As we reach the end of the year and look back on the last 12 months, it’s fair to say 2022 has been transformative in the drug development space. Quintessentially, industry leaders continued to think outside the box and challenge the status quo to keep clinical studies moving forward – an indication that 2023 will be a period of significant change and incredible opportunity…

If you work within Life Sciences, you don’t need me to tell you about the increasing costs of drug development or the growing demand for innovative treatments. Nevertheless, strategies must be altered in order to make processes more efficient and cost-effective. 

It’s no secret that since the COVID-19 pandemic, drug developers have experienced countless disruptions in the clinical trial process. In fact, did you know that throughout 2022, the FDA approved a total of 26 treatments? That’s remarkably fewer than 2020 and 2021, which yielded 53 and 50 approvals, respectively. 

But, in an industry that’s synonymous with innovation, we’ve grown to learn that nothing will hold Life Sciences back. Instead, new strategies and technologies have offered drug developers the opportunity to shift their approach and defeat these challenges, with 89% of biotech businesses altering their drug development strategy to focus on new priorities and collaborative processes, reports PPD (Thermo Fisher Scientific’s clinical research business). 

By using initiative and optimising the drug development process, drug developers can better evaluate potential therapies, identify the most promising candidates, and develop drugs faster and more cost-efficiently.

So, as we wind up the year, let’s look at five growing trends that we believe are only going to pick up more steam in the next 12 months… 

1.     Real-World Data Insights Will Refine Clinical Research

One major trend expected to influence the drug development space is advancements in data collection, with many pharma and biotech organisations following the FDA’s lead in relying on real-world data (RWD) and real-world evidence (RWE) in clinical trials. 

In fact, 45% of pharma and biotech businesses across North America, Europe, and Asia-Pacific believe a bigger and better use of RWD and RWE will be auspicious in clinical research. Plus, another 59% report that they’re increasingly using RWD and RWE in their drug development programs.

That’s because, due to the rise of this trend and developments in data science, more and more developers are now able to use RWD and RWE to their full potential. If we look at the last year, throughout 2022, the number of Phase IV clinical trials that leveraged RWD was more than double that in 2020.

So, as we look beyond and into 2023, that figure will surely only increase as the collection and assessment of RWD continues to grow. But that’s not all…

The use of data related to direct and target monitoring and site/trial risk will also help shape monitoring models so that studies can more swiftly and smartly adjust to new risks and critical findings. Plus, adaptive clinical trial designs allow for a new level of flexibility in study processes by laying the groundwork for specified, data-driven changes at interim points throughout trial phases. 

This means that in 2023, we should expect trials to become even more efficient, ethical, informative, and cost-effective. That’s because they’ll make better use of resources such as time and capital and might even require fewer participants. In fact, PPD report that 64% of organisations are already implementing adaptive trial designs in their studies to streamline their processes and increase scientific precision. 

 
2.     There’ll Be More Use For mRNA Technology

You don’t have to be a part of the Life Sciences industry to be familiar with the letters “mRNA”. That’s because a large proportion of us in the Western world have been jabbed by an mRNA COVID-19 vaccine. 

Behind the scenes, since mRNA COVID-19 vaccines were approved, the technology has shown great promise for preventing and treating a wide range of illnesses like respiratory diseases, cancer, HIV, and metabolic disease. And, with ongoing R&D, drug developers are backing mRNA as one of the greatest opportunity areas in clinical research! 

In fact, just last week (Dec 14th), Moderna and Merck announced their positive Phase II data for a personalised mRNA cancer vaccine aimed to treat patients with stage III/IV melanoma. The trials found that by combining Merck’s cancer immunotherapy, Keytruda, with Moderna’s mRNA technology, risk of death or disease progression was reduced by 44%, which implies that Phase III will begin in 2023 if results are approved by regulatory authorities (fingers crossed!). 

But it’s not only Moderna and Merck who are expanding their efforts to mRNA technology… Since the success of COVID-19 vaccines, more and more collaborations are happening throughout the Life Sciences industry to bring the technology to its full potential. 

Thermo Fisher Scientific, who was working with mRNA vaccines long before the pandemic, has also announced a 15-year strategic collaboration with Moderna. Together, their goal is to expand manufacturing capacity and applications of mRNA technology. 

For this exciting and promising research area, the proof of the pudding is in the eating, and we can only expect more pharma and biotechs to look into developing mRNA-based therapies. That’s because, if we look at the effects of COVID and its vaccines throughout the world, Western society has pretty much returned to normal, with the threat of the virus being neutralised for the last year – I mean, just look at events like the World Cup in Qatar!

