American Pharma Manufacturing & Outsourcing Summit
Lunch & Learn
Roundtables
Day 1
12:40 pm – 1:40 pm EST
12:40 pm – 1:40 pm EST
TABLE 1
Jared McDonald
VP, Formulation Development
Coating Place
From Complexity to Commercialization: Partnering for Breakthrough Results
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Alex Jacobine
Innoviva Specialty Therapeutics (IST)
Amanda Pergamo
Elanco
Andrea Aldridge
Biocryst
Brooke Heston
BioCryst Pharmaceuticals
Danielle Coelho
Elanco Animal Health
Doug Peterson
Hikma Pharmaceuticals
Jeffrey Haworth
Akston Biosciences Corporation
Jonathan West
BioCryst Pharmaceuticals
Omar Kassim
Takeda Pharmaceuricals
TABLE 2
Sean McCarthy
Senior Regulatory Manager
ECI
Navigating Regulatory Pathways for Drug-Device Combination Products
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Artur Serebrenik
Humanetics Corporation
Casey Rich
Curevo Inc.
Francisco Marin
Thea Pharmaceuticals
James Henshilwood
Neurocrine Biosciences
Margaret Hsiao
harvest moon pharma
Michael Balog
Hikma Pharmaceuticals
Shane Kelly
BioMarin
Victor Hedgecock
Eisai
Zaher Shabani
Incyte Corporation
TABLE 3
Rhonda Bronenberg
VP, Manufacturing Services
Process Alliance
The Essential Operational Readiness Milestones
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Alex Jacobine
Innoviva Specialty Therapeutics (IST)
Ashley Hamilton
Bausch + Lomb
Danielle Coelho
Elanco Animal Health
Harpreet Sangha Sangha
Catalyst Pharmaceuticals
Jon Harrell
Elanco
Laura Hoffman
Braeburn
Praveen Prasanna
Eli Lilly and Company
Rao Tatapudy
Mallinckrodt
Samuel Lopez De Victoria
J&J
TABLE 4
Jun Takada
Senior Marketing Director
Bushu Pharmaceuticals
Unlocking 25+ Years of Expertise: Innovative Perspectives on Contract Manufacturing in Japan
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Denise Powell
Merck
Elaine Wu
Exelixis
Keith Koneczny
Takeda
Komal Hingu
Galderma
Najeha Tassawar
Boehringer Ingelheim
Patrick Cheek
Elanco Animal Health
Santnukumar Patel
Neumora
Sarah Nawara
Takeda
Tom Lancaster
Akston
TABLE 5
Souroush Honary
Co-CEO
System Loco.
How To Build Systematic Control Across the End‑to‑End Pharma Supply Chain through IoT & Integrations
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Brian Feloney
Takeda Pharmaceuticals
Dipen Patel
BMS
James Varner
Madrigal Pharmaceuticals
John Sciscoe
BioMarin
Kim Gochioco
Vertex Pharmaceuticals
Paramita Sarkar
Ocusoft
Patty Donnelly
Eli Lilly and Company
Sheetal Chothe
Ironwood Pharmaceuticals
Solene Prodhomme
Thea Pharma Inc
TABLE 6
Bill Carpenter
Global Strategic Account Manager
Systech
Serialization, Compliance and Track & Trace – Rethinking Business as Usual
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Andrea Wang
Curevo Vaccine
Andri Halim
Disc Medicine, Inc.
Angela Repa
Edgewise Therapeutics
Donna Luisi
Vaxcyte
Jasmine Murphy
sanofi
Kari Frank
Par Health
Marika Thiessen
Thea Pharma Inc.
Nikhil Khadtare
SK Life Science Inc
Shawn Brueggemeier
Bristol Myers Squibb
TABLE 7
Dan Walles
VP, Product Marketing
TraceLink
Commercial and Logistics Orchestration: How a Leading Pharmaceutical Manufacturer Uses a Digital Network to Drive Growth and Service Excellence
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Allyson Maron
Braeburn
Bilen Gebremariam
Tarsus Pharmaceuticals
Colin Baker
Bimeda
David Livingston
Mallinckrodt Spec GX
Judith Cohen
Braeburn Inc.
Karina Vaida
AMGEN
Matthew Boone
RayzeBio Bristol Meyers Squibb
Meg Gao
Moderna
Moustafa Ragab
Galderma
Day 2
12:20 pm – 1:20 pm EST
12:20 pm – 1:20 pm EST
TABLE 1
Cedric Dubois
SVP, Head of Global External Manufacturing
Teva Pharmaceuticals
Navigating Tariffs and Mitigating Global Trade Challenges in Supply Chains
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Brian Feloney
Takeda Pharmaceuticals
Luke Kucala
Vertex
Moustafa Ragab
Galderma
Najeha Tassawar
Boehringer Ingelheim
Patty Donnelly
Eli Lilly and Company
Ron Nachum
Sapien
Shane Kelly
BioMarin
Shonna Scalfani
Amylyx Pharmaceuticals
Thorsten Biermann
Tianyu Pharmaceuticals
TABLE 2
James Tornos
VP, Global Supply Direct Materials Procurement
Pfizer
Optimizing Supplier Relationships & Effective Risk Management: Best Practices in Procurement and Outsourcing
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Artur Serebrenik
Humanetics Corporation
Bing Zheng
Tianyu Pharmaceuticals
Casey Rich
Curevo Inc.
