To investigate venom discovery practices to develop a strategy to translate venom into bio-applications

The process of translating venom into bio-applications is an arduous, lengthy process requiring numerous specialists. In the case of medicinal therapeutics, it takes on average 25 years to develop a marketable product. Conversely, antivenom development has seen little change in production techniques since 1908, e.g., snake antivenom based on equine or camelid antibodies, irrespective of known side effects and new technologies that have arisen. There is a need to reduce the deliverable time from translation to the availability of venom-derived bio-applications.

Aim: Acquire knowledge of international venom discovery processes to develop new strategies for translating venom into bio-applications to benefit the Australian community in a timely manner. Venom-derived bio-applications include therapeutics to treat disease (e.g., stroke or multiple sclerosis), develop antivenom, or control parasites/pests detrimental to the agriculture industry.

Specific areas of study for the Churchill Fellowship included:

·        applying venom evolution studies to aid in the development of bio-applications,

·        successful bio-medical applications developed from venom,

·        novel methodologies used to develop antivenom,

·        rearing of venomous animals seldom studied; and

·        utilisation and collection management practices of venomous animals in museum collections.

Churchill Fellowship outcomes were achieved through:

·      face-to-face interviews,

·      observation of techniques and practices, and

·      tours and visits to leading research institutes & businesses.

Key findings

The issues of translating venom into bio-applications are not unique to Australia and are ultimately a global issue, key issues include:

·        the intent of the NAGOYA protocol and its implementation are mismatched which is adversely affecting scientific collaborations between countries and development of important therapeutics, e.g. snake antivenom,

·        fundamental, baseline or innovative venom research is generally not funded. Funding agencies require evidence that projects will have a solid outcome i.e. preliminary results obtained prior to submission for funding,

·        non-standardised definitions of envenomation’s symptoms, chemicals and toxins make it difficult to translate one product to multiple markets globally,

·        museum collections are underutilised for venom research, and changes to collection management practices are having detrimental effects on irreplaceable collections,

·        requirements need to be clearly articulated for bringing novel venom-based therapeutics to market by regulatory bodies e.g., WHO, FDA, NHMRC, and

·        Australian bio-application development is generally conducted offshore, where venture capital is easier to obtain e.g., in the USA,

·        there is still a lack of understanding of the differences between toxinology and toxicology research fields, and

·        shortage of employment positions for postgraduates and skilled staff.

Conclusion and Recommendations

To improve venom bio-application development time frames, there needs to be a re-examination of current processes within Australia. Some issues, such as business regulations and investments law within Australia are outside the scope of this report. The priorities listed below align to the 2021 Australian National Research Infrastructure Roadmap.

Immediate priorities to be addressed, to enable shorter periods for development of venom bio-applications include:

·        review of the implementation of the Nagoya protocol in, and between, signatory and non-signatory countries and clarification of definition of terms,

·        review of envenomation reporting system in Australia; state by state and nationally, to form a cohesive picture of the current state of play,

·        roadmaps developed for bringing new classes of drugs to full development e.g., NHMRC, WHO, FDA to clearly lay the foundations required.

·        foster relationships between clinicians and venom researchers,

·        education of community and funding bodies regarding differences between toxinology and toxicology research fields, and

·        review of funding structures and sustainability within Australia.