TO BOOK CALL: +44 (0) 20 7336 6100 \ www.visiongain.com/biosim ORGANISED BY MEDIA PARTNERS Strategic planning to maximize benefits in a complex regulatory and legal environment 29th – 31st October 2012, Visiongain Conference Centre, London UK 11th Annual Biosimilars UK KEY SPEAKERS • Jim Roach, SVP, Development and Chief Medical Officer, Momenta • Peter Pitts, President, CMPI • Cyrus Chowdhury, CEO & Managing Director, CB Partners • Fredrik Sundberg, Strategic Market Development Director GE Healthcare • Anjan Selz, CEO, Finox • Judith MacDonald, EU Regulatory lead for Biosimilars, Pfizer • Brian Healey, Associate Director, Global Product Development, PPD • James Harris, CEO, Healthcare Economics LLC SILVER SPONSOR GOLD SPONSOR
Transcript
To Book Call: +44 (0) 20 7336 6100 \ www.visiongain.com/biosim
Organised ByMedia Partners
Strategic planning to maximize benefits in a complex regulatory and legal environment
29th – 31st October 2012, Visiongain Conference Centre, London UK
11th Annual Biosimilars UK
KEY SPEAKERS
• Jim Roach, SVP, Development and Chief Medical Officer, Momenta
• Peter Pitts, President, CMPI
• Cyrus Chowdhury, CEO & Managing Director, CB Partners
• Fredrik Sundberg, Strategic Market Development Director GE Healthcare
• Anjan Selz, CEO, Finox
• Judith MacDonald, EU Regulatory lead for Biosimilars, Pfizer
• Brian Healey, Associate Director, Global Product Development, PPD
• James Harris, CEO, Healthcare Economics LLC
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11th Annual Biosimilars UKConference Introduction
Who Should AttEnd thiS confEREncE?Presidents, Chief Executives, Chief Scientific officers, Chief operating officers, Senior Vice Presidents, Vice Presidents, Heads, Senior Directors, Directors, Clinicians, Principal Scientists, Principal Investigators, Managers, Project/Team leaders in:
SPonSoRShiP And Exhibition oPPoRtunitiESThis event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: • Hosting a networking drinks reception • Taking an exhibition space at the conference • Advertising in the delegate documentation pack • Providing branded bags, pens, gifts, etc.If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 2nd Vaccine Research and Innovation Conference, please contact us:Damian Gorman, +44 (0)20 7549 9934 [email protected]
Dear Colleague,With a patent cliff looming in the future, the market for biological therapeutics is looking to undergo radical changes. Both producers of branded drugs and upstarts looking to meet the demand for cost-effective healthcare will be looking to find the best strategies and solutions to compete in this dynamic environment. It is more critical than ever to make sure your company’s plan to tackle the issues of litigation, pricing and reimbursement, regulatory approval and risk management meet the benchmarks set by industry leaders.
Following the huge success of our events in Boston and London, we plan to continue with an agenda that will bring together big pharma, regulatory bodies, CROs, CMOs and law firms to discuss and develop strategies for a challenging market.
Visiongain’s 11th Annual Biosimilars event will provide a unique networking event to boost your understanding of how to:
• Review the latest regulatory guidelines and understand how it will affect you and your competitors
• Assess the financial viability of manufacturing biosimilars and explore alternative pathways for approval
• Learn how to incorporate a patent portfolio strategy to prepare for the changing landscape
• Explore strategies to overcome legal issues to gain marketing approval
• Analyse preclinical and clinical challenges in proving interchangeability and patient safety
• Gain insight into the role the US and European market will have in developing biosimilars
• Investigate pricing and re-imbursement plans especially for meeting government healthcare demands
• Plan a pharmacovigilance framework to monitor patient safety
• Utilise a great networking opportunity with key players in the market
I look forward to meeting you at the conference.
