3 CO LOCATED CONFERENCES

Transcription

1 IBC LIFE SCIENCES TEAM REGISTRATION BENEFITS! SEE REGISTRATION PAGE FOR DETAILS. PART OF 3 CO LOCATED CONFERENCES 45+ SPEAKERS 200+ PARTICIPANTS 2017 SPEAKERS LINE-UP INCLUDE: KEYNOTE PJ Chen Vice President of Global Clinical Development United Neuroscience, Taiwan Bertil Lindmark Chief Medical Officer ASLAN Pharmaceuticals, John Wilbanks Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and FasterCures, USA TEDGlobal 2012 Speaker on Let s Pool Our Medical Data Sumitra Sachidanandan GCP Inspection Consultant, Clinical Trials Branch, Health Products Regulation Group Health Sciences Authority, Melvin Sanicas Regional Medical Expert - Asia & JPAC Sanofi Pasteur, James Garner Chief Executive Officer Novogen, Australia Ritika Bajaj Associate Director, Global Clinical Trial Operation MSD Pharmaceuticals, India THIS WAS A FANTASTIC GATHERING AND A VERY WELL ORGANIZED EVENT. WOULD LOVE TO ATTEND THIS IN FUTURE. KEEP UP THE GOOD WORK! Rahul Mongia, Consultant, ICRIER, India Kurt Lackovic Chief Executive Officer Cancer Trials, Australia Professor Pierce Chow Professor, Duke-NUS Graduate Medical School, Senior Consultant, Division of Surgical Oncology, National Cancer Centre, Milan Paleja Country President and General Manager Novartis, Indonesia Vincenzo Teneggi Senior Medical Director D3 (Drug Discovery & Development) A*STAR, PRODUCED BY: ASSOCIATE SPONSOR: SESSION SPOTLIGHT SPONSOR: LANYARD SPONSOR: EXHIBITORS:

2 CONFERENCE DAY ONE WEDNESDAY 20 SEPTEMBER, Main Conference Registration Opens and Morning Coffee 0850 Welcome Address from IBC Asia 0900 Chairperson s Opening Remarks PHARMACON OPENING PLENARY SESSION Joint Session with Pharmaceutical Market Access & Pricing Summit and Pharmaceutical Regulatory Affairs Asia 9:10 KEYNOTE: From Trials to Table The Move Towards a More Patient-Centric Approach John Wilbanks Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman, Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on Let s Pool Our Medical Data John Wilbanks seeks to transform and innovate medical research by accelerating data sharing between clinical studies. As the Chief Commons Officer at Sage Bionetworks, he is in-charge of figuring out how to design policies and technologies that allow health and biological data to be broadly share between patients, clinicians and data analysis. Sage Bionetworks has put their open source toolkit innovation to the test by designing an application to conduct a set of Sage Bionetworks mobile research studies enrolling more than 100,000 participants in less than two years and integrated into more than 25 studies outside of Sage, including the US Precision Medicine Initiative. To view John s talk at TEDGlobal 2012, click here 0940 Drug Development, Pricing and Access Bringing Together the Technical, Regulatory and Economic Considerations Patient centric drug development and access ROI drivers, and outlook for the clinical research and drug development market Regulatory priorities across the pharma value chain Drug pricing developments Regulatory updates - harmonization, new policy, clarity and speed in licensing, submission and approval What are drug development ROIs looking like, and new partnership models for better harnessing ROIs Panellists: Milan Paleja, Country President and General Manager, Novartis, Indonesia Eva Kopecna, Sr Dir Generics Reg Affairs Global OTC, Teva Pharmaceuticals International GmbH, Switzerland Li Ling Liu, Director, Good Registration Management (GRM), Researcher, Deputy Director General Minister Office, Chinese Taipei Food and Drug Administration (TFDA), Taiwan Qing Xi, Senior Director, Government Affairs, Market Access & Communications, Pfizer, China Jean-François Baladi, Senior Executive Director, Health Economics and Market Access, Novartis Pharma K.K., Japan THOUGHT LEADERSHIP ROUNDTABLE 1030 Morning Networking and Refreshment Break ACCELERATING CLINICAL TRIALS IN ASIA THROUGH TECHNOLOGY ADVANCEMENT, REGULATORY REFORMS AND OPERATIONAL EFFICIENCY 1110 Chairperson s Opening Remarks ASIAN MARKET TRENDS 1115 Asia s Role in Novel Drug Development Clinical trials market in Asia, patient pools and regulatory aspects How is Asia shaping novel drug development? The need for diversity in clinical trials Novel drug trials pipelines and opportunities James Garner, CEO, Novogen, Australia 1200 Recent Regulatory Changes and the Impacts