There is no perfect formula when it comes to trying to organise any kind of work trip. Normally, you have to engage through a series of mental gymnastics to try and balance semi-quantifiable concepts such as ‘return on investment’ and ‘value’.
Let’s take ‘value’ for instance. Is the value of the trip based on a new sale? The time spent out of the office? Establishing a personal contact to secure existing business? Ensuring that the product that you’re supporting is used and understood to the maximum capacity?
Now balance that with travelling halfway across the planet, rather than a quick hop on the Eurostar.
In February and March 2020, Lhasa held an ICH M7 roadshow in Mumbai and Hyderabad. These two cities are an important member base for us (indeed, so is India in general), since there are a significant number of pharmaceutical companies in this region – specialising in both generics and new therapeutic pipelines. We organised the roadshow to try and reach out as far as we could to companies in this region, to present solutions to the ICH M7 guidelines and to give opportunities to enable scientific discussions with different companies. Challenges which are posed across the industry are always best met with a collaborative approach and we structure the roadshows so that experiences of challenges c be shared without needing to go into details that pose more of a… legal… challenge.
I was fortunate enough to be travelling to India for my second roadshow, which made its debut in 2017. Joining me for the roadshow from Lhasa were Krish Patel, Pearl Saville and Rob Foster from our Sales, Marketing and Science teams. All of us presented at the one-day events, covering the software solutions, our scientific direction and a practical workshop on examples of impurities. You could argue that would be enough for a roadshow – it met the criteria of boosting the profile of Lhasa and gave us the chance to meet prospective and existing members. However, the roadshow was enhanced by two external speakers, Dr. Mike Urquhart (GSK) and Dr. Muzaffar Khan (Laurus Labs) and it’s these two where I would like to give more focus to.
Dr. Muzaffar gave two presentations, the first being a workshop on the handling of impurities for the ICH M7 guidelines. Whilst in a similar format to previous workshops, it was great to see a perspective from the industry, rather than from the vendor – particularly with the comments on how conclusions may have been challenged. Muzaffar also guided the audience through his experience with regulatory submissions, highlighting the pitfalls of certain classes of compounds which posed a significant challenge.
Dr. Mike presented on the mutagenic impurity risk assessment process in place at GSK by focusing on a pair of case studies. Whilst never straying into the dangerous territory of reading a risk assessment procedure line-by-line, Mike provided a very honest account of a fine-tuned process and highlighted classes of molecules which created unexpected development issues in a project and therefore delays to delivery.
Back to the questions of value then. Organising roadshows like these are one of the best ways to spark conversations between attendees from different companies who wouldn’t normally have the chance to do so. Understandably, there is a base reluctance to want to talk to someone from a competing business, out of fear of giving away information. It takes a considerable length of time for this reluctance to erode, but it was good to see the difference between the roadshows of 2017 and 2019, where the workshops provided a platform for debate. The value for the attendees here, is not primarily a learning opportunity for the software that they’re using, but instead to identify shared challenges with their counterparts from other companies. Whilst it can work well to spark a debate, workshops of example molecules also have the risk of falling flat. Normally, the resisting factor is not wanting to appear like we are wrong in front of our peers, but this can be magnified if the other attendees are from other companies, where it’s easy to think of your opinion to be representing that of your parent company.
Mitigating this reluctance to venture an opinion is not an easy task. However, it was helped by the presentations from the speakers who stated that experts can disagree on subjects (as we frequently do) and more importantly, that you can admit that mistakes were made in the development of a particular target.
From an attendee point of view, the roadshow was received favourably. Lhasa had provided a platform for discussion on the hot topics of ICH M7, though the greatest value was from the delivery by the external presenters.
As for the future of the roadshows? Having attended this in 2017, I can see that there has been an improvement in the ‘know-what’ of the guidelines. However, the biggest challenge is improving the ‘know-how’ of ICH-M7. Improving the ‘know-how’ can only be achieved through effective collaboration across departments within an organisation and externally to other companies within the industry. In theory, the roadshows do provide this platform – but this could only be matched by the attendees to also share their knowledge. Obviously, this can’t be compulsory, for the reasons which I described above – but a starting point is making sure the right people are going. The software users? The regulatory affairs submitter? The decision maker? There’s no fixed answer here, but all events do have room to be even better…
My take home messages on the roadshow are that we benefitted from being able to present to a wider audience in one day, but the attendees benefitted from a series of talks at varying levels of understanding of ICH M7.
But the main thing is to talk. Sharing knowledge is easy and there is rarely anything to lose in doing this – we are all facing the same challenges regardless of who we are working for. Organising an event to provide an environment to share knowledge with our fellow scientists is unmeasurably valuable. Certainly worth flying halfway around the world for…