Kemi Williams is a transformational biotechnology leader with over 20 years combined experience in the pharmaceutical, medical device, and diagnostics industries covering multiple regions including the United States, Europe, Middle East, and Africa. Kemi has a wealth of expertise in organisational leadership, clinical affairs, regulatory affairs, change management, and program management. As a strategic and result-oriented executive, she has delivered outstanding results in both advanced and emerging markets, while enabling strategic transformation and optimising operational excellence in biotechnology organisations.
Kemi has held several leadership positions at various multinationals. Currently, she serves as the Vice President, Clinical & Regulatory Affairs at 54gene. 54gene is a health technology platform company that is building diverse datasets to develop insights that will improve treatment outcomes for Africans and the global population. In this role, Kemi leverages years of experience driving clinical excellence, regulatory competence, and operational efficiency to build the company’s clinical and regulatory infrastructure, establish compliant processes, develop local talents, and form strategic partnerships to successfully conduct inclusive clinical research in Africa.
Prior to joining 54gene, Kemi worked at multiple global biotechnology companies, such as Roche, Abbott, and Medtronic. Her most recent role before joining 54gene was as the Head of Clinical Affairs for Siemens Healthineers US molecular business, where she led the development of strategies, structures, and processes for conducting global clinical studies. Some of her career accomplishments include building and establishing a clinical and regulatory affairs department from the ground up. She has also led many teams to successfully launch critical medical products, such as abdominal aortic aneurysm stents, a mitral regurgitation clip for heart failure patients, and many in-vitro diagnostic tests for oncology, infectious diseases, and women’s health.
Kemi is passionate about closing healthcare gaps by ensuring that clinical research includes a diverse population. She applies a patient-centric approach to research design and conduct. She is equally passionate about paying forward her years of experience and achievements by investing in talent development to raise the next generation of leaders in the industry. She volunteers as a mentor with Reach Mentoring, an international non-profit mentoring program dedicated to helping young professionals looking to unlock their true potential through structured mentoring and professional support.
She holds a B.Sc., Computer Science from Loyola Marymount University, Los Angeles and an MBA from California State University, Monterey Bay.
Kemi is married with two daughters.
When you reminisce on your formative years, what memories can you share?
I am extremely thankful for my childhood. I grew up in a close-knit family where my parents raised their children to love God, be kind, to promote fairness and justice, and work hard to achieve success. These values define who I am today.
As the first of four children, my family’s expectations of me were high. However, I was indeed fortunate. Much was given to me, and it seemed fair that much was expected. I had a stable family life growing up. I was given a good education and encouraged to participate in multiple extra-curricular activities. My parents made me believe that I could do anything and everything.
My father travelled a lot for work, as a marketing executive in one of the major breweries in Nigeria, but spent quality time with the family when home. He taught me how to cook, spurred my interest in jazz music, and demanded the best of me in every situation. He provided a balanced level of exposure to his children. We were required to interact graciously, fairly, and respectfully across different socio-economic classes. We learnt to be kind, to give back to our community, and to define people by who they were, not what they had. I do not take these life lessons for granted.
My mother juggled many things simultaneously – her career as an educator, going back to school for more degrees, her side hustle running a small supermarket and managing the home, the children, and other relatives’ children.
Candidly, I still do not know how she did it! Inadvertently, she instilled in me a fearlessness about taking on more and stretching myself. I continue to reach for the moon because I grew up with women, like my mom and grandmother, who did not settle despite the odds. I continue to care about equality and fairness because I grew up in a family where everyone including the helps were treated with dignity and respect.
My parents were fully committed to the family while pursuing their dreams. They demonstrated to me that one could aspire to effectively balance having a family with having a successful career. I strive to achieve that balance while acknowledging that it’s no easy feat.
Tell us about your pharmaceutical, medical device and diagnostics industries experience, covering multiple regions including the US, Europe, Middle East and Africa.
With over 20 years’ experience in the biotechnology industry, I have led global initiatives and executed business and scientific strategies in multiple geographies covering advanced and developing markets.
My experience started out in the biopharma industry in the US managing drug trials in disease areas such as oncology, autoimmune, women’s health, urology and cardio metabolic. It was an exciting time filled with terrific learnings. I immersed myself in understanding the epidemiology of the diseases we were developing treatments for, the science and technologies behind the drug candidates, the business of running multi-centre interventional trials, the dynamics associated with managing different stakeholders, the regulatory requirements governing our work, and the underlying ethical principles guiding our interactions with study participants.
