Check out this year’s line-up of engaging and inspiring speakers.
Laurent Jeanmart is head of Primary packaging and medical devices at GlaxoSmithKline Vaccine worldwide. He has more than 15 years of experience in the chemical and pharmaceutical sectors and worked for different companies. He has managed life cycle activities such as qualification, validation and implementation of elastomeric compounds (stoppers,…), new containers like vials, syringes, LDPE tube but also single use systems (bags,..).
He has performed several studies about the compatibility between primary packaging and vaccines and also led life cycle development of secondary packaging items.
Laurent is Chemical Engineer and graduated from Louvain-La-Neuve University (UCL Belgium) specialized in Polymer Science. He also has a PhD in Material Sciences based on glass surface treatments. He’s member of pharmaceutical associations and writer of scientific articles and patents.
Brigitte Reutter-Haerle is the Vice President of Marketing / Corporate Communications for Vetter, a leading contract development and manufacturing organization that serves the global pharma/biotech industry. She was called to this new position in September 2014 and is responsible for the company’s international marketing activities, product and service management as well as HR marketing and internal communication. Between 2004 and 2014, she obtained the position of Director Corporate Marketing. In 2009, she led the communications program for Vetter’s U.S. expansion. Ms. Reutter-Haerle joined Vetter in 1996, serving in the company’s sales and marketing function, and transferred to corporate marketing three years later. She began her career in 1983, holding various positions in the sales organizations of firms including Hilton International and TNT Express Worldwide. Ms. Reutter-Haerle earned a B.A. and a degree in Business Administration from Baden-Wuerttemberg Cooperative State University. She has been leading the Prefilled Syringe Interest Group/Europe of the Parenteral Drug Association since 2007.
Theresa Bankston leads the WW Technical Services group for BD Medical – Pharmaceutical Systems that is responsible for providing technical support, solutions, and services around delivery systems for injectable drug therapies.
She has over 20 years of combined experience in the pharmaceutical and medical device industries. Her areas of expertise include process chemistry and engineering development, analytical method development, and drug-container integration science.
Theresa received her BS in Biochemistry from Florida State University and her doctorate in Chemical Engineering from the University of Virginia.
In his function as industrial electronic engineer, Thomas Seiffer gained extensive experience in the field of machine and line qualification when he was working in the qualification department of Bausch+Ströbel from 1995 - 2001.
From 2001 – 2004, he broadened his knowledge by completing academic studies in mechatronics. As “Diplom-Ingenieur” (German university engineering degree), he took over the research and technology department in 2004.
In his role as Technology Manager, Thomas Seiffer has made significant contributions to the integration of new technologies into Bausch+Ströbel equipment.
When it comes to Pharma Services, he as head of the Bausch+Ströbel lab has intensively dealt with dosing systems for pharmaceutical products during trials with and for customers over many years, achieving great success in this field.
Frank Bamberg has close to 20 years’ experience in the pharmaceutical industry in various leading roles such as in research & development, business development, and project management.
Before joining CSL Behring in Bern CH as Associate Director for Medical Device and Primary Packaging, Frank has been with Hoffmann-La Roche since 2011 as Section Head Pre-Fillable Syringe responsible for the development of primary packaging and devices which will be in contact with the drug.
Frank has gained experience in various positions at SCHOTT Pharmaceutical Packaging. He was also leading the global business development & customer service for Pre-Fillable Syringes.
Frank holds an MBA in Industrial Engineering and Management from the University of Bern/Zürich and he is Plastics Engineer by training.
Dr. Olivia A. Henderson works in the Mechanical Engineering Methods Department at Amgen in Thousand Oaks, California, where she leads a group to qualify, validate, and transfer physical methods for combination products. Prior to joining Amgen, Olivia worked at Biogen for 13 years and has extensive experience in CCI, extractables/leachables, single use systems, parenteral filling operations, and contract manufacturing/analysis. Olivia earned a BS in Chemistry from Truman State University, and MS and PhD degrees in Pharmaceutical Science from the University of Missouri-Kansas City. Olivia is an active member of Parenteral Drug Association; she is the Pre-filled Syringes Interest Group Leader for North America and a member of the Biopharmaceutical Advisory Board.
