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Injectable Drug Delivery
8 May - 9 May 2024
Injectable Drug Delivery

Conference Overview

Injectable Drug Delivery is an industry focused on two overarching topics the development of the device & the interaction between drug product and device. SAE’s 2024 Injectable Drug Delivery conference brings together a complete big pharma speaker line-up providing technical updates on the relationship between drug product formulation and the device primary packaging, with considerations for formulation strategies, extractables & leachables and toxicological testing of injectable devices.


This conference brings case studies from senior big pharma representatives providing an opportunity to discuss formulation considerations in depth for parenteral packaging, this is the perfect opportunity to benchmark your drug delivery programme and optimise the development of your injectable portfolio.
 

FEATURED SPEAKERS

Julian Dixon

Julian Dixon

Senior Director, AstraZeneca
Ryan Noble

Ryan Noble

Associate Director, Devices, GSK
Selenge Erdenechimeg

Selenge Erdenechimeg

Global Regulatory Specialist | RA Device Combination Products, Novo Nordisk
Simon Wilson

Simon Wilson

Device Development Lead, Pfizer
Soumen Das

Soumen Das

Associate Scientific Fellow, Takeda

Berna Kosekaya

Regulatory Professional, Novo Nordisk
Berna Kosekaya

Berna Kosekaya is an expert in regulatory affairs at Novo Nordisk, where she is responsible for driving global submissions for the combination products portfolio within a dynamic regulatory landscape. With a robust background as a pharmacist holding a Ph.D. in pharmacology, she brings a wealth of knowledge and expertise to her role. Her career journey includes pivotal roles within the national medicines agency of Turkiye. With over 8 years of regulatory experience spanning diverse product portfolios, her current focus is on navigating the complexities of combination products with precision and efficiency.

Cedric Gysel

Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson
Cedric Gysel

Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, driving human-centered solutions for patients and customers and leading key innovation projects for device & packaging sustainability as we all product end of life programs across the pharmaceutical and medical device sectors of Johnson & Johnson. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science.

Christian Proff

Senior Verification Engineer, Roche
Christian Proff

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 is working in Verification Engineering since 2018 on improvements in CCI testing and development of new device test methods.

Cinzia Rotella

Project Leader, Sanofi
Cinzia Rotella

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 Project Leader for Life Cycle Management activities in the Medical Device Unit

Clemens Gunther

Director, Senior Expert Nonclinical Safety, Bayer AG
Clemens Gunther

Fatima Bennai-Sanfourche

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
Fatima Bennai-Sanfourche

Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.
Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.
She has more than 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation.
She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays.
In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the Pharmaceuticals portfolio.
She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP).
She is also leading the project of the implementation of euMDR for PH-Bayer AG.
She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according the medical Device regulation. The period of nomination is of five years starting on 01 March 2019.

George Moore-Arthur

Senior Global Regulatory Professional, Novo Nordisk
George Moore-Arthur

Following an BSc in Biomedical science and MSc in Biotechnology I am currently working at Novo Nordisk as a global regulatory professional responsible for driving regulatory strategy in key global markets for Novo Nordisk digital health & IVD products. Prior to joining Novo Nordisk, I worked for the UK regulatory agency (MHRA) in various roles including medicinal pharmaceutical products and safety & surveillance for a range of medical devices (including surgical, wound management and IVD devices).

Hiroki Hasegawa

Assistant Research Manager, Mitsubishi Gas Chemical Company, Inc
Hiroki  Hasegawa

Mr. Hiroki Hasegawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2013 and a Master Degree of Science in 2015 from Osaka University.
Since April 2015 he has been working for Mitsubishi Gas Chemical Company, Inc. and in charge of macromolecular science,
especially in composition development of thermosetting resin.
Since 2018 he has joined a development team of multilayer plastic vial & syringe for biologics.

