SMi Group's inaugural Injectable Drug Delivery 2018 conference takes place in London this 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
A: Creating a human factors and usability engineering
file in line with the FDA and IEC62366-1
08.30 - 12.30
Workshop Leader:
Paula Wood, Director of Human Factors, Human Factors Centre Ltd
B: Wearable injectors: Serving clinical and
healthcare system needs
13.30 - 17.30
Workshop Leader:
James Blakemore, Senior Consultant, Medtech Consulting Group,
Cambridge Consultants
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS | TUESDAY 15TH MAY 2018, HOLIDAY INN KENSINGTON FORUM, LONDON, UK
SMi Pharma
@SMiPharm
WORKSHOPS: 15TH
CONFERENCE: 16TH-17TH
MAY
2018HOLIDAY INN KENSINGTON FORUM, LONDON, UK
SMi Presents the Launch of...
Injectable Drug
DeliveryDiscover the next generation of injectable drugs and devices through
emerging technologies and market opportunities
BOOK BY 31ST JANUARY AND SAVE £400
BOOK BY 28TH FEBRUARY AND SAVE £200
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CHAIRS FOR 2018:
• Jean-René Authelin, Global Head, Pharmaceutical
Engineering, Sanofi
• Joel Richard, Senior Vice President, Peptides Development,
Ipsen
FEATURED SPEAKERS:
• Anand Subramony, Vice President, Novel Product
Technologies, MedImmune
• René Holm, Head & Scientific Director, Liquids & Parenterals,
Janssen
• Ahmed Youssef, Head of Parenteral Unit, Sanofi
• Maxime Gaillot, Senior Device Engineer, Roche
• Pierre Goldbach, Senior Principal Scientist, F. Hoffmann-La
Roche AG
• Fie Falck Larsen, Senior Usability Engineer, Injection Devices,
Global Research and Development, LEO Pharma
• Francesco Malavasi, Medical Device Quality Device Risk
Manager, Novartis
HIGHLIGHTS IN 2018:
• Evaluate solutions for high-volume and highly-viscous drug
formulations and explore their increasing market opportunities
• Revolutionise the patient experience through connected
technologies, wearable injectors and maintenance of
patient-centric design processes
• Gain insight into the design strategies of industry-leaders
• Discover the practical industrial solutions to tackling the
critical fill and finish process
• Learn how vial-based novel delivery technologies can
overcome complex dosing regimens
• Discover how nanosystems can help address present and
future challenges in injectable peptide delivery

2. 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
Day One | Wednesday 16th May 2018 www.injectable-drug-delivery.com
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Jean-Rene Authelin, Global Head of Pharmaceutical Engineering,
Sanofi
EMERGING TECHNOLOGIES & OPPORTUNITIES
KEYNOTE ADDRESS
9.10 Drug Delivery: Emerging trends and opportunities
• A look at how fast the delivery technology field has
evolved until now – factors that will contribute to continued
development
• Discussing the future of evolving areas including polymer
technologies, auto injectors, microneedles etc.
• Learnings and Opportunities
Anand Subramony, Vice President, Novel Product Technologies,
MedImmune
9.50 Vial Based Novel Delivery Technology
• Weight-based dosing limits the primary packaging selection and
impacts the number of potential different product presentations
• Discover how vial-based presentation can provide a solution to
these complex dosing regimens
• Understand the background of vial-based presentation
• Learn the specifics of this novel delivery technology
Maxime Gaillot, Senior Device Engineer, Roche
10.30 Morning Coffee
DEVELOPING THE NEXT GENERATION OF DEVICES
11.00 Designing devices for a future portfolio
• Defining parameters and requirements
• Engaging stakeholders. How? Who? And when?
• Designing with the end users
Andrew Fiorini, Investigator, Device Engineering, GSK
11.40 Risk management for medical device and device part of
combination product
• Risk management: Why and What?
