Jean-Pierre Allard's nearly 20 years' experience in vision and electronics and a decade-long focus on the pharmaceutical industry have made him a recognized expert in global serialization. A founding member of the Open Serialization Communication Standard, Mr. Allard is currently Chief Technology Officer for Optel Vision, where his main role is to lead the company's general technological direction. Jean-Pierre Allard holds a bachelor's degree in electrical and electronics engineering from the University of Sherbrooke.
Mr. Shota Arakawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2007 and a Master Degree of Science in 2009 from Osaka University.
Since April 2009 he has been working for Mitsubishi Gas Chemical Company, Inc. and in charge of macromolecular science, especially in synthesis of polymers and material development.
Since 2012 he has joined a development team of oxygen absorbing resins for pharmaceutical containers like a multilayer vial and syringe.
Raphaële Audibert is Category Manager at Nemera in charge of the dermal range of proprietary products.
Raphaële joined the company in 2016. She had previously worked in medical devices at Landanger and Medex (Guerbet) in the development and marketing divisions.
She holds a biomedical engineer degree from ISIFC.
Jean-Marc BOBEE is Director, “Anti-counterfeiting Strategy” at Sanofi, Industrial Affairs. In this capacity, he is in charge of the definition and implementation of the industrial anti-counterfeiting strategy of Sanofi. This includes identification and evaluation of new anti-counterfeiting technologies in the domain of packaging tamper evidence, authentication, coding, traceability and serialization... as well as coordination of the corresponding development projects. Jean-Marc is Doctor of Pharmacy by education and holds a Master Degree in Industrial Pharmacy from Paris University. He has 30 years extensive experience in international products development (galenics, analytics & technology transfer) and management of Industrial Operations interfaces (risk assessment & strategy). Jean-Marc was also the chairman of the EFPIA project on codification and identification of pharmaceuticals in Europe from june 2007 to may 2010.
Master’s degree in Electronic Engineering from the University of Ferrara and MBA degree from Bologna Business School. Mr. Bonati has worked in the last 11 years for international companies in several different businesses, but with roles always related to portfolio management and business development. He is currently Head of Product Management in Ompi, a pharmaceutical glass primary packaging company, responsible for all the business lines related to Ompi’s portfolio, from ampoules to vials, from cartridges to syringes, in bulk and "ready to use" format.
As a pharmacist and after two previous professional experiences : the first in a pharmaceutical firm and the second in the French Authorities, I have almost 20 years of experience in the Leem in the field of pharmaceutical quality. As Pharmaceutical Affairs Director, I have the leadership for responding to enquiries and needs in various domains as quality regulation, bioproduction and biodevelopment regulation, management of the pharmaceutical sites and activities of the responsible pharmacist and thus to fulfil the role of interlocutor between the Pharmaceutical Industry and the National Authorities, and particularly with the inspection of ANSM (the French Medicines Agency) or with the Health Ministery. Otherwise I work every day with sister-Associations.
The Leem is the French pharmaceutical Industry Association and federates more than 95 per cent of companies in France. Its main role is to act as a coordinator between its members to better influence the pharmaceutical environment, in its large expertise field: scientific, legal, economic, industrial, training, communication.
Joel Cotten is heading Aptar Stelmi business development activities in emerging and mature markets.
Aptar Stelmi within Aptar Pharma is a leader in Elastomeric Closure Solutions for the Pharmaceutical Parenteral Packaging. Expertize in: Accute Care, Vaccines, Biologics - PFS, Vials, Cartridges and Customized Devices.
Joel Cotten is an expert in BtoB product management and business development focusing on medical devices, primary containers and self-injection devices.
Graduating as a pharmacist in 1989, Isabelle Debrix oriented her career towards hospital pharmacy. She was appointed Hospital Practitioner in 1995 at Hospital Tenon where she then served as the Pharmacy Department Head from 2009 to 2014. Presently Dr. Debrix manages the Medication Department for the Eastern Parisian Hospital Group including hospitals Saint Antoine, Tenon, Trousseau, Rothschild and Laroche Guyon.
Earning her PhD in 1994, Dr. Debrix pursued studies in medical and biological ethics and focused her research on the medical guidelines and proper use of oncological medicines. Part of this work was the subject of her 2002 post doctoral dissertation. She is the author or co-author of 24 international publications.
Dr. Debrix continues to engage in research and encourages the involvement of her team to evaluate professional pharmacy practices and develop innovative methods.
Her current research topics focus particularly on securing the delivery of medication to patients.
