Born 1976 and schooled in the city of Braunschweig, Germany. Completed his higher level school qualifications in 1995. Shortly after this he completed his conscription from 1995 to 1996. In 1996 till 2000 he studied business at the University of Göttingen. Secured a management position with ALDI from 2001 to 2003. He joined ivm-childsafe (ivm Institut VerpackungsMarktforschung) in 2003 as head of testing. Meanwhile he also completed his doctorate with the University of Göttingen in 2005. In 2006 he became the managing director of IVM.
Mrs. Susanne Backer is Project Manager for the 'Circular Economy' Project at Aarhus University Hospital in the Central Region of Denmark. Aarhus University Hospital employs approx. 10,000 people and conducted more than 100,000 surgeries in 2015. The Circular Economy Project focuses on how to improve the quality of recycling of plastic packaging from the hospital, through innovation and dialogue with all parties in the value chain. Mrs. Susanne Backer holds a M.Sc. in Modern Business Administration from Copenhagen Business School, Denmark.
As head of drug delivery, Uri has lead a variety of design projects including an award winning needle safety device, an emergency auto-injector, pen injectors packaging design for delivery devices and inhalation products.
Uri is an advocate of User centred design approach, specifically jobs to be done which guides the CDP design mentality for both devices and packaging.
Antoine is the CEO and co-founder of Early Metrics, the pan-european rating agency for start-ups and innovative SMEs, analysing non-financial metrics. Antoine is a frequent commentator on economic and strategic topics related to innovation, such as start-up/corporate relations, start-up valuation and international growth. A keynote speaker at VivaTech, Ignite 2016 and Bernardins College, he was featured in the Financial Times, Business Insider, TF1, BFM TV, Les Echos.
Antoine holds a MSc in Life Sciences from AgroParisTech, France’ leading Institute of Life Sciences. Currently living in the UK after many years in France, Italy and Spain, Antoine is a polyglot, and an avid rugby player.
Yanik Beaulieu has been with Optel for a total of 8 years, holding various positions in project management, PMO supervision, solution design and, more recently, product line management. Through this valuable experience, he has gained in-depth knowledge of the pharmaceutical industry and customer needs, as his roles have combined the technical aspect, implementation, as well as the business aspect, allowing him to provide excellent insight into the serialization process. Yanik Beaulieu holds a college diploma in Electrical Engineering Technology as well as PMP certification.
Simon Bellamy has worked for over 30 years in the Pharma/Healthcare market primarily in variety of technical, business development and marketing roles. A Chemist by training, he has worked in the Pharmaceutical processing, formulation development and medical device markets across the world including Japan, India and China. For the last 9 years, he has worked in business development within some of the leading Contract Development & Manufacturing Organisations (CDMOs) with experience in Solid oral dosage form, Antibody Drug Conjugates (ADC) coupling and Sterile technologies. A fluent French speaker having lived in France for 5 years previously.
David Braun is Global Head of Medical Device Business Solution for Merck Healthcare. David is an executive leader that has 20 years of experience in research and development, operations, strategy and business management working in Europe, USA and Asia, in startups and large multinational companies. Through his career David gained significant experience designing winning organizations, leading and coaching cross functional teams bringing innovative products from ideation to launch. David is actually a Board director of Cellect, a biotech startup active in the field of stem cells and medical devices.
Before joining Merck, David served as Head of Operations and Global R&D of the Technology Business unit at Newell Brands, a Fortune 500 company, where he led key growth initiatives and multimillion dollar projects.
Prior to that, he worked as Vice President of R&D and Operations at Biosafe SA a medical device company recently acquired by GE, developing and launching products in the field of stem cell banking and cellular therapies. Previously, David also held various senior management and engineering roles in the aerospace and high tech industry.
David holds a Master degree in applied physics from the Louis Pasteur University and a Degree in Electro-Optical Engineering from the Jerusalem College of Technology. He has participated in Executive leadership and general management programs at the Harvard Business School and IMD.
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.
Andrew leads the development of Portal's disposable system. Previously, Andrew was the first engineering hire at Fractyl, a surgical startup that he saw through first-in-human clinical testing. Prior to Fractyl, Andrew was at Cambridge Consultants where he developed drug delivery products for clients ranging from startups to large pharmaceutical companies. Andrew has a BS in Mechanical Engineering from F.W.Olin College of Engineering.
