We ended week 7 in high spirits by hosting a party at our apartment, where we were able to share the amazing view with friends and to strengthen those bonds with everyone that we have met over here. It was also an opportunity for Genzyme and Liberty Mutual interns to meet each other. Our American friends took the time to introduce us to a

With only two weeks left before our departure back to Scotland I feel I have become really settled here both in and out of work. As the other interns over here in Boston have already blogged all about our trip to New York last weekend, I won’t say too much, except that it is indeed a place that you must experience. There is something there for everyone to enjoy.

 I would also like to take this time to discuss an important part of drug development that I feel only a minority of people are 'in the know' about, which is the process taken to get a new drug from the stages of being made in a lab to being made on an industrial scale and having the correct paperwork to be able to market that drug. It is also an area that differs greatly between both the US and UK.

 Here is how... Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to either the FDA, US Food and Drug Administration, for approval in the US or the EMEA, European Medicines Agency and then through a secondary body for the individual country in Europe that the company wants to market the drug in. For the UK it is MHRA, the Medicines and Healthcare Products Regulatory Agency.

 Both processes have the same objectives to be met; safety, quality and efficacy in order to allow the drug to go through the numerous phases of drug trials and then be approved.

However, this is where the two Agencies differ. For the USA the major issue is efficacy, in order to be able to market a drug the company must be able to prove that the drug is effective in what it has been developed to do.

 In Europe, safety is the major factor. If a company can provide solid evidence that their drug is completely safe then approval is likely and they will be granted the ability to market the drug. The efficacy is not so important, which can provide problems with marketing the product so that people will buy it. The European process is quicker than in the USA, but it has to go through two governing bodies and each individual country has its own requirements for the drug approval.

 Once the FDA or MHRA give the go ahead and testing of the drug on humans has been approved, the stages that must be passed are as follows:

·                  Pre-clinical trials in vitro (in a testube) and in vivo (in animals)

·                  Phase 1 - uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) 

·                  Phase 2 - employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) 

·                  Phase 3 - involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

The company then submits an application to the FDA for approval, a process that can take up to two and a half years. In total, this process takes from 8 years and up, on average being 12 years and costing over $350 million to get a new drug from the laboratory onto the pharmacy shelf.

There have been many issues raised over which system is the most efficient, where the problems lie and how can the processes be sped up in order to help new drug therapies become available sooner. I feel that people do not have enough knowledge or understanding of the lengthy process taken to be able to put a drug on the market, or even just to test a drug on a patient. Only a small number of drugs that have gone through research studies actually make it to the clinical trials, and even then it is difficult to reach the approval stage. I imagine that with projects that take this long to complete, with the knowledge that it also may come to nothing, that there would be times when enthusiasm is low and direction is lost. I feel that Genzyme is able to overcome this on a daily basis and maintain a constant positive attitude about the work that is carried out by eveyrone by always having the thoughts of the patients that are being helped at the front of your mind. There are photographs of patients that have been helped and patients that still need treatment in all over the company, it is a very patient driven company, which ensures the work is done to the best degree.

And so with these thoughts in mind...What is more important to you, safety or efficacy?