Porton Advanced Partners with Dark Horse Consulting for Clinical Trials in China

Strategic Partnership to Enhance Clinical Trials in China

Porton Advanced, a leader in the field of contract development and manufacturing specializing in advanced therapy medicinal products (ATMPs), has forged a strategic alliance with Dark Horse Consulting Group (DHCG), renowned for its expertise in biotherapeutics consulting. This collaboration aims to effectively expedite the development and clinical translation of cell and gene therapies around the globe.

The Memorandum of Understanding (MOU) signed between these two powerhouses is set to create a smoother path for clients looking to conduct Investigator-Initiated Trials (IITs) in China—one of the fastest-growing markets for advanced medical therapies.

What This Partnership Offers

The collaboration combines DHCG's extensive consulting capabilities across various domains such as regulatory affairs, clinical compliance, supply chain management, and more, with Porton Advanced's comprehensive end-to-end GMP manufacturing infrastructure. This includes services covering lentiviral vectors, AAV, mRNA/LNP, plasmids, and a range of engineered cell therapies, including CAR-T and CAR-NK products.

By integrating these specialized skill sets, both firms will present clients with a cost-effective, rapid pathway to facilitate easier entry into clinical-stage manufacturing. By focusing on IITs in China, they address a common challenge faced by organizations as they navigate through the complexities of international regulatory strategies alongside local manufacturing constraints.

Proven Track Records

Porton Advanced has achieved notable success in this endeavor, holding 24 Investigational New Drug (IND) clearances across both the National Medical Products Administration (NMPA) and the FDA, already supporting more than 30 IITs. Meanwhile, DHCG excels at guiding sponsors through the rigorous regulatory and clinical design requirements that such projects necessitate.

This collaborative framework is strategically designed to empower sponsors and investigators to drive their clinical programs forward with heightened confidence, speed, and efficiency. The amalgamation of Porton Advanced's manufacturing expertise with DHCG's consulting capabilities will streamline the manufacturing-regulatory interface, reducing the delays often experienced in initiating IITs.

Expert Insights

Anthony Davies, the Founder and CEO of Dark Horse Consulting Group, remarked, "This MOU with Porton Advanced signifies a more efficient pathway for our client partners who are interested in pursuing IITs in China. With our aligned quality systems compatible with NMPA regulations, this partnership promises a quicker transition to first-in-human trials and rapid tech transfer. Our goal is to assist developers in delivering therapies to patients more swiftly, and this MOU articulates that mission."

Andrew Chen, CEO of Porton Advanced, echoed these sentiments stating, "Our partnership with Dark Horse Consulting Group brings us tremendous excitement. As we witness escalating demand for IIT-enabling services from foreign sponsors wishing to participate in China’s burgeoning market, our collaboration with DHCG will create a truly innovative offering available to developers at every stage of their clinical journey."

About Dark Horse Consulting Group

Founded in 2014, Dark Horse Consulting Group is a global entity with several offices spread across North America, Europe, and the Asia-Pacific region. Their mission is to advance the development and deployment of cell and gene therapies, backed by unparalleled industry expertise.

The extent of DHCG's consulting teams has widened since their establishment, now covering an extensive range of areas including strategy, operations, regulatory affairs, and supply chain optimization. Their white-glove service, based on rigorous scientific and technical competency, effectively guides clients from the early stages of discovery all the way to commercial launch.

About Porton Advanced

Porton Advanced, a subsidiary of Porton Pharma Solutions, is headquartered in Cranbury, New Jersey, with additional GMP sites located in Suzhou, China. They offer expansive CDMO solutions tailored for ATMPs, including from cell banking and method development to GMP production and formulation. Porton Advanced has earned a reputation for securing vital IND approvals and supporting clients throughout various phases of drug development, ensuring an agile customer-centric approach.

In conclusion, this collaboration between Porton Advanced and Dark Horse Consulting Group is poised to significantly enrich the landscape for advanced therapies in China, offering groundbreaking opportunities for developers aiming to transform medical solutions into tangible patient benefits, faster and more efficiently than ever before.