In 2020, the value of the global regulatory affairs outsourcing market size was 6.3 billion, with an expected compound annual growth rate (CAGR) of nearly 12% from the period between 2021 to 2028. Regulatory management has become an increasingly important service, with global market expansion and faster drug approvals enhancing the need.

The pharmacovigilance market is also set to increase at an expected 11.5% CAGR for the period between 2021 to 2028. The increasing demand for oncology, cardiovascular disease, diabetes and infectious diseases like COVID-19 continue to support the growth of this sector.

Our Global Head, Regulatory and PV, Mr. Marty Boom, takes us through the exciting trends in the regulatory affairs and pharmacovigilance sectors in an informal tete-a-tete.

What are the factors that led you to the regulatory and pharmacovigilance sector?

I have a background in manufacturing automation and my first job was in a pharma company, associated with sterile manufacturing of flu vaccines. I was fascinated by the effect of the pharma industry on improving health.

In 1997, I got into consulting, and we used the tools, technologies and methodologies (e.g. cellular manufacturing) from manufacturing in an office environment, which happened to be a drug safety department. So, it was interesting to see how manufacturing technologies could be used in an office environment. I love working on processes and making them efficient.

How did the the evolving regulatory eco-system during COVID-19 lockdowns impact the industry?

During Covid-19, the focus of regulatory bodies to safeguard and promote public health has remained the same, with regulatory decisions continuing to be based on scientific and evidence-based risk assessment. The pandemic, however, prompted regulatory agencies to announce accelerated COVID-19 research proposal reviews, insisting on consistencies with public health mandates. Regulatory agencies also issued guidance documents for COVID-19, with expediated review and process of approval. Consequently, some aspects of the overall eco-system which were in the making got accelerated by COVID-19.

These actions of the Regulators created impressions in the public minds that the entire drug approval process had become more lenient whereas in reality, all the Regulators did was prioritize COVID-19 responses over other decisions. The rules were still being applied which for example showed when some of the manufacturing processes needed to be changed to increase the supply. Following the rules led to interruptions in the supply which led to public apprehensions and anxiety about the availability of vaccines.

Navitas and our clients responded in a similar way as the regulators: priority 1, 2 …99 is COVID-19 related activity. The evolving eco-system didn´t impact this much besides easing/facilitating some of the processes, submissions.

How did the COVID-19 lockdowns affect regular operations? Were you prepared for it?

It affected us like it did everyone else in the world, sitting at home 24/7 and not being able to go out. From the services perspective, everything went amazingly well. We were well prepared and had started rehearsing for a lockdown scenario one month before the lockdown actually kicked in. During the rehearsals, we sent people home for a week; half the shift stayed at home and half the shift worked from office. We figured out how we needed to work, which helped in making sure that none of the services were affected. We received a lot of credit from our clients for our work during COVID-19.

How is AI currently being used in regulatory and PV?

AI is not yet sufficiently used in regulatory and safety sectors. The opportunities are there but applying AI or any other of the new technologies requires high investments, data volume but also changes in regulations and for example validation processes. The industry is working hard on getting a grip on the different factors with more clarity coming through all the time. I think we will see a rapid acceleration in the use of new technologies in 2021.

What are Navitas Life Sciences' key competitive advantages in the regulatory and PV space?

We have the strength of combining technology, services, consulting and networks (NETS), all in one group. There are not too many companies that can do that. On the clinical side, we use artificial intelligence and digital tools to enhance clinical trials, while our proprietary industry networks provide state of the art industry insights. Our ability to combine our various capabilities to give the best to the client is what holds us apart from the rest.

What are our accomplishments in the regulatory sector?

There are many significant steps that we have taken recently. An important recent milestone for us was when we provided additional capacity and capabilities in regulatory to a global pharma and took over a high volume of non-COVID regulatory support, so that the client could focus on successfully getting their COVID-19 vaccines to market.

Our years of experience and expertise helped us in seamlessly supporting the regulatory needs of the global pharma, leveraging our ability to rapidly mobilize our resources. The regulatory experts at Navitas Life Sciences assess the changing regulatory landscape, taking a holistic approach to regulatory management for enhancement of public health. To address the complexities that exist, we draw on successful strategies, and industry insights obtained through our networks to provide customized solutions for our clients.

How is Navitas Life Sciences positioned in the global regulatory affairs and pharmacovigilance market?

From the regulatory aspect, we are well established in the areas of technology, networks, consulting, services. We are highly respected. We are a brand and are sought after for our capabilities.

For safety services, our clinical safety services are well established, and we have been providing the service for many years. Post marketing safety started 2 years ago, but we have achieved massive growth since then. We are perceived as relatively new in this sector, but we are a global brand that clients easily recognize and want to associate with.

What are the regulatory and pharmacovigilance trends to look out for in 2021?

There will be a lot of additional work in terms of safety reporting for COVID vaccines, such a mass vaccination drive has never been carried out before. The adverse events reports will be higher, considering the number of people who will be vaccinated. There is a need for a lot of resources to gather the required safety data. This year’s primary focus will be associated with this global drive.

There will be continued innovation in terms of technology. The coming years could see most of the data residing in a common cloud that can be easily exchanged with regulatory agencies. Utilizing a cloud-based solution for regulatory submissions may help in augmenting regulatory clearance, as a more dynamic and fluid approach is used. For example, during COVID-19, research proposals were reviewed in 7 days, as against 30 days by regulatory agencies. Data present in a cloud-based system, may help increase the speed of reviews.

Further enhancement in regulatory services could occur if cloud-based systems could support large data set submissions, while also facilitating simultaneous global regulatory reviews instead of country by country. This may help get information in near real time.

COVID-19 has also shown that 100% work from office and 100% work from home is not the right way to go. It has to be a good balance of both, ensuring efficient use of time and resources. So, in that sense, remote audits may be the norm this year. Remote audits leverage digital tools to obtain audit evidence that are then used for evaluations.

The digital tools that are used for remote working have evolved over the year, with the people who use such technology also evolving with these tools. There is greater acceptance of such technology and increased use.

What has been your most satisfying moment when working in this field?

There is immense satisfaction in watching teams come together and deliver remarkable results. When our drug safety team began working, they faced tough client requirements and a steep learning curve. The team pulled together, analyzed their strengths and weaknesses, improved processes, training programs etc. and in a short time we started performing as a top tier safety services provider. The client recognitions that we got for this makes it all worthwhile.

How is Navitas nurturing talent to maintain quality in regulatory affairs and pharmacovigilance?

We recruit people talented people and we consciously nurture their growth. We identify their unique talents, some people may be good at communicating with clients or managing relationships, while some others may be good at processing data. It doesn’t matter what the talent is, but their talent has a place in our team. Understanding the talent that each of us has helps in positioning people in the right units, honing their skills and it helps them stay motivated as a member of a team to which their individual talent adds value and where they get appreciated for the talent that they bring.

We provide new challenges, place young recruits in projects that include working with seniors, and constantly encourage them to try new avenues. We keep our communication channels open at all time, encouraging new recruits to reach out when they need support. We are a people’s business and we know our people really well.

What is your advice for young minds looking for a career in this industry?

When working with young people, I have always focused on talent and the person. To me aspects like gender, race, age or global location are hardly of interest. In practice though, I see many young people feel constrained by for example culture or gender. This is a real pity as this could trigger a waste of talent. If you have good, positive ideas and you are convinced about these ideas, then you shouldn’t let yourself be constraint by whatever (perceived) rule.