CALL NOW FOR EARLY BIRD 2nd Prefilled DISCOUNTS Syringes Americas Examining the current market demand and developing safer, stable, cost-effective pre-filled syringes April 5th - 7th 2011, USA BOOK NOW! Key Speakers Dr.Ingrid Markovic,Expert Review Scientist , Food and Drug Administration Pankaj Paranjpe, Manager, R&D Operations, Bristol-Myers Squibb Jennifer Johns, Principal Packaging Engineer, Bristol-Myers Squibb Amanda Wolf, Scientist - Pharmaceutical Research and Development, Pfizer Crisanta Ransom, MS&T - Commercialization Technical Center, Eli Lilly Raul Soikes, Sr. Director Program Management, Baxter BioPharma Solutions Dr. Jan Jezek, Chief Scientific Officer, Arecor Jim Spolyar, Sales and Technical Director, SKAN US Stephen A. Barat, Director, Toxicology and Operations, Forest Research Institute Vinod Vilivalam, Director, West Pharmaceutical Dr. Arno Fries Director Product Management Tubular Glass, Gerresheimer Bünde Dr.Silke Conrad, Manager Regulatory Affairs, Ypsomed AG Patty Kiang, Consultant, Kiang Consultant Services Pre-conference Workshop, Tuesday April 5th 2011 Develop syringe materials and components that minimize and eliminate: contamination from leachables and extractables Led by: Dr. Patty Kiang, PhD, Consultant, Kiang Consultant ServicesAssociate Sponsor Organised By Driving the Industry Forward | www.futurepharmaus.comMedia Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pfsamericas
Conference Introduction 2nd Prefilled Syringes Americas April 5th - 7th 2011, USA Dear Colleague, ontinuous growth in vaccines, blood stimulants, therapeutic proteins, C Poster Presentation erythroproteins, interferons and rheumatoid arthritis has driven the growth of pre- filled syringes market At a busy conference it is hard to make sure everyone who ith promising growth of 10-15% per annum, there were 2 billion pre-filled syringe W shares your interests knows what you are doing. Maximise units sold in 2009 alone and expected to continue reaching 3.64bn units in 2015 your time at Visiongain’s 2nd Prefilled syringes Americas and 6.83bn by 20251. meeting by sharing your results in a poster presentation. afety, stability, convenience and cost-effectiveness are main factors driving growth S With a plethora of key decision makers, take advantage of of the pre-filled syringes market. Prefilled syringe manufacturers have had to therefore respond to increasing demand, new requirements and more sophisticated this senior networking opportunity. forms of drug delivery. Please send your 200 word abstract, in English, to: ollowing the success of visiongain’s previous pre-filled syringes conferences, we are F email@example.com for approval. The deadline proud to present the 2nd Pre-filled Syringes Americas conference. for submissions is Monday, March 21st, 2011. Please include t this global event of pre-filled syringes, meet industry leaders from around the A contact details for the corresponding author(s). world to discuss every aspect of pre-filled syringes market from technological needs, design to safety and quality through to regulatory issues. Spend three days in Academic institutions will not be charged a fee if booked as partnering; participate in special panel discussions and evening networking drinks. full-price delegates. Posters submitted by pharmaceutical tay ahead of competition by learning about the latest developments on S and biotechnology firms will be charged a fee of £199. technological advances in design, component materials, process engineering, siliconisation, dosage accuracy, auto-injections, quality, safety and regulatory issues. Posters submitted by service providers / vendors are welcome and will be subject to evaluation. Upon By attending this conference, you will: approval a fee of £500 will apply. Two delegates from • ear about new technological developments and changing market scenario H your organisation must be booked at full price to present • nderstand pharmaceutical industry expectations from manufacturers of pre- U a poster. fillable syringes • earn about recent achievements and trends for formulation and delivery of L Please note that all posters will be displayed at the protein pharmaceuticals, vaccines and blood stimulant drugs discretion of Visiongain Ltd and are subject to approval. • ain insight about developments in the areas of component materials, surface G Due to limited space, please register your interest early. treatments and filling processing and packaging • vercome challenges in prefilled syringes design, liquid viscosity, injection speed/ O flow rate, needle inner diameter, needle length etc • xplore auto-injection devices: convenience items, or a key component of E Who will attend? injectable products • ptimize siliconization with regard to product requirements, autoinjector O Vice/Presidents, Directors, Heads of: compatibility, general syringe performance • Packaging • iscover about applications & advantages of bubble-free filling for today’s D parenteral products • Labelling • evelop syringe materials and components that minimize and eliminate: D contamination from leachables and extractables • Manufacturing • tay ahead by learning about Ingenious advanced labelling technologies, including S • Product design peel off tabs and radio frequency