Agenda

Day 1

Wednesday 20 September, 2017

08:00
Main Conference Registration and Morning Coffee

08:50
Welcome Address and Ice Breaker from IBC Asia

09:00
Chairperson’s Opening Remarks

Alex Matter, CEO, Experimental Therapeutics Centre & D3, A*STAR, Singapore

Opening Keynote Sessions

Pharmacon Asia Opening Plenary Session
Joint Session with Pharmaceutical Market Access, Accelerating Clinical Trials in Asia and Pharmaceutical Regulatory Affairs Asia

0910
[Keynote Speech] 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
[Thought Leadership Roundtable] 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

Moderator:
Alex Matter, CEO, Experimental Therapeutics Centre & D3, A*STAR, Singapore

Panellists:
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 Office, Taiwan Food and Drug Administration (TFDA), Taiwan
Qing Xi, Head of Government Affairs, Market Access & Communications, Pfizer, China
Jean-François Baladi, Senior Executive, Health Economics and Market Access, Novartis Pharma K.K., Japan
PJ Chen, Vice President, Head of Medical and Clinical Affairs Centre, United BioPharma, Taiwan

1030
Morning Networking and Refreshment Break

Accelerating Clinical Trials in Asia Commences
Accelerating Clinical Trials in Asia through Technology Advancement, Regulatory Reforms and Operation Efficiency

1110
Chairperson’s Opening Remarks
Alex Matter,
CEO, Experimental Therapeutics Centre & D3, A*STAR, Singapore

Asian Market Trends

1115
Asia’s Role Clinical Trials Development   

  • Clinical trials market in Asia, patient pools and regulatory aspects 
  • Current and future landscape for clinical trials
  • Where is the major trials being conducted in Asia
  • How does regulatory aspects affect the clinical trials in Asia
  • Recent changes in monitoring approach will affect the clinical trials in Asia
  • Digitalisation going to affect the way trials are conducted in Asia
  • Patient pools in Asia

Interviewer:
Alex Matter, CEO, Experimental Therapeutics Centre & D3, A*STAR, Singapore
Interviewee:
Shubhra Bansal, Consulting Learning Partner, Pan Asian Clinical Research Association (PACRA) and Director, Apprentice Learning Solutions

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
[China Market Update] 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
[Going Global Case Study] 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

Kevin Cheong, Director, Clinical Operations - Asia, ALMAC Pharmaceutical Services, LLC, Singapore

Technology and Big Data in Clinical Trials

1430
[Case Study] 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
  • Healthcare system: paradigm shift towards value and outcomes
  • Outcome focus: example of public private partnership in Hematology

Tay Salimullah, Global Strategic Projects Leader, Real World Evidence, Novartis Pharma AG, Switzerland

1500
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

1540
Afternoon Networking and Refreshment Break

1610
Strategic Roles of Biostatisticians in Clinical Research
Wei Yuan, Senior Biostatistician, Singapore Clinical Research Institute, Singapore

1640
[Panel Discussion] 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

Moderator:
Mrunalini Jagtap, Data Management Lead, Singapore Institute for Clinical Sciences, A*STAR

Panellists:
Akhmal Yusof, Chief Executive Officer, Clinical Research Malaysia, Malaysia
Shubhra Bansal, Consulting Learning Partner, Pan Asian Clinical Research Association (PACRA) and Director, Apprentice Learning Solutions
Ivan John Clement, Data Scientist, MSD Innovation Hub, Singapore

1725
Chairperson’s Summary of the Day and End of Conference Day 1

Day 2

Thursday 21 September, 2017

0900
Chairperson’s Opening Remarks
Vincenzo Teneggi, Senior Medical Director, D3 (Drug Discovery & Development) A*STAR, Singapore

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, Head of Medical and Clinical Affairs Centre, United BioPharma, 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

Interviewer:
Vincenzo Teneggi, Senior Medical Director, D3 (Drug Discovery & Development) A*STAR, Singapore
Interviewee:
Dr Stephanie Danandjaja, Regional Head of Medical Affairs, Abbott Pharma, Singapore

1010
Morning Tea Break

1040
Leveraging on CRO Partnerships for Clinical Innovations

  • Developing drug development strategies
  • Scientific leadership
  • Technologies development

Mary Pan, Vice President General Management and Business Development 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, Professor in Pharmacology, Director, Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Sri Lanka

1140
Innovation and Adaptive Design in Early Clinical  Development Studies (Phase 1/First-in-human) Across Regions

  • Targeted drugs request a better definition of safety profile
  • Model-Based study design are considered a tool to contribute to the goal
  • Model-Based study design execution is perceived complicated

Vincenzo Teneggi, Senior Medical Director, D3 (Drug Discovery & Development) A*STAR, Singapore

1210
Networking Lunch

1310
[Case Study] Implementing Risk-Based Remote Monitoring for Clinical Trials in Asia

  • Need of Risk Based monitoring
  • Methodology & changing scenario
  • Optimising collaboration between stakeholders

Shubhra Bansal, Consulting Learning Partner, Pan Asian Clinical Research Association (PACRA) and Director, Apprentice Learning Solutions

1340
[PI’s Perspective] 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

Optimizing Operation 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
[Panel Discussion] Moving Towards Trials of the Future

  • The route towards personalized medicine: Which areas of research shows the most promise?
  • Navigating the new medical, regulatory and legal environments
  • How should clinical trial strategies adapt?

Moderator:
Roshan Padbidri, Chief Operating Officer (COO), Anidan Group Pte Ltd, Singapore

Panellists:
Mary Pan, Vice President, General Management and Business Development Asia Pacific, ICON Plc, Singapore
Yashaswi Gupta, Medical Science Liaison, Novo Nordisk, Singapore
Manish R Garg, Medical Director (Singapore, Malaysia and Brunei), MSD Pharma (Singapore) Ptd Ltd, Singapore
Craig R. Rayner, President, d3 Medicine, A Certara Company, Adjunct Associate Professor, Monash University - Monash Institute of Pharmaceutical Sciences, Australia

1620
Chairperson’s Summary of the Day and End of Conference 

 

*Session outline may change to accommodate market-specific or company development.