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6th Drug-Device Combination Products Conference

  • 15th – 16th October 2024
  • Germany flag Germany Berlin
  • Hotel Riu Plaza Berlin Martin-Luther-Str. 1, 10777

As drug–device combination products continue demonstrate growth at a rapid pace, the experts in drug delivery alongside device development engineers at the #VLDDCP summit will offer diverse perspectives on ensuring the compatibility and operational efficiency of drug products and delivery devices, exploring recent experience in the digital health, connected combination products and wearable injectors.

The 6th Drug-Device Combination Products Conference in Berlin aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms. Particularly during the challenging initial phases of development when finalising formulations and dosage while navigating regulatory complexities - it presents significant hurdles to the successful advancement of sustainable and connected combined drug-device products.

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About the 6th Drug-Device Combination Products (#VLDDCP by Vonlanthen)

As drug–device combination products continue demonstrate growth at a rapid pace, the experts in drug delivery alongside device development engineers at the #VLDDCP summit will offer diverse perspectives on ensuring the compatibility and operational efficiency of drug products and delivery devices, exploring recent experience in the digital health, connected combination products and wearable injectors.

The combination products professionals will focus on:

  • Harmonising design controls with quality by design principles
  • Determining device specifications during early development stages
  • Assessing material compatibility and safety
  • Navigating regulatory pathways and quality management systems
  • Defining essential performance criteria
  • Conducting design verification and validation
  • Managing risk factors
  • Ensuring device compliance and meeting essential performance standards
  • Facilitating compatibility and clinical assessments
  • Exploring sustainable and connected combination products and wearable injectors

The 6th Drug-Device Combination Products Conference in Berlin aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms, particularly during the challenging initial phases of development when finalising formulations and dosage while navigating regulatory complexities presents significant hurdles to the successful advancement of sustainable and connected combined drug-device products.

 

Who Should Attend  

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

  • Assembling
  • Automation
  • Chemistry, Manufacturing and Controls (CMC)
  • Clean Room
  • Combination Products
  • Compatibility
  • Connected Devices
  • Connected Health
  • Connectivity
  • Design & Engineering
  • Design Architect
  • Device Development
  • Digital Health
  • Drug Delivery Systems (DDSs)
  • Drug Development
  • Drug Packaging
  • eHealth
  • Emulsions
  • Extractables and Leachables (E&L)
  • Filling Process
  • Filtration Process
  • Formulation
  • Glass
  • Good Manufacturing Practice (GMP)
  • Human Factors
  • Human Factors Engineering (HFE)
  • Industrial Design
  • Injectable Drugs
  • Injectables
  • Injection Devices
  • Integrity Testing
  • Lyophilisation
  • Manufacturing
  • Material Science
  • Medical Devices
  • Needles
  • Packaging
  • Packaging Material
  • Parenteral Drugs
  • Parenterals
  • Pharmaceutical Products
  • Pharmaceutical Injectors
  • Plastic
  • Pre-Filled Syringes (PFS
  • Process Development
  • Processing
  • Quality Assurance (QA)l
  • Quality Control (QC)
  • Raw Materials
  • Regulatory
  • Regulatory Affairs
  • Research & Development
  • Risk Management
  • Robotics
  • Safety
  • Safety, Identity, Strength, Purity, Quality (SISPQ)
  • Smart Devices
  • Sterile Drugs
  • Sterile Production
  • Sterile Products
  • Suspensions
  • Sustainability
  • Syringe
  • Syringes
  • User Experience (UX)
  • Vaccine Product
  • Vaccines
  • Validation
  • Wearable Injectors

Key Practical Learning Points

  • Successful development of drug-device combination products requires interdisciplinary collaboration between drug delivery experts and device development engineers.
  • Harmonising design controls with quality by design principles ensures the compatibility and operational efficiency of drug products and delivery devices.
  • Early determination of device specifications streamlines development and addresses regulatory challenges.
  • Thorough assessment of material compatibility and safety is essential for product reliability and safety.
  • Understanding and navigating regulatory pathways is critical for achieving compliance and market approval.
  • Leveraging new EU Medical Device Regulations (MDRs) and future perspectives for successful combination products regulatory submissions.
  • Defining essential performance criteria establishes benchmarks for product effectiveness and reliability.
  • Conducting rigorous design verification and validation processes confirms device functionality and safety.
  • Effective risk management strategies mitigate potential hazards associated with combination products.
  • Achieving cost efficiency and reducing environmental impact are essential considerations in product development.
  • Exploring technology-based sustainability approaches can lead to innovative solutions for environmental sustainability.
  • Harnessing innovative technologies, strategies, and methodologies will advance development of sustainable and connected combination products and wearable injectors.

