IBC LIFE SCIENCES PRODUCED BY: ASSOCIATE SPONSOR: SESSION SPOTLIGHT SPONSOR: LANYARD SPONSOR: EXHIBITORS: PART OF 19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore Bertil Lindmark Chief Medical Officer ASLAN Pharmaceuticals, Singapore PJ Chen Vice President of Global Clinical Development United Neuroscience, Taiwan James Garner Chief Executive Officer Novogen, Australia Sumitra Sachidanandan GCP Inspection Consultant, Clinical Trials Branch, Health Products Regulation Group Health Sciences Authority, Singapore Ritika Bajaj Associate Director, Global Clinical Trial Operation MSD Pharmaceuticals, India Melvin Sanicas Regional Medical Expert - Asia & JPAC Sanofi Pasteur, Singapore Milan Paleja Country President and General Manager Novartis, Indonesia Kurt Lackovic Chief Executive Officer Cancer Trials, Australia Vincenzo Teneggi Senior Medical Director D3 (Drug Discovery & Development) A*STAR, Singapore Professor Pierce Chow Professor, Duke-NUS Graduate Medical School, Senior Consultant, Division of Surgical Oncology, National Cancer Centre, Singapore KEYNOTE 2017 SPEAKERS LINE-UP INCLUDE: 3 CO LOCATED CONFERENCES 45+ SPEAKERS 200+ PARTICIPANTS 19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore “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 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” TEAM REGISTRATION BENEFITS! SEE REGISTRATION PAGE FOR DETAILS.
Transcript
IBCLIFE SCIENCES
PRODUCED BY: ASSOCIATE SPONSOR: SESSION SPOTLIGHT SPONSOR:
LANYARD SPONSOR: EXHIBITORS:
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
PART OF
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
Bertil LindmarkChief Medical Officer ASLAN Pharmaceuticals, Singapore
PJ ChenVice President of Global Clinical DevelopmentUnited Neuroscience, Taiwan
James GarnerChief Executive OfficerNovogen, Australia
Sumitra Sachidanandan GCP Inspection Consultant, Clinical Trials Branch, Health Products Regulation Group Health Sciences Authority, Singapore
Ritika Bajaj Associate Director, Global Clinical Trial Operation MSD Pharmaceuticals, India
Melvin Sanicas Regional Medical Expert - Asia & JPAC Sanofi Pasteur, Singapore
Milan Paleja Country President and General Manager Novartis, Indonesia
Kurt Lackovic Chief Executive Officer Cancer Trials, Australia
Vincenzo Teneggi Senior Medical Director D3 (Drug Discovery & Development) A*STAR, Singapore
Professor Pierce Chow Professor, Duke-NUS Graduate Medical School, Senior Consultant, Division of Surgical Oncology, National Cancer Centre, Singapore
KEYNOTE
2017 SPEAKERS LINE-UP INCLUDE:
3CO LOCATED
CONFERENCES
45+SPEAKERS
200+PARTICIPANTS
WWW.CLINICALTRIALSASIA.COM
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
“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
John WilbanksChief Commons Officer, Sage
Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and
FasterCures, USA TEDGlobal 2012 Speaker on “Let’s
Pool Our Medical Data”
TEAM
REGISTRATION
BENEFITS!
SEE REGISTRATION
PAGE FOR DETAILS.
CONFERENCE DAY ONEWEDNESDAY 20 SEPTEMBER, 2017
WWW.CLINICALTRIALSASIA.COM
0800 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 ROIsPanellists: Milan Paleja, Country President and General Manager, Novartis, IndonesiaEva Kopecna, Sr Dir Generics Reg Affairs Global OTC, Teva Pharmaceuticals International GmbH, SwitzerlandLi Ling Liu, Director, Good Registration Management (GRM), Researcher, Deputy Director General Minister Office, Chinese Taipei Food and Drug Administration (TFDA), TaiwanQing 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
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 • 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
1430 Regional Regulatory Update Vietnam: Recent Regulatory Updates on Clinical TrialsA Senior Representative from Drug Administration of Vietnam
Malaysia: Regulatory Pathways that Support Phase 1 Clinical TrialsSenior 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, Singapore
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
makingCraig 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 [email protected]
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
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, Singapore Melvin Sanicas, Regional Medical Expert - Asia & JPAC, Sanofi Pasteur, SingaporeAkhmal Yusof, Chief Executive Officer, Clinical Research Malaysia, Malaysia
1815 Chairperson’s Summary of the Day and End of Conference Day 1
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, Singapore
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
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, Singapore
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 Singapore / Senior Consultant, Department of Hepatopancreatobiliary / Transplant Surgery, Singapore General Hospital
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 AsiaFor Speaking Opportunity, please contact [email protected]
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
1640 Chairperson’s Summary of the Day and End of Conference
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TUESDAY 19TH SEPTEMBER 2017 9AM – 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
Risk Management in Clinical TrialsAbout 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
FIRDAY 22ND SEPTEMBER 2017 9AM – 4PM
PRE-CONFERENCE WORKSHOP POST-CONFERENCE WORKSHOP
WHO WILL YOU MEET
BY COUNTRY Singapore/Malaysia ..59% South East Asia .............. 3% Japan/Korea/ Taiwan/China/ Hongkong ....................... 18%
India .................................... 4% Europe/USA ....................13% Australia ............................ 3%
BY INDUSTRY Pharma & Biotech ......65% CROs ..................................15% Government & Regulators ........................ 3%
“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
WWW.CLINICALTRIALSASIA.COM
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.
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: +65 6508 2489 l M: +65 9852 3283 l Email: [email protected]
Post-Conference Workshop
Pre-Conference Workshop
Opening Plenary Sessions
Networking Cocktails
Conference Day 1
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
Conference Day 2
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
19 - 22 September 2017 • One Farrer Hotel & Spa, Singapore
PHARMACON ASIA AT A GLANCE
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”
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.
View John’s talk at TEDGlobal 2012 here
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
Present a keynote, case study, or contribute to a panel
Be an Exhibitor
Demonstrate your products and engage with customers
Hospitality and Hosting
VIP Lunch, Closed door workshop, Refreshment breaks and many other options