• Type of risk analysis
• Benefit during design control
• Case study of a PFS with NSD
Francesco Malavasi, Medical Device Quality Device Risk
Manager, Novartis
12.20 Networking Lunch
ADVANCING THE FILL & FINISH PROCESS
13.20 AFTERNOON KEYNOTE ADDRESS
Protein aggregation and oxidation during processing
• Proteins are known to be sensitive to many stresses, including
oxidation and shear stress, leading to potentially immunogenic
aggregates
• Examine the theoretical aspects together with real-life industrial
examples that illustrate the possible traps we may find in the fill
& finish processing
• Learn which experiments need to be performed in order to
understand and predict risks associated with this process
• Discover the practical industrial solutions
• Hear how to implement these solutions accordingly
Jean-René Authelin, Global Head, Pharmaceutical Engineering,
Sanofi
14.00 Fill and finish of biotech products and hazards associated:
Derisking approach
The presentation outlines the description of the scientific
methodology that comports several steps:
• Basic data acquisition focusing on the main physical chemistry
properties of the drug product. This step is the foundation of
the process development: all process development should be
based on product knowledge
• Preliminary calculations of process parameters based on prior
knowledge using simulation tools in order to anticipate process
parameters of freezing, thawing, mixing, filtration and filling
parameters. The values allow to have a first idea of the process
design space and to restrict the experimental domain
• Set-up of Design space using Lab scale tests for each operation
units in order to fine tune the calculation results. Thanks to
preliminary calculations the number of experiments to be
performed is reduced
• Set-up of robust and efficient scale-up that can lead to stable
products in the monitored quality attributes
Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi
14.40 Afternoon Tea
REVOLUTIONISING THE PATIENT EXPERIENCE
15.10 What does it take to be patient centric?
• Shaping usability to fit the organization
• Systemising user involvement with tools and templates
• Hands on experience with study design and implementation
• Involving key stakeholders in the process to secure anchoring of
study insights
Fie Falck Larsen, Senior Usability Engineer, Injection Devices,
Global Research and Development, LEO Pharma
15.50 How connected are we to our users
• There is a consensus these days that better usability will lead to
better adherence and uptake
• One of the challenges we face today is how to get early real
usability data to give us design insights to improve devices
• A novel approach is to use existing connected technology
to monitor users over a longer time period than a formative
study and understand long-term use behaviour such as training
decay, adherence and use errors associated with longer use
• Jobs to be done approach is used to understand which metrics
should be measured
• We will show data analytics from long term studies we have
conducted, discuss how there were analysed and what insights
were gained
Uri Baruch, Head of Drug Delivery, Cambridge Design Partnership
16.30 Chairman’s Closing Remarks and Close of Day One
SUPPORTED BYOFFICIAL MEDIA PARTNER
Register online at www.injectable-drug-delivery.com

3. *Subject to Final Confirmation
INJECTABLE DRUG DELIVERY
www.injectable-drug-delivery.com Day Two | Thursday 17th May 2018
SUPPORTED BY
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Pav Solanki, SMi Marketing on +44 (0) 20 7827 6048 or
email: psolanki@smi-online.co.uk
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Joel Richard, Senior Vice President, Peptides Development, Ipsen
DEVELOPING BETTER BIOLOGICS
OPENING ADDRESS
9.10 Injectable peptide delivery: How can nanosystems help address
present and future challenges
• Peptide therapeutic landscape
• Injectable peptide sustained-release (SR) formulations
• Peptide delivery to the brain
• Peptide delivery to tumors and cells
• Alternative non-invasive peptide delivery routes
Joel Richard, Senior Vice President, Peptides Development, Ipsen
PANEL DISCUSSION
9.50 Tackling high-volume and highly viscous drug
formulations
• Describing current market opportunities and trends
• What common user problems do patients experience and how
have you mitigated these issues?
• What design challenges have you faced and how have you
overcome these hurdles?
• Identifying the best possible innovative drug delivery solution for
your drug product
• What novel technologies are you developing to combat difficult
formulations?