Dr Cole gained his PhD in Solid State Physics of Giant Magnetoresitive Materials grown by Molecular Beam Epitaxy at the University of Leeds in 2004. He then went on to work for Narec, the UK’s National Renewable Energy Centre in the Photovoltaics division where he initially worked as a Process Technologist and later a Business Development Manager. During this time, Dr Cole was part of the team responsible for a world record in photovoltaic conversion efficiency for multicrystalline solar cells. Subsequently, when faced with a change in government priorities and a reduction in funding for Photovoltaics, Dr Cole led a process of inward investment from a Swedish Greentech company leading in the separation of the Narec photovoltaics division into a separate company, Narec Solar. Dr Cole was appointed Managing Director of this company. Dr Cole then went on to work as Chief Scientist at PolyPhotonix, leading a team of 5 scientists to develop organic light emitting technology for sight saving retinal treatments. At the start of 2017, Dr Cole moved to CPI and is working within the Strategic Marketing team within the remit of printable electronics for smart supply chains and smart pharmaceutical packaging. He is currently leading an initiative to understand the capability requirements for a UK based centre of excellence in smart pharma packaging.
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.
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.
Alphons Fakler is heading the Medical Device Risk Management group in Biologics Technical Development and Manufacturing at Novartis Pharma in Basel. He holds a degree as pharmacist from Ludwig-Maximilian-University Munich where he graduated in 1993. He joined Novartis in 2012 as a Senior Packaging Expert coming from SCHOTT Pharmaceutical Packaging where he served in several functions at last as Head of Product and Process Development Sterile Products. For almost 20 years, he is working in the development of products and devices for pharmaceutical and biotech applications.
Nicolas Fieulaine is Professor of Social Psychology at the Institute of Psychology at the University of Lyon, France, and researcher at the Social psychology Research Group and at the Excellence Lab on Urban Worlds. He earned his BA, MA, and PhD from Aix-Marseille University. He was awarded with several research grants for applied studies, and is the program director of the Master of Applied Social Psychology at the University of Lyon. His research interests deal with how people perceive the world, take decisions, and behave… accordingly or not, using quantitative, qualitative and experimental studies.
Since recently, he took a leave from academia and joined the AplusBe start-up to apply behavioral science to design digital health solutions using packaging as a media channel to engage patients and improve adherence and well-being.
He is particularly interested by our relation to time, and in applying psychology to practical issues through action-research, field experiments, or professional training. As director of Applied Social Psychology Master Program at the University of Lyon, he is exploring how psychological, cognitive and behavioral sciences can be translated in practice, and be helpful in reframing visions and feeding innovation. He is currently working to implement social psychology in massive transit, artificial intelligence, health behavior change and actions for ecological transition and in many other fields where people are trying to make life better for everyone. As co-founder of the International Time perspective network, gathering more than 300 scientists from more than 45 countries, he is trying to help science to be more applied, technology to be more user-centered and practice to more empathic.
Martin Folger is currently Head of Pharmaceutical Development at Boehringer Ingelheim Vetmedica GmbH. He is pharmacist and holds a PhD in Pharmaceutical Technology from the Technical University of Braunschweig, Germany. After starting his career working in pharmaceutical manufacturing of oral solid dosage forms for two years for a major US-based pharmaceutical company, he joined the Animal Health business of Boehringer Ingelheim in 1997 as a manager in formulation development. Since 2002 he is responsible for all CMC-related activities like drug substance development, formulation development, process development and analytical development with a global focus. He currently also fulfils the function as the Qualified Person for veterinary investigational products.
Adriano has a University degree in Electronic Engineering from Politecnico di Torino, Italy and a Master in Business Administration from SAA, Torino.
He joined Antares Vision since its foundation in 2007 as Marketing director and moved to the US in 2014 to support the growth of the North America operations.
He serves as Marketing director in the OPEN-SCS workgroup, a collection vendors and pharma companies dedicated to standardizing serialization and aggregation communications across the different technology layers.
Prior to joining Antares Vision, Adriano has worked as management consultant for over 10 years.
Adriano Fusco serves as Marketing director in the OPEN-SCS workgroup, a collection vendors and pharma companies dedicated to standardizing serialization and aggregation communications across the different technology layers.
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).
