Africa: Biopharma's New Land of Opportunity
By: Michael Klein, MD; Erica Caveney, MD | January 26, 2015
Conducting clinical research in Africa can be fraught with risk. From overcoming basic infrastructure obstacles and finding reliable talent, to addressing personal safety issues for your team, these projects require an entirely different level of management and oversight.
But Africa also offers tremendous opportunities for biopharmaceutical companies interested in doing research into a wide range of prevalent and neglected diseases, including Malaria, HIV, Tuberculosis and sickle cell anemia. Over the last eight years, global funding for neglected diseases has grown substantially, reaching $3.165 billion in 2012, and much of this research is being done in Africa.
Biopharma companies who want to participate in these philanthropic endeavors need to overcome their fears about working in Africa. As long as you develop succinct strategies and strong partnerships to launch and manage these efforts, you can minimize your risks and increase your chances for success.
The right way to work in Africa
As with any philanthropic effort, the goal of these research initiatives is to be as efficient and cost-effective as possible while generating meaningful results – but when it comes to doing trials in Africa, the first goals can often get in the way of the second. When biopharma companies make choices based only on up-front costs, they often find themselves spending more time and money in the long run making up for poor choices.
Before launching a program in any African country, consider this advice:
1. Build extra time for every step.
From training staff and finding patients, to addressing basic infrastructure challenges, organizing clinical trials in Africa takes far more time and effort to set up than any traditional study. You have to account for that in your project plan. Key issues to consider include training investigators to run the study according to your requirements, identifying or building trial sites that can accommodate all of your infrastructure needs, and establishing trusting relationships with local regulators and healthcare providers – which will require multiple meetings. You may also need to address logistical challenges, for example setting up transportation options for remote participants, or creating multiple micro sites to accommodate far-flung patient communities. Every one of these steps will require extra time in the project plan.
2. Choose partners wisely
Most biopharma companies partner with local providers in Africa as a way to minimize risks and gain access to local talent and existing stakeholder relationships. But before choosing a partner, you have to do the due diligence. Many small contract research organizations will claim to be able to support any research program, but they often don’t have the robust processes, technology, and oversight that global organizations require. When assessing a potential partner, investigate their approach to patient safety, data integrity, data capture, and financial management. Many of the smaller organizations rely on spread sheets or hand written notes to collect data, which can make it impossible to interrogate the results. They may also lack the infrastructure, talent or networks needed to fulfill the requirements of the study, which means you will have to go back and redo much of the work if they fail to deliver.
3. Keep stakeholders informed
Most of the clinical R&D efforts in Africa involve neglected tropical diseases. That means funding for these projects will involve government agencies and philanthropic organizations, who will all expect rigorous reporting and updates on your progress, often in different formats and on different schedules. If you don’t have appropriate stakeholder involvement from the outset – particularly among government agency who wield power over your ability to operate – it can seriously jeopardize your ability to execute the study effectively.
4. Don’t make assumptions until you have feet on the ground
Even simple tasks, like transporting a live virus that requires a continuous cold chain, or shipping lab samples out of the country, can become insurmountable challenges in places like Nigeria or Burkina Faso. Yet such simple steps are vital to the success of these research efforts.
It’s easy to overlook potential risks when planning a research program in an London or New York, but until you are on the ground in Africa and have explored every aspect of the environment, infrastructure, culture and geography, you can’t know what obstacles you will face.
Before launching any program, send your team to the site, and partner with providers who can help you identify and manage risks throughout the program. Having a realistic sense of the obstacles you face, and partner who knows how to overcome them will increase your chances for success, and minimize the time and cost spent achieving the results you seek.