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Committee & Speaker Biographies

Committee & Speaker Biographies

4th PDA Europe Annual Meeting

25-26 June 2019, Amsterdam, The Netherlands

Committee & Speaker Biographies

  • Toni Manzano

    Toni Manzano

    Bigfinite

    Toni is the co-founder and R&D Director of Bigfinite, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry.

    Since 1996, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain (R&D, clinical trials, production, laboratory, quality assurance, warehousing and logistics).

    Toni has also led projects implementing solutions based on the 3 ICH (Q8, Q9 and Q10) and executing audit, qualification and validation tasks.

    Nowadays,Toni is participating in different worldwide forums related to the Industry 4.0.

    He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud.

    Toni is Physicist, Master in Information and Knowledge Society and post graduate in quality systems for manufacturing and research pharmaceutical processes.

  • Borke Van Belle

    Borke van Belle, MSc

    Janssen J&J Supply Chain

    Borke Van Belle holds a Master's Degree in Bio-engineering from the University of Ghent, Belgium. Borke joined Johnson & Johnson in 1998 and held several leadership positions in Quality Assurance, Aseptic Fill/Finish Operations for Lyophilized Biologicals, visual inspection, Quality Control in the Beerse (Belgium) and Schaffhausen (Switzerland) plants.

    Since 2015, Borke is Sr. Director Integrated Quality Solutions and PMO supporting the Janssen Supply Chain. Borke is a Black Belt in six sigma methodology, certified in Lean Excellence and certified in the J&J Executive Quality Leadership Development program.

  • Barbara Allen, PhD

    Eli Lilly & Company
    Barbara Allen, Ph.D. is Senior Director for Global Quality Systems for Eli Lilly and Company. Dr. Allen joined Eli Lilly and Company in 1991 in Ireland and has since held various assignments in API Manufacturing Technical Services, New Product Introduction, Quality Assurance, and Global Quality Systems, in Ireland and in the USA. In 2002, she began her current position in Global Quality Systems, where she is responsible for providing quality systems for Lilly manufacturing and for ensuring that Quality Systems are integrated across the corporation. Dr. Allen was a member of ICH Q10 EWG (Expert Working Group) representing PhRMA and currently serves as a member of IFPMA RPTS.
  • Ursula Busse, PhD, MBA

    Novartis

    Ursula is currently the Global Head of Quality Intelligence and External Affairs at Novartis. She drives the Novartis external engagement strategy in quality, technical and regulatory topics and leads global GxP regulatory intelligence.  Prior to her current role, Ursula held leadership roles in CMC Regulatory Affairs for biologics and in Biopharmaceutical Operations. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in R&D, Quality Assurance and CMC Regulatory Affairs.  Ursula has been a long time member and volunteer of PDA. She received several PDA awards and served on PDA’s Board of Directors from 2012 to 2017. She is actively involved in a number of PDA committees and initiatives such as PDA PAC iAM, the PDA task force for post-approval changes. Ursula holds a Master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.

  • Martin Dueblin

    One One Eleven

    Martin Düblin is a mechanic and process engineer and highly experienced in the field of the life science industry, infrastructure and health care community. During more than 25 years he has been involved in many major strategic projects in Europe and Asia for laboratories, pilot scale installations, production, office buildings, hospitals, education, warehouse, energy / utilities and waste management. He was responsible for consulting, project management, program management, controlling, design and engineering, documentation, validation and qualification. He has undertaken all aspects in the project initiation phase, through the execution till handing over and hold key roles for critical phases. Due to his wide and skilled knowledge of life science matters he was further active for business development of various suppliers within Europe and USA. Several products and brands have been launched under his responsibility. Since several years he is well involved in all kind of technical «revolutions» as with robotic and AI offering high quality products and global competitiveness, in his role as specialist for various life science companies.

  • Aidan Harrington

    Aidan Harrington, PhD

    DPS Engineering

    Dr. Harrington is a Senior Consultant with DPS Engineering based in Ireland, who has been working in the Pharmaceutical Industry since 1992. He is a graduate of University College Cork with a BSc in Microbiology and PhD in Molecular Biology.

