaker###President###HTD Biosystems Inc.###Prologue Speaker: – HTD Biosystems Inc.
###
Prologue: Opportunities and Implications for Using AI/ML in Bioanalytical Assay DevelopmentPrologue Speaker: – Accenture
Novel Strategies to Advance Biotherapeutic Development
Prologue: Opportunities and Implications for Using AI/ML in Bioanalytical Assay DevelopmentLocation:Online OnlyPrologue Speaker: – Accenture
Novel Strategies to Advance Biotherapeutic Development
Joe Rajarao, PhD (he/him/his) – Accenture ### 2204999###Prologue Speaker###Industry Senior Principal, Lifesciences Research###Accenture###Prologue Speaker: – Accenture
### he/him/his
Prologue: Patient Centric Sampling for Clinical Drug DevelopmentPrologue Speaker: – Merck & Co., Inc.
Novel Strategies to Advance Biotherapeutic Development
Prologue: Patient Centric Sampling for Clinical Drug DevelopmentLocation:Online OnlyPrologue Speaker: – Merck & Co., Inc.
Novel Strategies to Advance Biotherapeutic Development
Melanie Anderson, MS (she/her/hers) – Merck & Co., Inc. ### 846468###Prologue Speaker###Principal Scientist###Merck & Co., Inc.###Prologue Speaker: – Merck & Co., Inc.
### she/her/hers
Prologue: Technology Advances in Vaccine ResearchPrologue Speaker: – Takeda
Novel Strategies to Advance Biotherapeutic Development
Prologue: Technology Advances in Vaccine ResearchLocation:Online OnlyPrologue Speaker: – Takeda
Novel Strategies to Advance Biotherapeutic Development
Andrea Bertolotti-Ciarlet, PhD (she/her/hers) – Takeda ### 1061513###Prologue Speaker###VP Head pf Vaccine Research and Analytics ###Takeda###Prologue Speaker: – Takeda
### she/her/hers
- Monday, May 13, 2024
7:30 AM – 6:00 PM PT
Registration Hours
7:30 AM – 6:00 PM PT
Registration Hours
Location:Yosemite Foyer
8:00 AM – 3:00 PM PT
Exhibitor Move-In
8:00 AM – 3:00 PM PT
Exhibitor Move-In
Location:Grand Ballroom AB
12:00 PM – 4:00 PM PT
Speaker Ready Room
12:00 PM – 4:00 PM PT
Speaker Ready Room
Location:Executive Boardroom
3:00 PM – 4:30 PM PT
Opening Plenary with Hari Pujar, Ph.D.
3:00 PM – 4:30 PM PT
Opening Plenary with Hari Pujar, Ph.D.Location:Imperial BallroomPlenary Speaker: – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics
Hari Pujar, Ph.D. – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics ### 2242482###Plenary Speaker######Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics###Plenary Speaker: – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics
### 4:30 PM – 6:00 PM PT
Welcome Reception in the Solution Center
4:30 PM – 6:00 PM PT
Welcome Reception in the Solution CenterLocation:Grand Ballroom AB
- 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)
- Wednesday, May 15, 2024
8:30 AM – 9:30 AM PT
AAPS Biomarkers and Precision Medicine Community Membership Meeting
8:30 AM – 9:30 AM PT
AAPS Biomarkers and Precision Medicine Community Membership MeetingLocation:Yosemite ACommunity Leader: – Prothena Biosciences
Karen J. Quadrini, PhD – Prothena Biosciences ### 2207101###Community Leader###Director, Clinical Biomarkers###Prothena Biosciences###Community Leader: – Prothena Biosciences
### 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
Symposium: Advances in Analytical and Bioanalytical Platform TechnologyModerator: – PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
9:30 AM – 11:00 AM PT
Symposium: Advances in Analytical and Bioanalytical Platform TechnologyLocation:Plaza AModerator: – PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
Shoshana Oberstein (she/her/hers) – PPD, part of Thermo Fisher Scientific ### 849030###Moderator###Manager, Labs (R&D)###PPD, part of Thermo Fisher Scientific###Moderator: – PPD, part of Thermo Fisher Scientific
### she/her/hers9:30 AM – 10:00 AM PT
Personalizing Clinical Immunogenicity Risk Through HLA DR Alleles AssociationsLocation:Plaza ASpeaker: – Bristol-Myers Squibb
Novel Strategies to Advance Biotherapeutic Development
SURENDRAN RAJENDRAN, PhD (he/him/his) – Bristol-Myers Squibb ### 604748###Speaker###Senior Principal Scientist###Bristol-Myers Squibb###Speaker: – Bristol-Myers Squibb
### he/him/his10:00 AM – 10:30 AM PT
Unique Clinical Pharmacology Considerations for Allogeneic Cell TherapiesLocation:Plaza ANovel Strategies to Advance Biotherapeutic Development
Dhruvitkumar Sutaria, PhD (he/him/his) – Genentech ### 1976731###Speaker###Principal Scientist###Genentech###Speaker: – Genentech
### he/him/his10:30 AM – 11:00 AM PT
Methodologies for Biotherapeutic Biotransformation StudiesLocation:Plaza ANovel Strategies to Advance Biotherapeutic Development
Anton Rosenbaum – AstraZeneca ### 1092730###Speaker###Senior Group Director###AstraZeneca###Speaker: – AstraZeneca
### 9:30 AM – 11:00 AM PT
Symposium: Drug Delivery for New Modalities and TherapiesAdvances in Discovery, Formulation, and Delivery of New Modalities
9:30 AM – 11:00 AM PT
Symposium: Drug Delivery for New Modalities and TherapiesLocation:Yosemite BCAdvances in Discovery, Formulation, and Delivery of New Modalities
Asmita Khanolkar, MS – SMC Ltd. ### 2212300###Moderator###Senior Director, Cambridge Pharma/Oval ###SMC Ltd. ###Moderator: – SMC Ltd.
