The interview with Roche

Dr. Aslıgül Kendirci works as Drug Development Director of Roche and also PDGA Country Head Turkey, Middle East and North Africa. We want to make an interview with her to take her advice during the producing drug prototype. Pernicious anemia, iGEM, drug development and ethical issues were the main issues of interview. Dr. Kendirci answers all of our questions sincerely. Firstly we give her a brief about iGEM, pernicious anemia, our project and our future plans.

Do you have any drugs for treatment of Pernicious Anemia?

As far as I know, we do not have a drug for Pernicious Anemia.

Do you think our prototype can be approved by FDA and released?

FDA approval process is really long, complicated and expensive process. In order to get approval for a drug there are lots of experiment should be done in 10-15 years. First you should make experiments on animals. If you prove it is both effective and nontoxic on animals, you will make experiments on humans. There are lots of experiments to be done. You cannot afford these kind of experiments without sponsors. These whole process is required around 1,3 billion dollar and 10-15 years. That is the reason of big medicine companies make these kind of big researches. Because huge amount of investment is needed. In my opinion after producing your prototype, make presentation to big companies in congress. If you can find a sponsor and experiments prove that it is effective and not toxic, it can be released but it is a though process.

After taking approval do you think medicine companies release our drug willingly? Because our prototype is long term treatment. Patients don’t take pills every week, they will take it once in year or hopefully once in their life.

Let’s think about it strategically. B12 is really cheap but your project need to invest lots of money and time. Also it is not certain company will get profits on it. Even if the investments are done, your drugs will be taken once in year. In order to get profit, company should sell it very expensive but then it will be sold less in number. Therefore if I would be company, I guess I will not release it.

What is the importance of ‘Demand’ for company before deciding to invest on a drug?

Of course it is the first think for companies. That is the reason why companies investing huge amount of money to MS, cancer, AIDS. However there are also some other parameters to be considered such as ethical issues and benefit for humanity.

What is the importance of ethic during clinical experiments of a drug?

Ethic is very important issue for us. We give ethical education to our doctors. Doctors should not forget that they could be patient and they could undergo these researches. If they keep that in their mind and behave in that way, there will be no ethical problem.

What could be people attitude to drugs produced by genetically modified microorganisms? If you were a Pernicious Anemia patient would you take that drugs?

As a person who make clinical researches and pharmacist, I am completely positive about these kind of drugs. However you may not take same answer from someone who does not know bacteria. They may be scared and they may not take the pills even if your drugs are completely safe.

What do you think about the future of these kind of drugs?

In my opinion they will be widespread and no one scare of them and they will use it.

What is your advice to next iGEM teams who are planning to produce drug prototype?

It is very nice young people like you working on the disease. You can access all the theoretical information from articles, books, internet and you start to manipulate the organisms like a puzzle. I was like you at college, I joined project try to do something new. However you need some clinical information too. I guess you should discuss with experienced doctors if the prototype will work effectively and patients will take drugs willingly. You work so hard in lab but the thing is life could be different.