Novotech Launches Dedicated Early Phase Unit for Biotechs Leveraging the Australian and New Zealand Clinical Environment

San Diego, USA - Novotech, the global full-service Contract Research Organization (CRO) that partners with biotech companies to accelerate the development of advanced and novel therapeutics at every phase, today announced the launch of a dedicated early phase unit focussed on leveraging the unique advantage of Australian and New Zealand (ANZ) for early phase clinical development.

This Early Phase Strategic Delivery Unit (EP SDU) is the first in a series of new Strategic Delivery Units (SDUs) to be launched by Novotech over the course of 2024, each one being a dedicated delivery unit with specialist teams and tailored processes, for different types of complex clinical trials.

Novotech has long been a partner of choice for biotechs wanting to conduct early phase trials in ANZ and benefit from the clinical and scientific excellence, attractive financial rebates, and rapid start-up with streamlined regulatory processes.

Novotech CEO Dr John Moller said: “Our Early Phase Strategic Delivery Unit ensures that, as our global operations continue to grow, our commitment to excellence in Phase I delivery across ANZ remains a core and integral part of Novotech's service offering. This continues to serve as a platform for our biotech clients to expedite their early phase work before expanding into later phase global development with Novotech”.

Lynda Bluck, Director of Early Phase Project Management, who brings over 20 years of clinical trial experience said: “The EP SDU consists of a multidisciplinary team of experts in early phase clinical trials who provide support, expertise, guidance, and oversight to all our early phase projects, ensuring consistent high quality operational delivery”.

“ANZ is an attractive destination for early phase biotechs as it offers rapid, cost-effective, and high-quality clinical development solutions,” said Bluck.”

“Novotech has more than 30 years of experience in conducting early phase clinical trials in ANZ with a reputation for consistently delivering high quality data that is accepted by international regulatory agencies.”

“Our team offers proven optimized processes for rapid and efficient execution of Phase I clinical trials and are committed to helping our sponsors navigate both the preclinical and clinical stages of drug development.”

Bluck said central to the EP SDU’s offering is integrated engagement with Novotech's world-class Drug Development Consulting (DDC) team.

“The DDC is a full-service global product development and strategic regulatory group that supports sponsors through every phase of clinical development. The expert team is particularly integral in providing guidance and support prior to entering Phase I and ensuring our sponsors are HREC (IRB equivalent) ready,” said Scott Schliebner, Novotech’s Vice President of Drug Development Consulting.

Novotech's DDC team provides comprehensive "lab to launch" program development services, including regulatory strategy and operations, CMC and product/analytical consulting, clinical oversight, toxicology and other nonclinical consulting, quality/GMP consulting, and electronic submissions. We have a proven track record of successful FDA meetings and approvals.

The teams have the expertise to support projects over their entire lifecycle, all the way from preclinical development through to approval and post-marketing.