### 9:30 AM – 10:00 AM PT
Enabling Lipid Chemistry & Nanoparticle Surface Modification for Cytosolic DeliveryLocation:Yosemite BCSpeaker: – University of Connecticut
Advances in Discovery, Formulation, and Delivery of New Modalities
Xiuling Lu, Ph.D., FAAPS (she/her/hers) – University of Connecticut ### 603205###Speaker###Professsor###University of Connecticut###Speaker: – University of Connecticut
### she/her/hers10:00 AM – 10:30 AM PT
Auto-Mode Biomimicry: A Versatile Theranostic Model for Efficient Tumor TargetingLocation:Yosemite BCSpeaker: – University of the Punjab
Advances in Discovery, Formulation, and Delivery of New Modalities
Imran Tariq, PhD – University of the Punjab ### 1529550###Speaker###Assistant Professor###University of the Punjab###Speaker: – University of the Punjab
### 10:30 AM – 11:00 AM PT
Novel Engineering and Formulation Based Approaches for Delivery of CART to Solid TumorsLocation:Yosemite BCAdvances in Discovery, Formulation, and Delivery of New Modalities
Robert Dodge, PhD – Consultant ### 466130###Speaker###Scientific Consultant###Consultant###Speaker: – Consultant
### 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: Applications of qPCR/dPCR in Cell and Gene Therapies; Case StudiesHot Topic Moderator: – Janssen
Novel Strategies to Advance Biotherapeutic Development
10:00 AM – 11:00 AM PT
Hot Topic: Applications of qPCR/dPCR in Cell and Gene Therapies; Case StudiesLocation:Yosemite AHot Topic Moderator: – Janssen
Novel Strategies to Advance Biotherapeutic Development
Jacqueline Murphy, MS – Janssen ### 2173994###Hot Topic Moderator###Principal Scientist###Janssen###Hot Topic Moderator: – Janssen
### 10:00 AM – 10:10 AM PT
Introduction to PCR Assay Development and Validation Location:Yosemite AHot Topic Speaker: – PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
Timothy L. Lochmann, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific ### 1916628###Hot Topic Speaker###Manager, Labs###PPD, part of Thermo Fisher Scientific###Hot Topic Speaker: – PPD, part of Thermo Fisher Scientific
### he/him/his10:10 AM – 10:20 AM PT
A Case Study in AAV Gene Therapy Viral Shedding Location:Yosemite AHot Topic Speaker: – Ultragenyx
Novel Strategies to Advance Biotherapeutic Development
Mitra Azadeh, PhD (she/her/hers) – Ultragenyx ### 2173993###Hot Topic Speaker###Senior Director, Bioanalytical & Biomarker Development###Ultragenyx###Hot Topic Speaker: – Ultragenyx
### she/her/hers10:20 AM – 10:30 AM PT
A Case study in Cell Therapy Persistence by qPCR Location:Yosemite AHot Topic Speaker: – Johnson & Johnson
Novel Strategies to Advance Biotherapeutic Development
Kate B. Herr, M.S. (she/her/hers) – Johnson & Johnson ### 1730310###Hot Topic Speaker###Senior Scientist###Johnson & Johnson###Hot Topic Speaker: – Johnson & Johnson
### she/her/hers10:30 AM – 10:40 AM PT
A Case Study in Cell Therapy Persistence by ddPCR Location:Yosemite AHot Topic Speaker: – Bristol-Myers Squibb Company
Novel Strategies to Advance Biotherapeutic Development
Nanda Balasubramanian, PhD (he/him/his) – Bristol-Myers Squibb Company ### 1689823###Hot Topic Speaker###Senior Principal Scientist###Bristol-Myers Squibb Company###Hot Topic Speaker: – Bristol-Myers Squibb Company
### he/him/his10:40 AM – 11:00 AM PT
Panel DiscussionLocation:Yosemite AHot Topic Speaker: – Ultragenyx
Hot Topic Speaker: – PPD, part of Thermo Fisher Scientific
Hot Topic Speaker: – Bristol-Myers Squibb Company
Hot Topic Speaker: – Johnson & Johnson
Hot Topic Moderator: – Janssen
Novel Strategies to Advance Biotherapeutic Development
Mitra Azadeh, PhD (she/her/hers) – Ultragenyx ### 2173993###Hot Topic Speaker###Senior Director, Bioanalytical & Biomarker Development###Ultragenyx###Hot Topic Speaker: – Ultragenyx
### she/her/hers @@@ Timothy L. Lochmann, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific ### 1916628###Hot Topic Speaker###Manager, Labs###PPD, part of Thermo Fisher Scientific###Hot Topic Speaker: – PPD, part of Thermo Fisher Scientific
### he/him/his @@@ Nanda Balasubramanian, PhD (he/him/his) – Bristol-Myers Squibb Company ### 1689823###Hot Topic Speaker###Senior Principal Scientist###Bristol-Myers Squibb Company###Hot Topic Speaker: – Bristol-Myers Squibb Company
### he/him/his @@@ Kate B. Herr, M.S. (she/her/hers) – Johnson & Johnson ### 1730310###Hot Topic Speaker###Senior Scientist###Johnson & Johnson###Hot Topic Speaker: – Johnson & Johnson
### she/her/hers @@@ Jacqueline Murphy, MS – Janssen ### 2173994###Hot Topic Moderator###Principal Scientist###Janssen###Hot Topic Moderator: – Janssen
### 10:00 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
The Impact of Polysorbate Quality/Grade on Biopharmaceutical Formulations
10:15 AM – 11:00 AM PT
The Impact of Polysorbate Quality/Grade on Biopharmaceutical FormulationsLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Croda, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Sreejit Menon, PhD – Croda, Inc. ### 600820###Partner Presentation Speaker###Head of Life Sciences R&D, North America###Croda, Inc.###Partner Presentation Speaker: – Croda, Inc.
