Previous And Confirmed Speakers 2019

​Alain Bernard (Belgium)
Head of Biotech Process Development - R-PHARM
What do we need to know about our pharma products and processes ?
  • The management of knowledge of our pharma products and processes is, in general, not optimal 
  • Several approaches can be taken to improve, develop and strengthen this knowledge
  • Several case studies will illustrate the approaches described above
Bio Jens Vogel
File Size: 247 kb
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Jens Vogel (USA)
President & CEO BI Fremont - Boehringer Ingelheim

The Innovation Imperative in Biopharma
  • Boehringer Ingelheim’s approach to fostering and harnessing Innovation for internal and client projects will be discussed
  • The talk will highlight both global trends and illustrate examples with actual data
  • For example, it will cover:
    • Flexible Manufacturing in Global Networks
    • Batch vs Continuous manufacturing and hybrid approaches for both early- and late stage
Bio Berthold Boedeker
File Size: 309 kb
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Berthold Boedeker (Germany)
Chief Scientist, Global Biologics / Biotech Development - Bayer AG

Integration of single –use ADC production in a standard mammalian mAb facility
  •  Disposable based ADC conjugation
  •  Isolator technology
  • Multi-use  manufacturing suites
Bio Hitto Kaufmann
File Size: 270 kb
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Hitto Kaufmann (Germany)
Global Vice President Biopharmaceutics Development and Platform Innovation - Sanofi

Developing Next Generation Biologics
  •  Adapting to the evolution of diverse biologics pipeline
  •  Innovation as a key driver to deliver superior medicines to patients
  •  Convergence of technologies 
Bio Dorothee Ambrosius
File Size: 155 kb
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Dorothee Ambrosius (Germany)
SVP Global Bioprocess and Pharmaceutical Development - Boehringer Ingelheim

Innovation in Biopharmaceutical Development: Passion, Persistence and People: why does it matter?
  • Key aspects for Biologicals Drugs from research to market
  • Product knowledge and process understanding as guiding principles  
  • Application of QbD tools in early and late stage development
  • From mAb Platform to Complex Biologics  
Bio Hubert Chen
File Size: 154 kb
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Hubert Chen (USA)
Chief Medical Officer - Pfenex

Progress of Biosimilars: Emergence, Future Development and Manufacturing
  • Biosimilars innovation and development methodology
  • Bioprocess and biomanufacturing of biosimilars
  • Commercialization considerations in development
Bio Martin Mueller
File Size: 199 kb
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Martin Mueller (USA)
Director, Biotech Development - MSD

Biopharmaceuticals: The Future of Analytical Development & Control
  • Modern analytical tools (TAA, MAM, RTR)
  • Process Analytical Control
  • Challenges
Bio Oliver Chao
File Size: 153 kb
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Oliver Chao (France)
Head, Emerging Biomedical Sciences - Sanofi External Innovation Paris

Precision Medicine: from Blackhole to Aurora
  • Precision Medicine: the ultimate goal of medical treatments from prehistorical time to present days
  • Emerging technologies and approaches, from omics to AI, that may finally help us achieve the goal of precision medicine
  • I will provide an overview on the promise and liability of current innovations for precision medicine
Bio Patrick Sagmeister
File Size: 139 kb
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Patrick Sagmeister (Austria)
CTO - Exputec

Joint Presentation: Bioprocess data management and data analytics: Enabler for validation success of next level biologics
  • Process characterization studies (stage 1 process validation)
  • Continued process verification (stage 3 process validation)
  • Data platforms: CMOs and biotech collaboration
Bio Simon Haidinger
File Size: 211 kb
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Simon Haidinger (Austria)
Head of Unit Upstream Development I - Boehringer Ingelheim​

Joint Presentation: Bioprocess data management and data analytics: Enabler for validation success of next level biologics
  • Process characterization studies (stage 1 process validation)
  • Continued process verification (stage 3 process validation)
  • Data platforms: CMOs and biotech collaboration
Bio Michael Backhaus
File Size: 140 kb
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Michael Backhaus (Austria)
Lead of Manufacturing Intelligence IT Europe/Asia - Shire

