A year in review

Over the years friends, colleagues and industry leaders have shared their many of their insights with me freely and without agenda. Having absorbed 35+ years of ‘free’ wisdom I have always felt obliged to return the kindness. Running a lively and successful business and playing an active role in two industry-leading societies provides plenty of opportunities to comment on a wide range of topics and I am always looking to find new and interesting ways to share learnings. The last 12 months have been busy and I hadn’t tracked all my activities, so I was left wondering, what did I share in 2019?

I started the year with an article on how, in this age of electronic devices, one should seriously consider taking notes by hand and another exploring the value of doodling during meetings, describing how both activities can improve our retention of information . I also wrote a summary on the importance of the Investigator’s Brochure in drug development, pointing readers to our Insider’s Insight, which gives detailed information on its content and function . Our free online document template that accompanies this edition of our Insider’s Insight has continued to appear on the first page of Google searches (now for more than 3 years).

Brexit was at the forefront of everyone’s mind in the UK at the start of the year and in January I twice wrote about the impact it might have on our industry in the UK: first about no-deal preparations and then in more detail on the impact changes could have on the medical devices industry. It could be argued that these debates are returning to the fore following the election result this December. I finished the month off by discussing some interesting findings on patient adherence with their medicines that emerged from our RASP-UK programme in severe asthma.

February saw no respite from Brexit, with the MHRA updating its industry guidance. On a more positive note, Niche released a new Insider’s Insight, this time providing a ‘how-to’ on organising professional meetings and conferences. Our free to download resources continue to attract considerable attention with nearly 1,000 downloads in 2019.

When attending a reunion of my old classmates I became intrigued by the relationship between team size and its functionality – whether there is a golden number for how many people you should have in a team. During the evening we discussed our different career paths and the answer from one ex-classmate caught my attention – “Oh, I run a team of around 400 people for a blue-chip pharma company”. He quickly clarified that they didn’t all report to him directly but that he was ‘responsible’ for the massive team. It got me speculating, how can you possibly run a team of 400 people? 

March – Brexit – AGAIN! As Chairman of the Association for Pharmacology in the Pharmaceutical Industry (AHPPI) I felt obliged to respond to a damning assessment of how clinical research in the UK would be savagely undermined by Brexit. I underlined how innovation in the UK has long been the envy of the world and this opinion from one of our European colleagues was more like wishful thinking by a CROs in country eager to take advantage of the impending upheaval. I remain confident that, in the safe hands of the MHRA, the UK will remain a great place to conduct research – as long as we can avoid interference from our poorly informed government. 

April saw the website for the Clinical Trials Specialist Degree Apprenticeship go live. Recognising the scale and depth of the challenge ahead and wanting to maintain a thriving pharmaceutical sector in the UK, a group of industry professionals got together to develop the apprenticeship scheme to help train the workforce of tomorrow. Our trailblazing consortium had recognised the challenge of maintaining a ready supply of suitably trained people entering the industry. Our goal was to create a pathway to deliver future clinical study practitioners. The consortium involved partners from businesses across the industry, large and small, including GSK, Astrazeneca and Amgen (and Niche).

As well as seeing the publication of the 12 month data on our MID-Frail study, April also marked 21 years from when I first formed Niche. I marked the occasion by providing insights into what goes through your mind (or at least what you should go through your mind) when you are first taken by the idea of running your own company. I also shared an article summarising 21 key lessons I have learned over the last 21 years. April also saw the EUFEMED publication reporting on a stakeholder consensus meeting that focused on the new First-in-Human guidelines released by the European Medicines Agency. The open access manuscript reports on how the industry is absorbing the implications of the guidance.

Having reflected in April on the last two decades running Niche I began May by writing about the top 10 questions you should ask yourself if you are business ready. I am not sure that the ‘me’ of today would provide the same answers as I would if someone had asked me these questions in 1998. I subsequently returned to my (clinical) roots by commenting on the changing face of the ethics of clinical studies. Study medical sciences and you will quickly learn the extent to which man is able to commit atrocities on his fellow man in the name of scientific understanding. In a short article for Linked in I revisited the Dachau concentration camp hypothermia experiments that I learned about in my undergraduate studies. Their stated purpose was to establish the most effective treatment for victims suffering with immersion hypothermia, with a view to helping German aircrew shot down into the cold waters of the North Sea. Amazingly horrific but only one example of just how the relentless pursuit of ‘solutions’ through science can blind us to the big picture be.

