Bringing 10-plus years of industry experience, Marieta Duvnjak is passionate about innovative technology, scientific strategy, innovation, and supporting and connecting people. Marieta is a subject matter expert for in-vitro release method development and in-vitro/in-vivo (cor)relations for long-acting injectables.

Before joining Novartis technical R&D in 2018, she worked on preclinical and clinical development of value-added oral and long-acting generic products at Teva Pharmaceuticals.

Marieta holds a master's degree in drug research and development and PhD in pharmaceutical sciences.

Bjarne Sørensen is a director of front-end innovation at Phillips-Medisize, based in the company’s development centre in Denmark. With more than 35 years of experience within product, strategy, and business development, Bjarne has a very visible track record within different business areas. At Phillips-Medisize, he participates in customer projects, typically involving electronic injectors and connected health systems. He is also deeply involved in new electronic platform programs, especially on conceptual, technical, and sustainability aspects.

Ram Halthore has a BS in engineering from the University of Mysore in India and a MS in polymer engineering from the University of Akron, USA.  Ram has over 23 years of experience in the development and commercialisation of medical devices, pharmaceuticals, biologics, and combination products, including contact lenses, ophthalmic devices, pre-filled syringes, inhalation devices, implants, autoinjectors, and on-body injectors. In his current role, Ram is responsible for the lifecycle management of marketed combination products and the commercialisation of new combination products. Before joining Merck, Ram held progressive positions at 3M, Johnson & Johnson, Amgen, and Teva.

Reza Abedian is currently working as a senior medical affairs manager with Gerresheimer companies. He specialises in medical affairs and clinical research, supporting value-based product development with a strong focus on patient centricity. He holds a PhD in musculoskeletal biomechanics and tissue engineering from Hannover Medical School, laboratory for biomechanics and biomaterials. He has supported several product development/launches and market authorisation of medical devices under FDA, MDD/MDR, and other global market requirements during the past 10 years while having worked in multiple sectors of the medical device and pharma industry.

Since the 2022 fall semester, Reza has been a guest professor at the University of Applied Sciences and Arts Northwestern Switzerland. He is teaching and co-teaching several courses including introduction to QMS, post-market surveillance and combination products module of the masters studies in biomedical engineering at University of Basel.

Deep S Bhattacharya has been a principal scientist working with drug product design and development, pharmaceutical R&D (Andover, MA, USA) since November 2019. He received his PhD from the University of Nebraska Medical Center, College of Pharmacy in Pharmaceutical Sciences, with a focus in engineering polymer-protein conjugates and polymeric nanoparticles using computational chemistry, biophysical tools, formulation developments, to in-vivo characterisations in multiple animal models. After joining Pfizer, he has worked with multiple gene therapy, recombinant proteins, and multimodal antibody programs from preclinical through commercialisation. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilising NMR for structural determination of biologics, subcutaneous assessments of biologics, early-stage development of biologics, interfacing with early-stage discovery teams for candidate selection, and business strategies for developments of biopharmaceuticals.

Dirk Van Caelenberg joined BD in 1988 and has since held various roles including sales and product management, key account management, and business development management.

He is currently leading the European business development efforts for BD’s advanced drug delivery solutions, which focusses on partnering with pharmaceutical and biotechnology companies to provide drug delivery solutions and services that help successfully commercialise drug-device combination product therapies.

Dr. Joël Richard is the chief development officer at Enterome, leading CMC, non-clinical, and regulatory activities. He has 30 years of experience in biopharmaceutical R&D, including several previous global senior leadership positions in various biotech and pharma companies, such as MedinCell, Ipsen, Merck Serono, Serono, and Ethypharm. Joël used to be the chief development officer of MedinCell, leading all the drug development operations of the company. Prior to this position, for 10 years Joël led the pharmaceutical development and industrialisation activities of peptides and small molecules for Ipsen.

Joël graduated from Ecole Normale Supérieure (Paris-Saclay, France). He got his PhD in materials science/colloids and interface science from University of Paris and “Habilitation à Diriger les Recherches” (HDR) in chemistry from University of Bordeaux. He also had an entrepreneurial experience, co-funding with professor Jean-Pierre Benoit and leading the Mainelab Company (Angers, France), a drug delivery company specialised in the discovery and development of solvent-free processes for protein delivery systems.

In the past 20 years, Joël has focussed his scientific activities on new formulations and drug delivery systems (such as microspheres, nanoparticles, gelling and self-assembling systems, chemically modified proteins, supercritical fluid technology, etc.), especially for injectable protein and peptide formulations. Joël has published 75 peer-reviewed scientific papers, eight book chapters, and two editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein and peptides formulations, sustained-release formulations, etc.). He is the author of 125 invited international conferences, 50 international communications, and 55 international patent families.

Dr. Troels Keldmann has spent 25 years in the DDS devices and medical devices industry, working cross-functionally covering development, sourcing, innovation, IPR strategy, business development, partnering, and commercialisation. As interim technical lead on injection devices at LEO Pharma A/S, he headed identification, evaluation, and selection of SC injection devices. His prior DDS experience includes co-founding and heading innovative DDS startups, and consulting in DDS devices for pulmonary, nasal, SC (needle/needle-free), and IM delivery. He is an appointed business coach by the European Innovation Council and an industry fellow at Technical University of Denmark. He holds a BSc, MSc and PhD in mechanical engineering and innovation, as well as an MBA.

Roman Mathaes is the 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, pre-filled syringes, and ampoules. He also led the packaging and combination product development department as well as the lab automation group.

Roman joined Lonza from Roche. He is a pharmacist by training and holds a PhD in pharmaceutical technology from the University of Munich and an MBA. For 10 years he has been a lecturer at the University of Basel (Switzerland) teaching biopharmaceutical product development.

