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plus tWo iNteRaCtive half-DaY pRe-CoNfeReNCe WoRkshops
TUESDAY 10TH APRIL 2018, SHERATON BOSTON HOTEL, BOSTON, USA
B: human factors for Connected Drug Delivery systems
Workshop Leaders: melanie turieo, Director, Human Factors and
Industrial Design, Cambridge Consultants and karen unterman,
Group Leader, Human Factors Engineering, Cambridge Consultants
13.30 - 17.00
ChaiRs foR 2018:
	ā€¢		Dhairya mehta, Associate Director of Device
and Combination Products, shire
	ā€¢		stephen Barat, Head of Pre-Clinical
and Early Clinical Development, scynexis
featuReD speakeRs:
	ā€¢		Justin Wright, Vice President, Drug Delivery
Innovation, DDR&D Technology, eli lilly
	ā€¢		tieming Ruan, Associate Director of Device
Development, takeda
ā€¢		molly story, Head, Global Usability Engineering
and Risk Management, Sanofi
ā€¢		gary henniger, R&D Director, Discovery and
Product Development R&D, teva pharmaceuticals
	ā€¢		michael song, Pharmaceutical Device and
Digital Health, medimmune
	ā€¢		steve Bowman, Device Program Lead, shire
	ā€¢		gary mills, Associate Director, Drug product
Development
	ā€¢		kashappa goud Desai, Investigator,
Biopharmaceutical Product Sciences,
glaxosmithkline
www.pfsamericas.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
aCaDemiC & gRoup DisCouNts availaBle @smiphaRm
#smipfsusa
RegisteR BY 15th DeCemBeR aND save $400
RegisteR BY 31st JaNuaRY aND save $200
RegisteR BY 28th feBRuaRY aND save $100
a: Design Considerations for the World outside the Clinic
Workshop Leaders: Debbie mcConnell, Human Factors Technical Lead,
Human Centric Design, Battelle and annie Diorio-Blum,
Principal Industrial Designer, Human Centric Design, Battelle
08.30 - 12.30
spoNsoReD BY
SMi presents the East Coastā€™s Leading, 5th Annual Conference and Exhibitionā€¦
Sheraton Boston Hotel, Boston, USA
WORKSHOPS: 10TH
CONFERENCE:
11TH - 12TH
APRIL
2018
Pre-Filled Syringes
East Coast
enabling the next generation of pre-filled syringes from design to manufacture
NeW foR 2018:
	ā€¢				Understand end-use interaction with delivery systems and
Human Factor engineering methods
	ā€¢				Guidance in overcoming challenges of delivering high-
concentration formulations and challenges for biologics
	ā€¢				Explore how to integrate Quality-by-Design principles for best
practice solutions in developing your combination products
	ā€¢				Benchmark against updates on new technologies, including
digital monitoring biomarkers from Eli Lilly; electronic-
enabled drug delivery devices from MedImmune; and PFS
tech transfer of in-line products from Merck
	ā€¢				Engage with the latest results from recent studies in
chemical compatibility; comparison of COP vs glass; and
container integrity
	ā€¢				Participate in our two interactive panel discussions and gain
from over 5 hours of dedicated networking time
engage with top pharma scientists
and engineers in our
pfs focused conference
hear the very latest plans
about drug-device development
in the injectables industry
Network with industry
and pharma leadership
in the exhibition area
letteR fRom the ChaiRs:
Dear participants,
We are absolutely delighted to welcome each of you to SMiā€™s Pre-Filled
Syringes East Coast conference.
Over	the	past	decade,	pre-fi	lled	syringe	venues	have	grown	signifi	cantly	
in terms of content and attendance and much of this can be attributed
to the interest and need to share information, as the development of
pre-fi	lled	syringe	drug	products	are	a	prime	example	of	complex,	multi-
disciplinary	efforts.		Pre-fi	lled	syringes	have	undoubtedly	improved	the	lives	
of the patients who rely on these drug products. As such, as an industry,
we share a responsibility to continue to develop and evolve these drug
products as new technologies in delivery, formulation and manufacturing
emerge ā€“ also considering the impact that global regulatory and
geopolitical landscapes may have ā€“ in order to meet the needs of our
patients and improve upon therapeutic options.
The meeting will therefore allow for the face-to-face assembly of subject
matter	experts	in	all	areas	related	to	the	development	of	pre-fi	lled	syringe	
and other related combination drug products, and thereby provide a
tremendous opportunity for meaningful discourse.
We look forward to seeing you there!
Dhairya mehta,
Associate Director of Device and Combination Products,
shire
stephen Barat,
Head of Pre-Clinical and Early Clinical Development,
scynexis
08.30 RegistRatioN & Coffee
09.00 Co-ChaiRsā€™ opeNiNg RemaRks
Dhairya mehta, Associate Director of Device and Combination
Products, shire
stephen Barat, Head of Pre-Clinical and Early Clinical
Development, scynexis
RegulatoRY upDates foR the pfs iNDustRY
keYNote aDDRess
09.10 NavigatiNg RegulatoRY CoNsiDeRatioNs iN the pfs maRket
eNviRoNmeNt
	 ā€¢		Regulatory	considerations	for	industry	relating	to	USP	<1207>
	 ā€¢		Applicable	regulatory	schemes	and	potential	regulatory	
strategies
	 ā€¢		Latest	updates	and	changes	for	FDA	requirements
session Reserved for fDa Representative
pfs maNufaCtuRiNg aND pRoCess:
ChalleNges aND solutioNs
09.50 sYRiNge filliNg of high-CoNCeNtRatioN moNoColoNal
aNtiBoDY foRmulatioN: ChalleNges aND solutioNs
	 ā€¢		There	has	been	a	steady	increase	in	the	number	of	high-
concentration	mAb	formulations	in	ready-to-use	pre-fi	lled	
syringes for subcutaneous administration
	 ā€¢		Challenges	of	successful	syringe	fi	lling	of	high-concentration	
mAb	formulations	by	an	automated	fi	lling	machine
	 ā€¢		Outlining	challenges	associated	with	syringe	fi	lling	of	high-
concentration formulations
	 ā€¢		This	presentation	summarizes	the	key	challenges	and	
mitigation strategies
kashappa-goud Desai, Associate Fellow, gsk
10.30 moRNiNg Coffee spoNsoReD BY
11.00 Cop - teChNiCal Data upDate
	 ā€¢		Key	properties	of	COP	-	update
	 ā€¢		Case	Study:	Study	on	Protein	adsorption/aggregation	with	
actual protein drug - COP vs. glass
	 ā€¢		Case	Study:	Study	on	delamination	with	glass	syringe	vs.	COP	
syringe
	 ā€¢		Leachable	data	on	COP	syringe	with	various	chemicals
toshiro katayama, Product Manager,
zeon Chemicals l.p.
11.40 safetY evaluatioN of leaChaBles WheN DevelopiNg
a pRe-filleD sYRiNge DRug pRoDuCt
	 ā€¢		Background	on	leachables	from	pre-fi	lled	syringe	drug	devices
	 ā€¢		Why	is	safety	assessment	of	leachables	required?
