No IND Required for Cell and Gene Therapy Studies with Australia’s Accredited CRO Avance Clinical
Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.
According to a recent Global Data and the Alliance for Regenerative Medicine (ARM) report the sector raised a record $14bn in H1 2021, compared to $19.9bn for all of 2020.
The report also highlights that 2021 is on track to have the highest number of regulatory approvals of gene therapy and gene-modified cell therapy products, with Europe at risk of falling behind the US and Asia in terms of number of developers and new clinical trials.
GCT Regulatory Landscape
As biotechs continue to invest heavily in clinical research in this rapidly evolving sector, the global regulatory authorities are under pressure to keep up with consistent and adaptive guidance.
In Australia, the Office of the Gene Technology Regulator (OGTR) has developed globally compliant regulations and accreditations to ensure that dealings with genetically modified organisms (GMOs) are safely managed in Australia. The OGTR regulations are very much in line with international guidelines.
Avance Clinical is an OGTR-accredited CRO and already has a number of significant clinical trial success stories with US and APAC biotech clients.
Avance Clinical CEO Yvonne Lungershausen, said OGTR accreditation is important for our international clients.
“Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector,” she said.
“This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).”
Avance Clinical’s Chief Scientific Officer Dr. Gabriel Kremmidiotis said:
“Avance Clinical currently has a number of CGT studies underway and is expanding its services further to accommodate increasing global demand.”
This emerging sector presents a new regulatory frontier for specialist CROs, sites and participants.
“As an OGTR accredited CRO we can guide our international biotech clients with deep knowledge on the OGTR guidelines, allowing us to support our clients minimize delays and risks. Indeed, we would argue the clarity around the OGTR regulations makes Australia one of the most attractive destinations for CGT research,” said Dr.Gabriel Kremmidiotis.”
ClinicReady Manages Regulatory Process
Avance Clinical’s ClinicReady team supports biotech clients through the entire process.
The key to a successful drug or therapy development program is the foundation work by our experienced ClinicReady regulatory and scientific affairs team who understand the guidelines and pathways for approval for CGT products in development.
The CTN pathway with the TGA may be utilized for gene therapy clinical trials that are supported by evidence from previous clinical use or approval from comparable regulatory agencies.
Clinical trials of CGTs involving GMOs are conducted under a product-specific DNIR (Dealings not involving intentional release) or DIR (Dealings involving intentional release) license from the OGTR. Avance Clinical obtains the license on behalf of our client, prepares an OGTR Compliance Monitoring Plan, and monitors and manages the clinical site activities to ensure compliance with the license conditions. This effectively streamlines the approval process.
One of the most recent case studies was Tetherex Pharmaceuticals, a US-based company developing a single-cycle adenoviral vector vaccine (a genetically modified organism product) for the treatment of COVID-19. The treatment is designed for intranasal delivery which is expected to provide a more efficient front-line defense against COVID-19 in airway tissues, the site of virus entry into the body. The vaccine is currently undergoing safety testing in healthy volunteers.
The Avance Clinic Ready team worked with Tetherex in the development of the study protocol and the Investigator’s Brochure while concurrently working with the Office of Gene Technology Regulator (OGTR) in obtaining the necessary licenses to enable importation of the product to Australia for the purpose of clinical trial evaluation.
“The Avance Clinical team demonstrated flexibility and a solution-oriented attitude in working with us towards obtaining rapid ethics approval, thereby facilitating trial initiation in a timely and efficient manner.”
Dr. Russell Rother, President and Chief Operating Officer, Tetherex Pharmaceuticals
ClinicReady – Case Study
Tetherex Pharmaceuticals is a US-based company developing a single-cycle adenoviral vector vaccine (a genetically modified organism product) for the treatment of COVID-19. The treatment is designed for intranasal delivery which is expected to provide a more efficient front-line defense against COVID-19 in airway tissues, the site of virus entry into the body. The vaccine is currently undergoing safety testing in healthy volunteers.
The Avance Clinic Ready team worked with Tetherex in the development of the study protocol and the Investigator’s Brochure while concurrently working with the Office of Gene Technology Regulator (OGTR) in obtaining the necessary licenses to enable importation of the product to Australia for the purpose of clinical trial evaluation. Notably, Avance is accredited by the OGTR, which enables it to support the execution of trials evaluating genetically modified organism products in Australia. This support involves the application and acquisition of a product specific license from the OGTR and the monitoring and management of the clinical site’s compliance with that license.