Dr. Theresa Bankston is the VP Customer Success at BD Medical – Pharmaceutical Systems responsible for delivering maximum business value across the customer lifecycle, including leading customer scientific advisory services, customer project and program management, and customer combination product development and testing services. She has over 20 years of combined experience in the pharmaceutical and medical device industries with a broad range of expertise, including drug characterization and analytical method development, drug and device process and engineering development, and injection and drug-container integration science. Theresa received her BS in Biochemistry from Florida State University and her PhD in Chemical Engineering from the University of Virginia.
Alessandro has a background in Electronic Engineering with a Master's in Biomedical applications and Devices at the University of Padua. He has been working in the primary packaging field for more than 20 years, focusing on pharmaceutical glass products, combination products, and drug delivery devices.
Member of the PDA, he attended several conferences providing presentations and lectures about primary packaging solutions in the last years.
In addition, as a teacher, he was part of different training sessions with a focus on glass primary packaging properties.
Thanks to his expertise, his role has always been linked to highly technological projects, focusing on developing and promoting innovative solutions considering the different competencies part of Stevanato Group.
He was successfully contributing to developing and commercializing Pre-fillable syringes for Biologic Drug Products.
Frank Bamberg has more than 20 years’ experience in the pharmaceutical industry in various leading roles 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 in July 2019, Frank has been with Hoffmann-La Roche since 2011, responsible as Section Head Pre-Fillable syringe for the development of primary packaging and device which will be in contact with the drug.
Additional Frank has gained his experience in various positions at SCHOTT Pharmaceutical Packaging. He was leading at SCHOTT the global business development & Customer Service for Pre-Fillable syringes. Frank has the MBA in industrial engineering and management from the University of Bern/Zürich and he is plastic Engineer by education.
Nicolas Brandes has worked within the pharmaceutical packaging industry for more than ten years in areas of business development, research & development, technical services and marketing. Currently in his role as Director Global Product Management, Nicolas is responsible for defining new market requirements, launching new products, supporting business development plans, and overall execution of global marketing strategies, all related to West’s portfolio of polymer container solutions. Dr. Brandes received his Ph.D. in Biology from the University of Wurzburg, Germany, after performing his research studies at the University of Michigan, USA.
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.
Bart Burgess is SHL Medical’s Head of Account Management North America. He draws on his varied experiences in business development, primary container technologies, and injection device product development to build new relationships and advise on SHL’s product development approach. Previously, Bart led combination product development at Regeneron, overseeing injection device design from sketch to commercial scale. He also held a variety of technical and business development roles at West Pharmaceutical Services, in both primary container and device technologies. Also formerly, Bart also led business development and product strategy at Portal Instruments, a needle-free injection technology start up.
Christian Helbig leads the Glass Syringes Business Team at SCHOTT Pharma. Christian is focused on partnering with pharmaceutical and biotechnology to provide glass-syringe-based drug delivery solutions and services that help commercialize drug device combination product therapies. His background includes 15 years of experience in development and commercialization of pre-fillable glass and polymer syringes for vaccine & biologic applications. Christian holds Engineering degree in Chemical Engineering applied Biotechnology from University of Applied Science Emden in Germany.
Shirish Ingawale is a Director of Device Development Leadership at Takeda. Shirish has 20 years of diverse experience in research, development, manufacturing, and commercialization of medical devices, drug delivery technologies, and drug/device combination products. Before joining Takeda in May 2023, Shirish worked at Amgen for 10 years where he was accountable for technical leadership, people management, and cross-functional team leadership for the development, launch, and life-cycle management of combination products including reconstitution kits, pre-filled syringes, mechanical autoinjectors, and electro-mechanical autoinjectors and platforms. Before that Shirish worked in various medical device companies and academia. Shirish holds a BS in Instrumentation Engineering from the University of Mumbai, India, and earned his MS and PhD in Biomedical Engineering from Wright State University, Dayton, Ohio, USA.
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.
