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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 Meeting
Location: Yosemite A
Community Leader:
Karen J. Quadrini, PhD
– 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 Technology
Moderator:
Shoshana Oberstein (she/her/hers)
– 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 Technology
Location: Plaza A
Moderator:
Shoshana Oberstein (she/her/hers)
– PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
9:30 AM – 10:00 AM
PT
Personalizing Clinical Immunogenicity Risk Through HLA DR Alleles Associations
Location: Plaza A
Speaker:
SURENDRAN RAJENDRAN, PhD (he/him/his)
– Bristol-Myers Squibb
Novel Strategies to Advance Biotherapeutic Development
10:00 AM – 10:30 AM
PT
Unique Clinical Pharmacology Considerations for Allogeneic Cell Therapies
Location: Plaza A
Speaker:
Dhruvitkumar Sutaria, PhD (he/him/his)
– Genentech
Novel Strategies to Advance Biotherapeutic Development
10:30 AM – 11:00 AM
PT
Methodologies for Biotherapeutic Biotransformation Studies
Location: Plaza A
Speaker:
Anton Rosenbaum
– AstraZeneca
Novel Strategies to Advance Biotherapeutic Development
9:30 AM – 11:00 AM
PT
Symposium: Drug Delivery for New Modalities and Therapies
Moderator:
Asmita Khanolkar, MS
– SMC Ltd.
Advances in Discovery, Formulation, and Delivery of New Modalities
9:30 AM – 11:00 AM
PT
Symposium: Drug Delivery for New Modalities and Therapies
Location: Yosemite BC
Moderator:
Asmita Khanolkar, MS
– SMC Ltd.
Advances in Discovery, Formulation, and Delivery of New Modalities
9:30 AM – 10:00 AM
PT
Enabling Lipid Chemistry & Nanoparticle Surface Modification for Cytosolic Delivery
Location: Yosemite BC
Speaker:
Xiuling Lu, Ph.D., FAAPS (she/her/hers)
– University of Connecticut
Advances in Discovery, Formulation, and Delivery of New Modalities
10:00 AM – 10:30 AM
PT
Auto-Mode Biomimicry: A Versatile Theranostic Model for Efficient Tumor Targeting
Location: Yosemite BC
Speaker:
Imran Tariq, PhD
– University of the Punjab
Advances in Discovery, Formulation, and Delivery of New Modalities
10:30 AM – 11:00 AM
PT
Novel Engineering and Formulation Based Approaches for Delivery of CART to Solid Tumors
Location: Yosemite BC
Speaker:
Robert Dodge, PhD
– Consultant
Advances in Discovery, Formulation, and Delivery of New Modalities
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 Center
Location: Grand Ballroom AB
10:00 AM – 11:00 AM
PT
Hot Topic: Applications of qPCR/dPCR in Cell and Gene Therapies; Case Studies
Hot Topic Moderator:
Jacqueline Murphy, MS
– 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 Studies
Location: Yosemite A
Hot Topic Moderator:
Jacqueline Murphy, MS
– Janssen
Novel Strategies to Advance Biotherapeutic Development
10:00 AM – 10:10 AM
PT
Introduction to PCR Assay Development and Validation
Location: Yosemite A
Hot Topic Speaker:
Timothy L. Lochmann, PhD (he/him/his)
– PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
10:10 AM – 10:20 AM
PT
A Case Study in AAV Gene Therapy Viral Shedding
Location: Yosemite A
Hot Topic Speaker:
Mitra Azadeh, PhD (she/her/hers)
– Ultragenyx
Novel Strategies to Advance Biotherapeutic Development
10:20 AM – 10:30 AM
PT
A Case study in Cell Therapy Persistence by qPCR
Location: Yosemite A
Hot Topic Speaker:
Kate B. Herr, M.S. (she/her/hers)
– Johnson & Johnson
Novel Strategies to Advance Biotherapeutic Development
10:30 AM – 10:40 AM
PT
A Case Study in Cell Therapy Persistence by ddPCR
Location: Yosemite A
Hot Topic Speaker:
Nanda Balasubramanian, PhD (he/him/his)
– Bristol-Myers Squibb Company
