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The SMi Group is pleased to announce the second annual Injectable Drug Delivery conference which will be held in London on the 15th and 16th May 2019.

The global injectable drug delivery market is expected to grow from $400 billion to $1200 billion by 2046 with a CAGR of 12.8%.

Injectable drug delivery is a method of drug administration into the body with a needle via various routes including intramuscular and intravenous. These are examples of conventional drug delivery. Recently, there has been a focus on novel drug delivery, including needle-free injectors, and transdermal patches. Long acting injectables (LAI) are developing fast as a push towards patient centric devices drives the industry. Habitually, injectables were used for delivery of hormones, vaccines and insulin but as technology advances the application is continuing to expand. Now there is an emphasis on finding solutions to chronic conditions and the biological drugs required involve formulation development challenges for proteins, including high viscosity and high volume. Self-administrative, connected, and ergonomic devices are the new drive. Self-injectable devices include pen injectors for diabetic patients. The wealth of expansion available in the field of connected devices is huge. The regulatory landscape is challenging as it evolves rapidly with the market demand for new devices.
 

Developing on last years success, this event assembles an international audience to include regulatory, device design, packaging and  formulation professionals.  The devices need to be designed for the new generation of drugs and they need to provide safety with a strong patient focus. This event is will help inspire you to help drive this industry forward and learn about the predicted market trends, critical digital and chemical developments and the push for patient compliance in a changing regulatory landscape.  
 

This conference offers a chance to learn about innovative injectable drug delivery systems with industrial insights on the following: 

- Life cycle management for developing devices that are both user friendly and revenue effective
- Device design considerations
- Long acting injectables and bringing these therapeutics to market with case studies
- Connected devices, GDPR and cyber security programs
-Developments in primary packaging
-Growth in transdermal delivery and subcutaneous infusion devices
-Digital health partnerships
-Large volume patch pump innovation examples

 


 

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

 

AbbVie; Aptar France SAS; AstraZeneca; Barts Health NHS Trust; Cambridge Consultants Ltd; Cambridge Design Partnership; Cantab Innovations; Credence MedSystems; Crux Product Design, Ltd; Enable Injections; Enesi Pharma Ltd; F. Hoffmann-La Roche Ltd; Fresenius Kabi Deutschland GmbH; GSK; Human Factors Centre Ltd; IPSEN; Janssen; KCL; LEO Pharma A/S; Mallinckrodt Pharmaceuticals; MedinCell; MHRA; New Injection Systems Ltd; Novaliq GmbH; Novartis Pharma GmbH; Owen Mumford; Pfizer; Phillips - Medisize; Phillips-Medisize; Roche Pharmaceuticals; Sanofi-Aventis; Sanofi-Aventis R&D; University College London; UroPharma Limited; W.L. Gore & Associates, Inc.; Weidmann Medical Technology Ag; Worrell;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 Overcoming the challenges in development of injectable protein formulations

Vasco Filipe

Vasco Filipe, Senior research scientist - Formulation Development, Sanofi
View Bio

  • High viscosity that exceeds the capabilities of current manufacturing practices or available parenteral delivery methods
  • High concentration leading to stability and aggregation concerns and the associated material required for a robust development strategy
  • High volume biologic challenges and strategies to overcome them
  • Viscosity reducing excipients
  • 9:50 Formulation development for long acting injectables

    Joel Richard

    Joel Richard, Head of Technical & Pharmaceutical Operations, MedinCell
    View Bio

  • Considerations for long-acting formulation development
  • Overcoming challenges
  • A game-changing delivery system for long acting injectables
  • Future prospects
     
  • 10:30 Morning Coffee

    11:00 High Viscosity vs. High Volume - A case study of injection tolerability

    11:40 Developing complex injectable formulations

    12:20 Networking Lunch

    13:50 Ethical principleas in human factors studies and developing a code of conduct

    Miranda Newbery

    Miranda Newbery, Human Factors Consultant, Inspired Usability
    View Bio

  • Overview of current HF study trends
  •  Ethical considerations of HF Studies
  • Proposed considerations for ethical code of conduct
  •  

    14:30 A convergent approach to the regulatory framework for combination products

    Blake Green

    Blake Green, Senior Manager Regulatory Affairs, Amgen
    View Bio

  • An overview of current approaches for combination product regulations
  • Avoiding divergence, proposed convergent approach to ensure compliance and improve practice
  • Potential implications on the industry
     
  • 15:10 Afternoon Tea

    15:40 Understanding the medical device industry and its status – an industrial perspective on ICH Q12 and EU MDR

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Device Engineering Manager, GlaxoSmithKline
    View Bio