Akshay Kamdar is the Sr. Director for Container Closure, Materials and Process Innovation in the Delivery, Devices and Connected Solutions (DDCS) organization at Lilly. Akshay joined Lilly in 2009 after receiving his Doctorate in Polymer Science and Engineering from Case Western Reserve University and his Masters in Materials Science and Engineering from Rochester Institute of Technology. He has held various technical and functional leadership roles within Lilly’s Delivery and Device organization focusing on novel container closure systems and combination product development from innovation through commercialization. He is also responsible for leading Lilly’s device and packaging sustainability efforts.
Christian Kollecker is working in the aseptic and liquid filling business for over 14 years and has experience in project and product management, as well as a strong focus to sales and business development.
Christian Kollecker is working at Harro Höfliger as Director Aseptic Technologies. In this position, he is worldwide responsible for all projects regarding liquid filling applications and aseptic requirements for customized equipment solutions.
In this position, he is supporting and consulting his customers during product development until final production scale up. Following the credo “from lab to production”, all kind of aseptic projects are handled by Christian and his team at HH to find solutions for customer specific equipment and needs.
During his engagements in different companies, he gained experiences in various pharmaceutical manufacturing areas like parenterals device handling and manufacturing, product development and integrated machine solutions as well as different countries and cultures all over the world. He holds a graduate degree in industrial engineering from a German university as well as an Open University degree.
Jakob Lange recently started his position as VP & Head of Account and Business Development with responsibility for Ypsomed Delivery Systems' customer relationships and marketing activities. Prior to his current role, he has held different positions within marketing and sales as well as in R&D project management. He has been with Ypsomed for more than 16 years. Jakob holds 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 40 peer-reviewed papers on medical devices, packaging materials and polymers.
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently Director of Technology Development at Terumo Pharmaceutical Solutions 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 is a volunteer to the PDA organization and also serves as expert in ISO technical committees TC76 and TC84.
Manfred Mäder is VP Global Device & Packaging Development in TRD (Technical Research and Development) at Novartis.
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, being 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.
Roman Mathaes is CEO of Clear Solutions Laboratories. Before that he was Head of Pharmaceutical Services at Lonza Drug Product Services. In this role he was responsible for pre-clinical Drug Product manufacturing for vials, prefilled syringes and ampoules. He also lead the packaging and combination product development department and the lab automation group. Roman joined Lonza from Roche. He is a Pharmacist by training and holds a PhD in Pharmaceutical technology from University of Munich, as well as an MBA.
Maggie Reiff leads the R&D organization at Genixus, where she is focused on developing and launching critical care medicines in innovative delivery systems. She joined Genixus in January 2023, aligning with the company's mission to transform acute and critical care medicines through advanced manufacturing and progessive drug delivery systems. At Genixus, Maggie is responsible for leading scientific, technical, and operational efforts of the R&D organization, ensuring that our patients receive the medicines they need.
Maggie holds an MBA from Rutgers University and a BS in Biomedical Engineering from North Carolina State University and the University of North Carolina.
Brigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies including Hilton International and TNT Express Worldwide.
Brigitte joined PDA in 2005 and has been Vice Chair of the Marketing Advisory Board since March 2019. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007, and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of PDA
Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University.
As Director Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine is an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass).
Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87 and is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.
Veluska Bruce is environmental, social, and governance (ESG) Project Manager at SHL Medical.
She plays a key role in implementing SHL’s sustainability program, supporting initiatives that encompass SHL’s three focus areas, namely product, people, and planet.
Veluska holds a PhD in Fiber and Polymer Science from the KTH Royal Institute of Technology in Sweden where her research focused on the design of degradable polyester-based materials. Dr. Bruce has worked in the medical industry for over seven years working on product development and sustainability initiatives. She joined SHL Medical in 2018 where she has worked leading testing activities on primary packaging and devices for various customer projects, innovation research activities and most recently, driving innovations for ESG initiatives and ensuring that the global ESG strategic targets are achieved.
