The 6Cs driving competitive advantage in regulatory affairs

The life sciences landscape of today is practically unrecognizable from yesterday's. The rapid rate of change all but assures that the future will be more different still. Breakthrough innovations driven by medical and technological advances have all been enabled by regulatory affairs (RA). And now, RA teams must keep pace with change and disruption to drive further growth.

In an ever-changing and heavily regulated environment, we see six key drivers of change in RA: complexity, cost, competition, changing regulations, capabilities, and compliance – the 6Cs. Forward-looking RA teams are ready to contend with these to meet the future needs of their business and keep patient safety and wellbeing at the heart of everything they do. In doing so, they unlock another C for their life sciences organization, competitive advantage.

1. Complexity

The life sciences industry of today is increasingly complex. Governments are escalating the pressure to make drugs more affordable. The number of new market entrants is on the up. Accelerated clinical trials are shortening drug lifecycles. There is a sharper focus on novel treatments. And the industry is shifting toward patient-centric holistic care.

For example, heightened demand for new treatments such as gene and cell therapies, RNA interference, and endogenous metabolic modulators, has led some companies to deprioritize and even divest current assets dedicated to small molecule drug development in favor of more complex large molecules and advancing medical technologies. At the same time, collaborative partnerships offer new opportunities to develop scalable wraparound solutions, such as real-time monitoring of patient adherence to improve patient experiences and health outcomes.

These shifts have a notable impact on regulatory affairs as organizations must adopt new technologies, develop new skills, and connect internally and externally in a more seamless manner with key stakeholders, including employees, suppliers, partners, and regulatory agencies. Automating data collection, extraction, and content writing will unburden RA teams from labor-intensive tasks. Transforming the clinical development phase and simplifying market access will streamline the approval process to get drugs to market quicker.

2. Cost pressures

By 2022, global healthcare spending is projected to exceed $10 trillion. Continued economic instability increases downward pricing pressures and demands for pricing transparency. These trends have prompted organizations to find new ways to drive efficiencies and use scarce resources wisely.

A renewed focus on core capabilities places greater emphasis on make versus buy decisions. The outsourcing of noncore activities, such as routine post-marketing maintenance, offers greater expertise, robust processes, and advanced technology without the significant investment needed to develop the infrastructure in-house. RA can then shift the focus toward more value-adding activities, such as streamlining development and market access processes to bring new solutions to market faster and actively seeking ways to drive prices down, which will build trust through transparency.

3. Competition

Life sciences offer fertile ground for new investors and market entrants. Pharmaprojects' latest Pharma R&D Annual Review reveals a global pipeline growth to more than 17,000 drug molecules. In the past year alone, 4,800 companies had active pipelines – an 11% growth rate compared to 5% in the previous year.

Increasingly, we see more drugs per indication and shorter lifecycles for leading products. New global regulatory pathways are facilitating the way for aggressive market entries from outside of the sector, such as large technology companies like Google, Microsoft, and Amazon. For some organizations, building strategic partnerships with technology companies to develop holistic solutions for patients extends product lifecycles. For others, focusing on orphan drugs and expedited review designations for patients with rare diseases or unmet needs offers clinical differentiation in a crowded market. New avenues for growth need high capital investment and a risk-taking mindset, and regulatory affairs can help strike the right balance between speed to market and risk.

Innovating to get ahead of the competition is essential but creates increased challenges in data, processes, and compliance. The additional stretch means regulatory affairs must completely disrupt traditional processes. Accelerating digital transformation and as-a-service operating models can cut through routine data processing and management, increasing speed and accuracy while reducing costs and regulatory risk. AI-driven analytics to proactively identify potential instances of noncompliance and semi-automated content writing for research and submissions are just a couple of examples of technology lightening the load for RA teams.

4. Capabilities

Today, attracting and retaining the right talent is a top concern for CEOs and CHROs of life sciences companies. A challenge further exacerbated by people's anxiety to move jobs and re-evaluation of what they want from life sparked by the pandemic. Digitally savvy and socially aware generations aspire to work for cutting-edge companies that top workplace rankings, such as Glassdoor. They look for digitally enabled workplaces where operations run smoothly, AI powers automation, growth, and innovation, and learning is state-of-the-art and embedded in the culture.

Digital and data have become part of the life sciences DNA for clinical trials, regulatory submissions, quality assurance, and supply chain management. New roles, new skills, and new ways of working will be essential for forward-thinking RA teams. And an agile and adaptive workforce will be ready for changes to global regulations and embrace advancing medical sciences and disruptive technologies.

Though sourcing specific skill sets regionally may prove challenging, the shift to the cloud enables working from anywhere and opens the door to a growing network of collaborative resources across the business and beyond.

5. Changing regulations

Compliance remains a crucial component of regulatory affairs. There are a growing number of recalls mainly related to compliance breaches in chemistry, manufacturing, and controls (CMC) and label artwork. These recalls highlight the complexity of the life sciences sector and the challenges of siloed working and, in particular, disparate sources of data.

A hyper-competitive landscape demands faster and more efficient innovation, and a more ethically aware public demands greater transparency. Though trust in the industry is on the up due to the admirable efforts of the sector to protect the public against COVID-19, the Edelman Trust Barometer still holds the life sciences sector in the distrusted territory.

Harmonized terminologies, such as the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and the Investigational Medicinal Product Dossier (IMPD), alongside tighter controls on sensitive patient data, bolster the industry's efforts to become more efficient and trustworthy. But these are still further changes to the regulatory landscape with which RA teams must become familiar.

As organizations explore ways to speed drugs to patients in need, regulatory teams become the lifeblood of a connected ecosystem. They play a vital role in deploying AI and machine learning tools, such as natural language understanding and natural language processing, to automate data extraction from internal, external, and open sources quickly and securely.

6. Cybersecurity and data compliance

A vast volume of personal data and intellectual property passes through the life sciences ecosystem – data from pre-clinical research, development, manufacturing, in-market regulatory, pharmacovigilance, registration, and maintenance. The sudden shift to work from home during the pandemic led to a rise in cyberattacks as IT infrastructures fragmented. Data integrity across collection, analysis, governance, and security tops the priority list on the regulatory agenda.

Legacy systems have long hampered efforts to consolidate data. Migration to a regulatory information management system (RIMS) can overcome this challenge and help streamline the submission process for medical products and treatments and shorten approval times. Linking master data and electronic data management systems to RIMS builds efficiencies, reduces errors, and offers a single source of truth.

Robust data management and governance afford companies complete visibility of what is registered and what is in trade. Regulatory teams must now assume the role of data guardian for patient data. This stewardship extends beyond protecting the privacy and sensitive information of patients. RA must harness data and analyze it responsibly to share insights that can improve the experience for patients and lead to better healthcare outcomes.

Digital innovation continues to drive process improvement and harmonize data and content management end to end. For regulatory teams, this offers a deeper understanding of structured and unstructured data and a seamless flow of information throughout the product lifecycle from development to submission to health authorities globally.

For the life sciences sector, what is for sure is that old ways will not open new doors. Organizations must take bold steps now. Through investment in technology, analytics, and capabilities, the digital transformation of regulatory affairs will improve operational efficiency, effectiveness, and oversight and deliver better outcomes for both the business and the people it serves.