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7th Annual Monoclonal Antibody Examining new therapeutic applications, latest technological development and regulatory issues 18th – 20th May 2011, London, UK BOOK NOW! Key Speakers Ivan R Correia, MBA, Ph.D., Principal Research Scientist Protein Analytics, Abbott Bioresearch Center Yulia Vugmeyster, Ph.D., Principal Research Scientist, Pfizer Guodong Chen, Ph.D. Principal Scientist, Bristol-Myers Squibb Thomas Jostock, Ph.D., FellowTechnology Platform Leader Process Sciences and Production, Novartis Pharma Bailin X Tu, Ph.D., Principal Scientist, Abbott Diagnostic Division Laura Andrews, Ph.D., Vice President of Pharmacology and Toxicology, Genzyme Bernhard Helk Ph.D., Section Head, Novartis Pharma Qingyu Cao Ph.D., MBA Licencing and Technology, Lonza Development Services Justin A. Caravella, Ph.D., Senior Scientist, Biogen Idec Hans J Johansson, Staff Scientist, GE Healthcare Ralph Minter Ph.D., Head of Research - Technology, MedImmune Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director, Genmab Matthew Baker Ph.D., Chief Scientific Officer, Antitope Alfred Luitjens, Senior Scientist New Technology, Crucell Richard Stebbings, Ph.D., Transfusion Medicine & immunotoxicity section, Biotherapeutics Group, National Institute for Biological Standards and Control -Health Protection Agency (HPA) Pre-conference Workshop, Wednesday 18th May, 2011 Preclinical safety evaluation of mAbs Led by: Laura Andrews, Ph.D., Vice President of Pharmacology and Toxicology, Genzyme Driving the Industry Forward | www.futurepharmaus.com Organised ByMedia Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/mabs
Conference Introduction 7th Annual Monoclonal Antibody 18th – 20th May 2011, London, UK Dear Colleague, Media Partners: hile only 20% of the drugs on the market today are biologics, it is expected that with W PharmiWeb.com is the leading industry-sponsored portal 650 biotechnology medicines in development in 2010 for more than 100 diseases, for the pharmaceutical sector. Supported by most of the half the new drugs approved in 2015 will be biologics and most of them will be monoclonal antibodies.1 leading pharmaceutical corporations, PharmiWeb.com provides dynamic onoclonal antibodies (mAbs) currently generate global revenues of around $20 M real-time news, features, events listings and international jobs to industry billion including blockbusters such as Avastin, Herceptin, Remicade, Rituxan, Humira professionals across Europe and the US. and Erbitux and over the next five years it is expected to reach sales of $ 70 billion For further information please email: firstname.lastname@example.org with another 15 to 20 new mAbs to be approved by 2013.2 onoclonal antibodies are competing for targets in cancers, alzheimer, auto-immune M and various infectious diseases. With the rapid growth of mAbs-based products, BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY new technologies have emerged for creating modified forms of antibodies, including fragments, conjugates and multi-specific antibodies. WORLD. It is based and located in Warsaw, Poland. ue to the complex nature of mAbs and their inherent heterogeneity careful attention D Biotechnology World was founded in 2007 to provide the world’s biotech is required for product design and manufacturing to assure a safe, effective and and pharma information and market to make it universally accessible and consistent product.3 useful for scientific and business processes. Its first step to fulfilling that isiongain’s 7th Annual Monoclonal Antibody conference will gather global antibody V mission was building the BIOTECHNOLOGY EUROPE platform that will leaders and experts for this 3 day event focusing on developing cost-effective antibody products, advancements in manufacturing technologies, processes development allow a quick spread of information in different channels. BIOTECHNOLOGY of monoclonal antibodies product from initial discovery through the filing of an EUROPE offers companies completed internet public relations, publication investigational new drug application (IND). and marketing solutions. One of the mains goals of BIOTECHNOLOGY By attending this conference you will: EUROPE is to integrate the Biotech and Pharma Sector in Europe to global • ain insight on various therapeutic targets on oncology, multiple sclerosis, G biotechnology, pharmaceutical and life science activities. cardiovascular and autoimmune disorders For further information please visit: www.biotechnology-europe.com • valuate advances in antibody technology such as fragments, conjugates and multi- E specific antibodies • earn about future of monoclonal antibody technology L Future Pharmaceuticals has forged powerful relationships Driving the Industry Forward | www.futurepharmaus.com • ear about new antibody engineering and modification technologies H with key industry leaders to provide a platform for • xamine platform approaches to monoclonal antibody purification E successful brand recognition, and for senior decision-makers to have the • ind out new techniques in cell engineering for monoclonal antibody production F means to procure and plan implementation strategies based on the topics • xplore antibody-based targeted therapy: taking advantage of the human innate E covered. Positioned