Accelerating Clinical Trials – Agenda

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Day 1

1300
KEYNOTE ADDRESS:
COVID-19 Treatments and Vaccines – Ushering in a New Era for Regulation, Collaboration, and Drug Accessibility

Dr. Andreas Schmidt, Chief Executive Officer, Proteona, Singapore/Germany

Proteona and international Consortium including the Heidelberg University Hospital, Tübingen University Hospital, the German Cancer Research Center (DKFZ), the NMI Natural and Medical Sciences Institute, NUS Enterprise, US-based 10x Genomics, and NovogeneAIT.formed to develop SARS-CoV-2 neutralising antibody to help vulnerable immunocompromised individuals. With a focus on innovative AI-driven genomic and proteomic analysis platform for improving cell therapy and immuno-oncology.

1330
PHARMA LEADERS’ THINK TANK:
Redefining Pharma’s Role in the Global Healthcare Reform Agenda

  • COVID-19 vaccines candidate development
  • Regulations on pandemic drugs approval and accelerated clinical trials under diverse regimes
  • Future of pricing and affordability for Novel Drugs
  • Why technology should be the key component to surviving COVID-19?
  • AI and its immense potential in use of pandemic treatments and early detection

Panelists:
Dr. Sucharita Das, Head of Regulatory Affairs and Quality Assurance APAC, Pfizer, Singapore
Edsel Pereira, Group Vice President – Information Technology, Glenmark Pharmaceuticals, India
Alexander Zach, Senior Vice President, Global Head of Market Access and Policy, Biocon, India
Dr. Keith Carpenter, A*STAR Senior Fellow, Pharma Innovation Programme Singapore (PIPs), A*STAR, Singapore

1430
Networking Break


Accelerating Clinical Trials Conference commences
ACCELERATED DRUG DEVELOPMENT TRIAL


1500
THE GLOBAL DIALOGUE:
Reimagining Drug Discovery in The Face of COVID-19 and Current State of Treatment Trials

  • What are the key priorities for different region’s global race for COVID-19 vaccine development?
  • Government role in trials approval and funding support
  • Using adaptive trial design to fast track clinical programs
  • The collaboration between countries / institutions on COVID vaccine trials

Moderator:
Dr. Salma Michor, CEO, Michor Consulting, Austria

Panelists:
Dr. Anh Wartel, Associate Director General, Head of Clinical Development and Regulatory, International Vaccine Institute, Korea
Dr. Vu Dinh Thiem, Director, Center for Clinical Trials, National Institute of Hygiene and Epidemiology, Vietnam
More panellists to be confirmed

1545
Re-evaluating Trials Conduct for Rare Diseases – What Have We Learnt from COVID-19

  • Available clinical trial waiver and reduction negotiations
  • Patient recruitment options and reimbursement outlook
  • Market opportunity and viability for international biopharma companies to enter

For speaking opportunity, please contact Yvonne.Leong@informa.com


GOVERNMENT-LED INITIATIVES AND COLLABORATION


1615
VIETNAM’S GOVERNMENT INITIATIVE:
Combating the COVID-19 Global Epidemic through Partnerships and Technologies

  • Snapshot of Vietnam’s collective effort on the global race for COVID-19 vaccine development
  • Clinical trial study on the tuberculosis vaccine against the COVID-19 fight
  • Lessons learnt on pre- and post- clinical state monitoring and digital tools used to accelerate the trials
  • The collaboration strategy between WHO, government, sponsor sites and private institutions

Dr. Vu Dinh Thiem, Director, Center for Clinical Trials, National Institute of Hygiene and Epidemiology, Vietnam

1645
Regulatory Affairs for Clinical Trials During and Beyond Pandemic: Key Updates and Takeaways

  • Global regulators’ recommendations on conducting and monitoring clinical projects during COVID-19
  • Protocol deviations management during COVID 19
  • Global regulators’ emergency vaccine approval procedures, urgent importations, fast-track approval process (i.e.. FDA, EMA, NMPA, etc.)
  • The use of RWE in regulatory process

Dr. Salma Michor, CEO, Michor Consulting, Austria

1715
End of Conference Day 1


Accelerating Clinical Trials Conference commences
ACCELERATED DRUG DEVELOPMENT TRIAL


1500
THE GLOBAL DIALOGUE:

 [Panel discussion] Hear the latest developments in Asia, US and EU on vaccine pipelines, trial studies and clinical outcome outlook

Reimagining Drug Discovery in the Face of COVID-19 and Current State of Treatment Trials

  • What are the key priorities for different region’s global race for COVID-19 vaccine development?
  • Governments role in trials approval and funding support
  • Using adaptive trial design to fast track clinical programs
  • The collaboration between countries / institutions on COVID vaccine trials

