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Committee & Speaker Biographies

Committee & Presenter Biographies

2023 PDA Robotics and Automation Conference

03 - 04 May 2023

  • Dieter Bachmann

    Bachmann Dieter, PhD

    Janssen J&J

    Dieter is Dir. Aseptic Manufacturing at J&J's corporate Sterility Assurance group with a main responsibility for providing standardization, science and education across J&J in the field of aseptic processing technologies. He is a Pharmacist by training with 30+ years of experience and holds a PhD in Pharmaceutical Formulation Technologies. Dieter has worked with small family-owned companies as well as in global business. Since joining Johnson & Johnson in 1998 he held several positions in R&D, Operations and Quality of J&Js Pharma and Medical Device franchises. Alongside business Dieter always engaged in associations work. For 10 years Dieter used to work as a Swiss national delegate on developing monographs for the European Pharmacopeia (EP) at EDQM in Strassburg. He is a frequent presenter and active member of PDA and ISPE. Dieter engages at the German DIN/NA063 and ISO TC198. Since 2019 Dieter is the global convenor for ISO TC198/WG9 Aseptic Processing.

  • Toni Manzano

    Toni Manzano

    Aizon
    Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the Biomanufacturing IG and co-chair of the CPV of the Future initiative at the PDA, active collaborator in the AI initiative for AFDO and he teaches AI subjects at the Universities (UAB and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and collaborator with the UN in AI subjects. 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 graduated in quality systems for manufacturing and research pharmaceutical processes.
  • Sesethu Dowiasch

    Sesethu Dowiasch

    Rockwell Automation

    Sesethu Dowiasch brings with her more than 14 years of experience in automation and digitalization. In her current role, she helps Life Science manufacturers transform their manufacturing operations to bring innovative treatments to patients faster, while improving quality, yield, and product security. Her hands-on background in automation and mechatronics engineering gives her a unique perspective on the impact of converging IT and OT through a solid digital transformation journey. In addition to the strategy development of process control systems and secure network architecture design, Sesethu also supports manufacturers with the vertical and horizontal integration between systems such as Batch, DCS, MES, Historian, IOT, ERP, Cloud, etc. Sesethu also serves as the Co-Chair for the ISPE Women In Pharma community of practice in the DACH region. She is passionate about supporting the Life Science industry because of the positive impact it has on patients’ lives.

  • Yvonne Duckworth

    Yvonne Duckworth

    CRB

    Yvonne Duckworth, PE is a registered Automation Engineer at CRB with 30+ years of experience working in the pharmaceutical and biotech industries. Ms. Duckworth is also an Industry 4.0 subject matter expert (SME) providing Digitalization consulting for the pharma and biotech industries. With a strong background in both technical design and project management, her areas of expertise include process control system design including PLC and DCS based platforms, network infrastructure design, as well as leading Industry 4.0 and Digitalization initiatives.

    Ms. Duckworth is a frequent speaker at pharmaceutical conferences both nationally and internationally, featuring Automation and Digitalization. She has also presented as a guest speaker for local universities specializing in biotechnology. Ms. Duckworth has written multiple magazine articles featuring Pharma 4.0/Industry 4.0.

    Ms. Duckworth has a Bachelor of Science in Electrical Engineering from Widener University and a Master of Business Administration from Rider University. She is an active member of the International Society for Pharmaceutical Engineering (ISPE), Women in Pharma (WIP), International Society of Automation (ISA), and Women in Bio (WIB). She is also a co-chair of the ISPE Pharma 4.0 Holistic Control Strategy/Digital Maturity Special Interest Group (SIG).

  • Bernhard Gerl

    Bernhard Gerl

    Körber Pharma

    Bernhard Gerl is moderating the Think Tank Ecodesign at the Körber group and is driving sustainability in engineering projects. With many years of experience as a mechanical engineer in the design department, he understands the challenges in developing projects and the balancing of complementary and competing requirements. Integrating environmental considerations increases the complexity even further. He and his team of the Think Tank support all Körber's engineers in making the right decisions during product development towards more sustainable machines and promote a sustainable mindset throughout the group.

