Jens Smiatek has a PhD and habilitation in theoretical physics. He has taken various group leader positions in universities and research organisations, and his main biotechnological interests include modelling and advanced machine learning of coupled and single unit operations and formulation aspects. He is the author of more than 100 peer-reviewed articles with over 2600 citations (H-index 32). Since 2019, Jens has worked at Boehringer Ingelheim Pharma GmbH & Co. KG.

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, phar­maceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert con­tainment group of the ISPE DACH eight years ago. The containment group published the containment manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Executive Coach. Storyteller. Public speaker. Highly motivated, fast learner with strong dedication. Extensive scientific (BSc, MSc and PhD) background with over 20 years of pharmaceutical experience: sales, local & global strategic product management; global product commercial strategy training; scientific communications; digital innovation; mentoring, coaching and facilitating. Worked across all stages of the lifecycle (early launch, launch, LoE). Speaks several languages and has good interpersonal skills. 
Specialties: Experience in the following disease areas: Immunology, Infectology, Haematology, Urology, Oncology, Transplantation, Cardiovascular, and Neuroscience. 

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland.  From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals.  During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Körber.  In addition, Christoph is serial entrepreneur, currently, as CPO at fermify, he is focusing on the projection of precision fermentation on the commercialization of vegan cheese.

As the corporate global head of accessibility at Merck Sharp & Dohme GmbH (MSD), Dr. Stephen Framil has threaded the values of equal access throughout his formative and professional career – from building greenhouses for the Navaho Nation in New Mexico and brick and mortar schools in the Dominican Republic, to creating a Philadelphia inner city tuition-free music conservatory for at-risk neighborhood youth, to performing arts organisations in Pennsylvania and North Carolina that make great music accessible to all through admission free concerts. Steve has brought his multi-faceted diverse experience and sense of mission-calling purpose to mobilise digital accessibility across MSD, unifying thought leadership with business objectives and technical expertise to make the digital landscape accessible to all. Steve has over 25 years of professional experience with executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise – leading global cross organisational enterprise, consultant, and startup teams in the health and life sciences, finance services, non-profit, information technology, user experience, and marketing.

Dan Bach Kristensen holds a PhD in biology and a BSc degree in chemistry. Dan is specialised in protein chemistry and mass spectrometry, which he initially applied in the field of proteome research. For the last 19 years Dan has been working with analytical development in the biopharmaceutical industry, on projects ranging from early discovery to product registration. Clinical indications include bleeding disorders, neutropenia, autoimmune diseases, and oncology. Dan currently works as a principal scientist at Symphogen, a part of Servier, which specialises in the development of antibodies, antibody formats, and antibody mixtures for the treatment of cancer and neuro inflammatory diseases.

Alexander Krupp is responsible for the transformation of Bayer’s clinical development business towards innovative trial designs and to ensure seamless interactions with the ecosystem of discovery partners. He is passionate about delivering digital strategy in the life sciences industry. Previously, his organisations have delivered plug and play data to be easily usable, e.g. 293m patient records from 30-plus sources. As an enthusiastic executive in global enterprises with a PhD in neuroscience, molecular oncologist and certified paramedic, his professional experience covers the pharmaceutical value chain with a focus on digital health and data strategy.

Sesethu Dowiasch brings with her more than 15 years of hands-on experience in automation and digitalization in Africa, Europe, and USA. 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 practical background in automation and mechatronics engineering gives her a unique perspective on the impact of converging IT and OT through a scalable digital transformation journey. In addition to the strategy development for 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 applying her engineering background to support the Life Science industry because of the positive impact it has in the lives of patients.

Bora Erdemli has extensive medical affairs experience, leading ZS’s medical affairs practice in Europe. He has worked with pharmaceutical, biotech and medical technology/device companies globally. His focus has been on helping pharmaceutical companies develop sound medical affairs strategy, devise the right evidence/data generation plan, disseminate the information effectively, and collect/communicate insights back to the organisation.

Bora is a member of Medical Affairs Professional Society (MAPS) digital strategy focus area working group and co-leading the MAPS Switzerland/Nordics chapter. Prior to his current role, Bora worked as a management consultant within the healthcare and pharmaceutical practice of another global consulting firm. Bora holds a PhD in biophysics from the Johns Hopkins University School of Medicine.

