The life sciences industry is evolving rapidly, with groundbreaking advancements in research and development driving innovation across various sectors. With this innovation comes a changing legal landscape as companies seek to protect their intellectual property rights, navigate complex regulatory frameworks, and defend themselves against product liability claims. As life sciences litigation becomes increasingly complex, attorneys should consult with leading experts who can advise on industry trends, technological advancements, and emerging regulatory issues. These experts can play a critical role in informing litigation strategies and helping companies navigate the changing winds of life sciences disputes.
Here are three trends in life sciences with legal implications, their drivers, and the types of experts that would be advantageous to retain.
More M&A Deals Ahead
Life sciences M&A deals were mainly lackluster in 2022. But by the end of the year, two significant announcements—Johnson & Johnson’s $16.6B acquisition of Abiomed Inc. and Amgen’s $27.8B proposed acquisition of Horizon Therapeutics—signified the potential start to a domino effect in pharma M&A deals. As companies seek to secure future growth and a renaissance of revenue-generating innovation in the space, M&A will take a strategic and central role in the industry. Pharma companies flush with cash can effectively navigate the M&A landscape to be better positioned to command the market.
Key drivers for increased life sciences M&A deals include:
- Pharmaceutical companies are eager to fill looming growth gaps as best-selling drug patents expire. To fill these pipeline gaps, companies are turning to inorganic growth strategies to close them.
- Falling valuations resulting from the drop in M&A deals in 2022 create pressure on smaller companies with limited cash runways to exit. These smaller companies are cheap and valuable targets for growth for industry incumbents.
- A new pinnacle in life sciences innovation, including advancements in cell and gene therapies, mRNA, digital technologies, and data analytics that make the landscape robust and competition fierce.
- Implementing a faster time to market for new products and services with bolt-on acquisitions to leverage existing infrastructure and expertise.
As life sciences organizations look to future-proof their business models through more M&A deals, consulting with top experts can give companies a competitive edge. While having outside counsel to navigate complex regulations, assess the legal implications of a transaction, and draft the necessary agreements to ensure the deal’s success is critical, so too is having industry financial analysts and economists to provide insights into the valuation of a company and help assess the financial risks and opportunities of a potential deal. In addition, an expert’s financial modeling expertise and deal structuring capabilities can help ensure that the transaction is structured appropriately and financially viable.
Additionally, researchers, scientists, and engineers who understand the scientific and technological advancements driving the industry are essential to ensuring that companies fully understand what’s at stake and the opportunities that may lie ahead.
A Move Towards Digital Transformation
Digital transformation—integrating digital technology into business operations—is a growing strategy among life sciences organizations. From improving supply chain and manufacturing operations to innovating new products and services to redefining customer and patient engagement, digital transformation in the healthcare and life sciences industries is poised to revolutionize the efficiency and effectiveness of processes for pharmaceutical, biotech, and healthcare companies.
Life sciences companies are investing heavily in a digital transformation strategy to enable truly data-driven decision-making. And some key drivers igniting this shift to datafication in the industry include:
- The acknowledged benefits of using data science to identify trends that inform new drug development and treatment strategies.
- A competitive landscape that compels pharmaceutical companies to operate with cost efficiency, shorter timelines, and a steadfast commitment to maintaining quality and fostering innovation.
- A compelling digital age that fosters more connectivity, AI, and machine learning with smarter devices and extended reality capabilities that enhance customer experience.
More companies are focusing on securing digitalization on an organizational level. With that in mind, retaining experts becomes essential to help mitigate risk. After all, a robust data governance and management structure will enable data-driven decision-making to be more efficient, accurate, and achieved at a greater scale.
Supply chain experts can bring a unique perspective to the digital transformation process, considering not only the operational aspects but also the legal and regulatory implications that can arise. They can conduct risk assessments to identify potential vulnerabilities in the supply chain, such as cyber threats or intellectual property risks, and develop strategies to mitigate them.
Pharmaceutical companies rely more heavily on data analytics to evaluate complex data sets, identify drug usage and effectiveness patterns, enhance genomics research, and inform clinical trial design. As a result, data scientists are increasingly in high demand. They can help evaluate the potential benefits and risks of a deal by analyzing data on factors such as drug development pipelines, market trends, and clinical trial outcomes. They can also use data to identify potential synergies between two companies and help develop strategies for integrating data systems and processes.
Digital transformation can also create new intellectual property challenges. For example, companies may need to protect new software or data-related innovations, so retaining highly credentialled technical experts with expertise in data integration, computer science, and wireless and digital technology is crucial for protecting IP assets or navigating IP-related disputes.
Growing Regulatory Scrutiny Concerning MedTech
According to a recent survey by Norton Rose Fulbright, 46% of corporate counsel surveyed anticipate an increase in regulatory action in the near future in the life sciences and healthcare sectors. Some of that action likely concern the growing and significant advancements being made in medical technology. This has prompted industry players to prepare for increased regulatory scrutiny, largely driven by the following:
- The long-term adoption of telehealth and remote patient monitoring technologies
- Clinical trials being managed remotely
- More medical devices incorporating AI, machine learning, and other advanced technologies
- Rising ransomware attacks creating concerns over data privacy and the security of sensitive health data
- In 2023, new state privacy laws will introduce additional categories of sensitive personal data, including health data, and mandate innovators to obtain data-related consent
While medtech-enabled innovation drives opportunities for growth for pharma and biotech companies, they also sound alerts at government agencies who recognize a sustained demand for innovation around personalized healthcare requiring more oversight and guidance. Consulting with experts can help companies drive innovation while complying with industry standards.
A strong team of experts to help companies mitigate risk and drive opportunities would consist of medical device engineers who can offer technical expertise on the design, development, and safety of medical devices. Cybersecurity experts can advise companies on protecting sensitive health data and preventing data breaches, which are increasingly common in the healthcare industry. Clinical trial experts can provide guidance on the design, conduct, and analysis of clinical trials, which are subject to rigorous regulatory oversight. Former FDA officers can supplement legal advice on FDA regulations and enforcement actions and help attorneys navigate the complex regulatory landscape of the healthcare industry. Biostatisticians can provide statistical analysis and modeling of clinical trial data, which is critical for regulatory approval and market access. And finally, medical experts with clinical expertise can advise on the safety and efficacy of medical technologies and their potential impact on patient outcomes.
In conclusion, retaining experts is essential to navigating the complex and changing legal landscapes of the future forward life sciences industry. Having the right experts to consult with or provide expert testimony on various industry trends, technological advancements, and emerging regulatory issues can help determine whether a company wins or loses in a race for market dominance.
Learn more about our teams of life sciences experts who are highly credentialed scientists, medical doctors, engineers, industry veterans, and former regulators. Contact us for more information about retaining the best-suited experts to support your needs.