The new research organisation supporting New Zealand’s medical innovators to market
BioValeo Founder and CEO Julie Jones leads a new Contract Research Organisation specialising in personalised medicines and immunotherapy-based clinical trials.
The new Contract Research Organisation (CRO) will specialise in the provision of clinical trial services, with a particular interest in CAR T-cell therapies.
Julie explains, “CAR T-cell therapy stands for Chimeric Antigen Receptor T-cell therapy. The patient’s own immune cells, or T-cells, are reprogrammed to identify and attack a target, such as cancer cells. Each treatment is created specifically for the patient. Because they’re personalized and targeted, they can be incredibly effective.”
BioValeo will also provide consultancy and research services such as study monitoring, sponsor representative country oversight, assistance to navigate the complex research environment, or any combination of services needed by a sponsor.
Julie says, “Clinical trials require many different specialists to come together. You might need a project manager, quality manager, monitors, medical writers, experts in ethics and regulatory affairs, contract specialist, statistician, and data managers. These experts are commonly provided by a CRO. They plan, establish, manage, and oversee the trial; ensuring data quality and participant safety is maintained. The part of the study that involves the study participants is done at a site, the site will have medical experts in the disease area. A site conducts the study and handles everything related to the participants, which ensures the confidentiality and medical safety of the participants.”
“It’s very difficult to navigate the clinical trial process without years of experience in clinical research. People who are new to clinical trials often don’t know where to start or are not aware of the complex requirements. BioValeo covers most areas of research expertise in-house, and can coordinate studies end-to-end. We can set up the study, project manage it, and monitor it during conduct to make sure it stays on track, as well as supporting the medical professionals conducting the study at the site.”
Rich experience in all aspects of clinical research
After completing a masters in vaccine development in veterinary studies at Massey University, Julie began her career in immunology at the Malaghan Institute. There she established an accredited GMP (good manufacturing practice) lab to produce cell therapeutics for clinical trials and ran the dendritic cell clinical trial for melanoma.
This led to almost a decade managing European clinical trials for pharmaceutical multinationals, covering many diseases and all phases of the clinical trial process. Returning south, Julie became president of the New Zealand Association of Clinical Research and sat on the Health & Disability Ethics Committee. She combined governance with instituting a quality management system for the Medical Research Institute of New Zealand.
This broad experience gives Julie a robust grasp of the wide expertise needed for clinical trials. She has hands-on experience with cell-based personalised medicines, and immunology-based treatments as well as many other disease indications. When Bridgewest Ventures commissioned Julie to write a report on the New Zealand research environment they discovered how well her skillset was aligned to their start-ups’ need for a CRO to manage clinical trials.
“We believe a CRO focused on CAR T-cell therapy, personalised medicines, and immunology-based treatments will support the burgeoning New Zealand biotech industry but we can also support New Zealand biotech groups that have products outside of our speciality area as we have experience in a wide variety of study types.”
Julie explains: “There are no New Zealand CROs specialising in clinical trials for immunotherapy and personalised medicine. Other organisations offer it as an add on, but it’s a growing area, and there’s appetite for a niche service. Bridgewest recognise their own need and that of other products coming through the New Zealand research pipeline.”
A nimble CRO designed to meet new ICH guidelines
The international clinical research industry is based on ICH Good Clinical Practice (GCP) guidelines. ICH is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and they recently updated the guidelines for clinical trials. Julie says, “The guidelines focus strongly on a risk-based approach to mitigate safety risks to patients and improve the quality and integrity of the data. The updates represent a major change to the way clinical trials are conducted by identifying and focusing effort on aspects critical to the study and reducing non-value adding activities.”
“Because we’re new, BioValeo is well placed to adopt the new ways of working. We’re setting up all our systems and processes to be fully compliant with the updated ICH GCP guidelines, which gives us an advantage over some of the large established CROs who need to pivot and make significant changes to their systems and processes. At the moment, we’re reviewing the various systems available for clinical trials. The systems are cloud based and will allow us to provide effective and efficient oversight and management of studies, while also ensuring the study data is collected within fully validated and auditable systems, which is a requirement in our industry.”
BioValeo will also specialise in research for biotech start-ups who need a full-service research solution.
“We plan to stay nimble, so we can be dynamic and responsive to the fast-moving biotech market. I’ve seen where time and money can be wasted in clinical research, so we’ll eliminate things that don’t add value for our clients.”
“We believe organisations will choose BioValeo to manage their research, firstly for our experience and specialist expertise, which means they can rely on their study being efficient and delivering high quality data, but also because of the way we work. We’re very responsive. The management of studies can't be set in stone. You’ve got to keep a close eye on how things are going and adapt based on how the study progresses.”
Medical research represents a massive opportunity for New Zealand
Julie says, “I always thought it would be a good idea to set up a CRO one day. I didn't think it would happen so soon, but all of a sudden a number of things aligned, seemed to come full circle, and it became the right time to develop this opportunity with Bridgewest. Not only did we see the same opportunity, but we’ve the same ideals and ethics. Bridgewest believes companies should be run to support society and add value, and that sits well with me.”
“Bridgewest made it very easy for us to set up BioValeo because their start-up programme guides you through the start-up process and provides support until you're established. That takes a lot of the pressure off the administrative aspects of founding a business. I'm not sure I would've known how to get started otherwise because I haven't started a business before.”
“Medical research represents a massive opportunity for New Zealand. Even before adopting the new ICH GCP guidelines, research data from New Zealand is of the highest standard. We retain patients well because people understand the value of research, and they're well supported by hospitals and researchers. We can establish a fantastic reputation as a place to do quality medical research and develop life-changing products on the back of that data.”
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