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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

Favorite

8:30 AM – 2:30 PM PT
Speaker Ready Room

8:30 AM – 2:30 PM PT

Speaker Ready Room
Location:Executive Boardroom

Favorite

9:00 AM – 10:00 AM PT
Coffee Break

9:00 AM – 10:00 AM PT

Coffee Break

Location:Yosemite Foyer

Favorite

9:30 AM – 11:00 AM PT
Symposium: AI/ML in Drug Discovery and Development
Moderator: Maxwell Korang-Yeboah, PhD – 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 Development

Location:Yosemite BC

Moderator: Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR ### 2204966###Moderator###Senior Regulatory Research Scientist###FDA/CDER/OPQ/OPQR###
Moderator: Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR
###

9:30 AM – 10:00 AM PT

ML Enhanced DLS for Rapid Characterization of mAb Aggregation

Location:Yosemite BC

Speaker: Anurag S. Rathore, Ph.D. – Indian Insitute of Technology Delhi

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Anurag S. Rathore, Ph.D. – Indian Insitute of Technology Delhi ### 2126789###Speaker###Professor###Indian Insitute of Technology Delhi###
Speaker: Anurag S. Rathore, Ph.D. – Indian Insitute of Technology Delhi
###

10:00 AM – 10:30 AM PT

Harnessing Artificial Intelligence for Classifying Free-Fatty Acid Particles in Biopharmaceuticals

Location:Yosemite BC

Speaker: Filip M. Fedorowicz, MS (he/him/his) – Clear Solutions Laboratories AG

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Filip M. Fedorowicz, MS (he/him/his) – Clear Solutions Laboratories AG ### 2173984###Speaker###Lead Scientist###Clear Solutions Laboratories AG###
Speaker: Filip M. Fedorowicz, MS (he/him/his) – Clear Solutions Laboratories AG
### he/him/his

10:30 AM – 11:00 AM PT

Assessing Immunogenicity Risk of Biologics: Prediction Tools, and Case Studies

Location:Yosemite BC

Speaker: Swati Gupta, PhD (she/her/hers) – AbbVie

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Swati Gupta, PhD (she/her/hers) – AbbVie ### 1820665###Speaker###Executive Director###AbbVie###
Speaker: Swati Gupta, PhD (she/her/hers) – AbbVie
### she/her/hers

9:30 AM – 11:00 AM PT
Symposium: High Content Bioanalysis
Moderator: Eric Thomas, PhD – LabCorp
Novel Strategies to Advance Biotherapeutic Development

9:30 AM – 11:00 AM PT

Symposium: High Content Bioanalysis

Location:Plaza A

Moderator: Eric Thomas, PhD – LabCorp

Novel Strategies to Advance Biotherapeutic Development

Favorite

Eric Thomas, PhD – LabCorp ### 2211768###Moderator###Director, Scientific Affairs###LabCorp###
Moderator: Eric Thomas, PhD – LabCorp
###

9:30 AM – 10:00 AM PT

AAV8 Shedding Assay to Support Gene Therapy Clinical Trials

Location:Plaza A

Speaker: Johannes Stanta, PhD – Celerion

Novel Strategies to Advance Biotherapeutic Development

Favorite

Johannes Stanta, PhD – Celerion ### 2173985###Speaker###Global Director Molecular and Cell Biology###Celerion###
Speaker: Johannes Stanta, PhD – Celerion
###

10:00 AM – 10:30 AM PT

Companion Diagnostics for AAV-Mediated Gene Therapy: Recent Developments and Challenges

Location:Plaza A

Speaker: Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics, Inc

Novel Strategies to Advance Biotherapeutic Development

Favorite

Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics, Inc ### 821735###Speaker###Vice President, Biomarker and BioAnalytical Sciences###Sangamo Therapeutics, Inc###
Speaker: Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics, Inc
### she/her/hers

10:30 AM – 11:00 AM PT

Comparability Assessment Regulatory Considerations of Cell and Gene Therapy Products

Location:Plaza A

Speaker: Mo Heidarian, PhD – Cellx Inc. Consulting

Novel Strategies to Advance Biotherapeutic Development

Favorite

Mo Heidarian, PhD – Cellx Inc. Consulting ### 2232315###Speaker###Chief Regulatory Scientist###Cellx Inc. Consulting###
Speaker: Mo Heidarian, PhD – Cellx Inc. Consulting
###

10:00 AM – 11:00 AM PT
Hot Topic: Advances in in-vivo Therapeutic Nucleic Acid Delivery: Ushering New Era
Hot Topic Moderator: Sandeep Nema, PhD (he/him/his) – 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 Era

Location:Yosemite A

Hot Topic Moderator: Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

10:00 AM – 10:20 AM PT

Machine Learning-Guided Design of Polymer Nanoparticles for In Vivo Gene Therapies

