DIA's Yves Juillet Speaks to Pharma IQ about the Road to Convergence

Dr. Yves Juillet, DIA President, speaks to Pharma IQ, about the top 3 regulations impacting pharma in 2011 -2012 at DIA's 47th Annual Meeting. Juillet discusses the DIA's top priorities in the next 12 months and why convergence so important in the pharmaceutical industry and its impact on competition. To watch the video interview go to Exclusive: Dr. Yves Juillet, DIA President Speaks to Pharma IQ about the Top 3 Regulations Impacting Pharma in 2011 -2012


You have been successful in a variety of roles what are the common tennets?

Y Juillet: I think that having been in the position of different activities, I would say that what is important is that in my different jobs, I was, essentially, in strategy activities. So this has allowed me to have a view on the global picture.  The second is that I've always been acting in the international activities.  Particularly, for instance, in the ICH, which is the International Conference on Harmonisation, I used to be in the steering committee, so this allowed me to have discussions about the development at a worldwide basis.  And this, with the health authorities of the US, Japan and Europe. 

In all my jobs in the pharmaceutical companies also, I was in a strategic position.  In fact, overruling the technical aspects, not directly involved in the technical aspects.  So this needs different, well, pharmacy skills which is, firstly, to think politically.  The second is to try to, well, to like to put the people together in order to try to move forward.  The third thing is to be creative and to be positive for the future.  Just to take the good things and to try to put aside the negative aspects which would block you.  So I've always been somebody who likes to move forward in different activities that I've been very, well, you know, proud and also pleased to feel. 

What are the top 3 new guidelines/regulations that are likely to impact/ be key areas for discussion amongst pharma/bio companies in 2011/2012?
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Y Juillet: I would not speak about guidelines, I would speak about regulations and, particularly, in that case, because I'm more familiar with that with the European Regulations. I would say there are two main ones.  The first is around pharmacovigilance and the management of the risk.  As you know, our population is very natural, are more and more keen on securing the use of pharmaceuticals.  And also because of that, health authorities are who are in charge.  They have to be sure that things are going in the right direction.  So there is a specific aspect in pharmacovigilance and it's what is called risk management.  It's to try to, in fact, get information in order to be sure that we have enough and that this information is spread to the people.  And the second, within the risk management is what is called risk minimisation or mitigating risk.  And a different aspect there, and, particularly, all the stakeholders are involved in that.  Of course, the health authorities because they fix information, which is the official one.  But also the health professionals when, for instance, the doctors prescribe.  They have to be very careful in the way they prescribe, adapt to the needs of each patient in an individual way. 

Pharmacists who deliver and who have to take into account specific aspects in their delivery, particularly interaction between the different products.  And the patients themselves.  The patients, they have to take care of themselves, and, particularly, they have to read the leaflet of the product to be sure that the information that they have to take into account.  In particular, the way the drug can be used in the best way.  So all these aspects are very important.  The second important topic which is, essentially, in the developing countries but which has reached all developed countries, is the question of counterfeiting of drugs.  And in this aspect, there is a need for securing all the supply chain, starting with the APIs, they are active pharmaceutical ingredients.  Knowing that many, most of these ingredients are now produced abroad, for instance, in China and India.  So when these products are imported in the US or in EU or in Japan, there is a need for securing the quality of these products.  And also to be sure that the products which arrive are not only sub-standard but also could be, sometimes, counterfeit.  So then it's the reason why health authorities in the world have considered it very important to secure all these aspects. 

In particular, we see that the FDA has been very active on this side in establishing offices in China and in India, in order to secure this pharmaceutical chain and supply chain.  So this is the second aspect that is really important.  The third one, which is of interest and which is totally different is about patient information and the fact that more and more patients want to have their own information to make their own decision, so they want to have the global picture.  They have availability to information via the internet.  But sometimes, they also need to have some official information which allows them to be sure that what they read or to compare what they read and what they watch on the internet and what they read in the official information and to make their own decision.  I think that more and more, this is something which is essential is that patients want to have a, sort of, info consent in the way they move forward in taking their drugs. 

What are the DIA's top priorities in the next 12 months?

DIA is very active and as incoming president, I was there last year and until now, the chair of the Strategic Planning Committee, so we've been able to set up our main goals for the following years and especially for the following year.  I think, perhaps, there will be three aspects.  The first is the question of globalisation.  DIA is more and more global and I'm just a living example because I'm the first non English speaking, so I try to speak English, but it's not my mother language.  So I'm French and I'm the first European president of DIA, which is just a sign and a, sort of, symbol.  And the president elect next year, who will be president, is Chinese, so this is something which is really important.  So DIA is, naturally, established in North America, it's present in Europe, it's present in Japan.  This is somewhere the history.  But now the DIA is expanding, present in China, we had an annual meeting last May with 1,000 people and we have also DIA established in India.  And at the board just last week, we decided to go for a provisional advisory committee for Latin America.  So, for several years, DIA had some activities in Latin America with annual meetings and also more specialised meetings. 