Doug Peterson
Hikma Pharmaceuticals
Harpreet Sangha Sangha
Catalyst Pharmaceuticals
John Sciscoe
BioMarin
Komal Hingu
Galderma
Krysta Keyworth
Humanetics Corporation
Praveen Prasanna
Eli Lilly and Company
Santnukumar Patel
Neumora
TABLE 3
Gopi Vudathala
Head, Global Regulatory Affairs CMC
Incyte
Managing Post-Approval Changes in a Global Market
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Andri Halim
Disc Medicine, Inc.
Charles Van Kirk
Lantheus
Delia Snyder
Edgewise Therapeutics, Inc
Francisco Marin
Thea Pharmaceuticals
Judith Cohen
Braeburn Inc.
Kari Frank
Par Health
Paramita Sarkar
Ocusoft
Sheetal Chothe
Ironwood Pharmaceuticals
Victor Hedgecock
Eisai
TABLE 4
Sabrina Mattos
Senior Director, External Manufacturing Americas
Elanco
Rethinking External Manufacturing: Agility, Trust, and Performance
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Ashley Hamilton
Bausch + Lomb
James Henshilwood
Neurocrine Biosciences
Laura Hoffman
Braeburn
Michael Balog
Hikma Pharmaceuticals
Rao Tatapudy
Mallinckrodt
Samuel Lopez De Victoria
J&J
Shashikant Nagre
Akston Biosciences Corporation
Tom Lancaster
Akston
TABLE 5
Ashish Patil
Associate Director, Supply Chain Planning and Analytics
Bristol Myers Squibb
DRIVING SMARTER DECISIONS THROUGH ANALYTICS-ENABLED SUPPLY CHAIN PLANNING AND PERFORMANCE VISIBILITY
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Amanda Pergamo
Elanco
Evan Rodriguez
Vertex
Jake Schulman
Sapien
Laks Pernenkil
Deloitte Consulting LLP
Marika Thiessen
Thea Pharma Inc.
Matthew Boone
RayzeBio Bristol Meyers Squibb
Meg Gao
Moderna
Solene Prodhomme
Thea Pharma Inc
Victor Patterson
Thea Pharma Inc
TABLE 6
Brian Gregory
Director, MSAT Quality Control
Vertex
Building and Leading a High-Performing Quality Control Team
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Aaron Whitney
Mentor Mate
Angela Repa
Edgewise Therapeutics
Chris Wilson
Vertex
Christine Lang
Amgen
David Livingston
Mallinckrodt Spec GX
Dipen Patel
BMS
James Varner
Madrigal Pharmaceuticals
Patrick Cheek
Elanco Animal Health
Sandra Moreira
Bayer
TABLE 7
Joseph Graskemper
Director, External Network Strategy
Biogen
Building Strategic Partnerships from Clinical to Commercial
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Alex Jacobine
Innoviva Specialty Therapeutics (IST)
Bilen Gebremariam
Tarsus Pharmaceuticals
Emily Hession
Vertex Pharmaceuticals
Isaiah Bazal
Vibraclean
Jared Mcdonald
Coating Place Inc.
Jon Harrell
Elanco
Kim Gochioco
Vertex Pharmaceuticals
Omar Kassim
Takeda Pharmaceuricals
Rishabh Sachdeva
Coating Place
TABLE 8
Karina Vaida
Associate Director, Amgen Contract Development & Manufacturing
Amgen
Strategic Outsourcing: Matching the Right Partner to the Right Product
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Alex Jacobine
Innoviva Specialty Therapeutics (IST)
Andrea Aldridge
Biocryst
Brooke Heston
BioCryst Pharmaceuticals
Christopher Wilbert
Madrigal Pharmaceuticals
Danielle Coelho
Elanco Animal Health
Jeffrey Haworth
Akston Biosciences Corporation
Jonathan West
BioCryst Pharmaceuticals
Yang Yang
SK Life Science, Inc.
Yogesh Sonawane
Mirum Pharmaceutical
TABLE 9
Zaher Shabani
Director, Global Regulatory Affairs CMC
Incyte
Use of AI in Regulatory Affairs
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Andrea Wang
Curevo Vaccine
Chris Burger
VEDP
Delia Snyder
Edgewise Therapeutics, Inc
Faith Houle
Entrada Therapeutics
Francisco Marin
Thea Pharmaceuticals
Karen Meier
Virginia Economic Development Partnership
Pasarkar Manda
Sanofi
Sheetal Chothe
Ironwood Pharmaceuticals
Shrimati Balram
Ironwood Pharmaceuticals
TABLE 10
Patrick Hinojosa
SVP, Pharma Supply Chain Management
Bayer
"Who’s Really My Customer?” Rethinking Supply Chain’s Role in Patient Delivery
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Anders Alberg
Novo Nordisk A/S
Grace Festa
Virginia Economic Development Partnership
John Sciscoe
BioMarin
Mara Ketchum
Bristol Myers Squibb
Margaret Hsiao
harvest moon pharma
Mary Llewellyn
Prelude Therapeutics
Mary Llewellyn
Prelude Therapeutics
Niranjan Deo
Codia
Olajompo Moloye-olabisi
J&J
Priscilla Shin
Leadec
Rob Moore
Tianyu Pharmaceuticals
Stephen Agar
Amgen
Svobodka "bobbi" Kirova
Bausch and Lomb