Novel Strategies to Advance Biotherapeutic Development
10:40 AM – 11:00 AM
PT
Panel Discussion
Location: Yosemite A
Hot Topic Speaker:
Mitra Azadeh, PhD (she/her/hers)
– Ultragenyx
Hot Topic Speaker:
Timothy L. Lochmann, PhD (he/him/his)
– PPD, part of Thermo Fisher Scientific
Hot Topic Speaker:
Nanda Balasubramanian, PhD (he/him/his)
– Bristol-Myers Squibb Company
Hot Topic Speaker:
Kate B. Herr, M.S. (she/her/hers)
– Johnson & Johnson
Hot Topic Moderator:
Jacqueline Murphy, MS
– Janssen
Novel Strategies to Advance Biotherapeutic Development
10:00 AM – 4:30 PM
PT
Solution Center Hours & Poster Presentations
10:00 AM – 4:30 PM
PT
Solution Center Hours & Poster Presentations
Location: 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 Formulations
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker:
Sreejit Menon, PhD
– Croda, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
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-Injector
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker:
David W. Kang
– Halozyme Therapeutics Inc
Partner Presentation Speaker:
Michael Travanty
– Halozyme Therapeutics, Inc
Advances in Discovery, Formulation, and Delivery of New Modalities
11:30 AM – 12:30 PM
PT
Special Poster Collection
11:30 AM – 12:30 PM
PT
Special Poster Collection
Location: Grand Ballroom AB, Poster Forum 1
Poster Collection Host:
Katie F. Maass, Ph.D. (she/her/hers)
– Genentech, Inc.
Novel Strategies to Advance Biotherapeutic Development
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
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/MS
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker:
Suraj Dhungana, PhD, MBA (he/him/his)
– Waters Corporation
Novel Strategies to Advance Biotherapeutic Development
1:00 PM – 2:00 PM
PT
Keynote: Development of Oligonucleotide Therapeutics
Keynote Speaker:
Raman Bahal
Moderator:
Linzhi Chen, PhD (he/him/his)
– Boehringer Ingelheim Pharmaceuticals, Inc.
Novel Strategies to Advance Biotherapeutic Development
1:00 PM – 2:00 PM
PT
Keynote: Development of Oligonucleotide Therapeutics
Location: Plaza A
Keynote Speaker:
Raman Bahal
Moderator:
Linzhi Chen, PhD (he/him/his)
– Boehringer Ingelheim Pharmaceuticals, Inc.
Novel Strategies to Advance Biotherapeutic Development
1:00 PM – 2:00 PM
PT
Keynote: In vivo Delivery of mRNAs for Anti-Aging Applications: Potential and Challenges
Keynote Speaker:
Vittorio Sebastiano, PhD (he/him/his)
– Stanford University and Turn Biotechnologies
Moderator:
Nitesh Kunda, PhD
– 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 Challenges
Location: Yosemite BC
Keynote Speaker:
Vittorio Sebastiano, PhD (he/him/his)
– Stanford University and Turn Biotechnologies
Moderator:
Nitesh Kunda, PhD
– St. John's University
Advances in Discovery, Formulation, and Delivery of New Modalities
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 Panel
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker:
Amanda L. Hays, PhD
– BioAgilytix
Partner Presentation Speaker:
Mark C. Wissel, PhD
– Eurofins Viracor BioPharma
Partner Presentation Speaker:
Kelly S. Colletti, PhD, MBA (she/her/hers)
– Beam Therapeutics
Partner Presentation Speaker:
Russell K. Soon, Jr. (he/him/his)
– BioMarin Pharmaceutical, Inc.
Moderator:
Tina S. Morris, PhD
– AAPS
Advances in Discovery, Formulation, and Delivery of New Modalities
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 Center
Location: 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 Development
Location: Yosemite A
Hot Topic Speaker:
Parag Kolhe, PhD
– Pfizer Inc.
