Francesco Amarosi has a degree in mechanical engineering and a PhD in quality engineering. Francesco has 20 years of experience in managing international projects of process validation & equipment qualification. In 2004 he became partner of PQE and is the vice president of business development.
Dr. Caroline Bauer is a Pharmaceutical Development Manager at the Lonza Ploermel site in France.
Prior to joining Lonza, she worked in a biotechnology company in the field of innovative drug delivery systems. Dr. Caroline Bauer earned degrees in chemistry (PhD), a European Master in chemistry and formulation science from the University of Regensburg (Germany), and a doctorate in physical chemistry from Montpellier University (France). In her current role she deals with pharmaceutical development projects ranging from early to late stage development for NCE , lifecycle management as well as generic drug development.
Director R&D, Aker BioMarine. PhD, University of Oslo, and former Fulbright Scholar, Massachusetts General Hospital/Harvard Medical School. Research interests include nutritional and lifestyle factors associated with human health outcomes, with a particular focus on polyunsaturated long-chain omega-3 fatty acids.
Anil Busimi started his professional career in 2003 at SCHOTT AG in Germany. He worked in different roles including business development, project manager, and consultant in corporate strategy. In 2005, he moved to SCHOTT Pharmaceutical Packaging business and played a key role in building long-term business strategy with sound understanding of market trends, customer needs, and competitive lansdcape. He has more than 10 years experience in product management and innovation. From August 2009 until June 2016, he held various positions in global product management for pre-fillable syringe business including glass and polymer PFS solutions. Currently, he is in the strategy & innovation team as senior global product manager for Cartridges and led the iQ™ Platform market launch. He is a professional speaker at many conferences and seminars on topics realted to parenteral primary packaging and drug delivery devices. He holds M.Sc. degree in Agriculture Genetics and a MBA.
Lynne Byers has gained more than 35 years’ of extensive pharmaceutical manufacturing management and QA experience working for three major international pharmaceutical manufacturers, culminating in the role of Global Head (VP) of External Supply Operations QA for Novartis in Switzerland. In addition, she worked as Head of Inspectorate and Licensing for the MHRA from 2004-2006. She joined NSF in 2017. Ms. Byers has broad experience in manufacturing management and QA of a wide range of sterile and non-sterile dosage forms, and is fully conversant with current EU and FDA GMP regulations and requirements. She has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers who are suppliers to the pharmaceutical industry worldwide. She also has extensive experience in managing QA teams in country affiliates. Ms. Byers is eligible to act as a Qualified Person and was a QP assessor on behalf of the Royal Society of Chemistry from 1999 to 2004. During her tenure with the MHRA she was responsible for agreeing to QPs being named and removed from manufacturing authorizations.
Alberto Carazo is a Phd Pharmacist with more than 20 years of experience in the pharmaceutical sector. Actually, he is in charge of Azierta Industrial area implementing new normatives and giving 360º support to new companies that want to enter in the EU market (Market analysis, regulatory strategy, Pharmacoviligance, clinical support, GMP/GDP compliance, QP release, patent support, etc).
Reiner Christensen has more than 20 years of international experience in the pharma & OTC industry – in General Management and Sales & Marketing. He holds a Diploma in Industrial Engineering & Management and an Executive MBA from Ashridge in the UK. His work has lead him to many different regions including the CIS/CEE, Latin American, Asian and European regions and he is still a keen traveller and enjoys learning about different cultures. Reiner is the CEO of Chameleon Pharma Consulting and is delighted to share some insights with you. On a more personal level, Reiner has a passion for French and Thai cuisine and enjoys cooking with his two daughters.
Fernando Diez is Scientific Business Development Manager for ACG – the leading global manufacturer of empty hard capsules. He has an MBA and degree in chemistry. His work mission is creating new business opportunities outside of the formal review/tender process and the relation with external researching institutes and R&D centres. He has long experience in pharmaceutical industry and worked with renowned multi-national companies in the industry.
