Pre-Filled Syringes Americas Conference - by the SMi Group, 12-13 March 2014, Houston, USA

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“A wise choice of location and an intelligently designed program of expert
speakers promises to bring together the leading minds and influencers mapping
the future of the prefilled syringes sector.”
Guy Furness, Proprietor & Publisher, ONdrugDelivery Magazine
SMi present the 8th conference and exhibition in its world leading series...
Pre-Filled Syringes
Americas
Development, manufacture and regulation of
pre-filled syringe and injector devices
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
31ST MARCH
- 1ST APRIL
2014
KEY SPEAKERS INCLUDE:
• Scott Brown, Device Development Lead, Merck
• Alexei Goraltchouk, Senior Manager, Operations Regeneron
• Stephen Barat, Senior Director, Toxicology and Operations, Forest
Laboratories
• Steven Projan, SVP, MedImmune*
• Martin Dearden, Chief Corporate Microbiologist, UCB
• Thomas Osterberg, Senior Manager, Biologics, Pfizer Inc
• Greg Sacha, Senior Research Scientist, Baxter
• Christian Siegmund, Head of Prefilled Syringes and liquid vials, Roche
• Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA
Senior Executive
WHY ATTEND THIS EVENT:
• 3 days of presentations, panel discussions and interactive
workshops. Return to your business with the information and
contacts to make the right decisions for your products
• Focus sessions on biologics, manufacturing, polymers and
extractables and leachables
• 20+ expert speakers from throughout the PFS and device ecosystem
• 85+ key decision makers, influencers and innovation drivers
attending from the most relevant and sought after organisations in
pre-filled syringes
• Network with delegates from the leading Biotechnology and
Pharmaceutical businesses globally during the series of networking
breaks, lunches and networking evenings designed to help
conversation flow
• Hands on exhibition to help you evaluate the leading solutions in the
marketplace and meet the thought leaders who developed them
*stc
PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 2nd April 2014, Iselin, New Jersey, USA
Accelerating the regulatory approval of your pre-filled product:
Insight into combination product approvals
Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA Senior Executive, and Mr. Sall, Principal Consultant, ParExel
8.30am - 12.30pm
Sponsored by
www.pfsamericas.com
REGISTER BY 20TH DECEMBER 2013 AND SAVE $300 / REGISTER BY 28TH FEBRUARY 2014 AND SAVE $100
Register online or call +448709090711 to speak to an account executive

