sympsium · flexibility in the scalability and modifiability of plant configurations. the solutions...

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March 2 – 4, 2020 // AUSTRIA

SYMPOSIUM


SYMPOSIUM

KEY SPEAKERS & LECTURESwww.zeta.com/symposium



SYMPOSIUM

Predictive analytics and artificial intelligence applied for the interpretation of whole human genome data obtained by next-generation sequencing offer an enormous opportunity for the development of new therapeutic strategies. However, this current merger of biotechnology and information technology also calls for a biological and ethical discussion about the definition of health and disease. We all are genetic individuals and the vast majority of what defines an individual human being is the result of nature and nurture. Humans cannot be reduced to their genes. In November 2018, in China the claim was made that the first humans modified by germline gene therapy had been born on planet Earth. While there seems to be broad international consensus that genome editing is not yet mature enough to be used to modify the human germline, even in the context of monogenetic diseases, this „(un)scientific“ attempt once again stimulated the discussion on human enhancement and transhumanism. Medical genetics – what can be done, what should be done?

Tuesday, March 3, 2020 SESSION I, 09.15 – 10.00 am

Medical genetics – quo vadis?Univ.-Prof. Dr. Markus Hengstschläger, Institute of Medical Genetics, Medical University of Vienna

Biography

Univ.-Prof. Dr. Markus Hengstschläger studied genetics at the University of Vienna, did research at Yale University in the USA and was finally appointed university professor at the Medical University of Vienna, where he now heads the Institute of Medical Genetics. The award-winning and internationally recognized scientist teaches students and is active in the fields of genetic diagnostics, basic research and innovation consulting.He has received the order of merit for services rendered to the Republic of Austria and among other activities he is Deputy Chairman of the Austrian Bioethics Commission, Deputy Chairman of the Austrian Council for Research and Technology Development, a member of the University Council of the University of Linz and head of the think tank Academia Superior. Hengstschläger is also a science presenter on Austrian radio and the author of three bestselling books.



SYMPOSIUM

Personalized Medicine along with companion diagnostics are bringing a disruption potential not only for medical treatment standards but also for the way new modalities will be manufactured and applied. With first cell and gene therapy products on the market and about 1400 candidates in clinical development, significant gaps in the manufacturing infrastructure and its technological basis have become obvious and attempts to close them are numerous. At the same time the biopharmaceutical industry relies on change to make progress in a commercial environment that simultaneously demands higher productivity, higher quality, and lower costs. Biomanufacturing processes have become generic, robust, and efficient and some of the lessons learned can now be applied to new modalities and new manufacturing formats and examples will be discussed.

Tuesday, March 3, 2020 SESSION I, 10.10 – 10.40 am

Cell & viral therapies and the promise to solve current manufacturing challengesDr. Uwe Gottschalk, Chief Scientific Officer, Lonza Pharma Biotech & Nutrition

Biography

Uwe Gottschalk earned his PhD in Chemistry at the University of Müns-ter and Nottingham, delivering his dissertation on drug targeting with monoclonal antibodies. He worked in different capacities for Bayer He-alth Care from 1991 to 2004, when he became Group Vice President at Sar-torius Stedim Biotech, with a global responsibility for bioseparation-re-lated process technology. In 2014, he joined Lonza Pharma/Biotech to establish and lead the global Rese-arch and Technology organization. He has been chief scientific officer at Lonza since 2017. In academia, Dr. Gottschalk is currently senior lectu-rer at the University of Duisburg-Es-sen and also lectured at the École Polytechnique Fédérale de Lausan-ne. Uwe Gottschalk is a valued mem-ber of a number of associations connected to the pharmaceutical industries, such as the Society for BioChromatography and Nanose-parations, the Management Pool at the Institute of Marketing, University of St. Gallen and the American Che-mical Society. He sits on the editorial advisory boards of Pharmaceutical Bioprocessing, Genetic Engineering News and BioPharm International.

