Wspólnotowy Serwis Informacyjny Badan i Rozwoju - CORDIS


PIEDPIPERDA Streszczenie raportu

Project ID: 605574
Źródło dofinansowania: FP7-SME
Kraj: United Kingdom

Periodic Report Summary 1 - PIEDPIPERDA (Development of a novel method for rodent control)

Project Context and Objectives:
PiedPiper was a project funded by the EU in 2011 under grant 286852 R4SME to develop a new pest control device for rodents. That project commenced in December 2011 and ran until November 2013. The results of the project were a new formulation for the vitamin D3 dermal penetrant which has 2 patent applications currently in process. Additionally the project delivered a new PCD after having developed a new aerosol valve system to deliver the aerosol spray. The project also undertook R and D with Burgos university on identification of attractant marker compounds in rodent urine. The final component of the project was to look at the regulatory environment for registration of the product in the EU as a rodenticide. PiedPiper_DA is the follow on grant that aims to assist in the commercialization of this project.
PiedPiper DA had its kickoff meeting on 12.12.2014 at Aston University where we reviewed the original PiedPiper project, welcomed AJI Technology to the consortium and recognized IRIS had changed roles from RTD to SME. The review covered the areas of attractant, prototype development and toxin formulation with a view to registration under the Biocide Directive for use across the EU as a rodenticide.
The main focus of the PiedPiper DA is to look at the regulatory requirements for registration of our vitaminD3 formulation as a transdermal and the use of our Pest Control Device to deliver the aerosol spray. In order to allow this data to be presented we need regulatory approval to conduct field trials with the PCD device and preferably on wild rats as well as laboratory rats. The regulatory part of the work to get permission for field trials fell to Cellvax to obtain. The regulatory process for animal testing is a slow process and despite an early application for the certification to carry out trials and our EU required 6 month deliverable to get the certification we struggled due to the regulatory process with ethics committee reviews being quarterly. In May the ethics review was undertaken in Paris and we were granted the appropriate testing certification on 29th May 2015.
With this in place there are two other critical factors that need to converge so that the trial work can proceed - the first is to ensure that the formulation we use is as safe as we can make it for humans and that it conforms with EU regulatory requirements for trials in the EU. There was also a recognition from PiedPiper that there was a gap in our previous work in terms of data recording of the PCD device. We therefore had to look at the requirements that we need and then see if they related to the specification of the preproduction prototype that is hopefully going to be our commercially produced product. As there was a clear divergence - the need for data and the need for a basic cost effective PCD for the regulatory side it was agreed to develop a "cheap and cheerful" lab version in limited numbers for the data collection part of the regulatory requirements.
By the end of this PiedPiper DA project we will have a working pre production PCD as well as a data collection PCD system and both will have been utilized in the French trials. The data will be collated for the regulatory approval application for which external funding will have to be raised. The websites and will be updated during the project and we will be able to be contacted via the websites.
As of the end of the first period we have hit our targets for the test certification, we are in the final stages of signing off the pre-production PCD and we have developed a test device for data acquisition from the PCD for regulatory work. We will also have our patent at review and a business plan written to go alongside the regulatory review.