	 ā€¢		How	leachable	issues	related	to	drug	product	quality	can	
impact	safety	and	effi	cacy
	 ā€¢		Best	practice	recommendations	during	development
stephen Barat, Head of Pre-Clinical and Early Clinical
Development, scynexis
12.20 NetWoRkiNg luNCh spoNsoReD BY
iNteRgRateD QualitY BY DesigN (QbD)
pRiNCiples iNto DevelopmeNt
13.20 sessioN ReseRveD foR NemeRa
adrien tisserand, Category Manager - Parenteral,
Nemera
14.00 pRe-filleD sYRiNge seCoND souRCe iNitiative:
a Dual souRCe iDeNtifiCatioN to ReDuCe supplY usiNg
QualitY-BY-DesigN (QBD) pRiNCiples
	 ā€¢		Understanding	Quality	by	Design	(QbD)
	 ā€¢		A	global	regulatory	initiative	with	the	goal	of	enhancing	the	
quality	of	combination	products
	 ā€¢		Summary	of	the	application	of	QbD	principles	for	
combination product development
	 ā€¢		Evaluation	of	syringe	second	source	by	applying	QbD	principles
kashappa-goud Desai, Associate Fellow, gsk
Nathan heacock, Associate Scientist, gsk
14.40 iNtegRatiNg DRug-DeviCe ComBiNatioN pRoDuCt
DevelopmeNt
	 ā€¢		Integrating	the	design	process	with	methodical	
pharmaceutical development
	 ā€¢		QbD	and	design	controls	as	a	paradigm	for	aligning	
combination development
	 ā€¢		Comparison	with	regulatory	guidance	on	Combination	
Products and the current state of development of drug
device development
Justin lacombe, Senior Manager Process Development,
teva pharmaceuticals usa
gary henniger, Director Engineering,
teva pharmaceuticals usa
15.20 afteRNooN tea spoNsoReD BY
tReNDs toWaRDs a Rise iN BiologiCs
aND the impliCatioNs foR pfs
15.50 the Best plastiC sYRiNge foR BiologiCs
	 ā€¢		OXYCAPT	Multilayer	Plastic	Syringe	having	Glass-like	
Oxygen Barrier
	 ā€¢		Excellent	Oxygen	Barrier	contributes	to	Stability	of	Biologics
	 ā€¢		Very	Low	Extractables	contribute	to	Stability	of	Biologics
	 ā€¢		Good	UV	Barrier	contributes	to	Stability	of	Biologics
shota arakawa, Researcher,
mitsubishi gas Chemical america inc
16.30 paNel DisCussioN: DeBatiNg the ChalleNges
aND solutioNs foR pfs DevelopmeNt aND
the iNCReasiNg tReNDs toWaRDs BiologiCs
	 ā€¢		What	are	the	biggest	challenges	for	biologic	
drug products at the interface of formulation,
primary	packaging	and	applications?
	 ā€¢		How	should	we	bridge	the	gaps	in	drug-delivery	innovations	
to	address	the	challenges	of	delivering	complex	biologics?
	 ā€¢		How	should	we	maintain	patient	centricity	to	our	
development	processes?
Dhairya mehta, Associate Director of Device and Combination
Products, shire
steve Bowman, Device Program Lead, shire
Justin Wright, Vice President, Drug Delivery Innovation, DDR&D
Technology, eli lilly
17.10 Co-ChaiRsā€™ ClosiNg RemaRks aND Close of DaY oNe
pre-filled syringes east Coast www.pfsamericas.com
DaY oNe | WeDNesDaY 11th apRil 2018
Register online at www.pfsamericas.com
08.30	 Registration & Coffee
09.00	 Co-Chairsā€™ Opening Remarks
	Dhairya Mehta, Associate Director of Device and Combination
Products, Shire
	Stephen Barat, Head of Pre-Clinical and Early Clinical
Development, Scynexis
human factors and the end-user consideration
in the design feedback loop
	KEYNOTE ADDRESS
09.10	 The critical importance of recognizing the considerations,
decisions and trade-offs inherent
in all combination product development
	 ā€¢	Your product has multiple customers beyond patients - do
you know all of them? How well? Are you sure? Prove it!
	 ā€¢	The saying ā€œa chain is a s strong as its weakest linkā€ applies to
combination product development too. Whatā€™s yours (likely
there are many)? What are you doing to address them?
	 ā€¢	The future of combination products is bright - but are we
confident we know what it will look like?
	Steve Bowman, Device Program Lead, Shire
09.50 	 The Challenges of Platformization
	 ā€¢	From a human factors perspective, what would it take to
create a device that is a true platform which can be utilized
for multiple molecules and a variety of user groups?
	 ā€¢	What effects might the choice of molecule have on design
of the device?
	 ā€¢	What effects might the choice of molecule have on the
userā€™s interactions with the device?
	 ā€¢	For which users should the device be designed?
	Molly Story, Head, Global Usability Engineering and
Risk Management, Sanofi Pharmaceuticals

10.30 	 Morning Coffee Sponsored by
11.00 	Leveraging Preformative Research to Inform Lifecycle
Management of Combination Products for Complex
Disease States
	 ā€¢	Empathizing with total disease burden for complex
disease states
	 ā€¢	Challenges of managing drug delivery (use steps)
from patient perspective
	 ā€¢	How to identify opportunities to reduce complexity
for patients
	 ā€¢	Two case studies (Hemophilia  Primary
Immunodeficiency Disease)
	Joke Maes, Product Manager,
Terumo Pharmaceutical Services
	 Chris Franzese, Lead Clinical Analyst, Matchstick
11.40 	 Panel Discussion: What is missing from the
Human Factors studies and why is this still
a prevalent issue?
	 ā€¢	Are we misunderstanding patient compliance?
	 ā€¢	Real world case-studies and considering end-user group
needs - are we using the bigger picture?
	 ā€¢	How is IoT assisting in Human Factors studies and is this
actually a hinderance to device interaction?
	Gary Mills, Associate Director, Drug Product Development,
TESARO
	Stephen Barat, Head of Pre-Clinical and Early Clinical
Development, Scynexis
	Molly Story, Head, Global Usability Engineering and Risk
Management, Sanofi Pharmaceuticals
12.20 	 Networking Lunch Sponsored by
13.20	 Smart Labeling Solutions for Pre-filled Syringes:
Patient Centricity Enhanced
	 ā€¢	Innovative RFID/NFC solutions to improve user experience
and patient safety through connectivity
	 ā€¢	Customizing injection devices with multi-functional labels
	 ā€¢	User-friendly, label-integrated needlestick prevention
	 ā€¢	Low migration labels and challenges of COC/COP materials
	 ā€¢	Ensuring container integrity through novel technologies
	Eric Caro, Key Account Manager, Schreiner MediPharm
	
14.00 	Lessons learned from Human Factor studies of
pre-filled syringes
	 ā€¢	Formative study versus Summative study
	 ā€¢	Number of arms (IFU only versus IFU + QRG)
	 ā€¢	Formative study versus Summative study: Are both formative
and summative studies required if an off-shelf product is used
with certain modification?
	 ā€¢	Number of arms: How many arms need to be included in the
human factor studies? IFU only, IFU + QRG or QRG only
	 ā€¢	Use Errors: How to deal with Use Errors found from Human
Factor studies and what if these Use Errors canā€™t be
mitigated?
	Tieming Ruan, Associate Director of Device Development,
Takeda
the future of parenteral drug delivery
14.40	Composite Digital Monitoring Biomarkers Come of Age:
The Framework for Utilization
	 ā€¢	Activity and investments in connected injection systems and
platforms continues to increase
	 ā€¢	The opportunity exists to combine connected systems with
composite digital monitoring biomarkers to create hybrid
closed loop systems for all diseases.
	 ā€¢	The incorporation of digital monitoring biomarkers into
health, wellness and disease management will be reviewed
on the context of next generation drug delivery systems
	Justin Wright, Vice President, Drug Delivery Innovation, DDRD
Technology,Ā Eli Lilly
15.20 	 Afternoon Tea Sponsored by
15.50 	 PFS tech transfer of in-line products not originally
developed as combination prodcuts
	 ā€¢	Defining Design User Requirements
	 ā€¢	Dealing with suppliers providing device constituent components
	 ā€¢	Systems engineering needs
	 ā€¢	Retrospective design documentation
	Maria Linzmayer, Associate Director, Drug Delivery Devices,
Merck
16.30 	 Future of digitially connected device and changing
paradigm in disease management
	 ā€¢	Digitalization: Benefits of electronic-enabled drug delivery
devices in patient disease management beyond adherence
	 ā€¢	Tackling hurdles of connectivity for combination products:
cost, technology, regulatory and time-to-market
considerations
	 ā€¢	Evaluating add-on platforms as a step towards integrated
device ecosystem
	 ā€¢	Exploring opportunities for pharma, patient and HCP
engagement through connected drug delivery devices
	Michael Song, Sr. Manager, Drug Delivery and Device
Development, MedImmune Inc
17.10 	 Co-Chairsā€™ Closing Remarks and Close of Day Two
Pre-Filled Syringes East Coast 					 www.pfsamericas.com
Day Two | Thursday 12th APRIL 2018 	
ā€¢Abbott Laboratories
ā€¢AbbVie
ā€¢Alexion
ā€¢American Regent
ā€¢Amgen
ā€¢Aptar Pharma
ā€¢Aurobindo Pharma
USA Inc.