June saw me attending a couple of conferences and got me thinking about how you can get the best out of the investment of time and money they represent. We also took on several new staff and, as an aid memoir to our own managers (and any others) I summarised how you can make the best first impression with new starters. Six months on, it seems from our own experience that an effective on-boarding policy pays dividends in terms of employee acclimatisation and getting the best performance out of new starters. 

I was fortunate to be invited to annual British Pharmacology Society’s President’s Lecture in June. The event, which has seen ever more fascinating presentations over the years, surely reached a pinnacle with Dr Nessa Carey’s ‘Big Pharma – why even the best science might not be enough to save it’. Dr Carey, who is Visiting Professor, at Imperial College London, Translational Chair for Business Development and Innovation at the Quadram Institute and non-executive director at UCL-Business provided a superstar performance. I summarised the discussion as it needed to be shared with a wider audience than the lucky few who attended the lecture.

July is when we run our summer intern project. This year we had more applicants than usual. Rather than disappoint candidates, we decided to create an opportunity where a group of young people could come together to solve a unique problem currently facing the pharmaceutical industry – in this case the challenge of reducing the time it takes to complete the research programmes required to register new drugs. We called the experience ‘The Infinite Monkey Cage Challenge’ – after the original proposition by Aristotle, not the Radio 4 series. Our students took to the challenge like ducks to water. They even produced a video diary of their progress (xxxxxxx). I also returned to my routes as a medical writer in July in writing about the best use of abbreviations . How you use abbreviations tells me a lot about you as a writer. For example, I often judge authors to be less experienced if they use the ampersand (unless part of an organisation’s name), etc., the symbol for less than or greater than (in the text) and when they abbreviate seconds, minutes, hours and/or weeks. 

August was the actual 21st anniversary of me opening the doors at Niche – although I had registered the company a few months earlier. So, at 56 years of age, I felt it unlikely that I would be around in another 21 years to see whether any of the advice I have given people over the years was any use to them. My son kindly summarised my thoughts in a rather moving video blog . August also marked the end of our Infinite Monkey Cage Challenge and the sad departure of our temporary colleagues but the whole Niche team were seriously impressed by what they achieved in their brief time with us .

I was caught up with organisation of the annual conference of the AHPPI for most of September. The art of organising a great conference is best personified as a swan – seeming elegant and composed above the waterline, feet paddling like mad below the surface. Our own advice on organising conferences came in handy as the day approached. It was one of the best meetings I have attended. We managed to recruit the great and the good of early phase clinical pharmacology to talk about what the future of clinical research will look like. By some strange coincidence, the future of clinical research was a topic I covered at the “Innovation and Technology in Early Clinical Trials” conference in London later in the month. As attendance was by invitation only I summarised the presentation here .

November saw me sharing some of the key learnings from our AHPPI conference in the form of posts on how to get the most out of your Powerpoint presentations and the travesty of investment of time and resources associated in conference attendance that are often lost. Effectively, the scientific meeting is essential to the way the current reporting environment is set up. There is room for improvement and it seems logical to encourage all conference organisers to publish summary reports of their events in the scientific literature and make copies of poster and slide presentations available on their websites. There also seems to be a logical argument to create a central database, similar in form to that of Pubmed that can be used to store and make searchable conference materials generated for scientific meetings. 

I gave my final presentation of the year to the Pharmaceutical Industry Project Management Group in Cambridge in November. The meeting had perhaps the most interesting title I have ever encountered – The DNA of a Unicorn: How Project Management Helps Build Successful Businesses from Research. The focus of my talk was how to be successful at applying for grants. The talk drew from experience with our successful EU grant-funded MID-Frail and Frailomic projects as well as our MRC-funded RASP-UK programme. Sadly you will have to wait until next year for a summary of the talk.

As the year comes to a close at Niche we turn our Niche website to ‘festive mode’ and share our thoughts the best science-y presents you can surprize your loved ones with. My last success of the year was publication of the proceedings of the biannual EUFEMED conference in the Journal of Frontiers in Pharmacology with news breaking just as AHPPI, a founding member of EUFEMED headed off to our company seasonal festivities.

And that’s it for 2019, a busy year and a fruitful end to the decade. I hope that something I shared this year has been of benefit to you. Will it be better next year? Preparations are already well advanced for 2020 and you might want to consider signing up for our Insider’s Insights to make sure that you don't miss anything. We already have several new editions waiting for publication in 2020 as well as updates for some of our old favourites. It just leaves me wishing you the best for the season and a happy New Year (and a new decade).

Tim Hardman is Managing Director of Niche Science & Technology Ltd., a bespoke services CRO based in the UK. He is also Chairman of the Association of Human Pharmacology in the Pharmaceutical Industry and an occasional commentator on science, business and the process of drug development.