Christian Helbig is the business leader of the Strategic Business Field Glass Syringes at SCHOTT, based in Switzerland.
Mr. Helbig has more than 10 years of experience in pharmaceutical packaging sector, developing advanced pharmaceutical packaging i.e. surface modifications and coatings on glass and polymer, understanding of drug-container interaction investigations. Further, he has been working on development and commercialization of pre-filled glass and polymer syringes, including closure systems and compatibility with injection devices for various applications in various markets, e.g. in North America
He has a biotechnology engineering degree with emphasis on process engineering from the University of Applied Sciences Emden/ Leer, Germany.
Dr. Lei Li currently serves as an engineering advisor at Delivery Device and Connected Solutions, Eli Lilly and Company. Dr. Li’s has 9 years of experience in pharmaceutical and medical device industry, with focus on API and drug product packaging and cold-chain distribution development for biologic products. His current responsibilities include designing and evaluating container closure systems for pipeline molecules, supporting clinical development, tech transfer, and product commercialization. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Dr. Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last ten years with growing responsibilities in business development and technical roles. He is currently Director of Technology and Development at Terumo in Belgium.
Philippe graduated in Biotechnology from the University in Ghent, Belgium and worked as a scientific researcher at the Catholic University of Leuven.
Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment.
Philippe also serves as expert in ISO technical committees TC76 and TC84.
Dr. Mahler obtained his venia legendi (German Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland).
He was elected an AAPS Fellow in November 2013. His work experience includes early- and late-stage/commercial and line extension formulation development, primary packaging and device development, drug delivery, Drug Product process development, process characterization and validation, transfer to clinical and commercial drug product production and production support and preclinical and clinical (phase 1-3) Drug Product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.
Prior to his consultancy, he was with Lonza and Roche. From2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase.
Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing.
Manfred Mäder is Head of BTDM (Biologics Technical Development and Manufacturing) for Devices & Combination Products, Development and Commercialization since October 2015. Prior to this, he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development at Novartis Pharma starting in February 2011.
Prior to this position, he was Senior VP of Quality Management & Regulatory Affairs, at Ypsomed, a company producing Medical Devices and Combination Products starting in 2007. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site. Before then, based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC.
By training, he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.
Markus has over 10 years' experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development.
Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, Markus started his technology Start-Up company ConnectMeSmart GmbH in 2013.
In 2015 SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential application within each of SHL Group’s companies.
Markus graduated from Clausthal University of Technology with a degree in Process Engineering and Chemical Engineering.
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 an MBA from 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.
Amber Witteman is Founding – Managing Director at EPIWatch, part of Ebenroth B.V. EPIWatch (Combination Product) is the first wearable Auto Injector for intramuscular drug delivery that is also suitable for subcutaneous applications and markets. EPIWatch is a next generation wearable auto injector incorporated in a smart watch, that is connected to the IoT. Bio Sensor Health Care Technology (AI) can be incorporated within the EPIWatch housing in a later stage to generate patient centric healthcare profiles for improvement of future treatment and R&D. Amber has been in the industry since 2009 and her focus is on patient comfort, need and requirements. Amber is considered an Experience Expert and an Innovation Leader.
Amber is responsible for inventing, filling, and developing the concept patent, the mechanical patent and filling for the latest patent that contains a material that allows drug temperature control within the PFS, ampoules, vials, cartridges, etc. up to 50 degrees Celsius in the sun, keeping the drug cool while maintaining glass and polymer transparency. The mechanical patent contains a novel drug delivery system where the needle is integrated within the primary container called the needle in plunger (NIP) a novel drug delivery system making the PFS an integrated unit, extremely compact and easier to replace, taking away a significant deal of needle fear.
Amber also engineered the Oval shaped container for on body worn drug delivery devices, making the primary container as flat as possible. Amber her expertise is tackling critical aspects and innovating key drivers with a focus on low -and zero depth space, minimum waist, patient comfort -and safety.