to be an authoritative resource within top pharma immunity companies as well as small, specialty, and biotech, Future Pharmaceuticals • ssess trends in capacity utilisation for therapeutic monoclonal antibody production A magazine is geared to create a deep penetration into a highly targeted and • mprove antibody production using directed evolution I responsive audience, bridging the gap between the industries’ top issues and • nvestigate immunogenicity issues with drug development I the solutions top-tier vendors can provide. • dentify suitable assays for evaluating the immunogenicity of mAbs I • eview contract production of mAbs for research and pre-clinical purposes R For further information please visit: www.futurepharmaus.com • nderstand navigation strategies for intellectual property in the antibody world U • eview latest regulations, technologies, production methods and therapeutics R InPharm is the online platform for exclusive • e part of a major networking opportunity B pharmaceutical news, comment, contracts, services, jobs I look forward to meeting you at the conference and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. Best regards For further information please visit: www.In-Pharm.com Sonia Tomar Conference Producer Sponsorship and exhibition opportunities This event offers a unique opportunity to meet and do business with some Who will be there? VPs, Directors, Heads and Managers of: of the key players in the pharmaceutical and biotech industries. If you have a • Antibody development • CNS autoimmune and inflammatory disease research service or product to promote, you can do so at this event by: • Preclinical/clinical research and development • Cell and molecular biology • Hosting a networking drinks reception • Recombinant DNA biotechnology • Protein/biochemical antibody engineering • Taking an exhibition space at the conference • Cardiovascular R&D • Auto-immune disorders • Advertising in the delegate documentation pack • Arthritis R&D • Oncology R&D • Providing branded bags, pens, gifts, etc. • Age-related macular degeneration research/ophthalmology • Immunobiology If you would like more information on the range of sponsorship or exhibition • New product development • Business development possibilities for visiongains 7th Annual Monoclonal Antibody Conference, • Clinical diagnostics • Marketing please contact us: • Licensing • Biologics/biosimilars Ronald Magali, +44 (0)20 7549 9934 • Outsourcing/contract manufacturing • Contract research organisations email@example.com • Pharmaceutical and patent law1 Engaging with the global antibody and biological markets presentation, presented at Visiongain’s 6th Annual Monoclonal antibodies conference. 2 Visiongain (2010) therapeutic monoclonal antibodies: world market report. 3 Wendy C. Weinberg, Michelle R. Frazier-Jessen, Wen Jin Wu, Andrea Weir, Melanie Hartsough, Patricia Keegan and Chana Fuchs. (2005). Development and regulation of monoclonal antibody products: Challenges and opportunities. Special Issue: Therapeutic Antibodies and Their Use in Oncology. 24 (Number 4), 569-584
Pre-Conference Interactive Workshop 7th Annual Monoclonal Antibody Wednesday 18th May 2011 Preclinical safety evaluation of mAbsLed by: Laura Andrews, Ph.D. Timings: 9:30 - 10:00 Coffee & Registration 0 Vice President of Pharmacology and Toxicology 10:00 - 15:00 Workshop Genzyme T iming includes lunch and refreshment breaksAbout the workshop: About your workshop leader:Preclinical development programs that are designed to Laura Andrews, Ph.Dsupport the safe clinical use of biopharmaceuticals have Laura Andrews is Vice President of Pharmacology and Toxicology at Genzyme where she directs the nonclinical development programs forconsiderations that are very different from programs biotherapeutics. She is responsible for the nonclinical developmentdesigned to support the development of small molecule programs for therapeutic biologics, gene therapy products, and cell based therapies. Laura oversees the design, implementation anddrugs. In particular, with more and more targeted interpretation of the in vivo GLP studies and the in vitro assays totherapeutics being developed a traditional development support product development. Laura has authored the pharmacologyprogram is becoming more and more difficult. While the and toxicology section for several Genzyme INDs and marketing applications in several different territories. Dr. Andrews received a BSICH S6 guidance continues to drive the program decisions (1983) in Biology and Chemistry from Dickinson College, and a Ph.D.more often than not a different approach is warranted due (1987) in Pathology and Cell Biology from Thomas Jefferson Universityto species specificity and paucity of relevant animal models. and Medical College in Philadelphia, PA. She was Board Certified in General Toxicology in1998. She holds memberships in the Society ofTo design a predictive non clinical program that will Toxicology (SOT), Society for Toxicologic Pathology (STP) and thesupport not only first in human dosing but also eventual American College for Toxicology (ACT). She is on the nominationapproval of the therapeutic is becoming more complex. committee of ACT and recently was appointed as a member of SACATM (Scientific Advisory Committee on Alternative ToxicologicalAssuring