2. Pre-Filled Syringes Americas
www.pfsam
Day One | Monday 31st March 2014
8.30
Registration & Coffee
2.00
9.00
Chairman's Opening Remarks
Alexei Goraltchouk, Senior Manager, Operations Regeneron
Introduction to Medical grade Cyclo Olefin Polymers (COP)
• Key properties of current Medical grade Cycloolefin polymer
(COP)
• Regulatory Status
• Bio-Compatibility and Protein Adsorption study
9.10
9.50
10.40
KEYNOTE ADDRESS: Avoiding the pitfalls of device development
• What to look out for when developing your delivery device
• The 5 reasons product fail
• How can you plan to mitigate the risk of product failures
Scott Brown, Device Development Lead, Merck
• Effect of Gamma/EB/Steam sterilization
• Introduction of new product
Toshiro Katayama, Product Manager, Zeon Chemicals
2.40
products
HEADLINE PANEL: Developments in pre filled
syringes and injection devices
PANEL
• What are key aspects driving the exponential
growth of the market?
• Which challenges need to be worked out to continue
expansion?
• What’s next for pre filled syringes, where will the growth come
from?
Steven Projan, SVP, MedImmune (STC)
Lloyd Fishman, President, High Peaks Partners LLC
Michael Dudley, CEO, Artemes Technologies
Moderator: Cliff Mintz, Associate Editor, Life Science Leader
Morning refreshments and networking in the exhibition area
DEVELOPING YOUR COMBINATION PRODUCTS OR INJECTABLE DEVICE
Panel: Developing delivery systems for biological
• Overcoming viscosity and needle size challenges
PANEL
• How can you ensure E&L are within acceptable
limits?
• Seeking efficient FDA approval for RA and other drug products
• When should you develop your own solution and when should
you work with a partner?
Dr Thomas Osterberg, Senior Manager, Biologics, Pfizer
Martin Dearden, Corporate Microbiologist, UCB
William Lambert, Fellow, Drug Delivery and Device
Development, MedImmune
Moderator: Cliff Mintz, Associate Editor, Life Science Leader
3.30
Afternoon refreshments and networking in the exhibition area
4.00
Pre-filled syringe manufacturing, a review of processes and
challenges
11.10
11.50
12.30
Foreign Particulate Matter and Siliconization Testing
• rap.ID and Foreign Particulate Matter Identification
• Siliconization Process – Spray on vs. Emulsion
• Silicone Control Methods – Historical and Actual
• Layer Explorer – Technology and Case Studies
Oliver Valet, President, rap.ID
Next generation Pre-Filled Syringes: How are electronic auto
injectors changing the market?
• Trends in electronic injectors and how they compare to
pre-filled syringes
• What are the key procurement challenges that category
managers will face
• How these differ from conventional Pre Filled Syringe
challenges
Chanderkanth Gautam, Senior Research Analyst, Beroe Inc
Geetha Vaithyanathan, Domain Lead, Beroe Inc
Networking Lunch held in the exhibition area
• New challenges with COP and COC containers
• How to effectively reduce particle contamination
• When’s the right time in product development to decide on
delivery systems?
Greg Sacha, Senior Research Scientist, Baxter
4.40
Cutting edge developments in pre filled syringe design soon to
be ready for testing
• How are advances in syringe design going to open the market
for new applications in PFS
• Developments in 2 chamber syringes capable of mixing
powders and liquids
• Advances in large polymer syringes with the capacity to
administer of nutritional gels
Michael Spigarelli, Professor of Internal Medicine, Pediatrics and
Pharmacy, University of Utah School of Medicine
5.20
Chairman's Closing Remarks and Close of Day One
Register online at: www.pfsamericas.com • Alternatively fax you
Official Platinum Media Partner
Sponsored by
rap.ID Particle Systems GmbH
rap.ID Particle Systems provides compliant solutions for the control of silicone and other lubricants
thickness and distribution in pre-filled syringes. rap.ID also offers contract testing services
providing particles identification and root cause analysis. rap.IDs good particle ID equipment
reveals enumeration as well as the chemical structure and elements of microparticles. This
becoming a standard in the identification of foreign particulate matter with a unique speed and
power of distinction. www.rap-id.com
Zeon Europe GmbH
Achieve glass-like transparency and excellent long-term stability with protein- and peptidebased drugs by using ZEONEX®. ZEONEX® cyclo-oleflin polymers, break-resistant plastics
designed for critical pharmaceutical packaging applications including vials, pre-filled syringes,
and blister packaging. ZEONEX® COP is an ultra-clean plastic that does not contain additives or
components that leach-out over time. Additionally, for protein-based drugs, common proteins
show low adsorption onto ZEONEX containers as compared to other plastics. For more
information, visit www.zeonex.com or email zeonex@zeonchemicals.com
Official Leading Media Partner

