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SAE Media Group’s 6th Annual Conference
Injectable Drug Delivery 
8 - 9 May, 2024 |
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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.
 

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:
• Autoinjectors
• Wearables
• Device Engineering
• Human Factors
• CMC
• Injectables
• Sterile Manufacturing
• Packaging
• Regulatory Affairs
 

Previous Attendees Include:
 

3P Innovation Ltd; Amgen; Amgen Ltd; AstraZeneca; Bayer AG; BD Medical - Pharmaceutical Systems; Becton Dickinson; Boehringer Ingelheim Pharma Gmbh & Co. KG; BSI; BSI Group; Credence MedSystems; GSK; Harvey Medical; Johnson & Johnson; Kinnier Dufort; Medichem SA; Northumbria University/ EpiMoto; Novartis; Novo Nordisk; Novo Nordisk A/S; Owen Mumford; Owen Mumford Ltd; Pfizer; Pfizer UK; PHC Group; Roche; Sanofi; ten23 health AG; Teva Pharmaceuticals; TUV SUD Japan Ltd.; TUV SUD UK LTD; UserWise; Victrex Plc; ZwickRoell GmbH & Co.KG;

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

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9:10

Extractables and leachables assessment in PFS drug products

Carsten Worsoe

Carsten Worsoe, Principle Scientist Extractables and Leachables, Novo Nordisk

  • Choice of critical components for drug compatibility in PFS
  • Predictive tools for interactions in PFS
  • Relationship between extractables, simulated leachables and leachables in PFS
  • Case studies on leachable assessments in prefilled syringes
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    9:50

    Controlling Nitrosamine Impurities in the Injectable Drug Industry

    Clemens Gunther

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

  • Interpreting the updated guidance on nitrosamines: what
    does industry need to consider?
     
  • What are acceptable limits for nitrosamines in drug products?
     
  • Understanding the sources of the impurities and how to avoid
    them
     
  • Risk assessment on nitrosamines from a toxicology perspective
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    10:30

    Morning Coffee

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    11:00

    Patient Safety for Injectable Drug Delivery

    Joshua McClair

    Joshua McClair, Senior Scientist, AstraZeneca

     

  • Overview of AstraZeneca’s patient safety testing
  • Primary Packaging Testing and Biocompatibility
  • Lessons for the future
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    11:40

    Toxicology evaluation of injectable delivered drug products

    Joeri Lambrecht

    Joeri Lambrecht, Toxicologist and Comparability SME, Baxter AG

  •  A review of toxicological aspects of drug formulations needs for injectable devices 
  • Assessing the current injectable devices from a regulatory perspective
  • Delving into the next generation of injectable device formulations with considerations for safe product
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    12:20

    Networking Lunch

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    13:20

    Cell & Gene Therapy: Best Practices for an Evolving Drug

    Cinzia Federico, New Technologies Device Project Leader, Novartis

  • An update on the landscape of cell and gene therapy and identifying when injectable delivery is the appropriate approach
  • Assessing the impact of COVID and the use of frozen PFS
  • Potential benefits and challenges of a parenteral approach to delivery of cell and gene therapies using pre-filled syringes
  • Future development strategies for cell and gene therapy
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    14:00

    Transforming formulation strategies for injectable drug systems

    Kai Zwingenberger

    Kai Zwingenberger, Medical Director Global Quality, CSL Behring

  • Enhancing drug formulation for large molecule drug delivery from a parenteral delivery perspective
  • Key considerations for large volume drug delivery: a review of  high concentration stability 
  • Elevating container options for injectable delivery proteinbased products with future directions and next steps required for progression of the field
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    14:40

    Session reserved for Apiject

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    15:10

    Afternoon Tea

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    15:40

    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

  • An introduction to early phase primary packaging requirements of novel devices 
  • Exploring drug formulation considerations for device optimisation and strategies to reduce wastage
  • Implementing end of life procedures for device disassembly and correct material disposal
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    16:20

    Sustainability Strategies for Injectable Device Development

    Baijia Huang

    Baijia Huang, Global Environmental Lead, Novo Nordisk

  • Novel material development selection with cost, biocompatibility and sustainability all in mind to promote the sustainability profile of your device
  • Initial approaches to optimising device development practices for a reduced environmental footprint
  • Challenges in sustainable device development and looking forward
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    17:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

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    9:10

    Polymer vials - An alternative to glass for parenteral drugs?