ā€¢Baumann Springs
Usa Inc
ā€¢BCM Group LLC
ā€¢BD
ā€¢Bemis Healthcare
Packaging
ā€¢Biocorp
ā€¢Biogen Incorporated
ā€¢Bristol-Myers Squibb
ā€¢Centurion Medical
Products
ā€¢Connecticut Spring
 Stamping
ā€¢Cook Pharmica LLC
ā€¢Daicel Corporation
ā€¢Datwyler Schweiz AG
ā€¢Eastman Chemical
Company
ā€¢Eli Lilly
ā€¢Ermo
ā€¢FDA
ā€¢Fluid Imaging
Technologies
ā€¢GSK
ā€¢Janssen
Pharmaceutical
Incorporated
ā€¢Kashiv Pharma
ā€¢Key Tech
ā€¢McArdle 
Associates, LLC
ā€¢Merck  Company
ā€¢Mitsubishi Gas
Chemical Company
ā€¢Momenta
Pharmaceuticals Inc
ā€¢Mw Industries
ā€¢Nemera
ā€¢Nipro Pharma
Packaging
ā€¢NN Inc
ā€¢Noble
ā€¢Nye Lubricants
ā€¢Nypro
ā€¢Overlook Industries,
Inc.
ā€¢Owen Mumford Ltd
ā€¢Pfizer
ā€¢Philips - Medisize
ā€¢Plastibell DTP Holding
ā€¢rap. ID, Inc.
ā€¢Regeneron
Pharmaceuticals
ā€¢Robert Bosch
Packaging
Technology Inc
ā€¢Sagentia Ltd
ā€¢Sanofi
ā€¢SCA Pharmaceuticals
ā€¢Schott AG
ā€¢SCHOTT
Pharmaceutical
Packaging
ā€¢Schreiner Medipharm
ā€¢Shire
ā€¢Siegfried Irvine
ā€¢Smithers Rapra
ā€¢Suttons Creek Inc
ā€¢Takeda
Pharmaceuticals
ā€¢Teleflex
ā€¢Terumo
Pharmaceutical
Solutions
ā€¢TESARO
ā€¢Topas Advanced
Polymers
ā€¢Trinseo
ā€¢W.L. Gore 
Associates, Inc.
ā€¢Weidmann Medical
Technology AG
ā€¢West Pharmaceutical
Services, Inc.
ā€¢Zeon Chemicals L.P.
Pre-Filled Syringes East Coast 2017 Attendee List
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
SMiā€™s Upcoming
Events in
the Pre-Filled
Syringe Series:
Pre-Filled Syringes
Europe
Copthorne Tara Hotel,
London, UK
17th - 18thĀ January 2018
Pre-Filled Syringes
West Coast
Crowne Plaza,
San Diego, CA, USA
4th - 5thĀ June 2018
Workshop Leaders:
melanie turieo, Director, Human Factors
and Industrial Design, Cambridge Consultants and karen unterman,
Group Leader, Human Factors Engineering, Cambridge Consultant
half-DaY pRe-CoNfeReNCe WoRkshop B
tuesDaY 10th apRil 2018 | 13.30 - 17.00
sheRatoN BostoN hotel, BostoN, usa
humaN faCtoRs foR CoNNeCteD DRug DeliveRY sYstems
Workshop overview
This workshop will cover how to successfully incorporate Human Factors into the development process for
connected	drug	delivery	systems	to	achieve	both	commercial	goals	and	meet	regulatory	requirements.	The	
Human	Factors	engineering	process	and	regulatory	requirements	for	traditional	medical	device	development	
are fairly well established and will be reviewed to ensure there is a common understanding of the current
landscape.	We	will	then	explore	how	to	adapt	this	process	to	meet	the	needs	and	requirements	for	a	system	
which includes digital as well as physical elements.
Why you should attend
For anyone thinking about bringing digital health solutions to market, this workshop will identify the
considerations that need to be addressed when designing a comprehensive Human Factors engineering
process for a system which contains both physical and digital elements, and how to leverage the tools,
methodologies	and	best	practices	across	device	development,	User	Interface	(UI),	and	User	Experience	(UX)	
development.
about the workshop leaders
melanie is a Director in Cambridge Consultants Global MedTech division and head of Human
Centred Design. She has over 20 yearsā€™ experience providing human factors expertise to the design
and development of regulated and safety-critical items, including medical, military and consumer
products. She has extensive experience in the development of drug delivery systems from early
stage	needs	assessment	and	product	defi	nition	through	concept	generation,	detailed	development,	and	
HF validation. Melanie has a Bachelor of Science in Human Factors Engineering from Tufts Universityā€™s School
of Engineering.
karen is the Human Factors Group Leader at Cambridge Consultants in Boston MA. Her experience is
in performing human factors activities throughout the development process, including: ethnographic
research,	 translating	 stakeholder	 needs	 into	 measurable,	 technical	 requirements,	 facilitating	
creative	workshops,	assessing	product	risk,	and	designing,	conducting	and	analyzing	Formative	and	
Validation usability studies. Karen graduated from Northwestern Universityā€™s McCormick School of Engineering
and Applied Sciences with a Bachelor of Science in Biomedical Engineering.
about the organisation
Cambridge Consultants develops breakthrough products and technology for clients worldwide. For more
than 50 years, the company has been helping its clients turn business opportunities into commercial successes,
whether	they	are	launching	fi	rst-to-market	products,	entering	new	markets,	or	expanding	existing	markets	
through	the	introduction	of	new	technologies.	with	a	team	of	over	700	staff	and	offi	ces	in	Cambridge,	UK,	
Boston, MA and Singapore, Cambridge Consultants offers solutions across a diverse range of industries around
the world.
programme
13.30 Workshop Registration and
afternoon Coffee
14.00 Workshop leadersā€™ introduction
14.15 overview of human factors for
medical development
	 ā€¢		Human	Factors	Engineering	process
	 ā€¢		Regulatory	requirements
	 ā€¢		Commercial	goals
14.45 overview of the regulatory landscape
for digital health
	 ā€¢		Is	it	a	medical	system	or	not?
	 ā€¢		Consumer	digital	systems
	 ā€¢		Medical	digital	systems
15.30 afternoon tea and Networking Break
16.00 Bringing digital into the hf process
	 ā€¢		How	does	it	impact	the	process?
	 ā€¢		What	is	UX	and	how	is	it	interpreted	
for	hybrid	systems?
	 ā€¢		Tools,	methodologies	and	best	
practices
16.30 validation of the digital system
17.00 Closing Remarks from Workshop leaders
and end of Workshop
Workshop overview
This	workshop	will	provide	a	practical	approach	to	ensuring	that	your	prefi	lled	syringe	design	fi	ts	the	needs	
of	laypersons	and	supports	use	outside	the	clinic.	Youā€™ll	learn	how	to	characterize	the	intended	users	and	
use	environments,	discover	and	fi	ll	gaps	in	your	understanding	of	the	users,	explore	possible	risks,	convert	
user	needs	into	user	interface	requirements,	and	provide	a	complete	support	system	when	your	product	is	in	
commercial use. Gathering these usability design inputs creates a solid foundation for your product design
that will result in user satisfaction and ensure safe use.