Dr. Polina Dombure runs her own GxP consultancy providing support and advice to her Clients on regulatory affairs, drug safety, GMP, GDP, market access and P&R strategies. Dr. Dombure has worked in this field for over 18 years, with prior experience in manufacturing of finished medicinal products, quality assurance, regulatory affairs and pharmacovigilance. Years of experience have allowed for developing a strategic approach to complex regulatory issues allowing for regulatory product management over the whole life cycle. Dr. Dombure has created a CRO business model, which today is the only one providing full-scale GxP, regulatory, pharmacovigilance, and training and digitalisation services providing coverage of CIS countries with European level quality.
Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.positions. Currently at Lighthouse since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.
Susana Ecenarro is the Scientific Business Development Director of Qualicaps Europe.
She holds a MBA and a bachelor degree in Pharmacy. Prior to Qualicaps she worked
for the German pharma company Schering AG for 18 years in different quality
positions and covering several functions as analytical development, process
validations, technology transfers, operation excellence projects, etc., followed by 5
years of experience leading an analytical R&D unit of a Bayer Healthcare facility.
Her main work mission in Qualicaps® is to support R&D centers within the
pharmaceutical industry in new drug developments by providing the scientific and
technical expertise they might need, as well as promoting collaborations with European
universities and other third parties focusing on the application of state-of-the-art
Director SteriPro Consulting Pharma Services
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, guiding his Clients to raise efficiency 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.
Dr. Maurits Janssen is senior Director, Head of Commercial Development for the Active Pharmaceutical Ingredient (API) Business Unit at Lonza.
He earned his Ph.D. in organic chemistry from Utrecht University in The Netherlands (1996) and subsequently fulfilled several functions with increasing responsibility in consulting, marketing & sales and research & development.
Dr. Janssen has over 20 year experience in chemical and pharmaceutical industry and over 15 years in the custom manufacturing of active pharmaceutical ingredients. Throughout his career, Mr. Janssen worked across a broad portfolio of technologies in cGMP Chemical & Biological custom manufacturing from early stage to late phase/commercial and gained significant experience with Highly Potent Active Pharmaceutical Ingredients (HPAPI).
Jean-Paul Judson is the Public Affairs Manager at FEVE, European Container Glass Federation, which he joined in July 2015. He has been working on the Circular Economy Package, the revision of the EU waste legislation, EU Product Environmental Footprinting and all the policies directly affecting material choices on the packaging market. Prior to FEVE, he was working in the European Seed Association and as EU Representative of the Regional Innovation Agency of Provence-Alpes-Côte d’Azur. He is half-French & half-English and likes to call Brussels home.
Martin Junginger is Head of Global Product Management Pharma & Business Development Gelatine at GELITA AG in Eberbach/ Germany. He is responsible for the portfolio of pharma gelatine, mainly for soft capsules with different dissolution and cross-linking properties. Besides Mr. Junginger is in charge for the Global Innovation Process to establish, manage and report innovation projects at GELITA. Prior to joining GELITA in 2017, Mr. Junginger was Head of Product Development for Modern Wound Care dressings for the treatment of acute and chronically wounds. In the years before he was responsible for process development and establishing of pilot and production plants for medical devices. Mr. Junginger holds a Dipl. Ing. (M.Sc.) degree in chemical engineering from the University of Stuttgart, Germany.
Dr. Sanjeev Kulkarni is vice president, R&D and new technology Bilcare India. He is passionate for creating innovative products. He has worked as head of innovation with companies like ACG and Essel. He has patented, developed & commercialized multiple pharmaceutical packaging products. He established and maintained the innovation lab at Bilcare.
With a Master’s Degree in Chemical and Process Engineering at the University of Padua, Martina Largoni boasts a vast knowledge in chemistry, physics, informatics, mathematics and statistics. She worked on the optimization of pharmaceutical processes, engineering the monitoring and control of the quality of the product.She entered Stevanato Group in 2015 as Technical and Quality Assurance Front End for Ompi, gaining experience in the glass primary packaging and injectable delivery fields.Now she is Product Specialist EZ-fill Vials and Cartridges.
Dr. Enrique Lozano Diz has been responsible for Business Development at B&W Tek for the past 6 years with a focus on up-and-coming markets of South America and Africa. Dr. Lozano Diz has been in the spectroscopy industry for 14 years and has over 25 scientific papers and 2 patents focused on spectroscopy applications. He received his Ph.D in Chemistry from the University of Neuchatel after completing his Master's in inorganic chemisty at the University of Sevilla.