Daniele has over 10 years’ experience of purchasing in Global Pharmaceutical Manufacturing and Supply Chain environments. He has held roles with increasing responsibility in multiple locations across Europe. At Abbott Laboratories, he enhanced his procurement expertise and pharmaceutical knowledge while based at a manufacturing plant in Italy, in the divisional offices in London & Dublin and also in the headquarters in Basel.
Daniele joined Ferring HQ near Lausanne (CH) in October 2013 as Global Category Manager, in charge of the global purchasing strategy and its execution for key packaging materials and medical devices used in Ferring Finished Products.
Daniele was appointed Head of Purchasing, Solids and Packaging Cluster in February 2017 and Director of Product Supply Direct Procurement in November 2017.
Daniele has a Masters Degree in Industrial Engineering from the University of Rome, Italy, followed by an MBA at the UCD Michael Smurfit Graduate Business School, Dublin, Ireland.
Carolin Grab studied Industrial Engineering at the Baden-Württemberg Cooperative State University, which she finished successfully with a Bachelor’s degree in Engineering in 2010. Following experience as Key Account Manager at Trelleborg Sealing Solutions Germany GmbH she started as Product Manager Liquid Silicone Rubber (LSR) in 2015. Since August 2017 she is Commercial Director and Product Manager at Trelleborg’s Stein am Rhein (Switzerland) site.
Hadrien Gremillet holds engineering and business degrees. After creating a start-up in new technologies during his studies, he worked for 3 years as a strategy consultant for McKinsey. He joined Nemera strategy department in 2016. He is now in charge of Nemera’s electronic activity development.
Robert is the Group Head Packaging Technology in Device Development and Commercialization at Novartis Pharma. He holds a degree in biochemistry from the University Bayreuth and a Ph.D. from the University Heidelberg, where he graduated in 1998.
He joined Novartis in Basel in 2016. Before he worked with SCHOTT Pharmaceutical Packaging where he served in several leading functions in Product Management, Product Development for sterile primary packaging products and Technical Customer Support. He has 17 years of experience in packaging products and devices for pharmaceutical and biotech applications.
Russ Hornung is a Business Development representative for Drug Delivery and Packaging for W.L. Gore & Associates (GORE). Russ began his career at with a BSEE (Electrical Engineering) from The Pennsylvania State University and went to work at Westinghouse as a design & new product development engineer. He later transitioned into new business development representative while studying MSEE at Johns Hopkins University. Russ returned full-time to receive his MBA from the Katz Graduate School of Business, University of Pittsburgh. Since 1996, Russ has held various Product Management and Business Development positions at Gore focused on providing unique and valued material based solutions to difficult market needs in various industries including medical interconnects, high performance computing, military and defense, harsh environments and biologic drug delivery and packaging.
Frédéric Jailloux has more than 20 years of experience in Global Procurement, Supply chain and performance management, mostly in the Pharmaceutical and Packaging sectors.
He worked 13 years in Procurement for GSK Pharma where he was a former Global Procurement Director. He then lead a program to switch diverse Consumer Healthcare’s Products’ packaging to Child Resistant Senior Friendly ones across a network of 30+ contractors around the world.
In 2015, Frédéric Jailloux created VAL-U Advisory, a consulting company based in Belgium but acting internationally to improve his Clients’ profitability and growth. Negotiating and contracting the sourcing of equipment and software for serialization on behalf of a CMO, reorganizing and improving the supply chain of a site, raising performance management capability of a biotech R&D organization are among his recent successes.
He’s been also a speaker at different conferences to help Companies to better understand and respond to Pharma requirements and expectations.
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.
Thierry co-founded Kurma in 2009. He has 25 years of experience in the Life Science Venture industry and is a Pharmacist and PhD by training. Thierry started his career in Japan as a scientific representative for Laboratoires Fournier (1992-1996). Having then studied at Insead, he joined Flamel Technologies as project director for Pharmaceutical R&D, after its IPO on the Nasdaq (1997-1998). He then moved to the investment world, first at Caisse des Dépots (1998-2005), then to AGF Private Equity (2005-2009), where he supervised the healthcare investment team. Thierry led investments in companies like Actelion, Arpida, Targacept, Adocia, Auris, Erytech or Safe Orthopaedics. He is currently on the Board of Directors of Meiogenix, Pathoquest, Blink Biomedical, Asarina Pharma and Minoryx.
