|
||||||||||||||||
| HUM-MOLGEN -> Events -> Meetings and Conferences | ||||||||||||||||
| 21st Century Clinical Drug Development: Going Global | ||||||||||||||||
| January 17, 2001 | ||||||||||||||||
|
SMi, The Hatton, London 24th - 26th April, 2001 Day One – 25th April 8.30 Registration & Coffee 9.00 Chairman's Opening Remarks Zsolt Lavotha, President & CEO, Lavipharm Laboratories THE INTERNET AND THE PHARMACEUTICAL INDUSTRY 9.10 Global opportunities and global challenges Changing business models The clinical research process Strategic alliances Intellectual property: the new internet currency The challenge of on-line pharmacies The impact of privacy legislation Keith Korenchuk, Partner, Davis Wright Tremaine LLP PRODUCT DEVELOPMENT: BEATING THE INEFFICIENCY WITHIN 9.40 After e-trials, do we not need e-decisions? Accelerating trials: why lack of patients may soon be a problem of the past Committee decisions: how to audit them Learning from past decisions: a systematic approach How inexpensive is “proof of concept”? Development programme building to facilitate decisions E-decisions: what are the tools worth? Dr Michael Herschel, Head, Clinical Research, GlaxoWellcome THE GLOBAL ACCEPTANCE AND IMPLEMENTATION OF E-TECHNOLOGY IN PHARMA INDUSTRY AND HEALTHCARE WHERE THE DRIVERS DIFFER FROM THOSE IN OTHER INDUSTRIES 10.20 An international CRO perspective The aims: speed, quality & patient recruitment Defining the concept for universal acceptance and identifying the key players Justifying cost of ‘new developments’ and maintaining balance with the status quo Considering local and international issues Measuring success – those meaningful metrics Clinical priorities versus clinical trial participation Technology and the ‘human element’ in clinical trials The results: speed, quality & patient recruitment (!) Tom Ruane, Associate Director, Site Management, Kendle 11.00 Morning Coffee ORGANISATIONAL IMPACT OF NEW TECHNOLOGIES IN CLINICAL GLOBALISATION 11.20 Maintaining focus in the face of change is critical to business success. With impending change often comes opportunities to reconsider current technology choices. This presentation explores organisational considerations that management should incorporate into their technology evaluation plans: Practical transnational project team structure utilised for implementing two global data capture systems simultaneously Changes in resource allocation realised with implementation of EDC technology on a global level Strategic initiatives to harmonise data collection across various sources & systems The role of the clinical data warehouse in achieving the clinical globalisation vision Michele Thomas, Lead Global Database Manager, SmithKline Beecham PATIENT RECRUITMENT ISSUES: FIRST STEPS 12.00 Effective patient delivery strategies in global studies Creating a global recruitment strategy Ensuring local cultural restraints are incorporated How the internet is making access to clinical trial information globally available Is an internet patient an investigators nightmare? Karen Harmes, Director, Patient Recruitment & Retention, Acurian 12.40 Networking Lunch APPLICATION SERVICE PROVISION (ASP) 1.40 Is it the key to unlock the eClinical vision? What does ASP mean for the clinical trials industry? What should you look for from an ASP service provider? How will this address the technology adoption barriers? Is this really going to unlock the future? Chris Goldsmith, Business Development Manager, BT Clinical Trials Services ACHIEVING OPTIMISATION AND SYNCHRONISATION IN THE CLINICAL SUPPLY CHAIN 2.20 New opportunities for global organisations The current process Regulatory issues Achieving transparency - gaining ROI How private e-hubs are changing global procurement Dr Vaman Rao, Chief Executive Officer, LifetecNet MANAGING KNOWLEDGE ON GLOBAL PROJECTS 3.00 Merging and sharing global knowledge The impact of globalisation on internal communications and management ideas Successful global project management Knowledge sharing to guarantee continuous performance improvement Dr Sandra Webb, Executive Vice President, Global Development Services, CroMedica Global 3.40 Afternoon Tea MARKETING MIX STRATEGIES IN GLOBAL MARKETS 4.00 Packaging selection crucial for success of critical care drug launches What currently drives clinical drug delivery practice in emerging global markets environmental factors in key countries Clinical practice-methods of delivery