### 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
Recombinant Human Hyaluronidase Facilitated Subcutaneous Drug Delivery Using a 10mL High-Volume Auto-Injector
11:15 AM – 12:00 PM PT
Recombinant Human Hyaluronidase Facilitated Subcutaneous Drug Delivery Using a 10mL High-Volume Auto-InjectorLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Halozyme Therapeutics Inc
Partner Presentation Speaker: – Halozyme Therapeutics, Inc
Advances in Discovery, Formulation, and Delivery of New Modalities
David W. Kang – Halozyme Therapeutics Inc ### 627074###Partner Presentation Speaker###Director, Drug Delivery###Halozyme Therapeutics Inc###Partner Presentation Speaker: – Halozyme Therapeutics Inc
### @@@ Michael Travanty – Halozyme Therapeutics, Inc ### 2300467###Partner Presentation Speaker###Vice President - Product Development, Engineering###Halozyme Therapeutics, Inc ###Partner Presentation Speaker: – Halozyme Therapeutics, Inc
### 11:30 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: – Genentech, Inc.
Novel Strategies to Advance Biotherapeutic Development
Katie F. Maass, Ph.D. (she/her/hers) – Genentech, Inc. ### 847055###Poster Collection Host###Senior Principal Scientist, Clinical Pharmacology###Genentech, Inc.###Poster Collection Host: – Genentech, Inc.
### she/her/hers11:30 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
From ASO to mRNA—Oligonucleotide Therapeutics Separation and Characterization Using LC/MS
12:15 PM – 1:00 PM PT
From ASO to mRNA—Oligonucleotide Therapeutics Separation and Characterization Using LC/MSLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – Waters Corporation
Novel Strategies to Advance Biotherapeutic Development
Suraj Dhungana, PhD, MBA (he/him/his) – Waters Corporation ### 1600964###Partner Presentation Speaker###Director, Pharmaceutical and Life Science Market-Americas Market###Waters Corporation###Partner Presentation Speaker: – Waters Corporation
### he/him/his1:00 PM – 2:00 PM PT
Keynote: Development of Oligonucleotide TherapeuticsKeynote Speaker:
Moderator: – Boehringer Ingelheim Pharmaceuticals, Inc.
Novel Strategies to Advance Biotherapeutic Development
1:00 PM – 2:00 PM PT
Keynote: Development of Oligonucleotide TherapeuticsLocation:Plaza AKeynote Speaker:
Moderator: – Boehringer Ingelheim Pharmaceuticals, Inc.
Novel Strategies to Advance Biotherapeutic Development
Raman Bahal ### 2210214###Keynote Speaker#########Keynote Speaker:
### @@@ Linzhi Chen, PhD (he/him/his) – Boehringer Ingelheim Pharmaceuticals, Inc. ### 466129###Moderator###Sr. Research Fellow###Boehringer Ingelheim Pharmaceuticals, Inc.###Moderator: – Boehringer Ingelheim Pharmaceuticals, Inc.
### he/him/his1:00 PM – 2:00 PM PT
Keynote: In vivo Delivery of mRNAs for Anti-Aging Applications: Potential and ChallengesKeynote Speaker: – Stanford University and Turn Biotechnologies
Moderator: – St. John's University
Advances in Discovery, Formulation, and Delivery of New Modalities
1:00 PM – 2:00 PM PT
Keynote: In vivo Delivery of mRNAs for Anti-Aging Applications: Potential and ChallengesLocation:Yosemite BCKeynote Speaker: – Stanford University and Turn Biotechnologies
Moderator: – St. John's University
Advances in Discovery, Formulation, and Delivery of New Modalities
Vittorio Sebastiano, PhD (he/him/his) – Stanford University and Turn Biotechnologies ### 2204962###Keynote Speaker###Associate Professor of OBGyN, Founder and Head of Research ###Stanford University and Turn Biotechnologies###Keynote Speaker: – Stanford University and Turn Biotechnologies
### he/him/his @@@ Nitesh Kunda, PhD – St. John's University ### 1377462###Moderator###Associate Professor###St. John's University###Moderator: – St. John's University
### 1:15 PM – 3:00 PM PT
PCR Assay Recommendations for Cell and Gene Therapies: Insights from an Industry Panel
1:15 PM – 3:00 PM PT
PCR Assay Recommendations for Cell and Gene Therapies: Insights from an Industry PanelLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – BioAgilytix
Partner Presentation Speaker: – Eurofins Viracor BioPharma
Partner Presentation Speaker: – Beam Therapeutics
Partner Presentation Speaker: – BioMarin Pharmaceutical, Inc.
