Outsourcing in Clinical Trials Asia 2021
Virtual Event: 8am CST / 9am KST-JST
29th-30th June, 2021
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Outsourcing in Clinical Trials Asia 2021
DAY 1|29th June 2021
DAY 2|30th June 2021
OUTSOURCING IN CLINICAL TRIALS EAST ASIA
CLINICAL TRIAL SUPPLY EAST ASIA
9:00 am Outlining critical criteria to consider when selecting vendor to find the happy medium considering time, quality and cost
- Pinpointing experience as an essential element to scrutinize their capability to operate your trial successfully
- Recognizing soft skills such as time management and problem-solving competence as important When considering who should lead the trial
- Uncovering strategies for balancing time, quality and cost and how to achieve it by prioritising your needs

Alan Choi
Vice President
Ildong Pharmaceutical
9:30 am Accelerating Clinical Trials in China and the Asia-Pacific
- A word on Novotech
- Leveraging APAC regional advantages to accelerate development
- Understanding the benefits of running clinical trials in China

Donna Fraser
Director Client Operations
Novotech
10:00 am Adaptive designs in clinical trials: their use in accelerating clinical development

John Patava
Chief Operating Officer
AUM Biosciences Pte Ltd
10:30 am Reserved for Event Sponsor
11:00 am How opening clinical trials in different countries can benefit stakeholders (manufacturer, doctors and patients)
- The necessity for sponsors to have local clinical trials in countries where they tend to market the product
- The evidence would provide the confidence for healthcare professionals to prescribe the products
- The localized experience will boost patients to stick with the product

Ilwon Sun
Project Manager
GC Pharma
11:30 am Clinical Trials and Comparator Sourcing in China
- The challenges of running successful trials in China can be daunting, and getting comparator sourcing right from the start is essential.
- This session will focus on the key areas for success as participants hear both the pharmaceutical and service provider views on how to navigate the Chinese landscape effectively.
- Join this session to find out more about overcoming these challenges and learn how making the right strategic choices can have a positive impact on running clinical trials in China.

Chan Liu
Comparator Strategist Lead
Pfizer

Philip Gregory
Vice President, Asia Pacific, Clinical Trial Services
Inceptua
12:00 pm Networking Break
12:15 pm Experience of COVID19 clinical trials in India
- Considerations in clinical trials in India
- Challenges and Solutions in COVID19 Clinical Trials
- Requirements for determining clinical trials of start-ups

Jae-Hyun (Jay) Park
Director
Genencell Co., Ltd.
12:45 pm Shifting Gears - Accelerating APAC Clinical Trial Logistics in 2021 & Beyond
- Evolving Clinical Trial Logistics trends – Digitalization, sustainability and patient centricity
- Driving storage and transport efficiencies with an integrated regional distribution model to deliver seamless patient experience
- Increasing agility and reach with localized supply chain strategy for large domestic markets, taking a closer look into Australia, Japan and India

Wilman Low
Director, Life Sciences and Healthcare
DHL Supply Chain Asia Pacific
1:15 pm Risk-Based Monitoring & Quality Management
- Highlighting rising awareness of the major RBM pitfalls
- Utilizing advanced RBM models to improve data quality
- Leveraging experienced partners to RBM to ensure a best quality in your clinical trial
- Implementing technologies and setting expectations with the partner in RBM to make a smooth run of trial

Mainfong Ang
Region Head TMO China
Novartis
1:45 pm Reserved for Catalent
2:15 pm How clinical research can meet clinical practice through the use of Real World Evidence/Data (RWE/RWD) in clinical trials
- Implementing technology to maximise the value of RWD in your trials
- Navigating how early use of RWE can reduce Post market study costs and time-to-market
- Introducing the emerging applications of RWE that can increase trial research efficiency

Kumar Gaurav
Director & Cluster Head, Medical Affairs
Dr. Reddy's Laboratories
2:45 pm Close of conference
8:45 am Registration & Opening Remarks
9:00 am Sharing strategies for successful temperature management in IP management during transfer
- Addressing common events of temperature fluctuation during distribution and storage to understand the importance of real-time monitoring system
- Highlighting the significance of real-time online tracking tool to identify, trace, track, locate and protect perishable drugs on their journey through supply chain to provide immediate support to achieve high quality
- Examining best practices to monitor temperatures in difficult conditions to prepare for unexpected circumstances

Jihyun Yoo
Project Manager
SCM lifescience
9:30 am The benefits of incorporating a configurable IRT solution to your APAC strategy
- The IRT system plays an important role in patient randomization and inventory management. Despite the wider adoptions in recent years, Sponsors and CROs in APAC continue to face many challenges and obstacles when applying such technologies to manage their clinical trials.
- In this session, we will address some of these challenges (such as budget and resource constraints), recognize not all IRT solutions are the same, and why it make sense to adopt different IRT strategies depending on the specific needs of your clinical trial
- Almac’s newest offering, a configurable IRT solution (SimplifyTM), is designed specifically to address these challenges and the ever changing landscape of running clinical trials in APAC, especially in light of the trying time we are experiencing with the COVID-19 pandemic. As such, we will explore key benefits of this solution and how to make smart decisions when choosing an IRT solution.