Location:Yosemite A

Hot Topic Speaker: Shashi Murthy, PhD – Nanite Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Shashi Murthy, PhD – Nanite Inc. ### 2204996###Hot Topic Speaker###CoFounder & CTO###Nanite Inc.###
Hot Topic Speaker: Shashi Murthy, PhD – Nanite Inc.
###

10:20 AM – 10:40 AM PT

The Quest for Next Generation Lipid Nanoparticles for Cell-Specific Delivery of mRNA

Location:Yosemite A

Hot Topic Speaker: Gaurav Sahay, PhD – Oregon State University

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Gaurav Sahay, PhD – Oregon State University ### 758590###Hot Topic Speaker###Professor###Oregon State University###
Hot Topic Speaker: Gaurav Sahay, PhD – Oregon State University
###

10:40 AM – 11:00 AM PT

Panel Discussion

Location:Yosemite A

Hot Topic Moderator: Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics

Hot Topic Speaker: Shashi Murthy, PhD – Nanite Inc.

Hot Topic Speaker: Gaurav Sahay, PhD – Oregon State University

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics ### 2204995###Hot Topic Moderator###SVP###Saliogen Therapeutics###
Hot Topic Moderator: Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics
### he/him/his @@@ Shashi Murthy, PhD – Nanite Inc. ### 2204996###Hot Topic Speaker###CoFounder & CTO###Nanite Inc.###
Hot Topic Speaker: Shashi Murthy, PhD – Nanite Inc.
### @@@ Gaurav Sahay, PhD – Oregon State University ### 758590###Hot Topic Speaker###Professor###Oregon State University###
Hot Topic Speaker: Gaurav Sahay, PhD – Oregon State University
###

11:00 AM – 12:30 PM PT
Networking Lunch

11:00 AM – 12:30 PM PT

Networking Lunch
Location:Franciscan ABCD

Favorite

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 Process

Location:Yosemite BC

Keynote Speaker: Simon Wang, PhD (he/him/his) – Howard University

Moderator: Mitra Mosharraf, M Pharm, PhD, MBA – HTD Biosystems

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Simon Wang, PhD (he/him/his) – Howard University ### 2204969###Keynote Speaker###Associate Professor###Howard University###
Keynote Speaker: Simon Wang, PhD (he/him/his) – Howard University
### he/him/his @@@ Mitra Mosharraf, M Pharm, PhD, MBA – HTD Biosystems ### 2204970###Moderator###CSO###HTD Biosystems###
Moderator: Mitra Mosharraf, M Pharm, PhD, MBA – 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 A

Keynote Speaker: Zuben E. Sauna, PhD (he/him/his) – U.S. Food and Drug Administration

Moderator: Arkadeep Sinha, PhD (he/him/his) – Upstream BIo

Novel Strategies to Advance Biotherapeutic Development

Favorite

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: Zuben E. Sauna, PhD (he/him/his) – 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: Arkadeep Sinha, PhD (he/him/his) – Upstream BIo
### he/him/his

1:30 PM – 2:00 PM PT
Coffee Break

1:30 PM – 2:00 PM PT

Coffee Break

Location:Yosemite Foyer

Favorite

2:00 PM – 2:45 PM PT
Rapid Fire: AI/ML in Drug Discovery and Development
Rapid Fire Moderator: Swati Gupta, PhD (she/her/hers) – 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 Development

Location:Yosemite BC

Rapid Fire Moderator: Swati Gupta, PhD (she/her/hers) – AbbVie

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Swati Gupta, PhD (she/her/hers) – AbbVie ### 1820665###Rapid Fire Moderator###Executive Director###AbbVie###
Rapid Fire Moderator: Swati Gupta, PhD (she/her/hers) – AbbVie
### she/her/hers

2:00 PM – 2:15 PM PT

Data Quality and Data Integrity Considerations for Applying AI/ML as Part of Process/Product Development

Location:Yosemite BC

Rapid Fire Speaker: Bikash Chatterjee (he/him/his) – Pharmatech Associates

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Bikash Chatterjee (he/him/his) – Pharmatech Associates ### 1921888###Rapid Fire Speaker###President and Chief Science Officer###Pharmatech Associates###
Rapid Fire Speaker: Bikash Chatterjee (he/him/his) – Pharmatech Associates
### he/him/his

2:15 PM – 2:30 PM PT

Optimizing for Failure - Survivorship Bias in AI

Location:Yosemite BC

Rapid Fire Speaker: Andrew O'Connor, BSc (Hons) – ERA Sciences

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Andrew O'Connor, BSc (Hons) – ERA Sciences ### 2173987###Rapid Fire Speaker###Executive DIrector###ERA Sciences###
Rapid Fire Speaker: Andrew O'Connor, BSc (Hons) – ERA Sciences
###

2:30 PM – 2:45 PM PT

Mechanistic Insight into the Physical Stability of Oligonucleotides

Location:Yosemite BC

Rapid Fire Speaker: Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR

Advances in Discovery, Formulation, and Delivery of New Modalities

Favorite

Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR ### 2204966###Rapid Fire Speaker###Senior Regulatory Research Scientist###FDA/CDER/OPQ/OPQR###
Rapid Fire Speaker: Maxwell Korang-Yeboah, PhD – 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 Guidance