safety in humans is the first and foremost task of a Methods). She is currently on the Board of Directors for the Americanwell designed program but assuring safety and application Board of Toxicology and a Fellow of the Academy of Toxicologic Sciences.to specific patient populations is also essential to thetargeted therapeutic products. Topics to be addressed About the companyin this workshop will include general issues related to Genzyme is one of the world’s leading biotechnology companies. Itsdifferences between species that might contribute to approximately 10,000 employees work in countries throughout the world and are united by a common goal: to make a major positivespecies selection/interpretation, utility of tissue cross impact on the lives of people with debilitating diseases.reactivity to determine relevant species, considerations into Since its founding in 1981, Genzyme has grown from a small start-upthe development of a homologous protein (from bench to a diversified enterprise with 2009 revenues of $4.5 billion. Over the past three decades Genzyme has introduced a number of breakthroughto beast), development and characterisation of animal treatments in several areas of medicine, which have provided hope tomodels as relevant species (including KO animals and patients who previously had no viable treatment options. Genzymemodels of disease), and additionally what to do if nothing products are helping patients in 100 countries.is ‘relevant’. Included will be specific case examples. Today, Genzyme continues to be driven by its commitment to patients. The company is working to develop new medicines, improve its existingThe workshop attendee will learn key concepts in the therapies, secure approvals for its products around the world, andconsiderations for designing a predictive program for a ensure that patients have access to these treatments.biotherapeutic product. www.genzyme.com
Day 1 7th Annual Monoclonal Antibody Thursday 19th May 201109:00 Registration and refreshments 12:40 Networking lunch09:30 Opening address from the chair 13:40 Case study: Enhancing a CHO cell line development09:40 Evaluating primary structure and post translational platform: new technologies to increase speed, modification of mAbs in serum; implications for throughput and yield drug development • hallenges in cell line development C • Developing a high throughput method to evaluate mAbs in serum • ew technologies for enhanced selection and screening N • Monitoring clearance of fragments and molecules with different pI’s • mplications on platform performance I • valuating change in glycoform profile and its impact on clearance E • ase studies C in serum Thomas Jostock, Ph.D. • Evaluating deamidation and oxidation of mAbs in serum Fellow, Technology Platform Leader, Process Sciences and Production • Evaluating aggregates of mAbs in serum Novartis Pharma Ivan R Correia, MBA, Ph.D. Principal Research Scientist, Protein Analytics Abbott Bioresearch Center 14:20 Antibody engineering for diagnostics: anti-HCV chimeric antibodies10:20 Harnessing the power of biologics mass spectrometry • enerated 4 anti-HCV mouse-human chimeric antibodies to replace G in the characterisation of therapeutic antibodies: the use of human donor sera/plasma for HCV immunoassays recent developments and future prospects • table CHO cell lines were established to manufacture each S • Analytical challenges in the characterisation of therapeutic antibodies chimeric antibody • Mass spectrometric approaches to characterisation of PTMs • east display technology was used to map the epitope for each Y • Higher order structure characterisation of therapeutic antibodies chimeric antibody • Quantitative analysis of therapeutic antibodies including PTMs Bailin X Tu, Ph.D. Principal Scientist Guodong Chen, Ph.D. Abbott Diagnostic Division Principal Scientist, Bioanalytical and Discovery Analytical Sciences Bristol-Myers Squibb 15:00 Afternoon Refreshments11:00 Morning refreshments 15:20 Prediction of aggregation propensities11:20 Early engineering of antibodies for improved Bernhard Helk Ph.D. pharmaceutical properties Section Head • harmaceutical properties of antibodies can have a profound effect on P Novartis Pharma the development, methods of therapeutic use, and efficacy profile of a drug candidate • ocused engineering approaches have been used to eliminate potential F 16:00 Current advances in monoclonal antibody purification liabilities in several therapeutic antibodies • Designing the next platform for antibody purification • ntibody solubility has been improved by engineering approaches in two A • A novel high capacity Protein A resin cases, but prediction of solubility remains a challenging problem • he next generation polishing resins, including multi-modal T • echniques can be incorporated into an antibody discovery workflow to T resin technologies increase the quality and diversity of candidate molecules at an early stage Hans J Johansson Justin A. Caravella, Ph.D. Staff Scientist Senior Scientist GE Healthcare Biogen Idec12:00 Monoclonal antibody conjugation via 16:40 Closing remarks from the chair chemical modification • Fusion of a recombinant antibody fragment • hemical conjugation of small recombinant proteins with C 16:50 Networking drinks polyethylene glycol Take your discussions further