It seems that an ever increasing volume of clinical study work is being conducted outside the mature global pharma markets, with major companies investing heavily in some of the developing markets. So, ahead of his presentation at the marcus evans “5th Annual Clinical Research in Emerging Countries” conference in Miama, US on the 21st July, pharmaphorum spoke with Nathaniel Ramuthaga, Regional Clinical Operations Head for Pfizer for the Africa and Middle East at Pfizer about drug development in emerging markets and what role it has to play.
During the course of our discussion, we explored the opportunities and challenges of conducting clinical research in these regions and how it is likely to develop in the future. In addition, Nathaniel presented a clear case for how such activity can actually yield real win-win situations for both the pharma companies investing in these regions and the local populace, directly addressing some of the ethical concerns that such trials can raise.
To listen to the full interview, please click on the play button below, with a shortened transcript of some key highlights shown in print below.
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PT: Nathaniel, I'd like to start by just asking you to describe your role at Pfizer.
NR: I'm the Regional Head of Clinical Operations at Pfizer, responsible for Africa/Middle East, with the primary countries driving the operations being South Africa and Egypt. I'm a trained medical scientist, having specialised or done my basic training in microbiology, physiology and biochemistry, then I did postgraduate studies in microbiology and molecular genetics. After that I did some qualifications in marketing management as well as business management before I joined the industry. And I'm a registered medical scientist with the South African Health Professional Council as well as the South African Council for Natural Scientists.
PT: Which countries in particular do you to tend to focus on more heavily?
NR: South Africa and Egypt drive the process, however some countries feature in the Middle East region...like United Arab Emirates and the other Gulf States – Bahrain, Qatar, Lebanon, as well as Jordan. But in Africa we have South Africa, and Mali, Kenya, Uganda, Egypt as well as Ivory Coast and also Senegal and Malawi.
PT: Now, if we look at this region overall, why would you say it's important for pharma to conduct clinical studies in this area?
NR: I think when you look at the conduct of trials, even though we have not reached the era of genetic or individualised therapies, it's critical to obtain data from a wide range of patient pools of different genetic and environmental make-up because you can find certain things that are completely different...that may impact on how medical intervention can be seen.
PT: What do you see as the main differences in regulations when it comes to clinical trials [versus Western markets]?
NR: My experience informs me that the fundamentals are not necessarily completely different. The only challenges that you find, regulatory-wise as well as ethics-wise, in terms of the framework and the support structures, are that these countries are in an evolutionary era, except maybe for South Africa and Egypt. The majority of the countries are still developing in terms of infrastructure and support for their regulatory framework... still relying sometimes on external assistance from foreign bodies like non-profit organisations such as the Bill Gates Foundation, maybe sometimes Médecins Sans Frontières and other bodies that are coming out of the developed world. So it's pharma companies that are also propagating training to develop that regulatory aspect of it.
PT: And do you see these regulatory differences have an impact on the validity of the clinical data when it's viewed by Western regulatory authorities?
NR: The only concern they normally will look at, when they audit, is noting that the majority of the participants are indigent to ensure that GCP standards are complied with at the same levels that would be demanded of the developed world..., which means that even before one contemplates doing a study in those countries, you have to ensure that the training and the level of expertise in terms of GCP compliance – even with difficult logistics in some areas – as a minimum will be complied with across the board.
PT: And what would you say are the main advantages of conducting clinical trials in these emerging regions?
NR: What we have noted over the years is that the investigators or the doctors or the clinicians are very eager to learn and participate ...and it's easier to work with them because they don't carry any egos when they conduct their trials. They are prepared to learn and to follow to the letter the protocol... this allows a trial to move smoothly. The other advantage is that you'll find that patients who are participating in these trials are all new, so... the data validity is quite reassuring.
PT: What would you say are the main challenges of conducting trials in the Africa and Middle East regions?
NR: I indicated earlier that some of the countries are going through an evolutionary process. In the last five to six years I've seen a lot of countries enacting their own regulatory laws and ethics guidelines which is very comforting...because no stakeholder wants to go to a country where there are no laws that regulate the process. [Also] the issue of resources for both the investigators and the clinicians – finding a balance between those who will continue to give healthcare and those that will be able to conduct research.
PT: Talking about resources, what local capabilities do the pharmaceutical companies need in these regions to get the best outcome from clinical trials?
NR: It is important to do a proper pre-site and then pre-country visit to ensure one identifies any gaps...pharma companies must be prepared to capacitate where the gaps exist.
PT: How does the level of external commercial support (things like clinical trial supplies, logistics, even full-scale CROs) compare to the Western markets?
NR: I think maybe in five to six countries they are well-established...and there are certain countries that are used as a base to support those countries that do not have the capacity. And in the last five years we have seen a number of CROs setting up in some countries like Ghana or Kenya and this has made life easier for all the stakeholders and pharma companies...there are couriers as well who have set up logistics in these countries...that ensure a similar transfer of biological materials and documents without really one noticing that they are sending in a developing country.
