Susmita Gupta, Sr. CDM Project Manager, Endo Pharmaceuticals, USA

Transcription

1 March , Morristown, NJ, USA The 5th China and Asia Clinical Trials Outsourcing Congress Asia has the fastest growing pharmaceutical market in the world. The Chinese market is particularly vibrant and by 2015 it will have more have than doubled in value to $100bn. By 2020 it will be the largest in the world. More broadly, the wider Asian region has become well recognised as an attractive location for clinical trials. Developments in SFDA regulations and further developments in Hong Kong, India, Japan, Korea, Malaysia, the Philippines, Singapore, Taiwan, and Thailand mean that each country offers different benefits and presents different challenges. It is important to understand how different variables, such as regulation, logistics and cultural factors, in each country will impact the process of outsourcing and managing a trial. The congress features a series of interactive presentations, panel discussions and roundtable discussions designed to help you fully appreciate the opportunities and hurdles of working in this important and diverse region. Topics covered include: Clinical Outsourcing Strategies Regulations & IPR Challenges Regional Focused Case Studies CRO Selection & Management Clinical Operations Efficiency Risk Management, Quality & Safety Data Collection & Management Confirmed Speakers Include Alexandre LeBeaut, Senior Vice President, Clinical Development, IPSEN, France Millie Shultz, Ying Liu, Head of Asia Global Clinical Development, IPSEN, China Ying Lou, Chairman, President and Chief Executive Officer, Shanghai Genomics, China Eva Yang, Head of Monitoring and Site Management, Asia Pacific Global Clinical Operations, Bayer, China Associate Director, Clinical Operations, Millennium: The Takeda Oncology Company, China Susmita Gupta, Sr. CDM Project Manager, Endo Pharmaceuticals, USA CN Ramchand, Earl Hulihan, Principal, ew hulihan and associates and Professorships with U.M.D.N.J., S.U.T.C.M., and S.F.D.A. Institute of Educational Development President & CEO, Laila Pharmaceuticals Pvt Ltd, India Grace Halteh, Associate Director, Project Management - Quality and Business Solutions, Janssen Alzheimer Immunotherapy Trine Danø Klingberg, Senior International Clinical Trial Manager, Novo Nordisk, Denmark sponsors supporters Roger Luo, Director, Translational Medicine & Early Clinical Development, Oncology R&D, Janssen Pharmaceutical Company of Johnson & Johnson Christopher Milne, Director Research, Tufts CSDD, Tufts University Samy Tadros, Associate Director Strategic Sourcing, Celgene Chirag Trivedi, Associate Director Project Management & Strategic Initiatives, Sanofi, India Junyuan Wang, Director of Biostatistics, Bristol Myers Squibb Li Yan, Head of Clinical Development, Infectious Disease, Respiratory & Immunology, Oncology, Emerging Markets, Merck Brian York, Director and Regional Head Asia/Latin America; Global Head Payments & Pricing, Amgen

