There is increasing interest in the Asia-Pacific (APAC) biotech industry in initiating early phase clinical trials in the US. This webinar will address critical areas to consider when planning for the successful development and initiation of an early phase study in the US: regulatory, medical, operational and cultural.
In terms of the regulatory piece, the featured speakers will discuss the Investigational New Drug (IND) Application process, including requirements and timelines. In addition, incorporation of non-US data as well as the potential to bridge studies and arms will be explored. Other key considerations include Investigational Product (IP) export/import, shipping and customs, differences between medical and standard of care practices, study operations and site differences, and overall regulatory timeline differences.
It will be helpful for the audience to recognize pricing and negotiation differences between their local market and the US and the global markets. There are many reasons behind this, from the very tight labor market in the US in clinical development, to the costs associated with developing a new drug versus a commoditized generic. This webinar will examine the factors that drive negotiations: novelty, quality, timelines and price.
In addition to the differences between APAC and US markets, the speakers will look at the differences between Contract Research Organization (CRO) partners. Webinar attendees will learn about vendors and service providers, including specialized CROs that provide unique capabilities, including flexibility, proactivity and attention to studies. The emerging sponsor may also need help with protocol development and trial design. Therefore, it is important to find the appropriate service providers with capability and expertise.
Differences also abound in operational execution. For example, large academic institutions often have multiple committees that review new studies and provide guidance, approval and/or oversight, which ultimately could affect start-up timelines (versus Asia). In addition, the contracting process at institutional settings is more protracted compared with smaller research settings. The speakers will address the importance of knowing how each individual clinical research site navigates the study start-up process.
From a cultural standpoint, the speakers will discuss the landscape of clinical trial markets in APAC versus the US. It is important to note there is considerable interest in both oncology and non-oncology clinical development. Navigating the diversity of service providers (size, focus, technology) in the US will be extensively covered.
Because of the various differences in initiating and conducting early phase clinical trials between the APAC and US, it is important for the APAC sponsor to find the best CRO partner — one that is experienced in navigating the US clinical trials landscape, has proven expertise to support regulatory activities and understands cultural differences.
Join this webinar to gain insight into the key elements for APAC sponsors to consider when conducting early phase clinical trials in the US.
- Clinical trial start-up and execution in the US is complex and may differ from the APAC experience
- Timelines for new drug development are longer and riskier, so early planning is better
- The differences between service providers are vast in the US compared with APAC
- The diversity of sites and processes in the US demand different site selection strategies
- Chief Executive Officers
- Compound Lead Portfolio Managers
- Venture Capitalists
- Chief Medical/Scientific Officers
- Regulatory Leads
- Pharmacovigilance/Safety Teams
- Investigators
- Biomarkers Scientists
- Clinical Development Teams
- Clinical Operations Teams
- Project Management Teams
- Procurement Managers
- Clinical Supply Management Teams
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