Franck Lescure is Partner in charge of Life Sciences investments at Elaia Partners. Until 2018, Franck was Partner in charge of Life Sciences activities at Auriga Partners. Between 1990 and 1995, he has participated to the initial years of Genset, one of the first French biotech startups. Between 1997 and 2002, he joined the Air Liquide group in its healthcare subsidiary, followed by 2 years as member of the Venture Capital team of Crédit Lyonnais Private Equity. Franck Cumulates 28 years of experience in technology innovation, including 17 years in Capital Venture. He notably led investments in TxCell, Median or Erytech and he is currently on the board of directors of Amoeba, Enobraq, Fabentech, Flash Tx, Nosopharm, Pherecydes and Pylote.
Franck is an alumnus of the Ecole Normale Supérieure and of the Institut Pasteur. He holds a PhD in Microbiology and Virology and a MBA from the Collège des Ingénieurs.
Dr. Jan Luccarda is working since almost 2 decades in the packaging industry supplying to Pharma customers in an international level.
In the past years of his professional career he was mainly responsible for Sales, Marketing, PM and Innovation.
Head of non food sectors and Healthcare.
Mission to support companies in the deployment of GS1 standards in the non-food sectors, services and healthcare.
Member of the leadership of GS1 Healthcare.
Her role is to make GS1 standards available for the Healthcare industry and adapt them to the specificities of the sector to optimize the supply chain management, the definition of tools to fight against counterfeiting and the improvement of patient safety.
Bachelor’s degree in Mecatronics Engineering from the Instituto Tecnologico y de Estudios Superiores de Monterrey.
Mr Martinez has worked for the past 7 years for international companies dedicated in primary packaging for parenteral drugs. He has experience in different aspect and functions such as production, technical liaison, quality, project management and sales.
He currently holds a position as Product Manager and Special projects in Stevanato Group, responsible for the development and market placing of different products offered in Ompi’s portfolio.
Rajesh Mishra is currently working as Head–Packaging Development, I&D, Abbott Healthcare Pvt. Ltd. based out of Mumbai. He has over 20 years of industrial experience and had worked in various Pharmaceutical companies across India.
He has done Bachelor of Science (BSc) in Chemistry and Post Graduate Diploma in Packaging Technology from Indian Institute of Packaging, Mumbai.
His area of expertise are ‘Pharma Packaging Innovations’, ‘Pharma Packaging Development’, ‘Packaging Optimisation’ and ‘Packaging Material Studies & Controls’.
His current responsibilities include Packaging Material/Design Innovations & Packaging Development of new products for Abbott India and Global market.
In his current role for the last 9 years in Abbott, he has more than 12 Patents both in India & International on various Pharmaceutical Packaging Innovations platforms.
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.
- 21 years experience in the pharmaceutical packaging industry
- expert in anti-counterfeiting, serialisation and tamper evidence
- Chairman of CEN TC 261/SC 5/WG 12 that has created EN 16679
- Chairman of ISO TC 122/WG 15 that currently develops ISO 21296
- Chairman of the packaging standards committee at DIN
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.
Michel Raschas is Consulting Validation & Services Director of PROGMP, a consulting, engineering and validation company dedicated to the Life Sciences Industries. He is directly in charge of services related to information systems, bringing a strong expertise on all levels of decision from specification, design for implementation until later evolution. His knowledge is especially valuable when regulatory compliance is required.
He has an engineer degree and has been working for near 30 years in the Information System field. Michel Raschas is also CFPIM (Certified Fellow in Production and Inventory Management) by the American Production and Inventory Control Society (APICS).
Michel is member of ISPE (International Society for Pharmaceutical Engineering) and secretary of the French affiliate. He initiated and is the co-founder of the French Speaking GAMP® community of Practice “GAMP Francophone” and of the working group on Serialization at CMOs in Europe.
He is also member of APICS (the Educational Society for Resource Management). He provides training for professionals and lectures for major schools such as the Pharmaceutical Master of the University PARIS SUD. He is writer of reference documents and of press articles concerning various subjects of computer compliance and industrial and logistical management for the process industry.
