3rd Annual Accelerating Clinical Trials in Asia

Day 1 : Wed, 25 Sept 2019

0800
Registration Starts & Morning Coffee

0900
IBC Opening Address

0905
Chairperson’s Opening Remarks


PLENARY SESSIONS


0910
Pharma Transformation Keynote Address:
CLOSING THE DIGITAL DIVIDE BETWEEN PHARMA AND THE PATIENT: HOW IS DIGITAL TECHNOLOGY ENABLING PATIENT-CENTRICITY?

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

1000
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

Panellists:
Ryan Li, Head of Commercial Innovation & Alliance, Market Access, MSD, China
Angela Deluca, Head of Project Planning & Innovation Department, Japan Development, AbbVie, Japan

Aung Myo, Vice President of Clinical Development & Medical Affairs, Tessa Therapeutics, Singapore
Sophia Huang, Head of Regulatory Submission Management & Planning Beijing, Bayer Healthcare Company Limited, China
Amitabh Mishra, President & Chief Technology Officer, Emcure Pharma, India

1040
MORNING NETWORKING AND REFRESHMENT BREAK


3RD ANNUAL ACCELERATING CLINICAL TRIALS IN ASIA COMMENCES


1115
Chairperson’s opening remarks

Vincenzo Teneggi, Senior Medical Director, Drug Discovery and Development, A*STAR, Singapore


INNOVATIVE CLINICAL TRIAL DESIGNS


1120
THE VIRTUAL CLINICAL TRIAL:
THE USE OF MOBILE/DIGITAL TECHNOLOGY IN PATIENT RECRUITMENT FOR DECENTRALISED 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

1150
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
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

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

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

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 PANEL:
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:
Vincenzo Teneggi, Senior Medical Director, Drug Discovery and Development, A*STAR, Singapore

Panelists:
Mrunalini Jagtap, Data Management Lead, A*STAR, Singapore
Aung Myo, Vice President of Clinical Development & Medical Affairs, Tessa Therapeutics, Singapore
Zou Bin, Chief Scientific Officer, AUM Biosciences, Singapore

End of Conference Day One & Joint Networking Cocktail

Day 2 : Thu, 26 Sept 2019

0900
Chairperson’s Opening Remarks

Vincenzo Teneggi, Senior Medical Director, Drug Discovery and Development, A*STAR, Singapore


NEW THERAPUTICS 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

1045
Morning Networking and Refreshment Break

1115
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

1145
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:
Vincenzo Teneggi, Senior Medical Director, Drug Discovery and Development, A*STAR, Singapore

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
Kurt Lackovic, Chief Executive Officer, Cancer Trials Australia, Australia
Terig Hughes, Chief Financial Officer, AUM Biosciences, Singapore

1230
Networking Lunch


SPEED-TO-MARKET STRATEGY


1330
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

1400
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
GCP INSPECTION READINESS CASE STUDY:
BEST PRACTICES IN IMPLEMENTING GCP ICH E6 R2

  • Focus and trends from regulatory updates on global GCP inspections
  • What are the lessons learnt from global inspections for inspection readiness?
  • Clinical trials quality in the Digital Health era, taking guidance of JnJ’s experience

Ivy Yin, Market Access Director, JnJ Surgical Vision, Asia Pacific & Japan, Johnson & Johnson, Singapore

 1500
Afternoon Networking and Refreshment Break

1530
IMPROVING PATIENT ENGAGEMENT THROUGH ELECTRONIC CLINICAL OUTCOME ASSESSMENTS (eCOAs)

  • Paper-based patient reported outcomes (pPRO) vs electronic PRO (ePRO)
  • Understanding ePRO’s protocol compliance and its reliability
  • Using eCOA for clinical trials – cost, benefits, efficiency

Judy Walker, Chief Medical Officer, Cerecin, Singapore

1600
DESIGNING PERSONALISED CLINICAL TRIALS IN THE DIGITAL ERA

  • Why personalized studies “N-of-1 trials” is important in the current pharma landscape?
  • Which technology advances has made it feasible, and how to digitize the data?
  • What is the right electronic platform to manage these trials with the correct data influx?
  • Successful case studies sharing

Leslie Tan, Clinical Project Manager – Clinical Development Unit, Nestlé Research Singapore Hub, Singapore

1630
RWE DATA STRATEGY FOR CLINICAL TRIALS:
LEVERAGING RANDOMISED CLINICAL TRIALS TO GENERATE REAL-WORLD EVIDENCE

  • Selection of interventions appropriate in clinical care settings
  • Potential usefulness of real-world evidence to support regulatory decision-making
  • Addressing potential challenges around blinding, randomisation and bias

Nir Arbel, Co-Founder and Chief Executive Officer, Carmentix, Singapore

1700
Chairperson’s Summary & End of Main Conference