Originally training as a pharmaceutical scientist, Louise Place has over 14 years’ experience in drug delivery and medical devices with a focus on device technical management and regulatory strategy for EU and FDA submissions.

Louise joined GSK in May 2020 and leads the device team within CMC regulatory with responsibility for global regulatory and advocacy strategy (devices) across the GSK portfolio. With a solid background in inhalation and parenteral combination products from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

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.

Tieming Ruan holds his PhD in mechanical engineering from Ohio State University and an MBA from New York University. Currently, he is senior director of device development at Alexion and led different combination product developments such as auto-injector, pre-filled syringe, and on-body delivery system.

Jim McGough is co-founder of EdgeOne Medical Inc., a US-based contract device development organisation that supports 10 of the top 20 global biopharmaceutical firms with their device development programs. Over the past 10 years, EdgeOne Medical has performed over 160 test method validations and has completed over 500 test protocols for top 5 European pharma firms and has been the only independent firm operating with proprietary device testing labs, experienced combo product device development, and regulatory/quality personnel.

In addition, Jim is a managing partner at EdgeOne Venture Partners and is an angel investor. Jim has over 25 years of executive and entrepreneurial experience in the connected device development and commercialisation space across three industries: automotive (Audi), mobile devices (Motorola), and the last 10 (EdgeOne Medical) in medical devices/connected drug delivery/DTx and digital biomarkers.

Jim has a BA in history from the University of California-Berkeley and a master's in international management from the Thunderbird School of Global Management at Arizona State University.

Vincenza Pironti has more than 15 years of experience in the pharmaceutical industry, with consolidated experience in business development, product development, sterile manufacturing in aseptic conditions, and for terminally sterilised products. She has extensive knowledge of all phases of product development from formulation screenings to sterile product commercial manufacturing, with expertise in the CMC for small molecules and biologics for injectables.

Dr. Christian Proff is a 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 has been working in verification engineering since 2018 on improvements in CCI testing and development of new device test methods.

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.

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Yvonne 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. Yvonne holds a BSc in industrial design and an MSc in human technology interaction, both from Eindhoven University of Technology (NL).

Joan Malmstrøm is a principal scientist at Novo Nordisk A/S who holds a PhD in chemistry from the University of Copenhagen and has 20-plus years of experience with structural elucidation of organic molecules using nuclear magnetic resonance spectroscopy (NMR) and mass spectrometry (MS) as analytical tools. The projects she has been involved in at Novo Nordisk A/S range from small molecules (APIs, raw materials/excipients, etc.) up to peptides/proteins and RNA oligos. During the past years one of her main activities has been the development of NMR analytical methods suitable for analysis of all kinds of molecules included in drug development. The analytical methods are applied on all stages of the development pipeline and GMP validated when needed. She has for many years been the NMR laboratory manager, responsible for maintaining the equipment suitable for use both in the development and manufacturing part of the company. This has included both instrument qualification and IT validation. As head of the CMC technology group within analysis and characterisation, she is involved in exploring new technologies and their implementation.

Asmita Khanolkar has a master’s degree in materials science and engineering from Worcester Polytechnic Institute in Worcester, MA (USA). With over 25 years of manufacturing experience specialising in the medical device and pharmaceutical industries, she has managed various device projects from concept to commercial launch. Her product portfolio includes single-use, wearable and implantable devices, drug-device, device-biologic combination products for drug delivery, biotech, biotherapeutics, and pharmaceutical applications. She has held various engineering and management roles in new product development, manufacturing engineering, advanced quality planning, operations, supply chain, and product life cycle management. Her current responsibilities include a corporate leadership role supporting multiple sites for bringing complete solutions to the customers, working closely within the Oval Medical Technologies, Cambridge Pharma, and SMC Ltd. global sites in early technical engagement through commercialisation for combination products and pharmaceutical services.

Tiffany McIntire has been working as a human factors engineer for five years, developing delivery systems and labelling strategies in the pharmaceutical industry. After her studies in industrial/organisational psychology, she started her career at Lilly, where she worked on a range of combination products, including dial-and-dose injectors for insulin, autoinjectors, pre-filled syringes, digital products and an emergency inhalation device. After working at Lilly, she jumped across the pond to Germany, joining a recently established device group within Boehringer Ingelheim. While there, she worked to deepen the team's knowledge of HF and improve their quality management system and vendor management. At the beginning of August, she joined the Roche HF team in Basel, Switzerland, to work with the team there, generating external, scientific publications as well as guiding the team towards best practices in HF.

Jakob Lange is Head of Account and Business Development at Ypsomed with responsibility for all sales, customer relationships and marketing activities in the B2B Delivery Systems business.

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 18 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, and is a regular contributor to conferences on these topics.

Don Zinn has 25 years of experience in building biotech, pharmaceutical, and medical device companies from the benchtop to the marketplace, generating and cultivating business relationships, developing and implementing business strategies, fundraising, and executing deals. Don was the US head of innovation for Rentschler Biopharma, CEO of Aursos and AzoRX, and co-founder of Artesian Therapeutics and Genetic Immunity. Don volunteers at the National Institutes of Health (NIH) as a commercialisation grant reviewer for the commercialisation readiness program. Don has been the VP for US business for Crossject since the beginning of COVID, closing deals worldwide for their needle-free auto-injector platform and portfolio of emergency drug-device combinations.

Nicole Zangl has a degree in biochemistry and food and biotechnology, plus more than seven years of experience in the biotech industry. She’s a subject matter expert for mixing technology and magnetic coupled agitators, responsible for global business development of mixing technology and products.

Simon Hall is an experienced management and technology consultant specialising in the application of digital technologies in life sciences and healthcare. Almost 30 years of experience leading cross-functional teams, developing strategies, and implementing technologies for clinical trials and commercial solutions.

He is a partner in PA and leads on digital therapeutics, biomarkers, and connected drug delivery device design and commercialisation projects.

Kate Hudson-Farmer leads drug delivery in PA’s health and life sciences practice. She is a partner with a focus on end-to-end product and platform development and commercialisation in drug delivery and connected health.

Kate brings with her over 20 years’ experience in consulting, business development, new product innovation, and technology licensing in the pharmaceutical and medical technology industries. Kate’s focus lies in developing solutions that improve patient engagement and outcomes, whilst strengthening competitiveness in the drug delivery market.

Kate holds a PhD in molecular biology and medical microbiology as well as an MBA. She has led many innovative drug delivery developments and has worked in both industry and consulting.