SMi Group's 2nd annual Prefilled Syringes America conference returns to New Jersey next April

1. "Excellent, informative and good quality"
Delegate 2014
SMi presents its 2nd annual conference and exhibition on...
Pre-Filled Syringes
America
27 - 28
APRIL
Assessing the future of pre-filled syringes to improve innovation
and device development
2015 Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
BUSINESS BENEFITS FOR 2015:
• LISTEN to keynote addresses from the leaders in human
factors engineering with expert input on reaching
certain patient populations, considerations and
compliance in device design and how can we ensure
the drug product is administered safely and effectively
• LEARN about the critical issues surrounding safety
assessments of pre-filled syringes from extractables
and leachables to sterility and needle stick prevention
requirements – NEW FOR 2015
• ENHANCE your understanding of labelling and pricing
considerations with the competitive market for
biosimilars set to storm with patent expiries due
• ASSESS the future of pre-filled syringes with case study
led presentations addressing the challenges faced
with parenteral packaging innovations and reviewing
the strategies needed to overcome the hurdles with
importance insights into autoinjectors and pens
• ADDRESS the use of lyophilisation in pre-filled syringes, is
this the future vision?
CHAIRS FOR 2015:
Ravi Harapanhalli,
Vice President,
ParExel
William Beierschmitt,
Research Fellow, Drug Safety Research
and Development,
Pfizer Inc.
KEY SPEAKERS FOR 2015:
• Natalia Mazaeva, Usability Leader, Sanofi
• Stephen Barat, Executive Director, Forest Laboratories,
a subsidiary of Actavis
• Ed Israelski, Director of Human Factors, AbbVie
• Scott Brown, Device Development Lead, Merck
• Li-Chun Tsou, Global Device Technical Director,
AstraZeneca Pharmaceuticals
• Kiran Singh, Associate Director, Sandoz
• Michel Mikhail, Former Chief Regulatory Officer,
Executive Vice President, Global Regulatory -
Governmental Relations, Fresenius Kabi NV/SA
• Mark Tsai, Principal Engineer, Drug Delivery, Janssen
Pharmaceuticals
Plus many more...
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 29th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Will Drug Delivery in Coming Days be an Integral Part of DDM?
Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team,
Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative,
Sponsored by
Advanced Delivery Systems to Enable
Personalised Medicines
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and
Mr. Sall, Principal Consultant, ParExel
8.30am – 12.30pm
- Diagnose, Deliver and Monitor
www.pfsamericas.com
Beroe Inc.
1.30pm – 5.30pm
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2. Pharmaceutical industry’s perspectives:
• Drug stability (minimize drug-syringe interactions by
mitigating leachables and extractables, flakes (lamellae)
or deposits, glass fragments, and lubricant particles)
• Syringe durability
• Cost
Manufacturer’s perspectives:
• Simplified manufacturing/assembly processes to mitigate
batch variances
• Consider stringent sterilization and packaging processes
• Compliance of the mandatory "safety" PFS
Healthcare industry’s perspectives:
• Avoid needlestick injuries
• User-friendly
• Eco-friendly (minimum residual of medicine,
recyclable device material)
Patient's perspectives:
• User-friendly (convenience and safety in preparation
and self-administration)
• Eco-friendly (minimum residual of medicine,
recyclable device material)
• Price-friendly
Pre-Filled Syringes America
Day One | Monday 27th April 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
William Beierschmitt, Research Fellow, Drug Safety Research and
Development, Pfizer Inc.
HUMAN FACTOR STUDIES
OPENING ADDRESS
9.10 The importance of the patient and how each individual differs
• Reviewing the patient populations and the needs of certain
individuals in device design
• How can we enhance products to ensure they’re
specifically designed for the patient’s needs?
• Evaluating the best outcome for the patients, what
factors should be considered
Ed Israelski, Director of Human Factors, AbbVie
9.50 Success Criteria – How can the FDA’s requirements be met?
• Demonstrating safety and effectiveness in the hands of the user
• Reviewing the design requirements for validation purposes
• Are the customer requirements being met in design transfer?
• Post –market surveillance – What observations can
be made?