• Predicting the future of injectable biologics
Moderator:
Joel Richard, Senior Vice President, Peptides Development, Ipsen
Panelists:
René Holm, Head & Scientific Director, Liquids & Parenterals,
Janssen
Pierre Goldbach, Senior Principal Scientist, Late-Stage
Pharmaceutical and Processing Development, F. Hoffmann-La
Roche AG
James Blakemore, Senior Consultant, Medtech Consulting Group,
Cambridge Consultants
Chris Muenzer, Senior Device Technology Manager, Novartis*
10.30 Morning Coffee
11.00 Drug product: The big picture
• Formulation development
• Drug product: The big picture
• From Lab to Industry
Ahmed Youssef, Head of Parenteral Unit, Sanofi
11.40 Long Acting Injectables - current trends
• A generalized overview of technical options for LAIs
• Biopharmaceutical elements of LAIs
• Excipient and importance of excipient understanding for LAIs
• A summary of exciting new data
René Holm, Head & Scientific Director, Liquids & Parenterals,
Janssen
12.20 Networking Lunch
13.20 Compatibility challenges of biologics with high volume injectors
• Delivery of high volume biologics subcutaneously
• Different types of devices for high volume injection
• Compatibility testing with high volume injectors
• Potential impact on biologics product quality
Pierre Goldbach, Senior Principal Scientist, Late-Stage
Pharmaceutical and Processing Development,
F. Hoffmann-La Roche AG
14.00 Solutions to the problem of poor drug solubility
• Techniques available used to increase apparent aqueous drug
solubility
• Matching a drug with the most appropriate technique
• Clinical benefit and potential of technologies
Jayne Lawrence, Head of Division, Division of Pharmacy and
Optometry, University of Manchester
14.40 Afternoon Tea
DESIGN CONSIDERATIONS
15.10 Product development of 9-THC injection: Development challenges
of an oily drug substance
• Barts Health Pharmaceuticals and the limitation of the
production
• Requirements for THC injections
• Initial challenges during product design
• Unexpected adsorption issue and further investigation
• Future development: Pre-filled syringes?
Ee Li, R&D Technical Specialist, Barts Health NHS Trust
15.50 Experience design for pharmaceutical delivery systems - design
strategies and learnings
• Usability vs. User Experience
• Behavioural design
• Internal and external drivers for experience design strategies
• Human centered design and design controls
• Insights and examples from Janssen
Cedric Gysel, Staff Device Engineer, Janssen
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

4. HALF DAY PRE-CONFERENCE WORKSHOP A
Tuesday 15th May 2018
Holiday Inn Kensington Forum, London, UK
8.30 - 12.30
Creating a human factors and usability engineering
file in line with the FDA and IEC62366-1
Workshop Leader:
Paula Wood, Director of Human Factors,
Human Factors Centre Ltd
Workshop overview:
The Creating a Human Factors and Usability Engineering
File workshop aims to equip delegates with the ability to
make decisions on which filing route they should take when
putting together a Usability Engineering File for a product.
The training gives delegates an in-depth understanding
of all the elements of the Usability Engineering File and
Usability Engineering process in-line with the expectations
from IEC62366-1 and the FDA.
Why you should attend:
This workshop is recommended for anyone involved with
the research, design and development of a Medical
Device or Combination Product. The workshop will cover all
aspects of the file including Use Specifications, User Interface
Evaluation Plans, Use Risk Analysis (Overview), User Interface
Specifications, Formative Evaluations (Overview), Summative
Evaluations (Overview) and HFE Summary Report.
Agenda
08.30 Registration & Coffee
09.00 Workshop leader introduction
09.10 Overview of the Regulatory Landscape
• Learn what is required for Human Factors
Engineering in Medical Devices and Combination
Products
• Discuss the latest changes to regulations
10.00 Expectations from the IEC62366-1
• Discuss each element of the Human Factors and
Usability Engineering Process
• Provide an overview of the Legacy Devices
(Annex C) clause in IEC62366-1 and what
evidence Manufacturers need to supply
regulators with to qualify for this route to market
10.15 Creating a Use Specification
• Information to include in a Use Specification
and how it inputs into all UE documentation and
activities
10.30 Morning Coffee and Networking Break
11.00 Creating a User Interface Evaluation Plan
• What to consider when creating a User Interface
Evaluation Plan,
• How this this will affect the overall project delivery
plan.