of intravenous drugs with description of drug delivery systems Identify key countries where opportunities are the greatest for enhanced drug delivery systems Marketing opportunities for pharma companies to differentiate from competition Debra Gillmeister, Director, Global Market Development, Baxter Leigh Stewart, Director, Global Business Development, Baxter GLOBAL CLINICAL DEVELOPMENT, PLANNING WITH THE END IN MIND 4.30 With the ever increasing cost of research and the need for rapid return on investment, early global commercial planning is a key ingredient in the drug development plan Assessment of the global competitive market place Making the tough development choices early Life cycle planning through to patent expiry begins in phase II of clinical development plan Global execution of commercialisation plan; role of clinical development team Philippe Deschamps, Executive Vice President, Managing Director, GSW International 5.00 Chairman’s Closing Remarks and Close of Day One 5.10 NETWORKING DRINKS RECEPTION Day Two – 26th April 8.30 Re-registration and Coffee 9.00 Chairman's Opening Remarks Dr John Thottathil, Director, Bristol Myers Squibb OUTSOURCING: PLAYING THE GLOBAL FIELD 9.10 Outsourcing of API, intermediates, and development during the early stages of drug development What are the current drivers of outsourcing? What is out there? Playing the global field Pros and cons of the global field BMS perspective Dr John Thottathil, Director, Bristol Myers Squibb ACHIEVING GLOBAL HARMONISATION IN A MULTI-CULTURAL, MULTI-BOUNDARY ENVIRONMENT 9.40 Case study: Bayer Creating and using a ‘virtual project office’ to help achieve global harmonisation of business processes Project design and implementation Benefits to the team and to the business Rolling changes out across the World – the results Speaker TBA, Bayer CENTRAL AND EASTERN EUROPE: FERTILE GROUND FOR CLINICAL TRIALS? 10.20 Specific features associated with conducting trials in the region Market growth in CEE Clinical trials Features of the trial Costs of conducting trials in eastern Europe Patient information and consent Regulatory hurdles: GCP and ethics committees Reporting of ADRs: communications with investigators and patients Key advantages identified Higher incidence of certain disorders Drug naïve population: larger in CEE countries Patient motivation Investigator motivation Dr Heinz Carmann, Managing Director, Central & Eastern Europe, Quintiles 11.00 Morning Coffee EMERGING JAPANESE MARKETS 11.20 The internationalisation process: West meets East How is the Japanese pharmaceutical industry responding to international challenges? Advantages of this approach Promoted global progress Enhanced marketing strength in Japan and Overseas Focus on tighter integration of global operations Continued to improve the company's ability to meet global healthcare needs Difference of ethnic factors between Japanese and Western population Impact of ICH E5 guideline Best practice case study: Sankyo Tetsuya Kaiso, Team Leader, Clinical Development, Sankyo INDIA AS A CENTRE FOR GLOBAL PHARMACEUTICAL RESEARCH AND DEVELOPMENT 12.00 Quintiles goes East Why India? Expanding medical and information technology expertise Building a knowledge base and infrastructure How does Quintiles' worldwide Internet strategy fit into its India operations? Key advantages of this approach Providing access to the latest advances in medicine Giving India's physicians the opportunity to participate in global research programs and to publish internationally The ability to conduct quality research requires the highest level of expertise, and clinical trials are a mechanism for knowledge transfer Future outlook for Quintiles global R&D operations Dr Anand Tharmaratnam, Director, CNS Clinical Development, Quintiles 12.40 Networking Lunch LEVERAGING INTERNET CAPABILITIES TO CONSOLIDATE GLOBAL CLINICAL TRIALS 1.40 AstraZeneca’s experiences of Web based Clinical Trials The new paradigm - Common Information Access Benefits, disadvantages and experiences so far Integration - what about our in-house systems? Web data capture - more than just technology changes Future development Jorge Ferreira, Global Capability Network Leader, Clinical Data Capture, AstraZeneca OVERCOMING THE OPERATIONAL BARRIERS TO GLOBAL ELECTRONIC DATA CAPTURE DEPLOYMENT 2.20 Case study: PharmaNet Telephone infrastructure Local internet environment: availability, reliability and cost EDC