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

About Speaker

Dr. René Dathe, DE

Head Quality Advanced Therapy Medicinal Products

Novartis

About Speaker

Anne-Sofie Madsen Staples, DK

Innovation Lead, Devices and Delivery Solutions

Novo Nordisk A/S

About Speaker

Dr. William Denny, AT

Senior Project Leader - Drug/Device Combination Products

Sandoz Device Development Centre

About Speaker

Bernard Gauthier, FR

Global Product Owner – GenMed Digital HealthCare

Sanofi

About Speaker

Paul Johnson, UK

Managing Director

Paul Johnson Consulting Limited

About Speaker

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

About Speaker

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

About Speaker

Dr. Horacio M. Pace-Bedetti, DK

Principal Usability Researcher

Novo Nordisk A/S

About Speaker

Patrice Becker, FR

Global Director Scientific Communications

St Gilesmedical London & Berlin

About Speaker

Dr. Jakob Lange, CH

Head of Account & Business Development

Ypsomed AG

About Speaker

Dr. Javad Jabbari, DK

Regulatory Affairs, Associate Director of Device and Combination Products

Ascendis Pharma

About Speaker

Kevin Brunet, BE

Head of Devices Development and Primary Packaging Quality

UCB

About Speaker

Dr. Heather Johnson, UK

Senior Consultant – Devices

Granzer Regulatory Consulting & Services GmbH

About Speaker

Richard Kieran, IR

Director I Drug Delivery Support Services

West Pharmaceutical Services

About Speaker

Michael Stapleton, DE

European Sales Coordinator EMEA

Lohmann GmbH & Co. KG

About Speaker

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

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.

Dr. René Dathe, DE

Head Quality Advanced Therapy Medicinal Products

Novartis

Dr. René Dathe, MBA is a Biopharma professional with 15+ years’ experience in Drug Device Combination products, BD&L, CMC, Portfolio and Quality. Currently, he is Head Quality Advanced Therapy Medicinal Products at Novartis to support xRNA, Radioligand and Gene & Cell Therapy device development and commercial portfolios. Prior to this, René was establishing a Quality Connected Health organization and transforming a Quality shared function to a portfolio organization and expanding its footprint to China. At Sanofi, he was a PMO Project Manager in Cardiovascular & Metabolic, Immunology & Inflammation and Oncology Franchises. His career started René at a Start-up venture at Samsung. He obtained a degree in chemistry, followed by an MBA and was awarded with a doctor degree by the University of Gloucestershire.

Anne-Sofie Madsen Staples, DK

Innovation Lead, Devices and Delivery Solutions

Novo Nordisk A/S

Anne-Sofie Madsen Staples is a biomedical engineer with a PhD from the University of Copenhagen. She works as an innovation lead at Novo Nordisk  A/S, leading innovation projects focusing on combination products/injection devices. Anne-Sofie's work is motivated by a deep understanding of device-tissue interactions, as demonstrated by her Industrial PhD project on shield-triggered autoinjectors. With a solid academic background and extensive industry experience, she brings a unique combination of technical, clinical, and user-focused expertise to medical device R&D.

Dr. William Denny, AT

Senior Project Leader - Drug/Device Combination Products

Sandoz Device Development Centre

Will Denny, PhD has over 11 years’ experience in the medical device & combination products sector. He has worked with a number of companies on a broad range of product developments that include combination products, Class IIa, Class IIb, Class III and AMIDs. He holds a degree and PhD in Biomedical Engineering and is still active in publishing academic literature in the areas of device development concepts and in-silico modelling of drug delivery in-vivo.
Prior to his current role Will has worked for a number of other medical device and pharma companies in technical leadership roles.

Bernard Gauthier, FR

Global Product Owner – GenMed Digital HealthCare

Sanofi

Bernard spent the last 25 years to manage digital projects in a lot of different industries and role but always in pioneer field such as GSM, multichannel CRM, eBusiness, Disease management, PSP and lastly SaMD with telemedicine and connected medical device. In 2013 he started an international MBA to go beyond these technical & operational knowledge with skills in business administration, marketing and entrepreneurship.
Bernard moved in the Digital HealthCare space in 2015 : here with his skills he can have an positive impact on people's lives wihtout being a doctor ... and he feels personally concerned by helping people with diabetes.
His key words are involvement, deliver, innovate, team spirit and sharing, pugnacity, imagine new solution, benevolent, curious and build strong and honest relationships.

