The WP1 team formed at the CHEM21 kick-off meeting in November 2012, and a first attempt was made to map out the operating environment and challenges for the EU Pharmaceutical Industry in 2020, and to map these to the CHEM 21 scientific and education programmes.Workshop 1 was planned to build on the initial outputs of the kick off meeting, bring the full consortium, including active PhD students and post doctoral research associates, together for the first time and also to get input and direction from external experts and stakeholders.
Workshop 1 (WS1) was delivered in Manchester on 31st January and 1st February 2013.
The output of WS1 was collated, analysed and fed into workshop 2 (WS2) which was held in Helsinki on 15th March 2013. At WS2, the consortium considered the fit of the CHEM21 work progrmammes to the challenges identified, and conducted a gap analysis.
Running in parallel, and feeding into WS1 and WS2, were three significant review activities:
1) A portfolio review of drug projects running in the EFPIA members – 6,193 transformations were collated and analysed.
2) A review of the process chemistry literature from 1997–2012, some 330 papers were analysed.
3) A review of critical review articles (published up to December2012) focused on discovery/ med chemistry activities. A total of 52 publications were analysed.
The output from WS1 and WS2 and the results from the review activities were used to construct Vision 2020 which was delivered to the consortium in draft form in July 2013.
Conclusions from WP1
1) The CHEM 21 scientific work programme is fit for purpose as supported by the various review activities undertaken by WP1. The scientific programme and operating ethos of CHEM 21 also matches external stakeholder expectations.
2) Apart from developing novel reactions, there is a clear need and stake holder desire to drive sustainability through metrics, training and education, improved solvent selection, and a move towards greater use of biotechnology solutions and the scientific programme reflects these ideals.
3) Some technology gaps have been identified and these could be addressed through accessing more effort or re-focusing later in the CHEM 21 scientific program.
4) The scientific programme does cover some of the reaction classes identified as desirable for increasing diversity for medicinal chemistry , but not all. It would be unrealistic for one work program to cover all possible medicinal and process chemistry, and indeed it is unrealistic for a complete overlap of medicinal chemistry and process / manufacturing chemical space.
5) Ways of working and effective collaboration will be the key to success of CHEM 21. A key to success will be the selection of suitable target molecules, close association of the EFPIA members with the academic research programs and willingness for EFPIA members to adopt any new technologies developed when business drivers make sense to do so.
6) CHEM 21 needs to focus on understanding industry needs and the reasons and barriers for previous technology/market failures in rapid adoption of greener methodology.