Scalability of Manufacturing Intelligence IT Systems and Operational Support
  • Top-down vs bottom-up development
  • Standardization of technologies across large manufacturing networks
  • Listening to the voice of customers and empowering users
Bio Simon Fischer
File Size: 147 kb
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Simon Fischer (Germany)
Head of Cell Line Development CMB - Boehringer Ingelheim
​
Genome editing, NGS, microRNAs and beyond: Translating novel ideas into state-of-the-art CHO cell line development
  • Presentation of BI’s novel CHO-K1-GS host cell line 
  • Overview on how BI is translating new concepts into applications
  • Novel concepts to overcome challenges with regard to difficult-to-express proteins
Bio Xavier Derouck
File Size: 143 kb
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Xavier Derouck (Belgium)
Senior Manager, Global Operations Procurement​ - GlaxoSmithKline

Applying a Risk-Based Strategy for Implementing Disposables in a Commercial Manufacturing Process
  • Implement a risk-based strategy to your manufacturing process to capitalize of the potential of single-use technology
  • Examine the latest trends in risk-management and decide which strategies could work best for your site
  • Identify individual risks to your manufacturing process and cultivate smart guidelines for mitigating their effects
  • Learn how to ensure that your suppliers maintain strong quality oversight to support their product from a control process and ensure regulatory compliance
Dirk Voelkel (Sweden)
Chief Technology Officer - Innovation and Analytics - GE Healthcare Life Science

Industry 4.0: Digital transformation to tackle productivity and growth challenges
  • The industrial internal is changing how industries operate
  • Introduction of Digital Twins
  • Case studies for Life Sciences industry
Bio Thomas Kretschmann
File Size: 321 kb
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Thomas Kretschmann (Germany)
Field Application Specialist - cytena GmbH

Ensuring Clonality by Single-Cell Dispensing in Cell Line Development
  • Single-cell printer isolates single, living cells automatically
  • High cell viability, no cross-contamination (disposables), easy to use
  • Assurance of clonality by nozzle images
Bio Enrico Tavella
File Size: 160 kb
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​Enrico Tavella (Austria)
Pipeline Liaison Quality Lead - Product Lifecycle Quality - Shire

Clinical Products Release across Internal and External Networks: Dealing with Complexity
  • Challenges for Investigational Medicinal Product Release across an extended internal network of Biopharma plants, a huge external network of CMOs, CRO s, CTOs, and different product types (Biologics & Small Molecules)
  • Approaches and Good Practices we use to overcome them
  • Key takeaways and next steps on our Continuous Improvement Journey
Bio Romain Dabre
File Size: 213 kb
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Romain Dabre (Germany)
Product Manager Process Business - ​Tosoh Bioscience GmbH

Tackling current challenges in the purification of different antibody formats
  • Current antibody developments focus on increased titers and new formats, which challenge existing purification solutions
  • Tosoh Bioscience developed new chromatography media for capture as well as intermediate and polishing steps with a platform approach
  • These modern resins help improve process economics, offer higher product safety, and reduce time-to-market
Bio Ralph Daumke
File Size: 212 kb
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Ralph Daumke (Switzerland)
Market Manager Biologics - FILTROX Group
​
Using Alluvial Filtration as an Efficient and Economical Solution for Midstream Clarification
  • Alluvial filtration
  • Efficient and Economical
  • Midstream clarification
Bio Hans J Johansson
File Size: 207 kb
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Hans J Johansson (Sweden)
Application Manager - Purolite

Design of agarose-based Protein A affinity resins for continuous manufacturing
  • Novel method for continuous manufacturing of uniform agarose beads for chromatography applications
  • Application data from use of jetted resins in Continuous Countercurrent Tangential Chromatography (CCTC)
  • Productivities of > 100 g of mAb / L resin / hr achieved
Bio Kai Touw
File Size: 210 kb
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Kai Touw (The Netherlands​)
Process Development Consultant - Sartorius Stedim Biotech

