Introducing our keynote speakers

Meet the industry luminaries who’ll make downtown Austin the epicenter of drug development innovation next month. 

Keynote | 5:15PM - 6:00PM | WEDS 11/2

Transforming the CMC Lifecycle:
Why the Bio-Pharma Industry Can’t Afford To Wait

Daniel Matlis, Founder & President, Axendia, Inc

Daniel R. Matlis is the Founder and President of Axendia with over three decades of industry experience. He is an active contributor to the FDA’s Case for Quality Initiative and member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials.

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Daniel Matlis Headshot
Christoph Herwig Headshot

Keynote | 9:00AM - 10:00AM | FRI 11/4

Lifecycle Approaches for Robust Control Strategies

Christoph Herwig, Ph.D, Prof of Bioprocess Engineering, Vienna University of Technology

An accomplished professor and research scientist who works closely with ISPE, Pharma 4.0, and digital transformation initiatives, Dr. Herwig’s focus will take us on a deep-dive into the connection between science-based development methods and scalable bioprocess manufacturing. 

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Our marquee keeps getting brighter!

Check out the global thought leaders, industry veterans, and transformation experts who’ll deliver this year’s can’t-miss presentations and guide our hands-on breakouts.

Oliver Hesse Headshot

Oliver Hesse

VP & Head of Biotech Data Science & DigitalizationBayer Pharmaceuticals

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Joschka Buyel

Joschka Buyel

Process & Knowledge Management Scientist, Bayer Pharmaceuticals | Ph.D., Drug Science

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Rebecca Waterbury

Rebecca Waterbury

Founder, Exemplar Compliance LLC | ChE, JD

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Christopher Kopinski Headshot
Christopher Kopinski
Business Development Executive, Life Sciences and Healthcare at AWS
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Guy Verrastro Headshot
Guy Verrastro

Director of Strategic Account Management, Scitara

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Gloria Gadea-Lopez

Gloria Gadea-Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

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Jack Garvey

Jack Garvey

Managing Partner, Compliance Architects LLC 

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Kir Henrici Headshot

Kir Henrici

CEO, The Henrici Group

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Rob Brooksbank Headshot
Robert Brooksbank
Principal Consultant, Zifo R&D Solutions
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Sam Gardner Headshot

Sam Gardner

Senior Product Manager for Health and Life Sciences, JMP Statistical Discovery

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Michael Cody Headshot

Michael Cody

Director of Digital & Clinical Manufacturing, Zaether

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Steve Keizer Headshot

Steve Keizer

Senior Quality Assurance Director, Artisan Bio
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John Maguire Headshot

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

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Sachin Misra Headshot

Sachin Misra

Principal & Global Lead, Kalypso

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Amol Thote Headshot

Amol Thote

Senior Director, Bayer Pharmaceuticals
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Adam Cormack Headshot
Adam Cormack

Director of Product Management,

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Michalle Adkins Headshot

Michalle Adkins

Director, Life Sciences Strategy, Emerson Life Sciences
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Yash Sabharwal 

President & CEO, QbDVision

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Justin Grahek Headshot
Justin Grahek
Process Development & Digitalization Scientist, Bayer Pharmaceuticals
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