Fran DeGrazio has been in the pharmaceutical packaging industry for over 30 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, prefillable syringe systems and injectable combination products. Throughout her tenure at West, Fran has served in various functions within the analytical laboratory and research and development areas. In 2016, Fran was tasked with developing and leading a new organization for West – an enterprise wide Scientific Affairs and Technical Services organization. This role is focused on assuring West’s scientific industry leadership as the company develops new products and services for the market.
Carole Delauney has 15 years expertise in the field of Contract (Development) Manufacturing Organizations in which she is acting as a highly technically skilled commercial person looking for specific solutions adapted to the outsourcing needs of pharmaceutical and biotechnology companies. She holds a 5 years degree in Biochemistry.
Isabelle Delcroix holds a MSc in Neuropharmacology from Tokyo University. She is Strategy Director at Nemera and she is in charge of parenteral range of proprietary products including Safelia autoinjector and passive safety device Safe’n’Sound for prefilled syringes. Isabelle joined Nemera 8 years ago, previously named Rexam Healthcare Devices, she was Marketing Director for Devices Business Unit. In her previous career she worked for AirLiquide Santé HomeCare Division and as a consultant specialized in the strategy for innovation.
For more than 20 years at SANOFI, David Dronneau, was involved in the IT department in the first electronic submissions of dossier (NDA) and on electronic clinical trials before turning towards setting implementation of innovation process. For 4 years, he joined Clinical Supplies department as responsible Technologies, Innovation, and Process Solutions with a main objective: To develop innovative packaging that meets patient needs in following mainly three directions: Ensuring patient safety, improve usage and how to help improve patient compliance while ensuring continuity of operation in terms of development of solution and processes and finally ensuring the dissemination of business excellence good practices (LEAN) in the unit.
Olivier Feraille has been working with pharmaceutical companies in Europe for over 16 years, delivering Vision and Industrial Identification solutions to help track, trace and improve the production process. More recently, Olivier has become our expert on how Machine Vision can help pharmaceutical companies to achieve serialization compliance. Olivier holds an Executive Master degree from HEC, Paris, and a Master of Science (MSc) from UMIST, Manchester.
Andy is the founder of Cambridge-based Team Consulting, the leading medical product development organisation. Andy is a mechanical engineer by profession, with over 25 years’ experience in medical device development. He has played a leading role in developing Team’s drug delivery business, both in technology development and in development of partner relationships. With a background in materials processing and manufacturing automation, he is committed to transferring best practices from manufacturing industry to the pharma and medical sector. An active member of industry associations including the PDA and Aerosol Society, he is also a UK accredited expert serving on the ISO committee developing standards for parenteral delivery devices.
Graduated from West China Medical University, with a major in pharmacy chemistry.
8 years work experience in pharmaceutical R&D, production, and quality management in a pharmaceutical company.
Since January 2002 has worked for the China National Pharmaceutical Packaging Association, as pharmaceutical packaging Technology and R&D manager.
Dr Pascale Gauthier is Pharmacist (D.Pharm) she got Masters in Biopharmaceutical (‘New gelification method’), a specific Master (DEA) in Pharmacokinetics (‘Pharmacokinetic study on hypertensive drug…’) and PhD in Pharmaceutical Technology (‘Rotogranulation process for manufacture spheres’) form Auvergne University. She is in charge of Marketing and Design courses in the Faculty of Pharmacy of Clermont-Ferrand, and was involved in several patents, international publications and conferences. Her researches were focused on modified release forms, pharmaceutical design & categories of users, digital in health area and she has been invited speaker in various international events (Drug Formulation Strategies, Pharmapack, ADF, PCD, Glatt Technology Training Center) and various judging committees (WorldPack, Pharmapack, CPhI).
Oliver has a degree in Engineering from Cambridge University and works in the field of medical device development. Oliver’s experience has spanned a wide range of development activities, from early theoretical analysis through to production detailing and support. Recently, Oliver was a member of the development team responsible for the successful launch of Sanofi’s Toujeo® SoloStar® pen injector.
Frank Gilsebach joined gradient.Systemintegration GmbH in 2013 after 15 years of experience in the production of pharmaceutical packaging material, development of new and safer packaging material and the responsibility as Quality Manager.
Gabriele has been working for the Pharmaceutical industry for almost 20 years with distinguished performance as a Senior Business Manager. The terms Quality and Continuous Improvement are embedded firmly in his daily-life activities and are an integral part of his work ethic and beliefs.
