American Biomanufacturing Summit
Lunch & Learn
Roundtables
Day 1
12:45 pm – 1:45 pm PST
12:45 pm – 1:45 pm PST
TABLE 1
Simon Trigg
Senior Director, Supply Chain
Rentschler BioPharma Inc.
How is AI being embedded into your daily Supply Chain decision‑making and operations?
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Chidi Obi
Abcuro
Hirak Desai
Navigator Medicines
Jin Li
BeOne Medicines
Krishnaveni Gottam
Genetix Biotherapeutics
Michael Suarez
GSK
Padraig Gavin
N/A
Polly Mak
Kardigan
Rene Sielmann
Bayer
Yunzhi Xiao
89bio
TABLE 2
Michael Dunn
Chief Commerical Officer
Afton Scientific
Flexible Aseptic Fill‑Finish for Biologics & Small Molecules
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Cherie Ali
Alector, Inc.
Christopher Brown
Seattle Children's Therapeutics
Courtney Wood
SteriMax Inc.
Diane Yu
Electra Therapeutics
Ekta Mahajan
Gilead
Janice Salmon
BMS
Michael Wong
Nkarta
Ming Aquila
Ionis 6
Purbasa Patnaik
Exelixis
TABLE 3
Ross Turmell
Principal Scientist
Cytiva
Open Discussion: Reducing/Removing PUPSIT Requirements from Annex 1
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Ellen Huynh
Nkarta Inc.
Jose Caraballo
Kite
Mike Ong
Candid Therapeutics
Niraj Ramachandran
Genentech
Siegfried Hackl
Ultragenyx Inc..
Stephanie Le
Nkarta
Suri Monsef
BeOne medicines
Thomas Ridel
SANOFI
Zarna Patel
Abcuro. Inc,
TABLE 4
Gord Adamson, Ph.D.
Senior Directory of Technical Operations
Resilience
Accelerating Therapies to the Clinic While Assuring Commercial Success – Is There a Solution?
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Beatrice Smith
Keck Graduate Institute
Callum Chapman
AstraZeneca
Guido Palermo
Atara Biotherapeutics, Inc.
Lawhan Blackett
Astrazeneca
Monica Kukreja
ArsenalBio
Saurin Patel
Takeda Pharmaceuticals
Stephanie Hawthorne
Bristol Myers Squibb
Suzann Muy
Bayer
Wendy Larson
Astellas Gene Therapies
TABLE 5
Joe Petrosky
SVP, Global Sales
PBS Biotech Inc
Cell Therapy from Start to Scale: How to Stay on the Leading Edge without Ending Up on the Bleeding Edge
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Allen Henderson
Sutro Biopharma
Amy Giunta
Moderna
Athena Wong
Sana Biotechnology
Deep Shah
Sana Biotechnology
Edmond Ma
Boehringer Ingelheim
Purba Dain
Kite Pharma
Rajat Saggar
Vericel
Vikash Sharma
AstraZeneca
Zhuojin Xu
Allogene Therapeutics
TABLE 6
Sven Lee
SVP, Global Business Development
Bionova Scientific
Process by Design: De-Risking CMC Pathways from Development to GMP
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Alexis Chen
AstraZeneca
Angelina Johonnot
Johnson and Johnson
Anthony Wong
Nkarta
Anubhav Arora
Apellis Pharmaceuticals
Megumi Noguchi
Electra Therapeutics
Ranita Ramesh
Amgen
Sashi Banappagari
Earli Inc
Sean M Bell
Alector
Zhenyu Gu
Xencor
TABLE 7
Dustin Lafferty
Senior Pharmaceutical Scientist, Process and Product Development Supervisor, Analytical Development and Validation Supervisor
Singota Solutions
Early phase analytical validation
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Calvin Chen
Amgen
Christine Acklin
Xencor
Donovan Collins
Gilead Sciences
Doreen Ciolek
Daiichi Sankyo
Eike Zimmermann
Allogene Therapeutics
Joshua Lapin
Walden Biosciences
Julie Nguyen
Boehringer Ingelheim
Nathan Majewski
Iovance
Sam Lewis
Abcuro Inc
TABLE 8
Jon C Best
Director, Business Development
AbbVie
Building supply chain resiliency to mitigate risk for complex biologics (ie ADCs)
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Adeline Perez
Lilly
Aimee Kincaid
Jagaur Health
Al Terry
Bristol Meyers Squibb
Chupei Zhang
Wugen
Colin Cook
XDemics Corporation
Lewis Tsai
Merck
Nafees Rahman
Nkarta Therapeutics
Talena Williamson
Amgen
Tracy Nguyen
BMS
TABLE 9
Richard Richieri
Chief Operations Officer
Avid Bioservices
Mid-Phase Tech Transfer: Onshoring Strategies, Operational Pitfalls, and Lessons Learned
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Brigid Poling
Nkarta
Jill Cavanagh
UCB Pharma
Kate Nelson
Electra Therapeutics
Kim Caddy
Anaptysbio
Loleta Chung
Boehringer Ingelheim, Inc. Fremont
May Li
89bio Inc.