  • Changes in the global regulatory environment and processes for incorporating emerging trends into internal regulatory strategies
  • Guiding innovative development with regulatory leverage
  • Control strategies and compliance with quality systems for a medical delivery device
  • Compliance with quality systems and medical devices
  • Examples of how to direct a team for late stage parental development.
  • 16:20 Partnering for drug delivery innovation progress and AstraZeneca’s strategic considerations in successful outsourcing

    Terry Reed

    Terry Reed, Director Business Development, AstraZeneca
    View Bio

  • AstraZeneca’s approach to seeking and engendering innovation in its drug delivery organisation
  • Structuring deals to leverage the expertise of outsourcing partners – key considerations for commercial success
  • An overview of the search for key technologies and solutions to support the portfolio of activities and developments
  • Learning points from a recent case
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 The route to patient centric drug delivery

    9:50 Development of Visisure, a novel low volume high accuracy syringe for delivery of Lucentis to neonates

    Stephen Paboojian

    Stephen Paboojian, Senior New Technology Project Leader II, Novartis Pharma AG
    View Bio

  • Background on Retinopathy of Prematurity and impact to patients
  • Drivers and constraints for development: user, business, and regulatory
  • Technical challenges overcome: device, packaging, manufacturing, and HFE
  • Final product configuration and supply chain
  • 10:30 Morning Coffee

    11:00 Development of electronic auto-injectors - from concept to manufacture

    Quentin Le Masne

    Quentin Le Masne, Head of Engineering team - Electro-Medical, Drug Delivery Devices, Merck
    View Bio

  • Overview of the development process – the do’s and don’ts
  • The challenges and learnings of electronic and connected drug delivery devices
  • User experience and patient-centric design: what do patients really want from electronic auto-injectors?
     
  • 11:40 Digital rapid prototyping-using the latest prototyping methods to unlock the value of digital propositions faster

    Tom Lawrie-Fussey

    Tom Lawrie-Fussey, Head of Digital Health, Cambridge Design Partnership
    View Bio

  • Case studies that navigate through the risks and rewards of deploying digital into healthcare products and services
  • Learn how we uncover surprising insights in human factors and product development
  •  We’ll share a number of toolkits and approaches we use which help us to better quantify user experiences; highlighting where the value in digital can be captured and monetised.
  •  

    12:20 Networking Lunch

    13:50 Aseptic fill-finish processes - overcoming challenges and opportunities for growth

    14:30 Systematic approach to the removal of extractables and leachables

    15:10 Afternoon Tea

    15:40 Manufacturing of multi-component formulations

    16:20 Manufacturing inspection trends

    17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Joel Richard

    Joel Richard

    Head of Technical & Pharmaceutical Operations, MedinCell
    Quentin Le Masne

    Quentin Le Masne

    Head of Engineering team - Electro-Medical, Drug Delivery Devices, Merck
    Stephen Paboojian

    Stephen Paboojian

    Senior New Technology Project Leader II, Novartis Pharma AG
    Vasco Filipe

    Vasco Filipe

    Senior research scientist - Formulation Development, Sanofi

    Bjorg Kaae Hunter

    Device Engineering Manager, GlaxoSmithKline
    Bjorg Kaae Hunter

    Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg has been with GSK since graduating and has held different roles within the Device Engineering Group. In 2015 Bjorg moved into the late stage parenterals area as device lead for key GSK parenteral devices, working closely with internal GSK project teams and external partners. She progressed into leading a device management team in January 2017, where she has accountability of project management and regulatory compliance for parenteral devices. Bjorg has presented at several key pharmaceutical conferences on pharmaceutical topics, specifically in relation to combination product and regulatory guidance.

    Blake Green

    Senior Manager Regulatory Affairs, Amgen
    Blake Green

    Blake Green is a Regulatory Affairs Senior Manager with Amgen’s Global Medical Devices Regulatory team. Based in Cambridge UK. Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector. Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.

    Joel Richard

    Head of Technical & Pharmaceutical Operations, MedinCell
    Joel Richard

    Dr Richard is presently leading the Technical and Pharmaceutical Development activities for the Medincell Company, Lead Candidate Selection to all Clinical Development Phases.
     

    Dr Joël Richard graduated from Ecole Normale Supérieure (Cachan, France) and got his PhD in Materials Science/Colloids & Interface Science from University of Paris VI. Dr Richard has 30 years of experience in chemistry and biopharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Medincell, Ipsen, Merck Serono, Serono and Ethypharm. He also had an entrepreneurial experience, co-funding Mainelab (France) with Pr Jean-Pierre Benoit, a drug delivery company specialized in developing solvent-free processes for protein delivery systems. Dr Richard has focused his research activity on new formulations and drug delivery systems (such as microspheres, nanoparticles, self-assembling gel systems, chemically-modified proteins, supercritical fluid technology . . .), especially for injectable protein and peptide formulations. Dr Richard has published 68 peer-reviewed scientific papers, 8 book chapters and 2 editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein formulations, sustained-release formulations…). He is the author of more than 140 international communications and 55 patent families.

