We are delighted to host Dr Donna Lockhart within our Fusion Chat series, interviewed by Leah Heathman at Fusion Pharma. Donna is a highly respected independent medical, clinical and regulatory consultant to the pharmaceutical and medical device industry and is the Managing Director of Hurst Grange Associates Limited. Previously Donna has written a blog for us on the importance of quality and manufacturing strategy during product development planning, however today we are excited to discuss her career and the high and low points along the way.

Donna, thank you for giving up your time today, I want to start by delving into your fascinating career. You qualified in Medicine in 1984, worked in St Mary’s Hospital, London and then jumped across to industry in 1990. What prompted you to make this move and have you ever considered going back?

Unlike many newly qualified physicians, I had been aware of the pharmaceutical industry most of my life as my Dad worked for Eli Lilly for a large part of his career. That said, I originally set out to be an obstetrician and gynaecologist. At the time, this also involved spending time in related specialities so I worked in anaesthetics, accident and emergency medicine, and did a year in General Practice. However, when I was just about to become a specialist registrar in Obstetrics and Gynaecology, I realised that having two children under the age of 5 and working every other night and weekend on call (as we did back then!) was incompatible with being a well-functioning human being! I went to see a recruitment consultant to see if my skill set and competencies could be of interest to the industry and got my first job as a medical advisor within 2 weeks. When I worked in a hospital, I might be able to help 10 or perhaps 20 patients a day – very valuable work. But as a pharmaceutical physician, the medicines I have helped to develop and ensure are used safely have been taken by millions of patients globally. So, no, I have never been tempted to go back.

You are a highly respected and sought after consultant – at what point in your career did you become aware of this yourself and was this always your ambition or was it more ‘organic’?

I soon realised that my combination of medical/clinical and regulatory knowledge, alongside commercial experience gained while working in marketing, meant that I was in a great position to offer holistic support to my industry colleagues. I was also told that I had a knack for making complicated science easy to understand in both oral and written communications and that my problem solving skills were sought after. I have really enjoyed managing global medical, regulatory, clinical and quality teams within medium and large pharma companies and supporting the development of careers along the way. I still get amazing feedback from people I worked with many years ago thanking me for mentoring them and furthering their careers and that is just so satisfying. But in the end, there are only so many annual budget and strategic planning cycles an individual can go through, and office politics can become wearing. In the end, the call of the open road became stronger and stronger and I set up my own consulting business in order to provide my broad base of skill and knowledge to help smaller companies develop medicines in areas of unmet medical need.

Due to your level of seniority and the positions you’ve held, you will have been at the heart of making difficult decisions and delivering unwanted recommendations, whether that be product or HR related. What advice would you give to someone who doubts their ability to make difficult decisions, deliver this internally and stand their ground?

I had a mentor early in my career who said: “There’s only one thing worse than a wrong decision, and that’s no decision at all!” At least if a decision is made, everyone knows where they stand, so projects and people can move forwards. So here are my tips: Firstly, trust yourself and your feelings. Listen to what other people say about the issue and be open to asking questions so as to learn from others before you make a decision. My second tip is that engaging in a prolonged quest to get every last piece of information you could possibly have in order to make your decision is wasted time. There are usually only a few key facts which swing the pendulum of a decision from yes to no. Focus on getting these facts as accurately as possible and then make a decision. Finally, if you realise you made a mistake, say sorry. Admit you made the wrong decision and learn from the experience for the next time.

Having worked with you myself I know you run a tight ship, however you do this calmly and effortlessly. Is this down to your many years of experience or have you drawn on any specific skills?

Well, there is certainly an element of experience that helps it to appear calm and effortless! When I join an organisation or a new team, I always assume that every single person is 100% competent in their role and that I can trust them to do what they say they will do. Time always reveals the people where this assumption is incorrect but making snap judgements is misleading. Working in this way enables me not to worry about whether someone else is doing their work and stops the need to micro-manage, which I consider demeaning and stifling for colleagues and very time consuming as a manager. When it comes to my email inbox, I employ the 3Ds rule – every email is read once – then either DEAL with it, DELEGATE it, or DELETE it! OK, I admit there are a few emails where you need to wait for information to allow you to respond so you might store a few but I always have a mostly empty inbox every day when I close my laptop down. The final skill I try hard to employ is that work happens during the work day. Working long hours (outside of a real emergency situation) means you are either understaffed or inefficiently using time. In either of these cases, the overwork will lead to poor productivity and mistakes. Shut out the work at the end of the day. Spend time with family and friends, relax, eat well, exercise and sleep. These last few are just as critical to being an effective employee as the hours you spend at your computer.

What are some of the positive changes that you have witnessed over the past 25 years in industry, and in your opinion are there any changes that have been made that would serve industry and patients well if they were reversed?

When I joined the industry, pharma companies (and I won’t name them) were still accustomed to using money, trips abroad, attendance at all expenses paid sports events etc., to encourage doctors to prescribe their medicines. Each company competed to gain market share by throwing more and more money at this type of activity which I found distasteful. So, I am pleased that promotional regulations have put a stop to all that. That said, I think compliance culture has perhaps gone a little to the other extreme, with presumed promotional intent seen behind every interaction between a pharma company and an HCP. I think this can stifle much-needed scientific dialogue. As a medically qualified person, I always consider that patients are my main concern. If anything the industry does could intentionally or unintentionally cause harm to a patient, I will always stand up for the patient. I just hope that regulators remember that scientific communication is critical for innovation and that innovation is what drives new medicines and devices to the market that benefit patients.