Building the requisite clinical development infrastructure for medical innovation to thrive

Millions of people around the world each year face serious illness, with the promise of groundbreaking treatment being just out of reach. They wait for the therapies that could significantly improve their quality of life – or even save it – knowing approval could be years or decades away.

In an era where science and technology are surpassing what was ever thought possible, the need for the biotech industry to adapt, respond and evolve as quickly and cost efficiently as possible is more urgent than ever. Innovations like gene therapies are providing hope for diseases that previously had no treatment options, while precision medicine such as cell therapy personalises treatments to fit each patient’s signature biological characteristics. Yet despite this incredible potential, we often find ourselves hindered by the slow, outdated processes that prevent these advancements from reaching patients in time.

The COVID-19 pandemic highlighted these issues on a global scale. It forced the healthcare industry to rethink its limitations and embrace change. We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. And yet, despite this learning, traditional clinical development processes have failed to evolve; they still have high asset failure rates, longer development timelines, and significant costs. We are at a pivotal moment where we must consider how to improve these systems and ways of working to ensure critical therapies reach those who need them most.

While another pandemic has not reached our doorstep – at least not yet – our sense of urgency and creativity should be the fuel for reimagining clinical development processes. Those of us in drug development face not only scientific hurdles, but uncertainties at the federal level; a new Presidential administration and new leaders at the helm of US Department of Health and Human Services (HHS), US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) mean shifting regulatory environments, shifting priorities, and tenuous funding circumstances that can change overnight. No longer can we rely on outdated methodologies that stifle potential. Converting these challenges into opportunities, we must embrace new clinical development strategies that promote agility, efficiency and effectiveness.

In adopting the scientific method – experimenting with new options until you achieve your goal – those who make decisions about the people, processes and technologies that constitute our clinical development infrastructure must be willing to change up the variables, to yield better outcomes that translate into progress. Without this mindset, medical innovation will be delayed and costly.

The staggering average cost of bringing a drug to market (more than $1 billion) is accompanied by a dismal success rate of just five to seven percent.

Taking big risks with little reward

Current drug development frameworks are burdened with inefficiencies and high failure rates. Biotech companies continue to invest significant time and capital into rigid, linear processes that often yield disappointing results.

The staggering average cost of bringing a drug to market (more than $1 billion) is accompanied by a dismal success rate of just five to seven percent.¹ These numbers explain why so many promising biotech firms close their doors each year. Often, these companies shutter not only because of flaws in the underlying science, but because of outdated operational methods that cannot keep pace with today’s complex drug development landscape.

One of the biggest contributors to these unsustainable costs is companies building extensive in-house infrastructures based on antiquated assumptions about drug development. Many biotechs pour resources into assembling full teams and facilities, only to face setbacks that stall progress. When these trials fail, the repercussions can be devastating, leading to layoffs and a significant loss of morale among remaining team members. It is crucial to recognise that people are not just assets; they are integral to the success of any venture and should be valued as such, fostering a culture that prioritises their wellbeing and professional growth. This cycle of investment without assured outcomes raises the pressing question: How do we create a more effective framework for drug development?

The need for a paradigm shift – from ‘All In’ to ‘On Demand’

Adopting a modular, customisable, ‘on-demand’ approach to clinical development allows biotech companies to streamline operations, mitigate risks and improve their chances of success in a fluctuating market.

One industry where the on-demand model has played out on a large scale is rideshare services. The rideshare model illustrates how to offer efficient, on-demand services without the user incurring unnecessary overhead and fixed costs. In urban areas, for example, owning a car is often burdensome – encompassing expenses such as insurance, maintenance and parking. Rideshare users face none of these costs and get only what they need, at the right moment. The biotech industry can adopt similar principles, focusing on streamlined, purpose-driven infrastructure and modular clinical development methods that minimise recurring fixed expenses, ultimately enhancing agility and reducing financial burdens.

Rather than bearing the task of building extensive in-house infrastructures, biotech companies have the option of seeking out knowledgeable experts and specialised resources at the precise moment in the drug development process that they’re needed. This ‘task to talent’ approach can be likened to a superhighway – the solid, interconnected infrastructure needed to get the medical innovation industry successfully and efficiently from point A to point B.

There are several actions biotech companies can take today to bring this mindset to life in their organisations:

• Adopt a lean infrastructure – Instead of committing to the extensive fixed costs associated with hiring a full team, biotechs can remain agile by accessing people, processes and technology only at the moments and stages they are needed. This adaptability minimises risk, reduces potential losses if an asset does not succeed in the clinic, and empowers companies to respond dynamically to emerging data and evolving market needs.
• Evolve from data generation to actionable knowledge application – Taking action based on the knowledge our data provides is paramount in modern drug development, especially with so many fragmented databases and source systems with pre-clinical, clinical development, manufacturing and commercial functions. By investing in streamlined systems that create a ‘single version of truth’ for aggregating, managing and analysing data, biotech firms can ensure compliance with regulatory requirements, increase efficiency, and potentially reduce overall clinical development time. Advanced data management tools should be cross-functionally integrated at the outset.
• Learn from failures and foster collaboration – Encouraging collaboration and sharing the knowledge that comes from experience (both from failures and successes) among diverse stakeholders – including researchers, operations teams, regulatory experts and others – creates an open-minded environment in which best practices can be shared for the benefit of the business and the patients.

The shared knowledge that results from this methodology can be invaluable for biotech companies, particularly early-stage organisations with limited internal resources. This profound shift in how we approach clinical development is paving the way for cost-efficient, rapid advancement of life-saving therapeutics.

As we travel the superhighway towards the next major advancements in medical innovation, it is important that all stakeholders recognise this as a road we travel together. The African word ‘ubuntu,’ which translates to ‘I am because we are,’ serves as an important reminder that our interconnectedness and our shared experiences, successes and learnings are crucial in reaching the future we’re all striving for.

References:

1. Masson G. The 2024 Biotech Graveyard [Internet]. Fierce Biotech. 2024. Available from: https://www.fiercebiotech.com/special-reports/2024-biotech-graveyard