    He has worked in QA, Validation and Engineering roles in both manufacturing and Capital Project environments for the pharmaceutical industry. In support of capital projects for biopharmaceutical projects, his role has been on the planning and implementation of Commissioning and Qualification programs.

    Since 2007, he has worked on capital project programs from concept design phases to product Process Validation for primarily aseptic manufacturing facilities which have been underpinned by successful implementation of Quality Risk Management principles.

  • Falk Klar

    Falk Klar, PhD

    PDA Europe

    Falk Klar holds a PhD in Applied Physics and has more than 19 years of experience in Quality Assurance and Compliance. Before joining PDA Europe, he worked for the pharmaceutical, biopharmaceutical, and medical device industries, and in clinical research.

    Falk joined PDA Europe in 2015 as Senior Director Training & Education. He will develop and extend PDA Europe’s portfolio of training courses and workshops for the parenterals market. Recently, he was appointed General Manager and Vice President PDA Europe.

  • Yves Mayeresse

    Yves Mayeresse

    GlaxoSmithKline Vaccines

    Yves Mayeresse is director in manufacturing technology inside MSAT by GlaxoSmithKline Vaccines. He has more than twenty years of experience in the pharmaceutical sector and has worked for different companies.

    Yves has managed activities such as parenteral production, set-up of new Freeze Drying facilities, design of Freeze Drying cycle and development of new stabilizers for freeze-dried products, and transfer of product towards different internal and external sites. He has worked on the industrialization of new freeze-dried products and then in the technical life cycle management. Now, Yves is focusing on different technologies used for the primary and secondary operations.

    Yves holds an engineering degree in Biochemistry, has written articles about Freeze Drying science and is a regular speaker for conferences on Freeze Drying. Since 2016, he has been the Leader of the PDA Interest Group Lyophilization and coordinates the group’s activities in Europe.

  • Sebastian Brandes

    Sebastian Brandes, MSc

    Criterion AI

    Sebastian Brandes is the co-founder of Criterion AI, a company specialized in making use of Artificial Intelligence to increase patient safety while improving operational efficiency and lowering operational costs in the production of drugs.

    He holds an M.Sc. degree in Quantitative Methods and has previously been the AI Lead for Microsoft in Denmark before founding Criterion AI.

  • Jose Castillo

    José Castillo, PhD

    Univercells

    Jose’s has a background in Chemical Engineering, a PhD in Applied Sciences from Brussels University and an entrepreneurship degree from Solvay Business School (Belgium).

    José was Head of Viral Vaccine Industrialization at GSK Vaccines. Founder of Artelis start-up, he designed and developed bioreactors that transformed industrial operations – the iCellis system being now considered as standard in the vaccines and gene therapy industry. The technology was industrialized at ATMI LifeSciences and Pall Lifesciences, where José was Cell Culture Technologies Director.

    Currently, he is co-founder and CTO of Univercells, a Belgian company with the mission of increasing the availability of affordable vaccines and biotherapeutics to address global health challenges. The company develops turnkey solutions by relying on proprietary core technologies and a continuous process intensification approach, achieving production with a smaller footprint, and significantly lower overall capital and operational costs.

  • David Churchward

    David M. Churchward, MSc

    MHRA, UK

    David Churchward has been a GMP inspector with the UK MHRA since 2004 and is responsible for the strategic direction of the GxP inspectorate.

    He has extensive involvement in international regulatory harmonisation and collaboration through the PIC/S sub-committees for Strategic Development (deputy chair) and GMP Harmonisation. He is also PIC/S delegate to the ICH Assembly and MHRA’s representative at the EMA GMP/GDP Inspectors Working Group.

    David is co-chair of the PIC/S data integrity working group. He led the MHRA’s GxP data integrity expert group from 2013 to 2017, was rapporteur for the 2016 EMA data integrity guidance, and part of the drafting team for the 2016 WHO guidance on good data and record management.

  • Brendan Cuddy

    Brendan Cuddy, MSc

    European Medicines Agency (EMA)

    Brendan Cuddy joined the European Medicines Agency as a Scientific Administrator in October 2002.

    Brendan is currently Head of Manufacturing Quality and Supply Chain Integrity Service and since May 2017, he is Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG).