Julian Dixon

Senior Director, AstraZeneca
Julian Dixon

After 24 years at Team Consulting supporting the development of drug delivery devices, Julian joined AstraZeneca biopharmaceutical development in 2022 to be in one of the key player organizations as the future of combination product human factors is being shaped. Julian’s background is in mechanical engineering and psychology. Both have remained fascinating and provide more than enough fuel for continued curiosity.

Marc Egen

Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG
Marc Egen

Marc is a polymer chemist by training and joined Boehringer Ingelheim more than 20 years ago. He was working in various positions at the interface between Development and Operations. Dealing mostly with pharmaceutical technology, manufacturing, and packaging processes, he gained experience in inhalation drug product development, solids manufacturing, launches and transfers, and solids and parenteral packaging development.

Ryan Noble

Associate Director, Devices, GSK
Ryan Noble

Ryan Noble is an Associate Director at GSK in the Global Regulatory Affairs Devices Team. He is currently focused on integrating device engineering and drug product development to ensure regulatory compliance with the ever-changing regulatory landscape. Ryan has been working in combination product development for 25 years and has experience in testing, formulation, manufacturing, quality systems, and regulatory processes throughout the lifecycle of both respiratory and parenteral systems.

Selenge Erdenechimeg

Global Regulatory Specialist | RA Device Combination Products, Novo Nordisk
Selenge Erdenechimeg

Selenge is a Combination Products Regulatory Specialist for Devices at Novo Nordisk and is responsible for driving fast paced regulatory submissions in the growing combination products market in US with the FDA, in EU with EMA and Notified Bodies. She brings more than 10 years of experience to Novo Nordisk.
As a former Global Regulatory Strategist in Pfizer Devices Centre of Excellence Cambridge UK and a TOPRA member, she has worked with combination products regulations and design control compliance.
Selenge holds Postgraduate degree in Regulatory Affairs in Medical Devices from TOPRA and has undertaken BSc in Biochemistry from Monash University, Australia.
 

Senior Representative

, ApiJect
Senior Representative

ApiJect™ is a global medical technology company creating the future of pharmaceutical injections.

Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume.

Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.

The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.

Simon Wilson

Device Development Lead, Pfizer
Simon Wilson

Simon has spent over 30 years developing a wide range of products since graduating with a degree in Engineering Product Design. These have included consumer goods, handheld computers and mobile communications devices as well as a stint at a major London design consultancy. He joined Pfizer’s Cambridge based Device Centre of Excellence, DCoE, in 2007.
Whilst working for Pfizer, Simon has managed parenteral device development projects through from initial concept to clinical trials and beyond. Simon has worked on several digitally ‘connected’ device projects, helping to liaise between teams developing devices and mobile apps or other digital elements.
 

Soumen Das

Associate Scientific Fellow, Takeda
Soumen Das

Soumen Das is an experienced professional in the field of product development within the medical device industry, with a track record spanning over nine years. For the past five years, Soumen has dedicated his efforts to ensuring the biocompatibility of medical devices for the FDA, EU, and PMDA regulatory submissions. His expertise ranges from in-vitro diagnostics to implantable medical devices. His Ph.D. and postdoctoral work focused on material and nanoparticle compatibility with biology, including systemic and organ toxicity. His extensive research has resulted in over fifty peer-reviewed international journal publications showcasing his commitment to advancing the field. He holds eight patents alongside his publications, demonstrating his innovative and creative problem-solving abilities. Recognized for his achievements, Soumen has been honored with several prestigious awards, including the Young Investigator Award 2016 and the 2014 at Gordon Conference in Radiation Chemistry. Additionally, he received the University of Central Florida Innovator Award in 2014.

Victoria Ludlow

Program Manager, MediPhorum
Victoria Ludlow

BioPhorum is a collaboration of industry leaders and subject matter experts working together to pool knowledge, best practice, and ideas – these outputs lead to results that effect real progress.
Our mission is to create an environment where our members from the global biopharmaceutical and device industries connect, collaborate and accelerate progress – for the benefit of all.

What will you gain?

