"Manufacturing Sourcing Contract"
Register and pay by 9th April Presents The 3rd Annual 2010 and save up to £500 GlObAl PHARmACEUTiCAl CONTRACT mANUFACTURiNG 2010 GAiN CRUCiAl iNSiGHTS PRE-CONFERENCE WORKSHOPS: 28th June 2010 FROm 16 lEADiNG TWO-DAY CONFERENCE: 29th & 30th June 2010 PROFESSiONAlS iNClUDiNG: VENUE: CCT Venues, Canary Wharf, London Jim Browne, Director, Contract Manufacturing, Europe, GlaxoSmithKline Driving efficiency in your contract manufacturing Joaquin Santos, GPSG, Senior Director sourcing and management to ensure high quality External Manufacturing; EMEA Region, and timely supply Johnson and Johnson Béatrice Serckx-Poncin, Associate Avoid spiraling costs caused by production nightmares Director, Drug Product Industrial through enhancing your internal sourcing stategy to gain Strategy and CMO management, UCB full CMO compatability: PriceWaterhouseCoopers LLP and Kim Steffensen, Department Head Contract Manufacturing & Licensing, ProStraken discuss best practice in CMO sourcing and how you Novo Nordisk can reactively source when partnerships aren’t working Andrew McKerracher, Technical Ensure the patient gets a high quality product by setting firm Operations Director, ProStrakan quality agreements and KPI’s when working with a 3rd party: Richard Fazackley, Associate Director, Product Realisation, Eisai GlaxoSmithKline share their expertise and lessons learned Dr Ulrich Rumenapp, Head Biotech Mitigate your business risks when entering into contractual Projects, Bayer Schering Pharma AG agreements by effecting Legal Due diligence: Vischer discuss Maarten van Geffen, Senior Director CM&C, Movetis NV the common pitfalls that occur and how you can mitigate Ian Anderson, Director External contractually for any risk areas Network, Norgine Make sure your product is delivered on time and on budget Jan Gunner Gustafsson, Process by overcoming language, cultural and geographical barriers Development and Manufacturing Senior Vice President, Resistentia to create a tight cross-company team with the correct Peter Murray, Director, Operational relationship management strategies Quality, Europe Rx External Supply, GlaxoSmithKline Pre-Conference Workshops | 28th June 2010 Dr Richard Lucas, Bioprocess Workshop A | 10.00–13.00: Sourcing Strategies: Techniques to Help Specialist, Bioquell UK Ltd. You Find the Right Business Partner Johnathon Marshall, Director, Johnathon Marshall, Director, Pharmaceutical Operations Consulting, Pharmaceutical Operations Consulting, PriceWaterhouseCoopers LLP PriceWaterhouseCoopers LLP Stephen Barksfield, Pharmaceutical Operations Consultant, Stephen Barksfield, Pharmaceutical PriceWaterhouseCoopers LLP Operations Consultant, PriceWaterhouseCoopers LLP Workshop B | 14.00–17.00: Negotiating Contracts and Implementing Christian Wyss, Attorney at Law, Contractual Obligations Vischer Christian Wyss, Attorney at Law, Vischer Representative TBC, Osny Pharma An excellent process review of external manufacturing. Phil Thompson, Business Development Bruno Chetail, Merck Serono Director, Perrigo SESSION SPONSORS GOLD EXHIBITOR MEDIA PARTNERS EXHIBITORS TEl: +44 (0) 207 368 9373 FAX: +44 (0) 207 368 9377 EmAil: firstname.lastname@example.org PRE-CONFERENCE WORKSHOP DAY: mONDAY 28TH JUNE 2010 Workshop A | 10.00–13.00: Sourcing Strategies: Techniques to Help You Find the Right Business Partner With the contract manufacturing market constantly growing, and emerging companies offering new capabilities, it can sometimes be hard to ensure you are surveying and selecting the correct CMO for your needs. This workshop will give you the opportunity to discuss and address the challenges you are facing including: q Where to start: going from a needle in a haystack to a clear partner of choice that suits your needs W q hat to outsource and what to manufacture in-house: how can you make the correct decision every time? I q nternally formulating one strategy for sourcing across the business S q ourcing companies within emerging markets Johnathon Marshall, Director, Pharmaceutical Operations Consulting, PriceWaterhouseCoopers LLP Stephen Barksfield, Pharmaceutical Operations Consultant, PriceWaterhouseCoopers LLP Workshop B | 14.00–17.00: Negotiating Contracts and Implementing Contractual Obligations The effect of the decision to outsource a particular product manufacture has a knock-on effect on the entire business, so it is therefore crucial that the initial contract covers all bases, ensuring targets are constantly hit. This workshop will allow you to discuss some best practices the potential challenges when it comes to the legalities surrounding