Mithu Majumder
Novavax Inc.
Nekesha Kyle
TORL BioTherapeutics
Tham Hua
4DMT
TABLE 10
Beth Simmons
Director, Technical Excellence
OXB
Taking Viral Vectors from Clinic to Commercial: Strategic Choices that Define Biomanufacturing Success
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Arthur Edge
AstraZeneca
Aurelie Demont
METTLER TOLEDO
David Asarnow
4DMT
Elia Sanchez
Biomarin Pharmaceutical
Jay Kang
Legend Biotech
Joe Leonetti
4D Molecular Therapeutics
Mihir Patel
Rocket Pharmaceuticals
Susan Fisher
Gilead Sciences
TABLE 11
Pete Momjian
Associate Director, Business Development CDMO
Novartis
Geopolitical uncertainty and regional Supply Chain capacity strategy
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Alexandra Santoni
Beam Therapeutics
Andreas Wilmers
Mettler-Toledo
Angela Goodenough
AnaptysBio, Inc.
Erick Honores
Regeneron
Manny Otero
Lexeo Therapeutics, Inc.
Sumitra Angepat
Bayer
Vaidehi Saripalli
BeOne Medicines
Wenbin Qi
Neurocrine
Yuyi Shen
Abcuro
TABLE 12
Devan Howlett
Business Development Manager, Industrial
Honeywell
Implementing Smart Automation & MES for cGMP Biomanufacturing Control and Compliance
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Aditya Basrur
BMS
Ajay Chandrashekar
Bristol-Myers Squibb
Christine Chen
FateTherapeutics, Inc.
Marina Becker
Orca Bio
Michelle Shimberg
Bayer U.S. LLC
Pushpa Narayanan
Boehringer-Ingelheim
Sabrina Huynh
AstraZeneca Pharmaceuticals
Sonali Garg
AstraZeneca
Sophia Malki
Boehringer Ingelheim
TABLE 13
Relly Brandman
Moonshot Lead
A-Life - A Google X Moonshot
From Cells to Products: Leveraging AI for Efficient Biomanufacturing
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Anders Chan
Eli Lilly
Burkard Kolb
89bio
Jason Edwards
Genentech
Joseph Wypych
AscenT-cell Biotech
Marcus Price
Genentech
Maria Sohail
Genentech
Marisa Angela Sepulveda Becerra
Inovio Pharmaceuticals
Stan Khoruzhenko
Bayer
Umberto Scarfogliero
Toro Bio
TABLE 14
Vishal Prasad
Co-Founder, Chief Product Officer
Mareana
Knowledge Graph as the CPV and VSM Multiplier!
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Edward Kwong Kwong
Astrazeneca
Elizabeth Ziga
AstraZeneca Pharmaceuticals LP
Gnat Matthews
N/A
Jill Wilken
Genentech Inc.
Lisa Yap
Electra Therapeutics
Ming Aquila
IONS Pharmaceuticals
Roshni Pillai
AstraZeneca Pharmaceuticals
Stelios Tsinontides
Merck & Co., Inc.
Yamato Suzuki
Daiichi Sankyo
TABLE 15
Mayank Gupta
Principal
ZS
Steve Yu
Principal
ZS
Enabling faster, smarter manufacturing and quality operations augmented with agentic AI
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Ajit Smith-iyer
Sutro Biopharma
Janet Lee
Allogene Therapeutics - South San Francisco, CA
John Ruesch
BioCryst
Lilian Kee
GondolaBio
Lorena Barron
Atara Biotherapeutics, Inc.