     

    Miranda Newbery

    Human Factors Consultant, Inspired Usability
    Miranda Newbery

    Miranda is a creative design and usability consultant specialising in medical device developments. In 2016 she founded Inspired Usability, a medical device human factors consultancy. She works on early design research through to human factors validation on a range of medical device and combination products. Miranda originally studied Engineering (Cambridge University) and Industrial Design (Royal College of Art) and is a chartered ergonomist with the CIEHF. In 2018 Miranda and Louisa Harvey started the Medical Human Factors Network UK, with the aim of brining together like-minded professionals and raisi

    Quentin Le Masne

    Head of Engineering team - Electro-Medical, Drug Delivery Devices, Merck
    Quentin Le Masne

    Quentin Le Masne holds a Master’s Degree in Engineering for Ecole Centrale de Paris and a PhD in Physics from Paris University. He has worked in numerous positions in the field of medical devices, from In-Vitro Diagnostic to Drug Delivery Devices, restlessly bringing highly innovative ideas from lab to market. His work focuses on the management of engineering teams with diverse expertise like electronic, mechanics, human factors, physics, fluidics, and manufacturing to bring new products in the doctor’s and patient’s hands. He is now in charge of the development of novel electronic drug delivery devices for Merck.

    Stephen Paboojian

    Senior New Technology Project Leader II, Novartis Pharma AG
    Stephen Paboojian

    Stephen Paboojian is an engineer and senior project leader for the development of pharmaceutical delivery systems, from medical devices and primary drug packaging to instructional materials and custom outer packaging. Steve has a proven track record of over 25 years of driving novel inventions from concept to commercial launch, contributing to global products in development for treatment of Macular Degeneration, COPD, Cystic Fibrosis, Multiple Sclerosis, and Diabetes.

    Terry Reed

    Director Business Development, AstraZeneca
    Terry Reed

     

    Terry Reed is Director of Business Development in the Innovation Strategy & External Liaison group at AstraZeneca and has worked in the pharmaceutical industry for over 11 years. He has specific responsibility for the enhancement of AstraZeneca's Pharmaceutical Technology and Development capabilities, by enabling access to the best external science, technology and innovation. Terry has previous considerable experience in supporting Discovery opportunities with a specific focus on toxicological sciences. He’s been responsible for negotiating and executing over 200 transactions for a broad spectrum of activities spanning in-licensing/out-licensing of technology platforms and intellectual property as well as collaborations and consortiums with industry, biotech and academic partners.
    Prior to joining AstraZeneca Terry was Director of Commercial Development at Pharmagene. In all Terry has more than 25 years commercial experience in the life science sector, having also held business development and management positions at Oxford Gene Technology, De Novo Pharmaceuticals, Applied Biosystems, Amersham and Millipore.
     

    Tom Lawrie-Fussey

    Head of Digital Health, Cambridge Design Partnership
    Tom Lawrie-Fussey

    Tom Lawrie-Fussey is a digital services specialist at technology and product design firm Cambridge Design Partnership. He is a Chartered Engineer with a master’s degree and has more than 15 years’ product development experience. Tom works across multiple industry sectors, primarily focused on drug delivery, consumer health, and FMCG clients, where he drives various digital initiatives to help guide clients along their own digital roadmap. He specialises in digital implementation, linking device development with communications and data analytics platforms. Tom provides a technology-agnostic, pragmatic approach that is human-centred – unlocking benefits for all stakeholders and, ultimately, generating new revenue streams.

    Vasco Filipe

    Senior research scientist - Formulation Development, Sanofi
    Vasco Filipe

    Vasco Filipe is a Biological Engineer and obtained a Ph.D. degree in Pharmaceutical Sciences from the Utrecht University (The Netherlands) in 2011. His thesis focused on the physicochemical characteristics, stability in biological fluids and immunogenicity of monoclonal antibody aggregates. After a post-doc in 2012 on a similar topic, he then joined Adocia in 2013 (Lyon, France), where he worked as the Project Leader for all monoclonal antibodies collaborations. In 2015 he joined Sanofi (Paris, France), where he now works as a Section Head of Formulation and Process Development in the department of Biologics Drug Product Development.

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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, SMI 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@smi-online.co.uk

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