Moderator: – AAPS
Advances in Discovery, Formulation, and Delivery of New Modalities
Amanda L. Hays, PhD – BioAgilytix ### 1529523###Partner Presentation Speaker###Scientific Officer###BioAgilytix###Partner Presentation Speaker: – BioAgilytix
### @@@ Mark C. Wissel, PhD – Eurofins Viracor BioPharma ### 1651144###Partner Presentation Speaker###Director, R&D###Eurofins Viracor BioPharma###Partner Presentation Speaker: – Eurofins Viracor BioPharma
### @@@ Kelly S. Colletti, PhD, MBA (she/her/hers) – Beam Therapeutics ### 1940581###Partner Presentation Speaker###Director, Preclinical Bioanalytics###Beam Therapeutics###Partner Presentation Speaker: – Beam Therapeutics
### she/her/hers @@@ Russell K. Soon, Jr. (he/him/his) – BioMarin Pharmaceutical, Inc. ### 1930636###Partner Presentation Speaker###Technical Scientist###BioMarin Pharmaceutical, Inc.###Partner Presentation Speaker: – BioMarin Pharmaceutical, Inc.
### he/him/his @@@ Tina S. Morris, PhD – AAPS ### 1320364###Moderator###Executive Director###AAPS###Moderator: – AAPS
### 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 – 3:30 PM PT
Hot Topic: Prior Knowledge Integration in Product Development
2:30 PM – 3:30 PM PT
Hot Topic: Prior Knowledge Integration in Product DevelopmentLocation:Yosemite AHot Topic Speaker: – Pfizer Inc.
Hot Topic Moderator: – US Food and Drug Administration
Advances in Discovery, Formulation, and Delivery of New Modalities
Parag Kolhe, PhD – Pfizer Inc. ### 597465###Hot Topic Speaker###Senior Director###Pfizer Inc.###Hot Topic Speaker: – Pfizer Inc.
### @@@ Ping Ji, PhD – US Food and Drug Administration ### 624129###Hot Topic Moderator###Master Pharmacokinetist###US Food and Drug Administration###Hot Topic Moderator: – US Food and Drug Administration
### 2:30 PM – 3:30 PM PT
Rapid Fire: Advances in Analytical and Bioanalytical Platform TechnologyRapid Fire Moderator: – Genentech, Inc
Novel Strategies to Advance Biotherapeutic Development
2:30 PM – 3:30 PM PT
Rapid Fire: Advances in Analytical and Bioanalytical Platform TechnologyLocation:Plaza ARapid Fire Moderator: – Genentech, Inc
Novel Strategies to Advance Biotherapeutic Development
Nancy Yu (she/her/hers) – Genentech, Inc ### 2211761###Rapid Fire Moderator###Scientist 4###Genentech, Inc###Rapid Fire Moderator: – Genentech, Inc
### she/her/hers2:30 PM – 2:45 PM PT
Metabolite identification and Profiling Methodology - Application for GalNAc Conjugated OligonucleotidesLocation:Plaza ARapid Fire Speaker: – Ionis Pharmaceuticals
Novel Strategies to Advance Biotherapeutic Development
Asa Walander, M.S., PhD (she/her/hers) – Ionis Pharmaceuticals ### 2173979###Rapid Fire Speaker###Assistant Director, Bioanalysis###Ionis Pharmaceuticals###Rapid Fire Speaker: – Ionis Pharmaceuticals
### she/her/hers2:45 PM – 3:00 PM PT
Highly-Sensitive Hybridization ELISA Development for Oligonucleotide Quantitation at Picogram LevelsLocation:Plaza ARapid Fire Speaker: – PPD, Part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
Eric F. Tewalt, PhD – PPD, Part of Thermo Fisher Scientific ### 1820669###Rapid Fire Speaker###Director###PPD, Part of Thermo Fisher Scientific###Rapid Fire Speaker: – PPD, Part of Thermo Fisher Scientific
### 3:00 PM – 3:15 PM PT
Comparison of Four Bioanalytical Assay Platforms for siRNA Therapeutic QuantitationLocation:Plaza ARapid Fire Speaker: – Janssen Research and Development
Novel Strategies to Advance Biotherapeutic Development
Karan Agrawal, PhD (he/him/his) – Janssen Research and Development ### 1417721###Rapid Fire Speaker###Senior Scientist###Janssen Research and Development###Rapid Fire Speaker: – Janssen Research and Development
### he/him/his3:15 PM – 3:30 PM PT
Bioanalytical Strategy for Pharmacokinetic Characterization of Oligonucleotide-Protein ConjugatesLocation:Plaza ARapid Fire Speaker: – Dyne Therapeutics
Novel Strategies to Advance Biotherapeutic Development
Babak Basiri, PhD (he/him/his) – Dyne Therapeutics ### 2173966###Rapid Fire Speaker###Associate Director###Dyne Therapeutics###Rapid Fire Speaker: – Dyne Therapeutics
### he/him/his2:30 PM – 3:30 PM PT
Rapid Fire: Drug Delivery for New Modalities and TherapiesRapid Fire Moderator: – Genentech, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
2:30 PM – 3:30 PM PT
Rapid Fire: Drug Delivery for New Modalities and TherapiesLocation:Yosemite BCRapid Fire Moderator: – Genentech, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Karthik Nagapudi, PhD – Genentech, Inc. ### 1046110###Rapid Fire Moderator###Executive Director###Genentech, Inc.###Rapid Fire Moderator: – Genentech, Inc.
