GHP June 2017

10 GHP / June 2017 supports effective knowledge sharing and enhanced internal and external communication. Arran is situated perfectly as part of the Almac group and has access to a large pool of R&D, process development and biocatalysis technology facilities. Timeline acceleration from initial chemistry through to the appropriate scale-up quantities is a key element of some of the new integrated solutions models that are now available. Individually the services of chemistry, biochemistry, analysis, physical sciences and engineering all have relevance to these critical path supply activities. The full benefits of this integrated service model again come when all of the services are part of the one organisation. The close proximity of the sites supports more face-to-face communication both internally and with the client. It reduces the time that the client representative needs to spend on coordination activities and allows faster escalation and resolution of critical project issues. Experienced project teams Henry Ford, American industrialist and pioneer of the assembly line production method, once said “Coming together is a beginning, keeping together is progress, working together is success”. The contract chemistry, analytical and manufacturing business truly is a people-driven business where integration of technology and services must be firmly set in the context of integration within working teams. Two of the challenges this presents is the need for clear communication between all parties through the lifetime of the project and focused ownership of the individual programme components by the relevant scientists. Effective team working is perhaps the most fundamental benefit of an integrated outsourcing company. There are three components to effective teamwork on complex chemical development projects that underpins Arran’s approach: (i) Clearly defined roles for all team members (including customer values). To ensure that all of the project roles are undertaken, without having roles duplicated or missed, it is essential that all of the members of the project team understand their roles at the outset of a new programme. (ii) Experienced programme manager. There are many interconnected tasks that need to be completed during the successful journey of a project from the initial chemical synthesis through to the final commercial supply. To successfully identify critical path activities and to make good decisions about how best to mitigate the impact of any delays requires a strong and experienced programme manager. This individual needs to have a good working knowledge of the component tasks, well developed project management abilities and the respect of the team members. The relationship between the client and outsourcing company programme manager is a critical success factor. (iii) Clear communication practices internally and with the client. An essential component of any client– outsourced relationship is clear communication, characterised by accuracy and high integrity. Too much communication is sometimes as problematic as too little. Equally problematic is asymmetric communication in which one party communicates well while the other party communicates poorly. Conclusion At a time of great change in the global pharmaceutical and outsourcing markets, Irish companies like Arran are able to deliver development excellence through a combination of excellent technical knowledge and experience, integrated technologies and service areas, robust quality systems and experienced project teams. New relationships are forming and the value of these new ways of working is being recognised. True integration requires single organisation of the relevant services and people. The highest compliment that can be paid to an outsourcing company comes when the client feels as though the CRO is part of their company. Integration of high quality technologies (selectAZyme TM ), services and people supports such a relationship and will bring benefits to the whole sector for years to come at Arran Chemical Company. Biography Prof. Tom Moody graduated from The Queen’s University of Belfast with a 1st Class BSc(Hons) in chemistry in June 1998 before returning to gain a Ph.D. in Physical Organic chemistry in December 2001. He has also completed a Master’s Degree in Business graduating with distinction in July 2007 specialising in business strategy. His work has earned him numerous accolades and is co-author and author of >50 publications and patents. Tom is currently VP Technology Development and Commercialisation for Arran and Almac in Ireland and works in the area of Chemistry & Biocatalysis and its application towards the synthesis of chiral molecules, metabolites and labelled compounds. Tom is responsible for managing a multi-disciplinary team of both chemists and biologists to obtain commercially useful biocatalysts and their intended applications. Biocatalytic processes have been developed from mg to tonne manufacture including development of fermentation processes to yield the desired biocatalyst. He has been a scientific leader and problem solver in >50 commercial projects in the past 3 years and acts as a consultant in the area of biocatalyst development for pharmaceutical and biotech companies. He is also an honorary Professor at Queen’s University of Belfast in the area of biocatalysis. Tom may be contacted at tom.moody@ . Dr. Stefan Mix was born in Berlin / East Germany, where he also completed his secondary education. After graduation with a Diploma in chemistry, he received his doctorate in 2004 from the Technical University of Berlin after working in the group of Prof. Siegfried Blechert on stereoselective synthetic methodology and olefin metathesis. He is the author of several publications, and has been working with Almac Group since 2005. He has gained broad industrial experience including applications of biocatalysis, crystallisation development, process development for chiral building blocks and APIs, and technology transfer to manufacturing network partners. His hobbies include sailplane gliding, kayaking and gardening. Stefan may be contacted at [email protected] Dr. Peter Cairns graduated with a PhD from Nottingham University and followed this with a Postdoc’s at Leicester University & Indiana University. He then moved to industry as Senior Scientist with GD Searle and followed this as the Technical Manager with Arran since 1986. He has completed over 300 development projects for a wide range of customers in the pharmaceutical, aroma chemical and medical device fields. A significant number of which were scaled up to full commercial scale. Projects have involved both improving existing processes (at various stages of development), or developing processes ab initio. Pharma projects range from pre-clinical all the way through to Phase III and commercial manufacture. Peter may be contacted at [email protected] The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately-owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). Arran Chemical Company is part of the Almac Group and is responsible for the supply and scale-up of chemical intermediates for pharma, Flavour & Fragrance and speciality chemicals industries and is located in Athlone in Ireland.