If you have recently embarked upon your journey of statistical programming in the pharmaceutical world, the PSI Introduction to Industry Training (ITIT) course is a fantastic opportunity to get a stronger awareness of many aspects of the whole industry, understand how statistical programming fits into the bigger picture, and make some valuable contacts across a range of other pharmaceutical companies. The ITIT course describes the drug development process from research right through to toxicology, clinical trials, reimbursement and even marketing. We attended the course between November 2017 and July 2018, visiting six host pharma companies and CROs across the UK and mainland Europe to learn about a wide range of topics from the experts.
The ITIT course got underway with a session on drug development at Eli Lilly in the autumn. After an icebreaker and an introductory talk from the fantastic PSI Chair Nigel Howitt, speakers from the host company enlightened us on how they identify compounds with true potential to treat serious diseases. The second session at Covance in Harrogate in December focussed on the topic of toxicology and how you would design a study to research the possible reproductive, carcinogenic, or other adverse effects of exposing DNA to different doses of compounds. We were lucky enough to be given fascinating and highly informative tours of the on-site animal labs during each of the first two sessions, discovering more about the importance of pre-clinical testing.
There was also plenty of opportunity to interact socially with our fellow course delegates from other companies as the evening activities on the first day of each session typically involved dinner at a nearby restaurant and often led on to a semi-competitive game of bowling, trying our hand at shuffleboard, or winning big on the roulette table.
In March, we descended upon the IQVIA headquarters in Reading for Session 3 – Contract Research Organisations (CROs) and Data Management. Remarkably, it was the second snowstorm of the winter and the second snowstorm to coincide with ITIT – we persevered nonetheless! The highlight of this session was unquestionably the CRO bidding process workshop, where course delegates from the larger pharmaceutical companies became CROs (and vice versa) and competed to win a contract for the statistical work for a study. Finding out what CROs and large pharmaceutical companies think about when negotiating a contract and understanding the CRO viewpoint made this session a valuable one. Session 4 in April was hosted by Roche at their Welwyn Garden City office and, from a programmer’s perspective, was another insightful one. Speakers from study management, clinical science, operations, regulatory and biostatistics briefed us on their roles and responsibilities within a clinical study team, and the considerations they must think about when dealing with study-related issues, be it timeline, recruitment, planning, data quality, or otherwise.
The fifth session was an ITIT first, hosted by AstraZeneca in their Gothenburg office. This was the first time a session had been hosted outside of the UK. Whilst other sessions in the UK were a great opportunity to travel and visit the UK for delegates from continental Europe, this session was a chance for the UK delegates to head out of the UK and explore a different country – we had a great time! The dates in continental Europe are increasing and next year’s ITIT course will have three dates outside the UK.
AstraZeneca’s session was based on Patient Reported Outcomes (PROs) and Reimbursement. We were given interesting insights into different PROs and how they help payers understand treatment benefit and value, and how ePROs can provide better quality data. There were further sessions on Health Technology Assessment, Real-world Evidence and systematic literature review and network meta-analysis.
The final session was hosted by Pfizer in Walton Oaks and was an enjoyable end to the course. The focus of this session was Marketing and there were several presentations and workshops explaining the promotional laws that must be abided by. There were also sessions on soft skills and the work carried out by the medical affairs team.
This course is open to both programmers and statisticians and although at just a few points there was a focus on how departments interact with statisticians, it was a course that was just as valuable for a programmer as a statistician. We got a great view of the whole drug development process and how each team fits into it. Both programmers and statisticians work cross-functionally, so we’ve found this understanding to be really useful back in our daily roles. We would highly recommend ITIT! The course was also a great chance to begin building our networks, the delegates all have one to three years’ industry experience and it provided an easy opportunity to meet and get to know one another.