Sadly, the story isn’t the same for those in the East. So, why is there such a difference between the East and the West? 

Ultimately, it comes down to the fact that the Chinese-made vaccine is much less effective than mRNA shots that are widely available elsewhere. This only draws one conclusion: COVID is not the end for mRNA; it is, in fact, just the beginning. 

 
3.     Decentralised Clinical Trials Will Level Up

If you keep up to date with Life Sciences, you’ll know that the COVID-19 pandemic catapulted decentralised clinical trials (DCT) into the limelight as they became critical in continuing the work of many pharma and biotech businesses throughout national lockdowns. 

Since then, 55% of companies have admitted to suffering from challenges with recruiting patients for clinical trials. DCTs offer a potential remedy as they mean organisations can engage with a broader and more diverse patient population outside of a centralised location. 

In a report conducted by PPD, the clinical research business found that those yet to utilise DCTs predict that over a quarter (27%) of their trials will be decentralised by 2024. What’s more, those already making use of DCTs expect that another 24% of their trials will become decentralised by 2024 too. 

With this many Life Sciences companies forecasting an uptick in DCTs only proves that it’s a reliable way to conduct trials. Because of this, we can expect fresher tools and new infrastructure to support these types of trials to soon come to fruition. 

Overall, the Life Sciences industry expects these digital-based strategies to prioritise speed, deep regulatory expertise, and a technology-agonistic approach to improve patient experience, engagement, and retention. In turn, this should improve the overall results of clinical trials.

4.     Going Digital Will Open New Doors

As you’ll likely know, the rise of technology has meant that many processes throughout drug development cycles have, and continue to, become ever more digitalised. Just think about it… Over the last few years, we’ve already seen a wealth of Life Sciences businesses enthusiastically adopt new tech to conquer challenges within their trial efficacy.

So, as we see more DCTs, hybrid and adaptive trials become increasingly popular within the clinical trial sphere, we can anticipate that alongside cloud computing, AI, and APIs, new-fangled digital tools and platforms will arise to ensure compliance with Life Sciences’ strict regulations as well as accelerating necessary process changes. 

Of course, as mentioned, digitalisation can improve specificities within clinical trials, but it also holds promise to help overcome patient recruitment and retention challenges too. That’s because, through the use of technology, organisations are able to reach previously untapped patient populations and improve the overall patient experience. 

But they’re not the only ways technology will change the drug development game... 

Nowadays, since COVID-era trials introduced electronic outcome assessment (eCOA) tools, more and more clinical trials are requesting participants bring and use their own devices rather than providing study-issued ones. 

Doing so has lowered costs for organisations and encouraged participants to better comply with study protocols. That’s because regular reminders and data collection are thread through devices already interlaced into participants’ day-to-day lives. 

As this component of trials becomes increasingly more popular, we can expect an increase in the advancements of apps and wearable devices to correspond with these practices. 

5.     Collaborations With CROs Will Skyrocket

Drug developers are no strangers to decelerated timelines, increasing trial complexities, and struggles with recruiting and retaining staff and patients. For this reason, an increasing number of organisations are outsourcing a proportion of their clinical trial activities, with 47% of companies surveyed by PPD saying they’re likely to delegate some of their clinical trial activities to a CRO. 

The goal of doing so lies in the fact that each drug developer requires varying experience, priorities, and capabilities to complete their work. Oftentimes, this expertise takes time to come by. Outsourcing certain R&D activities to CROs allows pharmas and biotechs to save time and money, reduce risk, and access specialised proficiencies and resources that might not otherwise be available. 

Big names such as AstraZeneca have long been a fan of CROs, partnering with several academic institutions, such as the University of Cambridge to focus on drug development and the University of Texas MD Anderson Cancer Center to develop immunotherapy.

Like us, you’ll probably recognise that CROs have always been of great value to the Life Sciences industry, but it seems that only now are they receiving the full acknowledgement and appreciation they deserve. 

In fact, a study by the University of Cambridge reports that pharmaceutical companies are progressively steering away from one-time transactions with CROs and instead leveraging multi-year strategic partnerships. Doing so means that CROs become partners working to achieve a shared objective rather than acting as service providers to a larger organisation. 

And yep, you guessed it; it’s a win-win for all involved! That’s because by utilising strategic CRO partnerships, pharma and biotech businesses can expect their drugs to reach the market in a shorter timeframe, which can typically take an agonising 10-15 years and over $2.5 billion!

If you’re developing life-changing treatments and need an added boost of innovation and expertise, reach out to us! One of our expert consultants can help you find your missing link in advancing your drug developments to the next stage!