contract manufacturing partnerships as well as highlighting some of the legal pitfalls to avoid and how you can overcome major challenges. Topics to be discussed include: Good mix. Some great contacts & validation as to where q ecognising your needs and reflecting them in the negotiated contract R our sales message needs to be. q econciling contractual obligations and day-to-day business R Ross Errington, 3M M q anufacturing, supply, quality, and technology transfer case study examples It addressed a number of key issues Christian Wyss, Attorney at Law, Vischer (Basel, Switzerland) of relevance and had a good balance of topics. A valuable meeting. Paul Briner, Prosidion Ltd mEET YOUR CONFERENCE CHAiR Jim Browne is Director, Contract Manufacturing GlaxoSmithKline, based at GSK House in West London. He is a Chemist with an MSc and an MBA. Jim started his career in R&D with Beecham Pharmaceuticals working on product formulation and process development, before moving into New Product Development coordination. After ten years with Beecham he moved into production management with Roussel Laboratories, working his way up from Production Section Head to Manufacturing and Warehouse Manager. In 1987 he was recruited by Glaxo to set-up and manage their new Global Tablet Manufacturing Centre at Ware in UK. After five years he moved to Egypt as Site Director of the newly acquired Glaxo operation in Cairo. He subsequently took on responsibility for the Glaxo sites in Latin America, developing and implementing a strategy for site rationalisation and operational improvement, with the exit of two sites and refocusing of manufacturing and supply activities across the region. In 1996 he was appointed Area Supply Director, Eastern Europe with responsibility for the development of EE operations, which involved acquisition of a large pharmaceutical factory in Poland with subsequent managerial responsibility for restructuring and introduction of key Glaxo Welcome technologies, products and manufacturing standards. In 2001 Jim was appointed to his current role in GSK and has been instrumental in the introduction and implementation of Global External Sourcing Strategies for a range of dose forms, together with major investments in Contractors to support New and Specialist Product introductions. Web: www.pharmaceuticaliq.com Phone: 1-646-454-4559 Become a member of Pharma IQ and receive complimentary access to resourcesthat will keep you at the forefront of industry change. You will receive access to our growing library of multi-media presentations from industry leaders, an emailnewsletter updating you on new content that has been added, free aggregated news feed from over 1000 global news sources tracking your industry and special member only discounts on events. Become a member here:www.pharmaceuticaliq.com/IQLogin.aspx?IQ=pharma TEl: +44 (0) 207 368 9373 FAX: +44 (0) 207 368 9377 EmAil: email@example.com CONFERENCE DAY ONE: TUESDAY 29TH JUNE 2010 08.00 Coffee and Registration SUCCESSFUllY mONiTOR YOUR EXTERNAl mANUFACTURiNG bY CONSTRUCTiNG A 08.50 Pharma IQ Welcome and Chairman’s Opening Address REliAblE mANAGEmENT STRUCTURE AND Jim Browne, Director, Contract Manufacturing, Europe, RiSK miTiGATiON PlATFORm GlaxoSmithKline 13.30 Effective Management of External Supply: A Specialist EFFECTiVElY iNTERPRETiNG mARKET Pharma Perspective TRENDS AND FEEDiNG THiS iNTO YOUR q Learning points from implementing internal structures to CONTRACT mANUFACTURiNG STRATEGY manage 3rd parties 09.00 Successfully Planning Worldwide External q Major differences when working with 3rd parties within a Manufacturing Workforces: Delivering Organisational smaller pharmaceutical company vs... ‘’Big Pharma’’ Optimisation q Learning points from experiences related to improving q Understanding and accurately positioning the efficiency and effectiveness of 3rd party operations “globalisation” concept within manufacturing Ian Anderson, Director, External Network, M&S Business q Exploring how globalisation is still to arrive and in many Unit, Norgine cases a improbable scenario 14.15 Contract Manufacturing Network Risk Management: q Successfully finding the right granularity in geographical The UCB Story segmentation of suppliers q Identifying the risk parameters and setting up the risk q An overview of the external manufacturing outlook from methodology Janssen Cilag’s perspective q How the risk assessment was performed Joaquin Santos, GPSG, Senior Director External q Analysing the results and how these helped to put in Manufacturing; EMEA Region, Johnson and Johnson place a mitigation plan 09.45 Understanding