11th Annual Biosimilars Uk (2012)


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11th Annual Biosimilars Uk (2012)

  1. 1. 11th Annual Biosimilars UK Strategic planning to maximize benefits in a complex regulatory and legal environment 29th – 31st October 2012, Visiongain Conference Centre, London UK KEY SPEAKERS • im Roach, SVP, Development and Chief Medical Officer, Momenta J • 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 GOLD SPONSOR SILVER SPONSORMedia Partners Organised ByTo Book Call: +44 (0) 20 7336 6100 www.visiongain.com/biosim
  2. 2. 11th Annual Biosimilars UK GOLD SPONSOR Merck Millipore is the Life Science division of Merck KGaA ofConference Introduction 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 MilliporeDear Colleague, operates as EMD Millipore in the U.S. and Canada.With a patent cliff looming in the future, the market for biological therapeutics is looking to undergo radical For further information, please visit www.merckmillipore.comchanges. Both producers of branded drugs and upstarts looking to meet the demand for cost-effective healthcarewill be looking to find the best strategies and solutions to compete in this dynamic environment. It is morecritical than ever to make sure your company’s plan to tackle the issues of litigation, pricing and reimbursement, SILVER SPONSORregulatory approval and risk management meet the benchmarks set by industry leaders. United BioSource Corporation (UBC) is a global biopharmaceutical and medical device services organization of over 1200 staff members internationallyFollowing the huge success of our events in Boston and London, we plan to continue with an agenda that will that combines deep scientific knowledge with broadbring together big pharma, regulatory bodies, CROs, CMOs and law firms to discuss and develop strategies for a execution expertise across the product lifecycle. Our focus is strategizing tochallenging market. 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 provideVisiongain’s 11th Annual Biosimilars event will provide a unique networking event to boost your understanding strategic planning; scientific leadership; extensive experience in peri- and post-of how to: approval research; clinical and strategic development services; data integrity and technology services; investigator and patient programs; and medical education,• Review the latest regulatory guidelines and understand how it will affect you and your competitors communication and market access programs.• Assess the financial viability of manufacturing biosimilars and explore alternative pathways for approval For further information, please visit www.unitedbiosource.com• Learn how to incorporate a patent portfolio strategy to prepare for the changing landscape• Explore strategies to overcome legal issues to gain marketing approval MEDIA PARTNERS• Analyse preclinical and clinical challenges in proving interchangeability and patient safety PharmiWeb.com is the leading industry-sponsored• Gain insight into the role the US and European market will have in developing biosimilars portal for the pharmaceutical sector. Supported by• Investigate pricing and re-imbursement plans especially for meeting government healthcare demands most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to• Plan a pharmacovigilance framework to monitor patient safety industry professionals across Europe and the US.• Utilise a great networking opportunity with key players in the market For further information please email: corporate@pharmiweb.com BIOTECHNOLOGY EUROPE is owned byI look forward to meeting you at the conference. BIOTECHNOLOGY WORLD. It is based and located inBest regards, 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.Shahidul Islam BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals ofConference Producer 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 forWho should attend this conference? successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topicsPresidents, Chief Executives, Chief Scientific Officers, Chief Operating covered. Positioned to be an authoritative resource within top pharmaOfficers, Senior Vice Presidents, Vice Presidents, Heads, Senior Directors, companies as well as small, specialty, and biotech, Future PharmaceuticalsDirectors, Clinicians, Principal Scientists, Principal Investigators, Managers, magazine is geared to create a deep penetration into a highly targeted andProject/Team Leaders in: responsive audience, bridging the gap between the industries’ top issues and• Biosimilars/Follow-on Biologics/ • Patent Law the solutions top-tier vendors can provide. Follow-on Proteins For further information please visit: www.futurepharmaus.com • Regulatory Compliance• Biologics/Biopharmaceuticals/ • Health Economics InPharm is the online platform for exclusive Biogenerics/Biotechnology pharmaceutical news, comment, contracts, • Pricing and Reimbursement• Clinical Immunology services, jobs and events and is home to InPharmjobs.com, Pharmafile and • Marketing and Sales Pharmafocus.