As I grew in ranks in the industry, I transitioned into the medical device space covering endovascular and cardiovascular therapeutics. I picked up data management, project management and statistical analysis skills and expanded my coverage to international markets in Europe. A highlight of this time was traveling to six European countries on a 10-day business trip while managing the US and European clinical strategies for a company’s flagship device with the goal to expand the product’s clinical claims. We achieved this goal successfully and the European Society of Cardiology guidelines for heart failure treatment was updated to include the product.
My transition to the molecular diagnostics space was accompanied with awesome leadership opportunities and more international experience. I became responsible for departments and cross-functional teams working in different parts of the world. I designed and oversaw the execution of multiple clinical programs that brought high-quality diagnostic tests for cancer, respiratory diseases, and women’s health to the market. My expertise grew to include digital pathology, organisational leadership, and change management. I also started to drive engagements with the US FDA and EU regulatory agencies to craft out the development and commercialisation pathways for multiple molecular diagnostic tests.
Expansion of scope and coverage to include the Middle East came while in the diagnostic space. I later worked in the Middle East as Head of Clinical Strategies for the digital healthcare vertical of a start-up accelerator program.
Coming back to Africa to drive clinical research initiatives fills me with a great sense of responsibility. I believe that the continent is ripe for this type of engagement. I must acknowledge that my past work and experience in the industry seem to have prepared me exactly for this moment.
What are your responsibilities as the Vice President, Clinical & Regulatory Affairs at 54gene?
As the Head of Clinical Programs Group, one of 54gene’s business areas, I am responsible for developing and leading the execution of the organisation’s clinical research and regulatory affairs strategies. These include establishing an enabling infrastructure and developing the capabilities for us to successfully conduct end-to-end clinical development activities in Africa. I lead a team that actively creates partnerships with multiple stakeholders across Africa such as national regulatory agencies, hospitals, academia, and patients’ advocacy groups. Through these partnerships, we are building an ecosystem where we can perform ethical and inclusive clinical research.
Protecting the privacy and rights of study participants and staying compliant with regulatory requirements governing clinical research are important to us. Thus, I also lead the development of related processes and procedures following local and international regulatory guidelines, industry standards and global principles controlling the conduct of research in human subjects.
As the division I oversee is a revenue-generating business area, my other core responsibility is the development and execution of business development strategies to grow and sustain the division. I oversee the engagement of new partners and the acquisition of new deals. I also work closely with my team to define our business objectives, monitor metrics and mitigate or remediate risks associated with growing the business.
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How is 54gene improving treatment outcomes for Africans and the global population?
Globally, most genomics research performed to date has been done on non-African genomes, even though African populations have the most diverse genetic makeup of all populations. Less than 3% of genomic data represented in research is from African populations.
At 54gene, our mission is to deliver on the promise of precision medicine for Africans and the global population, by bridging the disparity gap in genomics data.
Unlike datasets obtained from other parts of the world, Africans are fully represented in the datasets we are building. Thus, Africans stand to benefit from the insights that we generate from our discoveries. We employ our three business units – drug discoveries, molecular diagnostics, and clinical trial programs to drive better health outcomes and close healthcare gaps.
Through our clinical trial programs, we address the inequality in medical products development by including patients currently underrepresented in clinical research used to validate medical products. We conduct ethical studies on the continent and can generate clinical evidence that is beneficial to Nigerians and the rest of Africa.
Experience and data have shown us that medicines known to be effective in high-income countries do not have similar effectiveness profiles in our context. We cannot expect medicines tested elsewhere to work just as well here. We can significantly improve healthcare in Africa by changing this narrative. One way is to conduct more inclusive research on these medications. This is just one of the ways 54gene is helping to improve treatment outcomes.
How important is clinical research to any country?
Clinical research is the process used to establish the safety and effectiveness of medical products (medicines, vaccines, diagnostic tests) before they are approved for commercialisation. It is a critical step in the development lifecycle of medical products and treatment regimens.
Clinical research contributes significantly to healthcare advancement by driving the development of new approaches to detect, diagnose, treat, and prevent diseases. Clinical trials provide proof on which medical products work and do not work in people in ways that cannot be achieved in the laboratory or in animal studies. Clinical trials also help doctors decide if the side effects of a new treatment are acceptable when weighed against the potential benefits.