Naresh Budhavaram is a Senior advisor in the Delivery, Devices and Connected Solutions (DDCS) organization at Eli Lilly. He leads material selection and evaluation efforts for new products within R&D division. He is currently leading the Sustainability initiatives in the Devices Group. He has held various technical roles within DDCS. Before joining Lilly, Naresh worked as a polymer product development engineer at Celanese. In this role his focus was developing engineering thermoplastic and bio-based grades for automotive, consumer and electronic applications. Naresh obtained his Bachelor’s in Chemical Engineering from Osmania University, Master’s in Chemical engineering from University of Mississippi and has a Doctorate in Biological Systems Engineering from Virginia Tech.
Teodora Caragea is a Senior Engineer, working for Merck KGaA., where she is responsible for finding digital solutions that can support HCPs (healthcare professionals), patients and their caregivers in their treatment journeys. At Merck KGaA., Teodora focuses on the implementation of the platform that processes data coming from various auto-injectors and she is the technical lead of digital solutions serving therapeutic areas like endocrinology and neurology.
Teodora started working for Merck KGaA. in 2020, where she is leveraging her technology skills that she developed in companies like Microsoft and LEGO to implement digital solutions that can improve patients' lives. She has a Master Degree in Computer Engineering acquired at Aarhus University, and a MBA from the Herriot-Watt University in Edinburgh.
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US), where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).
From 2001 onwards, Dr. Christiaens holds the position of Scientific Director at Nelson Labs (formerly Toxikon Europe) where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of extractables and leachables and developing state-of-the-art analytical methodologies. In the last decade, Dr. Christiaens has been a speaker on the subject of “extractables and leachables” at over 150 Conferences, and since 2014, he has been engaged in the two-day Extractables and Leachables training courses that are hosted by PDA across the Globe. In his current role at Nelson Labs Europe, Dr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.
Bas Coolsma is the Director of Europe for the Healthcare Plastics Recycling Council (HPRC.org). HPRC is a private, technical consortium of industry peers across the manufacturing, healthcare, and recycling industries seeking to improve the recyclability of plastic products and packaging within healthcare. Founded in 2010, and made up of globally recognized members, HPRC engages in pioneering projects designed to help boost plastics recycling efforts in clinical settings of hospitals. He combines this part-time position with a senior management role in ESG sustainability solutions for Antea Group, a global engineering & consulting firm member of the Inogen Alliance.
Eric Dessertenne holds a pharmaceutical degree from the University of Clermont-Ferrand (France), an MBA from ESSEC Business School (Paris, France) and is a graduate of the Therapeutic Chair of Innovation at ESSEC Business School. He began his career in the pharmaceutical industry working for Servier in France in the Corporate Strategy department and then moved to the Chinese subsidiary in Beijing, where he handled positions in the marketing and sales force department. Mr Dessertenne then joined LEK Consulting where he worked as a consultant in the Life Sciences and Private Equity practices. In 2014, he brought his experience and insights on market opportunities to Biocorp as Head of Business Development & Commercial Operations and was appointed Chief Operating Officer in 2016. Since 2019, Eric is CEO of Biocorp.
Wolfgang Friess is Professor for Pharmaceutical Technology and Biopharmaceutics at the LMU Munich since 2001. He received his PhD in Pharmaceutical Technology in 1993 and worked for several years in academia both in Germany and the US. His primary research goals are protein formulation and processing, freeze-drying and new analytical tools for characterization of protein formulations. He is co-editor of the European Journal of Pharmaceutics and Biopharmaceutics and has published over 150 research papers, patents and book chapters.
Bernhard Gerl is moderating the Think Tank Ecodesign at the Körber group and is driving sustainability in engineering projects. With many years of experience as a mechanical engineer in the design department, he understands the challenges in developing projects and the balancing of complementary and competing requirements. Integrating environmental considerations increases the complexity even further. He and his team of the Think Tank support all Körber's engineers in making the right decisions during product development towards more sustainable machines and promote a sustainable mindset throughout the group.
