Committee & Presenter Biographies

Dominick DeGrazio joined GlaxoSmithKline in August 2022 as an Early Device Project Engineering Lead where he is responsible for de-risking drug-device combination product development of early stage assets. Most recent to GSK, Dominick was a Manager of MS&T at PTC Therapeutics and lead drug product fill-finish process development, tech transfer, and process validation activities for early and late-stage gene therapy products. Additionally, he supported the commercial launch of Upstaza, the first approved gene therapy treatment for AADC. Prior to PTC, he spent about 10 years combined between Janssen R&D, Oncobiologics, and West Pharmaceutical Services. During this time, Dominick focused on formulation, process, primary packaging and combination product device development for large molecule drug products.

Kiley Djupstrom is a founding Sustainability and End-of-Life co-program manager with KiiP (Kilmer Innovations in Packaging) – a healthcare packaging industry collaborative seeking to improve patient outcomes and clinician delight through the science and engineering of sustainable packaging. For over 15 years, Kiley has dedicated her career to developing and commercializing novel technologies for the betterment of patients and the planet. Her professional experience has spanned the value chain as well as technical and commercial disciplines from upstream R&D to downstream commercial leadership.

Kiley started her career in research and development in the life science and biotechnology sectors. While at Virent, she contributed to developing catalytic chemistry technology to convert plant-based materials into chemicals and fuels identical to those made from petroleum. Kiley then gained downstream converting experience in progressive commercial roles with Plastic Ingenuity, a developer of thermoformed packaging solutions for the world’s leading brands.

Most recently, Kiley led commercial development with responsibility for crafting and executing growth strategies, identifying and developing market opportunities, and delivering a differentiated customer experience. Kiley studied biochemistry at the University of Wisconsin, holds a Master’s Certificate in Project Management, and values continuous professional development.

Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years of experience in Production Management, Quality Assurance, and Technical Leadership. More recently with a global technical role leading CCIT initiatives with an emphasis on quality risk management as part of the application of a holistic science-based approach.

Bridget is the Director of Supplier Sustainability at Takeda Pharmaceuticals. She is been with Takeda for 5 years, responsible for development and implementation of Takeda’s Net Zero strategy for Scope 3 and Takeda’s supply chain. Bridget is also the co-lead for the PSCI Scope 3 Topic Team and has held various roles within PSCI since joining Takeda.

Bridget has over 20 years of experience in sourcing and supply chain management, with the past 10 years focused on supply chain sustainability. She graduated with her bachelor’s degree from Arizona State University, and an MBA with a Finance concentration from Bentley University and a masters in International Relations from Northeastern University.

Amy Gindhart, MS is the Manager/Principal of Scientific Communications at West Pharmaceutical Services Inc. in Exton, Pennsylvania, USA where she works on various research projects to help evaluate performance of West products. Her previous experience involves working as a Senior Scientific Editor / Database Supervisor at the International Centre for Diffraction Data where she ran a top pharmaceutical drug and experimental x-ray diffraction database for the non-profit organization for over a decade. She received her Bachelor’s of Science degree in Chemistry from Lebanon Valley College, Annville, PA, USA and went on to receive her Master’s Degree in Chemistry/X-ray Crystallography from The University of Toledo, Toledo, Ohio, USA. Her research focus while there was on negative thermal expansion of AA’W3O12 compounds with respect to temperature and pressure changes using solid state chemistry techniques.

With a packaging degree from Michigan State University, Jenn has been dedicated to improving patient safety over the past 17 years. She has partnered with cross-functional teams across multiple organizations to bring lifesaving technologies to the healthcare market. Jenn began her career as a packaging engineer at Edwards Lifesciences where she held roles in new product development, global operations and quality engineering. She then moved to Stryker, taking on roles with increasing responsibility and complexity to further help drive change, reduce costs and develop talent. With a diverse background in packaging engineering, labeling, quality engineering and electrical approvals engineering, she can effectively identify and solve various problems in the healthcare sector. She now holds the role of Global Director, Product Strategy at Oliver Healthcare Packaging. In this role, she identifies unmet needs in the healthcare packaging market to better define and deliver Oliver's global product strategy.