Project Results:
PiedPiper DA was written in 2012 - between September and November and the project finally started some two years later on 1.12.2014. As PiedPiper had finished in the November 2013 it was prudent for the consortium to have a review of the technology and the regulatory situations at the beginning of the new project (PiedPiper_DA). The first consortium meeting was held on 12.12.2014 at Aston University Business School and hosted by Dr Andrew Ingham. All of the rest of the consortium were represented - Dr Ming Wei for Cellvax, Thomas Huurman for Summit Europe, myself as Coordinator and Biotronics - IRIS were present via Skype for the parts of the project relevant to themselves.
Our review of PiedPiper. Since the group last met there had been a number of developments - publications submitted - some approved and some still pending as well as a patent being filed right at the end of PiedPiper and news that my initial patent application from 2009 had been granted in 2014. Some of the group had also carried on with a number of tasks outside the PiedPiper project and before the beginning of PiedPiper-DA. Specifically myself, in looking at regulatory funding , new patent applications under PCT to give global coverage and keeping up to date with "rat world". Thomas still had samples of materials / valves in his facility in accelerated environmental assessment - 400 days + and Andrew had been in constant contact with regard to developments, submitting peer review documentation, giving presentations to some chemical companies - 2 whole day presentations to BASF in particular. We looked at the attractant product situation and concluded that we were happy that we had an attractant system based on the testing of Burgos.
Our tasks for the DA were specifically to design and submit documentation for trial certification for testing or the PCD in Paris. We ruled out the UK after the experiences in PP. Ming was tasked with this project and suggested that the time to get this certification was limited due to the length of time between ethics committee meetings of the French authorities. Ming submitted the documentation after Christmas and with only a couple of days left before our 6 month deliverable we received a signed copy of the certification from the ethics committee. Andrews role is to look at the regulatory position and assess what data we have to generate to move forward to get investors to fund this regulatory requirement. We did know from PiedPiper that there was insufficient data from the PCD in terms of spray, timing and angles of delivery. There are also other issues that the regulator will look at with regard to dose accuracy etc that the pre-production model will not be able to do but can be set up during manufacturing to perform. We have thus produced a cheap and cheerful lab version from (literally) drainpipe and a micro-processor. Andrew and I have spent a significant amount of time looking at solenoids and alternatives - actuators and servos just in case the solenoid route proves to be unreliable. We are confident that this is now under control and the risk removed.
As part of my Coordinator and disseminator / fund raiser role I have been to a number of events the most important being PestEx in London in March. Here I met most of the bigger names in pest control and talked them through our program in general terms and invited them to further discussions (Lodi of France have signed an NDA, Bayer AG have signed and NDA) and we now have ongoing dialogue.
The final task was the hardest - the specification for the PCD. This has taken up until 30th June to agree. We rejected out of hand the original Specification and finally we have a specification that is we believe commercially viable, attractive, functional and we believe economical to build in significant quantities. It has enhanced safety with the aerosol being totally enclosed in a tamper proof box.

Potential Impact:
PiedPiper DA effectively started at a disadvantage in that we had to file the application in 2012 well before the end of the PiedPiper project due to the end of the FP7 program. That aside we still have some very valuable work to do to benefit the consortium and the EU. In socio-economic terms the need for a solution like PiedPiper is more important than it was in 2010 when I wrote the initial PiedPiper application. The large chemical and pest control companies are lobbying Brussels to be allowed to use stronger formulations of their existing toxins which will just increase the rate of resistance build up in the rodents. The socio-economics of PiedPiper are that our technology is better than continuing with the existing toxins as we can not only kill rats per se but also toxin resistant rats - there is a paper - Cholecalciferol a unique toxicant for rodent control. Edward F Marshall 3.1.1984. It shows experimental evidence of kills of Vitamin D3 on warfarin resistant rats and also lays to rest an industry myth that vitamin D3 is not strong enough to kill by itself. The only thing that stopped D3 being the product of choice was it was difficult to use via the oral route - it takes longer and needs a higher dose (X5). Our transdermal route is the perfect rout for minimal dose and maximum effect.
In terms of final results I expect to see a preproduction PCD product as well as a data collection device for the regulatory process. The pre-production PCD will also come with documentation (as a deliverable) for CE certification, RoHs / Lead Free documentations and if possible scalable costs for mass production. One of the issues that we did not address in PiedPiper regarding the PCD was the drop in pressure as the aerosol becomes depleted of product (toxin and possibly propellant depending on the option we chose for delivery). This was not evident during PiedPiper but Thomas, Andrew and myself recognized it as a potential problem. The regulator will want the same dose delivered each time yet as the pressure drops the volume in unit time drops (probably by 15% or so) - we can correct the dose by adding a software program that adjusts the dose as the canister is used up.
The trial results are important and after a visit to Kenya in December Andrew was approached by Nairobi university to let them do some work on pest control with our device - the data will be fed back to PiedPiper for a small fee. It would be nice to see peer reviewed papers with an African university on them. The French trials with the PCD - Ming is more than capable of handling that and supplying the data back to the consortium.
The regulatory process we will deliver a checklist and approximate costing to complete the required work for an application. Investors / other grant organizations will require this type of information as part of their due diligence. Alongside this regulatory information we will also build a business plan for the raising of funds from investors - either private, corporate or financial. There will also be a second stage review of our patent applications and we would look to see if the PCD can be patented - either for the software dose profiling or an innovative use of the LED detectors for the rodent sensors in the PCD.
It is rather ironic that the socio-economic advantage that PiedPiper technology can deliver is dependent on the financial markets funding the project.
We are also currently looking at the demonstration and training options - for industry and interested market investors. Probably in Brussels in Feb 2016.
The use of animals such as rodents for terrorism is an ever increasing possibility - we just need to acknowledge it and act - we have the solution.
So to conclude by the end of the project I expect to have delivered as per the DoW but believe if we make some alterations to the program we can achieve even more.

List of Websites:


Alison Goode, (Administrator)
Tel.: +44 1568708830
Adres e-mail
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