Tonio is a mechanical & industrial engineer by training with degrees from Ecole Centrale de Lyon, Lyon (France) and Darmstadt (Germany) University of Technology.
Within Device and Packaging Development at F. Hoffmann - La Roche Basel he has been working in the Device Engineering group since 2017. Besides his work as Device Team Leader and Device Engineer for Small Molecule and Smart Device projects he is the Device SPOC for sustainability.
During his Bachelor's Theses at TU Darmstadt Tonio already performed a Life Cycle Assessment (LCA) for a truck chassis and now, ten years later, he can apply this scientific knowledge on coordinating the LCAs within the device development group. Prior to joining Roche Tonio worked within the Device Industrialization Department of Sanofi, Frankfurt (Germany).
Bart E. Burgess is Vice President of Business Development and Product Strategy, having joined Portal Instruments in August 2020.
He draws on his varied experiences in injection device product development, primary container technologies, and business development to develop new partnerships and advise on Portal’s product development approach.
Prior to joining Portal, Bart was head of combination product development at Regeneron, leading injection device design from sketch to commercial scale. Bart also held a variety of technical and business development roles at West Pharmaceutical Services, in both primary container and device technologies.
Pete Sargent is an Associate Senior Consultant Engineer in the Delivery, Device, and Connected Solutions Department at Eli Lilly and Company. He earned his B.S. in Chemical Engineering from Rose-Hulman Institute of Technology and his M.S. in Biomedical Engineering from Purdue University.
He is responsible for the development of primary packaging container closure systems for use with parenteral drug product and drug substance.
Pete has 15+ years of experience in the medical device and pharmaceutical fields. He’s led numerous projects for the development of drug substance and drug product container closure systems in support of Chemistry, Manufacturing, and Control content for Regulatory submissions for large molecule drugs.
His current responsibilities include senior technical oversight for the development and advancement of platform container closure systems for parenteral drug products and drug substance.
Javier Alonso, graduated from the University of the Basque Country and with an Executive MBA from ESEUNE Business School, has been successfully managing sales strategy of pharmaceutical machines for more than 12 years, merging his engineering expertise and leadership skills to guide through aseptic fill & finish process and meet customers’ needs.
Javier is currently Commercial Director at Dara Pharmaceutical Packaging, a Spanish manufacturer of aseptic fill&finish machines.
Marion Briggs is the Sustainability Manager at HealthBeacon – a digital health platform for injectable medications. She leads the HealthBeacon sustainability strategy to deliver initiatives to support HealthBeacon's clients with their sustainability goals.
Marion is leading the Green Labs initiative for more sustainable sharps waste management along with helping to drive other sustainability initiatives within the company.
She is also the Chair of the board of Friends of the Earth, Ireland, and the Secretary to the newly formed pharmaceutical supply chain non-profit, Alliance to Zero.
Rachel Poker is an Associate Director, Human Factors, at AstraZeneca, where she has responsibilities leading the incorporation of human factors and a patient- and user-centric mindset from early stage technology development to support for on market products for the biologics and parenteral portfolio.
With 15 years in both device and drug-led combination products across a range of roles in R&D, her experience includes parenteral, inhalation, and ocular drug delivery devices, connected device technologies, and vascular intervention products.
Rachel has a Bachelors in Biomedical Engineering from the University of Minnesota and PMP certification from the Project Management Institute.
Michael Roe is Senior Director of Development & Industrialization at Kaléo.
He has been with Kaléo since 2017 and is a subject matter expert in combination products and device development.
Prior to that, Michael spent over two decades with Eli Lilly and Company in device development and testing. He holds two degrees from Duke University and is a registered Professional Engineer.
Michael has been an expert member and convener for ISO Technical Committee 84 (Injection Devices) since 2006 and holds several patents for injection devices.
Ed Halili is Principal Mechanical Engineer – Autoinjector SME at Amgen. He has 30 years’ experience in the medical device industry, designing, developing, and bringing to market Class III devices.