    The Manufacturing Quality and Supply Chain Integrity Service is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products.

    The Service issues Certificates of Pharmaceutical Product and issues Notices for Parallel Distribution of for Centrally Authorised Products.

    The Service provides the Chair and secretariat of the GMDP Inspectors Working Group and the secretariat for the Quality Working Party.

    The Service plays a key role in collaborating and communicating with international partners on GMP standards and co-ordinates technical input into Mutual Recognition Agreements with third countries.

    Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

  • Thibaut Dedeurwaerder

    Thibaut Dedeurwaerder, MBA

    McKinsey & Company

    Thibaut is a Partner with McKinsey & Company based in the Brussels office, dedicating his work in the field of Pharmaceutical Operations. As leader of the Pharma Operations 4.0 service line at McKinsey,

    Thibaut has substantial experience with driving high impact Digital & Analytics transformations in pharma manufacturing and supply chain. Thibaut is also heading POBOS, McKinsey’s global Pharmaceutical Benchmarking service line.

    Before joining McKinsey in 2005, Thibaut worked at Toyota Motor Europe in the Supplier management department.

    Thibaut has a degree in Electro-Mechanical Engineering from the University of Leuven, Belgium, and also studied at the TU Graz, Austria. He holds an MBA from the Solvay Business School in Brussels.

  • Valerio Di Giovanni

    Valerio Di Giovanni

    Altran
    Valerio is currently managing the solution of transforming manufacturing environments to integrate new manufacturing technologies, data, computational power, connectivity, analytics and intelligence, human-machine interaction and advanced robotics, together with operational excellence approaches. Valerio has more than 20 years of international experience. He began his career as a consultant in the manufacturing industry, leading the implementation of improvement projects. He has consulted more than 60 companies along his career mainly in the Automotive, ASD, FMCG, Food & Beverage & Pharma industry. Main areas of expertise provided during these projects include Manufacturing Operations, Design of Organization & Corporate Transformation (both in the design and implementation). He started his career as an international manager trainee in automotive industry with Fiat Group experiencing 6 years of wide cross-functional experience, including Sales, Manufacturing Excellence and Product Development.
  • Brian Dooley

    Brian Dooley, MSc

    European Medicines Agency (EMA)

    Brian Dooley has worked as a quality specialist in the Specialised Scientific Disciplines Department of EMA since 2016.

    His role involves performing scientific peer review of assessments in new centralised marketing authorisation applications, line extensions, variations, scientific advice procedures, and supporting the development of scientific guidelines by the Committee for Medicinal Products for Human Use (CHMP), its Quality Working Party (QWP), Biological Working Party (BWP), and other working parties and committees of EMA as necessary. He has supported the ICH Q12 drafting process since 2016 and is the EMA member of the Q12 Expert Working Group since mid-2018.

    From 2008 to 2016, Brian worked as a pharmaceutical assessor in the IMB/HPRA (Ireland), where he assessed marketing authorisation, clinical trial and scientific advice applications and managed teams working on post-authorisation variations, renewals, parallel imports and herbal medicines. From February 2015 to January 2016, he was the Irish member of the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human).

    Brian’s main areas of interest within quality assessment are post-authorisation lifecycle management, assessment-inspection interface, synthetic peptides, oligonucleotides and sterile products. He holds a B.Sc. in Pharmacy (2005) and M.Sc. in Pharmaceutical Medicine (2015) from Trinity College Dublin, Ireland.

  • Derek Duncan

    Derek Duncan, PhD

    LIGHTHOUSE

    Dr. Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. He holds an undergraduate degree in Physics and Mathematics from Louisiana State University and a PhD degree in Atomic & Molecular Physics from the University of Virginia.

  • Mirko Ebeling

    Mirko Ebeling

    EBETECH GmbH

    After successfully finishing his apprenticeship to become a tool maker, he finalized his Master of Mechanical and Industrial Engineering at the University of Bremen.

    Mirko started his career in the area of semi-solid compounding and mixing equipment at EKATO UNIMIX, before he became the technical sales director for pharmaceutical blister equipment in HEINO ILSEMANN GmbH.

    Today at EBETECH GmbH, Mirko takes care of the development and introduction of new innovative robotic aided systems into sterile fill-finish market space supported by STERILINE in Italy.

