Expert’s Insights: Top Regulatory Trends in 2023 You Need to Know!

With Daniela Drago

The Life Sciences industry as a whole is very fast-paced; that isn’t more true than in the Regulatory space. With changes happening quickly, we met with one of the brightest regulatory minds to find out their opinions on the Top Regulatory Trends in 2023.

So who did we speak to?

None other than Regulatory Affairs expert, BioPharma Executive, and ex-Aurion CRO, Daniela Drago!

Daniela’s 20 years’ international experience in various businesses across Biotech and Pharmaceutical, alongside academic institutions and consulting organisations, has given her expertly honed insights.

Daniela Drago’s three top regulatory trends for 2023 are:

1. Advancing Digital Health
2. Expanding and Democratising Gene Therapies
3. Addressing the Regulatory Talent Shortage

Advancing Digital Health

Digital Health is responsible for revolutionising and modernising healthcare, from remote patient monitoring to data collection, sharing and analysis. The advancement of digital health is one of the most significant regulatory trends in 2023.

Continued developments in digital health can have some incredible potential outcomes. For example, reducing inefficiencies and costs within the development of specific products, or increasing patient access and flexibility of care.

But technological innovation must go hand-in-hand with regulatory approaches. Regulatory frameworks amplify the benefits of emerging technologies, while also guaranteeing safety and caution.

Daniela is encouraged by policymakers already defining standards and best practices, but anticipates this to increase in the coming years.

Expanding and Democratising Gene Therapies

Top of mind for many biopharma executives is the efficient development and commercialisation of innovative products; gene therapies are a prime example.

2022 was a record year for the approval of new gene therapies, but 2023 is set to bring this record even higher. In 2022, the FDA approved three rare disease therapies and one bladder cancer therapy. A further five therapies which had already been approved gained new jurisdictions or indications.

Meanwhile, it’s expected that by the end of 2023, 13 new gene or cell therapies could be approved in Europe and the US. This suggests we’re on the cusp of a Gene Therapy boom, which would be game-changing for the Regulatory Affairs space in 2023.

Regulatory bodies across Europe, the US, and other territories are working on modernising their processes to keep up with the increasing pace of these scientific developments. Of course, there are still barriers to patient access — especially in Low and Middle-Income countries.

However this regulatory trend progresses, it’ll be exciting to watch it unfold.

A Regulatory Talent Shortage

Perhaps the most significant regulatory trend currently happening is a talent shortage. Of course, this shortage isn’t just limited to Regulatory Affairs; it’s affecting the Life Sciences as a whole.

Known as the Talent Crunch, there is a worldwide shortage of qualified people across all industries. This is due to a combination of factors (lower birth rates, self-employment, etc.) but culminates in the fact that there aren’t enough people to fill the open roles. Experts anticipate the worldwide deficit to reach 85 million by 2030.

The Life Sciences industry has recently experienced significant growth, especially during the pandemic. While this growth is generally a positive, it does mean an enhanced need for new talent in the industry — something that has only worsened the impact of the Life Sciences Talent Crunch.

In other words, Regulatory expertise is in short supply and high demand. Qualified talent is becoming hard to find, and harder to acquire.

With that in mind, hiring practices must evolve if companies want to stay relevant and bring top talent on board. Listening to the needs of your potential candidates can help dramatically here; for instance, offering flexible or remote working can help secure a key new member for your team.

Daniela states, “One of the biggest barriers is that the regulatory profession suffers from an image problem”. She recounts a former colleague comparing how neither medicine nor regulatory are particularly ‘sexy’ jobs, but medicine looks good on TV. In turn, this contributes to more people entering the medical workspace.

The regulatory space needs to overcome its by-the-book perception, which should help alleviate parts of the current talent shortage.

Daniela’s Advice to Find Life Sciences Success

Through her own experiences, Daniela has learned the value of challenging and intimidating work, first-hand. For instance, her PhD position at ETH in Zurich, Switzerland was initially terrifying. Daniela had never lived in a foreign country before, didn’t speak the language, and was one of 22 female students in a class of 100.

3.5 years later, Daniela graduated with a PhD in Chemistry. Her biggest takeaways were how rewarding and fulfilling her PhD was, which led her to realise the importance of taking risks and going after opportunities that might scare you.

When people look back on their lives, it’s far more common to regret the things they didn’t do, rather than the mistakes they made. Daniela’s advice stems from this realisation; “take risks and do the things that scare you, because they will pay off in the end”.

Success rarely follows a straight path, and achieving success without taking risks is impossible. Daniela wishes she’d realised sooner that her most intensive challenges were what brought her the highest opportunities. After all, it’s easy to stay in your comfort zone, but extraordinary things don’t come from playing it safe.

Daniela followed with some advice for her younger self:

“There will be ups and downs, good days and challenging ones. Try to enjoy the journey and not only the destination. Working in the Life Sciences is not for the faint of heart, and I want you to come into this field knowing it’s all worth it – because it really is.”

Want first-hand information about the latest Regulatory Trends? Make sure you follow Daniela Drago on LinkedIn.