2 The 5 th China and Asia Clinical Trials Outsourcing Congress Conference Agenda Clinical Outsourcing Strategy Current landscape of clinical trial outsourcing in Asia Pacific Government support initiatives & key drivers in Asia to encourage clinical trials & fuel growth Opportunities and challenges of outsourcing to Asia M&A, partnering between western and Asian companies Planning an effective Asian clinical outsourcing strategy and models Market access & health outcomes Case Studies How big, medium & small Pharma companies successfully outsourced their clinical trial to Asia Panel Discussion: Critical factors for organising a successful clinical trial in Asia Panel Discussion: Successfully running oncology clinical trials in Asia Panel Discussion: Future of clinical trials in Asia Region Focus Advantages & disadvantages and other critical factors for conducting a successful clinical trial in: China, India, Japan, Korea, Malaysia, the Philppines, Taiwan, Thailand & Vietnam Improving ethical & safety concerns with Indian based clinical trials Regulations & IPR Challenges Main regulatory and approval process differences within the Asia Pacific, US & EU Navigating the Chinese regulatory system & keeping abreast of regulatory updates Receiving approval from SFDA and what to expect Monitoring compliance & quality Intellectual property and cross-cultural aspects Clinical Operations & Management Efficiency Strategic CRO selection & management Best practice techniques Benchmarking CROs what you need; matching to suppliers; and managing expectations Oversight, Monitoring & Site Management Global v Local - What to expect from a local CRO Increasing clinical trial efficiency Saving time, preventing delays in your clinical trial timeline and operating efficiently Panel discussion: Patient recruitment and retention Panel discussion: Vendor relationships and performance Safety and Data Collection/ Management Pharmacovigilance & safety Safety monitoring, risk management & patient safety in Asian clinical trials Achieving compliance with various country regulations in Asia while meeting global safety requirements Clinical trial data management in Asia Improving the integrity, quality, efficiency of data collection Biometrics and statistics - Statistical analysis of clinical trial data Supply Chain & Logistics Asian logistical challenges - import & export regulations Roundtable Discussions 1) CRO Selection & Management 2) Regulatory Hurdles 3) Patient Recruitment 4) Data Management 5) Supply Chain & Logistics Who should attend The congress will attract an audience consisting of CEOs, CSOs, Vice Presidents, Directors, Medical Directors, Managers and Heads of: Clinical Development Clinical Operations Clinical Trial Management Clinical Programmes Clinical R&D Clinical Oversight Clinical Budgeting Clinical Outsourcing CRO Management Vendor Scouting Contracts Purchasing/Procurement Alliances/Licensing Partnering Market Access Regulatory Affairs Quality Assurance (QA) Quality Control (QC) Good Clinical Practice (GCP) Compliance Intellectual Property Legal Counsel Emerging Markets Medical Affairs Business Development Operation & Planning Supply Chain Logistics Pharmacovigilance Drug Safety Clinical Data Management Statistics Biostatistics Biometry

3 Agenda Day One Monday 4 th March Registration & Coffee Chairman s Opening Remarks Shared Keynote Address Clinical Development in Asia from a Global and Asian Perspective Alexandre LeBeaut, Senior Vice President Global Clinical Development, IPSEN, France Ying Liu, Head of Asia Global Clinical Development, IPSEN, China 5 th China Clinical Trials Outsourcing Congress Early Clinical Trials in China - Opportunities and Challenges Why should we conduct early clinical trials in China? What are the challenges of conducting early clinical trials in China? What are the strategies and general approaches for MNCs in conducting early clinical trials in China Sean Zhang, Medical Director & Liaison to BMS China R&D, Discovery Medicine & Clinical Pharmacology, Bristol-Myers Squibb, Co Solution Provider Presentation Sponsored by: 3 rd Asia Clinical Trials Outsourcing Congress Opportunities And Challenges In Running Clinical Trials In Emerging Markets Creating opportunities in emerging markets Strategic questions you should consider before entering emerging markets Opportunities in emerging markets Understanding the local practices Challenges: perceived, substantial, both Brian York, Director and Regional Head Asia/Latin America; Global Head Payments & Pricing, Amgen Solution Provider Presentation For sponsorship opportunities please contact Nick Best at [email protected] Morning Refreshments One-to-One Meetings Poster Presentation Sessions Successes and Lessons Learnt: Clinical Pharmacology Trials in China Why China? How to work with China opportunity for synergy with global development; top trial centers and PIs; long lead time necessary for planning; need for understanding regulatory status and direction; need for understanding policies on biosample importation and exportation; opportunities for central and analytical labs Examples of successes and the lessons learnt Hequn Yin, Director Oncology Clinical Pharmacology, Novartis Navigating the Chinese Regulatory System for Drugs for Rare Diseases China Pharmaceutical Market Gains and Pains China SFDA organization and section responsibilities. Chinese Drug Regulatory Process Navigating the Chinese Regulatory System with Rare Disease Drug Applications Qansy Salako, Director, Regulatory Affairs (International), Genzyme, a Sanofi Company India, Emerging Region for Clinical Development Outsourcing with Special Reference to Ethical, Regulatory and Political Constraints CN Ramchand President & CEO, Laila Pharmaceuticals Pvt Ltd, India The CRO Market Landscape in India, China and the Emerging Asia-Pacific What does the CRO landscape look like in the major and emerging markets in Asia-Pacific? How is the landscape expected to change over the next 5 and 10 years and what factors will influence this? What are the CRO strategies employed by the MNCs looking to grow their markets in the region? Christopher Milne, Director Research, Tufts CSDD, Tufts University Lunch One-to-One Meeting at 13.30