  • Timothy W Hsu

    Timothy W Hsu

    AFDO/RAPS

    Before becoming the Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative, Timothy was a member of the AI Initiative’s Core Strategic Team and has also spent several years working with the GMLP, AIO, and [email protected] teams in varying capacities under the Xavier Health Artificial Intelligence Initiative. Timothy has served across the clinical, operational, and administrative spectrums in healthcare systems ranging from pediatric, academic, research, and community hospitals. His roles in healthcare systems have included work in strategy, planning, perioperative, service line, and population health divisions. Hsu was Product Manager in Clinical Intelligence at Premier Inc., where he was the product owner of Service Line Analytics, Cost Accounting, Patient Analytics, and Clinical Professional Partnerships. He was the market research strategist for healthcare market futures at GBBN Architects. Timothy has a BA in English and Neuroscience from Kenyon College and a master’s in Health Services Administration from Xavier University. He has completed a certificate program in AI & Business Strategy from MIT Sloan and CSAIL.

  • Florian Huber

    Florian W. Huber

    TissUse

    Florian started nearly a decade ago as an engineer in the field of production technology and Industry 4.0. His interest in this field was mostly focused on automation and machine learning. When moving to the field of life science around six years ago he used this experience to develop the first fully automated Multi-Organ-Chip platform. Today, he is responsible for the software development team at TissUse including the fields of robotics and data science.  His passion is to bring the newest developments in Machine Learning and Artificial Intelligence to the field of life sciences and laboratory automation.

  • David Hubmayr

    David Hubmayr

    Takeda

    David Hubmayr holds a degree in Physics from the Technical University Vienna, Austria, Europe as well as certifications in Data Science. His 10 years`+ experience in the biopharmaceutical industry stretch cross-functional from E2E Quality Assurance to R&D with a proven track record of leading and delivering global Quality and Digital Innovation advancements. In his current role, David is a member of the global Digital Innovation team in Data, Digital & Technology at Takeda, Zurich, Switzerland. David is member of the “CPV-of-the-future” working group and the 2023 PDA Robotics conference Scientific Committee, formerly chairing the PDA “Synthetic Data Generation” task force, publishing on both, the generation of synthetic batch data by Artificial Intelligence and AI-powered continued process verification for bioreactor processes. linkedin.com/in/david-hubmayr

  • Marilyn Romieux

    Marilyn Romeux

    Merck KGaA

    Marilyn Romieux is the Strategy and Execution Director of the Pharma Analysis & QC segment for Merck KGaA. She started as an R&D Scientist in the field of rapid microbiology before moving to a Marketing role where she created a new range of application services designed to support users in developing and implementing microbiology QC methods. Her later assignment as Head of Technical Marketing and Scientific Liaison includes employee education, customer training and application development. With an extensive knowledge of microbiology QC and nearly two decades in serving the pharma industry, she took the role of Strategic Marketing Director for the microbiology QC business in 2020, where one of her assignments was leading the marketing of Merck’s Robotics & Automation offer. She expanded her scope to all Science and Lab Solutions businesses of Merck in January 2022. She graduated in Cell Biology and Biochemistry from the University of Strasbourg, France, and earned her Master’s degree in Life Sciences from AgroParisTech in Paris, France.

  • Philipp Schmid

    Philipp Schmid

    CSEM

    Philipp Schmid is Head Research and Business Development for Industry 4.0 & Machine Learning at CSEM. He holds an engineering degree in Microtechnology focused on Robotics and a MAS in Management, Technology and Economics from ETH Zürich. Before joining CSEM he worked in several industrial companies including Roche and spent one year as research fellow at the ICT Robotics group (CSIRO) in Australia. From his experience as Section Head he gained a profound expertise in delivery of advanced solutions in robotics and machine learning to industry. Now he manages the research, development and industrialization of new technologies. He is member of various expert committees such as SATW and Data Innovation Alliance, works as an innovation coach and is co-founder of the Digital Innovation Hub Raisehub.swiss for Robotics & Artificial Intelligence.

  • Roberto Conocchia

    Roberto Conocchia

    EMA

    Roberto Conocchia is a GMP Technical Lead at the European Medicine Agency (EMA) since March 2018. He obtained a Master degree in Bio-Chemistry from the University of Rome (La Sapienza) and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry. Roberto worked in three different API manufacturing sites in Italy from 2000 to 2006. He worked as GMP inspector at the Italian Agency Medicine (AIFA) performing regulatory inspections of pharmaceutical manufacturers (all dosage forms), focusing on sterile, not sterile and biological products from 2007 to 2018.