Lionel Jeannin is an Arts & Métiers ParisTech Engineer with a Master degree in Business Administration from IAE Aix-en-Provence. He has more than 17 years’ experience in the Medical Device and Pharmaceutical industry. He held Project Manager and Development Team Manager positions in the Industrial Engineering, Medical Devices for eye surgery, Parenteral Nutrition and OTC/Rx Pharmaceutical domains. He had the Global responsibility of Packaging Development for OTC Brands like Voltaren, Nicotinell and Fenistil and is currently in charge of Device & Packaging Development projects for new oral medications at Novartis Pharma AG. He is also a member of Novartis Pharma Drug Delivery e-Device / Digital Development network.
Graduated from Loughborough University with a master degree of Polymer Technology. Worked in pharmaceutical packaging industry for 4 years with experience in packaging material R&D, technical and regulation affair support. Now worked in China pharmacopeia Commission and be responsible for pharmaceutical packaging project coordination.
Wendy Johnson studied Biochemistry at the University of Wales, UK, followed by Chartered Institute of Marketing studies. She joined Celanese in 2012, bringing a wealth of experience from her long career in the chemical industry. In her current role within the medical marketing team at Celanese, she searches for the trends and customer requirements in the medical market, supporting product application and development for the next generation of medical materials and services.
- Diploma in Industrial Engineering at RWTH Aachen
- Phd in Strategic Management at University of Duisburg-Essen
- Assistant to the Management Board at Heitkamp & Thumann Group
- Business Development Manager/ Program Manager eMDI at H&T Presspart
Osmo Korri leads Thin Film Electronics’s sales and business development in Europe, the Middle East and Africa (EMEA). At Thinfilm, Osmo has spearheaded collaboration with several pharmaceutical companies that have chosen to use innovation to achieve better outcomes for their patients. Osmo has developed over 20 years of leadership experience in sales, business development, and management consulting in previous positions at Opera Software, Accenture, Deloitte, Ericsson and several start-ups.
Jörg Liedtke, Sales Director for Atlantic Zeisers Software Solutions, is responsible for Brand Protection (BrandTracker) and Track and Trace Solutions (MedTracker). With his senior pharma experience of over 12 years in the field of Pharmaceutical Packaging Security and Track and Trace Solutions, he acts as consultant to the customers, bringing the knowledge into the industry.
Ex Manager in the IT industry, ex General Manager à of the French National Traceability Centre, Jean-Michel Loubry, founder of Elephant Conseil, intervenes in standardization committees and working groups in charge of defining tools to fight against counterfeiting and fake. He supports companies in defining, researching and deployment of solutions to provide the traceability and the protection against the counterfeiting of products.
Anna Malori has a Master degree in Chemistry and Packaging Technology at University of Parma, Italy. She has 10 years of experience in Bormioli Rocco guiding the R&D and Project management Department for Plastic primary packaging. She is currently leading the Business Development Team and she is in charge of promoting new products development and inspire innovation inside the Company.
Background in Electronic Engineering with a master in Biomedical applications and Devices at University of Padua. Alessandro Morandotti has been working in OMPI since 2001 covering different positions: Production Manager, Process Development Manager, Special Projects Leader and he is now leading the Technical & Quality Assurance Front End organization.
Project engineer for serialisation, tamper verification and anti-counterfeiting of pharma packaging
20 years experience in pharma packaging
Convenor of CEN/TC 261/SC 5/WG 12 “Marking – leading the development of EN ISO 17351 “Braille on packaging for medicinal products” and EN 16679 “Tamper verification features for medicinal product packaging”
Chairman of the packaging standards committee NAVp at the German Standards Institute DIN
David Nazzaro, Manager, Pharma Drug Delivery Engineering at Insulet Corporation, is responsible for leading innovative medical device design efforts for Insulet’s Delivery Systems Group. With over 10 years of medical device design and manufacturing experience, David also has three issued US patents and 22 patents pending. Prior to joining Insulet, David led efforts in the mechanical designs of the Apple Watch and the Ivenix IV Smart Pump. He holds his Bachelors of Science in Mechanical Engineering from the University of Massachusetts, Lowell.
Funso Olufade has over 15 years of bio-pharmaceuticals and consumer package goods (CPG) international experience. He has worked in functions of corporate controlling, marketing, strategic planning and business development. At Daiichi Sankyo, Funso leads the cross-functional decision-making across Europe for the technical development, regulatory submissions and readiness for end of lifecycle management programs and generic defense strategy across 12 EU countries.
Prior to joining Daiichi, he has worked mainly in the US with Sanofi, Bayer Healthcare and the Coca Cola Bottling Company.