study support: Multilingual help desk (study and technical support) Local hardware and software support User training Company staff Site personnel Local issues Encryption Restricted access to internet Resistance to using EDC technology Dr Richard Nelson, Senior Director, Clinical Operations Technologies, PharmaNet PROACTIVE DATA VISUALISATION & ANALYSIS 2.40 In the clinical environment Background Applications Benefits Challenges Why now? Dr Ursula Schwuttke, President & CEO, High Tower Software Matt D’Ambrosia, Director, TowerView Clinical 3.20 Afternoon Tea E-SOLUTIONS AND ONLINE APPLICATIONS FOR BIOSCIENCE LICENSING 3.40 Case study: Intellectual Property Technology Exchange Addressing content and knowledge collaborations across individuals, projects and communities Reducing time to market in the eR&D economy Creating directed serendipity Creating sustainable IP from knowledge based products Leveraging IP in a global market Jerry Williamson, President & CEO, Intellectual Property Technology Exchange HIGH PERFORMANCE CLINICAL DEVELOPMENT 4.20 Case study: Accenture Shift from product driven to patient driven strategy Focus on improving success rate Create a learning organisation Redesign the clinical trials process Support a common global regulatory framework Fraser Skirrow, Partner, Pharmaceuticals & Medical Products Practice, Accenture (Formerly Andersen Consulting) 5.00 Chairman's Closing Remarks and Close of Conference Workshop: In association with: answerthink Getting the Most from your eHealth Strategy: From R&D to Marketing 24th April 2001, The Hatton, London About your workshop leader: Mr David Duplay is the Practice Director for answerthink’s Life science industry practice. He has more than fifteen years of industry and consulting experience. He has spent the last three years focussed on developing strategies which concentrate on the utilisation of the internet to improve business in the pharmaceuticals and healthcare industries. His practice is a leader in developing implementable strategies to interactively market products, architecting internet enabled Customer Relationship Management of call centres operations, integrating sales and marketing operations via the web, and speeding time-to-market of clinical trials through eBusiness process improvement. Working primarily with pharmaceutical and biotech companies, Mr Duplay and the answerthink team have developed a strategic eBusiness approach that delivers results for large, complex organisations. It directly addresses the issues related to new technology adoption, process change, organisational consensus building, and measuring business results. Together with answerthink's worldclass interactive marketing and commerce applications groups, his team has created a drug marketing approach that integrates online and offline media campaigns, professional medical campaigns, CRM operations, and direct sales activities. answerthink inc. (www.answerthink.com) is a leading provider of technology-based business solutions. The company brings together multi-disciplinary expertise, best practice benchmarking and research, enterprise transformation, interactive marketing and design, business applications and technology integration to serve the needs of Global 2000 clients. answerthink’s solutions span all functional areas of a company including supply chain, sales and marketing, customer service, finance and human resources, as well as a line of business speciality marketing such as retail, telecommunications and financial services. Founded in 1997, answerthink has more than 1800 associates and offices in 17 cities throughout US and in Europe. About this Workshop: This powerful and provocative workshop will show you how to utilise e-technologies efficiently in order to help your company meet the forces which are constantly pressuring change within the industry. With a multi-disciplinary expertise, your workshop leader - Mr David Duplay of answerthink inc. - will review business applications and technology integration, interactive marketing and design, global security considerations, best practice benchmarking and how to build and sustain successful epartnerships. This workshop will benefit individuals in the pharmaceutical and biotechnology industry involved in all areas of clinical studies. 