3rd Annual Pre-Filled Syringes Americas Conference
14th May 2012 — 16th May 2012
14th - 16th May 2012, Boston, USA Investigating developments in Pre-Filled Syringes - what barriers are faced, and where to from here?
Background Info
Key Speakers
• Amanda Wolf, Scientist, Pfizer
• Edwin Chan, Process Engineer, Genentech
• Fangdong Yin, Research Adviser, Eli Lilly
• Thomas Scherer, Scientist, Genentech
• Brian Lynch, Program Lead - Health Science & Technology, Immunization, BD Medical - Pharmaceutical Systems
• Tom Walker, Director, Global Communications, West Pharmaceuticals
• Dr. Jan Jezek, CSO, Arecor
• Andy LaRose, Senior Engineer, Amsino
• Juan Cerdaz-Diaz, Director of R&D and Technical Service, NiproGlass Americas
• Dr. Andrew Feilden, Principal Consultant, Smithers Rapra
• Hemanth Panasa, Deputy General Manager, Aurobindo Pharma
The intravenous route of administration is the most effective route to administer medication fast and directly into the blood stream to facilitate the absorption and immediate onset of action, it also avoids 1st pass metabolism to increase the amount of active drug present. Other methods of administration may provide more comfort to the patient but have yet to be able reproduce the same rapid onset of action. Therefore parenteral administration is unlikely to be replaced in the near future.
Pre-filled syringes have been developed to improve the administration of parenteral drugs. They reduce wastage, save time and are easy to operate making self-administration by patients possible. These syringes come pre-filled with the medication in measured volumes most appropriate for recommended dosing.
There are many types of medications that are available as pre-filled syringes which include: vaccines, anti-coagulants, haematological products, insulins, human growth hormones and cancer therapies to name a few. These products come with their own barriers when manufacturing and packing them as pre-filled syringes - stability, formulation, volume restrictions, incompatibilities, fusion to the syringe barrel/needle, and interactions with silicon coatings. These barriers are not just confined to the medication but also to the production and manufacturing of the syringe components.
Pre-filled syringes continue to offer one of the highest future growth potentials in the pharmaceutical industry. Over the past 5 years the US pre-filled market has been growing by 20%1 making investing in R&D of pre-filled syringes worthwhile.
This conference will address some of the barriers involved in pre-filled syringe manufacturing, what is being done to overcome them, and the future developments in the industry and market.
Why should I attend?
• Discover new developments in the technology used to make pre-filled syringes
• Learn about the market for pre-filled syringes
• Explore the opportunities for outsourcing of pre-filled syringes, challenges faced and cost effectiveness
• Investigate the barriers for siliconisation, and the options available to overcome these
• Optimize the stability of products in pre-filled syringes
• Examine new developments in the formulation of products to be packaged in pre-filled syringes: proteins, vaccines, anticoagulants
• Learn about the use of lyophilised products in pre-filled syringes and delivery techniques
• Gain an insight into the development of dual chambers, and contributing factors
• Discuss the regulatory issues about the standardisation of pre-filled syringes
• Establish what inspection technologies are available to ensure validity and quality of pre-filled syringes
• Tackle challenges relating to syringe components – stoppers, plungers, barrels
• Learn about developments in filling techniques – volume, viscosity, foaming, reduction of the risk of trapped air in the syringe
• Advantages of pre-filled syringes, cost benefits, ease of access, reduced wastage,
• Investigate the composition of syringes – glass vs. plastic
• Source information about sterilisation techniques for syringes: e-beam technology, sterile manufacturing, x-ray capabilities
• Survey the future of pre-filled syringes and how they factor in the drug delivery systems of tomorrow
Who should attend?
VPs, Directors, Heads, Managers of:
Pharmaceutical & Biotech companies
Packaging
Labeling
Manufacturing
Product design
Technical support
Drug product process development
Drug device process development
Pharmaceutical sciences
Safe medication practice
Drug device safety
Contract sales/marketing organisations
Business development
Product management and sales
Pharmaceutical, healthcare and life sciences consultants
Analysts
Consultants
Researchers
Lawyers
Partners and senior counsel
1 Visiongain Report – Pre-Filled Syringes: World Market Outlook 2011-2021
Workshop
Pre-conference workshop, Monday 14th May 2012
Extractables and Leachables
Led by: Dr. Andrew Feilden, Principal Consultant, Smithers Rapra, Former Senior Scientist, AstraZeneca
Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks
About the workshop:
The purpose of the workshop is to allow you to engage in knowledge sharing with your peers in a smaller, less formal environment than the main conference. As such, the audience size will typically be no more than 20 participants in order to enable maximum interaction between the workshop leaders and the delegates. The format is also more interactive, with less emphasis on ‘lecture-style’ presentations and more emphasis on group discussions, exercises and Q&A sessions.
Agenda:
• Introduction
• Regulatory Requirements
- Current guidelines, recommendations and best practises
• How to carry out extractable and leachable testing
- Types of studies
- Techniques to use
- Limits of detection required
• Industry working groups
- What groups are there and what are they doing
• Hypothetical E&L Case Study
• Extractable and leachable risk assessment
• Change management
Day 1
Day One, Tuesday 15th May 2012
09:00 Registration and refreshments
09:30 Opening address from the Chair
09:40 Why prefills make good sense: perspective on the impact of packaging
The migration of care from traditional settings and the increased pressure on the healthcare system have brought packaging selection to the forefront of drug product development. A significant body of research and data has been developed which provide good evidence that prefilled syringes offer advantages in efficiency and an optimized safety profile. Data and perspectives on the health economic benefits of prefills and the corresponding clinical implications will be discussed.