on Clinical Trial Efficiency in Asia Recent update of regulatory changes in Asian countries How to increase clinical trial efficiency, with a focus on clinical trial start up Harmonising these changes with clinical trial operations for pan-asian Multi- Regional Clinical Trials(MRCT) Yooni Kim, Executive Director, Asia Operations, Novotech, South Korea 1230 Networking Lunch 1330 Emerging Roles in China Cancer Clinical Trial Development Evaluating gap analysis of talents in clinical trial professional Possible impact of the latest CFDA s regulation to hasten clinical trial approval Selection of qualified sites with the right PIs, right infrastructure capability and right competency in China CHINA MARKET UPDATE Preparation and proposal to raise the standards of qualified professionals Dr C.S. Chen, Executive Director - Cancer Center, Acting Chief of Medicine, Shanghai Jiahui International Hospital, China and and Consultant, Massachusetts General Hospital, Boston, USA 1400 Challenges from Local Sponsors Entering Their First Few Global or Regional Clinical Trials Adopting big pharma mindset to the local clinical development team Adapting existing service delivery models used by service providers to cater to needs and scale of operation of evolving local sponsors Key considerations for local sponsors going global GOING GLOBAL Kevin Cheong, Director, Clinical Operations - Asia, ALMAC Pharmaceutical Services, LLC, 1430 Regional Regulatory Update Vietnam: Recent Regulatory Updates on Clinical Trials A Senior Representative from Drug Administration of Vietnam Malaysia: Regulatory Pathways that Support Phase 1 Clinical Trials Senior Representative from National Pharmaceutical Regulatory Agency TECHNOLOGY AND BIG DATA IN CLINICAL TRIALS 1500 ICH GCP E6 (R2) Addendum and Its Impact Quality systems in clinical trials Key changes for Sponsors, Investigators and CROs to note Sumitra Sachidanandan, GCP Inspection Consultant, Clinical Trials Branch, Health Products Regulation Group, Health Sciences Authority, 1530 Afternoon Networking and Refreshment Break 1600 Modelling and Simulation Techniques: Value-Focused Drug Development Strategies through Data and Technology Practical tech application of modelling and simulation techniques in developing drugs strategies Regulatory and technology strategy to support drug development programme Importance of biosimulation framework to support strategic-level decision making Craig R. Rayner, President, d3 Medicine, A Certara Company, Adjunct Associate Professor, Monash University - Monash Institute of Pharmaceutical Sciences, Australia 1630 Capitalizing on Big Data for Better Clinical Outcomes to Speed Up Access for Patients Optimizing R&D efficiency and speeding up access to patients through big data Effective use of clinical data in R&D stage Healthcare system: paradigm shift towards value and outcomes Outcome focus: example of public private partnership in Hematology Tay Salimullah, Global Pricing and Market Access Director in Cell and Gene Therapies, Novartis, Switzerland 1700 Placing Your Digitalization Bets What Does It Take to Launch Digital Clinical Trials? Defining the specific needs of all clinical trials stakeholders Defining and implementing a digital clinical trial strategy Evaluating and incorporating the ongoing digital plans into overall digital clinical trial strategy For Speaking Opportunity, please contact Ariel.Tan@ibcasia.com.sg 1720 Assessing New Technology and Incorporating Digital Health in Your Clinical Trial Strategy Around-the-Pill VS Beyond-the-Pill application Accessing new technology scalability with novel digital health initiatives Key challenges of implementing and how to overcome it For Speaking Opportunity, please contact Yvonne.Leong@ibcasia.com.sg 1740 Leveraging Data and Technology as Key Enabler in Raising Clinical Trials Efficiency and Safety Digitalization and Big Data is the Asian market ready to embrace disruption? How do we anticipate and prepare for digital disruption in clinical trials? Effective applications of clinical and big data to achieve patient-centric trial outcomes Leveraging on Asian population and genomic profiling for drug development Rethinking clinical trials across Sites, Sponsors, CROs and Patients Panellists: Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, Melvin Sanicas, Regional Medical Expert - Asia & JPAC, Sanofi Pasteur, Akhmal Yusof, Chief Executive Officer, Clinical Research Malaysia, Malaysia PANEL DISCUSSION 1815 Chairperson s Summary of the Day and End of Conference Day 1