  • Evaluate how devices can be co-developed alongside drug products to foster a collaborative approach to improve biocompatibility and effective toxicological testing
  • Expand on design strategies for injectable delivery of advanced modalities, including cell and gene therapies, large molecule delivery and sub-zero device requirements
  • Learn through focused presentations tailored to a technical device development and primary packaging audience, exploring vial material and primary component selection, silicone layer thickness studies and standardisation of primary container formats
  • Benefit from spotlight sessions focusing on sustainable device materials, offering comprehensive perspectives on material development and selection through to disposal
  • Learn how major device developers are streamlining product development and CMC practices for effective compliance throughout and post-NDA/MAA approval

 Who should attend?

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:

  • Autoinjectors
  • Wearables
  • Device Engineering
  • Human Factors
  • CMC
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affairs

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

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9:10

What should combination product human factors engineering (CP HFE) look like in 2034?

Julian Dixon, Senior Director, AstraZeneca

  • Are we still on a learning curve or have we reached a knowledge plateau?
  • Our business is one of platforms. How will the reuse of existing drug delivery platforms – and the creation of new ones - be reflected in CP HFE?
  • In what ways will we be more truly patient-centric?
  • clock

    9:50

    FDA's Platform Technology Designation Program

    Selenge Erdenechimeg, Global Regulatory Specialist | RA Device Combination Products, Novo Nordisk

  • Are device delivery platforms in scope of this new program
  • The why(s) and the how(s)
  • Future opportunities and way forward
  • clock

    10:30

    Morning Break

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    11:00

    Empirical and digital tools for plunger stoppers characterization

    Cinzia Rotella, Project Leader, Sanofi

  • The presentation describes the approach used to characterize and discriminate different plunger stoppers
  • The characterization was performed by using empirical tests – standards & ad-hoc methods – and model digital twins
  • The approach was used to build a guideline for stopper selection inside Sanofi
  • clock

    11:40

    Evaluaton of Extractables and Leachables for Pre-filled Syringes

    Clemens Gunther

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG

  • Introduction: why do we need to care about E&L?
  • How to perform an E & L investigation? 
  • Principles of a Toxicological Risk Assessment on E & L
  • clock

    12:20

    Networking Lunch

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    13:20

    Change management and CMC best practices for streamlined injectable device development

    Ryan Noble, Associate Director, Devices, GSK

  • The latest updates in European regulatory guidance and MDR 
  • CMC guidance in approaching the injectable combination product development and change management lifecycle
  • Assessing interpretations across device and pharma landscapes, how can we control for differences across health authorities, notified bodies and industry
  • Projections and opportunities for improved alignment in change management across drug-device development teams
  • clock

    14:00

    Session Reserved for Apiject

    Senior Representative, , ApiJect

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    14:30

    Afternoon Break

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    15:00

    Container Closure Integrity of OXYCAPT Vial at Deep Cold Storage

    Hiroki Hasegawa, Assistant Research Manager, Mitsubishi Gas Chemical Company, Inc

  • Overview of OXYCAPT Vial
  • Oxygen & Carbon Dioxide Barrier
  • Break Resistance at -80 & -180?
  • CCIT at -80?
  • Comparison of CCIT among OXYCAPT, Glass and COP
  • clock

    15:30

    MediPhorum: Presenting a working tool for Device Design Changes [form, fit, function] to Drug Delivery Devices Post-Launch

    Victoria Ludlow, Program Manager, MediPhorum

  • An interactive document to support technical engineers in parallel to regulatory teams
  • MediPhorum Membership has developed a US based 'decision tree' tool which combines several guidance / frameworks and provides further user-guidance and case-studies across seven categories of design change, including key lists of considerations/evaluation for assessing if a design change is needed, and provides a library of justifications / evidence supporting why / why not
  • clock

    16:10

    Chair’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chair's Opening Remarks

