A WORLD-CLASS LINE-UP

Frank is a product and business model innovator, with a track record of developing and launching medical devices and therapies.

In 2011 he lead an Artificial Intelligence project at the world´s largest dialysis provider, resulting in a clinical decision support system. The success of this machine learning algorithm was based on the abundance of patient data available in dialysis.

Ever since Frank focused on collecting data at the point of care to enable development of the right therapies, for the right patient at the right time.

He holds a BSc from TH Nuremberg and an MBA from University of Cambridge.

Federico is a R&D Senior Engineer. He’s well skilled in product development process and design control in medical devices area. Previously to Roncadelle Operations, Federico was part of Peripheral division of Cardiovascular Group in Medtronic. He worked initially Design assurance engineer and then as senior R&D engineer, in which he worked as a tech lead in Product Development Project for medical device. Federico has a Master’s Degree in Biomedical Engineering.

Felix Georg Müller is CEO and Co-founder of plus10 GmbH, which he founded in 2019 together with Pablo Mayer and Thomas Hilzbrich as a high-tech spin-off of Fraunhofer IPA (Fraunhofer is Europe’s largest applied research association with more than 72 institutes) . plus10 delivers and implements AI-based continuously learning software tools for the automated optimization of complex production lines and machines. At Fraunhofer, Felix Georg Müller developed new methods for production optimization, patented and tested them. At the same time, he built up a Fraunhofer research group for autonomous production optimization. His expertise covers in particular data-driven methods for production optimization as well as AI and machine learning particularly on the basis of machine controller data and production data.

Gareth is the founder of PACIFI Ltd. - PACkaging IF I, could influence your intelligent and sustainable design decisions...
An engineers soul, a commercial mindset and a marketeers heart, inform and motivate his solutions to fulfilling challenging healthcare market needs.
DuoVIAL® and amPOD are at the forefront of his innovative new packaging platform.

Gautam Shetty is the founder and CEO of Congruence Medical Solutions, LLC and is based in Baltimore Maryland USA. Congruence Medical Solutions, is involved in design, development and supply of innovative device solutions for applications involving injection of microliter volumes, maximizing flexibility for injections and minimizing drug waste.

Prior to Congruence Medical Solutions, Gautam was responsible for all operations of the Novel Drug Delivery Systems business unit at Unilife Corporation, where he pioneered development of ophthalmic drug delivery devices, targeted organ delivery systems and other novel drug delivery devices. Prior to that, Gautam was with Becton Dickinson & Co. (BD) where he held roles involving R&D, Strategic Marketing, Commercialization Planning and M&A. Gautam holds a PhD in Biomedical Engineering from Case Western Reserve University. He has authored several patents in the injectable drug delivery device space covering ocular drug delivery systems, novel delivery systems, pen injectors and patch pumps.

Currently as a postdoctoral research fellow, Giana works on a project entitled “Patient-centered pharmaceutical packaging design for enhanced life quality of older people”, sponsored by the Kamprad Family Foundation. The on-going project investigates the challenges faced by older patients that need to manage their treatment, and that handle a variety of different medication packages every day. The project aims to contribute to the change from product-oriented to patient-oriented design processes for packaging in the pharmaceutical industry. The expected results from the project are to contribute knowledge about how future pharmaceutical packaging can best be adapted to older patients. With this knowledge, this research plans to inspire companies to change their design processes so that they consider the end-user perspective from early stages of packaging development. Consequently, we can have medication packaging that is designed with a greater understanding of patient’s needs.

Guillaume is an entrepreneur and convinced scientist, acting as Innovation Leader for BD since 2017, focusing on problem solving, need understanding and technology and solution enablement, mainly for pre-filled drug containers. Guillaume holds a MBA and Master of Engineering from Grenoble-Alpes University and a PhD thesis in Micro and Nanotechnology from University Paris-Saclay. Guillaume is also co-founder of PhDTalent, a start-up facilitating collaboration between scientists and industrials to accelerate innovation.

Hervé Michel is based at Däniken Switzerland and is Director of Radiation Technology EMEA-APAC at STERIS AST since 2013. He is responsible for EMEA-APAC of STERIS Radiation Technology Team who is in charge of supporting radiation processing, facility qualification, dosimetry system, Customer process validation for Gamma, Electron Beam and X-Ray technologies.
Prior to working for STERIS AST, he participated for 10 years in development of dosimetry system and perform research and development for radiation processing for Aérial in Strasbourg - France.