Presenting author details Dr. Uwe Gottschalk Linked In: linkedin.com/in/uwe-gott-schalk-a904722



SYMPOSIUM

Given increasing customer requirements for more individualized solutions and shorter delivery times, the need for digital transformation is also a clear priority in the pharmaceutical industry. This means a significantly increased demand for flexibility in the scalability and modifiability of plant configurations.

The solutions are modular production systems. Various process modules with integrated automation are combined to form one production plant (plug&produce). Currently, monolithic control systems are used for automation that control all modules centrally. This means the control system needs to be adapted whenever there is a change to the process, entailing corresponding qualification and validation effort.

Efficient automation will therefore require control system concepts that provide native support to the modular approach. The automated modules supplied by the manufacturer will log on to the process control level with their services and features so that they can be combined to form one production process.

It is to be expected that the future will see a move away from monolithic automation systems to flexible, service-oriented plug&produce solutions. This is the only possible approach to meet all customer and market demands. The technologies required for this digital transformation are already available. The open question is whether this transformation will happen at the classic pharmaceutical manufacturers or in IT companies.

Tuesday, March 3, 2020 SESSION II, 11.35 – 12.05 am

Modular automation as key enabler for modular production concepts in future biopharmaceutical applicationsDr. Ulrich Christmann, Bayer AG

Biography

Ulrich Christmann has a Master degree in chemical engineering from Dortmund University and a PhD in electrical engineering from the University of Halle/Wittenberg. He is a highly experienced expert in automation technology with many years in various engineering and operation roles with increasing responsibility with Bayer. In his current expert position in Engineering & Technology, he is responsible for the continuous development of Bayer’s automation strategy. He represents Bayer’s automation interests at ISPE, BioPhorum and NAMUR and is responsible for Bayer’s co- innovation activities in modular automation.

Presenting author detailsDr.-Ing. Ulrich CHRISTMANNContact number: +49 175 30 54047LinkedIn: linkedin.com/in/ulrich-christ-mann-7386196a



SYMPOSIUM

Industry 4.0: This topic has electrified the industry in the recent years as no other issue before it. The demands on the availability of affordable high performing materials and a reduced environmental footprint are increasing. Information exchange and utilization of data across the entire lifecycle of a process plant are key if these goals are to be achieved.

Today, almost every industrial facility is characterized by cumulative data evolution. Massive quantities of data are generated throughout the lifecycle. This data is spread over a multitude of software applications, databases, and paper files. As a result, the information is often inaccurate, out-of-date, incomplete, inconsistent and/or poorly synchronized. And this is where the digital twin comes into the game: the virtual representation of a real system. Its ultimate goal is the closed-loop connection between the virtual and real production. The appropriate digital infrastructure enables continuous update of the digital twin and faithful emulation of its physical counterpart both in behavior and informational context.

Sounds excellent – but is it real or just a nice piece of marketing blurb? Building up a digital twin in a greenfield environment may work, but what about a brownfield plant with all its long existing hardware, software and processes?

This presentation shows existing solutions and selected examples of what has already been achieved.

Tuesday, March 3, 2020 SESSION II, 12.15 – 12.45 am

Industry 4.0: An integrated solution for smart engineering and maintenance for existing and new factories – mere wishful thinking or already reality?Steffen Rosa, Head of Indirect Business, Siemens Industry Software GmbH

BiographySteffen Rosa discovered his affinity for CAD/ CAD tools right from the beginning of his professional career. The starting point was product management for CAE tools at Siemens in 1986. As a next step he took over the responsibility as a Marketing Manager for CAE Tools in SDRC, a US based company. Back to Siemens, Steffen Rosa was appointed as a world-wide sales manager for Engineering Tools for process and electrical engineering. After 13 years in the software business, Steffen Rosa moved to Automation Hardware, Business development for PLC and DCS business in Europe. Developing the business via solution partners was one of the key elements during this phase. With the acquisition of the company Innotec in 2009, Software business came back into the scope. Steffen Rosa built up the world-wide partner channel for Comos Industry Solutions and is heading this channel with global responsibility.