Natalia Mazaeva, Sr. Usability Leader, Global Usability
and Risk Management, Device Development, Sanofi
CASE STUDY
10.30 End user needs and perspectives for device assembly
End User Needs and Perspectives are critical for final device
delivery. This presentation will address the injectable device
trends and flexibility required for an assembly machine to adapt
to new market challenges while incorporating the ‘Human
Factor’. This presentation will also focus on recent Regulatory
updates (11608) for Combination Products
The lecture will show:
• Injectable Device Trends
• Human Factor - Increased focus on safety, usability and
handling studies
• Flexible standardized platforms to handle customized
assembly of pens and auto-injectors
• Gentle handling of the filled glass container during
assembly of the device using proven liquid fill finish
handling technology
Dena Flamm, Product Manager, Robert Bosch GmbH
11.10 Morning Coffee
KEYNOTE ADDRESS
11.40 Convenience and compliance: empower the user
through good design
• Reducing concerns by the end user is critical, what steps can
be taken to increase patient satisfaction?
• Precision and safety go hand in hand, let’s address
considerations to ensure the product designed is safe and
effective
• How do we ensure the patient receives the exact
dose intended?
Ben Bartfeld, Human Factors and Industrial Design
Consultant, Otsuka Pharmaceutical Companies
12.20 What makes a pre-filled syringes ergonomic?
• Addressing the importance of human factor studies
in device development
• Assessing the possibilities to ensure the drug product
is administered safely and effectively
• Working with clients concentrating on the design
based strategies
Saikrishna Garrepalli, Procurement Management
Representative, Beroe Inc.
1.00 BREAKOUT SESSION & OPPORTUNTY TO NETWORK PRE-LUNCH
• Are we seeing a growing trend in drug delivery being
administered outside traditional medical settings?
• How can we ensure this is safe?
Host: William Beierschmitt, Research Fellow, Drug Safety
Research and Development, Pfizer Inc.
1.30 Networking Lunch
CRITICAL ISSUES: SAFETY ASSESSMENT
2.40 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products
• Background on leachables and pre-filled syringes
• Why safety assessment for leachables is necessary
• How to approach and conduct a leachable safety
evaluation
• Current best practice recommendations and
examples
Stephen Barat, Executive Director, Forest Laboratories,
a subsidiary of Actavis
3.20 The Risk Assessment of Extractables - A Toxicological Window of
Opportunity
• Ensuring compatibility of the profile of the pre-filled syringe with
the biologic
• Avoiding changes in product quality
• Material selection and final assessment of leachables
William Beierschmitt, Research Fellow, Drug Safety
Research and Development, Pfizer Inc.
4.00 Afternoon Tea
4.30 CASE STUDY
Identifying incompatibility causes and challenges
• Assessing drug delivery studies and reflecting on the
impact
of incompatibility
• Assessing the specific fit of LAV valves and specific
issues surrounding prefilled syringe design
Kiran Singh, Associate Director, Sandoz GmbH
5.10 Assessing the safety of needle devices
• Looking at the global demand of safety needle
devices
• What necessary steps should be taken to ensure
a successful safety pre-filled syringe
• Creative design of safety pre-filled syringes
Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed
Technologies Co. Ltd.
5.50 ROUND TABLE DISCUSSION AND NETWORKING OPPORTUNITY
• Discussing the safety challenges surrounding pre-filled
syringes
Host: Pei-Yang Phillip Hsu, Chief Executive Officer,
SaferMed Technologies Co. Ltd
6.30 Chair's Closing Remarks and Close of Day One
NEW FOR
2015!
NEW FOR
2015!