  • Juergen Funk

    Jürgen Funk

    F. Hoffmann - La Roche

    Juergen Funk has more than 10 years of experience in the process validation program in different roles, starting as process engineer, working as a validation consultant, then as validation manager for process validation for Biologics and Biosimilar Drug Substances and Drug Products.

    This includes Process Validation Activities from Development via Process Performance Qualification to Continued Process Verification.

    Currently, Juergen is responsible for Process Validation at Roche site Mannheim, Germany.

  • Tara Gooen Bizjack

    Tara Gooen Bizjak, MS

    US FDA

    Tara Gooen Bizjak, is an engineering officer in the United States Public Health Service and a Senior Science Policy Advisor at the US FDA. She works in the Office of Policy for Pharmaceutical Quality in the area of developing new regulations, guidance, and standards.

    Commander Bizjak has been with the US FDA for 15 years, starting as a field investigator in the New Jersey District, primarily focusing on drug manufacturing and current good manufacturing practice (CGMP) inspections.

    In 2007, she transferred to CDER to the area of a manufacturing and product quality and was a subject matter contact for several CGMP topics, including pre-approval inspections, continuous manufacturing, pharmaceutical quality systems, water quality, and scale-up issues.

    Prior to her current role, she served in multiple roles, including branch chief and senior advisor.

    LCDR Bizjak received a B.S. in Chemical Engineering from Cornell University, a Masters in Biomedical Sciences from the University of Medicine and Dentistry of New Jersey, and is an ASQ (American Society for Quality) Certified Quality Engineer.

  • Rebecca Grant

    Rebecca Grant

    Loughborough University

    Rebecca is a PhD Researcher investigating bio-metrology within Cell and Gene Therapy manufacture.

    This encompasses quantifying the impact of the operator and respective Uncertainty upon their results and measures, through different models of cell complexity.

    She is also the IMechE Research Scholar for 2015-2019, helping to develop their new Biomedical Engineering theme, with interests in scale-up manufacture of cell and gene therapies.

    Rebecca has a diverse background within manufacturing and metrology, having spent time working with both Automotive and Healthcare Industries.

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    Anne Hayes

    HPRA, PIC/S

    Anne has been working with the Health Products Regulatory Authority for 20 years. As Inspection Manager, she has responsibility for inspection programmes relating to Good Manufacturing Practice, medical device auditing, Good Clinical Practice, Good Pharmacovigilance Practice and Good Practice in relation to blood, tissues, cells and organs for transplantation.

    In January, she became the PIC/S Deputy Chair and will be the PIC/S Chair for 2020 & 2021.

    Before joining the HPRA, she worked in the pharmaceutical industry for five years as a QC Supervisor and as a qualified person (QP).

  • Anthony Hereng

    Anthony Hereng

    Claranor

    Anthony holds an Engineering degree in Mechanics from the ICAM Toulouse and joined the commercial team in 2010.

    After spending a few years in the international sales department of several equipment suppliers for the food industry, he is now at the head of the Sales Department responsible for new market prospection as well as relationship with Claranor commercial partners abroad (distributors and agents).

  • Andrew Hopkins

    Andrew Hopkins

    AbbVie

    Prior to joining AbbVie, Andrew Hopkins was a GMP Inspector with the MHRA for the past 14 years.

    As an Inspector, Andy inspected in areas including Sterile Pharmaceutical Manufacturing facilities, non Sterile Pharmaceutical Manufacturing facilities and biotechnology and was responsible for ensuring that the Companies inspected are compliant with EU GMP. He has also taken part in a number of discussion groups.

    Mr. Hopkins has been involved in a number of technological papers including the current version of the PDA Technical Report No.1 and the UK PHSS paper for non viable monitoring.

  • Maik Jornitz

    Maik W. Jornitz

    G-CON Manufacturing Inc.