3. Pre-Filled Syringes Americas
mericas.com
8.30
Day Two | Tuesday 1st April 2014
Registration & Coffee
12.00
OVERCOMING MANUFACTURING CHALLENGES
OF PRE-FILLED SYRINGES AND INJECTOR DEVICES
REGULATORY SESSIONS: HOW YOU CAN ENSURE EFFICIENT APPROVAL
9.00
Chairman's Opening Remarks
Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior
1.30
The market and technologies for large volume (‘bolus’) injections
• Findings from study conducted in conjunction with the
Executive
9.10
Networking Lunch held in the exhibition area
Cambridge Judge Business School
• New drugs that require large injections: Why are bolus injectors
Managing the safety assessment of leachables for pre-filled
are required?
syringe drug products
• The limitations of autoinjectors and infusion pumps for large
• Current trends in the safety assessment of extractables and
volume injections
leachables.
• Why a new class of device, the bolus injector, is under
• The use of scientifically-justified threshold levels in the safety
development
assessment of leachables
• Example devices and their properties– Unilife, BD, West, Ratio,
• How to approach the qualification of leachables and
SteadyMed etc.
considerations needed during development and life-cycle
Tom Oakley, Director of Drug Delivery Device Development,
management.
Springboard
• Working examples to illustrate approach and key principles.
Stephen Barat, Senior Director, Toxicology and Operations, Forest
2.10
Laboratories
Case Study: Benefits and challenges of pre-filled syringe isolator
filling machines
• Latest updates on how to overcome challenges
9.40
Getting to market: Regulatory perspective
• Minimization of product errors and scratches
• Defining a pre-filled syringe as a product or device and its
• Overcoming the challenges of machine start ups
impact on regulatory approval
• Methods of inspection: Visual and automated machines
• Roadmap to approval for PFS’s and auto injectors
Christian Siegmund, Head of Prefilled Syringes and liquid vials,
• Insight into the FDA’s current thoughts
Roche
Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior
Executive
2.50
Afternoon refreshments and networking in the exhibition area
10.10
Morning refreshments and networking in the exhibition area
3.20
Developing your fill and finish production lines
10.40
Considerations to gain international regulatory approval
• Adhering to visual inspection guidelines
• Considerations to make when developing your manufacturing
• Considerations for international export markets
• Upcoming trends in fill and finish functionality
facility
Martin Dearden, Chief Corporate Microbiologist, UCB
• Overcoming the challenges of the Japanese market?
• Planning for success in multiple regions
4.00
Future trends in the pre filled syringes and medical devices
Brij Patel, CEO, RegExcel
• Delivery technology, business and operational needs from the
How should you manage your biological assessment of medical
• Usability, user preference, and learning from patient feedback
devices
• The next generation of needs, as opposed to the next
drug-makers perspective
11.20
• Safety evaluations of E&L
generation technology
• Adhering to regulations in the EU and beyond
Alexei Goraltchouk, Senior Manager, Operations Regeneron
• Benefits and pit falls of different container materials
Adam Wooley, CEO, ForthTox
4.40
Chairman’s Closing Remarks and Close of Day Two
ur registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Supported by

4. HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 2nd April 2014
8.30am - 12.30pm
Renaissance Woodbridge, Iselin, New Jersey, USA
Accelerating the regulatory approval of
your pre-filled product : Insight into
combination product approvals
Workshop Leaders:
Ravi S. Harapanhalli, Vice President, ParExel
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.
Why you should attend:
• 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 System
Regulation 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
Programme
9.00
Registration
9.30
Introductions and Opening Remarks
9.45
Session 1: Quality-by-Design in the
development of drug delivery systems
10.30
Session 2: Regulatory pit falls 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
About the workshop host
Dr.
Ravi
Harapanhalli
advises
bio/pharmaceutical companies on
CMC regulatory strategies and Qualityby-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.

5. SPONSORSHIP AND
EXHIBITION OPPORTUNITIES
Imagine a room full of the highest
level decision-makers from your
target market...
SMi offer sponsorship, advertising and
branding packages, uniquely tailored to
compliment 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.
Expected audience at
Pre-Filled Syringes Americas:
Audience by Location
■
■
North America
Europe
■
■
Asia
Rest of World
Audience by Sector
■
■
Bio Tech
/Pharma
Pre-Filled
Systems
■
■
Pre-Filled
Components
Product
Equipment
SPONSORSHIP ENQUIRIES
Should you wish to join the increasing number
of companies benefiting from sponsoring our
conferences please call:
Alia Malick, Director on +44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk
Want to know how you can get involved?
Interested in promoting your services
to this market?
Contact Julia Rotar, SMi Marketing on
+44 (0) 207 827 6088, or
email: jrotar@smi-online.co.uk

6. PRE-FILLED SYRINGES AMERICAS
Conference: Monday 31st March & Tuesday 1st April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshop: Wednesday 2nd April 2014, London
4 WAYS TO REGISTER
www.pfsamericas.com
FAX your booking form to +44 (0) 870 9090 712
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Book by 28th February to receive a $100 discount off the conference price
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