Wednesday, 26 March 2014

World Tuberculosis Day 2014 passes with a glimmer of hope

Even though tuberculosis kills 1.4 million people each year it is often thought of as a disease of the past. However, it is a very present danger, and is one of the three main killer infectious diseases (along with malaria and HIV/AIDS). One reason that it has been overlooked is that its main impact is in developing countries. Tuberculosis and poverty create a vicious cycle, whereby the disease exacerbates poverty and this in turn increases the possibilities of contracting the disease.

One estimate suggests that tuberculosis will effectively rob the world’s poorest countries of an estimated US$1 to US$3 trillion over the next 10 years. This “draining” economic effect means that it is very difficult for these countries to advance and improve conditions. The World Bank has put the loss of productivity due to TB at somewhere between 4 to 7 percent of some countries' GDP. At a community level, the economic burden of illness for households has been described as catastrophic.

Given the threat posed by the disease, greater efforts are being made to rectify the problems and complacency of the past. In particular, the World TB Day initiative, held on 24 March each year, has attracted a lot of media attention. This campaign produces a range of information in different languages (Arabic, Chinese, English, French, Russian and Spanish) to maximize its global impact.

Another area where progress is needed is in the area of drug development. The track record for new anti-tuberculosis drugs has been pitiful. New advances are badly needed as drug-resistant forms of the disease are a major health problem and current therapies are not adequate to deal with the situation. As tuberculosis offers low rates of commercial return, it has been of little interest to most pharmaceutical companies. The perceived lack of interest of pharmaceutical companies to go it alone in this area has prompted the idea that R&D partnerships with the public sector and other organizations might be a better approach. For example in 2007, seven pharmaceutical companies announced that they would team up with four research institutions and work with the Bill & Melinda Gates Foundation to create a partnership called the Tuberculosis Drug Accelerator (TBDA). Since then, other companies have joined this unique partnership. The TB Alliance, established in 2000 as a not-for-profit product development partnership, has played a major role in trying to deliver innovation for this area. At present, TB Alliance and its partners manage the largest pipeline of TB drugs.

The regulatory agencies also have a role to play in ensuring that new drug development is encouraged. In Europe, there has been a welcome step forward recently, with the European Medicines Agency having recommended granting marketing authorization to three medicines for the treatment of multidrug-resistant tuberculosis. US regulators have also been actively encouraging this field, with one product having benefitted from a number of the agency’s incentives.

There is no doubt that some progress is being made in tackling the disease, but the scale of the challenge is huge. Worryingly, there are signs that tuberculosis is gaining a firm foothold in a number of major European cities. A lot more will be expected in terms of new advances by the time that World TB Day 2015 comes around.

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Friday, 21 March 2014

It’s not all doom and gloom if you want to get into regulatory affairs

Job in regulatory affairs
No company can succeed these days unless it has a really good regulatory affairs department. This hugely important, but rather misunderstood, function sits at the interface between the company and health authorities and acts as the contact point for regulatory agencies regarding a company’s product.  

As a regulatory affairs professional you have to not only understand different aspects of product development, but also be able to provide input on how data can be used to support registration in numerous countries. This also means spending a lot of time in keeping up to date with changes in regulations in different markets. Nowadays, while an understanding of the regulatory agencies of the US, EU and Japan is still key, you may find yourself dealing with markets further afield such as China, India or Brazil.

As the regulatory affairs function has a multidisciplinary element to it there seems to be no set route into roles in the profession. For an interested newcomer it can be quite confusing to work out where to start to enter this field, particularly since it is changing all the time. Unfortunately, many people you meet working in regulatory roles come from such diverse backgrounds that their career path might not work for you.  As a job seeker, you can feel quite disappointed because there seems to be a general lack of interest in people who do not already have regulatory experience.

Thankfully, the area has grown so much in stature within the healthcare sector that there are now professional organisations to help regulatory professionals. Two such useful organisations are The organisation for professionals in regulatory affairs (TOPRA) and the Regulatory Affairs Professionals Society (RAPS). They are playing an increasingly important educational and networking role. Both these organisations actively seek to promote regulatory affairs as a profession and so are good places to figure out if this area is for you and help you develop your career. They have courses to give you a solid foundation in regulatory affairs and also run conferences where you can hear from senior regulators. Another useful organisation is the Drug Information Association (DIA).

General news websites running articles and news, and the websites of the major regulatory agencies are great places for self-education. While some information is highly technical and aimed at specialists, a lot is clearly introductory with the intention being to demystify what goes on. You would be surprised to see what sort of information they have – for example, the FDA has a fascinating section on its history which helps you understand exactly why the regulatory affairs profession has evolved to become what it is today. Also both the FDA and EMA manage a number of social media channels.

If you want to get into regulatory affairs you need to be both self-motivated and proactive to make headway.  The route might not be straightforward but there is a lot you can do for yourself.

Browse the latest regulatory affairs jobs