4 Agenda Day One Monday 4 th March th China Clinical Trials Outsourcing Congress Differences between US, EU and Chinese Approval Processes Monitoring compliance Aligning clinical development, medical affairs and regulatory affairs to enhance clinical trial design Earl Hulihan, Principal, ew hulihan and associates and Professorships with U.M.D.N.J., S.U.T.C.M., and S.F.D.A. Institute of Educational Development Panel Discussion: Critical Factors to Organizing a Successful Clinical Trial in China Cultural factors and local practice Operating efficiently Vendor management and communication James Cai, Medical Director, Roche Solution Provider Presentation Sponsored by: 3 rd Asia Clinical Trials Outsourcing Congress Integrate and Implement Biomarker Strategy into Asia Clinical Trials Either as Part of the Global Trials and Independent Regional Trials Oncology drug development Yaping Shou, Medical Director, Clinical Research, Millennium: The Takeda Oncology Company Panel Discussion: Future of Clinical Trials and Outsourcing to Asia Opportunities for outsourcing to Asia Which non-chinese country is best to outsource to Cost comparisons Cultural influences Fidela Moreno, Former Vice President, Global Development Operations Allergan Solution Provider Presentation Jim Wei, Medical Director, Medpace Afternoon Refreshments One-to-One Meetings Poster Presentation Sessions How to Conduct an Orphan Drug Trial in China - Pirfenidone for Idiopathic Pulmonary Fibrosis China SFDA has published guideline for "Special Review" on new drugs (Class 1) for orphan indications. However, due to the limited number of patients and the lack of accurate diagnostics, conducting such trials in China still faces big challenges today. To avoid time-consuming miscommunication among regulatory agencies, the company, and the clinitrial hospitals, Shanghai Genomics built its own CRA and regulatory team in a fast-changing environment. This method has been proved to be one of the most efficient and economical ways for Class 1 drug development in China. We also intend to use this hardto-build infra-structure for future collaboration with international partners. Expansion into Asia from the Perspective of Biotech Outsourcing Samy Tadros, Associate Director Strategic Sourcing, Celgene Ying Lou, Chairman, President and Chief Executive Officer, Shanghai Genomics, China Roundtable Discussions CRO Selection & Management Chaired by: Mark Peymer, Manager, Worldwide External R&D, Johnson & Johnson Data Management Chaired by: Susmita Gupta, Sr. CDM Project Manager, Endo Pharmaceuticals Regulatory Hurdles Chair to be confirmed Chain & Logistics Chair to be confirmed Patient Recruitment Chair to be confirmed China (General Discussion Group) Chaired by: Trine Danø Klingberg, Senior International Clinical Trial Manager, Novo Drinks Reception

5 Agenda Day Two Tuesday 5 th March Coffee & One-to-One Meetings Shared Keynote Address Risk Management in Clinical Trials Speaker to be confirmed 5 th China Clinical Trials Outsourcing Congress Focusing on Quality to Ensure Successful Global Development Ensuring the quality conduct of trials in Asia and China Challenges to conducting trials in the region Successful methods of partnering with CROs Millie Shultz, Associate Director, Clinical Operations, Millennium: The Takeda Oncology Company, China Clinical Trial Masterfile and Compliance Grace Halteh, Associate Director, Project Management - Quality and Business Solutions, Janssen Alzheimer Immunotherapy Solution Provider Presentation For sponsorship opportunities please contact Nick Best at [email protected] 3 rd Asia Clinical Trials Outsourcing Congress Establishing Relationships with Local CROs and their Changing role in the Clinical Trial Process Managing one of India s largest interventional studies outsourced to a CRO Critical success factors for high recruitment Chirag Trivedi, Associate Director Project Management & Strategic Initiatives, Sanofi, India Panel Discussion: Best Practice Techniques for Strategic CRO Selection & Management in Asia Benchmarking CROs Global v local What to expect from a local CRO Critical trial and vendor capability criteria Ensure correct relationship is formed Chaired by: Brian York, Director and Regional Head Asia/ Latin America; Global Head Payments & Pricing, Amgen Mark Peymer, Manager, Worldwide External R&D, J&J Chirag Trivedi, Associate Director Project Management & Strategic Initiatives, Sanofi, India Fernando Bognar, Asia Pacific Regional Director Medical Affairs Hepatitis, Merck, Hong Kong Solution Provider Presentation For sponsorship opportunities please contact Nick Best at [email protected] Morning Refreshments One-to-One Meetings Poster Presentation Sessions Oncology Clinical Trials in China Strategically include China in global development strategies for anti-cancer drugs the importance of early phase development Translational medicine capability and capacities and its impact on targeted agent development Build up academia-industry-government alliance to expedite cancer drug development in China US Chinese Anti-Cancer Association Pharmacovigilance and Patient Safety During Clinical Trials in Asia and how this Varies from Trials in Europe and the USA Frank Hong, Executive Director, Clinical Risk Management, Novartis Li Yan, Head of Clinical Development, Infectious Disease, Respiratory & Immunology, Oncology, Emerging Markets, Merck