Presenting author detailsSteffen ROSAContact number: +49 172 835 75 61Twitter: twitter.com/SteffenRosaLinkedIn: linkedin.com/in/steffen-ro-sa-51884135/



SYMPOSIUM

New pharmaceutical products and a fast to market delivery with shortened registration periods require new ways of executing capital investment projects to have the right assets faster qualified and in operation.

Applying lean methodologies and concepts will help us to decrease timeline and costs for capital investment projects. The demonstration on a recent project will give insights how to change the execution of large capital investment projects. More important is: how to sustain the new level of execution by implementing a new standard.

Tuesday, March 3, 2020 SESSION III, 02.30 – 03.00 pm

Applied lean methodologies in capital investment projectsRACE project and the life afterUwe Bank, Pharma Global Engineering, F.Hoffmann La Roche, Basel

Biography

Uwe Bank obtained his Master of Science degree in mechanical engineering at the University of Magdeburg. When he joined ROCHE 16 years ago, he had already gained experience in leading sub-projects and small capital investment projects in various companies (APV, GEA). He then relocated to Mexico and the US where he has managed large capital investment projects.For two years he has been leading a group of project managers responsible for a CAPEX portfolio in Europe/Asia Pacific.

Presenting author detailsUwe BANKContact number: +41 79 358 49 68LinkedIn: linkedin.com/in/uwe-bank-2196ab73/



SYMPOSIUM

As project implementation becomes ever more challenging, it is essential for the procurement function to change its position within project teams to bring about a new direction in current ways of working.

Tuesday, March 3, 2020 SESSION III, 03.10 – 03.40 am

Biopharma industry in transition – New purchasing strategies to enable faster project executionGeert van Acker, Head of Procurement SGI, Lonza

Biography

Geert Van Acker has over twenty years of experience within the pharma and healthcare industry. His current role is Chief Procurement Officer at Lonza, where he started in May 2017. Prior to this role, he worked for 17 years at Baxter Heathcare, where he also served as CPO. He holds a Master degree in Organizational and Labor Psychology and has an MBA from the European Institute of Purchasing Management (EIPM).

Presenting author details Geert VAN ACKERLinkedIn: linkedin.com/in/geertvanacker/



SYMPOSIUM

Increased cost pressure in the pharmaceutical industry is forcing pharmaceutical companies to optimize their production costs in order not to endanger their profitability. In addition to the optimization of production networks and the increase in efficiency at plant or group level, more radical innovations such as continuous production are becoming more and more important to the pharmaceutical industry.Continuous production offers numerous advantages compared to classic batch production, assets that are already evident in the development phase. The elimination of upscaling and the associated risks and material costs are particularly worth mentioning. The most important points, however, are the higher utilization of machines and the associated reduction of production costs as well as the shorter time line from production to the release of a drug. Furthermore, numerous ecological advantages can also be achieved by switching to continuous production.All in all, continuous production fits optimally into the increasingly data-driven value chain of the pharmaceutical industry and offers considerable potential for cost savings in the production of pharmaceuticals.

Tuesday, March 3, 2020 SESSION IV, 04.30 – 05.00 pm

Economic impact and challenges of continuous pharma processesDr. Thilo Kaltenbach, Senior Partner, Roland Berger GmbH

Biography

Dr. Thilo Kaltenbach is a pharmacist and senior partner in Roland Berger's Pharma & Healthcare Competence Center. He holds a PhD in pharmaceutical chemistry from the University of Münster and studied business administration at the IWW of the Open University of Hagen. During his scientific career, he has completed a number of quality-related studies together with the EDQM and the FDA. He joined Roland Berger in 2002 and has since then focused on the economic impact of strategies at the interfaces between R&D, manufacturing/supply chain and commercial functions.