Paul Johnson, UK

Managing Director

Paul Johnson Consulting Limited

Paul Johnson is an independent consultant to the pharmaceutical industry who has specialised in the CMC aspects of NCE and generic inhaled product development since 2018 serving clients in large/small pharma companies, pharmaceutical component suppliers, and pharmaceutical service providers.

Paul gained 20 years of experience leading teams and projects involved for the development of inhaled products at Glaxo Smith Kline in a range of delivery systems, including dry powder inhalers, pressurised metered dose inhalers, and nebulisers. He is most proud to have led the CMC teams from early development, through clinical stages, registration, launch and lifecycle management for Relvar/Breo Ellipta, and provided leadership for the CMC aspects for the entire GSK inhaled franchise.  

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

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).

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads Global Pharma clients in complex compliance projects to meet the latest regulatory requirements. In his role as Managing Director at Beyond Conception, Juan has pioneered efforts in Combination Products in Europe by leading clients to obtain Notified Body Opinions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest value to his clients.

Dr. Horacio M. Pace-Bedetti, DK

Principal Usability Researcher

Novo Nordisk A/S

Horacio Pace Bedetti is the Human Factors Specialist at Novo Nordisk, where he ensures compliance with global human factors regulations for medical devices and combination products. With over a decade of experience in human factors and a PhD in Healthcare Technologies, Horacio has led Human Factors and Risk Management efforts in the pharmaceutical industry for the past five years. He is an active member of the AAMI Human Factors Group, contributing to the review and update of the international standards, serves on the Combination Product Coalition’s HF working group, and is an editor for the Journal of Human Factors in Healthcare.

Patrice Becker, FR

Global Director Scientific Communications

St Gilesmedical London & Berlin

Patrice Becker is a medical device industry expert with more than 30 years of experience in clinical and medical affairs. He holds a masters degree in pharmacology and a masters degree in business administration for pharmaceutical and biomedical companies. After several years of experience in small medical devices companies, he joined Biomatech a consulting and testing company focused on medical devices testing  as a clinical research manager . Then he joined  Sofradim/Medtronic in 1998, building and taking the lead of the clinical research department for 13 years. then he was the leader of the scientific communication department for abdominal and robotic surgery until february 2023.  He is now leading activities for St Gilesmedical in France. St Gilesmedical is a scientific communication and medical writing independent company based in London and Berlin.

Dr. Jakob Lange, CH

Head of Account & Business Development

Ypsomed AG

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.

Dr. Javad Jabbari, DK

Regulatory Affairs, Associate Director of Device and Combination Products

Ascendis Pharma

Results-oriented professional with a proven track record in developing, registering, and commercializing medical devices, drug-device combination products, and software. With over +10 years of experience in R&D, QA, and RA departments, I excel in implementing regulatory strategies, preparing documentation, and liaising with regulatory authorities. Adept at navigating regulatory audits and ensuring compliance with submission requirements.

Kevin Brunet, BE

Head of Devices Development and Primary Packaging Quality

UCB

Kevin Brunet is currently leading the Device Devlopment and Primary Packaging Quality group at UCB.
During the last 12 years, he has developed a strong expertise in the development and manufacturing of Medical Devices and Drug-device combination products with roles in R&D, Supply chain, Operations and Quality.
His main expertise lays within Design and Development, Risk Management, Supplier Audits and Management with track records of innovative products brought to approval and launch (including N.B. Audits and H.A. Inspections).

Dr. Heather Johnson, UK

Senior Consultant – Devices

Granzer Regulatory Consulting & Services GmbH

Heather Johnson is a senior consultant with over 20 years’ regulatory expertise in drug-device combinations, borderline products and companion diagnostic devices. With a PhD in chemistry, her initial regulatory experience was with oral pharmaceutical products, followed by over 10 years leading global submissions for implantable, resorbable and drug-eluting orthopaedic devices with DePuy Synthes companies of Johnson & Johnson. Her career continued developing strategies for implementation of the EU Medical Devices Regulation across Johnson & Johnson devices companies. She then contracted for QIAGEN GmbH, to support clinical performance studies and marketing submissions for oncology companion diagnostic devices in US, EU, China and Japan. Heather now supports clients with US and EU submissions for drug-device combination products, strategies for development of novel devices, and the use of devices and IVDs within medicinal product clinical trials.

