Key drug development trends and predictions for 2024

Drug discovery technology

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year.

Financial landscape

In 2023, life science companies experienced a significant decrease in funding, particularly seed funding for early-stage drug development. This has been a real cause for concern for the industry, which is also facing growing competition in the investment market from big tech and AI.

However, despite these challenges, there are some positive developments; for instance, potential signs of improvement in the financial situation were flagged in late 2023 with AstraZeneca’s acquisition of cell therapy company Gracell for $1.2bn. This move indicates that, despite the financial downturn, there are still acquisitions and funding releases, particularly in the gene therapy space and for those developing promising small molecule or biologic products that are potentially transformative for patients and where a relatively short timeline to market is likely (e.g. antibody-drug conjugate [ADC] pipelines in some oncology settings).

We’re also seeing that the valuation of companies is dropping, opening the door for larger pharmaceutical companies to step in and make acquisitions.

Novel technologies

Despite the funding challenges of 2023, it was a landmark year for novel technologies, with the first ever CRISPR-based medicine approved by the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for the treatment of sickle cell disease, with the US Food and Drug Adminestration (FDA) and EU’s European Medicines Agency (EMA) following suit quickly in 2024.

There was a significant increase in cell and gene therapy product approvals by the FDA last year, and with the potential for up to 17 gene therapy approvals in the EU and US in 2024, the field is likely to continue to be at the forefront of drug development this year. Throughout 2023, oncology and rare disease indications consistently dominated the pipeline for advanced therapies, and this trend is expected to continue in 2024.

The transformative impact of gene therapy, particularly for paediatric and neurodegenerative conditions, cannot be overstated. However, challenges exist around making these therapies accessible and scalable globally, especially in less developed countries. The personalised nature of these treatments, coupled with logistical and cost barriers, pose significant challenges that drug developers will likely be tackling for decades to come. With this in mind, new small molecules and biologics will continue to dominate development pipelines across most therapeutic areas for the foreseeable future and, as such, the importance of advances in these areas should not be underestimated.

Artificial intelligence (AI)

The application of AI in drug discovery, imaging, toxicology studies and clinical protocols is revolutionising drug development. Whilst AI has clear benefits, it must be applied carefully and without compromising patient safety. A collaborative learning process between regulators and developers is required to build a pragmatic framework for AI’s use in drug development; 2023 saw the start of these efforts but it is expected to continue at pace in 2024.

Resurgence of antibody drug conjugates (ADCs)

There has been a recent resurgence of ADCs in drug development, informed by remaining unmet need, and fuelled by refined linker and payload technology and recent clinically validated targets. Exciting advancements, such as conjugating the antibody to another component such as an oligonucleotide, or cell, signify a departure from traditional methods of connecting chemical entities to antibodies and offer a whole new area for targeted treatments with improved efficacy and safety profiles. This renewed focus on ADCs is promising and serves as an excellent example of the industry’s focus on continuous innovation.

Looking to the future

There is light at the end of the tunnel for investment in the sector, and we hope to see growth in the second half of the year as funding increases and more companies receive (further) funding. The continued development of new medicines for patients remains critical, and with the right financial backing, the future holds promise for ground-breaking and innovative therapies that could transform patient care. There is a balance, however: fast-paced change often comes with a degree of regulatory risk. The recent efforts of regulators to support early and continued engagement with innovators during development via outreach exercises (such as the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot and the MHRA’s Innovative Licensing/Devices and Access Pathways (ILAP/IDAP) pilots) are very much welcomed.

Dr Julie WarnerAbout the author

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy Boyds and leads its regulatory team, supporting clients across the globe.

 

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