Presenting author details Dr. Thilo KALTENBACHContact number: +49 160 744 86 51Twitter: @thilokaltenbachLinkedIn: linkedin.com/in/thilo-kalten-bach-420ba74



SYMPOSIUM

Numerical simulations have become an important pillar of process and product development, and their possible applications range from process development and optimization to the supplementation of experimental work. Virtual study allows extensive analysis without the need for real experiments, reducing both time and costs. By far the biggest advantage of simulation technology, however, is the possibility of analysing data that cannot be measured because of the limitation of experimental techniques. Numerical processes are included in most stages of state-of-the-art process and product development in the biotech and pharmaceutical industries. Intensive design optimization and design space explorations are usually done numerically, and only the most promising design and operating conditions are validated by means of experiments. The approach will be explained, discussing the example of a process analysis of an ultraviolet C light lamp used for virus deactivation of plasma-derived therapeutic products. Numerically and experimentally obtained results and their potential to complement each other will be discussed to show important benefits of the integrated approach. Finally, the regulatory conformity report will briefly be addressed, focusing on the most important FDA requirements for simulation technology.

Wednesday, March 4, 2020 SESSION I, 08.30 – 09.00 pm

Combined experimental and simulation approach for the process analysis of an ultraviolet-C light lampSimulation and experiment, Yin and Yang of future process developmentDr. Dalibor Jajcevic,, Managing Director at SES-Tec OG

Biography

Dr. Dalibor Jajcevic is Managing Director of SES-Tec OG, where he leads the simulation group in the area of pharmaceutical engineering.He has a PhD in mechanical engineering from TU Graz in the field of computational fluid dynamics simulations. His post-doc position was related to particle flow simulation using the discrete element method with the focus on pharmaceutical processes, such as powder mixing, feeding, fluidized bed systems etc. He is the author and co-author of more than 20 journal publications. In the 15 years of his career, he has successfully completed more than 100 industrial projects using numerical methods to develop, analyse and improve different processes.He believes that truth is to be found where the virtual world of simulation meets the real world of measurement. They are the yin and yang of future process development.

Presenting author details Dr. Dalibor JAJCEVICContact number: +43 699 107 571 43LinkedIn: linkedin.com/in/dalibor-jajce-vic-48a90817a



SYMPOSIUM

The pressure on the biotech industry to launch new processes at great speed and low costs is a never ending story. BI, a leading biotech company, developed an improved strategy, beginning with development, to mitigate this challenge.

The key elements of this strategy are:

• A project team acquires knowledge in a very structured way to be prepared for process characterization, control strategies and new drug submissions. BI's strategy in structuring process development data to build process knowledge is presented.• Process development data is used to build effective models for better understanding of the data, focusing of development efforts and risk management. Some solutions, for bringing structure and accessibility to process knowledge will be proposed, that will enable functional knowledge management.• Process development is closely connected with a standardized method for scale-up and large scale production. Some examples will be presented on how BI is managing this.

Wednesday, March 4, 2020 SESSION I, 09.10 – 09.40 pm

The biopharma industry in transition – next generation downstream processing strategies Data structure, modeling and knowledge management are the backbones for developing processes to smooth and efficient BLAsBenno Knopf, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

BiographyBenno Knopf started his career in the biopharma business in 1986 at Boehringer-Ingelheim. Since then he has gained broad experience as a shop floor manager, a process engineer, Head of Formulation and Associate Director of Product Transfer & Process Engineering. Additionally, he was leader of the group responsible for automation planning and the start-up of the downstream part of the G104 production building at the Biberach site. His latest career steps are Downstream Lead of the planning group of the new cell culture plant in Vienna and Executive Director of Formulation. He has gained extensive knowledge of large-scale upstream & downstream processes in the course of his work.