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

    clock

    9:10

    CCI compliance challenges after (recent) regulatory updates

    Christian Proff, Senior Verification Engineer, Roche

  • USP<1207> and EU Annex 1
  • Expectations for pharmaceutical packaging development and lifecycle management
  • Details available from thorough packaging development which supports compliance to regulatory requirements
  • Typical examples we will shed light on selected aspects of individual packaging solutions
  •  

    clock

    9:50

    Selection of a new primary component: an interdisciplinary approach

    Soumen Das, Associate Scientific Fellow, Takeda

  • Understanding the importance of primary packing from the perspective of drug development
  • Optimising the process development approach can reduce lead times into manufacturing
  • Standardisation of primary container formats
  • Engagement of manufacturing and device development functions
  • clock

    10:30

    Morning Break

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    11:00

    Notified Body Opinion Considerations for Post-Authorization Changes

    Berna Kosekaya, Regulatory Professional, Novo Nordisk

  • What constitutes a non-substantial change?
  • What is the threshold for requiring an updated Notified Body Opinion?
  • What are the main challenges?
  • clock

    11:40

    Primary Packaging Supplier Selection and Portfolio Management

  • Selection Panel, fit for purpose
  • Deep dive into some important materials properties
  • Packaging portfolio management
  • Marc Egen, Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG

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    12:20

    Networking Lunch

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    13:20

    Risk Management Process for Connected Drug-Devices Combination product

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

  • Introduction : The future of patient care.
  • Impact of the EU MDR on connected drug-device risk management process
  • Cybersecurity
  • Usability engineering/Human Factors (HF)
  • Benefit-risk assessment of connected drug-device combination product
  • clock

    14:00

    Ensuring Patient Safety through Interoperability and Cybersecurity in Connected Drug Delivery Solutions

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk

  • Interoperable devices and changing landscapes
  • Cybersecurity risks and threats
  • Regulatory requirements for cybersecurity in medical devices

     

  • clock

    14:40

    Afternoon Break

    clock

    15:10

    Strategies to manage partner relations for collaborative, user-centric development teams

    Simon Wilson, Device Development Lead, Pfizer

  • Challenging the old school supplier-customer relationship: why complex projects require dynamic collaboration
  • Managing effective relationship building with suppliers as well as supplier sub-contractors to advance innovation
  • Working frameworks for improved synergy to ensure streamlined development of optimal user-centric devices
  • Looking forward: Toolkit for effective external stakeholder management for parenteral devices of the future

     

  • clock

    15:50

    Maximising pharmaceutical development of novel injectable delivery technologies through sustainable approaches

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

  • Designing for the future with sustainable device designs and partial reusability
  • Where does the industry need to collaborate on policy to enable circular supply chains
  • Implementing end of life procedures for device disassembly and correct material disposal
  • Looking to the future, what does the industry need to focus on for further sustainable approaches to device development
  • clock

    16:30

    Chairman’s Closing Remarks and Close of Day Two


    Regulatory Professional
    Novo Nordisk
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Senior Verification Engineer
    Roche
    Project Leader
    Sanofi
    Director, Senior Expert Nonclinical Safety
    Bayer AG
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Senior Global Regulatory Professional
    Novo Nordisk
    Assistant Research Manager
    Mitsubishi Gas Chemical Company, Inc
    Senior Director
    AstraZeneca
    Head of Primary Packaging & Process Development
    Boehringer Ingelheim Pharma Gmbh & Co. KG
    Associate Director, Devices
    GSK
    Global Regulatory Specialist | RA Device Combination Products
    Novo Nordisk
    ApiJect
    Device Development Lead
    Pfizer
    Associate Scientific Fellow
    Takeda
    Program Manager
    MediPhorum

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    Sponsors


    ApiJect™

    Sponsors
    https://info.apiject.com/industry-events

    ApiJect™ is a global medical technology company creating the future of pharmaceutical injections.

    Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume. 

    Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.  

    The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.



    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.

    Exhibitors


    KORU

    Exhibitors
    https://www.korumedical.com/

    KORU is, first and foremost, a patient-centric organization that will go the extra mile for our customers, providers, and partners who depend on our devices. We are a world-class manufacturer of subcutaneous infusion devices that deliver life-saving immunoglobulin therapies to patients with chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).


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    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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