For the latest edition of our In Conversation With, we are joined by Selma Kita, the Director of Clinical Operations at MCT-CRO. Selma joins us to share from her wealth of extensive experience supporting clinical trials across the Middle East and Africa.

APR: Welcome Selma, and thanks for chatting to us. Please tell us a bit about Selma. Who is Selma Aouadi Kita?

SK: I’m a French-Tunisian pharmacist. I have several master’s degrees (clinical research, cosmetic and management). I’m also a happy mum of three kids. I started a career in clinical research 16 years ago and the least I can say is that I love what I’m doing 😊 and that I’m trying my best to enhance Africa's visibility to attract more clinical trials to the region.

APR: In your current role, no doubt there is never a dull moment. What does an ordinary day look like as the Director of Clinical Operations at MCT-CRO?

SK: Oh no. There is no single day/hour that looks like the previous one. A colleague, Hella Ghorbel, did share recently that every day when she accesses her inbox, it is like she is opening a chocolate box. I see that she did summarize the situation quite well.

We spend the day jumping from one call to another. In parallel, there are always urgencies raining with multiple requests/ issues to fix.

APR: Your work cuts between Tunisia and France. Tell us a bit about this.

SK: Indeed, I’m based in France, but I’m fully turned to Africa. There are so many things to do in our region while in Europe everything is well set through detailed regulations and clear systems. The benefit from being involved with emerging countries is that we can make a difference. Plus, we are dealing with great stakeholders that are always open to discussions and willing to take Africa to the next level. As an example, recently, we did succeed to have Tunisia EC and RA sitting in their first AVAREF joint review session. You can’t imagine how proud I was. I was in tears the first 10 minutes of the meeting. I was so happy!

APR: In addition to the remarkable work you are doing, you also make time to make a difference through philanthropic efforts. Tell us more about this. What inspired this?

SK: From my childhood, I have always seen my mother helping people in need despite having very limited means. Subsequently, by becoming a mother in my turn and being in France, I noticed that we have everything in excess, clothes, toys, .... while in Tunisia many families lack necessities. In addition, thanks to my job, I’m traveling frequently to Tunisia, so I started by bringing a suitcase full of donations on each trip. I used to pass on these donations to the Maram’s association, an organization caring about children suffering from cancer. Quickly, things got carried away because many people showed their willingness to help and join the movement. Since then, we have organized several actions and here is some of them:

On 1- December 2020, we collected warm clothes for 150 schoolchildren from three schools in Seliana - an extremely cold mountain town in Tunisia.

On 2- April 2021, we distributed foodstuffs to more than 300 families for the month of Ramadan. And now, I’m done with planning the winter action to cover additional children in cold areas of Tunisia. I am also starting my own association with a wonderful group of friends.

APR: With the industry having undergone some fundamental shifts since last year, how has the landscape changed for you and MCT-CRO?

SK: I won't hide that the pandemic has not really impacted the work conditions of the MCT teams daily. Indeed, the fact that in the past we had been able to conduct our operations in countries in revolution and highly unstable, we were ready to switch at any time to remote work. In addition, MCT stands out for its coverage of the region via local teams. As a result, the travel restriction measures hardly affected us. At the same time, we have noticed for almost a year a great craze towards Africa. As they say the misfortune of some makes the happiness of others. So, the fact that Africa is the region that has least vaccinated it's population to date, it becomes the best location to conduct clinical trials aimed at evaluating the efficacy and safety of potential vaccines against COVID-19.

APR: You have been in the industry for quite a while and have worked across quite a lot of interesting geographies and countries over that period. Tell us more about this.

SK: In 2006, I started my career in France at the beginning with l'oreal Paris then with PPD France. It so happened that in 2008, I was assigned as a CRA of a study in neurology with two sites in Tunisia. Through my monitoring visits, I noticed the enormous capabilities and potential of my native country, Tunisia. However, at that time, PPD had no plan to settle there. In parallel, I was approached by the founders of MCT who had a crazy project to launch clinical trials in Tunisia. I believed in it and moved from France to Tunisia in early 2010. From that time, we started the expansion and now we are operating in almost 40 countries.

APR: What have been some of the most important learnings for you, as you’ve worked across Africa and the Middle East? What are some of the surprising differences you’ve come across between the two regions, if any?

SK: The biggest lesson I have learned through my work in the Middle East and Africa regions is to never give up. You often must knock on every door in order to start a clinical trial.

As such, I was able to have the authorization to perform genetic analyzes abroad as part of a protocol treating breast cancer while at the time this kind of test was not authorized in Tunisia and required an exemption. But after standing for hours and pleading the rationale behind such an analysis, an exceptional authorization was granted.

