4 th Annual Clinical Development and Trials Asia Congress. 5 th Annual Pharma R&D World Asia Congress

Transcription

1 Oxford Global Medical Conferences Imaging technologies are proud to present the 4 th Annual Clinical Development and Trials Asia Congress and Implementing biomarkers in co-located early phase Pharma clinical trials R&D Asia Congress to be held on the 27 th Development & 28 th January of Companion 2015 in Shanghai, Diagnostics China. Clinical Attended Trials by over 170 industry leaders in Clinical Development & Clinical Trials Development Managing in Safety Asia, and the Efficacy 4 th Annual Clinical Development and Trials Asia Congress will offer invaluable insights on successful strategies and technologies in enabling clinical development, clinical outsourcing strategies and clinical trial management. On day one hear from senior VPS and Directors in discussing clinical development strategies as well as clinical development in oncology and other therapeutic areas in China, Japan, South Korea, India, & Singapore. It will also cover key discussion on the changing regulatory environment in China and impact of this on multinational drug development activities. Do not miss out on updates in registration for multinational clinical trials and international regulatory updates including FDA breakthrough regulation, EMA RMP regulation There is also a featured enabling technologies stream dedicated to managing Clinical Development, implementing Biomarkers into Drug & clinical research, translational science and Clinical Data Management. Day two will focus on Clinical Trial Management strategies for minimising costs, bridging studies in Asia for Global Development, Safety and Pharmacovigilance and risk management. The 4 th Annual Pharma R&D World Asia congress will discuss novel scientific innovations in Discovery and Development in Asia. Topics will cover: global collaboration, changes in the model of CRO outsourcing & partnering strategies, regulation policies and drug innovation strategies. Our esteemed experts will discuss strategies to accelerate drug development timelines. 4 th Annual Clinical Development and Trials Asia Congress Day 1 Clinical Development Activities & Clinical Outsourcing Strategies Regional clinical development activities in Asia and Asia Pacific regions - China, Japan, South Korea & Singapore Clinical development activities in oncology and other therapeutic areas Selecting the correct Pharma CRO partnership for maximum success Changing regulatory environment in China and impact of this on multinational drug development activities Regulatory updates for Registration for Multinational Clinical Trials China, Japan, South Korea & Singapore Day 1 - Featured Technology Stream Enabling Technologies for Drug Development and Personalised Medicine Imaging biomarkers: bridging preclinical and clinical research Medical Imaging technologies Implementing biomarkers in early phase clinical trials Development of Companion Diagnostics in Clinical Trials Biometrics in Asia Pacific Clinical Trials Clinical Data Management Day 2 Clinical Trials Management Strategies in Asia and Asia Pacific Regions Implementing successful patient recruitment and retention strategies Opportunities of bridging studies in Asia for Global Development Country and site selection for global clinical trials Managing clinical trials in oncology and other therapeutic areas Ensuring pharmacovigilance and patient safety in clinical trials in Asia Managing Safety and Efficacy VP and Director Panel Discussion Topics PANEL 1: Will Asia Produce in Regards to Drug Development PANEL 2: Regulatory updates for Registration for Multinational Clinical Trials China, Japan, South Korea & Singapore PANEL 3: Innovation Strategies to Advance R&D in Asia PANEL 4: CRO - R&D Collaborations and Business Models 5 th Annual Pharma R&D World Asia Congress Day 1 - Innovation Strategies to Advance R&D in Asia R&D collaborations between East & West Guaranteeing successful outsourcing partnerships Successful business models in CRO partnership Multi-national pharma companies in emerging markets International regulatory updates including FDA breakthrough regulation, EMA RMP regulation Targeted Therapy & Molecular Targeted Drugs Drug development in oncology and other therapeutic areas Novel methods to accelerate drug development pipeline In licensing strategies

