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5th Annual Contract Manufacturing (2011) Pp


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5th Annual Contract Manufacturing (2011) Pp

  1. 1. 5th Annual Contract ManufacturingExamining the best outsourcing practices, new technological developments and the latest regulatory issues 7th - 8th December 2011, Visiongain Conference Centre, London, UK BOOK NOW! Key Speakers Dr. Dieter Roethlisberger, Outsourcing Manager & Senior Scientist, F. Hoffmann La-Roche Peter Murray, Quality Director, External Supply Strategy, GlaxoSmithKline Martin P Grosvenor, Drug Delivery Manager, AstraZeneca Andrea Calenne, Sr. Manager, Contract Manufacturing, Biogen Idec Gaelle Gibbs, QA Manager, MAX Products and Strategic Vendors, UCB Pharma Sohail Chohan, Manufacturing Outsourcing Manager, Era Consulting Dr. Nigel Allison, Process Development Specialist, Health Protection Agency Philip Pratten, VP Manufacturing Services, Elan Pharmaceuticals Professor Nigel Titchener-Hooker, Head of Department and Director Biochemical Engineering, University College London Paul Ranson, Partner, Fasken Martineau LLP Jo Pisani, Consultant, PricewaterhouseCoopers Jan-Gunnar Gustafsson, Consultant, Bio-consulting Alan Harris, Partner, Alacrity Pharma Associates Dr. Steve Musgrave, Founding Partner, Unicorn Biologics Driving the Industry Forward | www.futurepharmaus.comMedia Partners Organised ByTo Book Call: +44 (0) 20 7336 6100 |
  2. 2. Conference Introduction 5th Annual Contract Manufacturing 7th - 8th December 2011, London, UK Dear Colleague, Media Partners: he importance and role of contract manufacturing has changed over the years from T is the leading industry-sponsored portal for solely providing efficiencies in cost, capacity and time-to-market, or a specific expertise the pharmaceutical sector. Supported by most of the leading not available in-house to unique, innovative, and state-of-the-art processes and pharmaceutical corporations, provides dynamic real-time news, features, production technology to the pharmaceutical industry. events listings and international jobs to industry professionals across Europe and the US. s more and more pharmaceutical companies are willing to outsource, the contract A For further information please email: manufacturing market continues to grow and is expected to reach $61.51bn in 2015 and $94.70bn by 20251 BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World isiongain’s Contract Manufacturing conference has grown from strength to strength V was founded in 2007 to provide the world’s biotech and pharma information and market in the last couple of years and now in its 5th year, the conference will address to make it universally accessible and useful for scientific and business processes. Its first every aspect of the outsourcing process from selecting an outsourcing partner to step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will tech-transfer through to regulatory frameworks, latest FDA contract manufacturing allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers legislation, and recent patent and safety issues. companies completed internet public relations, publication and marketing solutions. One of t this 2 day event the attendees will learn, debate, discuss and network with leaders A the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector and key professionals from the industry. in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit: Whether you are a service provider or a pharmaceutical company by Driving the Industry Forward | Future Pharmaceuticals has forged powerful relationships with key attending this conference you will: industry leaders to provide a platform for successful brand recognition, • ssess future outsourcing trends and manufacturing strategies with changing CMO A and for senior decision-makers to have the means to procure and plan implementation industry structure strategies based on the topics covered. Positioned to be an authoritative resource within top • ear about emerging business models H 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 • etermine the essential criteria for CMO selection and effective relationship D gap between the industries’ top issues and the solutions top-tier vendors can provide. management For further information please visit: • earn key success factors for establishing successful CMO partnerships with analysis L of the multi-step sourcing process for CMOs InPharm is the online platform for exclusive pharmaceutical • ain insight on future growth potential, regulatory frameworks, recent patent and G news, comment, contracts, services, jobs and events and is safety issues home to, Pharmafile and Pharmafocus. • dentify the latest FDA contract manufacturing legislation I For further information please visit: • valuate the major risks and challenges of contract manufacturing projects by E “Supporting the Industry through Communication” gaining insights into the potential downsides IPI was established to fill in the void for effective marketing and • nvestigate about costs :importance of tech-transfer/scale-up I communication between all stakeholders in the life sciences sector globally. Clients use us due to the extensive knowledge and reach we have built • iscover the outsourcing potential of India and China D up over the years with our Editor, Editorial Advisory board and market research. We • aximise opportunities as a consequence of PAT and QbD initiatives M give you links into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. In • eliver successful external manufacturing supply chain and planning D addition to our extensive reach in the Americas & Europe, we have established a strong presence in the Middle East, Latin America, Eastern Europe, Asia and Africa which are • uild new relationships with other key players in pharmaceutical and contract B becoming increasingly important to the way the industry is moving forwards in areas of manufacturing industry Research and Development, Trials, manufacturing and Technology Transfer. I look forward to meeting you at the conference For further information please visit: Best regards is an efficient, targeted and easy-to-use- “Web2.0”-tool for finding the right partners in the pharmaceutical industry