• Considerations for packaging, Instructions and
Training
11.20 Considerations when creating a use related risk
analysis
• Task Analysis
• PCA
• Ufmea
11.40 Conducting Formative and Summative Evaluations
• What to consider when producing these
evaluations
• Looking at IFU testing
12.00 Generating a HFE summary report
• Learn what you need to consider
• How to remain FDA compliant
12.20 Closing Remarks
12.30 Close of workshop
About the Workshop Leader:
Paula is the Founder and Director of the Human
Factors Centre Ltd. She has a background in
Human Factors, Usability, User Research, User
Experience and Product Design. Paula has worked
with various Healthcare start-ups, Medical Device
Manufacturers and Pharmaceutical companies to provide
training, support and mentorship when constructing Human
Factors and Usability Engineering Files. She is a certified
Practitioner and has moderated numerous Formative and
Summative Evaluations across Europe, USA and China.
About the organisation:
We are a Human Factors and
User Research consultancy who
specialise in Human Factors and
User Research within Medical
devices and Drug delivery domains. Our background is
in Human Factors, Usability, User Experience and Product
Design. Over the years, we have helped guide numerous
Pharmaceutical and Medical Device Manufacturers in how
to successfully conduct front end user research, usability test
their products and navigate the needs of regulators with
relation to FDA requirements, IEC62366-1 and ISO14971.

5. HALF DAY PRE-CONFERENCE WORKSHOP B
Tuesday 15th May 2018
Holiday Inn Kensington Forum, London, UK
13.30 - 17.30
Wearable injectors: Serving clinical and
healthcare system needs
Workshop Leader:
James Blakemore, Senior Consultant, Medtech Consulting
Group, Cambridge Consultants
Workshop overview:
Wearable Injectors (or On-Body Injectors) are
predicted to have a significant impact on the
parenteral drug delivery landscape. To date, the case
for these platforms has largely focused upon their
ability to deal with viscosity and volume challenges
associated with administration of biologics. This
workshop will explore the current device landscape
and evaluate its future potential to fulfil broader drug
delivery demands.
Why you should attend:
To gain actionable insights into why wearable
injectors are a vital tool in the field of parenteral drug
delivery devices. We will explore the wider potential
of wearable injectors to meet clinical needs, including
improvements to drug efficacy, safety and tolerability.
We will also discuss its impact on healthcare system
needs, such as reducing overall cost of care.
Agenda
13.30 Registration & Coffee
14.00 Workshop leader introduction
14.10 Defining the Drivers for Wearable Injectors
• Part 1: Addressing clinical needs
• Part 2: Meeting healthcare system needs
15.10 Afternoon Tea and Networking Break
15.40 Case Study – Use of Wearable Injectors in
the Home
• Defining the patient journey
• Identifying the needs of the patient
16.10 Creating a next generation wearable
injection system
17.00 Final Discussion and close of Workshop
17.30 Close of workshop
About the Workshop Leader:
James Blakemore is a Senior Consultant in the
Medical Technology division at Cambridge
Consultants. He specialises in market
strategy and transaction support within
the pharmaceutical and drug delivery
device markets. He manages drug delivery device
development projects bringing together commercial
insight and technical expertise. Prior to working in
the healthcare consulting industry, Dr Blakemore
worked in a number of business development and
licensing roles for speciality pharmaceutical and
biotechnology companies, working towards the
identification, validation and commercialisation of
broad new therapies. He holds a PhD in Molecular
Biology from King’s College, University of London, UK.
About the organisation:
Cambridge Consultants
is a world-class supplier
of innovative product
development engineering
and technology consulting.
For more than 55 years, we have been helping
clients turn business opportunities into commercial
successes, whether they are launching first-to-market
products, entering new markets or expanding existing
markets through new technologies. By combining
scientific understanding with patient and healthcare
insight, we have created award-winning drug delivery
devices for the treatment of conditions ranging from
cancer and autoimmune diseases to diabetes and
asthma.

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INJECTABLE DRUG DELIVERY
Conference: 16th - 17th May 2018, Holiday Inn Kensington Forum, London, UK Workshops: 15th May 2018, London
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