Novotech
Empowering Enterprises with Full-Service CRO

Novotech, established in 1996 in Sydney, Australia, is an internationally recognized Asia-Pacific region full-service CRO. With offices in the U.S and across Asia-Pacific, the company has been the flag bearer for CRO services roll-out in the APAC region. They have completed more than 700 trials across most therapeutic areas including drug development and phase I to IV clinical trials, making it one of the leading midsize clinical research organizations globally. Recently, with its new owner TPG Capital Asia, the company made their first acquisition in the form of CNS or Clinical Network Services, an Australian specialist CRO. “We have a shareholder who is committed to helping us to execute our growth strategy, but very importantly is supporting us to make some quite significant capital investment. In addition, TPG Capital Asia helps us to maintain our rapid growth in a high-quality manner,” says Dr. John Moller, CEO at Novotech. This acquisition has further strengthened Novotech’s presence in the region, and has allowed them to bolt on an essential capability to the group, which is ‘BioDesk,' that will enable users access to an early stage product development advice including toxicology, CMC and FDA/EMA regulatory consulting and interactions, to support their clinical research programs. With increasing investment in upfront clinical development strategy, including the use of carefully designed adaptive protocols, the integration of capabilities such as BioDesk will bring tremendous support for Biotech companies looking for global regulatory services. “We are very selective about our acquisition, so we want to make sure, that the companies do bring certain value to the group, be it concerning local sponsor relationships or related to specific capabilities," he added.

Being a full-service CRO, Novotech offers all kinds of service, which would include elements such as feasibility, clinical services, project management, data management, statistical services, quality assurance, a full range of medical services and commercialization services. Additionally, a focus of the company is in serving the needs of the biotech sector, as it is a complex region and each of the countries’ regulatory systems in Asia are very different.

We remain very committed to the Asia-Pacific region, and so we are accelerating expansion, with our capability and development in Asia

However, their exceptional business model, having a great relationship with the countries as well as understanding the complexities in the region, enables them to deliver expertise to match the needs of the clients confidently. In fact, Novotech clinical staff numbers have grown by more than 20 percent in Asia over the last quarter, fueled by demand for a regional CRO with international accreditation and reputation, combined with local knowledge, partnerships, and expertise.

In one such instance, South Korean oncology biotechnology company PharmAbcine, was keen to move forward to phase II after completing phase I study for the treatment of a metastatic/ refractory solid tumor. As an early stage company, they were attracted by the funding support provided in Australia; additionally, they also had an excellent relationship with some of the key opinion leaders and had good sites in the country. The company asked Novotech for assistance, given their advantage of Australia’s supportive regulatory and rapid clinical trial environment. The challenge for Novotech was to meet the regulatory requirements for the Korean company. They worked along with PharmAbcine, and promptly secured HREC approval and managed site initiations.

Furthermore, Novotech’s strong Principal Investigator (PI) and site relations allowed PharmAbcine to accelerate feasibility activities, further expediting trial timelines. Finally, Novotech oncology team established a competitive recruitment environment between trial sites, resulting in full recruitment of one cohort within just four weeks of site initiation and overall recruitment closing two weeks early.

With biotech organization investing in more complex and global programs, the company expects the number of outsourced projects to continue growing and sponsors to increasingly consider the Asia Pacific as a key location for their trials. “We remain very committed to the Asia-Pacific region, and so we are accelerating expansion, with our capability and development in Asia,” adds John Moller. Indeed the company has ramped up the hiring process for extremely high-quality senior people—projects managers, senior projects managers, project directors and more in Asia.