    Maik W. Jornitz, CEO of G-CON Manufacturing Inc., is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 10 books, 15 book chapters and over 100 scientific papers. He is Chair of the PDA Science Advisory Board, task force member of Aging Facility and Post Approval Change Task Forces, as well as working member of BPOG, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of multiple training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

  • Alireza Khadem

    Alireza Khadem, PhD

    WHO

    Dr Alireza Khadem graduated from Shahid Beheshti University of Medical Science (Tehran, Iran) and CIGB (Havana, Cuba) in the field of Pharmaceutical Science, Biotechnology and Quality Management.  He has developed his experience and skills in the field of production, quality control, quality assurance and regulatory affairs of Biopharmaceuticals, pharmaceuticals, diagnostics and vaccines since 1997 when he started his career at Pasteur institute of Iran.

    During his career at the Pasteur Institute, he performed numerous missions for the World Health Organization (WHO) and participated in many WHO NRA assessments and GMP inspection workshops, mostly in countries in South-East Asia and the Western Pacific.

    In 2008, he joined the World Health Organization Regional Office for South-East Asia (SEARO) within the Immunization and Vaccines Department. In 2010, he joined the WHO Regulatory System Strengthening Program in WHO Head Quarters.

    Dr. Khadem has been involved in developing WHO guidelines, policy and methodology as well as benchmarking tools for regulatory systems as well as organizing and conducting numerous NRA assessments and observed audits in Members States. In addition, in recent years, he initiated or contributed to several initiatives including development of WHO Good Regulatory Practices (GRP) guideline, Coalition of Interested Partners (CIP) framework, prioritization model for RSS interventions and development of WHO Global Benchmarking Tools. 

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    Lou Killian

    Kneat Solutions

    Lou is the Kneat Solutions' Director for Customer Education & Success. He has 35+ years of BioPharma leadership experience in Quality (QA & QC), Operations, Regulatory, Engineering, Quality Systems, Enterprise Applications, and Compliance.

    His BioPharma industry experience includes positions at Abbott, Genentech and BioMarin.
  • Markus Lanz

    Markus Lanz, MBA

    InterLog Management

    Markus holds an Executive MBA from Business School Lausanne, Switzerland and a Federal Diploma for Logistics Management from GS1, Switzerland.

    He has over 20 years of international experience as senior executive and consultant within various industries like Mining, Chemical, Pharmaceutical, Minerals and Manufacturing.

    During the past 25 years, he has implemented demanding & complex projects in the field of logistics & supply chain management, automation and as well as in ICT.

    In 2018, he joined InterLog Management as Senior Consultant Professional and is also a member of the executive board.

  • Kaspar Malthe Larsen

    Kaspar Malthe Larsen

    Novo Nordisk

    Kaspar is Chief Technology Architect - Digital Manufacturing for Novo Nordisk and an industrial engineer with 20+ years of experience within the biotech and pharmaceutical industry.

    Kaspar graduated from the Copenhagen Engineering College in Manufacturing Science and Technology. He is a PMI certified PM, SABSA practitioner and member of the Danish Automation societies and the Digital Transformation of Factories board of directors.

    He has always worked in the GMP regulated industry with assignments including documentation, qualification and validation.

    His specialties are Enterprise Architecture, Project Management, Sr. Automation Solution Architect, Innovation, Manufacturing Intelligence. High expertise in MES application, batch and process reporting plus general industrial IT/Automation.
  • Jennifer Maguire

    Jennifer Maguire, PhD

    US FDA

    Jennifer Maguire is the Director of the Division of Quality Intelligence, Risk Analysis, and Modeling in the Office of Surveillance (OS) within FDA/CDER’s Office of Pharmaceutical Quality (OPQ).

    Her division assesses quality intelligence throughout the drug product lifecycle to inform business partners about the state of pharmaceutical quality and uses predictive analytics to drive surveillance decisions.

    Dr. Maguire joined the FDA in 2010 as a Chemistry Reviewer in the Office of Generic Drugs. Upon OPQ’s formation in 2015, she initially served as an Acting Branch Chief in OPQ’s Office of Process and Facilities before joining OS.

    During her FDA tenure, Dr. Maguire has reviewed a variety of dosage forms and has been involved with many initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including Question-based Review, Quality by Design, Established Conditions and ICH Q12 Implementation, CDER-ORA Site Selection Model, and Quality Metrics.

