The last two years have shown the incredible potential of biotechs when their expertise is directed towards a specific problem, and the correct infrastructure is set up around them to deliver therapies to patients quickly.

BioNTech – the developers of the first mRNA COVID-19 vaccine – is a shining example of what is possible when clinical researchers, the pharmaceutical industry, regulators and health systems are aligned. The BioNtech/Pfizer vaccine was developed in less than a year, altering the vaccine manufacturing landscape and potentially setting the stage for a therapeutic revolution touching every phase of drug development.

It is often said that the life sciences sector has experienced a ‘halo’ effect because of its work during the pandemic. However, there is now arguably increased pressure and expectation from investors, health systems and patient groups that the latest scientific advances and genomic technology can deliver therapies in areas of high unmet need that are increasingly personalised to subgroups of patients.

The journey from discovery to product development, through clinical trials and regulatory approval, to commercialisation, can be improved, but this requires a new way of thinking from both regulators and the life sciences industry.

In the UK and the EU, initiatives are underway to accelerate the journey of therapies from discovery through to widespread use. The European Commission (EC) and the European Medicines Agency (EMA) are progressing the Accelerating Clinical Trials initiative, which will strengthen the European clinical trial environment and will facilitate more efficient studies that are easier to coordinate at scale, without compromising on safety. The UK-focused Medicines and Healthcare products Regulatory Agency (MHRA) is developing a similar set of proposals to improve the efficiency of clinical trials, as well as increase public and patient involvement.

Furthermore, we are seeing increased public funding and incentives at other stages of therapy development, from skills and training of the clinical workforce to grant opportunities for life sciences manufacturing projects.
  
Taken together, these add up to significant improvements. Policymakers can point to how they are enabling a more favourable environment for the life sciences industry to both operate and invest in.

As one would expect, industry is actively evaluating how we drive more efficiency across the full biotech journey. As we know from real-world case studies, end-to-end drug development planning is the most effective and efficient means to bring critical therapies to market.

For example, while biotech companies are pioneers in experimental medicine, the ‘discovery’ phase is only one part of investigational medicinal products (IMPs) journey to commercialisation. This journey is often fragmented by disjointed, overlapping and incomplete solutions that elongate the process. This is often confounded by a lack of integrated digital information systems that hinder the use of data in making better decisions. Therefore, adopting smart programme management techniques and partnerships to ensure that the entire pathway is managed professionally and efficiently is paramount. Finding true end-to-end, scalable solutions that leverage integrated digital ecosystems can be challenging, but worth the effort as they make a significant difference in accelerating productivity and innovation.

What biotech leadership, their investors and policymakers all want to achieve is the balance between facilitating an environment and culture that has the greatest chance of scientific breakthroughs and an organisation that has a strategy to take those breakthroughs through each milestone in the most efficient and coordinated way, right through to marketing authorisation.

It is the latter point that can be challenging for biotechs, moving from discovery through development and clinical trials to regulatory approval, commercialisation and manufacturing.

During a process that can take several years, a disjointed and piecemeal approach can be a significant drain on resources and time. This is commonplace if an organisation must repeatedly go to market to procure specialist third parties to undertake different stages of the therapy development process. For example, in the pre-clinical phase biotechs require scientific support and clinical development planning, as well as regulatory and licensing guidance – these are all distinct and specialist skill sets that can be a challenge for biotech to source and partner with at the optimal time. The requirement for a wide range of expertise and scalability continues at each stage of the development process through to commercial launch.

IMP development is, by nature, characterised by evaluation points and thresholds that need to be met which, when combined with a high possibility that a project will not progress, makes it difficult for biotechs to see the benefit in investing in an enterprise or full workflow project management approach at the earliest stage.

However, there is significant value in doing so and many stakeholder groups have an interest in supporting biotechs to get their processes right. Ultimately it accelerates the decision on whether a therapy can progress or not, reduces cost for investors and can speed the timeline to get treatments to patients.
  
A more effective way of operating is for biotechs that are working on a promising new therapy to plan the overall journey of the product development at the earliest stage. Partnering with a company that can provide this level of expertise, scalability, digital ecosystem and flexibility can reduce the volatility and risk of the plan.

It is important to review the distinct stages of therapy development and to reiterate how a coordinated approach with a single trusted partner, such as Thermo Fisher Scientific, delivers value.

In the multi-stage drug development process, connections and integrated practice really matter. Clinical researchers and their backers want to be assured of several essential elements. First, that the infrastructure and equipment that supports their discovery research in the laboratory is appropriate and of high quality and value: everything from consumables, reagents and lab equipment to the digital analytical instrumentation that captures and interprets data.

Second, that there is a plan for moving promising IMPs from the laboratory to the clinic and that they can be accelerated through clinical trial regulation and scaled up as required. It is critical to involve a licensing team as early as possible during the development phase to help ensure a smooth path to commercialisation.

Clinical trials can be a drawn-out process – this is the phase when the risk of disruption and delay is most acute for biotechs. Improved coordination and control over trial development using the in-house scientific, regulatory and operational expertise of one partner means reaching endpoints faster – from pre-clinical to commercial launch.

Finally, it is important to have the commercial end goal in mind at the planning stage. Preparation is required to ensure that approved therapies can be manufactured and distributed at scale and can cope with fluctuating demand, so the product reaches customers and patients in a timely manner. It is also important that there is consistency, reliability and traceability.

Apple Founder, Steve Jobs, once said that the biggest innovations of the 21st century would come ‘at the intersection of biology and technology’. The pandemic has shown that rapid advances in applied science, delivery systems and manufacturing capabilities have enabled global vaccination to become a reality.

The potential is there for similar breakthroughs across a host of other pathogens and conditions using biologics and novel therapies. It is important that all stakeholders including industry, governments and regulators continue to both design an environment that helps to stimulate success and for researchers and developers to ask the right questions about the drug development journey, seeking the right partner to ensure that they can progress in the fastest and most efficient way, without compromising safety and quality.