Sharath Gopal is a Senior Advisor in Delivery Devices and Connected Solutions at Eli Lilly and Company. He has 20 years of experience in the medical device industry, spanning multiple roles in device design, computational modeling and testing. At Lilly he is part of the Container and Process Innovation team, leading the development of novel container platforms and related subsystems.

Key Account Manager Europe for Körber Pharma Packaging Materials. Sales responsiblity for European Pharmaceutical Companies. Packaging expert with more than 25 years of experience in the business of secondary packaging made from cardboard. As a cardboard packaging specialist for the pharmaceutical industry, Körber offers innovative high-quality packaging solutions that make the difference.

Peter Harley, MEng PhD FIMechE, Head of Technology, Crux Product Design. he is leading a multidisciplinary team of experts in applied sciences, simulation, data analytics, machine learning, life sciences, electronics and software. Peter has background in automotive and consumer electronics where simulation is key to rapid development and de-risking, and therefore reduced time to market. Now he is translating previous experiences into robust investment opportunities in the medical device and pharmaceutical space, with a key aim to deliver accurate digital twins, develop forensic post-processing techniques, and drive sustainable surrogate modelling techniques.

Dr.Ing. Kurt Kugler holds a Diploma in Chemical Engineering (2010) and a PhD in Electrochemistry (2015). Kurt has been working for Schreiner Group since 2015. He has deep knowledge and experience in product and process development for Printed Electronics and RFID applications. Since 2020 he is Business Development Manager for Healthcare Solutions at Schreiner MediPharm. His main focus is on Sustainability since 2021, being the Product Manager for Sustainable Solutions at Schreiner MediPharm. In this position he is also a Co-Founder and representative for Schreiner MediPharm within the Alliance to Zero.

Claudia Langjahr is Packaging Development Engineer since 4 years for Körber Pharma Packaging Materials with a focus on sustainable packaging made out of cardboard materials. Degree as a Bachelor of engineering at "Hochschule der Medien" in Germany. She is a cardboard packaging specialist for the pharmaceutical industry, Körber offers innovative high-quality packaging solutions that make the difference.

Diana started her career in the medical device industry prior she joined SCHOTT in Summer 2018. In her role as Global Product Manager for bulk vials, she is responsible for the product strategy, including the identification of new market opportunities and the development and launch of innovative products.

Marco Longhin is a Technical Leader in the Product Development of Stevanato Group. He obtained a master’s degree in Material Engineering at Politecnico di Torino, and a Ph.D. in material science at Université de Montpellier. He researched inorganic materials at Penn State University (PA, USA). He then worked as Researcher in the private company Luxottica (IT). He currently works on developing new primary and secondary packaging. He focuses on sustainability, optimizing products and processes to reduce their environmental footprint.

Ina Pahl studied Chemistry at the University of Hannover and earned the Ph. D in 1996 at the University of Hannover. She started with Sartorius Stedim Biotech 25 years ago. She has experience in Process Development and Cross Flow Product Development. Since the beginning of her career, Ina coordinated extractables topics in the product development department and worked with external analytical laboratories. Today Ina is Senior Scientist in the department of Bag Technology where she works in a team whose tasks are to develop and perform extractables studies, and to evaluate the results thereof. The data are used to provide customer information on extractables data for the assessment of material safety of single-use components. She is publishing in the field of analytical chemistry, extractables data of single use components, and sensors. Ina is active member of DECHEMA and ELSIE.

David Pehlman is Eli Lilly and Company's Group Leader for Container and Process Innovation and part of the company’s delivery device development team. At Lilly, David supports container closure and process development for new delivery needs of Lilly’s drug development pipeline. Prior to joining Lilly, David worked 22 years in elastomer product development with the bulk of that time at Freudenberg Sealing Technologies. His experience spans multiple industries with an emphasis on elastomer seal development and commercialization. David holds bachelor degrees in chemical engineering from Washington University in St. Louis and chemistry from Monmouth College.

Sarah Peláez is a PhD Candidate in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. Before joining ten23 health, she worked three years at Lonza, mainly as scientist in the field of primary packaging development. Her current research focuses on process-related quality considerations of disposable materials. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Frankfurt.

Eloïse has been working at BD as R&D Engineer since 2018. She focuses on evaluating new Plunger Stoppers, problem solving and scientific understanding in addition to supporting material and rubber expertise for pre-filled drug containers. She holds a PhD thesis in Material Science Engineering from National Institute of Applied Science (INSA) of Lyon.