Ed’s device experience includes three channel IV ambulatory pumps, implantable pain management pumps, insulin pumps, continuous glucose sensors, patch pumps, and high-volume consumables and accessories.
Prior to joining Amgen in 2014, Ed worked for Siemens infusion Systems, Medtronic MiniMed, Boston Scientific, and Advance Bionics in California.
His current role is to provide Amgen SME medical device support due to 2013 FDA combination product directive. Primary functions include design development, implementations, manufacturing and sustaining roles for single use prefilled syringes and autoinjectors. He is Amgen’s technical lead for SHL and Amgen engagement.
Jonathan Kearns is Senior Program Manager at SHL Medical. He leads Amgen’s complete project portfolio at SHL, ranging from device development, life-cycle management, to consolidation and industrialization. His focus in SHL is managing externally the customer and their needs whilst assisting in strategic initiatives to improve product quality. Internally, he leads the customers project portfolio on a technical level, ensuring that all projects are completed to the highest scientific level and on time/on budget.
Prior to SHL, Jonathan worked at Pfizer based in Cambridge, UK holding roles of growing responsibility within both R&D and operational support. Jonathan also has experience in designing and commissioning packaging lines for the pharmaceutical industry. Jonathan holds an MSc in Biomedical Engineering majoring in Medical Device Design.
Imad Sallit has been with Novartis for 4 years in the manufacturing science and technologies department. He is currently Senior Technical Steward Devices at Stein in Switzerland he is in charge of the technical transfer of the medical device combination product from development to technical operations, Process Qualification, Validation and ongoing process scale-up and improvement
Imad holds a PhD in Material Sciences from the University of Technology of Compiegne, France with a Mechanical Engineering degree from Aleppo University, Syria. He has gained deep experience in medical devices design & development and a solid knowledge of parenteral drug delivery systems. Imad is experienced in product and process supports, operational and manufacturing leadership.
Imad thrives to establish medical devices (mass production) as a factor of competitiveness and commercial advantage at the heart of the added value for the pharmaceutical industry business.
With a background in Industrial Engineering and a Master’s in Management at the University of Padua, Enrico Barichello acquired broad-spectrum skills in technical concepts and complex processes.
He joined Stevanato Group in 2017 as a Product Management Specialist for the Syringe platform.
He defined and coordinated all the activities required to bring the products to market, bridging gaps between different company functions and aligning the involved teams.
From January 2021, he is the product owner, responsible for the roadmap and execution of the new innovative platform SG Alba®
Oliver is a Senior Device Engineer at Roche, based in Switzerland. He has been working in medical devices for over 10 years, enthusiastically involved in technical innovation and development. His interests lie in the space where ingenuity meets with real patient needs.
After reading Engineering at the University of Cambridge, he began his career at DCA, a product development agency in the UK where he led cross-functional teams through the design process for a number of award-winning devices such as injection pens, wearable injectors and connected devices.
At Roche, he is responsible for development and delivery of technologies to support the Roche combination product portfolio.
Extensive experience in the pharmaceutical industry in the commercialization of drug delivery products. Phil has a specific focus on commercial aspects of combination drug-devices and IV to SC switching.
From 2009 to 2018 Phil was Executive Director, Biologics Device Strategy at Merck US. In this role he was responsible for formulating commercial strategies around several biosimilar and oncology device-based combination products including leading marketing efforts for a new subcutaneous Keytruda formulation.
Previously, Phil worked for 16 years with Becton-Dickinson where he was responsible for creating partnerships with Pharma Co’s for Advanced Delivery Technology including intradermal delivery systems, patch pumps and other injection devices. Before joining Becton-Dickinson he held multiple drug delivery roles with Novartis (Zyma) and L’Oreal/Galderma.
Phil received his BSc in Chemistry from Bristol University, UK, a doctorate degree in Pharmaceutical Chemistry from School of Pharmacy Dept, Cardiff University, UK and post doctorate training at University of California, San Francisco.