Also, it is often thought that young and unaccompanied women cannot make a business trip to Saudi Arabia. I can confirm that things have changed and at my level, I was able to visit Saudi Arabia in 2017 when I was under 40 years old. Of course, I had to comply with a lot of special requirements, but that is part of the flexibility required by our work. It is essential to understand the customs of each country and to respect them. The mistake I often hear is that people take Africa as one piece when it comes to 54 countries, each with its own specificities and regulations. Respecting cultural specificities and countries independence is a must to operate in Africa.

APR: In comparison to the more developed parts of the world, the two regions still lag behind in terms of the maturity of healthcare systems and clinical trials infrastructure, any thoughts about how you seeing these two regions evolving in the next few years?

SK: You will be surprised when I tell you that for my part, Africa is not at all lagging behind the developed countries. In fact, in Africa there are wonderful but little-known initiatives. There are also clinical research sites like the MRC Gambia which have enormous patient recruitment potential, and which exceed by far the capacity of many sites in Europe.

It is true that developed countries benefit from well-detailed regulations, a robust health system and mature health authorities. But I cannot hide that the whole is quite rigid, and it is less attractive for clinical trials. Actually, the growth of the clinical trials market that is announced in Africa for the next 5 years is higher than in Europe

From my experience, I much prefer the unofficial system that reigns in some African countries because it leaves us room to set up initiatives and to be in continuous discussions with health authorities and key opinion leaders. We end up launching large clinical trials that meet major health needs such as sickle cell disease protocols.

APR: The COVID-19 pandemic has brought patient-centric trials back to the fore, how have you seen this take shape across the two regions you oversee?

SK: You are highlighting here another point for which Africa was already prepared. It must be recognized that this is not the first pandemic the region is facing, unfortunately. Therefore, most of the measures that were announced after COVID-19 started were already in place, such as home nursing services, remote monitoring, and the expedited review of emerging disease submissions. It is true that some countries still have improvement to be done mainly with respect to review timelines of submission packages but I’m confident that they are working on it.

APR: With your wealth of experience and being an inspiration to others, any wise words for those looking to follow similar steps and rise to your level?

SK: There is a sentence that I’m always sharing with my team: Let your work speak for you.

Perseverance and hard work always pay.

APR: Tell us about some of the people who have influenced you along the way. Who would you say helped shape Selma into who she is today?

SK: I learned from all the people who have crossed my path, often about the right way of doing things and sometimes about what not to do. I also learned from my mistakes.

But if there is one person who has always inspired me, it’s my brother Bassem without any hesitation. My brother is two years older than me, and he has suffered for over 20 years from a rare disease which is extremely disabling. However, he was able to successfully complete his architectural studies, have a family and build a real estate company that manages several large-scale projects in Tunisia. When I see what he gets to accomplish while he has lost the use of one eye and his kidneys in his battle with the disease, I tell myself that we healthy people cannot use any excuse to fail in delivering per expectations. Everyone must give his best in everything he undertakes because no one knows when the fall will come especially now with this pandemic!

APR: With the industry being so fast-paced and there being so much to get through daily, now probably more than before, how do you recharge your batteries to keep yourself going?

SK: I’m someone who’s highly energetic and positive. Already during my working day, I try to put in a lot of fun and music with my team. For me, issues should come only from the projects. At team level, we need always to find a way to work together in a peaceful environment. Besides, I’m blessed to have a great family and friends that are always here to support. Then, whenever it is possible, I escape to my native island Kerkennah. It is a small island thrown in the middle of the Mediterranean Sea. It is known by the place where time stops, and it is so true and relaxing.

Thanks for chatting to us Selma. This has been a lovely discussion and your passion for your work is truly inspiring. It’s been a pleasure.

About Selma Kita

Selma is the Director of Clinical Operations at MCT-CRO and has more than 16 years’ experience in line, project and operation management. She has been involved in more than 150 trials from Phase I to Phase IV for different therapeutic indications, including but not limited to Infectious diseases like SARS-2 COV, rare diseases with an extensive experience in the SCD indication, neurology, …etc. For the past few years, she oversaw clinical operations (projects and programs) in more than 20 countries located in Middle East and Africa: Algeria, Tunisia, Morocco, Egypt, Mali, Ivory Cost, Lebanon, Saudi Arabia, UAE, Oman, Kuwait, Qatar, Jordan, Senegal, Burkina Faso, Gambia, Guinea, Sierra Leone, Ghana, Uganda, Kenya, Nigeria, Mozambique, South Africa and Zimbabwe.

Je suis une pharmacienne avec une spécialité dans le domaine des essais cliniques. Lors de mes 16 années de carrière, j’ai pu gravir les échelons jusqu’à ce que je prenne la direction des opérations cliniques sur l’Afrique chez MCT CRO. A travers mon parcours, j’ai eu la chance de gérer des ressources mais aussi des projets et des programmes de développement cliniques. A ce jour aucune aire thérapeutique ni phase de développement n’a de secret pour moi tellement je les ai toutes parcourus. En matière de couverture géographique, j’ai démarré ma carrière en France et j’ai pu l’étendre à l’Afrique et au Moyen Orient.