Valentina is a Scientific Program Manager in European Pharmacopoeia Department of the European Directorate for the Quality of Medicines & HealthCare (EDQM)and is a qualified pharmacist with a PhD in Chemistry obtained from the University of Zagreb, Croatia.

She started her professional career in 2006 with a community pharmacy internship and, in May 2007, went on to join the pharmaceutical company Pliva (later owned by Teva Pharmaceuticals) as a Research and Development analyst, remaining with the company for 13 years.

From 2015, she was a project leader within the Oral Dosage Forms Division and in 2017 she was promoted to the role of the Principal Scientist – Analytical Project Leader for externally developed products. In April 2020, she left Teva to join the EDQM where she currently co-ordinates and provides the technical secretariat for the work of three Groups of Experts and Working Parties that elaborate pharmacopoeial texts covering plastic materials, plastic and glass containers for pharmaceutical use and closures, and non-biological complexes.

Heino Prinz, Dr, PhD, Product Manager at Rommelag Education as a Chemist at the University of Ulm Main focus was Physical Chemistry within high resolution infrared spectroscopy. From 1991 Head of department of Theoretical Chemistry at „Centre of Solar Energy and Hydrogen Research“ in Ulm.

From 1997 at Uhlmann Pac-Systeme GmbH & Co. KG in Laupheim, responsible for the introduction of NIR-Spectroscopy into the packaging process Co-founder of Uhlmann VisioTec GmbH in 2000 where he became Head of R&D. In August 2010 he joined Wilco AG, in charge for research and development. In February 2014 he moved to Rommelag heading the department of inspection devices, working on vision technology, container integrity testing and many other monitoring techniques in the blow fill and seal area. Recently he took the position of a Product Manager for Rommelag with specific focus on GMP and Inspection Processes.

His profound knowledge of the pharmaceutical industry and his expertise in the equality aspects helped the companies to realize high-speed Inspection systems which are used in numerous applications in the pharmaceutical manufacturing process as in line Quality tools. His expertise in in physics and chemistry helps customers around the world to understand pharmaceutical processes deeply and better, thus improving quality and dramatically reducing QC costs.

Dr. Christian Proff is a Senior Verification Engineer at F. Hoffmann - La Roche in Basel. He is materials scientist with degrees from Chalmers, Gothenburg (S) and Darmstadt (D) Universities of Technology and a PhD from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory) and Switzerland (Paul-Scherrer-Institut). Within Device and Packaging Development at F. Hoffmann - La Roche he is working in Verification Engineering since 2018 on improvements in CCI testing and development of new device test methods.

Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions at Eli Lilly and Company, Indianapolis, U.S.

A native from France, she came to the U.S. to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards. In her current role she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping and distribution, surface science, and several related DDCS laboratories. Her global team support clinical and commercial development activities across all business units.

Accomplished primary packaging material expert with a master degree in Bioengineering with emphasis in drug delivery system and over 8 years experience in primary packaging development. After university, he joined Baxter Healthcare Inc. as Product Engineer where he was supporting the design verification/validation activities off new flexible bags for peritoneal dialysis and hemodialysis treatment and design change control tasks and CAPA assessment for products already on the market.

Then, Federico moved to glass primary packaging material industry where he was working for Nuova Ompi, Pharmaceutical System Division of Stevanato Grouo, as Technical Project Lead. In this role he was leading the development activities of an innovative multi-products platform of sterile glass primary packaging systems (e.g. syringes, cartridges and vials) for injectable, highly sensitive drugs (e.g. biotech drugs) from design concept to commercialization. He is currently working as Associate Principal Scientist in Primary packaging materials and Combination products at Lonza Drug Product Services leading the implementation of PPMs and Container Closure System Qualification strategy for Vial Closure System and PFS based combination products in the Lonza DPS manufacturing site network.

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.

Dr. Simianu is a transformational and influential leader in Bio-Pharmaceutical industry, poised to advance realization and supply of technology and therapeutic products in service of personalized medicine and public health outcomes.