Working since almost 2 decades in the Packaging Industry supplying to Pharma customers in an International Level. I was responsible for Sales, Marketing, PM and Innovation.
Engineer and PhD in science of matter. Loïc Marchin is an innovative entrepreneur for a dozen years, Loïc Marchin has created Pylote
in 2009 with the ambition to provide to the markets of the industrial innovations, cleaner, greener, safer.
Guenter Nadler is the Director of Business Development in Aptar Pharma’s Consumer Health Care division. Within Aptar, Guenter plays an integral role as part of their Global Market Development organization, heading strategy and innovation for the Cough & Cold business. He has 18 years of broad experience in drug delivery, including various technical and commercial roles. Guenter graduated with a degree in Business Administration and Mechanical Engineering, and is recognized as one of the leading experts in cough & cold treatment options worldwide.
Roberto Pace has been dealing with analytical research in pharmaceutical industries since 1990. He gained experience in the identification and analysis of natural products, herbal remedies and food supplements, being involved from early discovery to the market of a number of drugs, health foods and cosmetics. He is involved in the analytical study of several major classes of bioactive natural products, especially polyphenols, taxoids and cochicine derivatives along with the identification and analysis of active principles derived from plants for pharmaceuticals, health foods and cosmetics. He is co-ordinator of inter-laboratories trials with European Pharmacopoeia and AOAC International organisations and assistant in the monographs editing. He is a collaborator of United States Pharmacopeia for monograph revision and for definition and qualification of reference materials. He is currently involved, as responsible of Quality Unit of the Indena Groups, located in Italy, France and India, in the organisation/ harmonisation of the quality activities of the Indena SpA, an Italian Company leader in the manufacturing of herbal products and preparations.
Business Development Manager Product Partnering Sterile Pharmaceuticals Region Europe, LAM, Africa & Asia
Key Accounts & Business Development Manager Product Partnering Sterile Pharmaceuticals Central Europe
Education: Chemical engineer, Ph.D. – Economics and Management.
Employment: technical position in KAU?UK, a.s. Kralupy(1982-1995), then Development Director and Member of the Board of UNIPETROL, a.s. Prague (1995-2001), then Managing Director of refineries KORAMO, a.s. Kolin (2001-2002) and CESKA RAFINERSKA, a.s. Litvínov/Kralupy nad Vltavou (2002-2011). Advisor in consulting company ENA (2012). Project manager and advisor in NIS (2012-2016). Currently hosting professor at University of Chemical Technology, Prague (VSCHT Praha) and Director of Association of Chemical Industry of the Czech Republic.
Publishing activities: Co-author of 8 patents in polymer technology; number of articles in area of polymer technology, refining, bio-fuels, petrochemical and natural gas industry development and economics (1982-2018), number of international and domestic conferences: presentations in area of refining, bio-fuels, petrochemical and natural gas industry development, benchmarking and competitiveness; co-author of 5 books on Project decision making and management, Strategic planning.
Mr. Hiroaki Sugasawa is the director of the overseas business development department at Mitsui Chemicals Japan. He has lead the development of many path breaking products related to food and pharma packaging. He speaks five languages.
Julie D. Suman, R.Ph., Ph.D is the Founder of Next Breath, an Aptar Pharma business, and serves as its President. Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. Dr. Suman is the Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings, the FDA Visiting Professor Lecture Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001.
Dan-Ola Svensson has over 30 years of experience in the world of thermoplastics. He spent the early years as quality engineer with a major injection molding company, serving the automotive industry and laid the foundation to his profound interest for quality management systems, leadership for quality and quality improvements. While keeping his initial interest area, he moved further into the world of compounding of standard and engineering plastics, driving developments within the quality- and laboratory management systems. Furthermore, innovation became a key area leading to special raw material- and compound solutions. He joined Clariant in 1997. After a position within quality- and laboratory management, in 1999 Dan-Ola became technical manager for the Malmoe/Swedish masterbatch manufacturing site, focusing on technical- and regulatory innovations of processes, products and services. In 2010, in relation to Clariant implementing a dedicated medical- and healthcare organization and the brand name of Mevopur, he became regional technical manager for Europe within segment Healthcare Polymer Solutions. Within Clariant Plastics & Coatings, BU Masterbatches provides color - and functional additive masterbatches and compounds for the Medical & Pharmaceutical industry.
