Plenary Keynote Session

The Next 10 Years: Looking Ahead to Next-Gen Bioprocessing

Wednesday, August 15 (4:45 - 6:25pm)

4:45 pm Chairperson’s Remarks

John Sterling, Editor in Chief, Genetic Engineering & Biotechnology News (GEN)

 

4:50 Digital Transformation to Advance Next-Generation Biomanufacturing through Data Integration and Analytics

Alison Moore, PhD, Senior Vice President, Process Development, Amgen

Hundreds of millions of data points are currently generated through the development and execution of biopharmaceutical processes. It is expected that the volume and complexity of biomanufacturing data is set to grow exponentially as developers and manufacturers integrate novel sensors, smart materials, process analytical technologies and process automation into laboratories and manufacturing plants. This presentation will describe the value associated with a comprehensive digital strategy incorporating a structured data integration and analytics platform inclusive of AI, predictive modeling and visualization, and how digital transformation can advance next-generation biomanufacturing.

5:20 Driving Change in Biomanufacturing through Innovation in Processes, Technologies and Operations

Eliana Clark, PhD, Vice President, International Manufacturing Operations, Biogen

A critical step in meeting the demand of biologic production worldwide involves implementing disruptive manufacturing technologies, processes and capabilities. This talk will use Biogen’s new manufacturing site in Switzerland, due to go online in 2019, as an example to demonstrate the new processes, operational models and technologies being adopted to drive value through innovation and deliver new medicines in areas such as Alzheimer’s.

5:50 End-to-End Solutions Considering New Trends in Biomanufacturing

Guillaume Plane, MSc, MBA, Manager, Global Development, Biodevelopment Solutions, MilliporeSigma

The presentation will get into the current state of biomanufacturing, from DNA to market approval, considering the way a key supplier can support drug makers to the fullest, thanks to a deep understanding of the trends that could affect our industry in the midterm, including growth of the pipelines, strengthening of regulations, and acceleration of timelines, for development as well as for the set-up of capabilities. Some thoughts and ideas will be proposed to consider commercial manufacturing with single-use equipment.

6:25 Close of Plenary Keynote Session

Plenary Keynote Speaker Biographies

Alison Moore, PhD, Senior Vice President, Process Development, Amgen 

Dr. Alison Moore is senior vice president, Process Development serving both Operations and R&D organizations. Prior to this role, Moore served as senior vice president, Operations Technology. Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen's Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

 

Eliana Clark, PhD, Vice President, International Manufacturing Operations, Biogen 

Eliana Clark is Vice President of Global Manufacturing Sciences at Biogen. In this role, she leads the global network accountable for providing scientific and technical support for all process related aspects of clinical and commercial manufacturing of large and small molecules, and end to end manufacturing from raw materials to finished goods. Prior to her role as the leader of the Global Manufacturing Sciences organization, Eliana was the operations asset leader for Zynbrita, Biogen’s recently approved Multiple Sclerosis drug. Prior to Biogen, Eliana held positions of increasing responsibility at Genzyme, a Sanofi Company, where she led the Late Stage Drug Product Development organization, the Manufacturing Sciences and Technology group supporting both Drug Substance and Drug Product manufacturing at the Allston Landing Facility, and the CMC regulatory group, supporting US manufacturing sites for Genzyme. Prior to Genzyme, Eliana was a professor and a leader at Tufts University. During her tenure at Tufts, Eliana was the Assistant Director of the Biotechnology Center and the Chair of the Chemical and Biological Engineering Department. Eliana holds a Ph.D. in Chemical Engineering with post doctorates from the University of Delaware and Worcester Polytechnic Institute.

 

Guillaume Plane, MSc, MBA, Manager, Global Development, Biodevelopment Solutions, MilliporeSigma 

Guillaume Plane is a Global Development and Marketing Manager for MilliporeSigma’s Biodevelopment Solutions department.  Guillaume joined MilliporeSigma in 2012, bringing over 15 years of biotechnology experience spanning multiple specialties, including biochemistry, molecular biology and biomanufacturing. He also serves as Visiting Professor at Sup’Biotech Engineering School, after he served at ESCP Europe, ESC Toulouse, and IONIS School of Technology and Management.

Guillaume began his career as a Research Fellow with the University of Bordeaux, and later served as Business Developer with the Aventis Foundation. Guillaume went on to become an entrepreneur as a Founder of MitoProd SA over seven years, a biotechnology company devoted to the biomanufacturing of RNA.

Guillaume received a master’s degree in Biology and Health from the University of Bordeaux, and an additional master’s degree in Innovation and Entrepreneurship from ESCP Europe.


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