SMi Group's Injectable Drug Delivery 2019 conference takes place in London in May

1. www.injectable-drug-delivery.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Use-related Risk Analysis throughout a Design and Development Project
13.30 - 17.30
Workshop Leader:
Paula Wood, Director, Human Factors Centre
PLUS AN INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOP | TUESDAY 14TH MAY 2019, COPTHORNE TARA HOTEL, KENSINGTON, LONDON UK
SMi Pharma
@SMiPharm
WORKSHOP: 14TH
CONFERENCE: 15TH-16TH
MAY
2019COPTHORNE TARA HOTEL, KENSINGTON, LONDON UK
SMi Group Proudly Present the 2nd Annual Conference…
Injectable Drug
Delivery
Assessing the innovations in formulations and devices for enhanced
injectable delivery
BOOK BY 31ST JANUARY AND SAVE £400
BOOK BY 28TH FEBRUARY AND SAVE £300
BOOK BY 29TH MARCH AND SAVE £200
2019 CHAIRS:
• Joel Richard, Head of Technical and Pharmaceutical
Operations, MedinCell
• Sigrid Van Dyck, Senior Director, Technical Operations
Parenteral Platform Lead, Johnson and Johnson
FEATURED SPEAKERS:
• Vasco Filipe, Formulation and Drug Process Development
Section Head for Biologics, Sanofi
• Bjorg K. Hunter, Device Engineering Manager, GSK
• Sigrid Van Dyck, Senior Director, Technical Operations
Parenteral Platform Lead, Johnson and Johnson
• Quentin Le Masne, Head of Engineering Team for Electro-
Medical Drug Delivery Devices, Merck
• Steve Paboojian, Senior Project Leader for Device
Development, Novartis
HIGHLIGHTS IN 2019:
• HEAR from MedinCell about the solutions to overcoming
the challenges associated with formulation development
of long acting injectables
• LEARN about the solutions to overcome the changes in
the regulatory framework with Amgen
• GAIN INSIGHT into the current design systems that
overcome issues associated with patient centricity
• EXPLORE the strategic approaches on using the current
technologies regarding drug delivery, including real-world
examples with AstraZeneca
SPONSORED BY

2. INJECTABLE DRUG DELIVERY
Day One | Wednesday 15th May 2019 www.injectable-drug-delivery.com
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Joel Richard, Head of Technical and Pharmaceutical Operations,
MedinCell
FORMULATION DEVELOPMENT AND DEVICE OPTIMISATION
OPENING ADDRESS
9.10 Overcoming the challenges in formulation development
for injectable protein formulations
• 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
• Proteins and injectable gels
Vasco Filipe, Formulation and Drug Process Development Section,
Head for Biologics, Sanofi
9.50 Thinking real-world data collection: the added-value of digital
enhancement to serve patient treatment compliance and HCP
security
• How injectable drug delivery could be optimized within hospital
block chain
• Human Factor Engineering: where smart injectable drug delivery
is saving lives in emergency scenarios
Adeline Meilhoc, VP and Head of Sales & Marketing,
Eveon
10.30 Morning Coffee
11.00 Formulation development for long acting injectables
• Considerations for long-acting formulation development
• Overcoming challenges
• A game-changing delivery system for long acting injectables
• Future prospects
Joel Richard, Head of Technical and Pharmaceutical Operations,
MedinCell
KEYNOTE ADDRESS
11.40 Development of Visisure®, a novel low volume high
accuracy syringe for delivery of Lucentis® to neonates
• 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
Steve Paboojian, Senior Project Leader for Device Development,
Novartis
12.20 Networking lunch
13.20 Ethical principles in human factors studies and developing a code
of conduct
• Overview of current HF study trends
• Ethical considerations of HF Studies
• Proposed considerations for ethical code of conduct
Miranda Newbery, Human Factors Consultant, Inspired Usability
Louisa Harvey, Medical Device Director & Human Factors
Consultant, Harvey Medical Ltd
14.00 Partners in evolution: Challenges and changes in parenteral drug
delivery
• A summary of key trends and changes in the device landscape
• Highlight potential pitfalls to avoid
• The device as an enabler rather than a barrier to market
success
John Burke, Senior Industrial Design Consultant, Team Consulting
14.40 Afternoon Tea
REGULATORY UPDATES AND PATIENT SAFETY
15.10 A convergent approach to the regulatory framework for
combination products
• 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
Blake Green, Regulatory Affairs Senior Manager, Devices, Amgen
15.50 An industrial perspective on ICH Q12 and EU MDR
• 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
Bjørg Kaae Hunter, Device Engineering Manager, GlaxoSmithKline
16.30 Chairman’s Closing Remarks and Close of Day One
SPONSORED BY
Register online at www.injectable-drug-delivery.com
*Subject to Final Confirmation
Almac is an established CDMO organization that provides an extensive range of integrated services to the global
biopharma industry. Almac provides specialised packaging solutions for all biopharmaceutical dosage forms (vials,
ampoules, pre-filled syringes, auto-injector pens) and can support all your packaging needs from niche/orphan drug
launches to high volume products. www.almacgroup.com
Transforming patient experience. EVEON is the partner of pharmaceutical, biotech companies and medical device
manufacturers for the development of automatic, safe and connected devices. The company facilitates and controls
the handling, preparation and administration of molecules. Our innovative solutions meet specific requirements of a
wide range of applications. www.eveon.eu

3. SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime
networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
INJECTABLE DRUG DELIVERY
www.injectable-drug-delivery.com Day Two | Thursday 16th May 2019
SUPPORTED BY
8.30 Registration & Coffee
9.00 Co-chairman’s Opening Remarks
Singrid Van Dyck, Senior Director, Technical Operations Parenteral
Platform Lead, Johnson & Johnson
INJECTABLE DEVICE CONNECTIVITY
9.10 Driving innovation in the Injectable Drug Delivery market
• Future of drug delivery market – an overview
• How we can improve patient adherence with connectivity
and innovation
Mayur Patel, Principal Consultant Medical Devices, PA Consulting
9.50 Partnering for drug delivery innovation progress and AstraZeneca’s
strategic considerations in successful outsourcing
• 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
Terry Reed, Director of Business Development, AstraZeneca
10.30 Morning Coffee
KEYNOTE ADDRESS
11.00 Development of electronic injectables – from concept to
manufacture
• 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?
Quentin Le Masne, Head of Engineering Team for Electro-Medical
Drug Delivery Devices, Merck
11.40 Digital rapid prototyping-using the latest prototyping methods to
unlock the value of digital propositions faster
• Case studies of navigating through the risks and rewards of
deploying digital into their healthcare products and services.
• Learn how we uncover surprising insights in human factors and
product development
• We’ll share several toolkits and approaches we use which help
us to better quantify user experiences; highlighting where the
value in digital can be captured and monetised
Tom Lawrie-Fussey, Digital Services Specialist, Cambridge Design
Partnership
12.20 Networking Lunch
MANUFACTURING, FILLING AND QUALITY CONTROL
13.20 High viscosity vs high volume – a case study of injection
tolerability and influence on design formulation and devices
• Patient tolerability and safety
• Patient centric formulation design
• Safety considerations
• Optimal design strategy
Session reserved for leading pharmaceutical company
14.00 The route to patient centric drug delivery
• Patient considerations and pharmaceutical connectivity
limitations
• Cost vs. Adherence, where does the benefits lie?
• Contamination control where disposables are not an option –
patient safety focus
• Realistic patient experience approach
Olaf Lebau, Design Engineer for Medical Device and Combination
products, Boehringer Ingelheim
14.40 Afternoon Tea
KEYNOTE ADDRESS
15.10 Manufacturing, filling and quality control
• Device design – Long acting injectables and Biologics
• Design for Manufacturing – Filling, Automated inspection and
Packaging
• Quality assurance considerations
Sigrid Van Dyck, Senior Director, Technical Operations Parenteral
Platform Lead, Johnson and Johnson
15.50 Manufacturing inspection trends
• Manual Inspection
• Automated Inspection
• Future Trends
Paul Kinsey, Product Leader – Visual Inspection & Leak Detection,
GSK
16.30 Chairman’s Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
*Subject to Final Confirmation