Alastair leads Systech's European operations and takes a consultative approach that seeks to understand his clients' current processes and business issues to ensure the delivery of profitable technology solutions that add measurable value and a significant return on investment. With over 20 years of experience, Alastair has a deep, working knowledge of product tracking and security in pharmaceutical and CPG sectors.
Since obtaining his Ph.D. in the ion optics of mass spectrometers at the University of Manchester Institute of Science and Technology (UMIST) in England, Lester Taylor has worked in the field of mass spectrometry both in the areas of instrumentation and applications development. Subsequently Lester joined Burroughs Wellcome Co. in Research Triangle Park, NC, where he held positions of increasing responsibility in Drug Discovery and became Assistant Director in the Organic Chemistry Division. During this time he was responsible for applying mass spectrometry, NMR and optical spectroscopy methodologies to a wide range of analytical challenges in pharmaceutical drug discovery and development. More recently, he joined Thermo Fisher as the Marketing Director for life sciences mass spectrometry. In 2009, he joined Agilent technologies, Santa Clara, California as the Director of LC/MS Product Marketing, until May 2014 when he took on the role of Pharma market manager.
Mr. Kenichiro Usuda is a researcher of Advanced Business Development Division. He gained a Diploma in Engineering in 2009 and a Master Degree of Engineering in 2011 from Tokyo Institute of Technology. Since April 2011 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 multilayer vial and pre-filled syringe for pharmaceutical drugs.
Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2013 as study director at the Extractables & Leachables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. In 2016, she became Department Head Pharma Services at Nelson Labs Europe. The main focus of this department is identifying organic impurities in drug products as well as in use stability of drug-device combination. In 2017, the scope expanded and includes now also all microbiological testing offered at Nelson Labs Europe.
Tom Wilson is Vice President, CMO Operations, for Pfizer Global Supply (PGS) and Pfizer CentreOne Contract Manufacturing.Tom is a member of the PGS Pharma Ops Leadership Team as well as the CMO Leadership Team in Pfizer Essential Health. Tom is involved in strategic planning, commercial activities as well as manufacturing execution related to the CMO business.Prior to this assignment, Tom was leading the Pfizer Optionality Program for PGS, as well as the Integration Team for Hospira Device Operations. Prior to this, he served as the Operations Leader for the Meridian Medical Technologies remediation program.Tom joined Pfizer in 2010 with the acquisition of Wyeth as Vice President, Product Operations. He joined Wyeth in 1993 in Rouses Point, New York as Front Line Supervisor, Solid Dose & Liquid Manufacturing, and assumed increasing responsibility in operations and strategy roles. He holds a B.S. in Physics from St. Joseph’s University in Pennsylvania and an M.S.in Administration & Management from St. Michael’s College in Vermont.
Bernd Zeiss, Dipl.-Biol. studied biology, microbiology and chemistry at the University of Göttingen, Germany. He works in the Gerresheimer Centre of Excellence for prefillable syringes as Manager Technical Support. His main areas of work are investigating possible interactions between syringe components and drug as well as the evaluation of innovations like COP syringes in comparison to glass. Bernd also carries out inhouse functionality studies on prefilled syringes and prepares technical documentation for customers called "Technical Bulletins".
Laurent Zuber has a deep knowledge of the Pharma industry and of the Glass Industry since 2002. Laurent Zuber is CCO of SGD Pharma since October 2015, leading sales & marketing activities, as well as the trading company Embelia. Laurent joined the Commercial division of SGD Group (Perfumery and Pharmacy) in 2006, and defined the pharmacy strategy to further extend SGD’s leading position with stronger market shares in all segments. From 2010 to 2014, Laurent focused mainly on sales and operational performance resulting in a significant EBITDA increase. Laurent Zuber Started his career with Saint-Gobain Emballage (now Verralia), where he occupied various positions before he became Sales and Marketing VP of the containers division in 2002. He graduated from the Institut Supérieur de Commerce of Paris (France).