Hervé has more than 25 years of experience in all aspect of radiation processing industry including dosimetry system qualification (GAMP 5), development and qualification (IQ/OQ) of all 3 radiation technologies (Gamma, X-ray and Electron Beam), Sterilization and maximal dose qualification, Performance Qualification.

Hervé represents actively Switzerland in ISO/TC85 WG3 and ISO/TC198 WG2 for developing ISO 11137 standards. He is a also member of ASTM since 1998, chairman of Gamma 51702 and X-Ray 51608 standard and participate actively in different other working group.

Hervé is graduated in Bachelor of Science in Physics at the University Louis Pasteur - Strasbourg - France

Irving Paz Chagoya is Covestro´s Healthcare Segment Manager for EMEA. In this role he oversees the Industrial Marketing Strategy in the EMEA Healthcare plastics Industry for Covestro Polycarbonate Materials. Irving has more than 10 years of international experience in the Healthcare Industry, serving in various roles for fortune 500 companies in technical marketing, business development and strategic management roles. Irving earned his MSc degree from the University of Warwick, United Kingdom.

Graduated from Michigan State University with a mechanical engineering degree. Started with Covestro in 2013 having the opportunity to rotate through various business units with Covestro (then Bayer MaterialScience). Moved to application development within Engineering Plastics in 2014. Current role is a senior application development engineer focusing on the Healthcare industry providing engineering technical support to customers.

Watch her video!

With different job positions in R&D, Sales, managing business units in many fields like automotive, industry, aeronautics ,sport and Leisure and Heath, Jean-Jacques Legat is today the Innovation and Technical director for the french competitiveness cluster Polymeris fully dedicated to polymers, composites and rubbers.
we aim to help our members to innovate and anticipate the trends of circular economy and industry of the future

Juha Mattila is Director, Sterilization Technologies, responsible for the STERIS Life Sciences Finland portfolio, including steam and VHP sterilization and biodecontamination technologies, and WFI and Pure Steam generation systems. He has Bachelor of Science with Honors in HVAC and process engineering, and Master of Engineering in Business Informatics.
He has nearly 22 years of experience with pharmaceutical and research technologies, including R&D, engineering and product management and total of technology and engineering experience exceeding 25 years. He is an active member of PDA, ISPE and Finnish Biosafety Network and subject matter expert in relative international standard work groups, representing Finland.

High dose biologic formulations are pushing drug volume and viscosity beyond traditional self-injection design space limits (> 15 cP, > 1 ml dose volume), which can challenge patients’ capabilities to administer their injections based on injection time or force.12 We will discuss how ergonomic, manual, syringe-based injections can enable subcutaneous self-injections with characteristics that go beyond the traditional boundaries of volume and viscosity. Important factors for development of combination products involving delivery of higher volumes (1-2 mL) are presented, including assembly, human factors, documentation, and platform considerations.

Katsuyuki Takeuchi is an Associate Product Manager at Terumo Pharmaceutical Solutions.
With extensive knowledge in pharmaceutical science, he has worked in research and development of injectable drug products such as IV solution bags and prefilled syringes, and contributed to launch various products into the market.
Utilizing his experience, Mr. Takeuchi currently has product management responsibilities for the polymer-based prefillable syringes platform.

Kevin is the Director of Radiation Physics and holds corporate responsibility for measurement and calculation of absorbed dose associated with the radiation treatment of product, such as sterilization of health care instruments. Over his 30-year career, Kevin has been published many times. He has experience in radiation physics and radiation dosimetry within a highly technical industry. He is actively involved in numerous industry committees, task forces, and working groups. As a working group member, Kevin represents Canada on ISO TC 198 WG2 Radiation Sterilization. He is also a member of the AAMI Sterilization Standards Committee, WG2 – Radiation Sterilization and ASTM Subcommittee E61 Dosimetry for Radiation Processing, and is Chair or Co-chair of ISO/ASTM 51707 Estimating Uncertainties, 51275 Radiochromic Film, E2232 Mathematical Methods. Kevin is a former President/VP, Radiation Process Simulation and Modelling User Group (2002 – 2010). Education: BSc Honours Physics, University of Western Ontario (London)

Laurent is an expert on Automatic Identification and Data Capture, and Security at AFNOR, member of ISO. He is involved in several Working Groups at GS1. He is co-founder of XTAG, an innovative software solution to connect patients through objects, using optical identification systems. XTAG was awarded best project by HEC Challenge+ in 2020.