2 Clinical Asia and R&D Asia Confirmed Speakers 2015: Zhengqing Li, VP and Head of China Development MSD Cezary Statuch, Vice President of R&D, Bristol-Myers Squibb, China Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiovascular Risk Management and Women s HealthCare, Bayer HealthCare Company Limited Global R&D Centre Oliver Kong, Senior Director, Clinical Development Oncology, Celgene Corporation Akhilesh Sharma, Senior Vice President & Global Head Global Medical Affairs, Dr. Reddy's Laboratories India Victoria Elegant, Vice President of Medical & Regulatory Affairs, Baxter, China Dejun Tang, Site Head, Biometrics & Statistical Sciences and Methodology. Novartis, China Wei Wang, Associate Director, Safety Surveillance and Risk Management, Pfizer, China Yong-jiang Hei, Executive Medical Director, Amgen China Jagdev Sidhu, Senior Director Clinical Pharmacology & Pharmacometrics,CSL Limited Patrecia Valone, Senior Director, Development Operations, Takeda Development Center Asia and Takeda Shanghai Development Center Hua Mu, Senior Vice President, Global Head of Product Development Service and Partnership Business Unit, WuXi AppTec (Shanghai) Co., Ltd Jessie Gu, Head, Translational Medicine China, Novartis Institute for Biomedical Research, China Ming Ji, Sr. Medical Director, Medical Safety Evaluation, AbbVie Jason Yang, Senior Vice President, Head of Clinical Development, BeiGene(Beijing)Co., Ltd Yingmei Tu, Clinical Research Director, Merck Ralf Altmeyer, Director General, Institut Pasteur Shanghai, Chinese Academy of Sciences Yan Wu, Executive Director, Head of Clinical Operations and Drug Safety, Hutchison Medi Pharma Jennifer Huang Executive Director, Head of Global Clinical Trial Operations, Merck Research Laboratories R&D (China) Ltd Jingsong Wang, Head of China R&D, Head of Translational Medicine, Asia Pacific, Sanofi Chih-Liang Chin, Director and Site Lead, Imaging, Merck Singapore Frank Grams, VP, Head Alliance Management & Transactions, Sanofi R&D David Tattersall, Director, Neurodegeneration Parkinson's Disease Group, GSK R&D China Shanghai Mingde Xia, Senior Director, Johnson & Johnson Innovation Center, Asia Pacific Jenny Wei, Head of R&D Information Asia & EM, Innovation Center China, AstraZeneca Global R&D Zheng Li, General Manager, Head of Research China, Lundbeck Jun Bao, Senior Vice President and Chief Business Officer, Shenogen Pharma Group Jian Li, Director, Partnering and External Innovation - Asia Pacific, Sanofi R&D Yariv Hefez, Vice President Business Development, Portfolio Management, Strategy and Partnering, Biosimilars Unit, Merck Zhenping Wu, Senior Vice President, Pharmaceutical Sciences, Hutchison Medi Pharma Ming Guo, Co-Founder & COO, Ascentage Pharma Amar Kureishi, Chief Medical Officer and Head of Drug Development, Quintiles Asia Event Sponsor:

3 Hear from our 2015 Speakers: Cezary Statuch BMS Zhengqing Li MSD Yong Hei Amgen David Tattersall GSK Jingsong Wang Sanofi Patrecia Valone Takeda Jagdev Sidhu CSL Akhilesh Sharma Dr Reddy s Lab Who You Will Meet 175 senior attendees from leading academic institutions, pharmaceutical organisations and biotechnology companies will be attending. Meet VPs, Directors & Senior Managers with the following job titles: Clinical Research Clinical Biomarkers Clinical Supply Chain Safety In licensing Clinical Outsourcing Clinical Trial Management Personalised Medicine Regulatory Affairs Business Development Clinical Operations Clinical Development Translational Medicine Preclinical Development Biomarkers Patient Safety Medical Affairs Research and Development Discovery Data Management Networking And Business Meeting Opportunities Meet face-to-face with leading solution providers and senior-level industry peers through a series of formal and informal networking opportunities. Categories of solution provider include: Clinical Testing Supply Chain Management Cold Chain Management PKPD Clinical Trial Design Regulatory Compliance Outsourcing Strategies Imaging Solutions & Management Translational Research Companion Diagnostics Discovery Solutions Assay Development Patient Selection Biomarker solutions Data Management Biometric

