Ian C. Ellul

2014 will herald existing and new challenges for the pharmaceutical industry. Diminishing pipelines, increasing development costs, generic competition … pharmaceutical companies are under constant pressure to innovate and collaborate if they want to survive. As a point of fact, over 700 biotechnology and pharma takeovers have occurred in the past four years.

Although recent years have seen increases in R&D investment, yet new drug launches are fewer and farther between. The age of the blockbuster drug is foregone, with many drugs coming off-patent. Furthermore, advances in human genome mapping are increasing the demand for personalized medicines.

In my opinion, two strategies which should be embraced more thoroughly by the pharmaceutical industry.

1. Increase personalisation of drugs. In the US, PricewaterhouseCoopers expects the market for personalised medicine to grow by 11 per cent a year and be worth $452 billion by 2015. Identifying the patient populations for which a drug will be most effective is a win-win situation. Patients’ lives will be improved, the governments will save money by only giving treatments that work, and the pharmaceutical industry can benefit from value-based pricing structures.

2. Quickly understand and maximise the value of orphan drugs. This can be shown by the following example. Botox® started out life as Oculinum®, an orphan drug for uncontrolled blinking, neck pain and muscle spasms. Once the drug was being used, physicians reported unexpected adverse events including a more youthful appearance and the relief of migraines. While sales of the drug top $1.5 billion a year in the US alone, it took almost 20 years from Oculinum® going on sale for Botox® to get FDA approval for the treatment of frown lines. It took a further eight years for it to gain approval for the treatment of migraines. Presumably, if the marketing authorisation holder of Botox been able to tap into available data about Oculinum®, it could have identified its more lucrative uses – and the demand – much more easily and quickly.

Against this backdrop of a search for a holy grail, I seek refuge in popular fiction. Maybe the answer lies in devising bed-sized medical devices similar to those shown in Elysium [Med-Bays] which can cure people from all ailments, ranging from missing limbs to all types of cancers, thru’ a re-atomizing process. Or maybe the answer simply lies in the album Fitness to Practice which was produced in 2004 for charity by medics Dr Adam Kay and Dr Suman Biswas. Paracetamoxyfrusebendroneomycin is a [fictitional] medicine produced from the cerebellar cortex of a bison, and can be used to treat “anything from leprosy to SARS”; it thus enables medical students to avoid the study of pharmacology! Unfortunately, despite being a universal panacea, this whooping 31 letter innovation has some serious adverse reactions with the writers quoting “heart attacks, becoming gay, and growing extra breasts” as an example … but I am sure that with today’s knowledge these challenges can be overcome !