Lise WAGNER, accessibility specialist and user expert t at OKEENEA. Okeenea is a France-based worldwide leader in smart and inclusive solutions that make cities more accessible for people with disabilities. As Accessibility Specialist and User Expert, Lise ensures that solutions meet the needs of end users and regulatory compliance standards regarding accessibility. She is responsible for sharing knowledge and best practice about building barrier-free environments through articles, conferences, workshops, and involvement in standardization committees.

• 3 years of medical packaging experience
• Degree in sustainable engineering
• Honors in medical device innovation
  

Lionel Jeannin is an Arts & Métiers ParisTech Engineer with a Master degree in Business Administration from IAE Aix-Marseille Graduate School of Management.
He earned certificates in Biochemistry and Biology respectively from Harvard University and the Massachusetts Institute of Technology.

He has more than 22 years’ experience in the Medical Device and Pharmaceutical industry and has worked as a Project and Development Team Manager in the Industrial Engineering, Ophthalmic surgery Medical Devices, Parenteral Nutrition and OTC/Rx Pharmaceutical development domains.

He is currently heading the Oral Packaging and Delivery Systems Group in the Global Device and Packaging Development department of Novartis Pharma Technical Research and Development division.

OKEENEA is a France-based worldwide leader in smart and inclusive solutions that make cities more accessible for people with disabilities. As Accessibility Specialist and User Expert, Lise ensures that solutions meet the needs of end users and regulatory compliance standards regarding accessibility. She is responsible for sharing knowledge and best practice about building barrier-free environments through articles, conferences, workshops, and involvement in standardization committees.

Marie-Liesse Le Corfec leads global portfolio marketing for pre-fillable pharmaceutical systems at BD. Trained in Business Management at Kedge Business School and Aston University, and in Health Economics and Policy at the London School of Economics, Marie-Liesse has accumulated over 25 years of experience in the pharmaceutical and vaccine industry where she held varied marketing or market access roles at national, regional or global levels. Before joining BD, she specialized in launching new vaccines and drugs, and successfully expanding the use of in-market brands in diverse therapeutic areas. In companies such as Sanofi, Merck, Novartis or Takeda, she played a pivotal role in 7 major global launches of vaccines or medicines.

Mark Tunkel is Global Category Director for Insight Innovation at Nemera. With more than 20 years of global business development experience and a deep understanding of the marketplace challenges and trends impacting the pharmaceutical industry, Mr Tunkel has advised many of the world’s leading companies on their product development and innovation strategies, with an emphasis on driving realisation and the most favourable business outcomes.

Dr. Matthew Hall is principal technical affairs manager for Corning Pharmaceutical Technologies. He was previously an associate professor of Biomaterials & Glass Science and director of the Center for Advanced Ceramic Technology at Alfred University. Dr. Hall holds an MS and PhD in Glass Science from Alfred University and an MBA degree from the Simon School of Business at the University of Rochester.

Miles Kottman is Business Development Director at Bespak by Recipharm with more than 25 years’ experience in the medical device industry. Previously, Miles managed device, development, and industrialisation programmes, as well as heading up Bespak’s programme management function and new product introduction process. As part of his current role, Miles’ business development responsibilities are focused in the respiratory sector as well as providing commercial oversight for Bespak by Recipharm's proprietary respiratory device portfolio.

Miodrag Mitic is the Senior Global Marketing Portfolio Consultant at BD responsible for traceability projects. He has over 20 years of experience in managing digital startups, software solution providers, supply chain solutions & standards, and food safety & sustainability standards and certification schemes.

Miodrag is a former advisor to the European Commission on product traceability. He was an ISO, UN & CEN standards committees member, and member of a management team awarded the 2009 Tech Pioneer title by the World Economic Forum. He was the convenor and inaugural chair of GS1 Healthcare.

Prior to BD, Miodrag held the positions of MD at the European Traceability Institute, Supply Chain Standards Director at MSC, Head of Traceability Solutions at GLOBALG.A.P., MD Farmforce at Syngenta, VP of Trace Register, China Trace and Trace Tracker, General Manager Industry & Government Engagement and Solutions at GS1, and Business Development Group Manager at EAN International.

