As we reach the end of the year and look back on the last 12 months, it’s fair to say...
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…
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.
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.
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.
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.
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!
