3rd Annual Accelerating Clinical Trials in Asia

Day 1 : Wed, 25 Sept 2019

0800
Registration Starts & Morning Coffee

09:00
Chairperson’s Opening Remarks

Ron Kamienchick, Senior Director, Digital Health, Head of Diagnostics and Personalized Medicine, Teva Pharmaceuticals, United States


PLENARY SESSIONS


0910
Pharma Transformation Keynote Address:
MOVING PHARMA CLOSER TO ITS MOST IMPORTANT CUSTOMER: HOW DIGITAL TECHNOLOGY IS ENABLING PATIENT-CENTRICITY?

Ron Kamienchick, Senior Director, Digital Health, Head of Diagnostics and Personalized Medicine, Teva Pharmaceuticals, United States

0940
Pharma Leadership Roundtable:
THE NEXT PHARMA INDUSTRY PRIORITIES: BUSINESS, TECHNOLOGY, REGULATORY COMPLIANCE AND LEADERSHIP

  • Pharma landscape and evolving regulations
  • Revolutionising the pharma industry towards patient engagement
  • Capturing new revenue streams and markets
  • Leveraging on strategic partnerships and collaborations to drive growth
  • The shift towards value-based pricing
  • Embracing digital transformation – Challenges and opportunities in Asia

Moderator:
Christine Kuan, Market Access and External Affairs Director, Taiwan and South East Asia, Bristol-Myers Squibb, Taiwan

Panellists:
Angela Deluca, Head of Project Planning & Innovation Department, Japan Development, AbbVie, Japan
Sophia Huang, Head of Regulatory Submission Management and Planning Beijing, Bayer Healthcare, China
Amitabh Mishra, President & Chief Technology Officer, Emcure Pharma, India
Jennifer Harmon, Director of Clinical Affairs, SynAgile, Singapore
Zou Bin, Chief Scientific Officer,  AUM Biosciences, Singapore

1040
MORNING NETWORKING AND REFRESHMENT BREAK


3RD ANNUAL ACCELERATING CLINICAL TRIALS IN ASIA COMMENCES


1115
Chairperson’s opening remarks

Chong Chui Fung, Global Clinical Lead, APAC Regional GI Medical Director, Takeda, Singapore


INNOVATIVE CLINICAL TRIAL DESIGNS


1120
THE VIRTUAL CLINICAL TRIAL:
THE USE OF MOBILE/DIGITAL TECHNOLOGY IN PATIENT RECRUITMENT FOR DECENTRALIZED TRIALS AND CONNECTED DEVICE TRIALS

  • How technology can allow trials to lower the barriers to entry for clinical trial participants worldwide
  • Which trials are most appropriate for virtual/hybrid designs using mobile technology?
  • The use of mobile trial engagement in a Bring Your Own Device environment to ensure trial compliance
  • The types of data that can be collected remotely in a decentralised trial model
  • Regulatory framework for Virtual Clinical Trial designs

Kent R. Thoelke, Chief Scientific Officer & Executive Vice President, PRA Health Sciences, USA

1200
ACCELERATING ONCOLOGY THERAPEUTICS THROUGH BIOMARKER-DRIVEN PRECISION MEDICINE PLANS AND DIGITISATION TRIALS

  • Case study on developing small molecule therapies for targeted cancer treatments
  • Leveraging digitization for smart data access to provide a personalized patient engagement
  • Facilitating the development of affordable treatment options

Harish Dave, Co-founder and Chief Medical Officer, AUM Biosciences, Singapore

1230
THE USE OF REAL-WORLD EVIDENCE FOR MEETING REGULATORY REQUIREMENT AND FAST APPROVAL – IN THE CASE OF PEDIATRIC MEDICAL DEVICE

  • Challenges of pediatric medical device development
  • Opportunities of using real world evidence for regulatory purpose and fast-tracking approval
  • Case study of a pediatric medical device development
  • New scheme of reliability inspection on registry data
  • Introduction of Harmonization by Doing for Children (HBD for Children)

Kazuaki Sekiguchi, Director of Clinical Strategy and Study Execution, Abbott, Japan

1300
Networking Lunch

1400
BRINGING WORLD CLASS CLINICAL RESEARCH TO INDONESIA THROUGH PARTNERSHIPS IN THE EAST AND WEST

  • Shifting of Clinical Trials to Emerging Markets: Opportunities for ASEAN Countries
  • Why Indonesia? Challenges and Solutions for Conducting Clinical Research In Indonesia
  • The Integrated Research Organization (IRO) Model for Enabling Physicians to Conduct Clinical Research
  • Case Study – Bringing a US-based Pharma Company’s Phase III Clinical Trial to Jakarta
  • Collaboration Opportunities within ASEAN Countries and Beyond