Best regards,
Shahidul IslamConference Producer
Gold SPonSoR Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers’ success in research, development and production of
biotech and pharmaceutical drug therapies. Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science. Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 64 countries and pro forma 2009 revenues of $2.9 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada. For further information, please visit www.merckmillipore.com
SilVER SPonSoR United BioSource Corporation (UBC) is a global biopharmaceutical and medical device services organization of over 1200 staff members internationally that combines deep scientific knowledge with broad
execution expertise across the product lifecycle. Our focus is strategizing to identify, analyze and present real-world evidence to support the development and commercialization of medical products for emerging and established life science companies. We partner with our clients to meet their needs with experts to provide strategic planning; scientific leadership; extensive experience in peri- and post-approval research; clinical and strategic development services; data integrity and technology services; investigator and patient programs; and medical education, communication and market access programs. For further information, please visit www.unitedbiosource.com
MEdiA PARtnERSPharmiWeb.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: [email protected]
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 mains 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 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 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
11th Annual Biosimilars UKDay 1 / Thursday 30th October 2012
Fredrik Sundberg Strategic Market Development Director GE Healthcare
12:40 Networkinglunch
13:40 Managing the complexities in biosimilar development
• Overcoming hurdles from inception to submission
• Managing the evolving regulatory landscape
• Assessing the IP challenges
• Considering sourcing and partnering issues
Anjan Selz CEO Finoz AG
14:20 Immunogenicity issues with biosimilars
• The importance of immunogenicity issues
• Strategies and methods for detection of immunogenicity
• Update
15:00 AfternoonRefreshments
15:20 The challenge of discovering and developing biobetters – they had better be better!
• The challenge of discovering and developing “biobetters” is to translate modifications made in discovery to real clinical benefit
• Potential modifications engineered into a MAb or Fc fusion protein preclinically that may have potential impact on efficacy, safety, convenience, manufacturing, supply chain, cost, and/or patient compliance include modifications of Fc immune function activity, half-life, potency, formulation, stability, and route of administration
16:00 The Momenta approach to Developing Biosimilars and Potentially Interchangeable Biologics
Jim Roach SVP, Development and Chief Medical Officer Momenta
16:40 ClosingremarksfromtheChair
16:50 NetworkingDrinks
Takeyourdiscussionsfurtherandbuildnewrelationships in a relaxed and informal setting
Biosimilars and Follow-On Biologics: World Market 2012-2022What are the commercial prospects for biosimilar drugs? Visiongain’s report shows you potential revenues and trends to2022,discussingdata,opportunitiesandprospects.Thisstudyinvestigatesbiosimilars(follow-onbiologics).Itletsyouassessforecastedsalesatworldmarket,therapeuticsubmarketandnationallevelto2022.Thenewreportgivesyoucoverageofregulatoryaffairstoo-FDA,EMAandothers-assessingtrendsandoutlooksforbiosimilardrugs.
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11th Annual Biosimilars UKDay 2 / Friday 31st October 2012
Pharma Business DailyEachissueofPharmaBusinessDailynewsletterfocusesonlatestbreakingstoriesinyourmarket.Delivereddirectlyto your Inbox or available through the website, all the industry news is available to you all the time. When you want the news its there for you-itreallyisthatsimple.Over25+storieseverydayastheyhappen.Neveragainwillanyofyourcolleaguesbeawareofnewsthatyouaren’t.Plusexclusivefeaturesfromvisiongainconferencesandin-depthanalysisfromvisiongainanalystswillbeavailabletoyouthankstoyour subscription to PharmaBusinessDaily. This information is not available anywhere else. Call +44 (0)207 336 6100 or visit www.visiongain.com to sign up. N
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11th Annual Biosimilars UKRegistration Form
How to bookEmail: [email protected] Web: http://www.visiongain.com/biosim
UK Office:Tel: +44 (0) 20 7336 6100Fax: +44 (0) 20 7549 9932 Visiongain Ltd230 City Road LondonEC1V 2QYUK
General informationVenue: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.htmlTravelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain 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 right to charge interest on unpaid invoices.
Substitutions/name changes or cancellations: There is a 50% liability on all bookings once 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 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 change at any time, as long as we are informed in writing by email, fax or post. Name changes and 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.
Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made.
Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive 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 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 cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses.
Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data 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 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 send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com 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.
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).
VAT: VAT will be charged at the local rate on each conference. TaxPort USA Corp. specializes in recovering cross-border VAT. Delegates may be able to recover VAT incurred by contacting TaxPort USA Corp.on: Tel: USA 802.860.0250 or +1.888.298.8296, Europe +41(0)21 310 01 50 or via email on: [email protected], [email protected], [email protected]. For further information please check Terms and Conditions on the visiongin.com web site
How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you.
Unable to attendObviously 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.