Mandy Xie
Bristol Meyers Squibb
Moutasem Elsheikh
Allogene Therapeutics
Sam Lewis
Abcuro
TABLE 16
Reza Farahani
Co-Founder and CEO
Katalyze AI
Shreyas Becker
Co-Founder and COO
Katalyze AI
Leveraging AI Agents to Reduce RCA Investigation Time by Over 60% and Accelerate CAPA Execution in cGMP Manufacturing
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Adam Golin
Sanofi
Amit Syal
Vaxcyte
Ben Hsieh
ZdefLabs, Inc
Bob Thiessen
Genentech/Roche
Fatou Diagne
Sanofi
Jason Slye
Vericel Corporation
Jennifer Kim
Sanofi
Mareena Saini
AstraZeneca
Mike Riley
SteriMax Inc
TABLE 17
Roy Lin, Ph.D
Chief Technology Officer
Boston Insititute of Biotechnology
How can we Achieve Cost-Effective Biologic Manufacturing at Ultra-Large Scale Without Compromising Quality or Speed?
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Cassandra Gath
CRISPR Therapeutics
Christian Lyeo
Celltrion Inc.
Jay Howlett
AbCellera Biologics Inc.
John Miller
Genentech
Johnny Yin
Boehringer-Ingelheim Fremont, Inc.
Phong Nguy
Bayer
Seojun Noh
Celltrion
Tung Nguyen
Daiichi Sankyo
Day 2
1:00 pm – 2:00 pm PST
1:00 pm – 2:00 pm PST
TABLE 1
Debaditya Bhattacharya, Ph.D.
VP, CMC Development and External Manufacturing
Myrtelle
Navigating Manufacturing Comparability and Regulatory Expectations for Gene therapy products
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Ajay Chandrashekar
Bristol-Myers Squibb
Anders Chan
Eli Lilly
Brigid Poling
Nkarta
Colin Cook
XDemics Corporation
Edmond Ma
Boehringer Ingelheim
Erick Honores
Regeneron
Padraig Gavin
N/A
Suri Monsef
BeOne medicines
Wenbin Qi
Neurocrine
TABLE 2
Tiffany Cavallaro
Executive Director, Global Supply & IBP
Amgen
Transforming Supply Chain Planning: Aligning People, Processes, and Technology for Scalable Growth
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Angela Goodenough
AnaptysBio, Inc.
Beatrice Smith
Keck Graduate Institute
David Asarnow
4DMT
Doreen Ciolek
Daiichi Sankyo
Jason Edwards
Genentech
Jay Kang
Legend Biotech
Lawhan Blackett
Astrazeneca
Lewis Tsai
Merck
Maria Sohail
Genentech
TABLE 3
Anja Preissmann
VP and Site Head, BioPharma - US
Boehringer Ingelheim, Fremont
The Leadership Exchange: Best Practices for Advancing Women in BioPharma
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Alexandra Santoni
Beam Therapeutics
Gnat Matthews
N/A
Krishnaveni Gottam
Genetix Biotherapeutics
Mareena Saini
AstraZeneca
Michelle Shimberg
Bayer U.S. LLC
Sabrina Huynh
AstraZeneca Pharmaceuticals
Sam Lewis
Abcuro
Stephanie Hawthorne
Bristol Myers Squibb
Wendy Larson
Astellas Gene Therapies
TABLE 4
Stacey Cox
Senior Director, Manufacturing
BioMarin Pharmaceutical
AI-Driven Automation to Acceleration: Scaling BioPharma Manufacturing with Smart Tech
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Alexis Chen
AstraZeneca
Allen Henderson
Sutro Biopharma
Ben Hsieh
ZdefLabs, Inc
Chupei Zhang
Wugen
Diane Yu
Electra Therapeutics
Edward Kwong Kwong
Astrazeneca
Elizabeth Ziga
AstraZeneca Pharmaceuticals LP
Janet Lee
Allogene Therapeutics - South San Francisco, CA
Roshni Pillai
AstraZeneca Pharmaceuticals
TABLE 5
Amy Giunta
Senior Director, Central Supply Chain Planning
Moderna
Modernizing Integrated Sales and Operations Execution for Scalable Global Biomanufacturing Networks
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Arel Minoza
Boehringer Ingelheim
Christian Lyeo
Celltrion Inc.