    Benjamin Werner

    Benjamin Werner, Associate Head of Laboratory, Boehringer Ingelheim

  • Difference between materials - glass and polymer 
  • Challenges for drug stability and safety: permeation behaviour and differences regarding their break resistance
  • Points to consider in selecting polymer vials
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    9:50

    Method comparison study-one step forward towards robust silicone layer thickness measurements

    Christian Proff, Senior Verification Engineer, Roche

  • Optimizing the role of silicon layer thickness studies for primary packaging
  • Enhancing system injection functionality behaviour and device performance
  • Leveraging cutting edge technologies into the device improvement to mitigate risk, shorten lead time and reduce cost
  • Reproducibility of the thickness measurement method as a result of thorough method understanding and defining key method parameters
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    10:30

    Morning Coffee

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    11:00

    Selection of a new primary component: an interdisciplinary approach

    Soumen Das

    Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

  • 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
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    11:40

    Drug Delivery Systems - Patient Preference Study (PPS)

    Marie Picci

    Marie Picci, Delivery Systems Strategy Director, Device Development & LCM, Novartis

  • Implementing IMI PREFER in PPS design 
  • Patient Preference Study (PPS) creation and its role in achieving the project objective
  • Case Studies
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    12:20

    Networking Lunch

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    13:20

    Connected Devices: Responding to Patient’s Expectations and Some Simple Rules to Deliver a Great Product

    Simon Wilson

    Simon Wilson, Device Development Lead, Pfizer

  • Exploring connected ecosystem use cases (Connected Drug Delivery, Digital Therapeutics, Digital Diagnostics etc)
  • Understanding complexities of building connected ecosystems around parenteral delivery devices
  • Optimising components in a connected ecosystem to improve patient adherence and engagement
  • Ensuring the development process is a collaborative, user driven approach with end-to-end thinking
  • Case study on a ‘connected’ project
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    14:00

    Regulatory expectations for the design, implementation and launch of wearable injector platforms

    Selenge Erdenechimeg

    Selenge Erdenechimeg, GCMC, Medical Device Strategist, Pfizer Ltd UK

  •  Understanding Novo Nordisk’s approach to platform technology across the injectable portfolio
  •  Current priorities in multiple regions: cybersecurity, interoperability, and AI
  •  The CPC working group’s collaboration with FDA and the impact on future planning
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    14:40

    Afternoon Tea

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    15:10

    Streamlining product development through correct CMC practices and regulatory governance

    Ryan Noble

    Ryan Noble, Associate Director, GSK

  • Key considerations for drug product strategies from preNME to post-NDA/MAA approval, including Life Cycle Management (LCM)
  • A review of current European regulatory guidance for drug delivery devices and lessons from MDR implementation
  • Strengthening device optimisation with a review of article 117and available EMA guidance
  • Future labelling requirements and next steps in regulatoryguidance
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    15:50

    Form regulator to regulated – working under combination product regulation

    Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

  • As former member of MDCG (authorities) and now heading Novo Nordisk RA devices Thomas will share his experience working with both sides of the EU combination product regulation. Addressing topics like:
  • Challenges with art 117 in the MDR - Notified Bodie Opinions 
  • EMA/NB - and approvals vs. opinions 
  • Where to be cognisant of gaps and how to move forward
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    16:30

    Chairman’s Closing Remarks and Close of Day Two


    Global Environmental Lead
    Novo Nordisk
    Associate Head of Laboratory
    Boehringer Ingelheim
    Principle Scientist Extractables and Leachables
    Novo Nordisk
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Senior Verification Engineer
    Roche
    Senior Verification Engineer
    Roche
    New Technologies Device Project Leader
    Novartis
    Director, Senior Expert Nonclinical Safety
    Bayer AG
    Toxicologist and Comparability SME
    Baxter AG
    Senior Scientist
    AstraZeneca
    Medical Director Global Quality
    CSL Behring
    Delivery Systems Strategy Director, Device Development & LCM
    Novartis
    Associate Director
    GSK
    GCMC, Medical Device Strategist
    Pfizer Ltd UK
    Device Development Lead
    Pfizer
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    Director Global Regulatory Affairs - Device
    Novo Nordisk

    Sponsors

    VENUE

    Hilton London Kensington

    179-199 Holland Park Avenue, London, United Kingdom

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    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.


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    Hilton London Kensington

    179-199 Holland Park Avenue
    London W11 4UL
    United Kingdom

    Hilton London Kensington

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”
    HOTEL BOOKING FORM

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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:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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