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U.S. market entry for Japanese cell therapy specialist

Tags

US market entry
Public
Cell & gene therapy
CGT
Early-stage clinical

Overview

A Japanese-listed developer of cell therapies faced challenges progressing beyond Phase I clinical trials in the domestic market.

The company’s lead cell therapy had broad potential applications. The asset was being initially tested in an orphan, inborn, neurological condition.

Situation and Challenges

Whilst the asset had shown promising data so far, development to approval was bearing significant hurdles to be overcome:

  • Clinical heterogenity of chosen indication
  • Manufacturing and scalability
  • Regulatory alignment with the US FDA
  • Requirements of international partners and investors

Treehill Solution

Devised full global development plan and a strategy for U.S. IND.

Positioned the asset for the international markets.

Built a forceful infrastructure of leading, dedicated and engaged providers as well as thought partners around the asset.

Enabled a more sustainable, commercially viable milestones trajectory.

Conclusion and Outcome

Treehill’s involvement has:

  • Crystallized a viable path forward
  • Expanded development activities in line with US regulatory requirements
  • Put the asset on a path that is aligned with requirements of institutional investors 

Devised full global development plan and a strategy for U.S. IND.

Positioned the asset for the international markets.

Positioned the asset for the international markets.

Positioned the asset for the international markets.

Treehill Partners put the strategic development of the asset onto a global footing:

Devised full global development plan and a strategy for U.S. IND.

Positioned the asset for the international markets.

Built a forceful infrastructure of leading, dedicated and engaged providers as well as thought partners around the asset.

Enabled a more sustainable, commercially viable milestones trajectory.