Location:Yosemite A

Hot Topic Speaker: Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech

Hot Topic Speaker: Ching-Ha (Vicky) Lai, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc

Hot Topic Speaker: Will Williams, MS (he/him/his) – BioAgilytix

Hot Topic Moderator: Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech

Hot Topic Speaker: Yow-Ming Wang, PhD – US FDA, CDER., Office of Clinical Pharmacology

Novel Strategies to Advance Biotherapeutic Development

Favorite

Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech ### 2173976###Hot Topic Speaker###Sr Director and Distinguished Scientist###Genentech###
Hot Topic Speaker: Steve J. Swanson, PhD, FAAPS (he/him/his) – 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: Ching-Ha (Vicky) Lai, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc
### she/her/hers @@@ Will Williams, MS (he/him/his) – BioAgilytix ### 2173989###Hot Topic Speaker###Senior Director###BioAgilytix###
Hot Topic Speaker: Will Williams, MS (he/him/his) – 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: Steve J. Swanson, PhD, FAAPS (he/him/his) – 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: Yow-Ming Wang, PhD – US FDA, CDER., Office of Clinical Pharmacology
###

2:00 PM – 3:00 PM PT
Rapid Fire: High Content Bioanalysis
Rapid Fire Moderator: Devangi Mehta, PhD – Immunologix Laboratories
Novel Strategies to Advance Biotherapeutic Development

2:00 PM – 3:00 PM PT

Rapid Fire: High Content Bioanalysis

Location:Plaza A

Rapid Fire Moderator: Devangi Mehta, PhD – Immunologix Laboratories

Novel Strategies to Advance Biotherapeutic Development

Favorite

Devangi Mehta, PhD – Immunologix Laboratories ### 1690211###Rapid Fire Moderator###Executive Director###Immunologix Laboratories###
Rapid Fire Moderator: Devangi Mehta, PhD – Immunologix Laboratories
###

2:00 PM – 2:15 PM PT

Modeling Strategy to Inform Antibody Binding Affinity for Soluble Targets

Location:Plaza A

Rapid Fire Speaker: Kazi Tasneem, PhD – Genentech - South San Francisco, CA

Novel Strategies to Advance Biotherapeutic Development

Favorite

Kazi Tasneem, PhD – Genentech - South San Francisco, CA ### 1820675###Rapid Fire Speaker###Senior Scientist###Genentech - South San Francisco, CA###
Rapid Fire Speaker: Kazi Tasneem, PhD – Genentech - South San Francisco, CA
###

2:15 PM – 2:30 PM PT

Bioanalytical Functional Activity Measurement in Support of AAV Gene Therapy

Location:Plaza A

Rapid Fire Speaker: Sayali Saykhedkar, Dr. (she/her/hers) – Spark Therapeutics

Novel Strategies to Advance Biotherapeutic Development

Favorite

Sayali Saykhedkar, Dr. (she/her/hers) – Spark Therapeutics ### 2173991###Rapid Fire Speaker###Manager, Regulated Bioanalysis###Spark Therapeutics###
Rapid Fire Speaker: Sayali Saykhedkar, Dr. (she/her/hers) – Spark Therapeutics
### she/her/hers

2:30 PM – 2:45 PM PT

Bioanalytical Strategies, Challenges, and Solutions During PEGylated Drug Development

Location:Plaza A

Rapid Fire Speaker: Emma (Yanqiu) Liu, PhD – Genentech

Novel Strategies to Advance Biotherapeutic Development

Favorite

Emma (Yanqiu) Liu, PhD – Genentech ### 1075489###Rapid Fire Speaker###Senior Principal Scientist###Genentech###
Rapid Fire Speaker: Emma (Yanqiu) Liu, PhD – Genentech
###

2:45 PM – 3:00 PM PT

Longitudinal Multi-Omics Characterization of Propyl Gallate-Mediated Nephrotoxicity in Beagles

Location:Plaza A

Rapid Fire Speaker: Nathaly Reyes Garces, PhD (she/her/hers) – AstraZeneca

Novel Strategies to Advance Biotherapeutic Development

Favorite

Nathaly Reyes Garces, PhD (she/her/hers) – AstraZeneca ### 2173983###Rapid Fire Speaker###Senior Scientist###AstraZeneca###
Rapid Fire Speaker: Nathaly Reyes Garces, PhD (she/her/hers) – AstraZeneca
### she/her/hers

3:15 PM – 4:30 PM PT
Closing Plenary with Dr. Peter Lee

3:15 PM – 4:30 PM PT

Closing Plenary with Dr. Peter Lee
Location:Imperial Ballroom

Plenary Speaker: Peter Lee, Ph.D.

Favorite

Peter Lee, Ph.D. ### 2265846###Plenary Speaker###President######
Plenary Speaker: Peter Lee, Ph.D.
###