• Drug Safety • Branded and Generic For further information please visit: www.inpharm.com• Patient Safety Pharmaceutical Companies• Regulatory Affairs• Quality Assurance/Quality • Contract Research Organisations/ Contract Manufacturing Sponsorship and exhibition Control• Scientific Affairs Organisations opportunities • Drug Regulators This event offers a unique opportunity to meet and do business with some• Pharmacovigilance • Academics of the key players in the pharmaceutical and biotech industries. If you have a• Research and Development • Government service or product to promote, you can do so at this event by:• Process Science & Manufacturing • Contract management • Hosting a networking drinks reception• Analytical Characterization • Taking an exhibition space at the conference• Business Development • Process development • Advertising in the delegate documentation pack• New Product Development • Business development • Providing branded bags, pens, gifts, etc.• Commercial Affairs • Drug discovery & delivery If you would like more information on the range of sponsorship or exhibition• Legal Affairs • Patent law possibilities for visiongains 2nd Vaccine Research and Innovation Conference,• Intellectual Property • Investment and venture capital please contact us: Damian Gorman, +44 (0)20 7549 9934 damian.gorman@visiongainglobal.com
  3. 3. 11th Annual Biosimilars UKDay 1 / Thursday 30th October 201209:00 Registration and refreshments 13:40 Managing the complexities in biosimilar development • Overcoming hurdles from inception to submission09:30 Opening address from the Chair • Managing the evolving regulatory landscape • Assessing the IP challenges09:40 Clinical challenges with development of biologics • Considering sourcing and partnering issues • Biologics are complex molecules and challenges with manufacturing will be highlighted Anjan Selz CEO • Clinical trial design and complexity will be discussed Finoz AG • Issues with extrapolation and interchangeability will discussed with regard to biosimilar drug development 14:20 Immunogenicity issues with biosimilars • The importance of immunogenicity issues10:20 How to operationalize biosimilar product development • Strategies and methods for detection of immunogenicity • Addressing regulatory hurdles • Update • Efficient study designs to reduce patient enrollment requirements • Managing the specific clinical development environment for biosimilars 15:00 Afternoon Refreshments • Developing practical strategies for conducting clinical trials with biosimilars 15:20 The challenge of discovering and developing Brian Healey biobetters – they had better be better! Associate Director, Global Product Development • The challenge of discovering and developing “biobetters” is to translate PPD modifications made in discovery to real clinical benefit • Potential modifications engineered into a MAb or Fc fusion protein11:00 Morning refreshments 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-11:20 Biosimilars in the Age of Post-Patent Medicine life, potency, formulation, stability, and route of administration • How will the thorny issues of safety, efficacy and cost (and in that order) impact the role of biosimilars in 21st century healthcare 16:00 The Momenta Approach to Developing Biosimilars • What are the top 10 issues for regulators? and Potentially Interchangeable Biologics Peter Pitts Jim Roach President SVP, Development and Chief Medical Officer CMPI Momenta12:00 Using Innovative Protein Analytics to Characterize 16:40 Closing remarks from the Chair Biosimilars Fredrik Sundberg 16:50 Networking Drinks Strategic Market Development Director GE Healthcare T ake your discussions further and build new relationships in a relaxed and informal setting12:40 Networking lunchBiosimilars and Follow-On Biologics: World Market 2012-2022 REPORTWhat are the commercial prospects for biosimilar drugs? Visiongain’s report shows you potential revenues and trendsto 2022, discussing data, opportunities and prospects. This study investigates biosimilars (follow-on biologics). It letsyou assess forecasted sales at world market, therapeutic submarket and national level to 2022. The new report givesyou coverage of regulatory affairs too - FDA, EMA and others - assessing trends and outlooks for biosimilar drugs. Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers © Copyright visiongain Ltd, 2012
  4. 4. 11th Annual Biosimilars UKDay 2 / Friday 31st October 201209:00 Registration and refreshments 12:40 Networking Lunch09:30 Opening address from the chair 13:40 Biosimilar IP issues in Europe • Freedom to operate issues and confronting patents with broad09:40 Biosimilar Regulatory Policy: Current Issues and protection-pitfalls and tips thinking • Supplementary Protection Certificates and biosimilars – unresolved Judith MacDonald issues EU Regulatory lead for Biosimilars Pfizer 14:20 Licensing of biosimilars10:20 Biosimilars - beyond the injection • Experience to date in the EU • The existing “Biologic Experience” • Regulatory requirements and guidance • What Biosimilar manufacturers will likely need to do in order to provide • Scientific advice a optimal patient experience • Future biosimilar products11:00 Morning refreshments 15:00 Afternoon refreshments11:20 Biosimilars: delivering on global commercial potential in the emerging markets 15:20 New developments in the regulation of biosimilars • Which biologic therapies carry the greatest competitive pressures and in the US and EU why? • How are some of these competitive pressures relieved by environmental • Basic framework opportunities unique to the emerging markets? • Regulatory standards • Which emerging markets represent the greatest commercial opportunity • Latest developments in the US, EU and ROW for biosimilars and why? • What are the funding opportunities for biosimilars within the emerging markets? 