Read the Conversation
EF: Can you tell us about your role and PPD CLINICAL operations in South Africa?
HP: My role is to oversee our clinical operations in Africa and the Middle East. PPD has a presence in six countries: Offices in South Africa and Kenya; registered entities in Ghana and Uganda; and home-based staff in Malawi and Egypt. We do commercial clinical trials, working very closely with pharma and biotech companies, as well as government and non-profit organizations. We also collaborate with subcontractors and CRO partners in the Middle East. While we don’t have representation in every single African country, our model for Africa always has been to have a presence in Northern, Western, Eastern, Southern and Middle Africa servicing the different countries in each region through cross-border monitoring, using South Africa as the gateway.
EF: What is the strategic importance of PPD South Africa accessing the continent and the Middle East?
HP: South Africa is the benchmark for African countries when it comes to clinical research, mainly because we have the most developed clinical research regulatory authority and environment across the continent. Our regulations are comparable to Europe and the U.S. and we are looked upon as the key to African countries. I work with many other African countries where we conduct clinical trials and have our clinical operations, and it is surprising how different some of those countries’ regulations are.
EF: What do these operations represent for PPD global in terms of strategy, access to market or revenue?
HP: Africa is still the place to find treatment-naïve patients in comparison to the rest of the world. Africa has a large pool of patients and many countries have first-world medical facilities. I have been in this industry for a long time, and the challenges we have had in the past in Africa no longer exist today. We now have excellent sites, as well as experts and key opinion leaders in many therapeutic areas. Many of these African countries have clinical research sites just for conducting clinical trials with excellent infrastructure and equipment. South Africa is the gateway to conducting trials in central and southern African regions, as well as the Indian Ocean Islands. We have a strong predictable and enabling regulatory environment, which is a very satisfying environment to work with. Due to the escalating costs in research and development in Europe, we continually seek more cost-effective ways to bring drugs to market more quickly. Asia, Africa and Latin America are good alternative options for this, with 40% of the trials being conducted in these continents. Conducting the trials in lower- to middle-class countries really increases research standards, and also brings health improvements to the countries where the trials are done. As there is no access to some medications in these countries, trials serve as a gate for post-trial access, which is standard procedure for regulatory authorities. This has a great impact on the patients in those countries. CROs have a huge role to play in Africa because of the populations and type of country we service, which of course is great news for us.
EF: Could you define what access means to you?
HP: Clinical trials access provides medications to those patients who otherwise would not be able to afford them. Access in terms of clinical trials is the ability to help patients in remote settings. I have many examples where patients are so desperate to receive treatment that they will walk three or more hours to the trial site just to have access to the medications. Virtual trials, smart devices or AI will play an important role in third-world countries, because patients won’t have to go to sites that often since the data will be immediately available through the devices and save the patient long trips to the site.
EF: How do you think technology will change the business model of clinical research?
HP: We are in a constantly changing environment, but the biggest change will be how we monitor clinical trials in the future. This is something that gets me very excited when I think about how we used to handle/collect data, and how that has transformed over the years, it is absolutely amazing. We used to enter data on three-page NCR paper, one page was left at site, one page was collected and filed in the in-house TMF (trial master file) and one page sent to a central team for entering the data into a database. The whole process could take weeks to complete, but now it is all electronic and data is immediately available for analysis. In addition, we’ve introduced PAs (project assistants) to manage admin tasks, then introduced RSMs (remote site monitors) in order for CRAs to focus more attention on the actual monitoring tasks and identification of risk. The evolution of clinical trials has been incredible. There are many new technologies in progress, such as robotics, so the role of the CRA is becoming more advisory as they evaluate processes, conduct root cause analysis using critical thinking skills and identify risks. We are already training CRAs to think differently; not just collecting data but seeking to understand “the story” behind the data.
EF: What are the biggest opportunities you see in technology for clinical trials?
HP: The biggest advantage is how quickly the data is available, which allows us to reduce risk to the patient almost immediately. This allows our clients to make informed decisions faster: adaptive trial designs are contingent on access to data and ability to make decisions. We can implement and change strategies more quickly in terms of how we want to conduct the trial based on risk. In the past, it really took time to predict and adapt. Now we have the data immediately available to us and we can adapt the strategy more promptly, which helps us better protect patients. In the end, that is ultimately our role, to ensure patients safety, and with the availability of more data, safety can only increase.