    Dr. Maguire earned her BS in Chemical Engineering from the University of Virginia and her PhD in Industrial and Physical Pharmacy from Purdue University.

  • Aaron Mertens

    Aaron Mertens

    Steris

    Aaron Mertens has been a member of the STERIS Life Sciences Contamination Control Solutions as a Technical Service Manager since January 2015.  In this role, Aaron has responsibility for providing global technical support primarily for Critical Environments (i.e. environmental sanitizers, disinfectants, sporicides), Sterility Assurance Products (i.e. biological and chemical indicators), and Barrier Products Solutions (i.e. sterilization wrapping), application and validation.

    For nearly 20 years, Aaron has held a number of positions within the Pharmaceutical Industry, specializing in cleaning, disinfection, sterilization and contamination control in parenteral drug manufacturing.  In these roles, he has gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing quality assurance programs.

    Aaron has been a member of various industry organizations (PDA, ISPE) since 1999, contributing by presenting posters and talks at meetings, as well as participating in local chapter functions.

    Aaron holds a bachelor’s degree in Genetics from the University of Wisconsin – Madison.

  • Donncadh Nagle

    Donncadh Nagle, MSc

    Avara Shannon Pharmaceutical Services Limited
    Donncadh Nagle is a pharmaceutical industry professional based in Ireland and is a recent graduate from the masters degree programme, MSc. in Pharmaceutical Validation Technology, at the Technological University Dublin (TU Dublin).

    Donncadh is an experienced Validation Engineer with over eleven years of experience in all areas of validation including; Process/Product Validation, Equipment/Automation Qualification, Facilities Qualification, Computer System Validation, Test Method Validation, and Cleaning Validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries.

    Donncadh has ambitions to become an industry leader within the pharmaceutical industry and is the current Chair of the BPCI Validation group, Ireland. Donncadh is also a recent winner of the 2018 Thesis award presented by KENX, the Knowledge Exchange Network, at their C&Q and Data Integrity conference, in Dublin, Ireland. Donncadh is also a published author with IVT/JVT, USA.
     
  • Sarah Pelaez

    Sarah Pelaez, MSc

    LONZA

    Sarah Peláez is a scientist in the packaging department within the Lonza Drug Product Service organization. In this role, she develops container closure systems for parenteral drug products, which includes container closure system qualification, manufacturing process characterization as well as quality control testing. Sarah is experienced in vial, pre-filled syringe and auto-injectors. Before her engagement in the packaging department, she was part of the Lonza phys-chem analytical development team and the particle characterization core facility.

    She holds a BSc degree in Life Sciences and an MSc degree in Life Sciences with focus in Pharmaceutical Technologies, both from the University of Applied Sciences and Arts Northwestern Switzerland. She wrote her Master’s Thesis on Container Closure Integrity Testing of Parenteral Drug Products.

  • Marla Phillips, PhD

    Xavier University

    Marla A. Phillips, Ph.D. Director, Xavier Health. Xavier University. Marla founded Xavier Health in 2008 at Xavier University, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla has expertise in leading FDA inspections and readiness, quality, analytical testing, supply chain, stability program management, validation, manufacturing, and packaging operations. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

  • Michael Pratz

    Michael Pratz

    Bausch & Stroebel

    Michael Pratz is responsible for the Bausch+Ströbel Academy with customer training and employee qualification.

    Over the past 30 years, his career went from technical IT (CAD, PLM, VR) to technical documentation, equipment validation, automation and research and development.

  • Felix Rebitschek

    Felix G. Rebitschek, PhD

    Max Planck Institute for Human Development

    Taking into account the nature of decision problems, Felix Rebitschek aims at identifying accessible problem presentations, in order to empower decision-makers under risk and uncertainty.

    His work as a cognitive psychologist at the Harding Center at the Max Planck Institute for Human Development in Berlin (Germany) has its roots in his PhD about diagnostic reasoning with causal models.

    Among his teaching activities, he trains health professionals and managers on risk communication, risk literacy, and decision-making under uncertainty internationally.

    Dr. Rebitschek has published about psychological conditions of decision-making in the digital world, e.g. on educative interventions when encountering digital health information. He is also engaged in knowledge transfer concerning digital consumer and citizen scoring.