In the context of Nigeria and other developing countries, where there is a shortage of healthcare resources, there is an increased need for reliable healthcare evidence generated through clinical research to guide decisions about the most efficient and cost-effective interventions.
Clinical research also offers collateral benefits, such as access to innovative medical therapies investments in infrastructure and resources, and overall better healthcare prospects for a country.
Does Africa have sufficient clinical research programmes?
Although there has been a recent rise in the number of clinical studies being conducted in Africa, only 2.5% of global clinical trials are conducted in Africa. This is an abysmal estimate since the continent represents 17.5% of the global population, accounts for 49% of total deaths from communicable diseases, and has a more rapid increase in the burden of non-communicable diseases compared to the rest of the world.
Of the few clinical studies that take place in Africa, the majority are conducted in South Africa and Egypt, creating a huge research gap in many other African countries. It is important that we move the needle on this issue to ensure that Africa does not continue to miss out on the advantages of clinical research. More trial activities on the continent will enhance research knowledge and experience, raise research standards, provide badly needed investments, and boost the healthcare sector. Essentially, hosting more studies in Africa can lead to improved health outcomes in the region.
The continent offers many opportunities to clinical studies sponsors. Africa has a diverse treatment-naive population and conducting studies in Africa can be relatively more cost-effective than in other parts of the world. Also worth mentioning is that several neglected and tropical diseases are prevalent and widespread in Africa. Running trials in those disease areas in Africa will lead to faster trial execution timelines and potentially, more rapid launches of the applicable medical products. More importantly, it is the responsible thing to do. Clinical trials on drugs that treat diseases should be conducted in areas most affected by the diseases.
How can Nigeria do better in clinical research programmes and what can you identify as the challenges?
Nigeria faces a host of challenges common in many developing countries that conduct research. They include Limited financial and human resources, and this leads to a constrained capacity to conduct research effectively. The shortage of skilled research staff is fuelled by the absence of research degree offerings in higher institutions and well-defined career structures within medical schools or biomedical research institutions. Some healthcare systems do not have dedicated research teams. The available competent researchers grapple with the competing demands of providing clinical care, which accounts for a huge proportion of their time and executing research.
There are some operational barriers as well. For example, unreliable power supply and the need for more logistics infrastructure for the transfer and storage of clinical samples.
I believe that many of these challenges can be addressed, and in fact, there are already many initiatives focused on improving clinical research capacity in the country. Some solutions include more collaboration between the private and public sector players as an engine for distributing research and development costs, and in turn maximizing benefits for the individual partners and the public at large.
I am also of the opinion that the Nigerian government should recognise the healthcare sector as an important source of GDP growth and appropriately prioritise investments in healthcare and research infrastructure. With the increasing burden of diseases in the country and Nigeria’s rapid population growth, healthcare demands will continue to rise. Investments in healthcare and research capacity in Nigeria will not only address healthcare needs, but they will also yield positive economic returns.
How are you investing in talent development to raise the next generation of leaders?
A fulfilling aspect of my career is investing in talent development to raise the next generation of leaders in the industry. In addition to coaching many mid-level managers across multiple organisations that I have worked in, I also volunteer with an international organisation, Reach Mentoring, as a career mentor for women in STEM. My commitment to support and empower direct reports, and to align their passion with assigned work continues to be important.
Words of advice
I often joke that some of the luckiest are people like Bill Gates, who knew what he wanted to do with his life at a young age and devoted his time and resources to growing in his field of choice. Many of us discover our passion and purpose after multiple trials and errors, then pray we have enough time left to make the most of what we believe we have been called to do.
My general advice to my mentees is to start to explore these questions early; what is my passion? What are my strengths? What is my why? Knowing the answers to these questions and acting on them as early as possible will provide a solid foundation for living a productive and meaningful life.
They will serve as the anchor one needs to stay afloat when life’s ocean becomes tumultuous. They will allow you to love what you do so you never feel like you are working.
Versions of these questions have been answered by powerful countries with strong economies, by global multinationals maximising their impacts and their returns, and by many of the inspiring individuals that many people admire.
For me, I am driven by a passion to address healthcare inequalities and to transform healthcare through clinical research, leveraging my strengths at the intersection of science, business, and leadership.
To the readers, I ask – do you have clear answers to the questions?
