SPEAKERS
Meet Our Presenters & Panelists
Our inaugural Digital CMC Summit will be a one-of-a-kind opportunity to hear from some of the leading experts in modern drug development and digital transformation of life science organizations.
CHECK BACK SOON FOR THE FULL SPEAKER LINEUP!
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.
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.
Professor, Vienna University of Technology
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.
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.
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.
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.).
Cynthia Culmo
Principal Consultant, CC Consulting | R.Ph.
Cynthia Culmo
Cynthia has extensive experience with strategy, coordination, and management of the FDA, global agencies, and Notified Third Body inspection in the remediation of quality systems for compliance improvement. Her experience also includes 20 years as a United States Pharmacopeia volunteer, serving as a member of the USP Governance Committee and several USP expert committees and subcommittees.
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.
Coming soon!
Full list of speakers will be confirmed in the coming weeks.
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.
Coming soon!
Full list of speakers will be confirmed in the coming weeks.
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.
Coming soon!
Full list of speakers will be confirmed in the coming weeks.
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.
