Anyone involved in the drug development process – from pre-clinical, to clinical trials, to bringing the product to market – knows it is a long, complex process involving specialised expertise across numerous fields and costing quite a lot of money. Since every bit of time in the drug development process costs money, any delays or following the wrong avenues can have catastrophic effects on the whole process. Issues of ethics and regulation can also feature prominently as key challenges to drug development and senior management in these settings need to be aware of all of these complex issues at once in order to develop a smooth transition. And, in the constantly fluctuating world of pharmaceuticals and drug development, it is vital to be able to respond in a dynamic way to the many different challenges that may present themselves at different stages of the process.
A Bachelor’s degree in science may equip with you with the essential grounding in chemistry and biology to make you qualified to work in a pharmaceutical laboratory but, if involved in the drug development process, this can only get you so far. Pharmaceutical companies have wised up to potential knowledge gaps in their workforce by funding postgraduate study for their employees, giving future leaders in the business the essential skills and knowledge that will enable them to adapt to the demands of the industry, and lead successfully across the whole drug development process.
The complexities of drug development
It is a well-known fact that successfully creating, manufacturing, developing and marketing a new drug is a notoriously difficult task. The only thing that stays relatively constant, however, is the length of time it takes. All of the other factors can fluctuate wildly. David Michelson, vice president of clinical neuroscience and ophthalmology at Merck Research Laboratories outlined the current difficulties facing drug development teams today, saying “The years- to decades-long process can be complex, and there is nearly always a moment of uncertainty that a drug will succeed to the next phase of development. This long development pipeline faces increasing costs and additional challenges, including the lack of predictive validity of current animal models, insufficient knowledge regarding underlying mechanisms of disease, patient heterogeneity, lack of targets and biomarkers, a high rate of failed clinical trials, and regulatory challenges.”
Downs and Blackburn highlighted just how much the industry is changing and how care needs to be taken to retain vital knowledge when they pointed out: “The drug development industry is restructuring worldwide. This brings different ways of working and new challenges… There is a real danger the key skills will be lost across the world not least in the translation of potential drugs into early clinical trials.”
Wide estimations believe only 5 in 5,000 drugs that begin preclinical testing ever make it to human testing. Of those 5, only 1 is ever approved for human usage. After the original “hypothesis generation” stage, drugs in development need to go through four stages of clinical trials before the product can be approved and brought to market. A thorough knowledge of each stage of this process is pivotal in being able to react to, and solve, the problems that may arise at any stage.
And, often, the final hurdle can prove the most troublesome – getting the drug approved by the relevant authorities. An article in the New Yorker described the preparation that senior management at Merck needed when going before the FDA approval board for their new drug, suvorexant. “One evening in late May, four senior employees of Merck, the pharmaceutical company, sat in the bar of a Hilton Hotel in Rockville, Maryland, wearing metal lapel pins stamped with the word “TEAM.” They were in a state of exhausted overpreparedness… For months, in rooms across Merck’s archipelago of mismatched buildings north of Philadelphia, Michelson had taken part in role-playing rehearsals for the F.D.A. meeting. The focus had been on readying Joe Herring… During the meeting, Herring would have access to a library of twenty-one hundred and seventy PowerPoint slides.”
Each country has a specific method of regulating new drugs and, for the bigger pharmaceutical companies looking to market their product globally, a knowledge of what’s required to pass the regulatory requirements in each country is very helpful indeed.
Learn while you earn – the part-time approach
The solution for employees within the pharmaceutical, drug development and healthcare industries that will equip them with the thorough and comprehensive grounding needed to tackle these complex issues is further education. For many, the inability to give up work for numerous different reasons – financial, career, family etc. – can act as a barrier for them returning to education. Equally, it is difficult to manage full time work and travel to a university or college in their spare time. For a busy pharmaceutical or healthcare professional, any further education needs to be both part-time and online.
Online, blended learning has certainly become a standard when it comes to 21st century education (Read more on that here) and Healthcare Learning, the industry leader in blended learning programmes for healthcare and dental professionals, has a new postgraduate offering designed to solve the issues and face the challenges of pharmaceutical drug development. The Master of Science in Pharmaceutical Medicine, which was originally offered by Hibernia College in Ireland, was developed in partnership with key personnel in the likes of Pfizer, Novartis, Sanofi and Quintiles. It systematically covers the drug development process from discovery through research and development to regulatory approval and commercialisation.
Described as “The Executive MBA of the pharmaceutical industry”, this course is specifically designed to equip the future leaders of the industry with an extensive knowledge of the whole process, covering the whole lifecycle activities. Giving you the critical skills to interpret, analyse and develop, this part-time course allows you to “learn while you earn”. You can maintain your full time employment and learn in your spare time. Not only can you learn practical skills that you can apply straight away, you can boost your earning potential when you graduate from a world-class programme, recognised across the industry and beyond.
Set the future agenda in drug development
Drug development is certainly a hot topic at the moment. The rise in antimicrobial resistance is a real cause for concern. Those fiendish diseases have discovered how to effectively fight existing antibiotics, and the pressure is on the pharmaceutical and healthcare industries to find new ways to fight dangerous diseases. Completing an MSc such as this one would give an employee within this industry a vital edge that will allow them to set the tone and set the agenda for future pharmaceutical development. The industry faces regulatory pressures and financial pressures, and the ability to deal with these is just as essential as the necessary scientific knowledge. An MSc in Pharmaceutical Medicine allows you to take centre stage and become a key driver in your industry, steering a confident path through drug development, all the way to market.
To learn more about Healthcare Learning’s MSc in Pharmaceutical Medicine, please click here.