Hot Topic Moderator:
Ping Ji, PhD
– US Food and Drug Administration
Advances in Discovery, Formulation, and Delivery of New Modalities
2:30 PM – 3:30 PM
PT
Rapid Fire: Advances in Analytical and Bioanalytical Platform Technology
Rapid Fire Moderator:
Nancy Yu (she/her/hers)
– Genentech, Inc
Novel Strategies to Advance Biotherapeutic Development
2:30 PM – 3:30 PM
PT
Rapid Fire: Advances in Analytical and Bioanalytical Platform Technology
Location: Plaza A
Rapid Fire Moderator:
Nancy Yu (she/her/hers)
– Genentech, Inc
Novel Strategies to Advance Biotherapeutic Development
2:30 PM – 2:45 PM
PT
Metabolite identification and Profiling Methodology - Application for GalNAc Conjugated Oligonucleotides
Location: Plaza A
Rapid Fire Speaker:
Asa Walander, M.S., PhD (she/her/hers)
– Ionis Pharmaceuticals
Novel Strategies to Advance Biotherapeutic Development
2:45 PM – 3:00 PM
PT
Highly-Sensitive Hybridization ELISA Development for Oligonucleotide Quantitation at Picogram Levels
Location: Plaza A
Rapid Fire Speaker:
Eric F. Tewalt, PhD
– PPD, Part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
3:00 PM – 3:15 PM
PT
Comparison of Four Bioanalytical Assay Platforms for siRNA Therapeutic Quantitation
Location: Plaza A
Rapid Fire Speaker:
Karan Agrawal, PhD (he/him/his)
– Janssen Research and Development
Novel Strategies to Advance Biotherapeutic Development
3:15 PM – 3:30 PM
PT
Bioanalytical Strategy for Pharmacokinetic Characterization of Oligonucleotide-Protein Conjugates
Location: Plaza A
Rapid Fire Speaker:
Babak Basiri, PhD (he/him/his)
– Dyne Therapeutics
Novel Strategies to Advance Biotherapeutic Development
2:30 PM – 3:30 PM
PT
Rapid Fire: Drug Delivery for New Modalities and Therapies
Rapid Fire Moderator:
Karthik Nagapudi, PhD
– 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 Therapies
Location: Yosemite BC
Rapid Fire Moderator:
Karthik Nagapudi, PhD
– Genentech, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
2:30 PM – 2:45 PM
PT
Dry Powders for the Delivery of Biopharmaceuticals to the Nose
Location: Yosemite BC
Rapid Fire Speaker:
Irene Rossi, PhD
– Harro Höfliger
Advances in Discovery, Formulation, and Delivery of New Modalities
2:45 PM – 3:00 PM
PT
Development of an Inhalable and Temperature-Stable COVID-19 Liposomal Vaccine
Location: Yosemite BC
Rapid Fire Speaker:
Apoorva Daram (she/her/hers)
– St. Johns University
Advances in Discovery, Formulation, and Delivery of New Modalities
3:00 PM – 3:15 PM
PT
What Does “Biorelevant” Mean for Oral Peptides?
Location: Yosemite BC
Rapid Fire Speaker:
Tahnee J. Dening, PhD (she/her/hers)
– Genentech, Inc.
Advances in Discovery, Formulation, and Delivery of New Modalities
3:15 PM – 3:30 PM
PT
Molecular Investigation on Permeation-Enhancer Assisted Oral Peptide Delivery in Lipid-Bilayers
Location: Yosemite BC
Rapid Fire Speaker:
Jing Ling, PhD
– Merck
Advances in Discovery, Formulation, and Delivery of New Modalities
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 Analogs
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker:
Ebru S. Selen, PhD (she/her/hers)
– SCIEX
Novel Strategies to Advance Biotherapeutic Development
3:30 PM – 4:30 PM
PT
Happy Hour Sponsored by INTERPHEX
3:30 PM – 4:30 PM
PT
Happy Hour Sponsored by INTERPHEX
Location: Booth #805, Grand Ballroom AB
3:30 PM – 4:30 PM
PT
Special Poster Collection
3:30 PM – 4:30 PM
PT
Special Poster Collection
Location: Grand Ballroom AB, Poster Forum 1
Poster Collection Host:
Russ S. Weiner, Ph.D., FAAPS
– 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 Meeting
Location: Yosemite A
Community Leader:
Yan G. Ni, PhD
– 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 AstraZeneca
Location: Vista Lounge (45th Floor)