Now we have this group of people who are professionals and who will be able to discuss together how to move forward and how to measure needs of the different stakeholders.  Always to keep in mind that DIA is a neutral forum where we have the regulatory authorities, the industry people, the consultant, health professionals and now patients.  So this is really large and so, globalisation. 

The second is training.  Training is to us a real task and we are already present and we have some training activity in the US and the EU.  More and more now in developing countries, emerging countries. What is important is that we try to put all this in perspective to develop a real strategy to use in the best way our abilities and the skills of the people who participate with us as volunteers, as trainers.  I just met, a few minutes ago, somebody who is in the CMC activities and who is from Europe, and he, with DIA, went recently to India to train the people about the basics, about the quality aspects of the production of products.  So this is the second aspect. 

The third one is what we call here at the DIA the digital strategy, which is, in fact, to go, well, a community of people using these new technologies.  So not only revamping the website, but establishing some interaction and allowing the members of DIA to get information in specific ways.  So this is something that we have started to do and we hope that we will be able to finalise this project at the end of this year or the beginning of next year, but already we have for our members, and particularly for the members of what we call the SAIX which is a specialised area interest communiqué.  We have some what we call ConneX which allows them to be in connection, the word is well chosen.  But these people are really able to exchange about their interest at different levels.  The level of just asking questions and trying to get an answer from their counterparts and colleagues.  And the other is to go at, perhaps, a more strategic level to try to make moving forward their specialities.  So this is the third aspect which is important to us. So we have three and we can find several others, if you would like.

Why is convergence so important in the pharmaceutical industry? Does convergence lessen competition?

Y Juillet: Convergence is a need as we develop and is more and more complex.  In the past you had some scientists and we are able to know most of the picture, of the story.  Now it's totally impossible.  It is so difficult that we have to work altogether.  So we have to work together, the risk is always to be in silence, and also to consider that we know enough.  But we don't know enough, so we have to work together.  So we have to work together, the industry people within the companies, they have to work the different departments.  But they have to work with the health professionals and they have to work with the regulatory authorities.  We see that the need for more and more advice. 

In the US, you have the IND/NDA process, in Europe we have what we call the scientific advice.  So all this is something which is really essential, that's he first aspect.  The second is that the picture is really larger and so we have new stakeholders coming, for instance, the patients.  So patients are there and we will speak about that a bit later on.  but what is important is that they have a role which is essential in here. 

So convergence and competition. Competition is something which is very natural, but you have a lot of activities where you can discuss altogether.  And what DIA organises, like in the annual meeting here, is exactly that.  We share information and information which is global information, general knowledge and we don't speak about products, directly products.  Speaking about products would be commercial, but we are not in this activity, so we are able with regulatory authorities, with the industry people, with the companies in charge of development, particularly the CROs, to put things together on the table and can have a dialogue in this neutral forum. So this really is a very good example of convergence and it is the main theme of the annual meeting this year. 

What role can patients play in their own healthcare?

Y Juillet: Patients they want, as individuals, they want to make their own decisions.  They want to be well informed.  So then the word is informed consent.  So with that, they need to have this kind of information and they need to just be able to make that decision.  But I think that we can consider that patients have their own interest.  They are more and more organised in order to play a game in the global activities.  And we have a very good example here at the annual meeting where we have the first in the US Patient Fellowship, we have patients who are able to speak together, firstly.  Secondly, to speak to the regulatory authorities in the industry.  What is the interest?  The interest is that patients have their own views about their disease which is different or complementary to the ones of the regulatory authorities or what they think, the companies or pharmaceutical industry.  Namely that they have their own views about their perception. 

When you are a patient, when you wake up you are a patient, when you go to bed, you are a patient as well, the whole day.  If you are healthy, you're only a health consumer and you have a very external view.  When you are a patient and you know well.  And what is good for you and what is not good for you.  So then the patient will have more and more influence on the process because they will be able to tell the regulatory authorities, to the industry, to the health professionals, these are needs, it is what we would like to have.  So they will have influence more and more on, for instance, in the development, on the design of the trials and also they will have an influence on the perception of risk.  Because the external people have always, think always the risk is too high.  But the patients know well that the risk is a balance between the benefit and the risk and they are prepared to take a few risks in taking pharmaceuticals because all of us know that pharmaceuticals are not exempt of any risk.  Each time you take a pharmaceutical you have a potential risk.  So patients, they accept this as soon as everything is transparent.  So this is really very important.  So this is the first time here in the US. 

We have experience of this patient fellowship in Europe and that works very well.  And we will see the second aspect of this patient inclusion is that the patient will be more and more involved in the decision making process about pharmaceutical authorisation and granting.  So we had a discussion already here with the patients and the regulatory authorities about their roles and they raised good questions, I have to say.  And what is interesting also, I know well the relationship with the patients because I was at the origin of some of these activities in Europe to see that they have exactly in the US, in Europe, I don't know exactly about Japan, but they have the same questions and they give the same answers to the questions.  So this is an interesting exercise that we have been able to start here and that we will follow, of course.  We will just take the advantage of the comments in order to move forward in the right direction for the following year and years.

Interview conducted by Andrea Charles.

IQPC

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