  • Jordi Riulas

    Jordi Riulas, MSc

    Capital Cell

    Jordi Riulas is chief operating officer and cofounder at Capital Cell, a specialised biotech and life sciences equity investment platform. 

    He mastered in blockchain technology at IEBS school with the Fintech Master program. He is co-founder at Cell.market, the world´s first biotech equity token market.

    Jordi is a successful serial entrepreneur in technology with more than twenty years of experience at different companies.

  • Stephan Roenninger

    Stephan Rönninger, PhD

    Amgen Europe

    Dr. Stephan Rönninger is the 'Head External Affairs Europe, International Quality' of Amgen. He provides leadership, support and represent of external activities impacting Amgen's operations functions. He works with associations in the EU, Japan and emerging markets with focus on Russia and Turkey. He is responsible for advocacy in various external organizations and provides assessment and communication to Amgen.

    Stephan Rönninger holds a PhD and an engineering degree in Organic Chemistry. After his postdoctoral studies, he worked for Roche 1992 - 2013, starting in an API manufacturing site with responsibilities for laboratory, project management, as production manager, in Quality Assurance and Quality Management. In 2003, he changed to the Roche Global Quality organization and was responsible for the Global Quality System of Roche and external collaborations.

    He represents Amgen in industry trade associations (e.g. EFPIA) and the European industry on GMP/GDP topics as well as at ICH working groups such as Quality Risk Management (ICH Q9), Quality Implementation Working Group (Q-IWG), and the GMP for APIs (ICH Q7) Implementation Working Group. In the Parenteral Drug Association (PDA), he is elected for the board of directors, past chair of the Regulatory Affairs and Quality Advisory Board (RAQAB), leader of the PDA-Europe Inspections Trends Interest group and co-chairs several international conferences and training events (e.g. with PIC/S). He is one of the founders and co-chair of the 'Paradigm Change in Manufacturing Operations' (PCMO) project in PDA.

  • Diede Ruelens

    Diede Ruelens

    Johnson & Johnson

    Diede Ruelens is a lead IT Solution Architect and Blockchain subject-matter expert at Johnson & Johnson. At ten years old, Diede figured out how to publish his own website. That's when he fell down the rabbit hole of technology and hasn't emerged since.

    Diede graduated magna cum laude from the Catholic University of Leuven, Belgium, with a degree in Electrical Engineering and Computer Science. He joined Johnson & Johnson in 2014 as part of the J&J Technology Leadership Development Program, where he has worked on enhancements to ERP systems, large-scale acquisitions, manufacturing environments and enterprise systems.

  • Sebastian Scheler

    Sebastian Scheler, MSc

    Innerspace - The DeepTraining Company

    Sebastian Scheler MSc is CEO and Lead Psychologist at Innerspace – The DeepTraining Company.

    He is expert in psychology and neuroscience of training and data-based training analysis. As part of the Innerspace product development team, he designs the psychological training framework on how cleanroom operators can train their skills and mindset to avoid human error in the sterile area.

    Sebastian has extensive experience evaluating cleanroom training programs to find the best approach to ensure product safety and quality improvement.

  • Ueli Schläpfer

    Ueli Schläpfer

    Helbling Technik AG

    Ueli Schläpfer is a mechatronics engineer by training and highly experienced in innovation and engineering for the fields of industrial mechatronics and robotics.

    For more than 20 years, he has been involved in innovating, designing and developing products and automated solutions for lab automation, semiconductor manufacturing and packaging, mail and baggage handling equipment, packaging machines, medical device production, and industrial appliances.

    He was responsible for project scoping and management, controlling, design and engineering, documentation, and quality management.

    In his role as a service line manager at an innovation and engineering service provider, he has helped pushing the state of the art in numerous projects for many tech companies ranging from start-ups to global market leaders.

  • Bernadette Scutellà

    Bernadette Scutellà, PhD

    GSK

    Dr. Bernadette Scutellà received her M.S. in Food Engineering from the University of Salerno in 2013. She was awarded of a PhD from AgroParisTech for studies on the mathematical modelling of freeze-drying process in 2017.

    Presently, she is a drying scientist at in the Technical Research and Development department at GSK Vaccines, Rixensart, Belgium.