Claire Manning
Astellas
Ekta Mahajan
Gilead
Fransheska Rivera Vega
Bayer
Julie Hang
89Bio LLC
Nancy Flores
ImmunityBio
Prashant Majithia
Gilead Sciences
Seojun Noh
CELLTRION
TABLE 6
Harish Santhanam
VP, Cell Therapy Technical Operations
Bristol Myers Squibb
Digitizing Autologous Manufacturing: Lessons from Cell Therapy at Scale
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Adam Barron
Vericel
Andreas Wilmers
Mettler-Toledo
Arthur Edge
AstraZeneca
Donovan Collins
Gilead Sciences
Dr. Moira Monika
Wacker Biotech
Megan Bobel
METTLER TOLEDO
Ming Aquila
Ionis 6
Pushpa Narayanan
Boehringer-Ingelheim
Rohan Kulkarni
Bionova Scientific
TABLE 7
Niraj Ramachandran
Director, Technical Regulatory Cell and Gene Therapies (CMC)
Genetech
Developing effective CMC regulatory strategy for potency assets for cell and Gene therapies
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Anubhav Arora
Apellis Pharmaceuticals
Christine Chen
FateTherapeutics, Inc.
Jin Li
BeOne Medicines
Marcus Price
Genentech
Monica Kukreja
ArsenalBio
Nafees Rahman
Nkarta Therapeutics
Umberto Scarfogliero
Toro Bio
Yunzhi Xiao
89bio
Yuyi Shen
Abcuro
TABLE 9
Gerardo Rivera
Supply Chain director
AstraZeneca
SCALING LEAN AND DEMAND-DRIVEN SUPPLY MODELS ACROSS GLOBAL PHARMA NETWORKS TO REDUCE INVENTORY AND ACCELERATE PRODUCT VELOCITY
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Adam Golin
Sanofi
Fatou Diagne
Sanofi
Jennifer Kim
Sanofi
Kate Nelson
Electra Therapeutics
Lilith Baczynski
Boehringer Ingelheim
Marisa Angela Sepulveda Becerra
Inovio Pharmaceuticals
Saurin Patel
Takeda Pharmaceuticals
Thomas Ridel
SANOFI
Yamato Suzuki
Daiichi Sankyo
TABLE 10
Xiling Song
VP, Global Head of Regulatory CMC
BeOne Medicines
Accelerating Global Small Molecule Development Through Strategic Regulatory CMC Alignment
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Aimee Kincaid
Jagaur Health
Jill Cavanagh
UCB Pharma
Julie Hang
89Bio Inc
Loleta Chung
Boehringer Ingelheim, Inc. Fremont
Lorena Barron
Atara Biotherapeutics, Inc.
Nekesha Kyle
TORL BioTherapeutics
Suzann Muy
Bayer
Vaidehi Saripalli
BeOne Medicines
Zhuojin Xu
Allogene Therapeutics
TABLE 11
Sue Liu
Executive Director, Quality Assurance, Site QA Head
Gilead
Optimizing Quality Systems for Operational Excellence and Compliance
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Amit Syal
Vaxcyte
Bob Thiessen
Genentech/Roche
Daniel Harrison
Amgen
Jason Slye
Vericel Corporation
Jill Wilken
Genentech Inc.
Mike Riley
SteriMax Inc
Ming Aquila
IONS Pharmaceuticals
Polly Mak
Kardigan
Rajat Saggar
Vericel
TABLE 12
Rahul Kaushik
Chief Technical Officer
Disc Medicine
ALIGNING CMC STRATEGY WITH CLINICAL DEVELOPMENT: ACCELERATING LATE-STAGE BIOLOGICS TO MARKET
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Callum Chapman
AstraZeneca
Chidi Obi
Abcuro
Hirak Desai
Navigator Medicines
Kim Caddy
Anaptysbio
Lilian Kee
GondolaBio
May Li
89bio Inc.
Purbasa Patnaik
Exelixis
Ranita Ramesh
Amgen
Tham Hua
4DMT