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.

With over 9 years of specialized expertise in regulatory affairs and total of 15 years of professional experience, Dr. Berna Kosekaya offers a solid scientific foundation, focused on advancing regulatory success and strategic growth in the pharma industry.

Reto Falk, Director in Account & Business Development for Ypsomed. He holds an MBA with Edinburgh Business School. Reto is an account executive and team leader with extensive experience driving growth as a partner of MedTech, pharmaceutical and biotech companies.

He joined Ypsomed in 2020 with a focus on business development fostering and expanding the company’s global customer base.

Reto has more than 25 years of experience in global sales and marketing roles with MedTech providers, including Straumann, Camlog and Geistlich Pharma representing global leaders in the field of dental implants and hard/soft tissue regeneration.

Leandro Calle Burger is a Senior Primary Packaging Expert (at Novartis) with more than 20 years of experience in developing primary containers for different therapeutic applications. Since 7 years he successfully developed prefilled syringes for the ophthalmic area for Novartis. He has a degree in BSc Mechanical Engineering and has an EMBA. In his spare time he likes hiking in the Swiss mountains, reading books about historical topics and he also practice endurance sport like running or cycling.

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.

Bharat Arora is a seasoned Technical Quality Leader with over 18 years of experience in the medical device and life science industry. Currently a Director of Product Quality at Vertex Pharmaceuticals, Cell

and Gene therapies, Bharat has a record of establishing and managing global quality management systems, collaborating in product development and lifecycle management of diverse product portfolio includes Catheters, imaging system, software as medical device, injectable combination products, and mRNA vaccines. Bharat is known for his adaptive leadership and enjoys leading high performing teams in a fast paced environment

Estefania Dos Anjos is a Senior Product Specialist in TÜV SÜD, with authorizations as Technical Documentation Assessor for MDN 1201, MDN 1202, MDN 1206, MDN 1208, MDN 1211 and MDN 1213 devices. Medicinal product Specialist for MDS 7001 (drug-device combination devices) and Product reviewer for Article 117 devices. Pharmacist with 10 years of experience in regulatory affairs of medical devices, pharmaceuticals, and cosmetic products in Latin America and Europe, Quality Management Systems under ISO 13485 and Good Manufacturing Practices.

Hiten Gutka PhD., works as a Senior Principal Scientist, Sterile Product Development at Bristol Myers Squibb. Prior to this role he was Senior Scientist Biologics Development at Celgene. He worked as Associate Director Formulation Development at Outlook Therapeutics Inc. (formerly Oncobiologics Inc.) where he developed a proprietary drug product for intravitreal injection. He did a co-op at Medimmune LLC (AstraZeneca), in the Formulation Development group. Hiten holds PhD in Pharmaceutical Sciences (Pharmaceutical Biotechnology track) from University of Illinois at Chicago, College of Pharmacy. Hiten worked at Biocon, USV and Reliance Biopharmaceuticals in India, on analytical and pharmaceutical development of biosimilars. He holds a BS and MS Degree in Pharmaceutical Sciences from University of Mumbai, India. Hiten is a member of the American Association of Pharmaceutical Sciences (AAPS) and has served on the Sterile Products Community in various capacities since 2011. Hiten is the current chair of Sterile Products Community, AAPS. He also serves on the editorial board of Bioprocess International and the journal mAbs.

Hélène Vacelet is a Sustainability Senior Program Manager within BD Medical Pharmaceutical Systems. Prior to that, she drove quality engineering during 5 years on autoinjectors and safety devices and then she lead the R&D PFS portfolio sustaining and technical support activities during 6 years. Prior to BD, Hélène held progressing positions in R&D and process engineering with STMicroelectronics, Integrated Device Manufacturer.

She holds MS in Material Science & in Integrated Electronic devices and a PhD thesis in Microelectronics. In 2021, she certified on “Sustainability leadership and corporate responsibility” from the London Business School.

Since 2022, she is a Sustainability technical advocate to enable strategic innovation and continuous improvement on existing products while reducing our impact on the planet.

Deep S Bhattacharya is a Principal scientist working with Drug Product Design and Development, Pharmaceutical R&D Andover 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 characterizations in multiple animal models. After joining Pfizer, he has worked with multiple gene therapy, recombinant proteins, multimodal antibody programs from preclinical through commercialization. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilizing higher order spectroscopic tools for structural determination of biologics, subcutaneous assessments of biologics, early & late-stage development of biologics and business strategies for developments of biopharmaceuticals. 

Andreas studied organic chemistry at the University of Bielefeld in Germany, with the main focus on mass spectrometry and computational chemistry. Since the date of his Ph.D./doctorate in 1997, he worked in different scientific and managerial positions, ranging from the head of a laboratory to GMP QA site manager in the Life Science industry, prior to proceeding with his carrier at SGS in 2007. From 2007 to 2010, he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got his current position as a business development manager in 2010.

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from the pharmaceutical and medical industry.

With over 25 years’ experience in the Life Science segment, he is a frequent speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del Farmaco in Pavia and others) in the fields of Medical Devices, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory-controlled industries are challenged by ongoing regulatory systems. Changes must be set in practice, and cross-functional teams with different functional expertise must be organized to work toward a common goal. Andreas wants to motivate experts from the Life Industry or organizations to work together to realize or achieve a better and effective cross-departmental collaboration to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Cinzia holds a degree in Materials Science and a PhD in Polymer physics from the KULeuven University. She has joined Sanofi in 2016 as a Sr. Materials Scientist and she is now Program Leader for Life Cycle Management activities for primary containers in the Medical Device Unit 

Frauke Schuurkamp is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Frauke leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Frauke holds a BSc in Applied Psychology and an MSc in Human Factors Psychology.

Claus studied pharmacy and holds a PhD (University of Freiburg, Germany) and MBA (Henley Business School, UK). He is Qualified Person according to EU Regulations and holder of various expert qualifications.

For more than 30 years he worked for top ten global pharma companies Roche and Sanofi. He has held various roles in the field of injectable drug delivery systems for biotherapeutics, the first disposable pen for a once-daily insulin, with expanding responsibilities: QA/QC, Manufacturing, Supply Chain, Key Account Management of device partner companies, Global Medical Device Surveillance. As Global Device Leader and Drug Device Integrator he has set up cross-functional technology teams on 'Large Volume Drug Delivery' which has become the On-Body Delivery platform for Drug Device Combination developments like the subcutaneous administration of isatuximab (Sarclisa®).

Since October 2024 Claus is an Independent Drug Device Expert to provide guidance and expertise on complex injectable Drug Device combination products with special focus on integrating medical devices and large volume, highly viscous drug formulations as well as connectivity and sustainability.

Sven Pohle is Global Product Manager for Glass Syringes at SCHOTT Pharma, where he is responsible for portfolio management, component & device partnerships, and the launch of product innovations. Prior to that, Sven worked for over ten years in various R&D positions in the medical device industry. He holds a PhD in Polymer Chemistry from Technical University of Braunschweig, Germany.

Technology and process-focused operational Consultant with a focus on the intersection between Healthcare and Life Sciences. Skilled in Process Development, Product Innovation, Sales, Communication, and Vendor Management. 

Tom Lever is a Product Design Engineer at PA consulting, a global innovation and technology consultancy. He has helped a wide range of clients in both Health and Life Sciences and Consumer Goods achieve success through a creative and considered approach to product development. He has particular expertise in working with experts between Design, Human Factors and Engineering to refine initial concepts and guide concepts through the initial stages of User Centred design and Human Factors testing.