Cédric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design driving human-centered solutions for patients and Janssen customers and leading key innovation projects for device sustainability.
He has more than 15 years of experience in the development and design of devices and combination products. He holds a Bachelor’s in Pharmaceutical Technology from the University of Basel and a Master’s in Medical Device Technology from the Bern University of Applied Science and Stanford University with a specialization in human-centered design.
Keijiro Hatade is now a drug product technical leader for post-launch biotech product at Chugai Pharmaceutical Co., Ltd, Tokyo, Japan. He is responsible for primary packaging material, formulation, process, and device developments in these products. He has over 15 years of experience in the biotech industry. Over his carrier, he has accumulated expertise across a variety of protein therapeutics including drug product process development, combination product development, technical transfer, submission dossier preparation, facility engineering, and clinical trial material manufacturing for biologics. He received B.S. and M.S. in Bioscience from Tohoku University, Japan.
Christiana Hofmann is a medical device and combination product senior professional with more than 10 years experience in the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. From her educational background she is a biologist with holding a Phd in Toxicology. Over the years she gained profound expertise in auditing QMS / MDD / MDR, assessing technical documentation incl. biocompatibility of a wide range of class IIa products. Her main focus and experience is as SME is Art 117 MDR. Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region. She is a recognized conference speaker for drug device combination products, biocompatibility and EU medical device regulation. “She is very passionate about combination products because it is a perfect match for her as she can combine her passion for biomedicine, toxicology, and her experience in medical devices that she gained over the past years.”
Manfred Holzer studied Mechanical Engineering and is engaged as sales manager for isolators in the pharmaceutical industry since 1995. Joining SKAN AG in 2000 he worked in various positions, e.g. as international sales & project manager, USA business coordinator. Since 2016 dedicated Sales Manager for Ireland, he also covers since 2008 the strategic product management sPM for pharma ebeam applications at SKAN.
Chris Howell currently serves as Sr Director for Commercial Packaging and Packaging Engineering for the Pharma Services Group. He provides leadership and support to our global network of commercial packaging sites in North America and Europe. Prior to this global role, Chris was Senior Director with responsibility for the Cincinnati Operations Pharmaceutical Development Services business unit. He also held prior leadership roles in site manufacturing, packaging, and pharmaceutical technology. He holds degrees in chemical engineering (University of Kentucky), biomedical engineering (Vanderbilt University), and project management (Keller Graduate School of Management).
Christoph Joosten obtained a Ph.D. in Chemical Engineering from Cornell University (USA) in 2003, then worked as upstream process development engineer at Bristol-Myers Squibb (USA) and at Novartis (Switzerland). From 2009 to 2012, he held a CMC regulatory affairs role at Novartis. Since 2012, he has been employed at Roche (Switzerland) where he has led or supported several market authorization applications for biopharmaceuticals, with a focus on drug delivery devices and digital solutions.
Reto Jost is Innovation & Business Development Director with Ypsomed Delivery Systems. He has been with Ypsomed since 2014 in a number of roles in product management and business development, working with pharma companies to develop and bring to market innovative self-injection systems. Since 2018 his main focus is in new product innovation, with particular focus on large-volume injections. He holds a MSc in Mechanical Engineering from ETH Zurich and a CAS in Business Administration from HES-SO, Fribourg. Reto has broad experience in medical devices, working in the industry since 2006.
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.
Nathan Kast is the Global Commercial Development Leader for the Advanced Drug Delivery Systems at Becton Dickinson. Nathan has over 10 years of experience in developing, launching, and managing the lifecycle of combination products, including autoinjectors, pens, and wearable injectors. Over the course of his time engaged in combination products, Nathan has helped develop, launch, and commercialize more than a dozen combination products with various large, medium, and small pharmaceutical companies and partners.