Dr Joël Richard is currently Senior Vice President, Peptides in IPSEN (France). He is globally leading all the pharmaceutical development activities of both injectable and oral peptide-based products, including APIs and drug products, with major franchises in Oncology, Endocrinology and Neurology. Dr Richard has more than 25 years of experience in chemistry and biopharmaceutical R&D, including several global senior positions in various Biotech and Pharma companies, such as:
- Vice President, Drug Product Development in Ipsen (France) (2008-2011),
- Director, Pharmaceutical Development in Serono and Merck Serono (Italy, Germany) (2005-2008),
- Vice President Research, and Europe R&D Director at Ethypharm (France) (2001-2004),
- COO at Mainelab (France), a drug delivery company he co-founded, which was specialized in developing solvent-free processes for protein delivery systems (1999-2001).
Since 1996, Dr Richard has focused his research activity on new formulation technologies and drug delivery systems (such as polymer and solid lipid microspheres, nanoparticles, and nanocapsules, chemically-modified proteins, supercritical fluid technology . . .), especially for injectable peptide and protein formulations.
Dr Richard graduated from Ecole Normale Supérieure (Cachan, 1985). He has got a PhD in Materials Science (University of Paris VI, 1987) and “Habilitation à Diriger les Recherches” in Chemistry (University of Bordeaux I, 1994). He has published 67 peer-reviewed scientific papers, 8 book chapters and 2 review editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein formulations, nanoparticles, sustained-release formulations . . .). He is the author of more than 120 international communications and 53 patent families.
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
As counsel of our Life Sciences practice, Fabien Roy focuses his practice at Hogan Lovells on advising Clients on European Union and national regulatory matters applicable to medical devices, medicinal products and combination products throughout their entire life cycle. With a practice entirely focusing on complex regulatory issues faced by Life Sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling Clients to focus on their business.
Fabien focuses particularly on guiding Clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data), conformity assessment and registration procedures (e.g. preparation and review of Technical Files, preparation and review of responses to the competent authorities' and Notified Bodies' requests) and post-market activities (e.g. adverse event reporting, Field Safety Corrective Actions and promotional and advertising of medical devices).
Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device Clients. Fabien also assists Life Sciences Clients in the preparation, drafting and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.
PhD in engineering science. More than 25 years in life science industry. Starting working in international engineering company. After joining Sanofi company 16 years ago.
Tsachi Shaked, MBA, is Head at E3D (Elcam Drug Delivery Devices) a subsidiary of Elcam Medical. Tsachi is graduated for Master in Business Administration (MBA) with expertly in Marketing from Bar-Ilan University in Ramat-Gan, Israel. As part of the company's portfolio, Tsachi is deeply involved with the development of the new version of drug delivery devices that includes connectivity and electronic applications. Tsachi is with the company from 2006.
Sai Shankar is Director for Connected Devices Business Development at Aptar Pharma. Sai has 15 years of product development and business strategy experience in the pharmaceutical industry. He joined Aptar Pharma in April 2017, with previous stints at Allergan and Sanofi.
Yves Th. Tillet is a doctor in pharmacy, graduate of physiology and biochemistry, of the Business Administration Institute, and of Marketing and Strategy from the Centre for Higher Education.
Yves Th. Tillet began his professional career in the field of hospital biology and clinical pharmacy.
In 1994, Yves Th. Tillet created with and Marie D. White the Cabinet WHITE-TILLET providing expertise in quality, assessment, and regulation of health products.
Yves Th. Tillet has taught at several French universities and is author of numerous publications.
Andrew has 20 years’ experience bringing brands, technologies and services to market and managing them in-market, including 13 years in global marketing with Sanofi and 5 years consulting. He specialises in medical technology, integrated care, and beyond the pill programs, bringing technology and services (alone or with pharmaceuticals) to solve pernicious problems.
Robin Van Landeghem is Director Technology Global Films for Tekni-Plex, a globally-integrated company focused on developing and manufacturing innovative packaging materials and precision-crafted tubing solutions for some of the most well-known names in the healthcare, food and beverage, consumer and specialty-product markets. Tekni-Films, a Tekni-Plex company, is a leading manufacturer of stock and custom high barrier films, foils and pouch materials for the pharmaceutical, medical, diagnostic, health and beauty industries. With its 50 years of experience and five plants in North America, South America and Europe, Tekni-Films is well positioned to provide global packaging solutions. For more information visit www.tekni-films.com.
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.