Presenting author detailsBenno KNOPFContact number: +49 7351 54 52 29Linked In: linkedin.com/in/benno-knopf-55163aa2/



SYMPOSIUM

The main objective of designing a biologics facility – until now – was operational excellence that leads to a steady increase in drug safety, effectivity and availability and also to a faster, leaner and more customizable way of production. We have normally assumed that a biologics facility has a low environmental impact in its nature, since biological processes function in mild physiological conditions. As a consequence, very few references for a biologics facility design are available that follow the maxim of further reducing utilities and energy consumption. But today this has become a general principle that must be applied. This means that in addition to our demand for lean operations, we are further challenged to design facilities that achieve maximum energy efficiency and save resources. Using the example of a vaccine facility based on a biologics production platform, I will show how we have developed and designed a comprising facility and production concept with the aim of reducing energy and water consumption to a minimum. An analysis will be made of how the LEED (Leadership in Energy and Environmental Design) standards for green building design are to be applied on a biologics production facility, and the further requirements for achieving an appropriate process concept that is fit for future are explained.

Wednesday, March 4, 2020 SESSION II, 10.30 – 11.00 am

Leaner – Faster – Smarter: Developing scalable manufacturing platforms that would adapt to future demandsRüdiger Mechsner, CEO, Principal Consultant BIOTECS

Biography

With over 30 years of engineering and industrial experience, Mr. Mechsner has an extensive background in designing facilities for high tech biotechnology. He represents Biotecs – a network of consultants for biopharmaceutical manufacturing and engineering. His main current project is coordinating the realization of a modern biologics manufacturing platform facility for SaudiVax in Djeddah, KSA. He has contributed in leading positions to the engineering of the world scale production facilities for Celltrion I+II and Samsung Biologics I, -II, and -III in South Korea. Since 2010, he was responsible for developing the biopharmaceutical engineering competence in Samsung Engineering; he trained management and staff and he was responsible for concepts and the design review of large-scale biopharma production facilities.Mr. Mechsner has contributed as a panelist, speaker, and chairman at leading global conferences.

Presenting author details Rüdiger MECHSNER Contact number: +41 79 503 10 22



SYMPOSIUM

The hot topics in the pharma industry – agility, flexibility, adaptability – are pushed by business drivers such as reduced time to market, personalized medicine, improved cost effectiveness and “best in class” competitiveness.In parallel, digitization and its sub-domains such as Industry 4.0, IoT etc. have brought a huge boost to new trends and technologies (additive manufacturing, AI, ML....). Better trained employees (VR, AR Trainings), flexible production (MTP, Industry 4.0) and smart maintenance strategies (predictive maintenance) are seen as cornerstones for success. The digital twin approach represents a way to tackle these challenges. Integrated engineering paves the way forward to a new quality of the digital twin and is key to realizing the digital twin best in class – even before construction, enabling e.g. visualization, detailed specifications, links to article numbers, data sheets and vendors, to automation systems and REALTIME data.The digital twin applications in the front line of current discussion are:• virtual commissioning• smart maintenance• operator training (virtual reality / augmented reality)• startup trainings / operator training simulation (VR/AR)• change-over strategies.The talk will introduce a categorization of the digital twin in the context of Pharma 4.0, examples of digital twin applications and an outlook to the future, including ZETA’s activities in a showcase facility in Lebring (BIRE).

Wednesday, March 4, 2020 SESSION III, 11.10 – 11.40 am

The digital twin: Smart engineering services as the key to cost effective digitizationMartin Mayer, Business Development Manager, ZETA GmbH

BiographyMartin Mayer is member of the Steering Committee for the Plug&Produce activities within the ISPE Pharma 4.0 program. During his career a wide variety of senior roles from business development, research and development responsibility to general management challenged his skills in over 15 years of absorbing international project work. He has taken on responsibility for a number of projects in the chemical industry, pulp and paper as well in biotech/biopharma industries with the main focus in the fields of digitization, data management, data analytics and model based optimization (DoE). At Eppendorf, he was responsible for driving digitization towards new solutions from smart devices to cloud based services. At ZETA, he is responsible for business development in the area of Smart Engineering Services and Digitization.