Simon leads the Custom Design Solutions team at Cytiva Aseptic Filling (formerly Vanrx), working with new and existing component manufacturers to ensure their products are aseptic-filling machine compatible. The team designs and releases machine tooling that comes into contact with the suppliers' RTU components. Originally from New Zealand, Simon has lived and worked in the UK and Canada, and has been involved in the aseptic filling, medical device, and combination device industries for over 15 years. He graduated with a Bachelor of Engineering (Honours) in Mechatronics.
Peng Li, Ph.D. is currently a Device Program Lead/Principal Scientist in the Device Development group of Merck & Co., Inc. leading the development of various injectable combination products across disease areas and drug modalities. Peng has over 12 years of experience in new product development and project management in the pharmaceutical, medical device, and life sciences industries. Prior to joining Merck, Peng was with Becton Dickinson where he was the R&D lead of the BD Libertas™ Wearable Injector. Peng also worked at Thermo Fisher Scientific where he was a key designer of the SeqStudio™ Genetic Analyzer.
Paolo Mangiagalli is Head of Global Procurement for Device and Primary Containers within Sanofi’s Direct Procurement where he is responsible for defining the sourcing and partnering strategy for delivery drug devices and the associated containment systems. Paolo has more than 20 year’s industrial experience matured in different industries and academic background, including managing Primary Container development for eight years at Sanofi. Prior joining Sanofi in 2014 Paolo spent six years at Becton-Dickinson , most recently as R&D Director of Product & Technology Development. Prior to joining Becton-Dickinson, Paolo held various positions in semiconductor industry. Paolo has a degree in Physics from the University of Milan (Italy), and a PhD in Solid State Physics from the University of Caen (France). Paolo has more than 25 publications in peer reviewed journals and is frequently invited to international conferences.
Mr. Daniel Mueller studied Pharmacy at the University of Wuerzburg, Germany, followed by his doctorate. He started working in the pharmaceutical industry in 1998. Previously he served as a qualified person for sterile products (large volume parenterals) and in 2001 he joined a German GMP Inspectorate at Tuebingen, Baden-Wuerttemberg. Since then, he has been working as a GMDP-Inspector with focus on biotechnological active pharmaceutical ingredients and sterile drug products. Currently, he is the head of the GMP Inspectorate at Tuebingen. Additionally, Mr. Mueller is a member of the German Expert Groups "Biotechnology and Tissue" and "Quality Assurance". He has got further qualification in pharmaceutical analytics and public health management.
Chiko Ncube is an Inclusive Designer for GSK R&D. She has over 10 years work experience in Inclusive Design and User-Centered Design and Research. She has a PhD in Inclusive Design for Healthy Ageing from the UK SURFACE Inclusive Design Research Centre and has led and contributed to inter-disciplinary design research in healthy ageing and care, disability and user capability and digital technology innovations. Her work experience has focused on embedding the insights from people with diverse capabilities to develop innovative solutions, strategies, development processes, and designs. Chiko is currently leading and contributing to projects related to the investigation of patient insights and user capability data and insights for disease areas and exploring inclusivity in Human Factors device development and engineering processes.
Dave Pearce is Inclusive Design Lead for GSK R&D. His professional career of 26 years in the User-Centered Design and Human Factors space has spanned the Tech (Xerox) and Pharma (Pfizer; GSK) industries – all of which has focused on developing optimized solutions for usability and use experience through a deep understanding of users and their context. Dave is a tireless and passionate advocate for the user, continuously influencing his organization to move the user up the agenda and, through his strategic work, embed the voice of the user into product development processes. Recently, Dave led an industry/academia collaborative project to develop a robust research tool and methodology to gather User Capability data and insights, the output of which enables the construction of intimate user profiles that inform design decisions and provide key design signposting for drug product development programs.
Stephen Perry is the CEO and Founder of Kymanox – a diversified and global professional services company solely focused on the Pharmaceutical, Biotechnology, Medical Device, and Combination Product industries. Stephen has extensive CGxP experience as a Process Engineer, Technical Project Manager, Quality Auditor, and Regulatory Strategist. Stephen leads a team of 300 professionals worldwide and has been formally recognized as a top CEO in the Research Triangle Park (RTP) region. As an entrepreneur, Mr. Perry has successfully attracted growth capital from WestView Capital Partners and has further grown the unique Kymanox platform with the acquisition of four companies.