worldwide. It saves time and costs in all (out)sourcing and business development processes, as it fascilitates and accelerates the searching process for appropriate business partners significantly. is particularly Sumita Sengupta advantageous for projects where a special service is (immediately) required or to offer capacities which are currently available. It is useful for services in all categories Conference Producer and stages of drug development including contract manufacturing, contract research, laboratory investigations, contractual testing, non-clinical and clinical research, active pharmaceutical ingredients, consulting, marketing, registration, in- and outlicensing etc. For further information please visit: Who will be there? VPs Directors, Heads, and Managers in: Directors, Heads of Department, Team Leaders and Scientists of: • Research and Development Sponsorship and exhibition opportunities • PAT This event offers a unique opportunity to meet and do business with some of the key • QbD • CMC players in the pharmaceutical and biotech industries. If you have a service or product to • Process Development & Optimisation • Process Science/ Analytics promote, you can do so at this event by: • Manufacturing • Hosting a networking drinks reception • Contracts & Outsourcing • Formulation • Taking an exhibition space at the conference • Quality Assurance/ Quality Control • Advertising in the delegate documentation pack • Operations • Strategic Alliances • Providing branded bags, pens, gifts, etc. • Compliance • Regulatory Affairs If you would like more information on the range of sponsorship or exhibition possibilities • Legal/ Patents for visiongains 5th Annual Contract Manufacturing Conference, please contact us: Pharmaceutical and Biotechnological Companies Contract Manufacturing Organisations (CMOs) Damian Gorman, +44 (0)20 7549 9934 Drug Regulators, Intellectual Property/Law Firms Academia, Government Bodies, Regulatory AffairsVisiongain’s report: Pharmaceutical contract manufacturing: industry and market prospects 2010-2025 1
  3. 3. Day 1 5th Annual Contract Manufacturing Wednesday 7th December 2011 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the Chair 13:40 Methods for rapid process characterisation in the successful translation of process technologies 09:40 To outsource or not - is it a solution for you? • Defining the strategic direction of the pharma company • Case studies of methods developed to allow fast process characterisation • Risks and benefits of outsourcing • Tools for effective scale up • Impact of outsourcing on marketplace and pharma company • Examples drawn from industry collaborations • Manufacture of commodity products • Manufacture of products using proprietary technologies Professor Nigel Titchener-Hooker Head of Department and Director, Biochemical Engineering • Assessing value benefits in cost, time and quality University College London Martin P. Grosvenor Drug Delivery Manager Astrazeneca 14:20 Timing API process route changes for optimum value • The importance of choosing the best route and process to an API 10:20 Optimal information flow and communication • ividing when, if at all, to change – chemistry involved, regulatory D structure when outsourcing clinical manufacturing aspects, costs and speed of manufacture of biotechnological drug products • Main communication structures and their dilemma • ifferences in approach between small and large pharma when D it comes to route change • Information flow and how to avoid communication gaps • How to avoid data graveyards by using shared workspaces • The role of CROs • Integration of non compatible data in overview tools • hy changing early development makes sound scientific and W • Milestone and payment tracking economic sense Dr. Dieter Roethlisberger Alan Harris Outsourcing Manager & Senior Scientist Partner F. Hoffmann La-Roche Alacrity Pharma Associates 11:00 Morning refreshments 15:00 Afternoon refreshments 11:20 Experience, expertise and enthusiasm - key success factors in winning and keeping the deal. • his talk will outline why these three key elements are most important in not T 15:20 Sponsor Spotlight Session only winning the deal but also maintaining your CMO supplier contracts T ake this unique opportunity to be a part of the conference • xperience – critical for a company handing over their drug commercial E theme, network, share ideas and provide an overview of your manufacture. Without a track-record in manufacturing product, it is near product/services to the audience. For more information please on impossible to gain a company’s trust. (cite example of EDT’s experience contact in solid oral manufacture, this experience which is more evident in established markets of Europe and US is also an important factor) • xpertise – as well as experience, having the right expertise to solve the E problem at hand, tech transfer skills paramount for seamless movement 16:00 Challenges of outsourcing biopharmaceutical into full scale production, also regulatory expertise very important, manufacturing particularly for smaller pharma clients • Unique features of biopharmaceuticals • nthusiasm – essential for getting through when problems do inevitably E arise, always looking at ways to improve the service to the client (OE • Key considerations in outsourcing biological medicines manufacture initiatives), essential in building relationship with clients Dr Steve Musgrave • any other factors that are a given such as good quality record, GMP M Founding Partner facilities, competitive pricing, health and safety record etc, but the 3E’s Unicorn Biologics are most important Philip Pratten VP Manufacturing Services 16:40 Closing remarks from the chair Elan Pharmaceuticals 12:00 Using the principles of QbD for outsourced late phase process validation 16:50 Networking drinks Sohail Chohan Take your discussions further and build new Manufacturing Outsourcing Manager relationships in a relaxed and informal setting Era Consulting 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