Salvatore Forte is Innovation Manager at Flex’s Design Center in Milan, leading an R&D engineering team that enables innovative medical devices, while bridging the gap between technology breakthroughs and successful design implementations.
The team’s focus is on smart sensors, actuators, and low-power connectivity technologies. They scout and assess emerging technologies, generate device concepts, and create proof-of-concepts units with pre-verified sub-systems to facilitate the technology transfer into new product design.
Salvatore has a solid technical background in analog and digital electronics, with specialties in embedded system design for power-sensitive medical devices, such as wearable health monitors, disposable point-of-care, and automated drug delivery. Salvatore holds an MS degree in Electrical Engineering from Universita’ Federico II di Napoli, Italy.
Ute Schleyer studied biology with a focus on microbiology at the Johann Wolfgang von Goethe-University in Frankfurt. After receiving her Ph.D. with honors, Ute spent 4 years in the position of lab supervisor at the Institute of Biotechnology, based in the Research Center Juelich, one of the largest interdisciplinary research institutions in Europe.
In 2007, she joined Vetter as a Manager of Aseptic Production. In 2008, she was promoted to production manager for the manufacture and filling of sterile drug products, which included single-chamber and dual-chamber filling lines.
In 2016, Ute Schleyer was appointed Project Manager in the Site & Plant Development department of Vetter. In this position, she is responsible for supporting pharmaceutical engineering projects including V-CRT®.
Uri heads up the drug delivery sector within CDP, leading a variety of design projects including an award-winning needle safety device, an emergency auto-injector, a pen injector packaging design for delivery devices and inhalation products.
These projects included compiling design history files and led to successful submissions to both the FDA and the EMA.
Uri has worked in industries including aerospace and defence, medical devices, automotive and inkjet. He has extensive knowledge of design for manufacturing and process design and was involved in setting up several production lines around the world in the automotive inkjet and medical devices sectors.
Brennan is an accomplished medical device expert with an extensive background in managing and delivering innovative, high-value programmes across a range of medical technology and pharmaceutical delivery routes including: infusion, injection, intranasal, implantable, ocular, oral, respiratory, and topical applications. He also has hands-on experience of gaining device approval within the regulatory frameworks.
Prior to his appointment at Team, Brennan worked on the development of medical devices for the pharmaceutical company Pfizer as well as in other sectors for several large multi-national national companies. Brennan has a BSc (Hons) degree in Product Design and Engineering and is the named inventor on several patents.
Camille Maury joined BD in 2016. She currently holds the role of Project Manager, being responsible for the development of new products for BD Medical – Pharmaceutical Systems.
Camille held various positions in project management, with increasing scope of responsibilities in vaccine and chronic disease applications.
She graduated from Institut National des Sciences Appliquées at Lyon (France), holding an engineering degree in materials sciences, specialized in polymer processing and properties.
Anja Doerfler has been with Novartis for 9 years in several roles in sterile manufacturing, quality assurance and manufacturing science and technologies.
She is currently Senior Technical Transfer Lead at Stein in Switzerland and responsible for the project management of launches and technical transfers of pre-filled syringe and medical device manufacturing.
Anja graduated in Chemical and Biological Engineering at the Friedrich Alexander University in Erlangen, Germany and entered the pharmaceutical industry as Global Trainee at Sandoz gaining experience in different sites, countries and departments.
Nick Carrara is an Insights Manager at Matchstick, with experience in user research studies and empathy-building programs to create better delivery devices for infusion, inhalation, and injection.
Nick’s work with pharma clients spans HCP and patient research, translation to user requirements, and creation of target product profiles for devices, containers, and molecules. His work on patient-centered design initiatives for pharma clients empowers scientists and engineers to incorporate end-user insights early in the drug and device development process.
Prior to Matchstick, Nick worked as a translational research scientist for Prolong Pharmaceuticals in clinical biomarker and formulation development for PEGylated molecules. He is the author of 2 peer-reviewed publications and 7 international and regional conference presentations.
