The turn of the Century into the ‘noughties’ was always going to be an interesting time of evolution in industry. And true to form almost 15 years on, we can certainly see that there have been many changes within the Pharma Industry across all levels. From drug development, to manufacturing processes, to regulatory mechanisms, all the way down to the pharmacy door. The impact of health services and the end-user patient has pushed this global industry into a whole new period of history.

As an industry between 2000 and 2011 the Pharma work force contracted to the tune of almost 300,000 jobs. Given that, many of the victims have been re-employed, and the majority of these redundancies occurred as a result of mergers which have ultimately been synergistic. The new Century kicked off with the merger of GlaxoWellcome and SmithKline Beecham, followed swiftly by the merger of Aventis and Sanofi Synthelabo in 2004. Pfizer acquired Pharmcia Corporation in 2002 and Wyeth in 2009, and Bayer AG acquired Schering AG in 2006. The generics companies have been keen to keep up the momentum with Teva having acquired Ivax Corporation in 2005 and then swallowing Barr Pharmaceuticals in 2008. In total in the first 10 years of the new century there were 1,345 acquisitions and mergers in the Pharmaceutical industry.

There have been winners and losers in the midst of all these activities and those that have kept their heads above water have been the companies that have embraced a culture of innovation and change. From a personal perspective it’s been an incredible period of innovation within design and development of drugs, medical devices and medical packaging. The shift in focus from a very ‘inside-out’, step-based, process driven activity to a user-centric, ‘outside-in’ interactive project has been entirely refreshing and overtly fruitful.

Since 2000 the mechanisms and methods used in ‘new product development’ have changed immeasurably. Fifteen years ago an idea came along and the idea was developed—it was a complete ‘do or die’ attitude. Today companies that adopted that philosophy have failed and there are many industrial grave stones in place to prove it.  The companies that have grown and succeeded are those that have maintained the end-user as their point of focus, taken their interactive responses and embraced the external input of their customers. Fifteen years ago the ‘user journey’ didn’t exist. Ethnographic research was embryonic in product development, ‘user safaris’ were still only available as a holiday, and user insight gathering was someone else’s job of cobbling opinion together. In general if you were given a packet of elephant pills you were expected to take them whether or not you could open them, swallow them, and if you didn’t take them you got in to trouble like a small child. Patient ‘compliance’ was imprinted on you by the Holy Grail of the Doctor wagging his finger!

And then out of the fog emerged the ‘Voice of the Consumer’, and along came ‘Patient adherence’, empowering the patient, patient choice, ergonomics, usability and corporate social responsibility.  Getting the feedback from your sales reps is no longer deemed as high quality research and external agencies are more commonly being seen as being the ‘gold standard’ in generating qualitative immersion feedback to facilitate development of multi-billion dollar block buster health care products and devices.
Internally you often can’t see the wood for the trees, so bring in the professionals. This has seen a shift from using internal personnel to engaging external consultancies for ethnographic research and usability studies, and a massive growth in development consultancies offering these processes.

The last 15 years has seen a distinct move away from clinical devices. The arrival of smart phones and devices has resulted in a leap towards incorporating health Apps into cool gadgets. Your BP monitor can be sleek with no visual display and your inhaler should be something that all your friends want. Intuitive, simple, accurate, convenient and desirable leads to successful patient adherence, treatment and ultimately prognosis and clinical outcomes.

In drug development and delivery everything has shrunk and turned precious. Nano is the new buzz word, and wrapping your nano in gold, or adding diamonds seems to have created new mechanisms for bypassing cellular barriers and achieving complex drug delivery accurately to hard-to-get-at tumors. And in the fight against antibiotic resistance there has over recent years been a massive drive towards sourcing drug candidates from plant, sea and other natural resources, hoping to harness natural defence mechanisms and adapt them for human use. Bio-similar investigation is romping forward in the hope of being able to develop cures and preventative molecules without starting from scratch—a pharmacological head start in the development process. Indeed the FDA has had the ability to approve bio-similars since 2010, however as there are many questions yet to be answered over the changes that may occur during manufacturing processes, maybe the biggest momentum for this group of drugs will occur within the next 15 years?

We now live in a world with a different Pharma Industry. Companies must continue to drive forward user-centric research and development in order to create products and solutions regardless of whether or not they have in-house facilities. Procurement of ‘Innovative Skills’ is fundamental to commercial success especially in difficult economic circumstances. The best way out of a depression is to be innovative.

With regards to drug R&D a combined effort of considering tried-and-tested pharmaceutics combined with developing daring new technologies would seem to be the best way forward globally. Sometimes it’s ‘better the devil you know’. Just look at aspirin/salicylic acid. Initially it was simply an analgesic, but towards the end of the last century we began prescribing it in cardiac prevention, and in 2014 it’s being suggested as an effective cancer deterrent. But the new miniature technologies can’t be forgotten. There are many common forms of cancer that still hold terrible prognosis statistics. Pancreatic cancer, liver cancer, lung cancer and oesophageal cancer all have 5 year mortality rates of over 80%. And HIV, malaria, and Ebola? I could go on.

As someone once told me, “If you aren’t sitting on the edge, you’re taking up too much room.” It will be interesting to see who picks up this mantle over the next 15 years.