4 4 th Annual Clinical Asia Congress & 5 th Annual Pharma R&D Asia Congress Day One 27 th January Registration: The Atrium Conference Room: New Asia Ballroom 1 - Oxford Global s Welcome Address Chairperson s Opening Address Directors and VPs Panel Discussions Directors and VPs Panel Discussion Will Asia Produce in Regards to Drug Development Drug development in Asia is undergoing significant changes these days (regulatory, clinical, operational, etc.) and many companies are now experiencing a gap in terms of seeing results from significant investment in the region. Investments in infrastructure and development programs in Asia (sites and patients) have been made. The panel will discuss challenges in the productivity of sites, quality of production, and the changing regulatory environment in China, and will also rethink Development strategies for Multinationals.. Confirmed Panel Moderator: Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiovascular Risk Management and Women s HealthCare, Bayer HealthCare Company Limited Global R&D Centre Confirmed Panel: Cezary Statuch, Vice President of R&D, Bristol-Myers Squibb, China Akhilesh Sharma, Senior Vice President & Global Head Global Medical Affairs, Dr. Reddy's Laboratories India Yong-jiang Hei, Executive Medical Director, Amgen China Zhengqing Li, VP and Head of China Development, MSD Directors and VPs Panel Discussion Changing Regulatory Environment in China and Impact of this on Multinational Drug Development Activities Confirmed Panel Moderator: Cezary Statuch, Vice President of R&D, Bristol-Myers Squibb, China Confirmed Panel: Victoria Elegant, Vice President of Medical & Regulatory Affairs, Baxter, China Michael Rozycki, Vice President, Regulatory Affairs Asia Pacific, Allergan (TBA) Ming Guo, Co-Founder & COO, Ascentage Pharma Innovation Strategies to Advance R&D in China and Asia Open Innovation / Collaboration Strategy (east-west, academia-industry, company-company, private-public, incubator, consortium, co-investment, etc). Collaboration models (PPP, risk sharing) Innovation Strategies to boost China as a global R&D center Successful business models in Pharma R&D The role of MNC vs local companies in developing China as a Global R&D source What does the future hold, China in 2024 Panel Moderator: Jingsong Wang, Head of China R&D, Head of Translational Medicine, Asia Pacific, Sanofi Confirmed Panel: Mingde Xia, Senior Director, Johnson & Johnson Innovation Center, Asia Pacific Zheng Li, General Manager, Head of Research China, Lundbeck Jian Li, Director, Partnering and External Innovation - Asia Pacific, Sanofi R&D Yariv Hefez, Vice President Business Development, Portfolio Management, Strategy and Partnering, Biosimilars Unit, Merck Jun Bao, Senior Vice President and Chief Business Officer, Shenogen Pharma Group Directors and VPs Panel Discussion R&D Collaborations - The Changing Nature of CRO and Sponsor Relationships Type of R&D collaboration how the CRO is changing their model of support for domestic local clients and multinational clients Are the collaboration/business models different for China based clients versus that of other regions Training and dealing with workforce to sustain success in collaborations

5 CRO - innovative models of service offerings Selecting the Right Pharma CRO partnership for Maximum Success Confirmed Panel: Frank Grams, VP, Head Alliance Management & Transactions, Sanofi R&D David Tattersall, Director, Neurodegeneration Parkinson's Disease Group, GSK R&D China Shanghai Solution Provider Presentation For enquiries, please sponsorship@oxfordglobal.co.uk Exhibition Room: The Atrium Morning Coffee & Refreshments One to One Meetings x3 R&D Asia Congress Innovation Strategies to Advance R&D in Asia Clinical Asia Congress Clinical Development Activities & Clinical Research Outsourcing Strategies Enabling Technologies for Drug Development and Translational Medicine Conference Room: New Asia Ballroom 1 Conference Room: New Asia Ballroom 2 Conference Room 3: Stream Chair: Stream Chair: Stream Chair: New Drug Development, Global Health Trends and the Future of Bio-Pharma in Asia CONFIRMED: Amar Kureishi, Chief Medical Officer and Head of Drug Development, Quintiles Asia Solution Provider Presentation Global vs Local: Clinical Development, Clinical Trials & CRO Selection CONFIRMED: Yan Wu, Executive Director, Head of Clinical Operations and Drug Safety, Hutchison Medi Pharma Biomarkers in Early Clinical Development The key focus on early clinical development is achieve go vs. no go decision, early readout of intended pharmacological activities is critical. Well mapped biomarker strategy is must to have to achieve such goal. In addition of assessing pharmacological or intended biological activities, biomarker has been used routinely for patient selection and stratification. Validating and implementing biomarker strategy are essential for effective early development CONFIRMED: Zaiqi Wang, Head of Clinical Research, Merck, China Exhibition Room: The Atrium Lunch Hutchison Medi Pharma s Drug Development Pipeline and Innovation in China and other regions of Asia CONFIRMED: Zhenping Wu, Senior Vice President, Pharmaceutical Sciences, Hutchison Medi Pharma Regional Clinical Development in Asia and Asia Pacific Regions CONFIRMED: Yingmei Tu, Clinical Research Director, Merck Biomarker Development In Clinical Trials Design in Oncology CONFIRMED: Oliver Kong, Senior Director, Clinical Development Oncology, Celgene Corporation