PT: What is your strategy for ensuring that local populations aren't manipulated during clinical trials in these regions? And also are there ethical concerns that you feel perhaps need to be addressed more centrally by the local authorities in these markets?
NR: I must say that over the last five years we have seen a great improvement in the approach of involving patients in the developing world in trials...we have embarked on a non-sectarian ethics training that includes established regulators from South Africa, with global emphasis, to ensure that all countries who are participating in these trials are able to send one or two people from their ethics committee as well as from their regulatory bodies for training. Which means that you empower these authorities to make their own informed and independent decisions without being influenced as to who is coming to conduct a study in a particular country. And participants will always be reassured that there are protocols in the studies that are taking place in these countries and that they have gone through rigorous checks and balances. In addition to this, we have seen in areas like Mali for example, whereby even before you embark on a trial...you will have to go and engage the local traditional leaders who have got their own scientific advisors, independent of study structures, before you even submit your documentation to a properly-constituted ethics committee. So those are the kinds of safeguards that we have seen – they have reassured us that indeed all the fundamentals to safeguard the welfare and participation of patients and participants are well in place.
PT: Are there certain disease areas where perhaps genetic, environmental or even economic differences can actually cause problems when it comes to interpreting trial results?
NR: None that are observed in terms of the last few years, because the lifestyles in these areas – except when you go to quite remote areas – have similar patterns. If it's diabetes, it's diabetes – it doesn't matter whether it's happening right in the middle of Uganda or in the middle of Kenya or down off-limits in South Africa. However...you will not find malaria in the streets of London or the streets of New York so you would expect that there will be certain requirements or unique behaviour patterns of people being treated for diseases like malaria in those areas. But I would say 90% of the time, basically most of the aspects will be similar.
PT: Now you mentioned at the start of our discussion certain countries as being more important within these regions –South Africa, Egypt, some of the Gulf States. Why do you favour these particular countries for conducting clinical research, and how are they differentiated from some of the other markets?
NR: The great difference for those maybe top three, four or five countries would be the presence of enough medical and scientific researchers capacity-wise, so that some people are even able to spend 50% of their time doing just the research in terms of clinical trials and then spend the other half on their general medical care delivery. Whereas in some other countries that I say are still developing that is a luxury that the researchers and the clinicians cannot deal with. In addition to that you find that these countries - like South Africa, Egypt, United Arab Emirates, Jordan and Lebanon –do have well-established ethics and regulatory frameworks that regulate the conduct of trials as well as the logistics part of shipping investigational products into and out of the country.
PT: So if we play that process forward and we look ahead over maybe the 10 years or so, how would you see the role of these markets evolving from a clinical development perspective?
NR: I envisage that in about ten years time almost 60% plus of the development work will be done in the developing countries.
PT: How do you see clinical operations within the pharma companies themselves evolving to actually take advantage of these opportunities?
NR: Noting that in some of these developing countries there are quite a number of unmet medical needs, and also the civil society not being about to cater for everything in terms of healthcare I am seeing the pharma industry, as well as the stakeholders like even CROs, shifting to other developing worlds to ensure they are able to deliver their drug development processes earlier, as well as also reaching people who at the same time will be receiving some form of medical care, because not all investigational studies on drugs are for diseases that are long-term diseases. There are short-term diseases that, once the trial is finished the patient is cured. So in a way, a certain percentage of patients would benefit as part of the delivery of healthcare through clinical trials.
PT: If you were speaking with a pharma company that's considering expanding its clinical trial operations into Africa and the Middle East, or even moving into these regions for the first time, what would your key advice be to them based on your learnings?
NR: It would be for the company, or even the stakeholder who is entrusted to run those trials, to respect cultural differences when they first engage or when they are doing their engagement processes. And to also try to be a partner rather than somebody who needs to impose something they think is better...participate in allowing the host [country] where they are conducting trials to identify areas where they think capacity-building could be done in terms of partnering as well.
PT: Well, Nathaniel it's been an absolutely fascinating insight into your role and into these markets – I'd just like to thank you very much for your time.
NR: Thank you very much.
About the interviewee:
Nathaniel Ramuthaga is Regional Clinical Operations Head for Pfizer for the Africa and Middle East region, working within the Worldwide Clinical Study Operations division. He is presenting “An Overview of the Current Clinical Research Environment in Africa and the Middle Eastern Countries” at the marcus evans “5th Annual Clinical Research in Emerging Countries” conference in Miami, US commencing the 21st July.
All the answers reflect only personal opinion and views of the interviewee viz. Nathaniel Ramuthaga and that in no way represent or are expressing any comments or opinions on behalf of Pfizer
For queries regarding this article please contact Kelly Wixson at marcus evans on firstname.lastname@example.org.
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