  • Patrick Courtney

    Patrick Courtney

    Sila

    Dr Patrick Courtney has 20 years’ industrial experience in the development of technology notably in the areas of sensing and robotics with a special focus on technology transfer. He has worked as director for global firm PerkinElmer, as well as at Sartorius and Cap Gemini, with spinouts, SMEs and clients in the life science and healthcare sectors. He has a long involvement in EU and national programmes, leads a European working group on analytical laboratory robotics and is member of board of directors of SiLA (Standards in Laboratory Automation). He holds an MBA with a PhD in Robotic Engineering/Molecular Biology, and has 100 publications and ten patents. Dr. Courtney can be contacted at: [email protected]

  • Roger de Reus

    Roger De Reus

    Novo Nordisk A/S (Denmark)

    Roger de Reus works with process development, process management, and risk management in the Device Manufacturing Development area of Novo Nordisk A/S (Denmark), a company improving the lives of millions of people with chronic diseases, such as diabetes. Current work includes exploration and implementation of digital twins in device manufacturing, typically needle injection systems, for faster development and process control improvement. Roger holds a Ph. D. in physics from the University of Utrecht (The Netherlands). His career spans over more than 10 years in academia and since 2000 in industry. He participated in the development of a variety of products, both micro-electromechanical systems and medical devices. He is keen on innovation and working for purpose-driven organizations.

  • Scott Deckebach

    Scott Deckebach

    Lachman Consultant Services, Inc.

    Scott Deckebach is a Senior Director in the Lachman Consultant Services, Inc. Compliance Practice and is head of the organization's Data Integrity specialist team. He holds a B.S. in Chemical Engineering and an M.B.A. and has 30 years progressive experience in the pharmaceutical industry including global leadership positions and extensive manufacturing, information technology, quality and compliance, lean/six-sigma and project management experience that covers API, biopharmaceutical and medical device sectors and development through distribution and postmarket. Scott has spent the last 7 years globally leveraging his skills with companies at corporate and site levels developing robust, contemporary and sustainable data governance programs both proactively and in response to regulatory agency citations.

  • Richard Denk

    Richard Denk

    SKAN AG

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland  in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

  • Krishnakali Ghosh

    Krishnakali Ghosh, PhD

    U.S. FDA
    Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She currently is the subject matter expert at FDA for 21 CFR Part 11, Part 4, 211, 210 and 212. She has in-depth knowledge in implementation of digital technologies in pharmaceutical manufacturing and has presented at various conferences on proposed challenges and mitigations in adopting the latest digital technologies in a regulated environment. She was the chairperson and lead for FDA cross center initiative from CDRH, CBER,CVM,ORA on “Cloud Computing” to develop various internal policies related to outsourced IT services and cloud computing usage for regulated products for drug manufacturing. She has extensively worked on NDA and ANDA application reviews of complex drugs since 2012, with a focus on sterile injections, aseptic and combination drug manufacturing process. She has conducted manufacturing facility pre approval inspections in Europe, US, India and Japan as a subject matter expert and trained various ORA and CDER reviewers in various dosage form inspections.
  • Mauro Giusti

    Mauro Giusti, MSc

    Eli Lilly and Company

    Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is board certified by the National Chemist Association and board certified as Technical Director (Qualified Person) by the Italian Minister of Health.

    After serving as an army officer, he joined Eli Lilly Italy in 1988. He has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Operations, Technical Director/Qualified Person, Six Sigma Champion, Science and Technology, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in Europe, Africa, and Asia.

    Among the several experiences with Lilly, he has worked in the USA from 1992 to 1994 and in the United Kingdom from 1997 to 1999. In September 2019 he took his current role, as Senior Director, Site External Network.

    For more than 16 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for the Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB). In December 2021 he has been appointed President, PDA Italy Chapter.

  • Enxhi Gjini

    Enxhi Gjini

    Takeda

    Enxhi is the Digital Innovation Lead in Global Manufacturing & Supply Chain in Takeda Pharmaceuticals

    I have 4 years of experience in industry and my professional focus lies on how innovation and digital technologies can automate, optimize processes and drive business transformation. My educational background is Computer Science (BSc) and Management, Technology and Economics (MSc). For the past 2.5 years in Takeda my main focus has been on Augmented & Virtual Reality, Advanced analytics, and paperless solutions.

  • Steve Mehrman

    Steve Mehrman

    Janssen

    Steve Mehrman, PhD in Organic Chemistry and has worked 23 years in process development at J&J. He is currently a Scientific Director in the Data Integration and Modeling team as part of Janssen Biotherapeutics Development and an Adjunct Professor at Temple University School of Pharmacy. He has over 50 published patents and 20 publications spanning both large and small molecule focused on automation, technology and data science to support building control strategies, scale up and technical transfer in process development. Steve has defined and implemented a Digital Maturity framework and Model Factory as part of the overall digital transformations ongoing in Janssen. This approach is enabling data to flow within and across project teams supporting explicit knowledge creation through applied data science to achieve both the best process at first launch and accelerated product development.