Ying Wang is an Associate Research Fellow and the Head of Device Development Science (DDS) in DCoE at Pfizer Cambridge UK.  Ying holds a PhD in Pharmaceutical and Biomedical Analysis 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 DDS, she has steered the directions of the testing and control strategy development 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, she is an expert on statistical sampling, Quality by Design and data analysis. 

Ying is a member of ISO/ TC 84: Devices for administration of medicinal products and catheters, presenting on behalf of the BSI.  She is also a C.Chemist, MRSC.

Glenn Svedberg has spent 30 years in the manufacturing industry, in managerial and mainly commercial roles. He started at Volvo Group in 1990 as a trainee in purchasing and continued in 1994 to Ericsson as a marketing manager for a production unit. He then moved over to the contract electronics manufacturing industry, where in 1999 he joined Flex in northern Europe, assuming a role as business development director and part of the acquisition team as well as being a key account manager for ABB globally. At Flex he had different roles leading up to becoming managing director for the Scandinavian operations with some 1,400 people in five factories. In 2005 he moved over to the plastic packaging industry and joined Rexam (today part of Berry Global) as a managing director for sites in Sweden and Denmark.

Since 2007 he has been part of Nolato and served as managing director for Nolato Cerbo as well as head of pharma packaging and located in UK for two years when integrating Nolato Jaycare 2012-2014. He is dedicated to lean principles as well as quality and for four years, in parallel to his MD role, he led the medical excellence program across all medical solutions sites, globally. He has a genuine interest in sustainable development and has been laying the foundation for the work leading up to a Ecovadis silver status recognition for Nolato. In June 2021 he assumed the role as group sustainability director at Nolato Group and vice president of business development for medical solutions. Since 2023 he has been heading the technical design centres in three regions: Europe, North America, and Asia.

Dr. Nicky Bertollo is a biomedical engineer with over 15 years’ experience in the design, development, preclinical testing, and evaluation of medical devices. He is the inventor of the Latch platform tissue anchorage technology and he’s a medical device innovator with several medical device patents he has led having been licensed. Nicky is a fellow of the New South Wales health medical device commercialisation training program (Sydney, Australia) and holds a BE (mechanical), a masters (biomedical engineering), and a PhD from the University of New South Wales (Sydney, Australia).

Klaus Ullherr has a degree in engineering and is a senior product manager at Syntegon Technology. In March 2000 he joined Bosch Packaging Technology (which became Syntegon Technology in 2020) as project manager. Since 2002 he has been a product manager for the business field syringes/RTU with global product responsibility. He’s focussed on market analysis, initiating new product developments and business development, and he’s an expert for syringe/nested container processing. He is a member of the PDA and trainer at the PDA syringe training course. Klaus also works as an expert in the DIN/ISO group for primary packaging as well as in the APV, focus group packaging. He’s a member of ISPE and a member of the program committee of the yearly ISPE aseptic conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment.

Markus Balkenhol was educated in dentistry and dental biomaterials sciences. He has several decades of experience in conducting scientific studies, publishing, lecturing, and teaching at different universities. He is an experienced clinical and scientific writer. Markus has comprehensive experience in corporate leadership in the medical device industry. Among others, he was responsible for R&D projects, scientific and clinical affairs and product application. Markus has broad experience in regulatory topics as former clinical expert of a notified body (MDD) and senior clinical consultant of AKRATEAM (MDD & MDR), focussing on clinical and post-market aspects of medical devices including drug device combinations.

Stefano Pilati has a master’s degree in materials engineering at the University of Padova (Italy). He has been working in the primary packaging field for 10 years, focussing on pharmaceutical glass products, combination products, and Drug Delivery Systems. Stefano had the possibility to successfully leading and contributing in developing and commercialising glass vials and Pre-Fillable Syringes for biologic drug products.
With a background in project management in quality assurance, today he leads Drug Containment Solution 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.

Reto Falk is a director and leads a team in account and business development for Ypsomed. Reto has extensive experience driving growth as a partner for MedTech, pharmaceutical, and biotech companies.

In 2020, he joined Ypsomed with a focus on fostering and expanding the company’s global customer base.

Reto has more than 25 years of experience in executive global sales and marketing roles with MedTech providers, including Straumann, Camlog, and Geistlich Pharma.

Thomas Brun joined ZebraSci (a Becton Dickinson company) in 2021, bringing with him 10 years of experience in medical device and combination product development. He has held various positions, including development engineer, technical lead, and business development. Currently, he is managing the EMEA business development for ZebraSci combination product testing services.

Dr. René Holm is a professor in pharmaceutical physical chemistry at the University of Southern Denmark. After receiving master’s and PhD degrees in pharmaceutics from the University of Copenhagen, Denmark, he started his carrier in the pharmaceutical industry at H. Lundbeck in 2001 and changed to Janssen in 2016. René Das worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry, and material science covering both small and large molecules. In 2021, René engaged in a career change and became a full professor. René is (co-) author of more than 220 book chapters or original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation, and physical pharmacy, and is co-inventor on 13 published patents.

Tamara Will is a lead human factors specialist with Emergo by UL’s human factors research and design (HFR&D) team. She is based in the Netherlands and has been with the team since March 2016. She has experience managing a variety of projects in both Europe and the US, as well as developing a wide range of HFE documents and conducting analyses. She routinely develops use-related risk analyses and test protocols, conducts usability tests, analyses data, and develops tests and HFE reports that satisfy regulators’ expectations. She has extensive experience with applying HFE to a variety of products, including as combination products, injection devices, and connected devices (e.g., apps, treatment adherence tracking). Furthermore, she occasionally provides guest lectures at various universities in the Netherlands. She holds a BSc in psychology and an MSc in applied cognitive psychology, both from Utrecht University.