Legal transformation: empowering biotech for operational resilience

However, over the last few years, the Biotech industry has faced some significant challenges including the COVID-19 pandemic, regulatory change, supply chain disruptions, and increasing production and operational costs. These challenges have created an urgent need for organizations to rethink their current internal processes and take action to strengthen their ​‘Operational Resilience’.

Biotech leaders globally are looking to increase efficiencies and optimise their processes across the entire business. For many, the obvious way forward is through utilising digital and analytics tools to automate workflows and improve compliance.

“The pharma industry is facing a multitude of industry-specific and global trends. But a few major trends point to an industry tailwind; one of them is the advancement of digital and analytics tools.” — McKinsey & Company

Why Biotech industry needs to embrace digital transformation and automation

It’s not surprising to learn that digital technologies have proven to be highly valuable in Biotech operations. However, like in many other industries, companies have struggled to transition from isolated use cases to comprehensive and scaled solutions. 

In the recent EY Digital Investment Index, 55% of the 69-life sciences C‑suite executives part of a group of more than 1,000 surveyed by Oxford Economics said their company lacked a clearly defined digital strategy and goals, which led to only 23% saying they measured their return on digital investment (RODI).

This is particularly evident within the Legal function, whose workloads have increased due to complex legislative and regulatory landscapes. However, this has left the function to often be seen as a bottleneck in operations. 

Simply increasing the number of lawyers is not a sustainable solution. Instead, the most successful companies have discovered how better support their operations and their people by transforming the system itself through technology to support their day-to-day workflows.

The importance of Legal transformation for Biotech organisations

Unsurprisingly, General Counsel play a key role in driving value and increasing overall operational resilience for Biotech companies by transforming their legal function and integrating it into the wider business’ operational strategy.

Maintaining compliance with strict legal and regulatory requirements in the Biotech industry is crucial for business survival. This transformation is a critical step in ensuring the business can keep pace with the constantly evolving industry challenges. The CEO, COO, and GC, in their unique positions, are responsible for spearheading this endeavour.

Some Legal functions are employing matter management tools that are designed to specifically support in-house functions to manage their legal tasks. These tools intuitively triage Legal tasks according to pre-defined conditions to ensure the right lawyer is assigned the support request most in line with their area of expertise. Matter management tools designed for in-house teams also provide valuable insights on team and document performance which businesses often require to prove ROI on Biotech business initiatives — something which traditional law firms do not.

Legal transformation doesn’t just help the Legal team get their work done. In the Biotech industry, anyone can potentially expose the business to extreme risk and so the onus is on all employees to ensure their activities are compliant with the industry’s rules and regulations. Adopting legal technology initiatives can also help empower the entire business to own their operational activities without needing to rely on heavy Legal support. Legal technology, such as contract management, enables the automatic delegation of review, approval, and signing authority rules. This means the contract owner can be confident that the right stakeholders are involved at the right time, every time. The obvious advantage of this is that it helps ensure the business remains compliant with regulations and can execute its own contracts digitally, without adding to the bottleneck of Legal’s business support requests.

In conclusion…

Companies that successfully embrace digital transformation can safeguard themselves from the escalating cost pressures faced by the industry.