transmitters, to increase product safety and security • Technical support • eview current state of art and future technological developments in the field of R • Drug product process development RABS, isolators, e-beam and alternatives • xamine factors and recent developments in processing syringe nests E • Drug device process development • valuate benefits and challenges of outsourcing E • Pharmaceutical sciences • ssess the impact of new post-market surveillance regulations on pre-filled A medical devices • Safe medication practice • btain the latest market analysis, and meet manufacturers showcasing their O • Drug discovery & delivery leading products • Strategic alliances I look forward to meeting you at the conference • Clinical product resourcing Best regards • Supply outsourcing • Contract management • Process development Sonia Tomar • Investment and venture capital Conference Producer 1 Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025
Pre-Conference Interactive Workshop 2nd Prefilled Syringes Americas Tuesday April 5th 2011 Develop syringe materials and components that minimize and eliminate: contamination from leachables and extractables Led by: Dr. Patty Kiang Timings: 9:30 - 10:00 Coffee & Registration 0 Consultant 10:00 - 17:00 Workshop Kiang Consultant Services T iming includes lunch and refreshment breaks Workshop Agenda: About your workshop leader: The objective of this workshop is to provide the information Dr. Patty Kiang of critical factors which will impact the success of the prefilled Patty H Kiang, Ph.D. is a Pharmaceutical Consultant on syringe development. The material composition, component / Pharmaceutical packaging and delivery devices for liquid and lyophilized products, Prefilled syringe system, and CMC filing device design, manufacturing and sterilization processes are for Combination Products. all the important factors which will impact the extractables Prior to the consultant position, she was Account Director for Catalent Pharma and leachables from the syringe system. Improved glass syringe Solutions; she was responsible for business development of Analytical & Biotech operation and COC resin or Daikyo CZ resin syringes plus Services to Biotech and Pharmaceutical companies on the West Coast of USA, Canada and Asia pacific territory. Fluorocarbon film laminated plungers have demonstrated the She was Head of Device Development for Genentech Inc. in South San Francisco, reduction of contamination from extractables and leachables will CA. She was responsible for the development of a new autopen injector for be discussed in the workshop Growth Hormone; she was also responsible for setting up the Extractable / Leachable program for evaluation of primary container/closure systems and was a CMC leader for a prefilled syringe drug development. Prior to joining Genentech, she was Director, Delivery Device and Packaging Support for N EW Schering Plough, in Kenilworth, NJ. She was responsible for the development RE Pre-Filled Syringes and Related Systems: of PEG-Interferon dual chamber pen injector and various delivery devices. Prior PO World Market Outlook 2010-2025 RT to joining Schering Plough, she was Director of Technology Development for – how will rising demand and technological West Pharmaceutical Services in Lionville, PA, a developer and manufacturer of developments create opportunities? parental drug packaging components, where she coordinated with corporate The market for pre-filled syringes has achieved growth partners in Japan and Germany in the development of various new products. in recent years. In 2009, an estimated 2 billion pre- filled syringe units were sold and the market for that She was a member of the faculty of the PDA’s Training and Research Institute, technology was estimated to be worth up to $2.5 where she taught courses on Parenteral Packaging, and served as a member billion. There is a trend towards pre-filled drug injection of USP’s Expert Committee on Drug Packaging, Storage and Distribution. She systems, away from vials/ampules, for both new and existing products. Examples are filled glass and plastic was the chairperson for PDA Gamma Radiation Sterilization of Polymeric syringes, pens and low-volume auto-injection devices, Materials Committee. She is an expert in the area of drug and container/closure including refills. That sector has shown growth of interactions and compability issues. 10-15% in recent years, forming one of the fastest- expanding sectors in the pharmaceutical industry. In our She is a frequent speaker and has chaired many symposia on the packaging of new report, we predict that the pre-filled drug delivery pharmaceutical and biotechnology derived products. Most recently she chaired market will grow steadily from 2010, as the number of products launched in pre-filled injectable forms the PDA 2006 Global Prefilled Syringe & Injection Device Conference. Dr. Kiang increases. Medical professionals, patients and other holds five patents in the field of polymeric surface coatings. She received a Ph.D. in stakeholders see the benefits of that more-convenient Analytical Chemistry from Villanova University and holds an MBA from Pennsylvania system, raising demand at the expense of older formats. State University.