Funso holds an MBA – Finance from Fairleigh Dickinson University (USA).
Anne-Catherine is dual qualified as both a pharmacist and a lawyer, specialising in pharmaceutical issues. She has in particular significant expertise on regulatory matters such as clinical trials, marketing authorisation, pricing and reimbursement, advertising. She also assists pharmaceutical companies in product liability cases, contractual or litigation arising from unfair competition. She also has experience in regulatory issues related to medical devices and food supplements. Anne-Catherine is a Senior Lecturer (professeur agrégé des universités) in pharmaceutical law at the University of Lille and directs a Masters degree in regulatory affairs.
She is the author of La responsabilité du fait des médicaments. L'industrie pharmaceutique face à la loi du 19 mai 1998 (Medicinal Product Liability : the pharmaceutical industry and the law of 19 May 1998) and frequently publishes articles in national and international legal reviews on various subjects such as pharmaceutical liability, patients’ rights, clinical trials, pharmaceutical regulation, pricing, legal issues resulting from biotechnologies and the use of digital media. In December 2012 Anne-Catherine was awarded the French National Order of Pharmacists prize for her research into the liabilities of the pharmaceutical industry.
Tommy Persson is engineer in plastics from Helsingoer Teknikum, Denmark. He has many years experience with development and production of medical devices and primary packaging in plastics from his work as Product Development Engineer at Unomedical A/S, as well as Applications Development Engineer at Hoecht AG and Ticona GmbH, where he was a important part of the team developing the Ticona Medical Technology product range. As Project Manager at Gerresheimer Plastic Packaging, the main focus is on product- and process development.
A professional in the area of combination products such as auto injectors, pen injectors, and wearable injection systems, Mr. Kaufman has over 15 years’ experience working with biopharma companies to bring such devices to market. He is an active member of industry associations and is a frequent presenter and author on the topic of self-injection devices. He has a biopharmaceutical background, has worked for two leading device suppliers and has broad experience in the design, development, manufacturing, testing and final assembly of devices.
A member of the scientific community for 10 years, Jeffrey Reid earned his chemistry degree from the University of Delaware and his M.B.A from Goldey-Beacom College. Currently Jeffrey works at WHEATON® Industries as a Global Market Manager where his main focus is finding solutions for customers in the pharmaceutical industry.
Mathias Romacker is Senior Director, Device Strategy at Pfizer HQ in New York City. He joined Pfizer in March 2015. In this role within Pfizer Global Supply he focuses on the front end of device technology. He works with multiple functions and sites across the organization to develop a device strategy for Pfizer pipeline and inline products.
Previously Mathias worked over 9 years in the device area for Amgen in Thousand Oaks, California.
Before joining Amgen he held multiple sales and marketing positions with Becton Dickinson and Gerresheimer in Germany, South Africa and New Jersey.
Mathias holds a masters equivalent degree in economics from the University of Freiburg/Germany
Martin Schlaeppi has over thirty years’ experience in marketing development & market research His industry experience includes the International Marketing Development team at GSK where he worked with the respiratory & anti-infective portfolios. In 1996 Martin formed Praxis Research & Consulting offering services to the healthcare industry prior to setting up Greensand.
Helmut Schneider has been working for Atlantic Zeiser since 2013 as product group manager for pharma packaging and serialization. He is engaged in marketing and further development of solutions for this application area. Among his specific area of expertise is carton and label serialization and serialization data bases and late stage printing on blister lid foil, carton and label. He has prior experience as product manager and project manager dealing with deep insight with product individualization and has published articles in professional journals.
Craig Scott was born & brought up in Hong Kong before moving to the UK. His constant sense of being an outsider has served him well in his twenty plus year career in market research and insight. Craig held Insight leadership roles at Kimberly-Clark and Johnson & Johnson. Craig was appointed the European Head of Research for Pfizer prior to setting up Greensand.
Mr. Dana Shears has over 25 years’ experience within the Pharmaceutical Drug Delivery industry. He has spent the past 11 years with H&T Presspart, part of the Heitkamp and Thumann Group, currently as the Sales and Business Development Director for the Americas region. He is also responsible for commercial activities for the eMDI platform technology. Prior to joining Presspart, Mr. Shears held business development and marketing positions with Bespak, Allied Signal, Honeywell, AAI Pharma and Nypro Healthcare. Mr. Shears received his B.S. Degree in Engineering from West Virginia University in 1981.