4. HALF DAY PRE-CONFERENCE WORKSHOP
Tuesday 14th May 2019
Copthorne Tara Hotel, Kensington, London UK
13.30 - 17.30
Use-related Risk Analysis throughout a
Design and Development Project
Workshop Leader:
Paula Woods, Director, Human Factors Centre Ltd
Workshop overview:
This workshop will help delegates better link use-related
risk management throughout the product development
process. Delegates will come away with a greater
awareness of how to link Human Factors activities to
ensure use related risks are identified and mitigated
appropriately early and throughout the design process.
Why you should attend:
If you want to broaden your knowledge on use-related
risk management and if you want to understand
how Human Factors relates to the overall design and
development process.
Programme:
13.30 Registration & Coffee
14.00 Workshop leader introduction
14.10 What is Use-Related Risk Analysis and how
does it differ from other risk analyses?
• Understand what critical tasks are, how they
are identified and treated throughout the
Usability Engineering Process
15.00 Practical: Task Analysis and PCA on an
injectable device
15.15 How to identify critical tasks
How to write User Interface Requirements
• Understand how to write User Interface
Requirements and how to link these to other
design requirements
15.30 Morning Coffee and Networking Break
16.00 Human Factor’s studies
• Understand the main differences between
Formative and Summative Studies. Learn
more about considerations when planning,
executing and reporting on these types of
studies
16.20 Practical: Data Collection
16.40 Feeding data (findings) back into a use-related
risk analysis
• Understand how data collected from studies
should be handled post-study
17.00 What is data bias and why is it important to
mitigate against it? How to avoid data bias
• Learn about data bias and ways to mitigate
the risks associated with this
17.20 Closing Remarks
17.30 Close of workshop
About the Workshop Leader:
Paula has a background in Human Factors, Usability,
User Research, User Experience and Product Design.
Paula specialises in both Medical Device Human Factors
and Human Factors for Combination Products. She is
a certified Practitioner and has moderated numerous
Formative and Summative Evaluations across Europe,
USA and China. Paula is also a licentiate fellow of the
Institute of Training and Occupational Learning and
provides Human Factor’s training to both Pharmaceutical
and Medical Device manufacturers.
About the organisation:
The Human Factors Centre is a Human Factors and User
Research consultancy who specialise in Human Factors
and User Research within Medical devices and Drug
delivery domains. Over the years, we have helped
consult and train numerous companies on how to
successfully conduct front end user research, usability
test their products and navigate the needs of regulators
with relation to FDA requirements, IEC62366 and
ISO14971. Our training courses include how to develop
HFE files, how to plan, execute and report Formative and
Summative studies and how to effectively moderate
studies.

5. FEBRUARY 2019
Parallel Trade
5th - 6th February, London, UK
3D Cell Culture
20th - 21st February, London, UK
RNA Therapeutics
20th - 21st February, London, UK
MARCH 2019
Superbugs & Superdrugs
18th - 19th March 2019, London, UK
Drug Discovery Chemistry
18th - 19th March 2019, London, UK
APRIL 2019
Adaptive Designs
1st - 2nd April 2019, London, UK
Pre-Filled Syringes East Coast
8th - 9th April 2019, Boston, USA
Microbiology East Coast
10th - 11th April 2019, Boston, USA
MAY 2019
Highly Potent Active Pharmaceutical
Ingredients
13th - 14th May 2019, London, UK
Pain Therapeutics
13th - 14th May 2019, London, UK
Injectable Drug Delivery
15th - 16th May 2019, London, UK
JUNE 2019
Prefilled Syringes West Coast
3rd - 4th June 2019, San Diego, USA
Lyophilisation
3rd - 4th June 2019, London, UK
Microbiology West Coast
5th - 6th June 2019, San Diego, USA
SMi PHARMACEUTICAL
EVENT PLANNER 2019
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising
and branding packages, uniquely tailored
to complement your company’s marketing
strategy. Prime networking opportunities exist
to entertain, enhance and expand your client
base within the context of an independent
discussion specific to your industry. Should
you wish to join the increasing number of
companies benefiting from sponsoring our
conferences please call:
Alia Malick, Director on +44 (0) 20 7827 6168
or email: amalick@smi-online.co.uk

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INJECTABLE DRUG DELIVERY 2019
Conference: 15th - 16th May 2019, Copthorne Tara Hotel, Kensington, London UK Workshop: 14th May 2019, London
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
ONLINE at www.injectable-drug-delivery.com
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DOCUMENTATION
I cannot attend but would like to Purchase access to the following Document Portal/
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on the Document Portal £499.00 + VAT £598.80
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□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
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to distribution rights by speakers. Please note that some presentations may not be
available for download. Access information for the document portal will be sent to
the e-mail address provided during registration. Details are sent within 24 hours post
conference.
VENUE Copthorne Tara Hotel, Kensington, London UK
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712
□ Book by 31st January to receive £400 off the conference price
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□ Book by 29th March to receive £200 off the conference price
EARLY BIRD
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