Moderator:
Dr. Salma Michor, Chief Executive Officer, Michor Consulting, Austria

Panellists:
Dr. Anh Wartel, Associate Director General, Head of Clinical Development and Regulatory, International Vaccine Institute, Korea
Dr. Vu Dinh Thiem, Director, Center for Clinical Trials, National Institute of Hygiene and Epidemiology, Vietnam
Adama Ibrahim, Digital Solutions Director, Global Drug Development, Novartis, Switzerland
Dr. Chen Rong, Chief Medical Officer, JHL Biotech, China
More panellists to be confirmed

1545
CRO’s Insights:
Re-Evaluating Trials Conduct for Rare Diseases – What Have We Learnt From COVID-19

  • Available clinical trial waiver and reduction negotiations
  • Patient recruitment options and reimbursement outlook
  • Market opportunity and viability for international biopharma companies to enter

For speaking opportunity, please contact Yvonne.Leong@informa.con


GOVERNMENT-LED INITIATIVES AND COLLABORATION


1615
VIETNAM’S GOVERNMENT INITIATIVE:
Combating the COVID-19 Global Epidemic through Partnerships and Technologies

  • Snapshot of Vietnam’s collective effort on the global race for COVID-19 vaccine development
  • Clinical trial study on the tuberculosis vaccine against the COVID-19 fight
  • Lessons learnt on pre- and post- clinical state monitoring and digital tools used to accelerate the trials
  • The collaboration strategy between WHO, government, sponsor sites and private institutions

Dr. Vu Dinh Thiem, Director, Center for Clinical Trials, National Institute of Hygiene and Epidemiology, Vietnam

1645
Regulatory Affairs for Clinical Trials During and Beyond Pandemic: Key Updates and Takeaways

  • Global regulators’ recommendations on conducting and monitoring clinical projects during COVID-19
  • Protocol deviations management during COVID 19
  • Global regulators’ emergency vaccine approval procedures, urgent importations, fast-track approval process (i.e.. FDA, EMA, NMPA, etc.)
  • The use of RWE in regulatory process

Dr. Salma Michor, CEO, Michor Consulting, Austria

1715
End of Conference Day 1

Day 2


Accelerating Clinical Trials Conference continues
SMART TRIAL DESIGNS AND MODELS


1300
China’s Collaborated Clinical Trial Approach – Challenges, Solutions and Lessons Learned

  • Implications of COVID-19 on China’s clinical trials – patient enrolment, new drug testing and approval, study site budgets, sponsor communication etc.
  • Contingency plans to minimize delays, protect data integrity, limit attrition and ease site burden
  • Evaluate the concern about loss of trials during China’s lockdown: how long can the primary endpoint assessments be extended without losing entire trial cohort
  • The digital measures intervention to the disrupted drug development and trial scene in China

Dr. Chen Rong, Chief Medical Officer, JHL Biotech, China

1330
The Future is Now: The Role of AI in the Combat with COVID-19

  • Collaborating technology in search of cures
  • How AI has been leveraged in the search for optimal drug combinations to treat COVID-19 patients
  • How does IDentif.AI platform make precise recommendations based on dosage and mix
  • Key process implementations and what are the challenges faced
  • Success rate and key takeaways

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

1400
TECH TALK:

A Primer on Digital Tools in the Connected Era for Clinical Trials

  • Current state of play for digital innovation throughout clinical trials lifecycle
  • Types of tech solutions available in the market to improve efficiency, patient centricity and probability of success in trials
  • Practical tech application that helps accelerate R&D
  • How could we ensure that these innovations spurred by COVID-19 endures into the future?

Panellists:
Prof. Dean Ho, Provost’s Chair Professor of Biomedical Engineering and Pharmacology, Director of The N.1 Institute for Health (N.1), Director of Institute for Digital Medicine (WisDM), Department Head of Biomedical Engineering, National University of Singapore, Singapore
Adama Ibrahim, Digital Solutions Director, Global Drug Development, Novartis, Switzerland
Dr. Chirag Trivedi, Head of Clinical Study Unit (CSU) Asia Cluster, Sanofi, India

1500
Networking Break

1530
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 big data analytics and how it helps to learn about the virus progresses among diverse patient populations
  • What is the paradigm shift towards value and outcomes in the healthcare and pharma system?