  • Anders Meister

    Anders Meister

    CIM Industrial Systems

    Anders Meister is the Chief Commercial Officer of CIM Industrial Systems.

    He is a public speaker and opinion leader within digitalization and big data. With more than 20 years’ experience working with software for data collection and analysis, he is a leading expert on how new technologies can be used to augment human intelligence and improve current practices within manufacturing. He also participates in academic research projects within this field through MADE – Manufacturing Academy of Denmark.

    Anders is currently CCO at digital solutions supplier CIM, working with blue chip pharmaceutical companies and OEMs on pharma 4.0 digitalization projects aimed at data-driven process optimization, quality assurance and compliance.

  • Julian Petersen

    Julian Petersen

    Groninger

    Julian started his career in the pharma industry at a German fill and finish system supplier as a project manager. After a short timeout in the semiconductor/metrology business Julian returned to the pharmaceutical fill and finish business as a Sales Director responsible for the DACH market. Now leading the Business Development and Product management Julian is passionately focusing on emerging and future technologies to meet the requirements of the vastly changing pharma market. Julian is an active member at ISPE (SIG robotics) and PDA (PtC aseptic fill and finish). He enjoys public speaking and exchanging knowledge.

  • Alejandro Rivera Rojas

    Alejandro Rivera Rojas

    United Nations Industrial Development Organization (UNIDO)

    26 years of professional experience in the development of innovation policies and strategies; science, technology, and innovation ecosystems; industrial resources efficiency use and circular economy, development of technology parks, smart manufacturing centers and innovation clusters, including clusters in biotechnology sector and health industry centers; innovation management standards; quality infrastructure (QI), SMEs upgrading and digital transformation. Currently leading the UNIDO Health Industry Framework, an initiative aiming at promoting local production of pharmaceuticals, application of advanced technologies in the health industry, manufacturing capacities, and market opportunities for health products. Chemical Engineer degree from the Havana Technical University (CUJAE). Master’s degree with distinction in environmental engineering from International Institute for Water Education (IHE) in Delft, The Netherlands.

  • Sebastian Scheler

    Sebastian Scheler, MSc

    Innerspace GmbH

    Co-Founder, Managing Director and Chief Methodologist at Innerspace, a global provider of high-end virtual reality simulators. I am a psychologist by profession and have many years of experience in designing psychological methods for developing simulators for behavioral assessment and training of people in highly critical environments.

    At Innerspace, I am responsible for overall portfolio management, simulator methodology, and business relations with international clients and cooperation partners in the pharmaceutical industry. I am also a speaker at pharmaceutical events, author of several publications on simulator technology.

  • Herve Soukiassian

    Hervé Soukiassian

    BD

    Hervé Soukiassian joined BD-Pharmaceutical Systems business 15 years ago and is currently the leader for Product Development pertaining to Prefillables Syringes for Chronic therapeutic segment. He has also contributed actively within the PDA – co-author of the TR85 “Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers” and the TR 73 “Prefilled Syringe User Requirements for Biotechnology Applications”.

    Prior to joining BD, Herve worked for 13 years at Hewlett Packard in various positions gaining experience and developing expertise in the field of process engineering and product development. He later joined the board of Directors of ActiCM, a start-up company associated with the “Commissariat a l’Energie Atomique (CEA)” and specialized in optical Coordinate Measurement Machines.

    Herve graduated from the Institut National des Sciences Appliquées of Lyon as a mechanical and industrial engineer with a master’s degree in material sciences.

  • Salil Thakar

    Salil Thakar

    PricewaterhouseCoopers

    Salil Thakar has over 18 years of combined industry and consulting experience in Operations excellence for bio-pharmaceutical and medical device industry. He co-leads PwC’s Quality Management consulting team, and helps clients manage evolving global regulatory and patient expectations, industry trends and technology advances. His experience spans the operations value chain including manufacturing operations, distribution practices, quality systems, regulatory operations and post market business processes. He has led numerous teams to simplify processes, improve organizational effectiveness, and implement pragmatic technology solutions with a bias towards driving tangible business outcomes (operational efficiency, accelerated launches, quality productivity, scale/capacity).