Doherty Clinical Trials Ltd
Brooker Consulting is proud to partner with Doherty Clinical Trials Ltd to recruit a Chief Executive Officer.
The Peter Doherty Institute for Infection and Immunity (Doherty Institute) is establishing a new company to conduct clinical trials.
The facility will be the first of its kind in the Southern Hemisphere, dedicated to using the challenge model to test drugs and vaccines within a purpose-built controlled setting to accelerate the development of new therapies.
The company is established to operate a research-focused clinical trials facility, internationally renowned for the delivery of clinician-led activities. It will be a registered charity with the core objective of developing and researching treatment and prevention of disease in human beings. It will, in addition to conduct of challenge studies, undertake early phase studies in healthy volunteers, such as vaccine studies.
Why Doherty Clinical Trials Ltd exists
Formal clinical trials are the mainstay of developing new treatments, allowing the safe introduction of new therapies with a good understanding of their risks and benefits. Doherty Clinical Trials Ltd (DCT Ltd) is a company limited by guarantee designed to directly contribute to greatly accelerated development of new therapies for infectious diseases.
Standard clinical trials (Phase 1-4) use established methodologies to investigate new therapies and interventions. Clinical trials are well entrenched within the hospital system and other healthcare partners including universities, with hospital clinicians and university researchers involved in many studies. The clinical risks associated with such trials relate to adverse events caused by the investigational agent being tested.
Current barriers for clinical trials
Recent trials of vaccines and drugs to prevent or treat COVID were only viable due to the availability of tens of thousands of eligible participants who were readily identifiable and could be rapidly enrolled.
This is not the case for many infectious diseases which occur sporadically and therefore are difficult to recruit to for efficacy studies. The development of priority vaccines and drugs for many infectious diseases is therefore impeded by the high costs and lengthy duration required to execute Phase II and III efficacy studies (up to US$1.2 billion and greater than seven years, respectively (1)). These represent major barriers to the development of promising antimicrobial drugs and vaccines.
In addition, efficacy trials of naturally infected subjects are particularly difficult in diseases that affect vulnerable populations (such as children), hard-to-reach or marginalised groups, (such as those with sexually transmitted diseases or people who inject drugs), or in diseases that predominantly occur in low and middle income countries (such as those caused by parasites).
Doherty Clinical Trials Ltd
Doherty Clinical Trials Ltd (DCT Ltd) will be the first of its kind in the southern hemisphere, a facility dedicated to the use of innovative clinician-led challenge models.
An interim location is under development in East Melbourne, with the long-term home of the service intended to be the new Australian Institute for Infectious Disease located within the Melbourne Biomedical Precinct.
Human Infection Challenge Model
Human Infection Challenge (HIC) clinical trials differ from standard efficacy trials in that they involve deliberate infection of the trial participants under highly controlled conditions with the target pathogen.
Testing drugs and vaccines using human challenge models at the earliest stage of clinical development accelerates key decision making, saves millions of dollars and reduces the duration of trials by many years (2).
Established by
Finding solutions to prevent, treat and cure infectious diseases and understanding the complexities of microbes and the immune system requires innovative approaches and concentrated effort. This is why The University of Melbourne – a world leader in education, teaching and research excellence – and The Royal Melbourne Hospital – an internationally renowned institution providing outstanding care, research and learning – have partnered to create the Peter Doherty Institute for Infection and Immunity (Doherty Institute); a centre of excellence where leading scientists and clinicians collaborate to improve human health globally.
About the CEO position
Governed by a skills-based Board, a Chief Executive Officer will be appointed to provide effective leadership of the facility’s strategic and operational performance in conjunction with the Board, and will be responsible for developing an effective leadership structure and introducing business systems to allow for delivery of versatile clinical trials delivery of the highest quality.
This crucial role will lead foundational activities of the service, including development of the vision and mission, establishment of key partnerships, business development functions and sound business planning.
It is anticipated that the incumbent will have deep understanding of biotech or pharmaceutical industries, demonstrated business planning capability (ideally in a start-up context), risk and quality management experience in a complex regulatory environment and an understanding of clinical trials design and processes.
Find out more
Please contact Jeremy Wurm on 0419 529 525 or Lesley Lightfoot on 0458 543 485, in confidence.
1. Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020;323:844-53.
2. Roestenberg M, Hoogerwerf MA, Ferreira DM, Mordmuller B, Yazdanbakhsh M. Experimental infection of human volunteers. Lancet Infect Dis. 2018;18:e312-e22.