16:00 Uptake of biosimilars in clinical practice • What are the pricing and market access challenges associated with • What do doctors know about biosimilars? biosimilars within these markets? Cyrus Chowdhury • What are the obstacles to increased use? CEO Managing Director • What do we know about prices on biosimilars? CB Partners • Who shall decide which drug to use?12:00 Opportunities and challenges for biosimilars in the global market 16:40 Chair’s closing remarks • Assessing the promise and potential for biosimilars • Latest progress in biosimilars development 16:50 End of Conference • Regulatory update on bioequivalence, interchangeability and substitution for biosimilars • Provider perspectives and acceptance of biosimilars • Payer perspectives and formulary acceptance • Examining the viability of biosimilars ROI considerations James Harris CEO Healthcare Economics LLCPharma Business Daily NEWSLETTEREach issue of Pharma Business Daily newsletter focuses on latest breaking stories in your market. Delivered directly toyour Inbox or available through the website, all the industry news is available to you all the time. When you want the news its there foryou - it really is that simple. Over 25+ stories everyday as they happen. Never again will any of your colleagues be aware of news that youaren’t. Plus exclusive features from visiongain conferences and in-depth analysis from visiongain analysts will be available to you thanks toyour subscription to PharmaBusinessDaily. This information is not available anywhere else. Call +44 (0)207 336 6100 or visitwww.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 © Copyright visiongain Ltd, 2012
  5. 5. 11th Annual Biosimilars UKRegistration FormFor multiple bookingsPhotocopy this form Conf. code VG 11th Annual Biosimilars UKStandard Prices 29th – 31st October 2012Conference and workshop Fee: £1699 Location: Visiongain Conference CentreConference only Fee: £1299 Address: Workshop only Fee: £599 230 City Road London EC1V 2TT UKPromotional Literature DistributionDistribution of your company’s promotional literature to all conference attendees How to book Fee: £999 VAT: £199.80 Total: £1198.80 Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/biosimDetails UK Office: Tel: +44 (0) 20 7336 6100 Fax: +44 (0) 20 7549 9932 Forename: Surname: Visiongain Ltd 230 City RoadJob Title: Company: London EC1V 2QY UKMain Switchboard Number: General informationAddress: Venue: 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 8343 http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Travelodge 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=340Country: Postcode: 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 guaranteePhone: Fax: 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.Email: 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 invoiceSignature: 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/I confirm that I have read and agree to the terms and conditions of booking 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.Methods of payment 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 thePayment must be made in sterling customer by credit card prior to the changes being made. Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive By Mail: Complete and return your signed registration form together with your cheque briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled payable to Visiongain Ltd and send to: visiongain Ltd, 230 City Road, London, EC1V 2QY, UK 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 By Fax: Complete and fax your signed registration form with your credit card details 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 to +44 (0) 20 7549 9932 cost of the registration, travel and expenses. Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details 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 Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 By 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 By Bank Transfer 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 debit my credit card: 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 Access MasterCard Visa American Express 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 stronglyExpiry Date: 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 TaxPortSecurity number (last 3 digits on back of credit card): USA Corp.on: Tel: USA 802.860.0250 or +1.888.298.8296, Europe +41(0)21 310 01 50 or via email on: vat@taxport-usa.com, vat@taxport-switzerland.com, vat@taxport-uk.com. For furtherSignature: 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 andCardholder’s name: phone. Please ensure that you complete the registration form in full so that we can contact you. Unable to attendNews updates 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.Please tick if you do not want to receive email news updates in the future Yes, please send me speaker talks Price: £550 VAT: £110 Total: £660 www.visiongain.com/biosim