Register online at: www.pfsamericas.com • Alternatively fax yo

3. Pre-Filled Syringes America
Day Two | Tuesday 28th April 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Ravi S. Harapanhalli, Vice President, ParExel
ENHANCING DEVICE DEVELOPMENT
OPENING ADDRESS
9.10 Getting to market: Regulatory perspective
• Defining a pre-filled syringe as a product or device
and its impact on regulatory approval
• Insight into the FDA’s current thoughts
Ravi S. Harapanhalli, Vice President, ParExel,
former FDA Senior Executive
9.50 Biosimilars and Delivery Devices…here we go!
• Patent expiries for biologics are creating a new
competitive market for biosimilars in particular
Monoclonal antibodies
• How to differentiate from the innovator with a device
• Factors to Review: e.g. Interchangeability studies
Michel Mikhail, Former Chief Regulatory Officer,
Executive Vice President, Global Regulatory
- Governmental Relations, Fresenius Kabi NV/SA
10.30 Morning Coffee
CASE STUDY
11.00 The partnership reviewed between a pharmaceutical company
and the manufacturer/supplier
• Overview of the relationship and how it was managed
•An explanation on why the products have been developed
PHARMA
• What worked
(Existing Actions)
Pharma companies
sometimes use mono-layer
plastic containers
to prevent the below
problems, but all of
them don’t have
enough oxygen barrier.
• What could’ve been
improved?
(Existing Problems for
Glass Container
- Breakage
- Heavy Weight
- Difficulty of disposal
- Protein Adsorption
- Inorganic Extractable,
etc.
• Moving forward, what
would you have done
differently?
(Future actions)
Some antioxidizing
agent might be used for
injectable drugs.
SUPPLIER
• What worked
(Existing solutions by
suppliers)
Some supplies provide
mono-layer plastic
containers instead of
glass, but all of them
don’t have enough
oxygen barrier.
• What could’ve been
improved?
- Oxygen Barrier
• Moving forward, what
would you have done
differently?
(Our solutions)
- We developed an
oxygen absorbing
polymer.
- We also developed 3
layers-containers
- The oxygen absorbing
polymer is used for
the middle layer
- COP which is well-known
as a high
moisture
Shun Ogawa, Research Manager, Mitsubishi Gas
Chemical Company, Inc.
11.40 Combination Product Considerations- Starting with the End in Mind
• Evolving trends for the pre-filled syringe and self-injection markets
• Industry/Supplier partnership is key to successful development
outcomes
• Patient considerations and building strong product brands
through innovation
Royce Brockett, Senior Product Manager, West Pharmaceutical
Services, Inc.
ROUND TABLE DISCUSSION
12.20 The partnership reviewed between a pharmaceutical
company and the manufacturer/supplier
• Choosing a partner: What are the decision criteria?
• Who owns what: Equipment, IP, regulatory
requirements?
• Managing the partnership
Scott Brown, Executive Director/ Device Development
Lead, Merck Research Laboratories
1.00 Networking Lunch
KEYNOTE ADDRESS
2.00 Parenteral Device Strategy for Patient-Centric
Therapeutics
• Advantages and Constraints of Pre-filled Syringes in Designing
Cutting Edge Devices
• Global Design Control Process in Meeting Country
Specific Regulatory Expectations
• Concurrent Engineering Commercialization Model
in Achieving Successful New Product Launch
Li-Chun Tsou, Global Device Technical Director,
AstraZeneca Pharmaceuticals
2.40 Product Line Management, sustaining activities
• Engineering change plan
• Product enhancement, material change, CAPA
• Post market risk management
• Design control, sustaining activities
Mark Tsai, Principal Engineer, Cell Therapy, Janssen R&D
3.20 BREAKOUT SESSION & OPPORTUNTY TO NETWORK
• Glass v Plastic
• The advantages and disadvantages
• Is once still more favourable, if so why? Discuss
Host: Ravi Harapanhalli, Vice President, ParExel
4.00 Afternoon Tea
CASE STUDY
4.30 Process Development studies to optimize process
parameters and finalize presentation format
Case studies included:
• Development study to evaluate hold times on the
filing line
• Stopper movement studies to evaluate effect of
headspace
Aarti Gidh, Senior Scientific Investigator,
GlaxoSmithKline
5.10 Electronics and Mobile Apps role in drug delivery
and dosage adherence
• How electronics and mobile apps in device development are
going to affect dosage areas in the medical device space
• Some of major development in patch front which has circuitry
embedment and other innovative add on
• Increasing penetration of electronics in drug delivery
• Vision of leading device manufacturers and their take on
electronics future
• Role of mobile apps in complimenting the growth of
electronics in device arena
Chanderkanth Gautam, Domain Lead and Medical
Device Community Leader, Beroe Inc.