For speaking opportunity, please contact Yvonne.Leong@informa.com

1600
CASE STUDY:
Blockchain and Drug Development – An Opportunity Ready for The Prime Time

  • The value of blockchain technology usage across trials in response to COVID
  • Best practices on technologically apply blockchain to trials and harmonize
  • How blockchain-powered health wallet boost efficiencies across clinical trial process
  • Successful used cases and applications sharing

Adama Ibrahim, Digital Solutions Director, Global Drug Development, Novartis, Switzerland

1630
Clinical Trials at Home – How Telemedicine Could Be the Game Changer?

  • Overview of the telemedicine technology landscape
  • Understanding how the deployment of virtual solutions could help maintain patient safety, study integrity and data quality
  • Considerations around vetting and implementing these solutions during the pandemic
  • Future of virtual visit technology shaped by the current environment

Dr. Chirag Trivedi, Head of Clinical Study Unit (CSU) Asia Cluster, Sanofi, India

1700
End of Virtual Conference Day 2

Day 3


IMPROVED CLINICAL TRIALS COLLABORATION


1300
Leveraging the Sponsor Relationship Between KOL and Sites to Accelerate Non-COVID Trial Timelines

  • Identifying the right KOL for study – Capability of the KOLs and willingness to be involved in new development
  • How to leverage the collaboration between KOL and communication between sites-sponsors to accelerate non-COVID trial timelines during the COVID pandemic?
  • Developing a sustained KOL management program across the product development cycle
  • Reviewing recent trends and creative ways to engage KOL

Judith Walker, Chief Medical Officer, Cerecin, Singapore

1330
Assessing Collaborated Efforts for Regulatory Interactions, Inspections, and Audits

  • What are the limitations on on-site pre-approval facility, clinical and sponsor inspections during COVID-19?
  • Critical parameters to note for inspections and audits in trials, trial initiation and risk assessment
  • Inspection readiness risk management plan in the changing global regulatory environment
  • What are the expectations of trial sponsors for CROs in terms of inspection readiness?

Maggie Lim, Director, Clinical Quality Development Assurance APAC, GSK, Singapore

1400
The Improved New Normal Beyond the Pandemic: Risk-Based Monitoring and Quality Management Strategies

  • Enhanced data quality oversight and regulatory compliance
  • Proactive risk management to protect patient safety and support site conduct
  • Driving improved quality, accuracy, and integrity of clinical trial data
  • Increasing productivity, efficiency and cost effectiveness for sponsors

For speaking opportunity, please contact Yvonne.Leong@informa.com

1430
The Evolving Medical Device Landscape — Considerations for Clinical Trial Design

  • How has COVID-19 impacted trial studies and how are medical device companies taking the hit?
  • Pre- and post- market studies: addressing challenges unique to medical devices
  • Case Study/Example of using real world data to address regulatory needs for product approval or post market needs
  • Case study sharing of Abbott EDC Portal – a collaborative platform for sites and sponsors to manage trials from start-up to completion

Ashish Oza, Senior Director, Clinical Strategy & Study Execution JAPAC, Abbott, Singapore

1500
Networking Break


NEW NORMAL SCENARIO PLANNING


1530
Conduct of Clinical Trial – A New Game Plan for A Challenging Era of COVID -19

  • Adapt, mitigate, and innovate- making conduct of clinical trials smarter and safer for site and patients
  • Developing proactive strategies under reactive circumstances
  • Planning and adjusting to a new “normal”
  • How best to address statistical implications from missed patient visits, tests, and increased protocol deviations
  • Communications and planning from a quality perspective
  • Assessing near-term needs from sites to mitigate the impact, and outlining long-term needs for future support

Joanne Chio, Head of Clinical Trials, National University Health System, Singapore

1600
Identify High-Value Patient Engagement Strategies: A Collaborative Approach During Difficult Times

  • COVID-19 implications on sponsors and study sites regarding ongoing and planned clinical trials
  • What are the changes in system navigation and support provided to patients to access care?
  • How have organizations pivoted to support non-COVID-19 patients and families?
  • How can communication and collaboration with pharma, sites and investigators be improved?

Dr. Aaron Tabensky, Director, Clinical Operations & Medical Affairs, Prota Therapeutics, Australia


JOINT CLOSING PLENARY SESSION


1640
DIVERSITY AND INCLUSION ROUNDTABLE:
Cultivating the Next-Gen of Women Leaders in Pharma

  • Why does gender equality matter on the board?
  • Key challenges facing women leaders in Pharma
  • Management efforts to address some of these challenges, and remaining gaps
  • Reflections on the journey to the top
  • Breaking the glass ceiling: Lessons learnt along the way, and advice to my younger self
  • Management efforts to address some of these challenges, and remaining gaps

Panelists:
Anupama Rao Singh, Business Head – LATAM | Head – Oncology and Institutional Business COE, Dr.Reddy’s Emerging Markets, Dr Reddys, India
Angela Brady
, Director of Innovation Research, APAC R&D, GSK, Singapore
Chandana Yeluri, Head- Digital and Continuous Improvement, Sandoz Development Center, Novartis, India
More panelists to be confirmed.

1740
End of Virtual Conference Day 3