3 CONFERENCE DAY TWO THURSDAY 21 SEPTEMBER, Chairperson s Opening Remarks ESTABLISHING OUTSOURCING STRATEGIES 0910 Strategic Alliance Partnership with CROs - the Specialized, the Regional, the Multinational Optimizing collaboration between key stakeholders Common pitfalls associated with forecasting and budgeting for clinical trials and how to overcome Changing business model with diversified outsourcing alliances PJ Chen, Vice President of Global Clinical Development, United Neuroscience, Taiwan 0940 Myth vs. Reality, Optimizing the Relationship Between Sponsors and CROs Cost, Quality, Governance, and Effectiveness The fallacy of cost vs. price Managing expectation and effective execution Lowest total delivered cost as a guiding principle Jeffrey Scott Yablon, Vice President and General Manager, Asia Pacific, InClinica Sdn. Bhd., Malaysia 1010 Morning Tea Break 1040 Leveraging on CRO Partnerships for Clinical Innovations Developing drug development strategies Scientific leadership Technologies development Mary Pan, Vice President, Asia Pacific, ICON Plc, CLINICAL INNOVATION 1110 Is Working with Academic Research Organizations (AROs) a Good Model in Emerging Countries? Establishing credibility and ease of doing business Advantages of working with regulators and facilitation of submissions Access to sites with highly qualified investigators and tertiary care level facilities Asita de Silva, Director, Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Sri Lanka 1140 Implementation of Innovative (Model-based) Design in Early Clinical Development Studies (Phase 1/First-in-) Across Regions Targeted drugs request a better definition of safety profile Perceived complexities Model-Based study design and contribution to the goal Vincenzo Teneggi, Senior Medical Director, D3 (Drug Discovery & Development) A*STAR, 1210 Networking Lunch 1310 Data Sharing Framework and Platform for Collaboration on Data Sharing: How Can The Industry Prepare for This? Clinical Trial Data: Current frameworks for data sharing and harmonization, challenges, and important considerations Case studies: Learning points from academia to industry the importance of speaking a common language Looking forward: Remembering the end goal - how do we get there? Chang Mei Ling, Manager, Regulatory Affairs and Clinical Data Management, Tessa Therapeutics, 1340 The Pains and Gains of Running Multi-Centre, International Investigator Initiated Trials The role of investigator-initiated trials The unique challenges of investigator-initiated trials in the Asia-Pacific A model of public-private partnership Pierce Chow, Professor, Duke-NUS Graduate Medical School / Senior Consultant, Division of Surgical Oncology, National Cancer Centre / Senior Consultant, Department of Hepatopancreatobiliary / Transplant Surgery, General Hospital PI S PERSPECTIVE OPERATIONAL EFFICIENCY 1410 Cancer Trials Australia Enabling Clinical Trials Through Strong Clinical Networks and Operational Efficiency Harmonization and efficiency in coordinated feasibility responses, ethics and governance submissions and trial administration Phase 1 specialists, including first-time-in-human process developed by CTA Comparative advantage of conducting clinical trials in Australia Kurt Lackovic, CEO, Cancer Trials Australia 1440 Integrating Quality Management in Day-to-Day Operations Supporting global clinical operations Innovative ways to improve operation efficiency Ways to improve communication and transparency amongst all stakeholders Ritika Bajaj, Associate Director, Global Clinical Trial Operations, MSD Pharmaceuticals, India 1510 Afternoon Networking and Refreshment Break 1540 Implementing Risk-Based Remote Monitoring for Clinical Trials in Asia CASE STUDY For Speaking Opportunity, please contact Ariel.Tan@ibcasia.com.sg 1610 Finding an Efficient And Cost-effective Operating Model Sponsors expectation vs CROs expectation Ways to accelerate study start up Optimizing site and patient engagement For Speaking Opportunity, please contact Ariel.Tan@ibcasia.com.sg 1640 Chairperson s Summary of the Day and End of Conference THE MEETING WE JUST HAD WAS GOOD, WELL- ATTENDED AND LIVELY! Dr Alex Matter, CEO, Experimental Therapeutics Centre & D3, A* Star