Mr. Perry has also helped several CEOs raise Series A venture capital. Before starting Kymanox in 2004, Stephen had various leadership roles supporting scale-up, start-up, and commercialization initiatives at Abbott Laboratories (now AbbVie), FujiFilm Diosynth Biotechnologies (a global CDMO), and Human Genome Sciences (now GSK). Stephen has a diverse educational background with a high-honors bachelor’s degree in Chemical Engineering from the University of Notre Dame and studied at the graduate level at Purdue University. Stephen is a long-time supporter of the International Society of Pharmaceutical Engineering (ISPE), Parental Drug Association (PDA), Project Management Institute (PMI), and Regulatory Affairs Professional Society (RAPS).
Stefano holds a master degree in Materials Engineering at the university of Padova. He has been working in the primary packaging field for eleven years, focusing on pharmaceutical glass products, combination product and drug delivery devices. He had the possibility to successfully leading and contributing in developing and commercializing glass Vials and Pre-fillable syringes for Biologic Drug Products. With a background in project management in Quality Assurance, today he is leading DCS Process Development, responsible for overseeing the initial phase of product development projects being the reference for the technical knowledge of processes and materials related to container closure system.
Andrea Pisa leads the Human Factors and Usability team at Crux Product Design Ltd (Bristol, UK), ensuring that the Human Factors process is seamlessly integrated into product development to produce safe, effective and user empathic solutions. She has supported leading pharmaceutical clients on projects spanning the entire design process, taking medical devices and combination products from design input to market submission. With a passion for uncovering latent user needs and a global background in design engineering, Andrea brings a wealth of knowledge when tailoring usability strategies to maintain the integrity of design development whilst keeping the user at the core.
Sven Pohle is Global Product Manager for Glass Prefilled Syringes at SCHOTT Pharma, where he is responsible for portfolio management and launching product innovations. Prior to that, Sven worked for over ten years in various R&D positions in dental industry. He holds a PhD in Polymer Chemistry from Technical University of Braunschweig, Germany.
General Manager of a Multi-country organization managing the General Medicines portfolio in the BeNeLux & Nordics (Denmark, Island, Norway, Sweden & Finland) for Sanofi. Passionate about Pharmaceutical Strategy & Marketing with focus on creating meaningful & valuable outcomes for customers. Strong believer that excellent cross-functional collaboration with good team leadership is key to success. Not the best player but the best TEAM will win. Alexander brings 20 years of experience and leadership in Pharma & Medical Devices with a strong footprint in Diabetes & Cardiovascular.
Throughout his career he had the opportunity to support various product launches of pharmaceuticals & medical devices in global and local leadership functions. In addition to that he has led several device development projects. Alexander has a background in Marketing & International Management holding a Master’s degree of the University of Mannheim.
Andreas Schneider, PhD, is Head of Innovation at Ypsomed Delivery Systems. He leads the design and development of new products, services, and business models focusing on improving the self-management of chronic diseases. He specializes in the pharmaceutical industry and medical devices with an emphasis on drug delivery technologies, pharmaceutical development & manufacturing, and digital health.
Andreas has published numerous articles on innovation management and drug-delivery and is an avid speaker on these subjects. He holds a Ph.D. in Innovation Management from ETH Zurich, Switzerland.
Jiaying Shen obtained her Ph.D in Industrial and System Engineering from University of Wisconsin – Madison and she has over 18 year experience in pharmaceutical and medical device industry. She is currently a distinguished scientist in the device development department at Merck, managing a team that are responsible for Design Control and Risk Management process and strategy and other Device Quality and Regulatory issues for drug delivery devices. She also has a focus in digital solutions and digital health areas. Prior to join Merck, she worked at Medtronic Neuromodulation R&D and Honeywell automation and control laboratory.
