Dark Horse Consulting Group and KunTuo Team Up To Accelerate Cell & Gene Therapy Trials In China
The partnership combines Dark Horse's regulatory and development consulting with KunTuo's on-the-ground clinical trial execution to help companies launch studies faster and generate data to support regulatory submissions.
Key Points
- Dark Horse Consulting Group and KunTuo have signed an MOU to help cell and gene therapy developers run clinical trials in China.
- The collaboration combines global regulatory and development consulting with local clinical trial execution and site access in China, helping sponsors start studies faster and generate data that can support future regulatory submissions.
China is a massive market for advanced therapies, but sponsors often face practical challenges aligning global regulatory plans with local study operations. To help address the issue, Dark Horse Consulting Group (DHCG) and KunTuo have signed a memorandum of understanding to create an integrated path for developers planning clinical trials in the region.
DHCG, a biotherapeutics consulting group based in the Bay Area, has deep experience with regulatory expectations tied to Chinese trials, including how data from those studies may be viewed by the FDA or other regulators. They will provide consulting support across regulatory, chemistry, manufacturing and controls, nonclinical, clinical, quality and compliance, supply chain, commercial launch, and business analytics.
KunTuo, a Chinese contract research organization, brings a dedicated cell and gene therapy clinical team and experience working across major research institutions in China, and will provide clinical research execution, including access to local clinical resources and operational support for complex studies.
Linda Wang, General Manager of KunTuo, said the partnership will hopefully develop a “one-stop solution that spans global regulatory strategy, drug development, and clinical trial execution — enabling innovative therapies to reach patients faster and more efficiently.”
The collaboration is effective immediately, and the companies expect client engagements to begin in the near term.
KunTuo was established in 2011 and has reportedly delivered more than 1,000 clinical research services for pharmaceutical and medical device companies in China and abroad. The company also states that it maintains IQVIA quality systems and has built substantial institutional and enrollment data resources across China.
DHCG, founded in 2014, provides consulting services across the biopharma development process. The company has expanded beyond its original focus on cell and gene therapy to provide broader support across strategy, operations, quality, regulatory affairs, manufacturing, modeling, supply chain, commercial launch, and business optimization.
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