4 PRE-CONFERENCE WORKSHOP TUESDAY 19 TH SEPTEMBER AM 4PM Clinical Data Management About the Workshop: Clinical trial data right from collection, validation, evaluation and reporting according to protocol and international guidelines is a critical phase in clinical research. It can lead to generation of high-quality, reliable and statistically sound data from clinical trials. Applying big-data strategies can heighten the chance of making better informed decisions right from drug discovery and raise efficiency of clinical trials. Key Learning Points: Identifying project data management goals Plan, prepare and conduct data collection and validation How to handle data inconsistencies Implement proper SOP for data management Data entry and Query tracking Avoiding potential mistakes to produce high quality data Drawing effective end-to-end data integration framework POST-CONFERENCE WORKSHOP FIRDAY 22 ND SEPTEMBER AM 4PM Risk Management in Clinical Trials About the Workshop: This essential one day course will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection in this area. Key Learning Points: Understand the importance of using risk analysis and risk management techniques in clinical trials Learn how to identify, evaluate and implement specific risk-based techniques for risk management used in clinical trials Risk-based Quality Management System key elements, risk-based tools, approaches to monitoring and data handling WHO WILL YOU MEET WHAT THEY SAY ABOUT US BY INDUSTRY Pharma & Biotech...65% CROs...15% Government & Regulators... 3% Hospitals/Trial Sites/ Research Institutes & Centers... 6% Technology & Solution Providers...11% THE EVENT IS WELL ORGANIZED AND BENEFICIAL, ESPECIALLY IN UNDERSTANDING THE LEGAL ASPECTS OF CONDUCTING CLINICAL TRIALS IN THIS REGION. Dr. Normando E Iznaga-Escobar, Chief Scientific Officer, Innokeys Pte Limited BY COUNTRY /Malaysia...59% South East Asia... 3% Japan/Korea/ Taiwan/China/ Hongkong... 18% India... 4% Europe/USA...13% Australia... 3% MEDIA PARTNERS

5 THE ONLY PLATFORM COVERING REGIONAL COUNTRY UPDATES, ACCELERATING CLINICAL TRIALS IN ASIA ZEROES IN ON NEW OPPORTUNITIES AND OPERATIONAL INNOVATION IN THE BURGEONING TRIAL MARKETS WITHIN ASIA PACIFIC. Balanced with commercial information on Pharma spend areas and growth segments, this is your one-stop shop to accelerate cost-efficient clinical development. Part of PharmaCon Asia Congress, this is Asia s only such conference that will put the spotlight on commercial, operational and compliance issues over the two days. PHARMACON ASIA AT A GLANCE Pre-Conference Workshop Conference Day 1 Conference Day 2 Opening Plenary Sessions Networking Cocktails Post-Conference Workshop THOUGHT LEADERSHIP KEYNOTE! JOHN WILBANKS Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and FasterCures, USA TEDGlobal 2012 Speaker on Let s Pool Our Medical Data RAISE YOUR BRAND AWARENESS AT ASIA S TOP CLINICAL TRIALS EVENT! We offer a variety of opportunities to raise your profile with some of the most influential people in the clinical trials industry. Shape the Debate John Wilbanks seeks to transform and innovate medical research by accelerating data sharing between clinical studies. As the Chief Commons Officer at Sage Bionetworks, he is in-charge of figuring out how to design policies and technologies that allow health and biological data to be broadly share between patients, clinicians and data analysis. Present a keynote, case study, or contribute to a panel Sage Bionetworks has put their open source toolkit innovation to the test by designing an application to conduct a set of Sage Bionetworks mobile research studies enrolling more than 100,000 participants in less than two years and integrated into more than 25 studies outside of Sage, including the US Precision Medicine Initiative. Hospitality and Hosting View John s talk at TEDGlobal 2012 here Be an Exhibitor Demonstrate your products and engage with customers VIP Lunch, Closed door workshop, Refreshment breaks and many other options Brand Awareness Through the Smartphone App, Corporate Gifts, etc. WE WOULD BE GLAD TO DISCUSS CUSTOMISED OPTIONS THAT WOULD SUIT YOUR BUDGET, AND HELP ACHIEVE YOUR DESIRED MARKETING OBJECTIVES. For more information about how you can leverage on our events to optimise your marketing budget, and reach your target audience please contact: Ms. Yvonne Leong at Tel: l M: l Yvonne.Leong@ibcasia.com.sg