Presenting author detailsMartin MAYERContact number: +43 3136 9010 180LinkedIn: linkedin.com/in/martin-mayer-63740946



SYMPOSIUM

As the pharmaceutical industry has become increasingly globalized over the last 20 years, FDA has strived to keep pace. An agency that regulates products representing over 20% of every US consumer dollar spent cannot focus inward. This presentation will cover FDA’s international activities, with an emphasis on its efforts related to medicinal products in Europe. The case of the U.S.-EU Pharmaceutical GMP Mutual Recognition Agreement will be highligthed – including the rationale for the agreement, member state authority assessments, implementation progress and future activities. Lastly, the presentation will include some common observations from FDA experts on best practices and common mistakes of manufacturers that can impact a product’s time-to-market.

Wednesday, March 4, 2020 SESSION III, 12.00 – 12.30 pm

FDA international engagement and impact of the US-EU mutual recognition agreementMatthew Scherer, International Policy Advisor, United States Food and Drug Administration

Biography

Matthew Scherer is the Assistant Health Attaché for United States Food and Drug Administration’s Europe Office. In this role, he works to develop relationships and further FDA’s engagement with European regulatory counterparts and other stakeholders in the interest of advancing FDA’s public health mission. Much of his time is devoted to projects in support of the FDA-EU Mutual Recognition Agreement for pharmaceutical GMP Inspections, but his current portfolio covers all FDA regulated commodities. He joined the FDA in 2007 in the Center for Drug Evaluation and Research's Division of Gastroenterology and Inborn Errors Products where he managed the review of new drug applications and worked with external stakeholders to facilitate new drug development. Prior to joining the FDA, he provided market research and competitive intelligence consulting services for biotechnology, pharmaceutical and private equity clients. Matthew has a degree in Molecular Biology from the University of Wisconsin and a Master’s in in Business Administration from Georgetown University.

Presenting author details Matthew SCHERER Twitter: @FdaUseu @FDA_GlobalLinkedIn: linkedin.com/in/matt-sche-rer-276b763/



SYMPOSIUM

The main objective of a project organization when designing a new office buil-ding is to create an ideal workspace for the team. The working environment should be pleasant and conducive to high end design and project work. The principal challenge lies in finding the right balance between individual privacy and team cooperation, while also taking projects needs into account. These needs may change frequently during a project timeline – be it because of chan-ges in the team set-up or because of variable project requirements. In a nutshell: We need flexible, multi-functional and stable workplaces for the employees of ZETA, a “home base” as we refer to it.It goes without saying that all workplaces have to meet the latest requirements in terms of technical equipment, and meeting rooms have to be equipped with state-of-the-art communication tools, seeing that communication is the main factor for successful project execution. ZETA has designed the IZZ (InnovationsZentrumZETA) to meet both personal requirements and project needs. This high-quality building provides a highly ad-aptable workspace with various meeting rooms, co-working areas and common rooms while still offering each employee an individually assigned desk.

Wednesday, March 4, 2020 03.30 – 04.00 pm

IZZ – Creating the perfect work environment for agile project execution, and how to overcome the challenges of a matrix organizationDoes the workplace influence the overall project organization performance?Alfred Marchler, Managing Director, ZETA GmbH

BiographyWith over 20 years of experience in engineering and various management positions, Mr. Marchler has an excellent background in strategic management, organizational development and leadership.As a project manager and Managing Director of Agrana Fruit in Russia and Director Eastern Europe of Agrana Fruit, he managed several productions sites in Eastern Europe and was responsible for a green field investment in Russia that is now one of the most successful productions sites in the Agrana Fruit Group.He was appointed Managing Director of ZETA in 2011 in charge of technology, production organizational development and project execution.

Presenting author detailsAlfred MARCHLERContact number: +43 664 808 528 106LinkedIn: linkedin.com/in/alfred- marchler-996251112/



SYMPOSIUMThe ZETA Symposium is sponsored by:

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sympsium · flexibility in the scalability and modifiability of plant configurations. the solutions...

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