Tony has a First Class honours degree in Electrical and Electronic Engineering and has been designing and developing electronic devices and instruments for over 30 years. The first commercial product he designed remained in production, virtually unchanged, for more than 18 years. Some of the “firsts” he developed include a WYSIWYG typesetting system written in assembler on an Apple IIe derivative, a nautical Decca Navigator tracking system used by the Swedish navy to track Soviet submarines during the cold war, a Heat Flux data logger that (amongst other things) helps ensure your Shredded Wheat is baked to perfection and, his personal favourite, an electronic beer dispense quality monitoring device! For the last 5 years Tony has been managing medical and scientific sector projects at DCA.
Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn Germany. After finishing his awarded PhD doctoral thesis in inorganic Chemistry at the Universities of Bonn Germany and the Fredericton New Brunswick in Canada he worked as a post-doc at the Department of Chemistry at the Technical University of Dresden. After that period he transferred as the Head of R&D of the green high temperature resistant inorganic fiber manufacturer at belchem, responsible for R&D management, product development and ramp up. Ten years ago he joined SCHOTT as a scientific Consultant for technical and pharmaceutical tubing applications. In the years 2010 to 2012 he was located in Shanghai responsible for Scientific Consulting, Business Development and B&I activities in Asia. Since 2012 he is leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills he is working world wide as a “missing link” between customers and local R&D units, focusing on future customer needs and presents frequently on international conferences on subjects related to special glass for technical and pharmaceutical applications.
Packaging Engineer graduated from former-ESIEC (now ESIREIMS), Packing and Packaging Engineer School from Reims, Arnaud Steiner evolves in this world of packaging since its beginnings. After 5 years in pharmaceutical industry for human health at AstraZeneca, on sites of Reims and Dunkerque, and 10 years in the food industry at Hochland near Verdun, it is now in pharmaceutical industry for animal health at Virbac, that he is head of primary packaging development in the corporate R&D department, for the 8th veterinary company worldwide.
Heidi Vanheerswynghels carries responsibility for all medical and pharmaceutical business within Videojet EMEA with the support of the dedicated pharma team bringing more than 10 years’ experience in the medical and pharmaceutical packaging industry having held various roles as Global Strategic Account Manager Pharma and Key Account Manager Healthcare in addition to speaking four languages fluently (Dutch, English, French and German) and has a basic knowledge of Italian.
Ludwig Weibel, CEO of Weibel CDS AG, MSc in biotechnology. After several years of experience in the biotech industry he joined a specialised pharmaceutical company where he was first leading the quality control department and later building up the life cycle management. With this experience and a great network of development and production partners, Ludwig Weibel founded Weibel CDS AG in September 2010. Since then the company successfully developed their SuperCapSyringe® as well as the Reconstyringe® and DrugDeliverySystems.
Bill Welch has over 25 years of contract design, development, and manufacturing experience, primarily serving customers in the drug delivery, medtech, and diagnostics markets. In his current capacity as CTO at Phillips-Medisize, he leads a global, 500+ person development, engineering, tooling, program management, and validation organization with more than 75 concurrent programs. Welch has been with Phillips-Medisize since 2002.
Valerie Wentzky received her pharmacist diploma in 2013 from Ruprecht Karls University of Heidelberg, Germany. She worked - and is still working - in a community pharmacy until she joined the Pharmaceutical Care Research Group as PhD candidate in July 2015 with focus on “electronic monitoring of adherence to polypharmacy in primary care”. She achieved the ‘Certificate of Clinical Pharmacy’ from University of Tübingen and takes part in a trainee program on clinical pharmacy.
Simon has spent almost 25 years developing a wide range of products since graduating from Southbank University in London with a degree in Engineering Product Design. Simon has worked in the development of consumer goods, hand held computers, mobile communications devices and mobile communications infra-structure products as well as a period of just under three years at a major London design consultancy before joining Pfizer’s Device Centre of Excellence, DCoE in 2007.
Whilst working for Pfizer Simon has managed complex parenteral device development projects right through from initial concept development to clinical trials and the scale up beyond. Being well-known within DCoE as technology enthusiast and early adopter, Simon was tasked with managing one of the first connected device development projects that DCoE were asked to undertake it in 2014. Simon is now working on a number of ‘connected’ projects, helping other groups within Pfizer understand the complexities of developing products of this nature.
Graduated from Medical University. Worked for government as public health management about 10 years. Over 10 years experience on secondary pharmaceutical packaging industry. Organized and got involved standardization, policy study projects, foreign exchange, technical seminar after join CNPPA from 2010.