Day 1 2nd Prefilled Syringes Americas Wednesday April 6th 2011 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the chair 13:40 Overview of drug delivery devices for pre-filled Pankaj Paranjpe syringe products Bristol-Myers Squibb • User Benefit • A new generation of device and compromises in device design Jennifer Johns • Aseptic pre-filled drug-delivery systems Bristol-Myers Squibb • Future opportunities 09:40 Update on pre-filled syringes: trends, materials, 14:20 Sponsor Spotlight Session components, processes and quality T ake this unique opportunity to be a part of the conference theme, • Market dynamics and trends network, share ideas and provide an overview of your product/services • New syringe materials to the audience. • Value added components For more information please contact firstname.lastname@example.org • Syringes for biotech drugs • Quality aspects Dr. Arno Fries 15:00 Afternoon Refreshments Director Product Management Tubular Glass Gerresheimer 15:20 Panel discussion: New technological developments and changing market scenario 10:20 Recent trends in the application of plastic prefillable P anlists will discuss the market trends and emerging requirements, latest syringe systems for biopharmaceutical drug delivery developments in all areas of pre-filled syringe product development; from • yclic olefin polymers: properties, applications and commercial drug products C formulation to manufacturing, considerations for component and system • ecent trends in the use of newer plastics for delivering mAbs, R selection, supplier role in quality for any questions or participation please proteins and vaccines contact email@example.com • olve challenges associated with glass prefilled syringes, including S breakage reactivity and leachables like silicone, tungsten and glue • arket and scientific needs for plastic prefillable syringes for M biopharmaceutical drugs and high viscosity formulations 16:00 Advanced formulations of biologics • lastic vials for break resistant, less reactive and cold temperature P • Stability of biologics storage/transport containers for biologics and stem cells • Stable aqueous formulations for pre-filled syringes • Reduced rate of aggregation Vinod Vilivalam • High concentrations of antibodies Director • Terminal sterilization by gamma radiation or e-beam West Pharmaceutical Dr. Jan Jezek Chief Scientific Officer Arecor Limited 11:00 Morning refreshments 16:40 Closing remarks from the chair 11:20 Rational selection of primary packaging components for pre-filled syringe products • Primary packaging components • Packaging and drug delivery trends 16:50 Networking Drinks • Developing primary and critical secondary packaging components Take your discussions further and build new relationships in a relaxed and informal setting. 12:00 Fill-finish for prefilled syringes in a contract manufacturing setting with the following emphasis N EW • lient Teams dedicated to your product – relentless focus on your product C Pharma Business Daily SL by knowledgeable individuals ET Each issue of Pharma Business Daily newsletter focuses on latest • etrics to drive performance – leading indicating metrics; tangible output M TE breaking stories in your market. Delivered directly to your Inbox or R translating to a timely deliverable available through the website, all the industry news is available to you • CMO-Client partnership – conclusion highlighting best practices all the time. When you want the news its there for you - it really is that simple. Over 25+ stories everyday as they happen. Never again will any Raul Soikes of your colleagues be aware of news that you aren’t. Sr. Director Program Management Plus exclusive features from visiongain conferences and in-depth Baxter BioPharma Solutions analysis from visiongain analysts will be available to you thanks to your subscription to PharmaBusinessDaily. This information is not available anywhere else. Call +44 (0)207 336 6100 or visit www.visiongain.com to sign up. Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
