- 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)
