What trends do we expect to see in the Life Sciences sector for 2022? We’ve had a look into our Life Science crystal ball and picked out some of the trends to consider for the year ahead:
1. Decentralised clinical trials
Applying the learnings from the COVID-19 pandemic will be a key driver for many trends in 2022, and its influence is clear in the increased popularity and use of ‘decentralised’ clinical trials. Decentralisation in the context of clinical trials means conducting clinical trials, or, more commonly, part of them, away from a central trial site – either in a patient’s home or another satellite location. This decentralisation is enabled by various technological advancements, such as improved digital health technology and telemedicine (the use of video chat to diagnose and treat illness). Paired with these advancements is patients’ growing familiarity with health tracking devices, driven by the increased popularity of consumer health devices such as smart watches, and the ubiquity of video chat as a tool to work with your colleagues, socialise with friends, and even speak to your doctor.
There remain limitations on the trials that can be conducted remotely and it is likely that in the near-term use cases will be limited to trials with a low possibility of adverse events and outcomes that are easy to measure remotely. However, clinical trial sponsors, emboldened by the use of remote trial techniques during the pandemic, are likely to seek to implement more remote elements in a trial, particularly where such remote elements reduce cost, are more convenient for the patient, or allow for more diverse recruitment. The final benefit may become increasingly important with the UK Government announcing a review into bias in medical devices in November 2021.
Decentralising clinical trials does not come without risks, especially with regards to monitoring and data quality. Clinical trial sponsors and regulators will need confidence that the technology being used is reliable, particularly in a setting where the patient isn’t being watched. Regulators will also want to ensure that decentralised trials retain the same safety standards as those conducted at a central site. Both the EMA and the FDA allowed for decentralised techniques to be used in their respective guidance on the conduct of clinical trials during the COVID-19 pandemic, and it will be interesting to see whether this materialises in broader guidance on decentralisation.
2. mRNA technology
The Pfizer/BioNTech and Moderna COVID-19 vaccines have fired mRNA technology into the public consciousness, and, as detailed in our recent series ‘Spotlight on mRNA’ mRNA technology, has uses far beyond COVID-19. Described as a platform technology, synthetic mRNA can be used to produce proteins and antigens with relative ease once the genetic sequence of such molecules has been discovered.
The potential for an mRNA platform to be used to code for various molecules means the technology has many use cases. The most obvious of these is building on the work done in relation to COVID-19 and applying it to other infectious diseases, such as influenza, cytomegalovirus (CMV), zika virus, respiratory syncytial virus (RSV), Epstein-Barr virus (EBV), rabies, yellow fever, rotavirus and malaria. There are other use cases beyond infectious diseases, including protein replacement therapy for some genetic diseases, cancer immunotherapy and regenerative therapeutics.
The broad potential for the technology and its proven use in the COVID-19 vaccination effort has unsurprisingly led to a great deal of interest and investment in mRNA technology from many pharmaceutical companies. Hopefully this interest and investment leads to effective treatments being developed in 2022.
3. Cell and gene therapies
The mood regarding cell and gene therapies (CGT) at the 2021 Genesis Life Sciences conference was positive (for details regarding deal trends discussed at Genesis, see our blog post here), with some predicting that around 50% of new drugs on the market within the next five years would be CGT. This shows a belief that CGT can extend beyond the orphan diseases with which it has traditionally been associated. Whether this prediction becomes a reality will depend on the industry developing methods of addressing the well-documented hurdles to the commercialisation of CGT, including high upfront costs and manufacturing constraints.
The UK BioIndustry Association took a positive step to address the high upfront cost of CGT by encouraging the use of innovative payment models in this November 2021 press release. Pharmaceutical companies offering CGT have shown a willingness to adopt such models, including outcome-based models where some of the risk of the treatment not working is taken by the pharmaceutical company as opposed to the payer. For further information on the challenges connected to alternative payment models and related issues in licensing agreements, see our Lexology article here.
It is a predictable answer, but investment is most likely key to improving the manufacturing constraints of a lack of capacity and expertise to manufacture CGT. The reproducibility of the process of manufacture is likely to be a key consideration in the development of CGT going forward, and techniques to bring the lab work closer to the patient, such as a ‘homebrew’ CAR-T therapy recently developed in Spain (see the following article), show an innovative approach to addressing the logistical difficulties with CGT manufacture. It is also hoped that the move to allogeneic therapies over time will help reduce the costs of CGT and potentially overcome some of the other issues currently facing autologous treatments – although undoubtedly allogeneic therapies have some challenges of their own, including the risk of graft-versus-host disease and rapid rejection by the patient’s immune system which is forming a focus area for vital research.
4. Artificial Intelligence and personalised medicine
Over the last few years pharmaceutical companies have made no secret of their desire to harness AI in drug discovery and development. Collaborations between big pharma and AI specialists are common, such as the 2019 drug discovery collaborations between AstraZeneca and BenevolentAI, who recently announced that they were extending their partnership and doubling the number of indications being considered.
Other models are also being adopted, with AI companies developing their own drug development pipelines, as well as pharmaceutical companies increasing their own AI expertise. Big tech is also aiming to join in this convergence of AI with life sciences, with Alphabet Inc. establishing Isomorphic Labs in 2021 with the aim of approaching drug discovery with an ‘AI-first approach’.
Technology companies are used to tailoring everything we hear and see to our characteristics, so now that the big tech gatekeepers to the rich sources of data contained in the devices on our wrists and in our pockets are increasingly involved in the life sciences space, AI’s potential to create increasingly personalised medicine could be realised.
5. UK National Security and Investment Act
The National Security and Investment Act came into force in the UK on 4 January 2022. It introduced a mandatory prior notification regime for acquisitions in certain sensitive sectors, as well as powers for the Government to ‘call-in’ certain transactions that give rise to national security concerns. The sensitive sectors covered by the Act include Synthetic Biology and Artificial Intelligence (examples of both of which are discussed above), as well as Advanced Robotics, which are of relevance to the life sciences sector and areas that are growing at rapid pace. According to some, the global Synthetic Biology market alone is expected to roughly triple within the next five years.
Notably the ‘call-in’ powers in the Act can be exercised in relation to licensing and collaboration deals up to five years after their conclusion, although the Government is subject to a six-month limit to call-in from its awareness of certain trigger events. If the call-in powers are used, then the Government would have the power to block or unwind the transaction, although it is likely to only resort to such measures where softer measures, such as restricting access to certain sensitive material, would not remedy the national security concern. The mandatory notification powers only apply to the acquisition of shares, so will not apply to the majority of licensing and collaboration deals. The fines for failing to make a notification are hefty – they are capped at the greater of 5% of annual global turnover or £10 million.
The residual risk of a deal being called-in will clearly be of concern to life sciences companies. However, similar regimes have been implemented in other jurisdictions, such as the CFIUS regime in the US, without a chilling effect on the sector. The Government has suggested it will exercise restraint in the use of its new powers under the Act; it will be interesting to see if this is the case.