Why you should attend
ā€¢		Understand	diverse	users,	from	parents	caring	for	children	to	aging	adults	caring	for	their	spouses
ā€¢		Explore	environments	ranging	from	the	home	and	workplace	to	worldwide	travel	destinations
ā€¢		Plan	for	fi	eld	research	
ā€¢		Map	user	needs	to	demonstrable	user	interface	requirements	
ā€¢		Provide	a	complete	support	system,	including	effective	instructions	for	home	use
ā€¢		Capitalize	on	early	research	to	reduce	the	number	of	design	iterations
about the workshop leaders
ms. mcConnell has more than 25 years of experience working with product development teams in
private industry, public service, and government agencies. She has worked exclusively in the Medical
Device industry for the past 12 years. As a Human Factors Technical Lead, Ms. McConnellā€™s focus is on
identifying and delivering medical device design solutions that exceed customersā€™ expectations and
ensure safe use. Ms. McConnell has experience in all phases of the product development lifecycle, including
research-based design inputs, use error analysis, prototyping, usability testing, summative validation studies,
regulatory submissions, and product launch support. Her recent work ranges from large scale robotic systems
used by surgeons during procedure in an operating room to handheld devices used by patients to deliver
therapy at home.
ms. Diorio-Blum	has	10+	yearsā€™	experience	in	the	medical	device	design	and	product	development	
fi	eld.	 She	 has	 experience	 working	 in	 multi-disciplinary	 teams	 consisting	 of	 industrial	 designers,	
engineers and human factors engineers. She has spent the majority of her career primarily focused
on design and ethnographic research in the healthcare space. Her research efforts have taken her
to many hospitals, clinical care, and home health care settings throughout the United States and Europe. She
has	extensive	experience	in	data	analysis,	synthesis,	and	translating	research	fi	ndings	into	user	requirements	
for design and engineering teams. She conducts conducting focus groups, contextual research, and in-depth
interviews from the RIVA training institute, and has conducted over 500 interviews in her career.
about the organisation
Our	mission	at	Battelle	is	to	translate	scientifi	c	discoveries	and	technology	advances	into	societal	benefi	ts.	
Battelle was formed in 1925, as a charitable trust, from the will of industrialist Gordon Battelle. Today, Battelle
is	the	largest	private,	independent	research	and	development	organization	in	the	world.	Battelle	has	about	
22,000	employees.	Our	headquarters	is	in	Columbus,	OH	and	we	have	over	130	locations	worldwide.
programme
8.30 Workshop Registration and
morning Coffee
9.00 Workshop leadersā€™ opening Remarks
and introduction
9.10 exploring diverse users and use
environments
	 ā€¢		Breakout	groups:		How	to	draft	profi	les	
for users and environments with design
inputs in mind
10.10 getting the most out of early user
research
	 ā€¢		Case	Studies:	How	user	and	
environment	profi	les	inform	plans	for	
early user research
10.30 morning Coffee
11.00 mapping user needs to user interface
requirements
	 ā€¢		Case	Studies:	How	to	trace	user	
research	fi	ndings	to	user	needs	and	user	
interface	requirements
11.30 providing a complete support system
	 ā€¢		Discussion:	use	outside	the	clinic	
requires	multiple	forms	of	support
	 ā€¢		Discussion:	Instructions	for	use	are	part	
of the user interface and should be
created using a Human Centric Design
approach
12.30 Closing Remarks from Workshop leaders
and end of Workshop
DesigN CoNsiDeRatioNs foR the WoRlD outsiDe the CliNiC
half-DaY pRe-CoNfeReNCe WoRkshop a
tuesDaY 10th apRil 2018 | 08.30 - 12.30
sheRatoN BostoN hotel, BostoN, usa
Workshop Leaders:
Debbie mcConnell, Human Factors Technical Lead,
Human Centric Design, Battelle and annie Diorio-Blum,
Principal Industrial Designer, Human Centric Design, Battelle
Register online at www.pfsamericas.com
pRouDlY spoNsoReD BY:
suppoRteD BY
spoNsoRship aND exhiBitioN oppoRtuNities
smi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you companyā€™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 conference please call:
alia malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
maRketiNg oppoRtuNities
Want to know how you can get involved? interested in promoting your services to this market?
Contact teri arri, smi marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
pre-filled syringes east Coast
www.pfsamericas.com
mitsubishi gas Chemical
Mitsubishi	Gas	Chemical	is	a	leading	company	in	the	fi	eld	of	oxygen	barrier	and	absorbing	technologies.	Based	
on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe
having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for
injectable drugs. www.mgc.co.jp
Nemera
NEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for
pharmaceutical, biotechnology and generics industries. Nemeraā€™s expertise covers several modes of delivery:
Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages
decades of experience in the parenteral device segment from full development to pure contract manufacturing,
through	 customized	 solutions.	 Nemera	 developed:	 Safeā€™nā€™SoundĀ®,	 a	 fully	 passive	 safety	 device	 for	 prefi	lled	
syringes	 to	 avoid	 accidental	 needle-sticks.	 SafeliaĀ®,	 a	 new	 generation	 of	 2-steps	 auto-injector	 for	 fl	uid	 and	
viscous formulations. www.nemera.net
NN, inc precision engineered products
NN, Inc Precision Engineered Products Group is an engineered solutions company, focusing on medical and drug
delivery	devices.	We	provide	components,	complex	assemblies	and	clean	room	packaging,	specializing	in	metal	
stamping, injection molding and ISO Class VIII clean room assembly. Learn more at www.pep-corp.com
owen mumford
Owen Mumford offer an integrated design and build service from a broad base of proven self-injection and
blood-sampling platform devices and intellectual property. Find out more at omdevicesolutions.com or contact
us at devicesolutions@owenmumford.co.uk www.owenmumford.co.uk
schott
SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech,
biopharmaceutical, diagnostic, analytical, dental  ophthalmic markets. Products include glass and polymer
prefi	llable	syringes	(bulk	and	sterile),	cartridges,	ampoules,	vials,	and	innovative	coated	containers.	Ready-to-use	
solutions	are	available	to	meet	existing	and	new	fi	ll		fi	nish	equipment. www.us.schott.com/pharma
schreiner medipharm
Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-
added	benefi	ts	for	the	pharmaceutical	industry.	The	product	portfolio	includes	labels	with	integrated	hangers,	with	
detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle
protection,	anti-tampering	and	counterfeiting	protection	solutions	as	well	as	NFC/RFID	labels.	These	products	
simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process
costs.	Thanks	to	its	strong	solutions	expertise	and	specialized	know-how	Schreiner	MediPharm	has	established	itself	
worldwide	as	a	highly	capable	development	partner	and	reliable	quality	supplier	to	leading	pharmaceutical	
companies. www.schreiner-medipharm.com
terumo pharmaceutical solutions
Terumo	 Pharmaceutical	 Solutions	 offers	 the	 pharmaceutical	 and	 biotechnology	 industry	 unique	 solutions	 in	
medical	technology.	In	addition	to	offering	our	valued	products,	our	specialized	team	also	provides	customized	
and	dedicated	solutions	designed	to	meet	your	specifi	c	requirements. www.terumo-ps.com
zeon Corporation
ZEONā€™s	ZeonexĀ®	and	ZeonorĀ®	cyclo	olefi	n	polymer	(COP)	allow	for	advanced,	break-resistant	syringes,	vials	and	
lyophilization	containers	for	protein-based	biopharmaceuticals,	high	viscosity	drugs,	and	contrast	media.	They	
also	offer	high	purity,	ā€œglass-likeā€	transparency,	sterilization,	low	water	absorption,	and	superior	moldability,	as	well	
as overcome protein adsorption and ph shift concerns. www.zeonex.com
offiCial meDia paRtNeRs
pRe-filleD sYRiNges east Coast
Conference: Wednesday 11th  Thursday 12th April 2018, Sheraton Boston Hotel, Boston, USA
Workshops: Tuesday 10th April 2018, London, UK
4 WaYs to RegisteR
www.pfsamericas.com
fax your	booking	form	to	+44	(0)	870	9090	712
phoNe	on	+44	(0)	870	9090	711
post your booking form to: Events Team, SMi Group Ltd,
Ground		First	Floor,	1	Westminster	Bridge	Road	London,	SE1	7XW,	UK
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
title: forename:
surname:
Job title:
Department/Division:
Company/organisation:
email:
Company vat Number:
address:
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Direct tel: Direct fax:
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switchboard:
signature: Date:
I agree to be bound by SMiā€™s Terms and Conditions of Booking.
aCCouNts Dept
title: forename:
surname:
email:
address (if different from above):
town/City:
post/zip Code: Country:
Direct tel: Direct fax:
payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit	card	details	will	be	requested	and	payment	taken	before	entry	to	the	event.	Bookings	within	
7	days	of	event	require	payment	on	booking.	Access	to	the	Document	Portal	will	not	be	given	until	
payment has been received.
substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ā€˜shareā€™ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute,	then	we	will	refund/credit	50%	of	the	due	fee	less	a	Ā£50	administration	charge,	providing	
that cancellation is made in writing and received at least 28 days prior to the start of the event.
Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to	attend	for	any	reason.	Due	to	the	interactive	nature	of	the	Briefi	ngs	we	are	not	normally	able	to	
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for	Documentation	or	the	Document	Portal	as	these	are	reproduced	specifi	cally	to	order.	If	we	have	
to cancel the event for any reason, then we will make a full refund immediately, but disclaim any
further liability.
alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act1998andwemayusethistocontactyoubytelephone,fax,postoremailtotellyouaboutother
products and services. Unless you tick here ā–” we may also share your data with third parties offering
complementary	products	or	services.	If	you	have	any	queries	or	want	to	update	any	of	the	data	
that we hold then please contact our Database Manager databasemanager@smi-online.co.uk
or	visit	our	website	www.smi-online.co.uk/updates quoting the uRN as detailed above your address
on the attached letter.
Payment must be made to smi group ltd, and received before the event, by one of
the following methods quoting reference p-243 and the delegateā€™s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
ā–” uk BaCs	 Account	Name:	SMi	(Group)	Ltd	
ā–” Wire transfer Sort Code: 30-00-09, Account: 11775391
	 	 Lloyds	TSB	Bank	Plc,	39	Threadneedle	Street,	London,	EC2R	8AU
	 	 Swift	(BIC):	loYDgB21013, Account 11775391
IBAN gB75 loYD 3000 0911 7753 91
ā–” Cheque	 We	can	only	accept	US	Dollar	Cheques	drawn	on	a	US	Bank
ā–” Credit Card ā–” Visa ā–” MasterCard ā–” American Express
All credit card payments will be subject to standard credit card charges.
Card No: ā–”ā–”ā–”ā–” ā–”ā–”ā–”ā–” ā–”ā–”ā–”ā–” ā–”ā–”ā–”ā–”
Valid From ā–”ā–”/ā–”ā–” Expiry Date ā–”ā–”/ā–”ā–”
CVV Number ā–”ā–”ā–”ā–” 3	digit	security	on	reverse	of	card,	4	digits	for	AMEX	card	
Cardholderā€™s Name:
signature: Date:
I agree to be bound by SMiā€™s Terms and Conditions of Booking.
Card Billing address		(If	different	from	above):
		VAT	at	20%	is	charged	on	Document	portal	and	literature	distribution	for	all	UK	customers	
and for those EU customers not supplying a registration number for their own country here.
______________________________________________________________________________________
if you have any further queries please call the events team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
ā–” 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
i cannot attend but would like to purchase access to the following Document
portal/paper copy documentation price total
ā–” Access to the conference documentation
on the Document Portal Ā£499.00 + vat Ā£598.80
ā–” The Conference Presentations ā€“ paper copy Ā£499.00 - Ā£499.00
(or	only	Ā£300	if	ordered	with	the	Document	Portal)
unique Reference Number
our Reference lvp-243
eaRlY BiRD
DisCouNt
ā–” Book by 15th December to receive $400 off the conference price
ā–” Book by 31st January to receive $200 off the conference price
ā–” Book by 28th february to receive $100 off the conference price
Delegate Details
terms and Conditions of Booking
paYmeNt
vat
DoCumeNtatioN
veNue sheraton Boston hotel, Boston, usa
CoNfeReNCe pRiCes
i would like to attend: (Please	tick	as	appropriate) fee
ā–” Conference  2 Workshops $2997.00
ā–” Conference  1 Workshop A ā–” B ā–” $2498.00
ā–” Conference only $1999.00
ā–” 2 Workshops $998.00
ā–” 1 Workshop only A ā–” B ā–” $499.00
pRomotioNal liteRatuRe DistRiButioN
ā–” Distribution of your companyā€™s promotional
literature to all conference attendees $1598 + vat $1917.60
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject 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.

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Human Factors Considerations for Combination Product Design

  • 1. plus tWo iNteRaCtive half-DaY pRe-CoNfeReNCe WoRkshops TUESDAY 10TH APRIL 2018, SHERATON BOSTON HOTEL, BOSTON, USA B: human factors for Connected Drug Delivery systems Workshop Leaders: melanie turieo, Director, Human Factors and Industrial Design, Cambridge Consultants and karen unterman, Group Leader, Human Factors Engineering, Cambridge Consultants 13.30 - 17.00 ChaiRs foR 2018: ā€¢ Dhairya mehta, Associate Director of Device and Combination Products, shire ā€¢ stephen Barat, Head of Pre-Clinical and Early Clinical Development, scynexis featuReD speakeRs: ā€¢ Justin Wright, Vice President, Drug Delivery Innovation, DDR&D Technology, eli lilly ā€¢ tieming Ruan, Associate Director of Device Development, takeda ā€¢ molly story, Head, Global Usability Engineering and Risk Management, Sanofi ā€¢ gary henniger, R&D Director, Discovery and Product Development R&D, teva pharmaceuticals ā€¢ michael song, Pharmaceutical Device and Digital Health, medimmune ā€¢ steve Bowman, Device Program Lead, shire ā€¢ gary mills, Associate Director, Drug product Development ā€¢ kashappa goud Desai, Investigator, Biopharmaceutical Product Sciences, glaxosmithkline www.pfsamericas.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 aCaDemiC & gRoup DisCouNts availaBle @smiphaRm #smipfsusa RegisteR BY 15th DeCemBeR aND save $400 RegisteR BY 31st JaNuaRY aND save $200 RegisteR BY 28th feBRuaRY aND save $100 a: Design Considerations for the World outside the Clinic Workshop Leaders: Debbie mcConnell, Human Factors Technical Lead, Human Centric Design, Battelle and annie Diorio-Blum, Principal Industrial Designer, Human Centric Design, Battelle 08.30 - 12.30 spoNsoReD BY SMi presents the East Coastā€™s Leading, 5th Annual Conference and Exhibitionā€¦ Sheraton Boston Hotel, Boston, USA WORKSHOPS: 10TH CONFERENCE: 11TH - 12TH APRIL 2018 Pre-Filled Syringes East Coast enabling the next generation of pre-filled syringes from design to manufacture NeW foR 2018: ā€¢ Understand end-use interaction with delivery systems and Human Factor engineering methods ā€¢ Guidance in overcoming challenges of delivering high- concentration formulations and challenges for biologics ā€¢ Explore how to integrate Quality-by-Design principles for best practice solutions in developing your combination products ā€¢ Benchmark against updates on new technologies, including digital monitoring biomarkers from Eli Lilly; electronic- enabled drug delivery devices from MedImmune; and PFS tech transfer of in-line products from Merck ā€¢ Engage with the latest results from recent studies in chemical compatibility; comparison of COP vs glass; and container integrity ā€¢ Participate in our two interactive panel discussions and gain from over 5 hours of dedicated networking time
  • 2. engage with top pharma scientists and engineers in our pfs focused conference hear the very latest plans about drug-device development in the injectables industry Network with industry and pharma leadership in the exhibition area letteR fRom the ChaiRs: Dear participants, We are absolutely delighted to welcome each of you to SMiā€™s Pre-Filled Syringes East Coast conference. Over the past decade, pre-fi lled syringe venues have grown signifi cantly in terms of content and attendance and much of this can be attributed to the interest and need to share information, as the development of pre-fi lled syringe drug products are a prime example of complex, multi- disciplinary efforts. Pre-fi lled syringes have undoubtedly improved the lives of the patients who rely on these drug products. As such, as an industry, we share a responsibility to continue to develop and evolve these drug products as new technologies in delivery, formulation and manufacturing emerge ā€“ also considering the impact that global regulatory and geopolitical landscapes may have ā€“ in order to meet the needs of our patients and improve upon therapeutic options. The meeting will therefore allow for the face-to-face assembly of subject matter experts in all areas related to the development of pre-fi lled syringe and other related combination drug products, and thereby provide a tremendous opportunity for meaningful discourse. We look forward to seeing you there! Dhairya mehta, Associate Director of Device and Combination Products, shire stephen Barat, Head of Pre-Clinical and Early Clinical Development, scynexis 08.30 RegistRatioN & Coffee 09.00 Co-ChaiRsā€™ opeNiNg RemaRks Dhairya mehta, Associate Director of Device and Combination Products, shire stephen Barat, Head of Pre-Clinical and Early Clinical Development, scynexis RegulatoRY upDates foR the pfs iNDustRY keYNote