6 Innovative Collaboration In Pharmaceutical R&D - managing our global network of alliances CONFIRMED: Frank Grams, VP, Head Alliance Management & Transactions Sanofi R&D Exploring and Applying Innovative Strategies and Models to Pursue Effective New Drug Development in China CONFIRMED: Hua Mu, Senior Vice President Global Head of Product Development Service and Partnership Business Unit, WuXi AppTec (Shanghai) Co., Ltd Implementing Biomarkers in Clinical Development in China CONFIRMED Jessie Gu, Head, Translational Medicine China, Novartis Institute for Biomedical Research, China Conference Room: New Asia Ballroom 1 Conference Room 2: New Asia Ballroom 2 Conference Room Drug Development in Asia - Regulatory Strategies and Clinical Plan Key Developments in Regional and Global Clinical Trial Activities & Clinical Research Outsourcing Strategies Regulatory Requirements Clinical plans for Global Clinical Studies CONFIRMED: Jason Yang, Senior Vice President, Head of Clinical Challenges and Opportunities CONFIRMED: Ralf Altmeyer, Director Development, BeiGene(Beijing) Co., Ltd General, Institut Pasteur Shanghai, Chinese Academy of Sciences Exhibition Room: The Atrium Afternoon Refreshments One to One Meetings x Development of Translational Imaging Biomarker for Drug Discovery and Development Leverage advanced imaging technologies to understand disease biology and validate novel therapeutic targets Develop biomarkers using multi-modality imaging approaches across species to de-risk clinical development Enable early GO/No-Go decisions using translational imaging biomarkers in animal models of human disease and humans. CONFIRMED: Chih-Liang Chin, Director and Site Lead, Imaging, Merck Singapore Cardiovascular Drug Development: Cardiogenomics and Asia, is there Potential for a Personalized Approach to Medical Care? CONFIRMED: Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiovascular Risk Management and Women s HealthCare, Bayer HealthCare Company Limited Global R&D Centre Companion Diagnostics Development in Both Preclinical and Clinical Context Tero Laulajainen, RPD Global Head of Clinical Operations, Roche Diagnostics International Ltd, Switzerland Biometrical Challenges in Asia Pacific Clinical Trials Current status of biometrics applications in clinical trials including Asia Quantitative trial design and decision making Challenges due to new innovations and health authority requirements Difference in challenges for global pharma and domestic ones Impact from big data and its applications CONFIRMED: Dejun Tang, Head of Integrated Information Sciences, Site Head, Biometrics & Statistical Sciences and Methodology. Novartis, China Exhibition Room: The Atrium Networking Drinks End of Day One

7 4 th Annual Clinical Asia Congress & 5 th Annual Pharma R&D Asia Congress Day Two 28 th January 2015 Clinical Asia Congress Conference Room 2: New Asia Ballroom Patient Recruitment Strategies: Does One Size Fit all Globally? Can learning from the global operations be translated into effective local strategy The inter-geography variations In patients factors impacting recruitment and retention Perceived differences by investigator s & patients between a generic and innovator product study impacting patient drop-outs Broad guidelines to improve patient retention in clinical trials across geographies CONFIRMED: Akhilesh Sharma, Senior Vice President & Global Head Global Medical Affairs, Dr. Reddy's Laboratories India Solution Provider Presentation For enquiries, please sponsorship@oxfordglobal.co.uk Exhibition Room: The Atrium Morning Coffee & Poster Presentations Poster Presentation Sessions Optimization of the Clinical Trial Conduct CONFIRMED: Jennifer Huang, Executive Director, Head of Global Clinical Trial Operations, Merck Research Laboratories R&D (China) Ltd Clinical Trials in Neurodegenerative Diseases especially Parkinson's Disease CONFIRMED: David Tattersall, Director, Neurodegeneration Parkinson's Disease Group, GSK R&D China Shanghai Developing Clinical Investigators and Sites in Asia & Pacific Region for Global Studies CONFIRMED: Jenny Wei, Head of R&D Information Asia & EM, Innovation Center China, AstraZeneca Global R&D Solution Provider Presentation Lunch - Exhibition Room: The Atrium An Alternative Perspective to Clinical Development: Challenging the Norm with Pharmacometrics CONFIRMED: Jagdev Sidhu, Senior Director Clinical Pharmacology & Pharmacometrics, CSL Limited Australia Opportunities of Bridging Studies in Asia for Global Development CONFIRMED: Patrecia Valone, Senior Director, Development Operations, Takeda Development Center Asia and Takeda Shanghai Development Center Lucitanib, A FGFR, VEGFR, PDGFR Inhibitor in Solid Tumor Introduction of Haihe, A translation/clinical development platform Our collaboration with Servier-the develop of lucitanib - trial in Europe - trial in China CONFIRMED: Lei Jiang, CEO, Shanghai HaiHe Pharmaceutical Co., Ltd Exhibition Room: The Atrium

8 Afternoon Refreshments Practical Considerations For Benefit-Risk Assessments Benefit risk evolves throughout the life-cycle of a drug Signal detection is an ongoing process where no single method will meet all needs and all circumstances All potential signals need to be documented, systematically investigated, and appropriately addressed Pharmaceutical companies cannot effectively monitor the safety of their products without the close cooperation of Health Authorities, healthcare professionals and patients An effective risk management system is the key to maximizing patient benefits while minimizing their risk CONFIRMED: Wei Wang, Associate Director, Safety Surveillance and Risk Management, Pfizer China Research & Development Center, China Managing Pharmacovigilance and Patient Safety Practices for Global Studies, given Ethic and Regulatory Differences CONFIRMED: Ming Ji, Sr. Medical Director, Medical Safety Evaluation, AbbVie End of Conference