Dr. Laure Gurcel is the Business Process Owner for Product Quality Review (PQR) within Global Quality at Sanofi.  In this role, Dr. Gurcel implemented the use of GenAI for authoring PQR reports.  Dr. Gurcel received her PhD in Biochemistry from the University of Geneva in 2006 where her research focused on immunity and host-pathogen interactions. Following this, Dr. Gurcel engaged in a postdoctoral fellowship at the University of Lausanne and EPFL Dr. Gurcel joined Sanofi as an Affiliate Quality Officer in 2012, and she was subsequently the Sanofi Country Quality Head in Switzerland.  Dr. Gurcel has experience in various quality systems as well as in change management and development and implementation of GxP validated computerized systems for training and batch release.

Lukáš Dvořák is a pharmaceutical consultant with more than 15 years of experience in the pharmaceutical industry over Europe and Asia territories. He mainly focusses on the establishment and maintenance of the pharmaceutical quality systems, both production and quality practice. He has auditor skills and practise and is a professional adjudicator in the Czech Accreditation Institute.

Stephen Judd is a chartered chemical engineer and fellow of engineers Ireland. He is an experienced technical manager and principal process engineer with more than 15 years’ experience in process engineering and facility design, mainly in biotech projects. He has an excellent mix of design office and field experience across a wide range of international clients with significant experience in process technology selection and facility design. He has experience across the full project life cycle from feasibility study to commissioning and qualification and now focusses on the early project phases developing the facility design and manufacturing philosophies. Stephen has significant experience with different process technologies across all parts of the manufacturing process for biologics, ATMP, and other novel therapies such as SPPS and mRNA vaccines. This includes selecting the optimum approach to suit the specific needs of the client/project with respect to hard-piped, single-use, or hybrid systems.

Stephen has also authored or co-authored a number of technical papers including a paper on multi-modal facility design published in the ISPE PE Magazine. He is actively involved in the development of a number of ISPE guides currently in development relating to C&GT topics.

Dimitrios Lamprou (PhD, MBA) is a full professor (chair) of biofabrication and advanced manufacturing, and a director at MSc industrial pharmaceutics at Queen’s University Belfast (QUB). He is also the chair at United Kingdom and Ireland Controlled Release Society (UKICRS) and the chair of the Academy of Pharmaceutical Sciences (APS) emerging technologies focus group. Dimitrios is the author of over 150 peer-reviewed publications, has over 350 conference abstracts, has given over 150 invited talks in institutions and conferences across the world, and has secured funding of more than £4M.

Dimitrios has been recognised as a world leader in 3D printing and microfluidics. PubMed-based algorithms placed him in the top 0.088% of scholars in the world writing about 3D printing and in the top 0.071% of scholars in the world writing about microfluidics in the past 10 years. Moreover, PubMed-based algorithms placed him in the top 0.63% of scholars in the world writing about nanofibers.

Dimitrios has also twice been named in Stanford University’s list of the world’s top 2% scientists (2021 and 2022) for his research in pharmaceutics and biomedical engineering. His research and academic leadership have been recognised in a range of awards, including the Royal Pharmaceutical Society Science Award and the Scottish Universities Life Sciences Alliance Leaders Scheme Award. For more info, please visit www.emergingtechnologieslab.com.

Thomas Hauser is working since June 2023 for C-CUBE as a Sales Director in the EMEA region to educate the market for offsite prefabricated and prequalified turn-key factory and smart module concept in a drive to bring forward the pharmaceutical facility of the future concept.  

In his former work for G-CON and his consulting agency, he has supported companies in the life science segment mainly for expansion strategies, strategical facility implementation, start-up support and pharmaceutical packaging supply and technologies and in questions of manufacturing set-up. 

Before 2020, Thomas worked in various leading global positions in Business Development, Strategic Implementation and Sales in the Pharmaceutical Packaging field, namely in injectables, semi solid and oral solid packaging. He has more than 25 years of experience dealing with the global Lifesciences Industry and their market and manufacturing requirements.  

Thomas holds an International MBA from the University of Ottawa / Canada, and a BA for European Business from the ESB Reutlingen and the ESC Reims. 

Fabian Stutz is the CEO and founder of Pharmabotix, which is committed to revolutionising pharmaceutical production through innovative automation solutions. Their vision is to assist companies in the pharmaceutical sector in automating and robotising their processes, thereby enhancing the quality of their products, maximising efficiency, and reducing costs. They offer a comprehensive range of services, from feasibility studies to concept development and the realisation of turnkey systems.

Sunil has over 17 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors.  

Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.  

Prior to joining Valgenesis, Sunil has had variety of Validation roles as consultant and corporate employee with increased responsibilities within Pharmaceutical and Biologics industry including Catalent, Eisai, Pfizer, Teva and Novartis.