- Addressing major challenges in international cold chain shipping, pitfalls to avoid
- Utilizing advanced technology for complete remote temperature monitoring
- What are the most recent developments and advancements in cold chain technology?
Archives: Agenda
NAVIGATING CLINICAL TRIAL SUPPLY CHALLENGES
In the ever-evolving world of clinical trials, navigating product sourcing and supply chain challenges is a formidable task.
Join this session to unravel the complexities of clinical trial supply, with expert tips for overcoming hurdles.
- clinical trial supply trends in Asia-Pacific
- early identification of clinical trial supply challenges,
- strategic supply and logistics planning,
- using market intelligence and global insights for informed decision-making,
- fostering collaboration for a successful clinical trial
Selecting CDMO Partners and Product Manufacturing for Cell & Gene Therapy
• Analyze and select CDMO candidates from a technical, facility, quality, and communication perspective
• Work with selected CDMOs to select raw materials, develop processes and analytical methods, and apply them to scale-up processes to produce consistent cell and gene products
• Ultimate responsibility for product development lies with the sponsor
Lunch and networking
Registration and refreshments
Chairperson’s opening remarks
The Biotech’s Gambit: Key considerations to identify right CRO/vendor partners
- What is vital for a biotech in CRO/vendor selection?
- As a biotech, who is a good partner? A small/medium-sized CRO or large global CRO?
- How can a biotech engage a CRO to prioritize its study?
Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning
- Identify critical areas often overlooked in clinical supply chains that lead to inefficiencies
- Explore the benefits and limitations of each type of tool: from excel-based to specialized forecasting tools dedicated to the clinical supply chain
- Gain practical insights from case studies that explore complex trial designs, waste management, monitoring processes, and adaptability to changes
ICH E6R3 – What we need to know and do to optimize trial management
| · Familiarize with the major revisions and updates in ICH E6R3 guidelines compared to previous versions
· Adopt standardized documentation practices to ensure consistency and compliance with ICH E6R3 · Training and Capacity Building |
What is needed to build a major biotechnology/pharmaceutical company: an evaluation of the level of ambition and the possible underlying causes
- Investing in the right people – early gap analysis
- Financial strategy leading to success
- Competitive Intelligence – market analysis & selection of indication
- Common factors of management that succeed