6 Agenda Day Two Tuesday 5 th March Shared Panel Discussion: Successfully Running Oncology Clinical Trials In Asia Panel Chair: Li Yan, Head of Clinical Development, Infectious Disease, Respiratory & Immunology, Oncology, Emerging Markets, Merck Roger Luo, Director, Translational Medicine & Early Clinical Development, Oncology R&D, Janssen Pharmaceutical Company of Johnson & Johnson Li Xu, Vice President, Oncology Strategy, Implementation and Oncology Operations, Pfizer Oncology Michael Shi, Senior Director, Oncology, Novartis Lunch 5 th China Clinical Trials Outsourcing Congress The Journey of Strategic Partnership with CROs in China CRO trials in China Oversight expectations Forging a compliant partnership for a win-win situation Eva Yang, Regional Head of Monitoring and Site Management, Asia Pacific. Bayer HealthCare Company, China China Experiences and Challenges: Why Novo Nordisk run trials in China Ethical challenges Regulatory challenges SFDA focus GCP Sites the pros and cons Language barrier and cultural differences Trine Danø Klingberg, Senior International Clinical Trial Manager, Nov#o Nordisk 3 rd Asia Clinical Trials Outsourcing Congress Panel Discussion - Managing Clinical Trial Operations: Patient Recruitment and Retention Chaired by: David E. Weinstein, Chief Scientific Officer, Intekrin, Inc Unity in Diversity Regulatory requirements as well as value offerings How do we harmonize and synergize the research activities in Asia Data gaps and ever increasing Burden of Disease Shift from Communicable diseases to NCDs Universal health coverage planned in Asian countries Data requirement to provide the Value proposition to the payers/policy makers etc. Public-private partnership and opportunities to provide end to end solutions Shailendra Bajpai Regional Medical Director - Diabetes (Asia), Sanofi, Singapore Assessing Consistency of Treatment Effects in Multi- Regional Clinical Trials and Considerations for Dealing with Apparent Inconsistency More and more countries accept multi-regional clinical trials as basis for approval of marketing authorization. Besides the overall study results, subgroup results from particular region of interest often are also considered to determine the applicability of the overall treatment effect to the patients in individual regions. Due to potential heterogeneity of patient populations, medical practice, and trial conduct, the consistency of treatment effects across different regions may not always apparent. In this talk, methods to evaluate the consistency and strategies to deal with the apparent inconsistency will be discussed. Junyuan Wang, Director of Biostatistics, Bristol-Myers Squibb Improving Strategic Partnerships with CROs to Obtain Better GCP Compliance Richard Malloy, Assistant Director Clinical Quality Assurance, ViroPharma Developing an Asia Clinical Trials Strategy Yide Alan Jiang, Director-Asia R&D Strategy, Sanofi-Genzyme R&D Center Title to be Confirmed Patrick Ezeh, Director Clinical Development Operations, Vertex Chairman s Closing Remarks and Conference Close Afternoon Refreshments

7 The 5 th China and Asia Clinical Trials Outsourcing Congress Global Engage Events 5 th China Clinical Trials Outsourcing Congress (March 4-5, Morristown, New Jersey, USA) 3 rd Asia Clinical Trials Outsourcing Congress (March 4-5, Morristown, New Jersey, USA) 6 th Oncology Clinical Trials in Emerging Regions (May 13-14, Prague, Czech Republic) Oncology Clinical Trials Congress (May 13-14, Prague, Czech Republic) 1 st Plant Genomics Congress (May 13-14, London, UK) 2 nd Global Clinical Trials Outsourcing Congress (May 20-21, Seoul, Korea) 6 th China & Asia Clinical Trials Outsourcing Congress (September 9-10, London, UK) 7 th Oncology Clinical Trials in Emerging Regions (October USA) 2 nd Oncology Clinical Trials Congress (October USA) 1 st Oligonucleotide & Peptide Based Therapeutics Congress (November Philadelphia, USA) 3 rd Asia Pharma R&D Outsourcing Congress (November 21-22, USA) Sponsor this event Current Supporters Sponsorship offers a number of benefits including the opportunity to meet and form partnerships with delegates on a formal and informal basis in a relaxed and professional atmosphere. There are social networking opportunities during refreshment and lunch breaks held in our exhibition area and at cocktail receptions and gala dinners. Global Engage sponsorship packages offer a wide range of attendance options to suit your budget and, as well as exhibiting and taking part in prearranged one-to-one meetings, you can also incorporate pre-event marketing, branding and speaker presentations on the main conference agenda. For more information contact Steve Hambrook, Conference Director, Global Engage Ltd. [email protected] +44 (0)