### 2:30 PM – 2:45 PM PT
Dry Powders for the Delivery of Biopharmaceuticals to the NoseLocation:Yosemite BCRapid Fire Speaker: – Harro Höfliger
Advances in Discovery, Formulation, and Delivery of New Modalities
Irene Rossi, PhD – Harro Höfliger ### 2086972###Rapid Fire Speaker###Consultant Inhalation Technology###Harro Höfliger###Rapid Fire Speaker: – Harro Höfliger
### 2:45 PM – 3:00 PM PT
Development of an Inhalable and Temperature-Stable COVID-19 Liposomal VaccineLocation:Yosemite BCRapid Fire Speaker: – St. Johns University
Advances in Discovery, Formulation, and Delivery of New Modalities
Apoorva Daram (she/her/hers) – St. Johns University ### 2030864###Rapid Fire Speaker###Doctoral Student###St. Johns University###Rapid Fire Speaker: – St. Johns University
### she/her/hers3:00 PM – 3:15 PM PT
What Does “Biorelevant” Mean for Oral Peptides?Location:Yosemite BCRapid Fire Speaker: – Genentech, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Tahnee J. Dening, PhD (she/her/hers) – Genentech, Inc. ### 2173992###Rapid Fire Speaker###Principal Scientist###Genentech, Inc.###Rapid Fire Speaker: – Genentech, Inc.
### she/her/hers3:15 PM – 3:30 PM PT
Molecular Investigation on Permeation-Enhancer Assisted Oral Peptide Delivery in Lipid-BilayersLocation:Yosemite BCRapid Fire Speaker: – Merck
Advances in Discovery, Formulation, and Delivery of New Modalities
Jing Ling, PhD – Merck ### 1329726###Rapid Fire Speaker###Associate Principal Scientist###Merck###Rapid Fire Speaker: – Merck
### 3:30 PM – 4:15 PM PT
Bioanalytical Strategy for Quantitation of GLP-1 Analogs
3:30 PM – 4:15 PM PT
Bioanalytical Strategy for Quantitation of GLP-1 AnalogsLocation:Learning Lab, Grand Ballroom ABPartner Presentation Speaker: – SCIEX
Novel Strategies to Advance Biotherapeutic Development
Ebru S. Selen, PhD (she/her/hers) – SCIEX ### 2086970###Partner Presentation Speaker###Biopharma Applications Scientist ###SCIEX###Partner Presentation Speaker: – SCIEX
### she/her/hers3:30 PM – 4:30 PM PT
Happy Hour Sponsored by INTERPHEX
3:30 PM – 4:30 PM PT
Happy Hour Sponsored by INTERPHEXLocation:Booth #805, 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: – Takeda
Russ S. Weiner, Ph.D., FAAPS – Takeda ### 1650369###Poster Collection Host######Takeda###Poster Collection Host: – Takeda
### 4:00 PM – 5:00 PM PT
AAPS Gene and Cell Therapy Products Community Membership Meeting
4:00 PM – 5:00 PM PT
AAPS Gene and Cell Therapy Products Community Membership MeetingLocation:Yosemite ACommunity Leader: – Passage Bio
Yan G. Ni, PhD – Passage Bio ### 803355###Community Leader###Executive Director###Passage Bio###Community Leader: – Passage Bio
### 4:30 PM – 8:00 PM PT
Exhibitor Move-Out
4:30 PM – 8:00 PM PT
Exhibitor Move-Out
Location:Grand Ballroom AB
5:00 PM – 6:30 PM PT
Women in Biotech Reception Sponsored by AstraZeneca
5:00 PM – 6:30 PM PT
Women in Biotech Reception Sponsored by AstraZenecaLocation:Vista Lounge (45th Floor)
- Thursday, May 16, 2024
8:30 AM – 2:00 PM PT
Registration Hours
8:30 AM – 2:00 PM PT
Registration Hours
Location:Yosemite Foyer
8:30 AM – 2:30 PM PT
Speaker Ready Room
8:30 AM – 2:30 PM PT
Speaker Ready Room
Location:Executive Boardroom
9:00 AM – 10:00 AM PT
Coffee Break
9:00 AM – 10:00 AM PT
Coffee BreakLocation:Yosemite Foyer
9:30 AM – 11:00 AM PT
Symposium: AI/ML in Drug Discovery and DevelopmentModerator: – FDA/CDER/OPQ/OPQR
Advances in Discovery, Formulation, and Delivery of New Modalities
9:30 AM – 11:00 AM PT
Symposium: AI/ML in Drug Discovery and DevelopmentLocation:Yosemite BCModerator: – FDA/CDER/OPQ/OPQR
Advances in Discovery, Formulation, and Delivery of New Modalities
Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR ### 2204966###Moderator###Senior Regulatory Research Scientist###FDA/CDER/OPQ/OPQR###Moderator: – FDA/CDER/OPQ/OPQR
### 9:30 AM – 10:00 AM PT
ML Enhanced DLS for Rapid Characterization of mAb AggregationLocation:Yosemite BCSpeaker: – Indian Insitute of Technology Delhi
Advances in Discovery, Formulation, and Delivery of New Modalities
Anurag S. Rathore, Ph.D. – Indian Insitute of Technology Delhi ### 2126789###Speaker###Professor###Indian Insitute of Technology Delhi###Speaker: – Indian Insitute of Technology Delhi
### 10:00 AM – 10:30 AM PT
Harnessing Artificial Intelligence for Classifying Free-Fatty Acid Particles in BiopharmaceuticalsLocation:Yosemite BCSpeaker: – Clear Solutions Laboratories AG
Advances in Discovery, Formulation, and Delivery of New Modalities
Filip M. Fedorowicz, MS (he/him/his) – Clear Solutions Laboratories AG ### 2173984###Speaker###Lead Scientist###Clear Solutions Laboratories AG###Speaker: – Clear Solutions Laboratories AG
### he/him/his10:30 AM – 11:00 AM PT
Assessing Immunogenicity Risk of Biologics: Prediction Tools, and Case StudiesLocation:Yosemite BCAdvances in Discovery, Formulation, and Delivery of New Modalities
Swati Gupta, PhD (she/her/hers) – AbbVie ### 1820665###Speaker###Executive Director###AbbVie###Speaker: – AbbVie
### she/her/hers9:30 AM – 11:00 AM PT
Symposium: High Content BioanalysisNovel Strategies to Advance Biotherapeutic Development
9:30 AM – 11:00 AM PT
Symposium: High Content BioanalysisLocation:Plaza ANovel Strategies to Advance Biotherapeutic Development
Eric Thomas, PhD – LabCorp ### 2211768###Moderator###Director, Scientific Affairs###LabCorp###Moderator: – LabCorp
### 9:30 AM – 10:00 AM PT
AAV8 Shedding Assay to Support Gene Therapy Clinical TrialsLocation:Plaza ANovel Strategies to Advance Biotherapeutic Development
Johannes Stanta, PhD – Celerion ### 2173985###Speaker###Global Director Molecular and Cell Biology###Celerion###Speaker: – Celerion
### 10:00 AM – 10:30 AM PT
Companion Diagnostics for AAV-Mediated Gene Therapy: Recent Developments and ChallengesLocation:Plaza ASpeaker: – Sangamo Therapeutics, Inc
Novel Strategies to Advance Biotherapeutic Development
Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics, Inc ### 821735###Speaker###Vice President, Biomarker and BioAnalytical Sciences###Sangamo Therapeutics, Inc###Speaker: – Sangamo Therapeutics, Inc
### she/her/hers10:30 AM – 11:00 AM PT
Comparability Assessment Regulatory Considerations of Cell and Gene Therapy ProductsLocation:Plaza ASpeaker: – Cellx Inc. Consulting
Novel Strategies to Advance Biotherapeutic Development
Mo Heidarian, PhD – Cellx Inc. Consulting ### 2232315###Speaker###Chief Regulatory Scientist###Cellx Inc. Consulting###Speaker: – Cellx Inc. Consulting
### 10:00 AM – 11:00 AM PT
Hot Topic: Advances in in-vivo Therapeutic Nucleic Acid Delivery: Ushering New EraHot Topic Moderator: – Saliogen Therapeutics
Advances in Discovery, Formulation, and Delivery of New Modalities
10:00 AM – 11:00 AM PT
Hot Topic: Advances in in-vivo Therapeutic Nucleic Acid Delivery: Ushering New EraLocation:Yosemite AHot Topic Moderator: – Saliogen Therapeutics
Advances in Discovery, Formulation, and Delivery of New Modalities
Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics ### 2204995###Hot Topic Moderator###SVP###Saliogen Therapeutics###Hot Topic Moderator: – Saliogen Therapeutics
### he/him/his10:00 AM – 10:20 AM PT
Machine Learning-Guided Design of Polymer Nanoparticles for In Vivo Gene TherapiesLocation:Yosemite AHot Topic Speaker: – Nanite Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
Shashi Murthy, PhD – Nanite Inc. ### 2204996###Hot Topic Speaker###CoFounder & CTO###Nanite Inc.###Hot Topic Speaker: – Nanite Inc.