Martin Lim, Founder and Chief Executive Officer, ONWARD Health Research, Singapore

1430
ETHNICITY BRIDGING – AN INNOVATIVE APPROACH TO SUPPORT GLOBAL SUBMISSIONS FOLLOWING ICH E5 PRINCIPLES

  • Ethnic sensitivity analysis based on the ICH E5 principles to support organization – intrinsic and extrinsic factors analyses
  • Data required during the clinical development stage
  • Impact of ethnicity bridging on clinical development

Chong Chui Fung, Global Clinical Lead, APAC Regional GI Medical Director, Takeda, Singapore


TECH USE CASES IN TRIALS


1500
REINVENTING CLINICAL TRIALS IN THE AGE OF DIGITAL DISRUPTION

  • Optimising clinical trial recruitment with digital platforms: Matching patients to the right research
  • Applications of Natural Language Processing (NLP) and AI in Pharma: Regulatory compliance; clinical trials; R&D and drug discovery
  • The potential of blockchain tech in clinical trials?

Angela Deluca, Head of Project Planning & Innovation Department, Japan Development, AbbVie, Japan

1530
Afternoon Networking and Refreshment Break

1600
CASE STUDY OF CURATE.AI:
HOW AI COULD ULTIMATELY ENHANCE PATIENT ACCESSIBILITY TO OPTIMIZED COMBINATION THERAPIES

  • Technology overview: Simultaneously optimising drugs/dosages with small data-based AI for N-of-1 medicine
  • How combination therapy can be dynamically dosed to sustain individualised treatment
  • Realising population-optimised therapies using enhanced trial designs

Dean Ho, Provost’s Chair Professor of Biomedical Engineering and Pharmacology, Director of The N.1 Institute for Health (N.1), Head of Department of Biomedical Engineering, National University of Singapore, Singapore

1630
INNOVATION FIRESIDE CHAT:
ACCELERATING CLINICAL TRIALS THROUGH ENHANCING DATA ANALYSIS AND PREDICTIVE ALGORITHMS

  • How to better inform decision-making through precise data capture
  • Generating structured information out of data sets through predictive modelling
  • How machine learning algorithms leverage EHRs from patient identification to recruitment
  • Case study sharing – digital tools in enabling real-time remote patient monitoring and engagement

Moderator:
Mrunalini Jagtap, Data Management Lead, A*STAR, Singapore

Panelists:
Aung Myo, Vice President of Clinical Development & Medical Affairs, Tessa Therapeutics, Singapore
Zou Bin, Chief Scientific Officer, AUM Biosciences, Singapore

1700
Chairperson’s Summary & End of Conference Day 1

Day 2 : Thu, 26 Sept 2019

0900
Chairperson’s Opening Remarks

Ameet Ambarkhane, CMC Manager, Cerecin, Singapore


NEW THERAPEUTICS TRIALS


0910
REVOLUTIONISING CANCER TREATMENT THROUGH VIRUS-SPECIFIC T CELL THERAPIES

  • How VSTs overcome key challenges faced by other T cell therapies
  • Potential of genetic modifications and rational combination on enhancing treatment efficacy
  • Optimal strategies to overcome challenges in clinical development
  • Building next generation VST therapies through technologies

Aung Myo, Vice President of Clinical Development & Medical Affairs, Tessa Therapeutics, Singapore

0940
AUSTRALIA’S INITIATIVES THAT ENSURE A SOUGHT-AFTER CLINICAL TRIAL ECOSYSTEM

  • Clinical trial landscape in Australia
  • Infrastructure, including new facilities for cell and gene therapy
  • Australian Government Policy
  • Clinician Engagement & Networks
  • Working in partnership with international biotech companies
  • Software implementation to reduce clinical site workload, without compromising quality or compliance
  • Potential for real world data to enhance clinical trials

Kurt Lackovic, Chief Executive Officer, Cancer Trials Australia, Australia


CLINICAL OUTSOURCING AND COST MANGEMENT


1010
SINGAPORE: APAC’S CLINICAL SUPPLY GATEWAY TO THE WORLD

  • What makes Singapore an ideal clinical supply hub in the APAC region
  • The economic and regulatory advantages of using Singapore to supply global studies
  • The importance of clinical supply management to optimize strategy and support timely execution of trials