Day 2 2nd Prefilled Syringes Americas Thursday April 7th 2011 09:00 Registration and refreshments 13:40 Pre-filled syringe processing with RABS, Isolators, E-beam & Alternatives • Isolator technology with latest E-Beam design features 09:30 Opening address from the chair • Comparison of RABS vs Isolators • Alternative tub entry system for slow speed production • Expansion of the areas of application of syringe technology Jim Spolyar 09:40 Extractables and leachables in pre-filled syringes Sales and Technical Director Dr. Ingrid Markovic SKAN US Expert Review Scientist Food and Drug Administration 14:20 Processing solutions for pre-filled syringes from conditioning to aseptic filling and final assembly 10:20 How to select syringe components - Minimize • yringe conditioning including the processing steps washing, silicone S potential extractables and leachables coating, needle or needle shield assembly, nesting and packaging • Tips to establish user requirements - Special topic: Features and challenges of the silicone coating process • Examples of extractable/leachable failure modes experienced by industry • n-line washing and sterilizing solutions (for syringes without a glued-in needle) I • Risk based approach in evaluating extractables/leachables - pecial topic: Sterilizing tunnel for syringes with non-glass-to-glass S • trategy for selecting syringe components used for different drug products S contact transport system and coming from various sources • septic filling including the processing steps debagging, delidding, filling A and closing Crisanta Ransom, Ph.D. - pecial topic: Vacuum filling and closing as well as in-process control S MS&T - Commercialization Technical Center (IPC) capabilities Eli Lilly and Company • ssembly including the processing steps denesting, plunger rod assembly, A labeling, safety device assembly - Special topic: Needle protection labels and safety devices 11:00 Morning refreshments Markus K. Hoersch Technical Sales Manager BAUSCH + STROEBEL 11:20 Toxicological risk assessment of leachable substances from container-closure systems • eneral background on leachables from container-closure systems G 15:00 Regulatory issues relating to combination products • egulatory expectations for the safety assessment of R with delivery devices leachable substances • Definition of “combination product” • Current approaches to evaluate the potential for safety concerns • Regulatory paths for combination products / Primary Mode of Action • orking examples to demonstrate how to conduct a W • eCTD content planning for combination products with delivery devices toxicological assessment • hallenges in eCTD content planning for combination products with C delivery devices Stephen A. Barat, Ph.D. Director, Toxicology and Operations Dr. Silke Conrad Forest Research Institute Manager Regulatory Affairs Ypsomed AG 12:00 Practical considerations for shipment of pre filled 15:20 Afternoon refreshments syringes and experimental approaches taken • Overview on practical consideration for shipment • Shipping and handling charges • Current practices in shipping and handling 16:00 Panel discussion: Evaluate benefits and challenges of outsourcing Amanda Wolf Panelists will assess the importance of pharma-device alliances and design Scientist partnerships on pre-filled syringe products, discuss how to make most of the Pfizer partnership with contract manufacturers for any questions or participation please contact firstname.lastname@example.org 12:40 Networking lunch 16:40 Chair’s closing remarks 16:50 End of Conference
Partners 2nd Prefilled Syringes Americas April 5th - 7th 2011, USA Associate Sponsor: The BAUSCH + STROEBEL product range specializes Sponsorship and exhibition opportunities: in machines for pharmaceutical primary packaging, including equipment for washing, sterilizing / This event offers a unique opportunity to meet and do business depyrogenating, filling, closing and labeling of containers such as ampoules, cartridges, disposable syringes, vials and bottles of all kinds. Our systems are with some of the key players in the pharmaceutical and biotech designed to comply with the latest FDA and GMP requirements and are available for all capacity ranges, starting from laboratory testing and clinical batches to fully industries. If you have a service or product to promote, you can integrated commercial production. With more than 40 years of experience and over 10,000 machines delivered BAUSCH + STROEBEL is a leading manufacturer of high- do so at this event by: quality equipment for the pharmaceutical industry. For further information please visit: www.bausch-stroebel.com • Hosting a networking drinks reception Optima Group pharma is comprised of the trademarks Inova, Klee, Kugler and effective January 1, 2011 Metall + Plastic. First-class • Taking an exhibition space at the conference pharmaceutical filling, closing and freeze-drying now united with isolator technology. Optima Group pharma manufactures • Advertising in the delegate documentation pack cGMP compliant standard