### 10:20 AM – 10:40 AM PT
The Quest for Next Generation Lipid Nanoparticles for Cell-Specific Delivery of mRNALocation:Yosemite AHot Topic Speaker: – Oregon State University
Advances in Discovery, Formulation, and Delivery of New Modalities
Gaurav Sahay, PhD – Oregon State University ### 758590###Hot Topic Speaker###Professor###Oregon State University###Hot Topic Speaker: – Oregon State University
### 10:40 AM – 11:00 AM PT
Panel DiscussionLocation:Yosemite AHot Topic Moderator: – Saliogen Therapeutics
Hot Topic Speaker: – Nanite Inc.
Hot Topic Speaker: – Oregon State University
Advances in Discovery, Formulation, and Delivery of New Modalities
Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics ### 2204995###Hot Topic Moderator###SVP###Saliogen Therapeutics###Hot Topic Moderator: – Saliogen Therapeutics
### he/him/his @@@ Shashi Murthy, PhD – Nanite Inc. ### 2204996###Hot Topic Speaker###CoFounder & CTO###Nanite Inc.###Hot Topic Speaker: – Nanite Inc.
### @@@ Gaurav Sahay, PhD – Oregon State University ### 758590###Hot Topic Speaker###Professor###Oregon State University###Hot Topic Speaker: – Oregon State University
### 11:00 AM – 12:30 PM PT
Networking Lunch
11:00 AM – 12:30 PM PT
Networking Lunch
Location:Franciscan ABCD
12:30 PM – 1:30 PM PT
Keynote: Artificial Intelligence for Drug Discovery (AIDD)-Are We There Yet? How AI is Transforming the Drug Discovery Process
12:30 PM – 1:30 PM PT
Keynote: Artificial Intelligence for Drug Discovery (AIDD)-Are We There Yet? How AI is Transforming the Drug Discovery ProcessLocation:Yosemite BCKeynote Speaker: – Howard University
Moderator: – HTD Biosystems
Advances in Discovery, Formulation, and Delivery of New Modalities
Simon Wang, PhD (he/him/his) – Howard University ### 2204969###Keynote Speaker###Associate Professor###Howard University###Keynote Speaker: – Howard University
### he/him/his @@@ Mitra Mosharraf, M Pharm, PhD, MBA – HTD Biosystems ### 2204970###Moderator###CSO###HTD Biosystems###Moderator: – HTD Biosystems
### 12:30 PM – 1:30 PM PT
Keynote: Getting Up Close and Personal: Can Understanding the Pharmacogenetic Determinants of Immunogenicity Help in the Design of Safer Biologics?
12:30 PM – 1:30 PM PT
Keynote: Getting Up Close and Personal: Can Understanding the Pharmacogenetic Determinants of Immunogenicity Help in the Design of Safer Biologics?Location:Plaza AKeynote Speaker: – U.S. Food and Drug Administration
Moderator: – Upstream BIo
Novel Strategies to Advance Biotherapeutic Development
Zuben E. Sauna, PhD (he/him/his) – U.S. Food and Drug Administration ### 1216503###Keynote Speaker###Division Director###U.S. Food and Drug Administration###Keynote Speaker: – U.S. Food and Drug Administration
### he/him/his @@@ Arkadeep Sinha, PhD (he/him/his) – Upstream BIo ### 2211774###Moderator###Associate Director, Bioanalytical Sciences###Upstream BIo###Moderator: – Upstream BIo
### he/him/his1:30 PM – 2:00 PM PT
Coffee Break
1:30 PM – 2:00 PM PT
Coffee BreakLocation:Yosemite Foyer
2:00 PM – 2:45 PM PT
Rapid Fire: AI/ML in Drug Discovery and DevelopmentRapid Fire Moderator: – AbbVie
Advances in Discovery, Formulation, and Delivery of New Modalities
2:00 PM – 2:45 PM PT
Rapid Fire: AI/ML in Drug Discovery and DevelopmentLocation:Yosemite BCRapid Fire Moderator: – AbbVie
Advances in Discovery, Formulation, and Delivery of New Modalities
Swati Gupta, PhD (she/her/hers) – AbbVie ### 1820665###Rapid Fire Moderator###Executive Director###AbbVie###Rapid Fire Moderator: – AbbVie
### she/her/hers2:00 PM – 2:15 PM PT
Data Quality and Data Integrity Considerations for Applying AI/ML as Part of Process/Product DevelopmentLocation:Yosemite BCRapid Fire Speaker: – Pharmatech Associates
Advances in Discovery, Formulation, and Delivery of New Modalities
Bikash Chatterjee (he/him/his) – Pharmatech Associates ### 1921888###Rapid Fire Speaker###President and Chief Science Officer###Pharmatech Associates###Rapid Fire Speaker: – Pharmatech Associates
### he/him/his2:15 PM – 2:30 PM PT
Optimizing for Failure - Survivorship Bias in AILocation:Yosemite BCRapid Fire Speaker: – ERA Sciences
Advances in Discovery, Formulation, and Delivery of New Modalities
Andrew O'Connor, BSc (Hons) – ERA Sciences ### 2173987###Rapid Fire Speaker###Executive DIrector###ERA Sciences###Rapid Fire Speaker: – ERA Sciences
