Final Report Summary - PIEDPIPERDA (Development of a novel method for rodent control)
Executive Summary:
In 1948 Warfarin was identified as a poison for rats and was first registered in the USA in 1952. It quickly gained popularity as it was highly effective and easy to use. There was, however, an enormous mistake made with Warfarin and all second-generation anticoagulants which have become apparent over time as rats have developed resistance due to the need to consume poisoned baits over several weeks to ingest a lethal dose. The use of warfarin has also resulted in deaths to humans from accidental poisoning and secondary poisoning of other species. It is also now evident that anticoagulant products remain in the environment for years posing an ongoing risk. In 1984 Marshall presented a paper on cholecalciferol where he specifically included a trial of cholecalciferol (vitamin D3) on Warfarin-resistant rats. In the following forty-two years since his paper, the situation has deteriorated and today society faces a crisis with ever increasing rodent populations. Against this background PiedPiper project began in 2006 with three main aims, to replace multi feeding of bait thus preventing resistance developing, achieve a more humane approach with a shorter time to death and deliver this in an environmentally safe way. The solution was to identify a replacement toxin and develop a novel and unique delivery system. Cholecalciferol was selected as the toxin and a transdermal delivery system developed.
The main objectives of the PiedPiperDA were related to IP in the form or patent applications under the PCT system, A review of the requirements for the regulatory requirements in several territories but focusing primarily on the EU. Given the cost of EU regulatory approval, we would need and additional grant or a funding/partnership arrangement. The current approach is to proceed with regulatory approval in New Zealand and then to address the US and Australian regulatory requirements. This is to be led by our retained regulatory consultant/toxicologist.
An important objective was to develop a pre-production prototype Pest Control Device (PCD) that was consistent and reliable - essentially to deliver the same dose on triggering each time. This has been the biggest proportion of the project and surprisingly it proved far more complex than we anticipated. The trial work on dose levels and product formulation were completed in the original PiedPiper project and all the trial work since our first trials in August 2012 have been 100% successful. A small number of clinical trials have been conducted at Cellvax and Aston University All trials were conducted under OECD and EU requirements with the required ethical approvals. All trials were successful and conformed to the internationally recognized three R's guidelines - Replace, Reduce, Refine.
The final part of the project was to produce a strategic plan – to move the project forward – billed as a business plan it is far more comprehensive than that and is a dynamic document constantly being updated to reflect the ongoing developments and opportunities.
The conclusion of PiedPiperDA project is that it delivered on IP and gaining an increased understanding of both the patent PCT and the regulatory system to get the PiedPiper product to market. What did come into sharp relief was the disparity of pricing for the various markets whilst retaining the same general regulatory requirements of safety and efficacy. The pre-production prototype PCD design, production, commissioning, testing and pilot production were in the hands of IRIS who developed a very creditable product for the project. The project ended without the final field trials being conducted but fortunately for the consortium independently Kenyatta University carried out their own independent trials on wild rats with one of our PCD units, in a university compound. The PiedPiper trials were scheduled for the last few days of the project but due to delays the PCD units were not finally signed off and shipped until July
Project Context and Objectives:
see details in PDF
Project Results:
see details in PDF
Potential Impact:
see details in PDF
List of Websites:
www.piedpipertech.com
In 1948 Warfarin was identified as a poison for rats and was first registered in the USA in 1952. It quickly gained popularity as it was highly effective and easy to use. There was, however, an enormous mistake made with Warfarin and all second-generation anticoagulants which have become apparent over time as rats have developed resistance due to the need to consume poisoned baits over several weeks to ingest a lethal dose. The use of warfarin has also resulted in deaths to humans from accidental poisoning and secondary poisoning of other species. It is also now evident that anticoagulant products remain in the environment for years posing an ongoing risk. In 1984 Marshall presented a paper on cholecalciferol where he specifically included a trial of cholecalciferol (vitamin D3) on Warfarin-resistant rats. In the following forty-two years since his paper, the situation has deteriorated and today society faces a crisis with ever increasing rodent populations. Against this background PiedPiper project began in 2006 with three main aims, to replace multi feeding of bait thus preventing resistance developing, achieve a more humane approach with a shorter time to death and deliver this in an environmentally safe way. The solution was to identify a replacement toxin and develop a novel and unique delivery system. Cholecalciferol was selected as the toxin and a transdermal delivery system developed.
The main objectives of the PiedPiperDA were related to IP in the form or patent applications under the PCT system, A review of the requirements for the regulatory requirements in several territories but focusing primarily on the EU. Given the cost of EU regulatory approval, we would need and additional grant or a funding/partnership arrangement. The current approach is to proceed with regulatory approval in New Zealand and then to address the US and Australian regulatory requirements. This is to be led by our retained regulatory consultant/toxicologist.
An important objective was to develop a pre-production prototype Pest Control Device (PCD) that was consistent and reliable - essentially to deliver the same dose on triggering each time. This has been the biggest proportion of the project and surprisingly it proved far more complex than we anticipated. The trial work on dose levels and product formulation were completed in the original PiedPiper project and all the trial work since our first trials in August 2012 have been 100% successful. A small number of clinical trials have been conducted at Cellvax and Aston University All trials were conducted under OECD and EU requirements with the required ethical approvals. All trials were successful and conformed to the internationally recognized three R's guidelines - Replace, Reduce, Refine.
The final part of the project was to produce a strategic plan – to move the project forward – billed as a business plan it is far more comprehensive than that and is a dynamic document constantly being updated to reflect the ongoing developments and opportunities.
The conclusion of PiedPiperDA project is that it delivered on IP and gaining an increased understanding of both the patent PCT and the regulatory system to get the PiedPiper product to market. What did come into sharp relief was the disparity of pricing for the various markets whilst retaining the same general regulatory requirements of safety and efficacy. The pre-production prototype PCD design, production, commissioning, testing and pilot production were in the hands of IRIS who developed a very creditable product for the project. The project ended without the final field trials being conducted but fortunately for the consortium independently Kenyatta University carried out their own independent trials on wild rats with one of our PCD units, in a university compound. The PiedPiper trials were scheduled for the last few days of the project but due to delays the PCD units were not finally signed off and shipped until July
Project Context and Objectives:
see details in PDF
Project Results:
see details in PDF
Potential Impact:
see details in PDF
List of Websites:
www.piedpipertech.com