    She is in charge of freeze-drying cycle development, transfer and scale-up, as well as of the evaluation of novel process monitoring and drying technologies.

    Her research interest presently focuses on mathematical modelling of transport phenomena, rheology and thermodynamics in pharmaceutical and biological processes.

  • Helen Thomas

    Helen Thomas, PhD

    Janssen Vaccines

    Helen Thomas studied Mechanical Engineering and Biotechnology, she finished her studies with a PhD in Bioprocessing at ETH Zurich.

    Helen has extensive  experience in Process Development, Process Characterization, Clinical Trial Manufacturing (CTM) and lately Data Management as Scientific Lead at Janssen Vaccines, Bern, Switzerland.

  • Carmen Verhoeven

    Carmen Verhoeven, MSc

    Johnson & Johnson

    With a master’s degree in Bio-engineering from the University of Leuven in Belgium, Carmen joined Johnson & Johnson Belgium in 1998.

    While at Johnson & Johnson, Carmen held several leadership roles in the areas of Quality Control and Quality Assurance in both Beerse and Geel.

    In 2012 Carmen moved to GE in Eindhoven in the Netherlands, becoming Head of Quality/QP, before returning to Johnson and Johnson in 2014.

    Since her return, Carmen as held the role Director of Lab Systems, supporting the lab system network across the multiple Johnson & Johnson segments – Consumer, Medical Devices and Pharmaceuticals.

    Recently, Carmen’s role has expanded to support Johnson and Johnson laboratories in building their digitalization and automation strategies, focusing primarily on the areas of Method Execution, Planning and Scheduling. This work aligns with Carmen’s personal passion for innovation and finding solutions to improve the daily work of her Lab System customers.

  • Alex Viehmann

    Alex Viehmann

    US FDA

    Alex Viehmann is currently a branch chief in the Office of Surveillance, Division of Quality Intelligence, Risk Analysis and Modeling.

    His team focuses on the application of data analytics in supporting comprehensive surveillance and decision making.

    He is a subject matter contact for quality metrics, statistical quality control, sampling, and design of experiments.

    Prior to joining the Quality Intelligence Branch, Alex worked as a statistician in the Science staff within the Office of Pharmaceutical Science where he provided statistical support for CMC review and GMP inspections. He also collaborated with internal and external stakeholders on developing policy and standards on sampling, test method evaluation and statistical quality control. Alex received his degree in Economics from the University of Maryland at College Park.

  • Oskari Vinko

    Oskari Vinko

    UniteLabs

    Oskari Vinko is the CEO and Co-Founder at UniteLabs, a life science laboratory automation company that builds solutions that can be repurposed to new tasks.

    Oskari's passion is also in science communication, and he has been competing and teaching more effective talks since 2015.

  • Markus Zeitz

    Markus Zeitz, PhD

    Novartis

    Markus has been working with Novartis in Basel since 2004.

    He started in Novartis Technical Research & Development in 2004 and has held roles of increasing responsibility in Technical Research & Development, Quality, Novartis over the Counter Division and Global QMS.

    In his current role, he is leading the Novartis Quality IT Strategy and has been instrumental in setting up the Quality Analytics Tool (QANTO), Novartis Quality’s leading edge platform for quality data and analytics.

    A German national, he holds a Ph.D in Chemistry from the Saarland University, Germany.

  • Arne Zilian

    Arne Zilian, PhD

    Novartis Pharma AG
    Arne has 20 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.

    In Novartis, he is the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He serves as the lead author for the cross-divisional quality standards process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization.

    In PDA, he is engaged in the interest groups for CPV and Manufacturing Intelligence.

    Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry. He is also a certified Kepner Tregoe trainer for situation, decision and problem analysis.
  • René Zoelfl

    René Zoelfl

    Parametric Technology GmbH

    René with his experience in several industries and life sciences in particular helps companies to transform to an agile enterprise through Industrie 4.0 & digitization. Based on this experience he has a deep understanding on how new technologies support digital transformation and how companies can benefit from digitization in different process areas and how regulations impact this journey
    René is also one of the experts that contributed to the acatech Study Industrie 4.0 Maturity Index published in April 2017.