5.50 Chairman’s Closing Remarks and Close of Day Two
Official Platinum
Media Partner
NEW FOR
2015!
NEW FOR
2015!
NEW FOR
2015!
Supported by
ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

4. HALF-DAY POST CONFERENCE WORKSHOP AM
Wednesday 29th April 2015 | 8.30am – 12.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Advanced Delivery Systems to Enable Personalised Medicines
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel and
Mr. Sall, Principal Consultant, ParExel
Workshop overview:
Run by one of the US’s leading figures in regulatory approval processes
and drug delivery systems, Dr. Ravi Harapanhalli. This industry leading
workshop will help you plan for smooth regulatory approvals and help with
avoiding pitfalls that can cause expensive delays in taking your product to
market.
Who should attend this workshop:
R&D Scientists, Regulatory Affairs, Device specialists, Formulators,
Business Development Staff
HALF-DAY POST CONFERENCE WORKSHOP PM
Wednesday 29th April 2015 | 1.30pm – 5.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Will Drug Delivery in Coming Days be an Integral Part of DDM?
- Diagnose, Deliver and Monitor
Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team, Beroe Inc. and
Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc.
Overview of workshop:
Drug delivery device market would no longer exist as standalone entity. As
healthcare longs to address all the solution through single gateway,
technologies such electronic bandage, artificial pancreas pave their way
into the market. They provide a holistic solution by diagnostic, delivering and
monitoring. This is likely to be future of healthcare.
Why you should attend this workshop:
• To understand the platform that will be face of healthcare in coming days.
• To understand how fast are new technologies are advancing in the space of
Medtech, and how considerable these devices were in addressing the gap the
currently prevails will be the focus of the workshop.
About the workshop hosts:
Chanderkanth Gautham A Medical Device Procurement
Management Representative (Sr. Research Analyst) with
experiences in R&D, Human Factors, Contract Research Services
facilitating Medical Devices, Pharmaceutical, Cosmetics and
Herbal Companies with Product development, Regulatory and
Post Marketing (Medical Affairs) and Business Development
support activities across global regions.
Saikrishna Garrepalli Procurement Management Representative
(Sr. Research Analyst) of leading medical device companies, Sai
has experience in R&D, Human Factors, Contract Research
Services and regulatory pathways. Currently he is analyst at
Medical device team at Beroe handles various client initiatives
such as supplier relationship, negotiations and others.
About Beroe Inc.
Beroe is procurement pioneer which addresses USD 15 Billion+ spend of its
clients globally. It carefully monitors the market for any sort of trend at
supplier or buyers end. And is very instrumental in benchmarking markets
and supplier capabilities across various facets of value chain ranging from
design to manufacturing. beroeinc.com
Programme
8.30 Registration & Coffee
9.00 Introductions and Opening Remarks
9.45 Session 1: Quality-by-Design in the development
of drug delivery systems
10.30 Session 2: Regulatory pitfalls to avoid
11.00 Coffee break
11.30 Session 3: New combination product regulations
and how to comply with them
12.00 Session 4: How to accelerate approval through FDA
12.30 End of Workshop
Why you should attend this workshop:
• Accelerate the time it takes to
take your drug delivery system to
market
• Find out how to navigate new
combination product guidelines
• Assess the right time to start thinking
about your drug delivery
mechanism
• Develop a strategy for product life
cycle management by switching
over to PFS
• Understand how to apply the FDA
Quality SystemRegulation to
delivery device development
• Know how to apply FDA Design
Controls to delivery device
development
• Get to appreciate how to selection
of a delivery device development
partner
• Perform risk analysis and Human
Factors assessment
About the workshop host:
Dr. Ravi Harapanhalli advises bio/pharmaceutical companies on
CMC regulatory strategies and Quality-by-Design approaches to
medicinal product development and flexible regulatory
approaches.
About the workshop co-leader:
Mr. Sall is a Principal Consultant with PAREXEL Consulting in
Waltham, MA. PAREXEL provides clinical trial, clinical data
management, medical and regulatory services to the
pharmaceutical and medical device industries.