Brian Lynch
Program Lead - Health Science & Technology, Immunization
BD Medical - Pharmaceutical Systems
10:20 Drug Product Development in Pre-Filled Syringes: Considerations for formulation, manufacturing and packaging
Amanda Wolf
Scientist
Pfizer
11:00 Morning refreshments
11:20 Manufacturing consideration in developing a prefilled syringe
• Overview of syringe filling process
• Using QbD approach in process development
• Evaluating syringe siliconization process and optimization
• Applying mathematical model to predict syringe gliding force
Edwin Chan
Process Engineer
Genentech
12:00 Presentation to be announced
Dr. Jan Jezek
CSO
Arecor
12:40 Networking lunch
13:40 Manufacturing elastomeric components for pharmaceutical applications
• Formulations and ingredients
• Compounding and missing
• Curing
• Finishing
Andy LaRose
Senior Engineer
Amsino
14:20 A global approach to creating innovative value in parenteral packaging
• Chemical properties of glass
- Improving chemical durability and resistance to glass corrosion/delamination through chemistry enhancement in glass manufacturing
• Mechanical properties of glass
- Handling technologies to reduce scratches in glass to improve mechanical properties including resistance to breakage
Juan Cerdaz-Diaz
Director of R&D and Technical Service
NiproGlass Americas
15:00 Afternoon Refreshments
15:20 Presentation to be announced
Dr. Andrew Feilden
Principal Consultant
Smithers Rapra
16:00 Considerations for the packaging of different types of medications
• Proteins – preventing aggregation in the syringe
• Vaccines – how to deal with lyophilized products in a PFS
• Anti-coagulants
16:40 Closing remarks from the Chair
16:50 Networking Drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Day Two, Wednesday 16th May, 2012
09:00 Registration and refreshments
09:30 Opening address from the Chair
09:40 Presentation to be announced
Fangdong Yin
Research Adviser
Eli Lilly
10:20 High concentration products in PFS
Thomas Scherer
Scientist
Genentech
11:00 Morning refreshments
11:20 Presentation to be announced
Tom Walker
Director, Global Communications
West Pharmaceuticals
12:00 Considerations for validation of manufacturing processes for prefilled syringe products
• Overview of regulatory perspective
• Equipment and aseptic process attributes
• Considerations on product attributes
Hemanth Panasa
Deputy General Manager
Aurobindo Pharma
12:40 Networking lunch
13:40 Dual chamber devices
• Are these viable for lyophilized products
• What reconstitution devices are available to ensure integrity of the syringe and viability of the lyophilized pharmaceutical ingredient
14:20 Regulatory issues facing the pre-filled syringe manufacturers
• How are syringes regulated
• What standardisation techniques are in place
• What new regulations are coming to light and how will these affect manufacturers and R&D alike
15:00 Afternoon refreshments
15:20 Needle stick injuries
• How to prevent them
• New devices in the pipeline to ensure the safety of end-line-users
16:00 What new developments are in the pipeline for pre-filled syringes?
• Safety devices
• Methods to make administration easier for those with dexterity problems
16:40 Chair’s closing remarks
16:50 End of Conference
Partners
Media Partners:
PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com
BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com
Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com
InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.InPharm.com
Enquiries:
If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 3rd Annual Pre-Filled Syringes Americas Conference, please contact:
Peter Barfoot peter.barfoot@bioportfolio.com
Speakers
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Amanda Wolf
Scientist
Pfizer
Amanda Wolf is a formulation scientist in Pfizer's Biotherapeutics Pharmaceutical Sciences group. She earned her BS in chemistry from Truman State University and her MS in chemistry from Southern Illinois University. She worked as a scientist in the Washington University School of Medicine, Department of Internal Medicine doing Proteomics research prior to joining Pfizer. As a Pfizer scientist, Amanda has guided formulation and process development efforts for a wide variety of biomolecules, including small proteins, monoclonal antibodies, conjugated proteins and DNA vaccines. Her project experience includes process development for a variety of novel delivery systems, including pre filled syringes, needle-less injection devices and particle mediated delivery systems as well as traditional sterile liquid and lyophilized presentations. Her responsibilities include leadership of project teams, driving technology innovation and leadership of scientific initiatives within the biotherapeutics formulation development group at Pfizer.
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Brian Lynch
Program Lead - Health Science & Technology, Immunization
BD Medical - Pharmaceutical Systems
Spanning several industries and product technology environments, Brian Lynch has over 20 years of marketing management experience. For the past five years, Brian has held roles of Senior Product Manager and Marketing Manager for BD Medical-Pharmaceutical Systems, focused on prefillable solutions for both the biotechnology and vaccine market segments. In his current role, Brian now leads a innovative program to develop and bring health science and technology research to various government, industry, healthcare, and patient organizations on the subject of best care options in vaccine preparation and administration.
Prior to joining BD, Brian worked for Stryker Orthopedics as a Strategic Marketing Manager, and, Innovative Brand Programs Manager, and prior to this held various marketing positions in the electronic materials and chemical industries.
Brian received a BS in Chemical Engineering from Lafayette College and an MBA from the Stern School of Business at NYU.
Suggested Attendees
VPs, Directors, Heads, Managers of: Pharmaceutical & Biotech companies Packaging Labeling Manufacturing
Expected Number of Attendees
MA
View Conference Website: 3rd Annual Pre-Filled Syringes Americas Conference
Contact
Name: Peter Barfoot
Email: peter.barfoot@bioportfolio.com
Tel.: +44 (0)1300 321501
URL: Website
Price of Attendance
US$2050
Brochure
Location
Boston
Boston
Boston
United States
MA 02210