aDDRess 09.10 NavigatiNg RegulatoRY CoNsiDeRatioNs iN the pfs maRket eNviRoNmeNt ā€¢ Regulatory considerations for industry relating to USP <1207> ā€¢ Applicable regulatory schemes and potential regulatory strategies ā€¢ Latest updates and changes for FDA requirements session Reserved for fDa Representative pfs maNufaCtuRiNg aND pRoCess: ChalleNges aND solutioNs 09.50 sYRiNge filliNg of high-CoNCeNtRatioN moNoColoNal aNtiBoDY foRmulatioN: ChalleNges aND solutioNs ā€¢ There has been a steady increase in the number of high- concentration mAb formulations in ready-to-use pre-fi lled syringes for subcutaneous administration ā€¢ Challenges of successful syringe fi lling of high-concentration mAb formulations by an automated fi lling machine ā€¢ Outlining challenges associated with syringe fi lling of high- concentration formulations ā€¢ This presentation summarizes the key challenges and mitigation strategies kashappa-goud Desai, Associate Fellow, gsk 10.30 moRNiNg Coffee spoNsoReD BY 11.00 Cop - teChNiCal Data upDate ā€¢ Key properties of COP - update ā€¢ Case Study: Study on Protein adsorption/aggregation with actual protein drug - COP vs. glass ā€¢ Case Study: Study on delamination with glass syringe vs. COP syringe ā€¢ Leachable data on COP syringe with various chemicals toshiro katayama, Product Manager, zeon Chemicals l.p. 11.40 safetY evaluatioN of leaChaBles WheN DevelopiNg a pRe-filleD sYRiNge DRug pRoDuCt ā€¢ Background on leachables from pre-fi lled syringe drug devices ā€¢ Why is safety assessment of leachables required? ā€¢ How leachable issues related to drug product quality can impact safety and effi cacy ā€¢ Best practice recommendations during development stephen Barat, Head of Pre-Clinical and Early Clinical Development, scynexis 12.20 NetWoRkiNg luNCh spoNsoReD BY iNteRgRateD QualitY BY DesigN (QbD) pRiNCiples iNto DevelopmeNt 13.20 sessioN ReseRveD foR NemeRa adrien tisserand, Category Manager - Parenteral, Nemera 14.00 pRe-filleD sYRiNge seCoND souRCe iNitiative: a Dual souRCe iDeNtifiCatioN to ReDuCe supplY usiNg QualitY-BY-DesigN (QBD) pRiNCiples ā€¢ Understanding Quality by Design (QbD) ā€¢ A global regulatory initiative with the goal of enhancing the quality of combination products ā€¢ Summary of the application of QbD principles for combination product development ā€¢ Evaluation of syringe second source by applying QbD principles kashappa-goud Desai, Associate Fellow, gsk Nathan heacock, Associate Scientist, gsk 14.40 iNtegRatiNg DRug-DeviCe ComBiNatioN pRoDuCt DevelopmeNt ā€¢ Integrating the design process with methodical pharmaceutical development ā€¢ QbD and design controls as a paradigm for aligning combination development ā€¢ Comparison with regulatory guidance on Combination Products and the current state of development of drug device development Justin lacombe, Senior Manager Process Development, teva pharmaceuticals usa gary henniger, Director Engineering, teva pharmaceuticals usa 15.20 afteRNooN tea spoNsoReD BY tReNDs toWaRDs a Rise iN BiologiCs aND the impliCatioNs foR pfs 15.50 the Best plastiC sYRiNge foR BiologiCs ā€¢ OXYCAPT Multilayer Plastic Syringe having Glass-like Oxygen Barrier ā€¢ Excellent Oxygen Barrier contributes to Stability of Biologics ā€¢ Very Low Extractables contribute to Stability of Biologics ā€¢ Good UV Barrier contributes to Stability of Biologics shota arakawa, Researcher, mitsubishi gas Chemical america inc 16.30 paNel DisCussioN: DeBatiNg the ChalleNges aND solutioNs foR pfs DevelopmeNt aND the iNCReasiNg tReNDs toWaRDs BiologiCs ā€¢ What are the biggest challenges for biologic drug products at the interface of formulation, primary packaging and applications? ā€¢ How should we bridge the gaps in drug-delivery innovations to address the challenges of delivering complex biologics? ā€¢ How should we maintain patient centricity to our development processes? Dhairya mehta, Associate Director of Device and Combination Products, shire steve Bowman, Device Program Lead, shire Justin Wright, Vice President, Drug Delivery Innovation, DDR&D Technology, eli lilly 17.10 Co-ChaiRsā€™ ClosiNg RemaRks aND Close of DaY oNe pre-filled syringes east Coast www.pfsamericas.com DaY oNe | WeDNesDaY 11th apRil 2018 Register online at www.pfsamericas.com
  • 3. 08.30 Registration & Coffee 09.00 Co-Chairsā€™ Opening Remarks Dhairya Mehta, Associate Director of Device and Combination Products, Shire Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis human factors and the end-user consideration in the design feedback loop KEYNOTE ADDRESS 09.10 The critical importance of recognizing the considerations, decisions and trade-offs inherent in all combination product development ā€¢ Your product has multiple customers beyond patients - do you know all of them? How well? Are you sure? Prove it! ā€¢ The saying ā€œa chain is a s strong as its weakest linkā€ applies to combination product development too. Whatā€™s yours (likely there are many)? What are you doing to address them? ā€¢ The future of combination products is bright - but are we confident we know what it will look like? Steve Bowman, Device Program Lead, Shire 09.50 The Challenges of Platformization ā€¢ From a human factors perspective, what would it take to create a device that is a true platform which can be utilized for multiple molecules and a variety of user groups? ā€¢ What effects might the choice of molecule have on design of the device? ā€¢ What effects might the choice of molecule have on the userā€™s interactions with the device? ā€¢ For which users should the device be designed? Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals 10.30 Morning Coffee Sponsored by 11.00 Leveraging Preformative Research to Inform Lifecycle Management of Combination Products for Complex Disease States ā€¢ Empathizing with total disease burden for complex disease states ā€¢ Challenges of managing drug delivery (use steps) from patient perspective ā€¢ How to identify opportunities to reduce complexity for patients ā€¢ Two case studies (Hemophilia Primary Immunodeficiency Disease) Joke Maes, Product Manager, Terumo Pharmaceutical Services Chris Franzese, Lead Clinical Analyst, Matchstick 11.40 Panel Discussion: What is missing from the Human Factors studies and why is this still a prevalent issue? ā€¢ Are we misunderstanding patient compliance? ā€¢ Real world case-studies and considering end-user group needs - are we using the bigger picture? ā€¢ How is IoT assisting in Human Factors studies and is this actually a hinderance to device interaction? Gary Mills, Associate Director, Drug Product Development, TESARO Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals 12.20 Networking Lunch Sponsored by 13.20 Smart Labeling Solutions for Pre-filled Syringes: Patient Centricity Enhanced ā€¢ Innovative RFID/NFC solutions to improve user experience and patient safety through connectivity ā€¢ Customizing injection devices with multi-functional labels ā€¢ User-friendly, label-integrated needlestick prevention ā€¢ Low migration labels and challenges of COC/COP materials ā€¢ Ensuring container integrity through novel technologies Eric Caro, Key Account Manager, Schreiner MediPharm 14.00 Lessons learned from Human Factor studies of pre-filled syringes ā€¢ Formative study versus Summative study ā€¢ Number of arms (IFU only versus IFU + QRG) ā€¢ Formative study versus Summative study: Are both formative and summative studies required if an off-shelf product is used with certain modification? ā€¢ Number of arms: How many arms need to be included in the human factor studies? IFU only, IFU + QRG or QRG only ā€¢ Use Errors: How to deal with Use Errors found from Human Factor studies and what if these Use Errors canā€™t be mitigated? Tieming Ruan, Associate Director of Device Development, Takeda the future of parenteral drug delivery 14.40 Composite Digital Monitoring Biomarkers Come of Age: The Framework for Utilization ā€¢ Activity and investments in connected injection systems and platforms continues to increase ā€¢ The opportunity exists to combine connected systems with composite digital monitoring biomarkers to create hybrid closed loop systems for all diseases. ā€¢ The incorporation of digital monitoring biomarkers into health, wellness and disease management will be reviewed on the context of next generation drug delivery systems Justin Wright, Vice President, Drug