Hervé Soukiassian joined BD-Pharmaceutical Systems business 15 years ago and is currently the leader for Product Development pertaining to Prefillables Syringes for Chronic therapeutic segment. He has also contributed actively within the PDA – co-author of the TR85 “Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers” and the TR 73 “Prefilled Syringe User Requirements for Biotechnology Applications”.
Prior to joining BD, Herve worked for 13 years at Hewlett Packard in various positions gaining experience and developing expertise in the field of process engineering and product development. He later joined the board of Directors of ActiCM, a start-up company associated with the “Commissariat a l’Energie Atomique (CEA)” and specialized in optical Coordinate Measurement Machines.
Herve graduated from the Institut National des Sciences Appliquées of Lyon as a mechanical and industrial engineer with a master’s degree in material sciences.
Glenn Svedberg, M.Sc. in Industrial Engineering & Management, is an experienced leader serving as Managing Director in various companies such as Flex, Rexam and Nolato for more than two decades. He has been in the Pharma Packaging and Medtech industry for 15 years. Today he has a combined role as Group Sustainability Director for Nolato group, member of the Executive team, and VP Global Business Development & Technical Design Center for Medical Solutions at Nolato. He has a genuine interest in sustainable development and lean philosophy, and by combining that with the product and business development this is a hot spot for many companies today.
Ying Wang is an Associate Research Fellow and the Head of Device Development Science in Device Centre of Excellence (DCoE) at Pfizer, Cambridge UK. Ying holds a PhD in Pharmaceutical Development and a BSc in Analytical Chemistry. Ying joined Pfizer, Cambridge UK after completed her PhD in 2006. Ying has over 25 years of analytical, statistical, and engineering experience in small molecule, large molecule, inhalation and injectable drug delivery device development. As the head of Device Development Science, she has led the testing and control strategy development activities for several now marketed or to be marketed products. Ying is a technical expert on combination product development with extensive focus on testing and control strategy, design verification, stability and shelf-life assessment, transportation and shipping studies, test method development and validation, process qualification and validation. She is also an expert on statistical sampling, Design of Experiment, Quality by Design and data analysis. Ying is a member of ISO/Technical Committees (TC) 84: Devices for administration of medicinal products and catheters, presenting on behalf of the British Standards Institution. She is also a Chartered Chemist, Member of the Royal Society of Chemistry.
Dr. Weikart is responsible for managing both internal and external R&D initiatives, including collaborative studies at domestic and international universities, customers and research centers. He has oversight for the company’s innovation strategy and the development of new technologies to address customer-centric problems. Dr. Weikart works closely with SiO2’s Scientific Advisory Board and technical consultants for launching new technical initiatives. He also works closely with the intellectual property department to provide technical support for patent filings and trade secret preservation. He is the technical ambassador and spokesman at conferences, customers, and regulatory bodies. Dr. Weikart earned a PhD in chemical engineering from the University of Missouri-Columbia. He worked in Central Research at the Dow Chemical Company for 12 years in various R&D, engineering and leadership roles.
Markus Winter is Mechanical Engineer with Harro Höfliger’s Engineering and Technical Services department and works in the field of standardization and advanced development. His primary role is to promote and implement eco-design practices at Harro Höfliger. He is responsible for the application and expansion of energy and material efficiency, as well as employing techniques such as additive manufacturing and topology optimization. He holds a bachelor's degree in Mechanical Engineering and a master's degree in Resource Efficiency.
Rumi Young, MENG, RAC is the Director of Regulatory Policy at Becton Dickinson (BD) responsible for US and Global Harmonization regulatory policy. Rumi leads a team that advances policies promote innovation and reduce regulatory burden for medical devices, diagnostics, and drug delivery combination products. Rumi joins BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors, and smart connected devices. Prior to FDA, Rumi worked at Genentech and AstraZeneca for eight years in combination product development. She has both a Bachelor’s in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.