the Macro Supply Chain Drivers and Béatrice Serckx-Poncin, Associate Director, Drug Product Their Impact on Your Business Model Industrial Strategy and CMO management, UCB q The blurring boundaries between traditional CMO and 15.00 Networking Coffee Break Pharma Company q The shift towards localisation of healthcare on the REAliSiNG THE POTENTiAl OF EmERGiNG asset base mARKETS WHilST PROTECTiNG YOUR q The patent cliff and the drive to release cash COmPANiES iP AND REPUTATiON Stephen Barksfield, Pharmaceutical Operations Consultant, PricewaterhouseCoopers LLP 15.30 Mitigating Against The Effect of “Lost in Translation”: Successfully Outsourcing in Emerging Markets 10.30 Contract Manufacturing: The GAIN Without the PAIN? q Is this still a viable option that will show financial benefits? q Is Outsourcing Manufacturing right for your business? q How to effectively plan and manage geo-separation issues q Does Contract Manufacturing really offer a “One Stop and cultural differences Shop”? q Risk mitigation strategies that can be employed to q The benefits of good Relationship Management provide a shield against failure q Essential criteria for success q Discussion of case study examples and lessons learned Phil Thompson, Business Development Director, Kim Steffensen, Director, Contract & Licence Manufacture, Perrigo Novo Nordisk 11.00 Networking Coffee Break bREAK-OUT DiSSCUSSiON SESSiON: TimE TO SHARE YOUR ViEWS AND bENCHmARK 11.00 Successful Sourcing Strategies for a Virtual AGAiNST OTHERS’ STRATEGiES Pharmaceutical Company 16.15 Break-Out Round Table Discussions q How in-licensing determines the shape of the external Participants will be able to choose between the different supply chain roundtables and spend 60 minutes discussing the points q The risks associated with managing this type of supply outlined below and how they can be mitigated q Using reactive sourcing to rationalise the CMO landscape q Discussion of case study examples and the lessons learned Andrew McKerracher, Technical Operations Director, A Outsourcing in Emerging Markets: The Risks and the Benefits Facilitator: Kim Steffensen, Director, Contract & Licence ProStrakan Manufacture, Novo Nordisk B Successful Sourcing Strategies: The Do’s and Don’ts 11.45 Facilitator: Stephen Barksfield, Pharmaceutical Operations Consultant, PricewaterhouseCoopers LLP C Maintaining the Product Quality when Outsourcing For further updates please visit www.gpcmevent.com Facilitator: Peter Murray, Director, Operational Quality, Europe Rx External Supply, GlaxoSmithKline 12.05 Networking Lunch Break 17.15 Chairperson’s Closing Remarks and End of Day One TEl: +44 (0) 207 368 9373 FAX: +44 (0) 207 368 9377 EmAil: firstname.lastname@example.org CONFERENCE DAY TWO: WEDNESDAY 30TH JUNE 2010 08.30 Coffee and Registration the challenges and the benefits q The importance of relationship management when working 08.50 Chairman’s Opening Remarks with 3rd party manufacturers; the challenges faced Jim Browne, Director, Contract Manufacturing, Europe, Dr Ulrich Rumenapp, Head Biotech Projects, Bayer GlaxoSmithKline Schering Pharma AG DAViD AND GOliATH: UNDERSTANDiNG THE 12.45 Networking Lunch Break FUNDAmENTAl DiFFERENCES iN APPROACH bY SmAll AND lARGE COmPANiES AND HOW SUCCESSFUllY OUTSOURCiNG AS A ViRTUAl bEST PRACTiCES COUlD bE SUCCESSFUllY COmPANY AND ENSURiNG CONSiTENT TRANSFERRED ACROSS QUAliTY iN YOUR PRODUCT 09.00 Outsourcing from a Different Vista: The Small Company 13.45 CMO’s and Virtual Pharmaceutical Companies: A Lean Approach and Beneficial Partnership Model q Assessing the importance of collaborations with 3rd q Outlining the virtual specialty pharmaceutical concept of parties for small and start-up companies Movetis NV and the use of 3rd parties across the entire q What tools can be transferred from a large Pharma approach? supply chain q Locating the correct CMO that is geared towards working q Outsourcing manufacturing as a virtual pharmaceutical specifically with smaller companies company: the challenges faced and the benefits reaped q Discussion of case study examples q Successfully managing a large external network with Richard Fazackley, Associate Director, Product limited in-house resource Realisation, Eisai q Highlighting a case study and the lessons learned Maarten van Geffen, Senior Director CM&C, Movetis NV 09.45 Selecting and Managing a Contractor Network for Large Pharma 14.30 Quality Management of Established 3rd Party Supply q Understanding the drivers for maintaining a contractor q Setting-up the agreement: definition of responsibilities network for big pharmaceutical companies and expectations