Outsourcing in Clinical Trials & Clinical Trial Supply East Asia 2021

• Outline on the Korean capabilities of Novotech, the Asia Pacific CRO and how we support the fastest growing clinical trial region globally
• an introduction to BioDesk, Novotech’s in-house Regulatory Affairs consultancy
• what are the latest regulatory trends we are seeing across APAC

Discussion point : What is core competency that must be internalized by a small biopharmaceutical venture

• Finding out unmet medical needs and forecasting the future
• Producing persuasive nonclinical data
• Determining the clinical indication
• Organizing the echelon for efficiency in clinical trials

The rise of decentralized trials has provided sponsors with the opportunity to improve patient recruitment and retention by reducing or even eliminating the need for patients to travel to a clinical site. Compliance with the varying regulations around the globe with regards to direct-to-patient distribution of clinical supplies can be especially challenging for sponsors with studies held across multiple regions or countries. In this session, we will explore several of the direct-to-patient models currently available today, their benefits and use cases, possible limitations and option to combine one or more models into a hybrid approach that together best meets the needs of the trial sponsor and patients alike.

• Genvuv and its science
• Pros and cons of clinical development in Korea, China, and the US
• Clinical development challenges and overcoming strategies

• People: How concierge participant support provides direct engagement with participants through the various stages of their study journey, including device offerings and logistics management to optimize the participant’s access and experience.
• Processes: How operationalized workflow and data flow provides ability to decentralize what would otherwise be a site based study into a DCT model without degradation of data quality or integrity.
• Technology: How purpose-built and configurable DCT platforms provide the backbone and data hub for powering the decentralized trials of today and the future.

• How did the FDA and MFDS react to COVID?
• What does a post-COVID regulatory world look like?

• Key considerations for your clinical trial design
• Pros and cons of DCTs to overcome barriers to clinical trial access
• Key considerations to ensure success with reaching and engaging patients from underrepresented -communities
• Centralized Data Monitoring and Electronic Monitoring

• 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

• How do we move clinical operations to think about mitigating risks in the design phase and translating these into action?
• How can clinical teams step back and self-analyse what risk could occur rather than rush straight in?

• People: How concierge participant support provides direct engagement with participants through the various stages of their study journey, including device offerings and logistics management to optimize the participant’s access and experience.
• Processes: How operationalized workflow and data flow provides ability to decentralize what would otherwise be a site based study into a DCT model without degradation of data quality or integrity.
• Technology: How purpose-built and configurable DCT platforms provide the backbone and data hub for powering the decentralized trials of today and the future.

• Using AI Technology to help identify order processes to ensure they are delivered without issues
• Applying digital technology at sites to keep them operating during pandemics and to avoid delayed delivery of products

• Discussing the level of risk involved in virtual, adaptive and other innovative trial designs so you are best prepared for potential pitfalls
• Determining how to find the right partner for virtual/ siteless trials to ensure you have the specialized technology and expertise required to be successful

• Overcoming common events of temperature fluctuation during distribution
• 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

• Assessing current data collected to determine the current steps needed of your study
• Liaising with CRO’s to ensure they can fulfil their duty at hand
• Identifying alternative solutions if your current site is not in operation

• Treatment of PII(personally identifiable information
• Decentralized Identity, Blockchain, Verificable Credential
• Safety Pass App for COVID-19 test result (2021 KISA(Korea Internet & Security Agency) DID Pilot project)

• Gain a high level of commitment for compliance throughout the storage, distribution, shipment & transportation of products
• Balancing the quality, risk and cost to achieve compliance & maintain end-to-end product integrity
• Work closely with business partners to prevent inventory breaches and employ innovative end to-end technology solutions

• Drug Development Strategy in China
• Regulatory Revolution and Global Simultaneous Development
• Clinical Operations Considerations

• Unlocking efficient strategies to manage multiple countries’ regulations for global trials to increase productivity and achieve high quality results from all operation sites