Delivery Innovation, DDRD Technology,Ā Eli Lilly 15.20 Afternoon Tea Sponsored by 15.50 PFS tech transfer of in-line products not originally developed as combination prodcuts ā€¢ Defining Design User Requirements ā€¢ Dealing with suppliers providing device constituent components ā€¢ Systems engineering needs ā€¢ Retrospective design documentation Maria Linzmayer, Associate Director, Drug Delivery Devices, Merck 16.30 Future of digitially connected device and changing paradigm in disease management ā€¢ Digitalization: Benefits of electronic-enabled drug delivery devices in patient disease management beyond adherence ā€¢ Tackling hurdles of connectivity for combination products: cost, technology, regulatory and time-to-market considerations ā€¢ Evaluating add-on platforms as a step towards integrated device ecosystem ā€¢ Exploring opportunities for pharma, patient and HCP engagement through connected drug delivery devices Michael Song, Sr. Manager, Drug Delivery and Device Development, MedImmune Inc 17.10 Co-Chairsā€™ Closing Remarks and Close of Day Two Pre-Filled Syringes East Coast www.pfsamericas.com Day Two | Thursday 12th APRIL 2018 ā€¢Abbott Laboratories ā€¢AbbVie ā€¢Alexion ā€¢American Regent ā€¢Amgen ā€¢Aptar Pharma ā€¢Aurobindo Pharma USA Inc. ā€¢Baumann Springs Usa Inc ā€¢BCM Group LLC ā€¢BD ā€¢Bemis Healthcare Packaging ā€¢Biocorp ā€¢Biogen Incorporated ā€¢Bristol-Myers Squibb ā€¢Centurion Medical Products ā€¢Connecticut Spring Stamping ā€¢Cook Pharmica LLC ā€¢Daicel Corporation ā€¢Datwyler Schweiz AG ā€¢Eastman Chemical Company ā€¢Eli Lilly ā€¢Ermo ā€¢FDA ā€¢Fluid Imaging Technologies ā€¢GSK ā€¢Janssen Pharmaceutical Incorporated ā€¢Kashiv Pharma ā€¢Key Tech ā€¢McArdle Associates, LLC ā€¢Merck Company ā€¢Mitsubishi Gas Chemical Company ā€¢Momenta Pharmaceuticals Inc ā€¢Mw Industries ā€¢Nemera ā€¢Nipro Pharma Packaging ā€¢NN Inc ā€¢Noble ā€¢Nye Lubricants ā€¢Nypro ā€¢Overlook Industries, Inc. ā€¢Owen Mumford Ltd ā€¢Pfizer ā€¢Philips - Medisize ā€¢Plastibell DTP Holding ā€¢rap. ID, Inc. ā€¢Regeneron Pharmaceuticals ā€¢Robert Bosch Packaging Technology Inc ā€¢Sagentia Ltd ā€¢Sanofi ā€¢SCA Pharmaceuticals ā€¢Schott AG ā€¢SCHOTT Pharmaceutical Packaging ā€¢Schreiner Medipharm ā€¢Shire ā€¢Siegfried Irvine ā€¢Smithers Rapra ā€¢Suttons Creek Inc ā€¢Takeda Pharmaceuticals ā€¢Teleflex ā€¢Terumo Pharmaceutical Solutions ā€¢TESARO ā€¢Topas Advanced Polymers ā€¢Trinseo ā€¢W.L. Gore Associates, Inc. ā€¢Weidmann Medical Technology AG ā€¢West Pharmaceutical Services, Inc. ā€¢Zeon Chemicals L.P. Pre-Filled Syringes East Coast 2017 Attendee List Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 SMiā€™s Upcoming Events in the Pre-Filled Syringe Series: Pre-Filled Syringes Europe Copthorne Tara Hotel, London, UK 17th - 18thĀ January 2018 Pre-Filled Syringes West Coast Crowne Plaza, San Diego, CA, USA 4th - 5thĀ June 2018
  • 4. Workshop Leaders: melanie turieo, Director, Human Factors and Industrial Design, Cambridge Consultants and karen unterman, Group Leader, Human Factors Engineering, Cambridge Consultant half-DaY pRe-CoNfeReNCe WoRkshop B tuesDaY 10th apRil 2018 | 13.30 - 17.00 sheRatoN BostoN hotel, BostoN, usa humaN faCtoRs foR CoNNeCteD DRug DeliveRY sYstems Workshop overview This workshop will cover how to successfully incorporate Human Factors into the development process for connected drug delivery systems to achieve both commercial goals and meet regulatory requirements. The Human Factors engineering process and regulatory requirements for traditional medical device development are fairly well established and will be reviewed to ensure there is a common understanding of the current landscape. We will then explore how to adapt this process to meet the needs and requirements for a system which includes digital as well as physical elements. Why you should attend For anyone thinking about bringing digital health solutions to market, this workshop will identify the considerations that need to be addressed when designing a comprehensive Human Factors engineering process for a system which contains both physical and digital elements, and how to leverage the tools, methodologies and best practices across device development, User Interface (UI), and User Experience (UX) development. about the workshop leaders melanie is a Director in Cambridge Consultants Global MedTech division and head of Human Centred Design. She has over 20 yearsā€™ experience providing human factors expertise to the design and development of regulated and safety-critical items, including medical, military and consumer products. She has extensive experience in the development of drug delivery systems from early stage needs assessment and product defi nition through concept generation, detailed development, and HF validation. Melanie has a Bachelor of Science in Human Factors Engineering from Tufts Universityā€™s School of Engineering. karen is the Human Factors Group Leader at Cambridge Consultants in Boston MA. Her experience is in performing human factors activities throughout the development process, including: ethnographic research, translating stakeholder needs into measurable, technical requirements, facilitating creative workshops, assessing product risk, and designing, conducting and analyzing Formative and Validation usability studies. Karen graduated from Northwestern Universityā€™s McCormick School of Engineering and Applied Sciences with a Bachelor of Science in Biomedical Engineering. about the organisation Cambridge Consultants develops breakthrough products and technology for clients worldwide. For more than 50 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching fi rst-to-market products, entering new markets, or expanding existing markets through the introduction of new technologies. with a team of over 700 staff and offi ces in Cambridge, UK, Boston, MA and Singapore, Cambridge Consultants offers solutions across a diverse range of industries around the world. programme 13.30 Workshop Registration and afternoon Coffee 14.00 Workshop leadersā€™ introduction 14.15 overview of human factors for medical development ā€¢ Human Factors Engineering process ā€¢ Regulatory requirements ā€¢ Commercial goals 14.45 overview of the regulatory landscape for digital health ā€¢ Is it a medical system or not? ā€¢ Consumer digital systems ā€¢ Medical digital systems 15.30 afternoon tea and Networking Break 16.00 Bringing digital into the hf process ā€¢ How does it impact the process? ā€¢ What is UX and how is it interpreted for hybrid systems? ā€¢ Tools, methodologies and best practices 16.30 validation of the digital system 17.00 Closing Remarks from Workshop leaders and end of Workshop Workshop overview This workshop will provide a practical approach to ensuring that your prefi lled syringe design fi ts the needs of laypersons and supports use outside the clinic. Youā€™ll learn how to characterize the intended users and use environments, discover and fi ll gaps in your understanding of the users, explore possible risks, convert user needs into user interface requirements, and provide a complete support system when your product is in commercial use. Gathering these usability design inputs creates a solid foundation for your product design that will result in user satisfaction and ensure safe use. Why you should attend ā€¢ Understand diverse users, from parents caring for children to aging adults caring for their spouses ā€¢ Explore environments ranging from the home and workplace to worldwide travel destinations ā€¢ Plan for fi eld research ā€¢ Map user needs to demonstrable user interface requirements ā€¢ Provide a complete support system, including effective instructions for home use ā€¢ Capitalize on early research to reduce the number of design iterations about the workshop leaders ms. mcConnell has more than 25 years of experience working with product development teams in private industry, public service, and government agencies. She has worked exclusively in the Medical Device industry for the past 12 years. As a Human Factors Technical Lead, Ms. McConnellā€™s focus is on identifying and delivering medical device design solutions that exceed customersā€™ expectations and ensure safe use. Ms. McConnell has experience in all phases of the product development lifecycle, including research-based design inputs, use error analysis, prototyping, usability