Matthew Do
Head of APAC Operations Clinical Technologies
Almac Pharmaceutical Services
10:00 am Adaptive designs in clinical trials: their use in accelerating clinical development

John Patava
Chief Operating Officer
AUM Biosciences Pte Ltd
10:30 am Reserved for Akesa Pharma
11:00 am Blockchain - Exploring the Implications for the future in drug development
- Describing the landscape in the biopharma’s current settings and exploring the areas where blockchain could be used
- Navigating blockchain approaches to address clinical trial management challenges
- Exploring how blockchain can be used for the design and implementation of faster, easier user identification processes

Frank Leu
CEO, Novapeutics
11:30 am Clinical Trials and Comparator Sourcing in China
- The challenges of running successful trials in China can be daunting, and getting comparator sourcing right from the start is essential.
- This session will focus on the key areas for success as participants hear both the pharmaceutical and service provider views on how to navigate the Chinese landscape effectively.
- Join this session to find out more about overcoming these challenges and learn how making the right strategic choices can have a positive impact on running clinical trials in China.
12:00 pm Networking Break
12:15 pm Navigating the Supply Chain Challenges in Cell Therapy product
- Considering what makes the delivery complex, including sensitivity, shelf-life and temperature control requirements
- Sharing key elements of how to successful delivery cell therapy products
- Presenting supply chain specific regulations to improve efficient supply distribution process and secure IPs in high quality

Sangeun Cho
Analytical research Team Manager/CMC RA
Daewoong Pharmaceutical
1:15 pm Significant differences in CMO relationships and cooperation between Big pharma and small medium pharmaceutical companies

Jun Park
EVP and Chief Technology Officer
ILIAS Biologics
1:45 pm Reserved for Catalent
2:15 pm Convergence of Big Data and Artificial Intelligence in Augmenting Drug Discovery, Development and Supply Chain Management

Prasun Mishra
Founder CEO
Agility Pharmaceuticals
2:45 pm Close of conference
OUTSOURCING IN CLINICAL TRIALS EAST ASIA
CLINICAL TRIAL SUPPLY EAST ASIA
9:00 am Developing a holistic-approach to protocol development to avoid costly changes during your Phase 1 trial

Jeong-Hyun Ryou
Medical Director, Research & Development
Boostimmune, Inc.
9:30 am Emerging trends in clinical supply, cold chain development and repackaging specialty solutions
- Dramatically increasing demands of cold chain
- What is your challenges from this new trend?
- How to turn challenges into chances?

Alex Ho
Zuelling
10:00 am Preparing global approval: How to navigate 505(b) 2 USFDA pathway in different scenarios
- IND Document preparation and approval procedure
- Exploring the impact of FDA requirements to conduct self-inspection and verification on clinical trial data
- Preparing communications with the inspector and pre-requisitions

Akhilesh Sharma
President & Chief Medical Officer
Alkem Laboratories
10:30 am Clinical Outsourcing- New Trends in New Normal
- Overview and comparison of past and current dynamics of clinical outsourcing activities amid covid-19 situation
- Emerging trends and paradigm shift in outsourcing method
- Evolution of service provider selection strategy
- Use of digital techniques-platform and impact in decision making process

Vaibhav Choudhary
Joint Director- Medical and Clinical Affairs
Fresenius Kabi Oncology
11:00 am PANEL DISCUSSION: Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future: How long will we feel the ripples of this pandemic?
- Developing a clinical trial model that is able to withstand global disruption
- Switching gears: Should we be analyzing which parts of our clinical trials can go virtual?
- Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic
Future trials: Assessment of how upcoming clinical studies will be conducted in light of the pandemic and what the long-term effects will be

Moon Hwan Kim
Chief Technical Officer
BiSiChem Korea

Vaibhav Choudhary
Joint Director- Medical and Clinical Affairs
Fresenius Kabi Oncology

Leonora Lim
VP Life Sciences & Healthcare Sector, Asia Pacific
DHL Customer Solutions & Innovation
11:45 am Close of conference
9:00 am New GCP and the regulation about the good manufacturing practice for study medication

SeungHyun Hong
Deputy General Manager - clinical supply
GC Pharma
10:00 am How to Develop and Maintain an Inspection-Ready Trial Master File (TMF)
- Understand the purpose and value of a TMF
- Define what an inspection-ready TMF means to different regulatory bodies
- Evaluate how different regulatory agencies may interact with the TMF during an inspection
- Assess the current state of your TMF to determine how to achieve inspection-ready status
- Identify common areas of non-compliance

Arani Chatterjee
Senior Vice President, Clinical Research
Aurobindo Pharma
10:30 am Choosing the right IRT vendor for your company to ensure your supply chain is adequately monitored

Prasad Mandrekar
Senior Manager-Global Quality & Compliance
Celltrion
11:00 am PANEL DISCUSSION: Debating how COVID-19 will impact the way we outsource and conduct clinical trials in the future: How long will we feel the ripples of this pandemic?
- Developing a clinical trial model that is able to withstand global disruption
- Switching gears: Should we be analyzing which parts of our clinical trials can go virtual?
- Lessons learned from developing protocol designs and vendor/site relationships quicker during the pandemic
Future trials: Assessment of how upcoming clinical studies will be conducted in light of the pandemic and what the long-term effects will be

Vaibhav Choudhary
Joint Director- Medical and Clinical Affairs
Fresenius Kabi Oncology

Moon Hwan Kim
Chief Technical Officer
BiSiChem Korea

Leonora Lim
VP Life Sciences & Healthcare Sector, Asia Pacific
DHL Customer Solutions & Innovation
11:45 am Close of conference
Sponsorship opportunities
To enquire about sponsorship opportunities for the conference, please contact:
Nick McCudden
T: +61 280 978 126
E: NicholasMcCudden@arena-international.com
Speaker opportunities
The Outsourcing in Clinical Trials East Asia programme is written in collaboration with industry, if you would have a case study, idea or just a comment, please contact:
Chloe Roberts
Portfolio Director
T: +44 (0) 207 936 6822
E: chloe.roberts@arena-international.com