Julie Delaney, Director, Clinical Supplies and Project Management APAC, Catalent Pharma Solutions, Singapore

1040
Morning Networking and Refreshment Break

1110
CONDUCTING CLINICAL TRIALS IN PRIVATE HOSPITALS IN THAILAND’S PRO-PUBLIC SYSTEMS – EXPENSE MANAGEMENT AND PARTICIPANT RECRUITMENT

  • Clinical trials sites in Thailand: public vs private hospitals – key differences in efficiency, costs and trial’s outcome
  • Understanding Thailand’s pro-public systems that affect the conduct of clinical trials in private hospitals
  • Case study on enhanced productivity and strategic participant recruitment

Krit Pongpirul, Assistant Director of Thailand Research Center for Health Services System, Faculty of Medicine, Chulalongkorn University, Research & Quality Counselor, Bumrungrad International Hospital, Thailand

1140
COST MANAGEMENT PANEL:
OUTSOURCING, PARTNERSHIP AND COST MANAGEMENT

  • CROs joining forces – what it means for renewed partnership with pharma manufacturers?
  • Clinical trials OPEX considerations
  • Budgeting and financial resource deployment
  • Speed to market and associated costs management
  • Measuring ROI for trial and investment outcomes

Moderator:
Xiaowei Shi, Head of APAC Clinical Operations, BeiGene, Australia

Panellists:
Krit Pongpirul, Assistant Director of Thailand Research Center for Health Services System, Faculty of Medicine, Chulalongkorn University, Research & Quality Counselor, Bumrungrad International Hospital, Thailand
Terig Hughes, Chief Financial Officer, AUM Biosciences, Singapore
Jennifer Harmon, Director of Clinical Affairs, SynAgile, Singapore
Talita Hilse, Vice President of Operations and Programme Management, Cerecin, Singapore

1210
Networking Lunch


SPEED-TO-MARKET STRATEGY


1310
ADVANCING EARLY PHASE CLINICAL TRIALS IN AUSTRALIA

  • Emerging trends in early phase clinical trials landscape in Asia Pacific
  • Working with efficient regulatory authority to reduce clinical trial timelines
  • Well established infrastructure and highly trained trials personal suitable for early phase clinical trials
  • High quality clinical trial data and good compliance to GCP
  • Government support and incentives to be cost effective

Xiaowei Shi, Head of APAC Clinical Operations, BeiGene, Australia

1340
‘SHORT CUTS AND LONG DELAYS’ TO STREAMLINED DRUG DEVELOPMENT: CMC PERSPECTIVES

  • What is the role of CMC in drug development activities and support for different phases of clinical trials, from a global pharma perspective?
  • How this could be achieved in a small biotech CRO setup
  • Opportunities and threats for accelerating the drug development and clinical trials

Ameet Ambarkhane, CMC Manager, Cerecin, Singapore

1410
KOL & CLINICAL TRIAL TIMELINES:
EFFECTIVE KEY OPINION LEADERS (KOL) ENGAGEMENT IN THE EVER-CHANGING CLINICAL LANDSCAPE

  • How is the evolving clinical pharma landscape dramatically shaping KOL engagement?
  • Developing innovative way to source names and establish a KOL database
  • Strengthening KOL relationships through collaborative interactions and clear developed upfront objectives
  • Align the KOL engagement strategy with evidence and confidence imperatives

Nantha Kumar, Vice President, Head of Global Medical Affairs Intercontinental, Ipsen Pharmaceuticals, Singapore

1430
Afternoon Networking and Refreshment Break

1500
CONTINUOUS ORAL DRUG DELIVERY: CASE STUDY OF DOPAFUSE

  • Continuous oral drug delivery using OraFuse
  • Levodopa delivery options for Parkinson’s Disease
  • DopaFuse studies and results
  • Future of continuous oral delivery
  • Global startup, combination product – a fun challenge

Jennifer Harmon, Director of Clinical Affairs, SynAgile, Singapore

1530
A SOLUTION FOR EFFICIENT EARLY CLINICAL TRIALS WITH A MEDICAL FOOD

  • How clinical trials with medical foods differ from drugs
  • A creative approach to study design and execution for a product reformulation
  • A case study and lessons learned

Talita Hilse, Vice President of Operations and Programme Management, Cerecin, Singapore

1600
Chairperson’s Summary & End of Main Conference