He received his BS in Biology from Longwood University and his MS in Biology from The University of Kentucky.
Emil Fraenkel works as part of Phillips-Medisize’s Development as a sustainability engineer.
As a young professional, Emil is passionate about investigation environmental issues in the pharmaceutical industry.
By working at Phillips-Medisize, he can engage with quantitative sustainability assessments, practice life cycle assessments, and drive product sustainability initiatives.
Vincent Cazanave is a senior device engineer and has more than 10 year's experience in the medical device and pharmaceutical industry in various leading roles.
Today, belonging to Device & Packaging development group at Roche, in Basel CH, Vincent is leading device teams for developing specific drug delivery solutions for molecules in the pipeline. He is also leading the global Roche/Genentech Ophthalmology Device Technology Center, which has the objective to develop drug delivery platforms for the future Roche Ophthalmology portfolio.
Before his time at Roche, Vincent spent five years at Technoflex in France in different R&D and product development roles to develop IV bags and medical device polymer-based components.
Vincent holds a Master's degree in Mechanical and Material Engineering.
Edgar Bauer started working for Bausch+Ströbel in 1989. He completed several dual training courses (technical and commercial) and has taken several opportunities to acquire proficiency in other fields.
He has held various positions in different departments and has therefore gained thorough knowledge of the requirements of the pharmaceutical industry over the past years.
Since 2000, he has been in charge of the French market as well as the support of international Key Accounts. Together with his team he is responsible for sales, marketing and project coordination.
Dr Beck is the Connected Health Innovation Leader for Advanced Drug Delivery Solutions for Pharmaceutical Systems, Becton Dickinson (BD). She is responsible for driving the digital program for connected drug delivery solutions, identifying & developing future innovative value offerings and leading research & development activities.
Prior to joining BD Dr Beck successfully delivered a wide range of multidisciplinary projects in clinical and neuro-rehabilitation settings, academia and in business.
She holds a PhD in Biomedical Engineering, a primary degree in Electronic Engineering and has 47 publications in peer-reviewed scientific journals and conference proceedings in biomedical engineering and medical fields.
Josh Horvath is a Senior Director at Genentech in the Device and Packaging Development organization. His team focuses on the development of novel device technologies for early stage clinical trials and human factors engineering support for the Genentech combination product portfolio.
Josh joined Genentech in 2013 and prior to joining Genentech, Josh spent seven years with Becton Dickinson in variety of R&D and product development roles.
He is listed as an inventor on more than 35 issued patents and is the author or co-author of 15 peer-reviewed journal articles. Josh holds a B.S. in Chemical Engineering from the University of Florida and a Ph.D. in Chemical Engineering from Carnegie Mellon University.
David Kang is Associate Director of Drug Delivery at Halozyme Therapeutics. He has been with Halozyme since 2008 and is a subject matter expert in recombinant human hyaluronidase facilitated rapid, large volume subcutaneous administration of biotherapeutics.
Prior to that, David spent over a decade between Pfizer and Schering-Plough researching oncology therapeutics and viral based gene delivery.
David is a graduate of the University of California at San Diego and started his research career at UCSD Medicine working on gene therapy approaches on infectious disease before transitioning to the bio-pharmaceutical industry.
Guido has over 15 years of diversified experience in process design, product development, project management and manufacturing for medical devices, biotech and pharma industries.
He joined Roche in June 2018, currently he is leading a large team of medical device engineers, process engineers, project leaders to file and launch new combination products to enable home use for several therapeutic areas. Prior to Roche he worked for Merck, Röchling, Nemera und Balda in similar positions with increasing responsibility.
He holds a degree in Process Engineering from OWL University of Applied and Lean Six Sigma Black Belt.
Tom studied chemical engineering in Antwerp and added a MBA from the university of Sankt Gallen to his resume.
After working in the chemical and pharmaceutical sector in Belgium for 3 years he joined SCHOTT in 2008.
After different positions in the pharmaceutical product development department he became part of the product management team with focus on the SCHOTT TOPPAC® brand. In this role he works on the strategic orientation and innovation pipeline of the product group.
