SUMMIT HEADLINERS
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.
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.
Dr. Christoph Herwig
Christoph worked in biopharmaceutical process design and facility design prior to becoming a full-time professor of biochemical engineering at TU Wein. His research focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. Christoph is now the Senior Advisor within Körber Pharma Austria, where he works closely with ISPE, Pharma 4.0, and digital transformation initiatives.
PRESENTERS & PANELISTS
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
VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals
Oliver Hesse
Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.
Joschka Buyel
Process & Knowledge Management Scientist, Bayer Pharmaceuticals | Ph.D., Drug Science
Joschka Buyel
Process Knowledge Management Scientist, Bayer
Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.
Rebecca Waterbury
Founder, Exemplar Compliance LLC | ChE, JD
Rebecca Waterbury
Advisor | Founder, Exemplar Compliance LLC | ChE, JD
Rebecca is the founder and former Head of Quality at Exemplar Compliance with over 19 years of experience in Quality Systems, Regulatory Compliance, FDA remediation, and new product approval. She studied Chemical Engineering, Chemistry, and Business at Vanderbilt University, and received her Juris Doctorate of Law.
Business Development Executive, Life Sciences and Healthcare at AWS
Director of Strategic Account Management, Scitara
Guy started his career as an analytical chemist at Ingredion, but quickly levitated toward the intersection of science and technology. Key founding positions within Waters Corporations Informatics group in 1984 and NuGenesis Corporation in 1998. Over 40 years in customer-facing roles including Informatics Business Management and Strategic Account Management. Founding member of Scitara Corporation since 2019.
Gloria Gadea-Lopez
Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering
Gloria Gadea-Lopez
Advisor | Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering
Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.).
Jack Garvey
Managing Partner, Compliance Architects LLC
Jack Garvey
Advisor | Managing Partner, Compliance Architects LLC
Jack Garvey is a life sciences industry thought leader and operations veteran. As both a chemical engineer and licensed attorney, Jack brings deep insight into industry issues at the intersection of law, regulation, science, and business. Embracing innovation and advocacy, Jack’s ability to resolve the problems faced by regulated industry is unparalleled.
Kir Henrici
CEO, The Henrici Group
Kir Henrici
CEO, The Henrici Group
As a life science consultant working domestically and internationally for over 12 years in support of quality and compliance in pharma and biotech, Kir Henrici’s work in holistic quality systems and data integrity remediation is unparalleled. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board.
Principal Consultant, Zifo R&D Solutions
Robert has worked for over 20 years in the pharmaceutical industry, specializing in both enterprise pharma and biotech start-ups. He joined the consulting team at Zifo five and a half years ago and has engaged in projects with numerous organizations over various phases of research & development in the scientific informatics space.
Sam Gardner
Senior Product Manager for Health and Life Sciences, JMP Statistical Discovery
Sam Gardner
Senior Product Manager for Health and Life Sciences, JMP Statistical Discovery
Sam is an experienced pharmaceutical scientist who has worked as a statistician, process engineer, and advanced analytics specialist in pharma R&D and manufacturing for over 15 years. In his current role, he focuses on the statistical and data analysis needs of scientists and engineers in the life sciences fields.
Michael Cody
Director of Digital & Clinical Manufacturing, Zaether
Michael Cody
Director of Digital & Clinical Manufacturing, Zaether
As the Director of Digital & Clinical Manufacturing at Zaether, Michael focuses on biologic modalities and GMP manufacturing that inspire new approaches to integrated data solutions for informational and operational technologies. Previously, he was the Digital Operational Technology Architect for Clinical Stage ATMP clients and overall Technical Lead for OT deployments at two ISPE Facility-of-the-Year Award winning facilities.
Steve Keizer
Steve Keizer
Senior Quality Assurance Director, Artisan Bio
John Maguire
Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence
John Maguire
Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence
Sachin Misra
Principal & Global Lead, Kalypso
Amol Thote
Amol Thote
Director of Product Management, Apprentice.io
Director of Product Management, Apprentice.io
Michalle Adkins
Director, Life Sciences Strategy, Emerson Life Sciences
With 18 years at Emerson Life Sciences, Michalle was previously a Life Sciences team leader and now runs Life Sciences strategy across Emerson digital. Prior to Emerson, Michalle was with Merck for 13 years in instrumentation, automation, manufacturing, and scheduling and planning.
Yash Sabharwal
President & CEO, QbDVision
Yash Sabharwal
President & CEO, QbDVision
Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.
Justin has over 20 years of biopharmaceutical lab experience in process development, scale-up, technology transfer, process characterization, and digital implementation. In his current role he is responsible for driving the rollout and integration of QbDVision for biologic projects at Bayer Pharmaceuticals.