in a quality agreement q The importance of network rationalisation q Effective management of change and deviation q Successful management structures for complex external q Stability monitoring: ensuring product performance does networks not change adversely with time Jim Browne, Director, Contract Manufacturing, Europe, q Regulatory interactions: definition and updating of GlaxoSmithKline market specific requirements q Management of incidents: complaints, recalls and alleged 10.30 Panel Discussion: Outlining the Similarities and Adverse Drug Events Difference Between Large and Small Pharma companies q Product/process review: the place of periodic product review Approach and Execution of External Supply Chains q The importance of audits in monitoring the overall q What lessons can be learned from each side of the fence? system of control q Assessing the different management models and Peter Murray, Director, Operational Quality, Europe Rx communication strategies used External Supply, GlaxoSmithKline q Relationship management: what is done differently and how can one company learn from another’s approach? 15.15 Networking Coffee Break Jim Browne, Director, Contract Manufacturing, Europe, PROTECTiNG YOUR iP RiGHTS WHEN GlaxoSmithKline OUTSOURCiNG AND iNTEGRATiNG EXTERNAl Jan-Gunnar Gustafsson, Senior Vice President, Process mANUFACTURiNG iNTO YOUR SUPPlY CHiAN Development and Manufactuirng, Resistentia Richard Fazackley, Associate Director, Product Realisation, 15.45 Protect Your Business By Avoiding the Legal Pitfalls Eisai When Working With Contract Manufacturers q Tackling the pitfalls associated with contract 11.00 Networking Coffee Break manufacturing from a legal stand point 11.30 Overcoming the Challenges of Outsourcing q Effectively ensuring the contract reflects your Biopharmaceutical and Biotechnology Products businesses true needs q Protecting product integrity via the integration of q Satisfying expectations of prospective buyers of your business biodecontamination solutions into process q Discussion of case study examples q How to minimise the risk of outsourcing through rapid, Christian Wyss, Attorney at Law, Vischer proactive biodecontamination between batches and campaigns 16.30 Avoiding Product Delays Through Planning and q An introduction to Bioquells novel Hydrogen Peroxide Executing Seamless Integration with the Supply Chain Vapour biodecontamination technology, insights into q Managing the integration for a 3rd party manufacturer efficacy, safety and regulatory compliance with you supply chain Dr Richard Lucas, Bioprocess Specialist, Bioquell UK Ltd. q Effective use of demand forecasting tools when working 12.00 Outlining the Unique Challenges that Occur When with CMO’s to supply demand Outsourcing Biotechnology Manufacturing q Outlining the challenges that can arise when integrating a q Discussion of the process and process complexity issues CMO into your supply chain and how you can overcome these that cause challenges in biotechnology outsourcing Jan-Gunnar Gustafsson, Senior Vice President, Process q Making the make or buy decision for biomanufacturing Development and Manufactuirng, Resistentia q Working with external partners for biotech production: 17.00 Chairman’s Closing Remarks and Close of Conference TEl: +44 (0) 207 368 9373 FAX: +44 (0) 207 368 9377 EmAil: email@example.com SPONSORS AND EXHibiTORS SESSION SPONSORS BIOQUELL are world leaders in the provision of bio-decontamination systems and services for pharmaceutical and biotechnology applications. BIOQUELL’s unique hydrogen peroxide vapour (HPV) process is capable of a reliable 6-log sporicidal reduction of bacteria, viruses and fungi from surfaces. The BIOQUELL HPV process is ‘residue-free’, safe, easily monitored, repeatable and fully compliant with regulated cGMP environments. This process is an effective alternative to outmoded formaldehyde or, inherently variable, manual cleaning methods. In the evolving risk-assessed environment, BIOQUELL HPV is effective at de-risking the critical disinfection process and can be easily applied to the disinfection of laboratories, complete buildings and process equipment. 