Process Intensification considerations towards the factories of the future
  • Continuous and intensified bioprocessing is attracting much attention from biopharmaceutical companies seeking to maximize the efficiency of their manufacturing assets. Continuous and intensified bioprocessing promises smaller facilities, reduced scale-up risk, more consistent product quality and higher throughputs
  • However there are still many (technical) challenges for practical implementation of intensified and continuous bioprocesses. In the upstream processing many single use bioreactors may not be suitable to support the high cell densities required for intensified processing. In addition clarification of extremely high cell density cell cultures is challenging
  • In the downstream processing MCC product capture is finding its way into manufacturing, and flow-through polishing steps with e.g. membrane adsorbers are becoming viable options, however scalability, sterility and robustness over longer times are still challenging. Furthermore robust solutions for continuous low pH viral inactivation, continuous virus filtration and continuous diafiltration need further attention
  • The wide adaptation to process intensification is leading to many technological advances in these fields. Cost-of- Goods modeling is an excellent tool to get a better understanding of a production process and evaluate process options. Here the path set by these developments are assessed on their impact on the Cost-of- Goods. This evaluation gives a unique insight on the impact of new technologies and how to combine them to reach a cost-effective facility of the future
Bio Frank Abbato
File Size: 208 kb
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Frank Abbato (USA)
Principal - Enguition (on behalf of Bio-G)

Rapidly Deployable High Resolution Facility Models
  • Rapid deployment means less than a week, with most facility functions "switchable"
  • High Resolution means variable task durations, shift-based labor, and consumables such as utilities as constraints
  • Allows precise balancing of resources during facility design, saving cost, avoiding risk, and increasing efficiency
Bio Alessandro Butte
File Size: 209 kb
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Alessandro Butte (Switzerland)
Lecturer and Senior Reseacher - ETH Zurich

Process digitalization and hybrid process modeling for efficient predictions
  • Process digitalization: integrating data, online sensors, data management and SCADA platforms as prerequisite to process digitalization
  • Hybrid models: how to efficiently combine process knowledge and the power of machine learning tools to quickly setup predictive models
  • Hybrid models for monitoring, optimization and control: examples from industrial application in upstream (fed-batch and perfusion) and downstream
Bio Ulrich Rumenapp
File Size: 203 kb
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Ulrich Rümenapp (Germany)
Head of Launch Preparation - Bayer

Outsourcing Biologics CMC Development and Manufacturing – The Benefits and Challenges
  • The crucial make or buy question
  • The current industry environment for outsourcing
  • Best practices for a successful CDO/CMO partnership
  • Understanding and mitigating the risks in outsourcing
  • How to protect your IP?
Bio Frank Agbogbo
File Size: 238 kb
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Frank Agbogbo (USA)
Director of Microbial Bioprocess - Cytovance Biologics

Designing a representative scaled-down model (SDM) that links upstream input parameters with downstream output parameters
  • SDM qualification is an essential step in process characterization
  • Qualifying fermentation SDM is challenging due to a general lack of precision in measurement systems for process outputs
  • Linkage of upstream parameters to product CQAs can aid in the SDM qualification approach
Bio Moritz von Stosch
File Size: 209 kb
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Moritz von Stosch (Belgium)
Senior Manager Fermentation - GSK Biologicals

Considerations for efficient knowledge management during process development or Turning the Quality by Design workflow into a cycle
  • Models for knowledge transfer
  • Feeding back the learnings into future development projects
  • Beyond data storing and analysis
Bio Louis Boon
File Size: 214 kb
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Louis Boon (The Netherlands)
Chief Scientific Officer - Bioceros

SPOT™ and Upstream Process modulation to generate more effective therapeutic antibodies and reducing COGs
  • Critical Quality Attributes
  • Costs of Goods
  • Functional bio-assays 
  • Optimising effector function
Bio Markus Haindl
File Size: 208 kb
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Markus Haindl (Germany)
Director Development Analytics - Roche

A holistic phase appropriate strategy for HCP limits and HCP characterisation
  • ​Increased usage of new technologies like Mass Spectrometry opens up entirely new strategic possibilities to test and characterize HCP – not only in purified Drug Substance to ensure patient safety but also for in-process samples to characterize downstream process performance
  • A smart and phase-appropriate combination of traditional assay formats with new technologies becomes key to support an IMP product during its development lifecycle until launch
Bio Georgios Kararigas
File Size: 220 kb
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Georgios Kararigas (Germany)
DZHK Professor - Charite University Hospital Berlin

En route to precision medicine through sex/gender-based science
  • Importance of Precision Medicine and relevance for current Bio Innovation
  • There are major sex differences in the response to disease and therapies: cardiovascular diseases will be presented as a case study
  • The integration of sex/gender-based science in Bio Innovation will pave the way for Precision Medicine
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