8 The 5 th China and Asia Clinical Trials Outsourcing Congress - March, Please do not cover this address, even if incorrect HOW TO REGISTER it contains your customer code Phone: +44 (0) Fax: +44 (0) Web: Mail: QR: [email protected] Global Engage, Suite B, The Kidlington Centre, Kidlington, Oxfordshire OX5 2DL, United Kingdom. Enter Your Discount Code Delegates ONE TWO THREE this place is free Mr, Mrs, Ms, Dr, Prof: First Name: Family Name: Position: Contact Organisation: Address: Mobile: Fax: Payment Details Total: Cheques should be made out to: Global Engage Ltd. Please tick here to receive an invoice in advance of payment Bank transfer IBAN: GB17 MIDL Credit Card: VISA AMEX MASTERCARD Card No: 3 digit security code: Expiry Date: Issue Date: Conference Fees Book 3 places and pay for two whenever you book. Pharmaceutical and Biotech Organisations Book before 14th December 2012 Book between December 15th, 2012 and 4th February, ($880) SAVE 515 ($824) Academic Institutions 399 ($639) SAVE 100 ($160) 795 ($1272) SAVE 270 ($432) Tel: Book between February 5th and March 4th 2013 *(Opt out of one - one meeting fee) 1065 ($1704) 499 ($799) 499 ($799) CRO and Vendor Companies 1495 ($2392) 1495 ($2392) 1495 ($2392) Venue Hyatt Morristown at Headquarters Plaza 3 Speedwell Avenue, Morristown, New Jersey 07960, USA Tel: Fax: [email protected] Web: Accommodation Hotel accommodation is not included in your fee. To reserve a room at the conference hotel, please send an to Scott Taylor at [email protected]. Other details Full Terms & Conditions are set out at THE DELEGATE BOOKING FEE INCLUDES: all meals and refreshments throughout the conference day, conference presentations, open workshop and general panel sessions and networking/social events, conference and speaker notes. *Unless you have requested the one-to-one opt out fee you agree to participate in one-to-one networking meetings. QUESTIONNAIRE: Each Delegate must complete and return a Personal and Company Details Questionnaire issued by the Organiser on receipt of the Delegate Booking Form. CONFIRMATION: If you have not received confirmation of your booking prior to the event, please call Global Engage on +44 (0) Your delegate place is not confirmed until payment is received. Payment must be received before the conference date. If payment has not been received before the conference date Global Engage reserves the right to ask for a credit or debit card guarantee of payment when you register at the conference. *BANK TRANSFER PAYMENTS: When paying by Bank Transfers quote this reference: CTOCUS (Please ensure ALL bank charges are met by your organisation) CANCELLATIONS/SUBSTITUTIONS: Delegates cancelling more than one calendar month prior to event receive a full refund, one calendar month or less prior to event there is no refund. A substitute delegate of equal standing can be nominated within a week of the event and must be approved by the Organiser in advance in order to avoid cancellation charges. ORDER CONFERENCE DOCUMENTATION: I cannot attend the conference but wish to buy the event documentation pack, which includes the speakers presentations Full documentation costs VAT. To order, complete the registration form and method of payment. Payment must be received before the documentation and password can be despatched. PROGRAMME CHANGES: Global Engage reserves the right to make any necessary alterations/ changes to the programme. Personal Data is gathered in accordance with the Data Protection Act If you do not wish to receive promotional material from Global Engage, please tick here If you do not wish to receive promotional material from the Event Sponsors, please tick here If you do not wish to receive promotional material from any other 3rd party, please tick here Please return this form with the address and customer code, clearly visible if you wish us to remove your records from our database.