Richard Kieran, IR

Director I Drug Delivery Support Services

West Pharmaceutical Services

Richard has over 12 years of experience in medical device manufacturing and analytical laboratory services, working with emerging and established pharma companies to bring multiple projects to market. Currently Richard is heading up West's Combination Products Solutions offering, which leverages our deep experience in device development, manufacturing, testing, drug handling and packaging to provide a comprehensive range of services to streamline our clients route to market with a Combination Product.

Richard has a BE in Mechanical Engineering along with an MSc in Pharmaceutical & Biopharmaceutical Technology.

Michael Stapleton, DE

European Sales Coordinator EMEA

Lohmann GmbH & Co. KG

Michael Stapleton, based in Berlin offers over 25 years of commercial experience in leadership functions across various industries.

Throughout the past decade Michael has worked in the healthcare industry gaining experience with DuPont Healthcare, amongst others, where he headed up the EMEA sales team and partnered with numerous medical wearable and drug delivery manufacturers.

In his current role Michael coordinates the European Sales force for Lohmann.

Headquartered in Neuwied Germany Lohmann are a leading manufacturer and converter of pressure-sensitive adhesives and component parts for wearable, ostomy, diagnostic, and other medical applications, Lohmann delivers comprehensive solutions and provides a complete value chain, minimising risk and accelerating your medical device innovations to market.

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

Dr. René Dathe, DE

Head Quality Advanced Therapy Medicinal Products

Novartis

Anne-Sofie Madsen Staples, DK

Innovation Lead, Devices and Delivery Solutions

Novo Nordisk A/S

Dr. William Denny, AT

Senior Project Leader - Drug/Device Combination Products

Sandoz Device Development Centre

Bernard Gauthier, FR

Global Product Owner – GenMed Digital HealthCare

Sanofi

Paul Johnson, UK

Managing Director

Paul Johnson Consulting Limited

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

Dr. Horacio M. Pace-Bedetti, DK

Principal Usability Researcher

Novo Nordisk A/S

Patrice Becker, FR

Global Director Scientific Communications

St Gilesmedical London & Berlin

Dr. Jakob Lange, CH

Head of Account & Business Development

Ypsomed AG

Dr. Javad Jabbari, DK

Regulatory Affairs, Associate Director of Device and Combination Products

Ascendis Pharma

Kevin Brunet, BE

Head of Devices Development and Primary Packaging Quality

UCB

Dr. Heather Johnson, UK

Senior Consultant – Devices

Granzer Regulatory Consulting & Services GmbH

Richard Kieran, IR

Director I Drug Delivery Support Services

West Pharmaceutical Services

Michael Stapleton, DE

European Sales Coordinator EMEA

Lohmann GmbH & Co. KG

BROCHURE 

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What our
participants
are saying

I want to express my gratitude to Vonlanthen for hosting such a fantastic event and for giving me the opportunity to hear from esteemed speakers like Susan Neadle, Mark A. Chipperfield, Mike Wallenstein, and Roman Mathaes. It was truly an honor to be able to participate in this live event and I appreciated the opportunity to learn from such knowledgeable individuals. Thank you for putting together such a great conference! 

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Attendee

Attending the Drug-Device Combinational Products Conference by Vonlanthen was an exceptional and enlightening experience. The caliber of speakers was truly outstanding and the diversity in geography was incredibly valuable to me as I work between the USA and Europe. The conference provided me with an abundance of cutting-edge information on the latest advancements and challenges in the field of drug-device combinations and sustainability of products. The networking opportunities were also fantastic, allowing me to connect and collaborate with a diverse group of professionals in my field. I am already eagerly anticipating the next meeting and I extend my gratitude to the dedicated organizers for putting together such a successful and informative event.

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Attendee

I recently attended the Drug-Device Combinational Products Conference by Vonlanthen and it was an incredibly informative and valuable experience. The speakers were top-notch experts in their fields and provided valuable insights on the latest developments in the industry. The networking opportunities were also great, allowing me to connect with other professionals in my field. I highly recommend this conference to anyone in the pharmaceutical industry looking to stay informed and stay ahead of the curve. 

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Attendee