### 2:30 PM – 2:45 PM PT
Mechanistic Insight into the Physical Stability of OligonucleotidesLocation:Yosemite BCRapid Fire Speaker: – FDA/CDER/OPQ/OPQR
Advances in Discovery, Formulation, and Delivery of New Modalities
Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR ### 2204966###Rapid Fire Speaker###Senior Regulatory Research Scientist###FDA/CDER/OPQ/OPQR###Rapid Fire Speaker: – FDA/CDER/OPQ/OPQR
### 2:00 PM – 3:00 PM PT
Hot Topic: Navigating the New FDA Immunogenicity Labelling Guidance
2:00 PM – 3:00 PM PT
Hot Topic: Navigating the New FDA Immunogenicity Labelling GuidanceLocation:Yosemite AHot Topic Speaker: – Genentech
Hot Topic Speaker: – Regeneron Pharmaceuticals Inc
Hot Topic Speaker: – BioAgilytix
Hot Topic Moderator: – Genentech
Hot Topic Speaker: – US FDA, CDER., Office of Clinical Pharmacology
Novel Strategies to Advance Biotherapeutic Development
Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech ### 2173976###Hot Topic Speaker###Sr Director and Distinguished Scientist###Genentech###Hot Topic Speaker: – Genentech
### he/him/his @@@ Ching-Ha (Vicky) Lai, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc ### 1653895###Hot Topic Speaker###Fellow Scientist###Regeneron Pharmaceuticals Inc###Hot Topic Speaker: – Regeneron Pharmaceuticals Inc
### she/her/hers @@@ Will Williams, MS (he/him/his) – BioAgilytix ### 2173989###Hot Topic Speaker###Senior Director###BioAgilytix###Hot Topic Speaker: – BioAgilytix
### he/him/his @@@ Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech ### 2173976###Hot Topic Moderator###Sr Director and Distinguished Scientist###Genentech###Hot Topic Moderator: – Genentech
### he/him/his @@@ Yow-Ming Wang, PhD – US FDA, CDER., Office of Clinical Pharmacology ### 2228893###Hot Topic Speaker###Associate Director for Biosimilars and Therapeutic Biologics###US FDA, CDER., Office of Clinical Pharmacology###Hot Topic Speaker: – US FDA, CDER., Office of Clinical Pharmacology
### 2:00 PM – 3:00 PM PT
Rapid Fire: High Content BioanalysisRapid Fire Moderator: – Immunologix Laboratories
Novel Strategies to Advance Biotherapeutic Development
2:00 PM – 3:00 PM PT
Rapid Fire: High Content BioanalysisLocation:Plaza ARapid Fire Moderator: – Immunologix Laboratories
Novel Strategies to Advance Biotherapeutic Development
Devangi Mehta, PhD – Immunologix Laboratories ### 1690211###Rapid Fire Moderator###Executive Director###Immunologix Laboratories###Rapid Fire Moderator: – Immunologix Laboratories
### 2:00 PM – 2:15 PM PT
Modeling Strategy to Inform Antibody Binding Affinity for Soluble TargetsLocation:Plaza ARapid Fire Speaker: – Genentech - South San Francisco, CA
Novel Strategies to Advance Biotherapeutic Development
Kazi Tasneem, PhD – Genentech - South San Francisco, CA ### 1820675###Rapid Fire Speaker###Senior Scientist###Genentech - South San Francisco, CA###Rapid Fire Speaker: – Genentech - South San Francisco, CA
### 2:15 PM – 2:30 PM PT
Bioanalytical Functional Activity Measurement in Support of AAV Gene TherapyLocation:Plaza ARapid Fire Speaker: – Spark Therapeutics
Novel Strategies to Advance Biotherapeutic Development
Sayali Saykhedkar, Dr. (she/her/hers) – Spark Therapeutics ### 2173991###Rapid Fire Speaker###Manager, Regulated Bioanalysis###Spark Therapeutics###Rapid Fire Speaker: – Spark Therapeutics
### she/her/hers2:30 PM – 2:45 PM PT
Bioanalytical Strategies, Challenges, and Solutions During PEGylated Drug DevelopmentLocation:Plaza ARapid Fire Speaker: – Genentech
Novel Strategies to Advance Biotherapeutic Development
Emma (Yanqiu) Liu, PhD – Genentech ### 1075489###Rapid Fire Speaker###Senior Principal Scientist###Genentech###Rapid Fire Speaker: – Genentech
### 2:45 PM – 3:00 PM PT
Longitudinal Multi-Omics Characterization of Propyl Gallate-Mediated Nephrotoxicity in BeaglesLocation:Plaza ARapid Fire Speaker: – AstraZeneca
Novel Strategies to Advance Biotherapeutic Development
Nathaly Reyes Garces, PhD (she/her/hers) – AstraZeneca ### 2173983###Rapid Fire Speaker###Senior Scientist###AstraZeneca###Rapid Fire Speaker: – AstraZeneca
### she/her/hers3:15 PM – 4:30 PM PT
Closing Plenary with Dr. Peter Lee
3:15 PM – 4:30 PM PT
Closing Plenary with Dr. Peter LeeLocation:Imperial Ballroom
Peter Lee, Ph.D. ### 2265846###Plenary Speaker###President######Plenary Speaker:
###