1.30 Registration & Coffee 2.00 Current Trends in eHealth eR&D eClinical Trials eMarketing 3.00 Information Security Considerations: Managing the Risks Understanding the risks Global security considerations Review of technology’s role Managing the risk 3.40 Afternoon Tea 4.00 Developing Successful ePartnership Strategies Why should I consider an ePartner? Who should I partner with? Managing the ePartnership risk Methods and tools used to perform ePartnerships Turning data into knowledge Case study 5.00 Discussion and Questions – Review of the Session 5.30 Close of Workshop 21st Century Clinical Drug Development: Going Global Dear Pharmaceutical Executive With the world market for pharmaceuticals at $340 billion in 1999, companies are making feverish efforts to catch a sizeable portion of this multibillion dollar pie. Indeed, as the multinational nature of the industry rapidly prevails and more and more pharmaceutical and biotechnology companies join the worldwide race towards globalisation - we ask the question: are you ready? Globalisation largely affects the industry through mergers and the emergence of biotech consolidators, changing the balance of key players in the field. It has major impacts such as widening the gap, in terms of access to drugs, between developed and developing countries. Why must you attend this event? How will your company survive these changing innovations within the industry? How will you restructure your business to contend with these changes? You can begin by attending our unique conference. This meeting will provide a comprehensive forum comprising a collection of innovative presentations presented by highly acclaimed pharmaceutical executives who will address implementation of new structures, best practice strategies, novel concepts and e-methodologies necessary to give your company that competitive advantage as large-scale pharmaceutical consolidation continues to elevate. PLUS A HALF DAY INTERACTIVE WORKSHOP Getting the Most from your eHealth Strategy: From R&D to Marketing 24th April 2001, p.m, The Hatton, London To attend this essential forum please register now using the booking form on the back of the brochure or visit www.smi-online.co.uk/globalisation.asp to register online. I look forward to seeing you in London in April. Yours faithfully, Susie Palmer Ph.D. Conference Producer Tel: +44 (0)20 7827 6042 Email: spalmer@smi-online.co.uk |
||||||||||||||||
| Organized by: | Dr Susie Palmer at SMi Pharma Conference | |||||||||||||||
| Invited Speakers: | Confirmed Speakers: Dr Michael Herschel, Head, Clinical Research, GlaxoWellcome Michele Thomas, Lead Global Database Manager, SmithKline Beecham Dr John Thottathil, Director, Bristol Myers Squibb Jorge Ferreira, Global Capability Network Leader, Clinical Data Capture, AstraZeneca Tetsuya Kaiso, Team Leader, Clinical Development, Sankyo Speaker TBA, Bayer Debra Gillmeister, Director, Global Market Development, Baxter Leigh Stewart, Director, Global Business Development, Baxter Dr Heinz Carmann, Managing Director, Central & Eastern Europe, Quintiles Dr Anand Tharmaratnam, Director, CNS Clinical Development, Quintiles Tom Ruane, Associate Director, Site Management, Kendle Dr Sandra Webb, Executive Vice President, Global Development Services, CroMedica Global Dr Richard Nelson, Senior Director, Clinical Operations Technology, PharmaNet Karen Harmes, Director, Patient Recruitment & Retention, Acurian Chris Goldsmith, Business Development Manager, BT Clinical Trials Services Dr Vaman Rao, Chief Executive Officer, LifetecNet Dr Ursula Schwuttke, President & CEO, High Tower Software Matt D’Ambrosia, Director, TowerView Clinical Fraser Skirrow, Partner, Pharmaceuticals & Medical Products Practice, Accenture(Formerly Andersen Consulting) Jerry Williamson, President & CEO, Intellectual Property Technology Exchange Philippe Deschamps, Executive Vice President, Managing Director, GSW International Keith Korenchuk, Partner, Davis Wright Tremaine LLP Chaired by: Zsolt Lavotha, President & CEO, Lavipharm Laboratories Dr John Thottathil, Director, Bristol Myers Squibb |
|||||||||||||||
| Deadline for Abstracts: | all slots now taken | |||||||||||||||
| Registration: | By internet - www.smi-online.co.uk Email - spalmer@smi-online.co.uk for brochure with registration form attached |
|||||||||||||||
| E-mail: | spalmer@smi-online.co.uk | |||||||||||||||
| Posted by: | Dr Susie Palmer | |||||||||||||||
| Host: | 213.38.112.46 | |||||||||||||||
|
||||||||||||||||
|
Generated by meetings and positions 5.0 by Kai Garlipp |
||||||||||||||||