testing, summative validation studies, regulatory submissions, and product launch support. Her recent work ranges from large scale robotic systems used by surgeons during procedure in an operating room to handheld devices used by patients to deliver therapy at home. ms. Diorio-Blum has 10+ yearsā€™ experience in the medical device design and product development fi eld. She has experience working in multi-disciplinary teams consisting of industrial designers, engineers and human factors engineers. She has spent the majority of her career primarily focused on design and ethnographic research in the healthcare space. Her research efforts have taken her to many hospitals, clinical care, and home health care settings throughout the United States and Europe. She has extensive experience in data analysis, synthesis, and translating research fi ndings into user requirements for design and engineering teams. She conducts conducting focus groups, contextual research, and in-depth interviews from the RIVA training institute, and has conducted over 500 interviews in her career. about the organisation Our mission at Battelle is to translate scientifi c discoveries and technology advances into societal benefi ts. Battelle was formed in 1925, as a charitable trust, from the will of industrialist Gordon Battelle. Today, Battelle is the largest private, independent research and development organization in the world. Battelle has about 22,000 employees. Our headquarters is in Columbus, OH and we have over 130 locations worldwide. programme 8.30 Workshop Registration and morning Coffee 9.00 Workshop leadersā€™ opening Remarks and introduction 9.10 exploring diverse users and use environments ā€¢ Breakout groups: How to draft profi les for users and environments with design inputs in mind 10.10 getting the most out of early user research ā€¢ Case Studies: How user and environment profi les inform plans for early user research 10.30 morning Coffee 11.00 mapping user needs to user interface requirements ā€¢ Case Studies: How to trace user research fi ndings to user needs and user interface requirements 11.30 providing a complete support system ā€¢ Discussion: use outside the clinic requires multiple forms of support ā€¢ Discussion: Instructions for use are part of the user interface and should be created using a Human Centric Design approach 12.30 Closing Remarks from Workshop leaders and end of Workshop DesigN CoNsiDeRatioNs foR the WoRlD outsiDe the CliNiC half-DaY pRe-CoNfeReNCe WoRkshop a tuesDaY 10th apRil 2018 | 08.30 - 12.30 sheRatoN BostoN hotel, BostoN, usa Workshop Leaders: Debbie mcConnell, Human Factors Technical Lead, Human Centric Design, Battelle and annie Diorio-Blum, Principal Industrial Designer, Human Centric Design, Battelle Register online at www.pfsamericas.com
  • 5. pRouDlY spoNsoReD BY: suppoRteD BY spoNsoRship aND exhiBitioN oppoRtuNities smi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you companyā€™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 conference please call: alia malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk maRketiNg oppoRtuNities Want to know how you can get involved? interested in promoting your services to this market? Contact teri arri, smi marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk pre-filled syringes east Coast www.pfsamericas.com mitsubishi gas Chemical Mitsubishi Gas Chemical is a leading company in the fi eld of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs. www.mgc.co.jp Nemera NEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical, biotechnology and generics industries. Nemeraā€™s expertise covers several modes of delivery: Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: Safeā€™nā€™SoundĀ®, a fully passive safety device for prefi lled syringes to avoid accidental needle-sticks. SafeliaĀ®, a new generation of 2-steps auto-injector for fl uid and viscous formulations. www.nemera.net NN, inc precision engineered products NN, Inc Precision Engineered Products Group is an engineered solutions company, focusing on medical and drug delivery devices. We provide components, complex assemblies and clean room packaging, specializing in metal stamping, injection molding and ISO Class VIII clean room assembly. Learn more at www.pep-corp.com owen mumford Owen Mumford offer an integrated design and build service from a broad base of proven self-injection and blood-sampling platform devices and intellectual property. Find out more at omdevicesolutions.com or contact us at devicesolutions@owenmumford.co.uk www.owenmumford.co.uk schott SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental ophthalmic markets. Products include glass and polymer prefi llable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fi ll fi nish equipment. www.us.schott.com/pharma schreiner medipharm Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value- added benefi ts for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies. www.schreiner-medipharm.com terumo pharmaceutical solutions Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical technology. In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed to meet your specifi c requirements. www.terumo-ps.com zeon Corporation ZEONā€™s ZeonexĀ® and ZeonorĀ® cyclo olefi n polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, ā€œglass-likeā€ transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. www.zeonex.com offiCial meDia paRtNeRs
  • 6. pRe-filleD sYRiNges east Coast Conference: Wednesday 11th Thursday 12th April 2018, Sheraton Boston Hotel, Boston, USA Workshops: Tuesday 10th April 2018, London, UK 4 WaYs to RegisteR www.pfsamericas.com fax your booking form to +44 (0) 870 9090 712 phoNe on +44 (0) 870 9090 711 post your booking form to: Events Team, SMi Group Ltd, Ground First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK Please complete fully and clearly in capital letters. Please photocopy for additional delegates. title: forename: surname: Job title: Department/Division: Company/organisation: email: Company vat Number: address: town/City: post/zip Code: Country: Direct tel: Direct fax: mobile: switchboard: signature: Date: I agree to be bound by SMiā€™s Terms and Conditions of Booking. aCCouNts Dept title: forename: surname: email: address (if different from above): town/City: post/zip Code: Country: Direct tel: Direct fax: payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ā€˜shareā€™ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a Ā£50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefi ngs we are not normally able to provide documentation in these circumstances. 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Card Billing address (If different from above): VAT at 20% is charged on Document portal and literature distribution for all UK customers and for those EU customers not supplying a registration number for their own country here. ______________________________________________________________________________________ if you have any further queries please call the events team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk ā–” 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 i cannot attend but would like to purchase access to the following Document portal/paper copy documentation price total ā–” Access to the conference documentation on the Document Portal Ā£499.00 + vat Ā£598.80 ā–” The Conference Presentations ā€“ paper copy Ā£499.00 - Ā£499.00 (or only Ā£300 if ordered with the Document Portal) unique Reference Number our Reference lvp-243 eaRlY BiRD DisCouNt ā–” Book by 15th December to receive $400 off the conference price ā–” Book by 31st January to receive $200 off the conference price ā–” Book by 28th february to receive $100 off the conference price Delegate Details terms and Conditions of Booking paYmeNt vat DoCumeNtatioN veNue sheraton Boston hotel, Boston, usa CoNfeReNCe pRiCes i would like to attend: (Please tick as appropriate) fee ā–” Conference 2 Workshops $2997.00 ā–” Conference 1 Workshop A ā–” B ā–” $2498.00 ā–” Conference only $1999.00 ā–” 2 Workshops $998.00 ā–” 1 Workshop only A ā–” B ā–” $499.00 pRomotioNal liteRatuRe DistRiButioN ā–” Distribution of your companyā€™s promotional literature to all conference attendees $1598 + vat $1917.60 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. 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