Connect with him on LinkedIn: www.linkedin.com/in/miodragm

Natasha Bolick is an Associate Director in the Translational & Clinical Sciences Center of Excellence at BD Technologies & Innovation (RTP, North Carolina, USA). She has 20 years’ experience in the medical device industry including R&D, Product Development, Translational Science, Clinical Research, and Management. Natasha has multiple patents and publications in research areas from implantable sensors to drug delivery. She holds Bachelor’s and Master’s degrees in Biomedical Engineering, a MBA, and a Project Management Professional Certification. At BD, she leads a team developing parenteral drug delivery technologies with emphasis on translational research through preclinical and clinical implementation.

Nathalie graduated with a PhD. in Pharmacy from the University of Paris V, France.

She completed her business background at HEC in Geneva, Switzerland with degrees in Human Resources management, and in Board effectiveness in international companies from St Gall university.

She started her career 30 years ago in a pharmaceutical multinational company. After spending the first part of her career in QA and Technical Operations at site and headquarter level, she has founded Nad Consulting, company active in improving Manufacturing and Distribution Operations efficiency and compliance of companies in Life sciences in EMEA. Since June 2019, Nathalie has been working on a digital solution Dose For Patient (D4P) based on the traceability of medicinal unit doses from manufacture to patients delivery in order to improve adherence to treatment. Nathalie’s expertise:
 Coaching and/or leading project teams involved in Product Supply and Track & Trace projects
 Assistance in designing and implementing Contract Manufacturing processes, from Request For Proposal (RFP) to first batch manufacture
 QA compliance to international new regulations (cGMDP; traceability), with assistance in designing QMS; training in GMDP, compliance Project Management in Supply Chain and Technical Operations

Nathalie has been teaching in several Universities in Switzerland, France and Lebanon, and a regular speaker at various seminars organized by professional associations such as A3P, SAQ, SFSTP and ISPE.
Since 2011, she has been working with GS1 France in promoting the use of international standards in the Healthcare Supply Chain in order to reduce the risk of medical errors and falsification, and member of the ISPE committee for the management of workshops about the Falsified Medicines Directive (FMD) implementation.
Since 2017, she has been GRIP Pharma (Groupement Romand de l’Industrie Pharmaceutique) Board Member.

Noel Gibbons BSc (Hons) is the Technical Advisor for Medical Device and Pharmaceutical packaging within STERIS AST. Has significant experience in a wide variety of areas from manufacturing, process validation, package testing, packaging process validation, package integrity testing, quality and international test standards. He has significant practical experience in medical device packaging at all levels, including evaluation of proposed packaging and current packaging designs and related validation documentation.

Noel has presented nationally and internationally on Medical Device and Pharmaceutical package testing.

Click here to access his LinkedIn profile

Bio available soon

Check his LinkedIn profile: here

Riccardo Morsiani got a Master’s Degree in Mechanical Engineering in 2007 and started his career in SACMI Imola as a machine designer. During the following years, he specialized on several technical matters and gained a Ph.D title in 2012 after Doctoral Degree. In 2014, Riccardo started new position as Competitor Analyst and, in 2017, he was appointed Competitor Analysis Manager. Meantime, in 2016, he got an Executive Master in Technology and Innovation Management at Bologna Business School. In March 2018, Riccardo started a new role as Sales Area Manager for Containers Business Unit. Later, in July 2020, he has been appointed also as Sales Area Manager for Russia and CIS countries on all products of Rigid Packaging Division.

I graduated in Agronomy Engineering at Montpellier SupAgro. I started my career in the food industry, working in Environmental Services.

I joined Adelphe in July 2020 as a Key Account Manager. My mission is to support companies, mainly in the pharmaceutical sector, around 3 main themes: simplification of administrative procedures, eco-design of packaging and support for companies in their CSR strategy.

Sagar Bejalwar is a Senior Portfolio Manager at BD Medical – Pharmaceutical Systems, wherein his responsibilities include developing prefillable syringe solutions that most closely address drug manufacturer and clinician needs. Mr Bejalwar holds an MBA and a Bachelor’s degree in Electrical Engineering.

Serkan Oray leads the “Devices, Packaging, and Wearable Technologies” team at UCB Pharma and is based in Belgium. Over his career he has progressed through diverse functions, including medical affairs, commercial, strategy, and technical operations. Over the past seven years, Serkan has led the devices team whose members have successfully developed, industrialised, and launched several drug delivery devices, including those supporting certolizumab pegol. Beyond drug delivery devices, his role also covers all primary and secondary packaging as well as transversal support across UCB for innovative new biosensor technologies. Serkan is passionate about developing his team and providing an environment to drive excellence and deliver patient value.

