top of page
  • Morula Health

Breaking Barriers: Facilitating FDA Approval

A Case Study of Streamlining IND Submission for a Leading South Korean Pharma Company


Highlights


  • Our team developed a FIH phase 1 protocol for a large South Korean pharmaceutical company's IND submission to the FDA

  • Effective collaboration across UK and South Korean time zones to generate a high-quality protocol using diverse source documents

  • Proactive planning to expedite project and contract timelines, including contracting and reviews, and strategic meetings


Pharmaceutical company


Background


A large South Korean pharma needed to submit an IND to the FDA to conduct clinical trials in the US. As part of the IND submission, they had to develop the FIH phase 1 protocol within tight timelines.


The medical writer that Morula Health assigned developed a high-quality protocol within 5 weeks, which included 2 rounds of client review and comment resolution meetings. An equally experienced writer then performed a formal quality control (QC), to ensure the document was ready for submission to the FDA as part of the IND application. Our project manager provided strategic input throughout, to ensure the timelines and budget were strictly adhered to.


What the client cared about:


  • Writers with specific immuno-oncology expertise and FDA protocol experience

  • Completion of a high-quality protocol in line with their strict timeline and budget

  • Inclusion of a formal QC process, to finalize the document going toward their IND submission


Challenges


  1. To develop the protocol to the standard required by the FDA, the client needed the assistance of a team of medical writers with a thorough understanding of the specific immuno-oncology drug pathways and who are experienced in writing FIH phase 1 protocols for clinical trials conducted in the US.

  2. The client provided source documents in various formats, requiring us to collaborate with them to gather all the information necessary for a high-quality protocol.

  3. This was our first project together, so we needed to draft, review, and circulate contracts for signature before work could begin. Working across time zones required flexibility for strategic meetings.


Solutions


  1. Morula Health assigned a native English-speaking medical writer who has expertise in immuno-oncology. This writer and the QC expert also had extensive experience developing phase 1 protocols and working on IND submissions for the FDA. The assignment of such an experienced writer resulted in a high-quality protocol that was finished on time and within budget.

  2. Before starting work on the protocol, our writers conducted a thorough review of the protocol synopsis. As the Investigator's Brochure (IB) was unavailable, our writer was able to identify and incorporate the relevant information from the related briefing book instead. Tip: The client provided a blinded version of a previously approved protocol and their protocol template, which was extremely helpful!

  3. Our experienced project management team ensured strategic meetings, rounds of review, and communication were not impacted by the time differences between South Korea and the UK-based team. By scheduling meetings at times that worked for both sides, we were able to maximize efficiency while still ensuring all key decision-makers could attend strategic meetings. Both legal teams worked efficiently and proactive planning and preparation, e.g., reviewing source documents before the kick-off meeting, ensured we could begin work as soon as all the necessary contracts were in place.


Results


Our approach ensured that we met our client's strict 6-week timeline, and helped them avoid delays in their IND application.


What the client had to say:


"We would like to express our appreciation to collaborate with you and Morula Health. It has been a valuable experience."

"We will not hesitate to reach out to you for your expertise and assistance"

Comments


bottom of page