52 Royce Close, West Portway, Andover, UK, SP10 3TS Tel: +44 (0)1264 835835 | Fax: +44 (0)1264 835836 | Email: firstname.lastname@example.org | Web: www.bioquell.com In partnership with major pharmaceutical, healthcare & grocery companies, Perrigo is the world’s largest manufacturer of OTC & Healthcare medicines for both branded & Private Label customers. For almost thirty years our UK-based business has worked with major European household names to provide affordable healthcare products in key OTC categories through successful contract manufacturing, product improvement and range extensions, with bespoke and in-house NPD and market-leading Regulatory strategies forming a stable foundation on which Perrigo and our customers can build mutually beneficial commercial relationships. UK manufacturing, backed by global sourcing of materials, bulks and finished products if appropriate, makes Perrigo the power behind your brands. GOLD EXHIBITOR OSNY Pharma offers integrated pharmaceutical services, from formulation to commercial manufacturing and packaging, focusing on highly-potent compounds. For over 30 years, our key differentiating factor has been our well-recognized expertise in handling compounds such as hormones, narcotics or oncology agents. We have developed an unparalleled range of specific skills and requirements such as preliminary risk assessment studies, dedicated facilities, dedicated equipments, and advanced EH&S policies. Tel: +33 1 34 20 44 20 Located 30 km NW of paris, we offer 4,000m2 of flexible manufacturing and development space, to be tailored to your specific needs: 17, rue de Pontoise, 95520 Osny - France | +33 1 34 20 44 20 | +33 1 34 20 44 75 | email@example.com EXHIBITORS LTS Lohmann Therapie-Systeme AG is a world class developer and manufacturer of transdermal systems, oral film drug delivery systems and adhesive laminates. We use leading edge technology to manufacture developed products on a large and cost effective commercial scale. LTS develops products from inception through commercialisation in our facilities in Germany and U.S.A. under GMP conditions, both approved by the FDA and European Authorities. Our partners include many of the world’s successful pharmaceutical, consumer healthcare, medical device and diagnostic companies. Our resources include: research & development, clinical pharmacology, technology transfer, analytical, regulatory affairs, quality assurance, operations and product support. LTS Lohmann Therapie-Systeme AG | Lohmannstr. 2 | D- 56626 Andernach | Tel.: +49 (0) 2632 99 - 2216 | Fax: +49 (0) 2632 99 - 2515 Patheon Inc. is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon’s services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi-solid and liquid forms. Patheon uses many innovative technologies including single-use disposables, Liquid-Filled Hard Capsules and a variety of modified release technologies. Patheon’s comprehensive range of fully integrated Pharmaceutical Development Services includes pre-formulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization. Patheon, with its integrated network, strives to ensure that customer products can be launched with confidence anywhere in the world. European Headquarters Patheon International AG | Lindenstrasse 14 | 6340 Baar | Switzerland | Tel: +41 41 766 25 80 www.PATHEON.com Why Now? What Does GPCM 2010 offer? With the pharmaceutical landscape evolving at a rapid rate and the number of This platform offers direct access in-licensed products having an impact on the external supply chain, companies to an elite audience of senior are leaning more and more towards contract manufacturing as a long term cost decision makers from department cutting exercise. heads to group leaders. The event is carefully structured Networking at the Event and designed to provide valuable Gain unparalleled networking opportunities, with a large number of senior opportunities for you to showcase decision makers through discussion sessions, extended breaks and critical case your capabilities and develop study presentations. You will spend critical face-to-face time with industry crucial new business relationships. experts and position your company as a leading innovator in the contract For sponsorship and exhibition opportunities contact sponsorship on +44 manufacturing arena. (0) 207 368 9373 or email firstname.lastname@example.org MEDIA PARTNERS TEl: +44 (0) 207 368 9373 FAX: +44 (0) 207 368 9377 EmAil: email@example.com Global Pharmaceutical Contract 3 WAYS TO REGISTER Manufacturing 2010 VENUE: CCT Venues Canary Wharf MAIN TWO-DAY CONFERENCE: 29th and 30th June 2010 PRE CONFERENCE WORKSHOP: 28th June 2010 Hotline: +44 (0)20 7368 9373 To speed registration, please provide the priority code located on the mailing label or in the box below. My registration code is #/R Fax: +44 (0)20 7368 9377 Please contact our database manager on +44(0) 207 368 9300 or at firstname.lastname@example.org quoting the registration code above to inform us of any changes or to remove your details. 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