She has delivered business, technical and operation outcomes for large biopharmaceutical. Led to successful approval of more than twenty (20) new therapeutic agents. Operated cross-functionally and applied boundaryless leadership principles in complex matrix organizations. Directed teams on the introduction of commercial processes at more than (thirty) manufacturing sites in US, Europe, and Asia.

Mihaela managed technical groups responsible for implementation of post-approval changes for more than forty (40) commercial products manufactured at Merck &Co, Amgen, Eli Lilly and their respective Contract Manufacturing Organizations.

Currently Dr. Simianu is Scientific Advisor at SmartSkin Technologies and President of Concordia MCS, LLC, applying strategic and tactical expertise in sterile product end-to-end life cycle management to guide executives, business, operations, technical and quality leaders achieving targeted outcomes for modern or legacy therapeutic agents (biologics, vaccines, and pharma products). Dr Simianu holds a Ph. D in Chemistry from Marquette University, WI, a M.S/B.S. degree in Chemical Engineering from Babes-Bolyai University of Cluj-Napoca, Romania, and certification from Jack Welch Management Institute.

Dr. Satish K Singh is currently a Distinguished Fellow and leads the Drug Product Development group at Moderna Inc., where he has been deeply involved with the development, launch, and commercialization, of the mRNA-based Covid-19 vaccine. Satish has held a related position at Lonza Pharma and Biotech and was Research Fellow and Group Leader at Pfizer’s BioTherapeutics Pharmaceutical R&D unit prior to 2016.

Satish has long experience in the biopharma industry in product development activities and is an internationally recognized expert in all aspects of (bio)pharmaceutical Drug Product (biologics, vaccines) development. Satish has a strong technical background in (biological) drug product development, complemented by a deep understanding of regulatory challenges and the evolving regulatory landscape, and has more than 90 peer-reviewed scientific publications as well as several book chapters covering multiple topics.

He is involved in various professional groups through the AAPS as well as the USP and is a member of the expert panels that wrote USP<787>, <1787>, and <771>. He was elected as a Fellow by the AAPS in 2018. His research interests also include the investigation of impact of freezing processes on proteins, use of computational approaches to mitigate develop-ability issues, protein aggregation and immunogenicity.

Satish obtained his B.Tech. Chemical Engineering from the IITD Delhi and an M.S. and Ph.D. in Chemical Engineering from Kansas State University. Satish also holds the positions of Adjunct Professor at the Dept. of Physical Pharmaceutical Chemistry at Uppsala University, Sweden, and at School of Pharmacy, University of Michigan, Ann Arbor, USA.

Jean-Sébastien Steffen leads the Combination Product and Primary Packaging development organization with Lonza Drug Product Services (Basel, Switzerland). He supports Lonza’s customers with a long experience in technical development of combination products for clinical and commercial applications.

Jean-Sebastien has also been a key player in establishing global prefilled syringe technology platforms for different large pharmaceutical companies and developed extensive expertise regarding container closure integrity, drug-container interaction and combination product functionality questions. Jean-Sébastien holds a PhD in Health Engineering from Arts et Metiers ParisTech (France) and a Master’s degree in Mechanical Engineering from Karlsruhe Institute of Technology (Germany).

Steve Whettingsteel is founder and CEO of Krysteline Technologies Ltd, developer of specialised engineered solutions for the waste management sector, particularly in the recovery and refinement of glass. In the 1990s Steve was working as a marine engineer on cruise ships, there was an urgent need to change and develop the way glass recycling was being handled onboard. This led to him developing “glass implosion”, the unique, patented technology behind Krysteline’s machinery.

Since its formation in 1999 Krysteline has been exporting, with machines being sold around the world. Early customers including; the British Antarctic Survey, a laboratory in the Falkland Islands, super yachts, hotels and pharmaceutical companies. Fast forward 20+ years and thanks to years of ongoing investment in research and development Krysteline has also developed an enviable reputation for high quality refined glass suitable for cullet, cement, foam glass, fertilizers, water filtration and expendable abrasives.

His extensive experience in developing specialised engineered solutions for the waste management sector, particularly in the recovery and refinement of glass has refined a strategy for approaching resource recovery from a clearer and more tangible perspective. A hands on approach in the development of an International corporate strategy has reinforced a belief that all waste glass arising’s can and should be recovered with equal priority and importance.