Wenzel Novak is the Global Senior Director Business Development MDS at Gerresheimer Bünde GmbH.
Bob Scrase is Director of User Experience at Phillips-Medisize.
Bob has a background as a product designer, with over 18 years’ experience in design and research consultancy where he has worked across many sectors including Medical, Diagnostics, Pharma, Consumer Electronics, FMCG and industrial.
He is an expert in working with people to understand their fundamental needs, shaping them into meaningful innovations and engaging experiences across systems of product, digital, service, packaging and brand.
Jakob is an Engineer and Materials Scientist by training with an MSc degree in Chemical Engineering from the Royal Institute of Technology in Stockholm, Sweden and a PhD in Polymer Science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers and is a regular contributor to technical and scientific conferences.
Jakob started his professional career as a Research Scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, Switzerland. He then worked in R&D Management with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006.
With Ypsomed he has held different positions within Marketing and Sales as well as in R&D Project Management. Currently he has the role of Senior Director Delivery Systems, overseeing two teams of Product Managers, one managing Ypsomeds autoinjector platforms and the other focusing on customer relationships for device development projects and marketed device products.
Wendy 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.
Wendy 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.
Paul leads Design and Innovation at Team, working closely with clients and colleagues to improve the user experience of medical devices, through carefully crafted industrial design, digital UI/UX, packaging and information design solutions.
With over 20 years’ experience helping clients bring innovative, user centred products into reality, Paul focuses on helping clients at the front end of development, to set the right direction and ensure user, commercial and technical needs are thoroughly understood.
His recent involvement in a number of early stage connected device programmes has reinforced Paul’s belief that the adoption of design thinking not only results in great products but helps to overcome many of the challenges that project teams face during the early stages of development.
During his time at Team, Paul has led the development of many innovative award-winning products including drug delivery devices, surgical devices, consumer medical products and complex critical care systems.
Andreas is Innovation & Business Development Director with Ypsomed Delivery Systems. He leads a team that focuses on the definition and development of new drug delivery device platforms, such as next-generation autoinjectors, wearable large-volume injectors, connected systems and digital solutions.
Andreas drives Ypsomed’s Scientific Research & Communication Program with the goal of creating new insights around self-injection devices that are relevant to both industry and academia.
Andreas has published various articles in leading peer-reviewed journals and held various conference presentations in the area of drug delivery, including Podium Presentations at earlier PDA Universe of Pre-Filled Syringes and Injection Devices.
He received his PhD in Innovation Management and Organization Sciences from ETH Zurich, Switzerland.
Susan is currently Director of Commercial Technology Development at West Pharmaceutical. Prior to joining West, Susan has held various technical, commercial and academic roles in the Healthcare industry with Datwyler, W.L. Gore and as an Adjunct Professor at Temple University. She also serves as Vice Chair for the PDA Packaging Science Interest Group. She holds a B.S. in Chemistry from the University of Rochester and a Ph.D. in Physical Chemistry from the University of Pennsylvania.
Mathias Romacker was most recently Senior Director, Device Strategy at Pfizer HQ in New York City. He joined Pfizer in March 2015. In this commercial role, he focused on the front end of device technology. He worked with multiple functions and sites across the organization to develop a device strategy for Pfizer pipeline and inline products.
Previously, for a duration of 9 years, Mathias worked 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.
Mathias is on the PDA Board of Directors.
Klaus Ullherr has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry.
In March 2000, he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid (now Syntegon Technology). During the first two years, he was responsible for handling complex customer orders. Since 2002, he is product manager for the business fields syringes and filling systems with global product responsibility.
His main responsibilities are Market Analysis, Initiating New Product Developments, and Business development. He is an expert for syringe processing. He is member of the "PDA Interest Group Pre-filled Syringes" and works as an expert in the DIN/ISO group for primary packaging.
He is a well-known speaker at conferences covering trends and solutions for fill/finish equipment especially for pre-filled syringes and single-use-filling-systems.