and build new relationships Yulia Vugmeyster, Ph.D. (tentative) in a relaxed and informal setting Principal Research Scientist Pfizer 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 7th Annual Monoclonal Antibody Friday 20th May 201109:00 Registration and refreshments 12:40 Networking lunch09:30 Opening address from the chair 13:40 Flexible Facilities with single-use systems for mAb production09:40 Immunogenicity of protein therapeutics can give rise • Introduction of FlexFactory concept in GMP manufacturing to partial or complete loss of drug efficacy, altered • Main advantages of the FlexFactory are: pharmacokinetics, or cross-reaction with a patient’s - Increased flexibility endogenous proteins - Ease of segregation • Overview of the immunogenicity causes and drivers - Lower building costs • pplying the novel EMEA guidance and industry whitepapers to A antibody therapeutics - Efficient use of floor space • linical and non-clinical strategies to assess/control immunogenicity of C • he FlexFactory is introduced with unit operations having fully T therapeutic antibodies disposable flow paths • rediction and assessment of T-cell epitope driven immunogenicity at P • oals and challenges of GMP manufacturing run of a Monoclonal G early stage of product development using in silico and in vitro tools. antibody with the flexfactory • ntibody deimmunisation to further mitigate immunogenicity risk A Alfred Luitjens • Selected case studies Senior Scientist New Technology Crucell Qingyu Cao Ph.D., MBA Licencing and Technology Lonza Development Services 14:20 Panel discussion: improving monoclonal antibody10:20 Reducing immunogenicity in therapeutic antibodies manufacturing technology • Processes of complementarity-determining region grafting, resurfacing P anlist will discuss about manufacturing issues in product development, • Hyperchimerisation diminish mAb product failure, product testing, effective and new ways to reduce production cost. for any questions or participation please contact • immunogenicity by reducing the number of foreign residues firstname.lastname@example.org Matthew Baker Ph.D. Chief Scientific Officer Antitope 15:00 Afternoon refreshments11:00 Morning refreshments 15:20 Cytokine storm after TGN1412: better understanding11:20 Antibodies as tools to identify and validate novel and prediction targets in multiple disease areas • Is TGN1412 cytokine release similar to that caused by other therapeutic mAbs? • he need for novel antibody targets and challenges faced by T • What are the key in vitro biomarkers of TGN1412 cytokine release? conventional target discovery approaches • What is the cellular source of TGN1412 cytokine release? • Using antibodies as tools to find and validate new targets • Why did pre-clinical safety testing in macaques fail? • Challenges of performing phage display selections on diverse cell types • What lessons have we learnt from TGN1412? • Target deconvolution and in vivo target validation Richard Stebbings, Ph.D. Ralph Minter, Ph.D. Transfusion Medicine & Immunotoxicology Section, Biotherapeutics Group Head of Research - Technology National Institute for Biological Standards and MedImmune Control -Health Protection Agency (HPA)12:00 Case study: Daratumumab, a novel therapeutic 16:00 Navigation strategies for intellectual property in human CD38 antibody for the treatment of the antibody world multiple myeloma • Legal and regulatory update • Daratumumab, a novel therapeutic human IgG1 antibody • Regulatory challenges for approval of antibody • Mechanisms of action • Patents and intellectual property right • Potent anti-cancer activity in animal models • Synergisms with conventional drugs 16:40 Chair’s closing remarks • Clinical development in multiple myeloma Paul W.H.I. Parren, Ph.D. 16:50 End of Conference Senior Vice President & Scientific Director Genmab
Registration Form 7th Annual Monoclonal Antibody 18th - 20th May 2011, London, UK Conf. code VGStandard PricesConference and workshopConference only Fee: £1699 Fee: £1299 VAT: £339.80 VAT: £259.80 Total: £2038.80 Total: £1558.80 7th Annual Monoclonal AntibodyWorkshop only Fee: £599 VAT: £119.80 Total: £718.80 18th – 20th May 2011Number of bookings: Total cost: London, UKPromotional Literature DistributionDistribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £199.80 Total: £1198.80Details How to bookForename: Surname: Email: email@example.com Web: http://www.visiongain.com/mabs Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain LtdAddress: BSG House 226-236 City Road London EC1V 2QY UKCountry: Postcode: General informationPhone: Fax: Venue: TBA, London, UK Payment terms: Visiongain require the full amount to be paid before the conference. 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Please ensure that you complete the registration form in full so that we can contact you.Security number (last 3 digits on back of credit card): Unable to attend Obviously nothing compares to being there but you need not miss out. Simply tick the box and send Signature: with your payment. You will receive speaker talks in PDFs two weeks after the event. Yes, please send me speaker talks Price£550 VAT:£110 Total:£660Cardholder’s name: Office use onlyNews updatesPlease tick if you do not want to receive email news updates in the future www.visiongain.com/mabs