Peter Vogel is Slovene nationality, married and father of two children. He graduated 1996 as Bachelor of Science in Chemical engineering at University of Ljubljana, Slovenia. His professional carrier is 21 years and all dedicated to pharmaceutical industry at different positions with companies Lek Pharmaceuticals, Sandoz and Novartis. He started within production site as technologist, later as researcher in charge for generic pharmaceutical products development form development stage to production transfer and launch to the market. During his carrier he was also managing Health & Safety department and Chemical safety of production site. He was also managing products transfers and involved into green filed production plant set up as International project manager. Peter was heading Packaging materials development and Packaging department as well as Packaging materials Sourcing & Purchasing department. His current position is Global packaging development manager within Novartis technical operations.
Thierry Wagner has spent nearly 30 years working for DuPont in its polyester films and nonwovens businesses in a variety of assignments ranging from process development and project management to operations and business management. He is chairman of the board of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging like ISO TC198 “Sterilization of Health Care Products—Packaging” (ISO 11607), CEN TC102 “Sterilizers for Medical Purposes—Packaging” (EN868), and ISO TC76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”. Thierry is also a member of ISO/TC 210 in charge of ISO 13485 and ASTM Committee F02 – Flexible Barrier Packaging and of the CEN ABHS (Advisory Board for Healthcare Standards-Europe).
Thierry Wagner earned a master’s degree in mechanical and process engineering from ETH Zürich in Switzerland. He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.
Dr. Nathalie Wardé graduated with a PhD. in Pharmacy from the University of Paris V, France. She completed her business background at HEC in Geneva, Switzerland with a degree in Human Resources management. She started her career 27 years ago in a pharmaceutical multinational company in France, then she joined CIBA/Novartis group in Switzerland.
After spending the first part of her career in managing Quality Assurance then Production department in a manufacturing site, she moved to the Headquarter of the OTC Business Unit, focused on Sourcing Strategy and Technical Support at an international level, dealing with affiliates but also with 3rd party manufacturers worldwide. In this context, she had the opportunity to lead important projects such as new product launches, potential plants closure evaluation, production transfers of various products in and out, starting from the evaluation of the potential suppliers and/or manufacturing sites to the implementation phase. In September 2005, Nathalie Wardé has founded her own consulting company, active in improving Manufacturing Operations efficiency and compliance of Healthcare & FMCG manufacturers, in Europe and in Middle East countries.
- Coaching or leading project teams involved in Sourcing and Supply Chain projects (e.g. production transfer, new product launch, track&trace)
- Assistance in designing and implementing Outsourcing / Contract Manufacturing processes, from Request For Proposal to first batch manufacture
- Preparation of licensing deals
- Assistance in designing QMS in compliance with cGMP/GDP
- Training (seminars and on-the-job, customized) in GMP/GDP, compliance to new regulations on traceability (e.g. serialization, UDI) , Contract Manufacturing, Project Management in Technical Operations
She has been teaching in several Universities in Switzerland, France and in Lebanon, and a regular speaker at various seminars organized by A3P and GRIP in Switzerland, and SFSTP in France. From 2007 until 2013, she was a member of the judging panel of the European Outsourcing Award organised in the frame of CPHI.
Some references : GS1 (Healthcare); Procter & Gamble International Operations (EMEA) ; Johnson & Johnson Consumer (EMEA); Novartis Pharma (EMEA) ; CareFusion (EU&US); Sanofi (CH); Interdelta (CH); MedTronic bioPharma (CH); Labatec (CH) ; Boiron (FR) ; Guerbet (FR); Famar (GR); Mediterranean Pharmaceutical Industries (SY)
Susanna White graduated from the University of Cambridge in 2012 with a Masters in Engineering for the Life Sciences. Since then she has been a mechanical engineer at Oval Medical Technologies, pioneering autoinjector technology. Much of her work has focused on using numerical modelling techniques to deliver highly viscous and non-Newtonian drugs.
After obtaining his Ph.D. from the University of Wales, UK in 1985, Dr Gerallt Williams has held various industrial positions at Monsanto Inc. (UK), Fisons Ltd (UK), Valois (France) and Inhale/Nektar Therapeutics (USA). He is now in charge of scientific affairs for the Aptar Pharma Prescription division, Le Vaudreuil, France and is engaged in the development of new devices for nasal, inhaled and injectable drug products.