EF: How do you rate the current level of physician’s skill set? In keeping them up to date with the latest technologies, diagnose etc.?
HP: Africa is fortunate in that the clinical industry has an obligation to build capacity through training physicians and clinical research staff. In fact in September for the DAIDS (Department of AIDS) we deployed training for more than 15 clinical research staff representing 54 sites for 10 different sub-Saharan countries in Africa. We help our CRAs and sites to be trained and prepared for the future. The implementation of the wrist device monitoring was a huge change for researchers. At first physicians were hesitant, but when they learned about the advantages of the system, they immediately came on board. I think we have to train physicians to help them move forward. Through their professional training, doctors have been taught to do things a certain way. Our job is to open doors to make technologies available for them, to work better in the future. We must give physicians access to the latest technologies so they use them to benefit their patients. The motivation for doctors in Africa to do clinical trials is high because they are passionate about helping patients. Due to our lack of available treatments, which are more easily available in the Western world, doctors see their work as a calling because they give patients access to beneficial alternative therapies. Mostly, the drugs we test in clinical trials will be registered first in the countries where they were tested. One of the regulatory requirements is post-trial care, which means access to new therapies. Therefore, the more trials we do in Africa, the more new medications will be registered and available across the region.
EF: How do you adapt your service offering to each of the sectors you work with: the government, private and NPOs? What is the percentage of allocation of resources to each of those?
HP: The difference in the models is that for commercial trials we provide both full service and functional services depending on the client’s need, from feasibility services, site startup and site management until study close, whereas for government studies, we usually are contracted to just do the monitoring services, because the government has a different model to conduct trials, and their structure involves different companies or institutions. The nature of trials as well are different. The government focuses mainly on infectious diseases such as TB, malaria, HIV, among others. On the other hand, the commercial side covers the full spectrum of therapeutic areas.
EF: Do you think CEOs of other sectors of the economy understand the complexity of the pharma business?
HP: In health care, because things are changing so quickly, we need to adapt much faster. I have been in this industry for nearly 30 years and for the last 15 years at PPD, we have nearly tripled the number of employees here in Africa during that time. I have seen the dramatic transformation, which has been a fast lane all the way, making it difficult to keep up if you do not follow the industry closely. We need to stay on top of technology innovation for the pharma and biotech industries to grow. I do not know of another industry where things happen so rapidly, and we can see the changes going even further. There are so many pieces to the puzzle and if one piece is missing it doesn’t work.
EF: You will be celebrating your 15th year at PPD in 7 months: When you raise your glass of champagne to celebrate with your team, what will you say to them?
HP: Look back to where we started and where we are now! It has been a steep learning curve, but one our team has handled extremely well. When we started, we were only a small office in South Africa. Now, we have a presence in five countries across Africa. We now do trials not only in infectious diseases, but also in many other therapeutic areas. As a CRO, we have to “walk the talk.” If we want to bring more business into Africa, we have to deliver on what we promise at the highest quality, because that is the only way our clients are going to trust us with their clinical trials. There are pharmaceutical companies that have one excellent product, and if we do the clinical trial on that product, we need to remember that this is their bread and butter. It is a huge responsibility. It is great to see the evolution in clinical trials, and see how we are penetrating the African region. A Tufts report indicated the global clinical research market at around $44 billion U.S., and South Africa contributes $2.6 billion to that.
EF: What initiatives and strategies do you have to attract more participants to build on that number?
HP: PPD has a business called Accelerated Enrollment Solutions, which is a combination of three formerly individual operations: Synexus, which is a global site network with more than 200 sites in 12 countries; Acurian, which is a global enrollment and retention company with more than 100 million patients on their database; and Optimal Research, which focuses on oncology sites across the world. PPD relies on these entities to find the right patients and the right sites. As a result, we can accelerate our enrollment. If we bend the time-cost curve, we will bring drugs to the market in a shorter time and will save our clients money.
EF: Any final message you would like to share?
HP: Be proud of what we are doing. Africa has so much to offer. Remember to “walk the talk” and be proud of Africa in whatever you do. I have seen how the younger generations have grown up with the newer technologies, which they will implement quicker and adapt faster. Just remember that, as an industry, we need to deliver on what we promise and we will continue to grow and be successful in the region.