and custom filling, closing, processing, freeze drying and isolator equipment for the pharmaceutical industry. Offering • Providing branded bags, pens, gifts, etc. an immensely diversified and innovate range of solutions. We do believe: Optima Group pharma is your ideal partner – also for the efficient and precise realization of If you would like more information on the range of complex turnkey projects. For further information please visit: www.optima-packaging-group.de sponsorship or exhibition possibilities for visiongains SCHOTT forma vitrum is one of the world’s leading suppliers 2nd Prefilled Syringes Americas Conference, of parenteral packaging for the pharmaceutical industry. More than 600 production lines in 14 countries worldwide please contact us. produce 7 billion syringes, vials, ampoules, cartridges and special articles made of tubing glass or polymer. Excellent raw materials, state-of- the art manufacturing, the use of the latest technologies, continuous research and Ronald Magali, +44 (0)20 7549 9934 development enable innovative product solutions that meet our customers‘ stringent demands. The back-up possibilities offered by our production sites situated all over email@example.com the world provide flexibility, reliability and security to our partners. For further information please visit: www.schott.com Media Partners: 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. About visiongain: For further information please email: firstname.lastname@example.org Visiongain is a specialist business information company focused on BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY providing cutting edge products and services across the Pharmaceutical/ WORLD. It is based and located in Warsaw, Poland. Biotech, Telecommunications, Defence and Finance sectors, which Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful include reports, conferences, online daily news and offline news 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 analysis and bespoke consultancy. With a commitment to innovation information in different channels. BIOTECHNOLOGY EUROPE offers companies and excellence, visiongain offers flexible solutions to meet our clients’ completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma business intelligence needs, providing the right information at the Sector in Europe to global biotechnology, pharmaceutical and life science activities. right time to facilitate the commercial decision-making process. Our For further information please visit www.biotechnology-europe.com pharmaceutical products include Pharma Business Daily, the leading InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is daily email newsletter for the pharmaceutical, biotech and healthcare home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com industries, and a range of independent, high-quality, in-depth reports Future Pharmaceuticals has forged powerful relationships Driving the Industry Forward | www.futurepharmaus.com covering focused and topical areas of concern. Our pharmaceutical with key industry leaders to provide a platform for successful conferences address the hottest commercial, regulatory and technical 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 topics and provide an ideal forum for debate and networking for authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration pharmaceutical professionals from around the world. into a highly targeted and responsive audience, bridging the gap between the For further information, please visit: www.visiongain.com industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: www.futurepharmaus.com
Registration Form 2nd Prefilled Syringes Americas April 5th - 7th 2011, USA Conf. code VG Standard Prices Conference and workshop Fee: £1699 (USD* 2629) 2nd Prefilled Conference only Workshop only Fee: Fee: £1299 £599 (USD* 2010) (USD* 927) Syringes Americas Number of bookings: Total cost: April 5th - 7th 2011 *USD price is estimate only USA Promotional Literature Distribution Distribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £199.80 Total: £1198.80 How to book Details Email: email@example.com Forename: Surname: Web: http://www.visiongain.com/pfsamericas UK Office: Job Title: Company: Tel: +44(0) 20 7336 6100 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd BSG House 226-236 City Road Address: London EC1V 2QY UK General information Country: Postcode: Venue: TBA, USA Payment terms: Visiongain require the full amount to be paid before the conference. 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