A Member of Quanticate’s Statistical Consultancy Team writes about their experiences whilst attending the course entitled “PSI Introduction to Industry Training Course”.
“PSI Introduction to Industry Training Course” is a course run by PSI (Statisticians in the Pharmaceutical Industry) which started in November 2010 and finished in July 2011. The course consisted of six, two-day courses being hosted at different Pharmaceutical or CRO companies in the UK. Each course consisted of talks, workshops and tours of the companies’ sites. The course was aimed at Statisticians and Programmers within the Pharmaceutical Industry who have one to three years experience in the industry. The aim of the course was to give an overview of the drug development process, from pre-clinical research through to marketing, and the involvement of statisticians and programmers along these stages.
Session 1: Pre-Clinical Research
This session introduced the topic of pre-clinical research and how statistical analysis could be involved at this stage. It focused on how compounds are developed from the perspective of Biologists, Chemists and Pharmcokinetisists. The workshop encouraged us to think about the questions that should be asked when involved in pre clinical testing. Whilst at the site we were also given tours around some of the laboratories to see the types of experiments that are undertaken on compounds at the pre-clinical stage.
Session 2: Toxicology
The next session was on Toxicology. It included talks about the different types of toxicology that were interspersed with tours around the facilities, histology laboratory, and the central dispensary. This was a unique experience because statisticians and programmers in the pharmaceutical industry do not often get to see this area of drug development. This tour gave us the opportunity to see these laboratories in action and understand where the data is coming from at this stage of the development process.
Session 3: CROs and Data Management
The third session was split into two topics, Clinical Research Organisations and Clinical Data Management. The first day consisted of background information about CROs and what role they play within the Pharmaceutical Industry. The day concluded with a BID Defence workshop where the roles of the delegates were reversed. All delegates on the course who worked in Pharmaceutical companies became the staff of a CRO, and all the delegates who worked for a CRO became the employees of Pharmaceutical companies. The second day focused on Data Management and concluded with the design of a CRF page. Working for a CRO lead me to be concerned that there would be little to gain from this session but I enjoyed hearing about topics and issues that my colleagues speak of, such as AE coding, and this helped to increase my knowledge of the tasks undertaken by other groups at Quanticate.
Session 4: Clinical Trials
The fourth session was focused on Clinical Trials. We were lucky enough to be able to go to the manufacturing site of a major pharmaceutical company and to get an insight into how the drugs are made. This was a very interesting experience as it is not an area that you see when working for a CRO. We saw how the drugs are produced and how to ensure the correct concentration of the raw ingredients of a drug is measured when tablets are manufactured. The main session included talks on the challenges that are faced within clinical trials and a workshop on designing a clinical trial. Within our teams each member was given a different role and had information that would make or break our trial. As a team we needed to collate the information and decide on our design, and the branding of the drug.
Session 5: Licensing and Reimbursement
New for the 2010/2011 course, the fifth session was on licensing and reimbursement. The session discussed the requirements for licensing and regulatory approval, as well as Health Technology Assessments. We concluded the penultimate session with a Quiz on the information learnt on the course. This was a good chance to review what we had already learnt and it also included questions on famous statisticians and acronyms.
Session 6: Marketing
The last course finished our tour of drug Development with a session all about Marketing. The course concentrated on the Marketing strategy of the drug, from the planning of any publications through to the branding of the product. The final workshop of the course made us think about how products are marketed and what images or words are associated with different brands. It was particularly interesting to learn about the training of the sales rep before he markets a new drug and the regulations of marketing pharmaceutical drugs.
This ITIT course aims to provide a general overview of the Pharmaceutical Industry from drug discovery through development to marketing. The role of the statistician in the pharmaceutical industry is discussed and a general overview of the whole drug discovery and development process is presented. The course has enabled me to understand the processes involved throughout drug development and has helped me to understand the needs of other departments. I would highly recommend the course to anyone new to the industry as it gives a greater understanding of the processes involved throughout the stages of drug development. A review at the end of the course showed the workshops and the networking opportunities throughout the course were an invaluable experience.
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