  4. 4. Day 2 5th Annual Contract Manufacturing Thursday 8th December 201109:00 Registration and refreshments 12:40 Networking lunch09:30 Opening address from the Chair 13:40 Contractual arrangements • Technology transfer09:40 Identifying and managing risks of contract manufacturing • IP rights • Understanding the concept of ‘risk’ • Liability issues • Key risks applicable to contract manufacturing Paul Ranson • Managing and modelling risks Partner Fasken Martineau LLP Peter Murray Quality Director, External Supply Strategy GlaxoSmithKline 14:20 Sponsor Spotlight Session10:20 Contract manufacturing: sharing the risk T ake this unique opportunity to be a part of the conference • Setting up the assignment covering: theme, network, share ideas and provide an overview of your - Deliverables product/services to the audience. For more information please contact - Economical - Regulatory • Small biotech vs. big CMO • How to create a win-win deal 15:00 Afternoon refreshments Jan-Gunnar Gustafsson Consultant Bio-consulting 15:20 Process technology transfer between the US and the UK – a case history11:00 Morning refreshments • Technology transfer at the HPA • ransfer of a vaccine manufacturing process from the US to the UK for T11:20 Evolution in contract manufacturing organisation CASE STUDY late stage process development management and risk management • Process verification at small-scale • hanges in contract manufacturing organisation management and C regulatory requirements • Scale-up and process improvement • Complexity in product supply chains • Post-development transfer of a “GMP-ready” process to a US CMO • Contract manufacturing organisation and risk management Dr Nigel Allison • Proactive risk management of new business development opportunities Process Development Specialist • daptation of the industry to the new risks with focus on patient safety A Health Protection Agency and regulatory requirements Gaelle Gibbs QA Manager MAX Products and Strategic Vendors 16:00 Supplying the future: how to develop effective UCB contract manufacturing relationships • n update on the trends impacting the pharma and life sciences industries A12:00 Auditing regulatory compliance within a contract manufacturing business scenario • review of current outsourcing trends A • ntroduction: what is regulatory compliance, Module 3, typical I • n outline of new business models for success A discrepancies and their origin Jo Pisani • ackground: contractual scenario, regulatory requirements, setting B Consultant of boundaries PWC • reliminary steps: defining an agenda for regulatory compliance audits P • udit execution: strategy and prioritisation of schedules A 16:40 Closing remarks from the chair • ollow-up: review of a CAPA/Remediation plan related to regulatory gaps F • onclusion C 16:50 End of Conference Andrea Calenne Sr. Manager, Contract Manufacturing Biogen Idec
  5. 5. Registration Form 5th Annual Contract Manufacturing 7th - 8th December 2011, London, UK Angel Conf. code PP Pentonville Road 5th Annual Contract CiStandard Prices ty Manufacturing Ro adConference only Fee: £1299 VAT: £259.80 Total: £1558.80 7th - 8th December 2011 Old Street Location: Visiongain Conference Centre Old StreetNumber of bookings: Total cost: Address: 230 City Road City Road LondonPromotional Literature Distribution EC1V 2TTDistribution of your company’s promotional literature to all conference attendees UK Fee: £999 VAT: £199.80 Total: £1198.80 How to bookDetails Email: Piyush.patel@visiongainglobal.comForename: Surname: Web: UK Office:Job Title: Company: Tel: +44 (0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd 230 City Road LondonAddress: EC1V 2QY UK General information Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Country: Postcode: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 Phone: Fax: 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 Email: 628 2503, Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once Methods of payment made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice Payment must be made in sterling must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences. However, if you cannot attend the conference, you may make a substitution/name By Mail: Complete and return your signed registration form together with your cheque payable change at any time, as long as we are informed in writing by email, fax or post. Name changes and to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK substitutions must be from the same company or organisation and are not transferable between countries. Please note that discounted delegates places at a visiongain event are non refundable.By Fax: Complete and fax your signed registration form with your credit card details Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, to +44 (0) 20 7549 9932 excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made.By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try By Bank Transfer: to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the Barclays Bank Sort Code: 20-71-64 cost of the registration, travel and expenses.Piccadilly Branch Account No: 6038 7118 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data 48 Regent Street Swift Code: BARC GB22 Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We London, W1B 5RA IBAN: GB80 BARC 20716460387118 may also share your data with external companies offering complementary products or services. If you wish for your details to be amended, suppressed or not passed on to any external third party, please Please debit my credit card: send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Access MasterCard Visa American Express EC1V 2QY. Alternatively, you can visit our website at and amend your details. Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect.Card number: Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain).Expiry Date: VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, Security number (last 3 digits on back of credit card): Eurocash specialise in recovering cross-border VAT. How we will contact you: Visiongain Ltd’s preferred method of communication is by email and Signature: phone. Please ensure that you complete the registration form in full so that we can contact you. Unable to attendCardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive speaker talks in PDFs two weeks after the event.News updates Yes, please send me speaker talks Price£550 VAT:£110 Total:£660Please tick if you do not want to receive email news updates in the future