Séverine Duband is Marketing Director for drug delivery Devices at Nemera, steering overall category strategy, product portfolio and innovation development for five key delivery routes. She has been leading the parenteral segment at Nemera since 2018, focusing on proprietary products such as safety systems, pen injectors and on-body injectors. Ms Duband graduated from Emlyon Business School (Lyon, France) in 2004, and joined Nemera’s Global Marketing team in 2018 as a Global Category Manager, focusing on the parenteral segment.

Steven Meun, Sr. Managing Consultant with Antea Group, and director HPRC Europe, is a sustainability consultant with a background in chemical engineering, plastics, and technical fibers. He is able to link the business value of sustainability with technical and organisational solutions. Steven has international working experience, worked, and lived in the USA for 3 years and has managed various sustainability projects all over the world. He currently is living in the Netherlands and leading the sustainability consulting team within Antea Netherlands.

Sylvine Raverdy-Wilson received her Ph.D in cellular and Molecular Biology from Strasbourg University and received her master in Biotechnology from the Ecole Superieure de Biotechnologie de Strasbourg. She is currently the BD Evolve™ On-body Injector Clinical and Human factor engineer at BD. Her prior work was related to development and clinical evaluation of blood collection devices, immune system evasion by pathogens and drug target discovery for parasitic diseases.

• In 2019 Tom formed NV Sustainability LLC, a consulting organization to advise companies, financial institutions, and non-profit organizations to create leading sustainability programs.
• Tom is also an adjunct professor teaching “Enterprise Sustainability” to Clarkson University graduate students pursuing a Master of Science in Engineering Management.
• Previously, Tom spent more than 30 years at Pfizer leading various global environmental, health and safety (EHS) programs. In 2010 he was appointed to champion Pfizer's Environmental Sustainability program. Tom led efforts to reduce Pfizer’s environmental impacts throughout the product life cycle – from research, to procurement, to manufacturing, to product disposal.
• Tom earned a master's degree from the Harvard School of Public Health and a bachelor’s in Biochemistry from Brandeis University.

• 10+ years of medical packaging experience​
• Experience in material development
• Degree in Polymer Science​
• PhDin Polymer Engineering
  

Click here to access his LinkedIn profile

Wendy D Woodley is a Staff Scientist II for the Translational and Clinical Sciences Center of Excellence at BD Technologies and Innovation (BDTI). She is a published author and inventor with 21 years of R&D and Product Development experience in the medical device industry with a focus on innovation in drug delivery devices and diagnostics. She received multiple degrees (BS microbiology, BS zoology, BA English, BA history) from North Carolina State University. Her current work at BDTI focuses on drug delivery innovations with a concentration in preclinical model development, clinical testing and translation of new ideas to product development.

Wenzel studied biology, did his PhD in physics at the Max-Planck-Institute for Neurochemistry in Munich.

As head of laboratory in a Swiss biotech-company, he worked on Keratinocytes.

In charge of project management and as head of production for presterilzed syringes, he designed the manufacturing area and operated the production start-up phase.

He took role as Chief-Innovation-Officer at a pharmaceutical equipment supplier. Two years in USA, he developed the market for cell- and gene therapy equipment.

In 2018, he returned to the same primary packaging manufacturer, left 13 years ago in a new global senior role for business development.

Yasemin is a Consultant in the European Thought Leadership team based in IQVIA’s London office. Her primary areas of focus are; trends in innovative launches, drug delivery and formulations as well as the oncology market with an emphasis on commercial trends. She has presented and moderated panels on these subjects in a variety of conferences. Yasemin holds a Masters in Cancer Research and a Bachelor of Science degree in Biomedical Sciences both from Newcastle University. Prior to her role in Thought Leadership, Yasemin was part of the Real-World Insights – Global Oncology team where she worked on the co-ordination and set-up of reports focusing on various cancers.

Ziv has over 15 years of experience in leading positions in Business Development, Product Management, Marketing, and R&D in a variety of industries. Prior to joining DALI, he worked in both startups and global corporations, such as Dip-Tech (acquired by Ferro), Siemens, and Radwin.

Ziv holds a BSc in Mechanical Engineering from Ben-Gurion University. He also received an MBA from the Interdisciplinary Center.