About ParExel:
Over the past 30 years, ParExel has developed significant expertise to
assist clients in the worldwide pharmaceutical, biotechnology and
medical device industries with the development and launch of their
products in order to bring safe and effective treatments to the global
marketplace for the patients who need them. Headquartered near
Boston, Massachusetts, ParExel operates over 77 locations throughout
more than 51 countries around the world, and has over 14,400
employees. www.parexel.com
Programme
1.30 Registration and Coffee
2.00 Will drug delivery in coming days be integral part of DDM
<diagnose, deliver and monitor>
Areas Covered
• Introduction on these developments
• Some case studies indicating the inception of the trend
• Will developments in non-invasive sensor based
technologies and automatic modes of delivery increase
inclination of patients and physicians to home care
technologies.
• Do acquisition of monitoring device companies by
Medtech giants’ indicate bigger role of DDM platforms
in future?
3.30 Coffee Break
4.00 Will artificial pancreas penetration in market pave way for
non-conventional diabetic therapy?
Areas to be covered
• Will the aforementioned platform challenge the
conventional, glucose measurement and injection
therapy to a significant amount?
• Does this mean that conventional modes insulin delivery
via auto injectors, pen injectors now needs a massive
scale up technology wise?
• Who are those technology pioneers that need special
mention on their recent developments in same space?
5.30 End of Workshop

5. Pre-Filled Syringes Americas
SPONSORED BY:
Bosch Packaging Technology is the world leader in the design and manufacture of pharmaceutical
processing and packaging systems. Bosch offers a range of syringe filling systems in both nested and
bulk styles of systems. Bosch also now offers syringe pen assembly systems and single use dosing
systems with scalable solutions. With Bosch one supplier solutions are a real possibility.
www.boschpackaging.com
JOT Automation is driven by a passion to develop and manufacture test and production solutions for
mobile devices, components and electronics. JOT Automation offers product platforms to solve
versatile volume manufacturing challenges in the most cost-effective manner. The company is a
global partner for several industry leading companies in the telecom, automotive and life science
industries. www.jotautomation.com
Mitsubishi Gas Chemical (MGC) is well-known as an expert in unique polymers and oxygen absorbers.
Based on our experience and expertise, MGC has successfully developed multilayer plastic vial and
syringe with oxygen absorbing function. MGC believes they will be an only solution to replace glass
with plastic. www.mgc.co.jp/eng
West works side by side with its healthcare partners from concept to the patient, designing and
manufacturing packaging, diagnostic and delivery systems that promote the efficiency, reliability
and safety of their products. Every day, West is leading the way with cutting-edge technologies and
quality systems, a thorough understanding of global regulatory compliance, and an unmatched and
growing knowledge base of relevant pharmaceutical product testing, development and packaging.
Based in Exton, Pa., West supports its customers from sales, manufacturing, customer support and
research and development locations in North and South America, Europe, Asia and Australia.
www.westpharma.com
100+ATTENDEES
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
Attendee by Location
Want to know how you can
get involved?
Interested in promoting your
services to this market?
USA 71%
Contact Julia Rotar, SMi Marketing
on +44 (0) 207 827 6088, or email:
jrotar@smi-online.co.uk
WHO SHOULD ATTEND:
Those involved in the following:
• Pharma Development
• Engineering
• Manufacturing
Technology
• Biopharma Operations
• Regulatory Affairs
• Parenterals
• Packaging
• Formulation Aseptic
• Device Development
• Device Design
• Labelling
• Manufacturing
• Drug Delivery
• Formulation & Aseptic
Filling Technologies
• Chemistry Manufacture
Controls (CMC)
• Quality Assurance
• Safe Medication
Practice
11
Canada 7%
India 5%
2BREAKOUT SESSIONS
4CASE STUDIES
LEADING PHARMA
COMPANIES SPEAKING
2KEYNOTE ADDRESSES
2 ROUND TABLE
DISCUSSIONS
Europe 17%
KEY HIGHLIGHTS:

6. PRE-FILLED SYRINGES AMERICA
Conference: Monday 27th & Tuesday 28th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Wednesday 29th April 2015, USA
FAX your booking form to +44 (0) 870 9090 712
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