Balancing innovation, safety, compliance, risk in life sciences

Surge in Drug Approvals 

One significant trend Ampulski has seen in the life sciences sector is the surge in drug approvals — particularly in cell and gene therapy.  

"We're seeing an upward trend in drug approvals since the pandemic," said Ampulski. She then highlighted the increased efficiency in regulatory processes facilitating faster market entry for new drugs. "The FDA has four approaches to making drugs that treat serious diseases available as rapidly as possible: priority review, breakthrough therapy, accelerated approval, and fast track."  

These expedited approval pathways have contributed to increased drug approvals, enabling companies to bring innovative therapies to market more quickly. For instance, the FDA has used its expedited approaches to authorize over 30 new drugs and biologics through priority review, around 20 COVID-19 treatments and vaccines as breakthrough therapies, several COVID-19 treatments through accelerated approval, and dozens of COVID-19-related drugs and vaccines through fast-track designation since the start of the pandemic in 2020 alone. 

Cybersecurity Threats 

Cybersecurity has become a critical concern as technology continues to integrate with healthcare. Ampulski stressed the importance of recognizing the vulnerabilities introduced by connected medical devices.  

"Many medical devices today are connected to the Internet, which opens up a potential entry point for cybercriminals,” she emphasized.  

The potential for cyberattacks on devices like pacemakers or blood glucose monitors poses significant patient safety risks. Additionally, the aging infrastructure in hospitals further complicates cybersecurity efforts, as older machines may lack the necessary software updates to fend off cyber threats. 

Addressing these cybersecurity challenges in healthcare will require a multi-pronged approach, said Ampulski. Ensuring medical devices are designed with robust security measures, regularly updating hospital IT systems, and educating healthcare staff on best practices will all be crucial to mitigating the growing risk of cyberattacks in this increasingly connected landscape. 

Mitigating Risks 

To mitigate these risks, life sciences companies must implement rigorous testing and trials. Ampulski stressed the importance of continuous quality control and alignment between sales, marketing, and regulatory teams.  

"Develop a rigorous quality control program from the process and the material controls to formal inspections and testing protocols," she advised.  

Ensuring marketing materials comply with regulatory standards is crucial to avoid civil lawsuits and criminal penalties associated with off-label promotion. Life sciences organizations need a comprehensive review process to verify that all claims and messaging in sales and marketing collateral are supported by clinical data and align with approved product labeling. Proactive coordination between these different functions can help companies stay compliant and avoid costly regulatory violations. 

Regulatory Adaptations 

Regulatory agencies like the FDA are adapting to the rapid pace of innovation in the life sciences sector. Ampulski noted that while the FDA is streamlining administrative processes to expedite drug approvals, there remains a delicate balance between speed and safety.  

"Life sciences companies need to know the regulations and standards in every country in which they operate and monitor how they may evolve to ensure they're maintaining compliance," she underscored. 

This vigilance is essential for maintaining product quality and patient safety amidst evolving regulatory landscapes. Life sciences firms must stay agile and proactive in their compliance efforts, as rules and guidelines can shift quickly in response to new technologies and safety concerns. Closely tracking regulatory changes, both domestically and internationally, allows organizations to nimbly adjust their processes and procedures to avoid costly lapses. 

Regulatory bodies are tasked with ensuring innovative treatments reach patients safely and effectively. By closely collaborating with these agencies and thoroughly understanding the regulatory environment, life sciences companies can navigate the complex risk landscape while bringing important healthcare solutions to market promptly. Balancing speed, quality, and compliance is crucial for sustainable success in this dynamic industry. 

Technological Advancements and Risks 

Technological advancements bring both benefits and risks to the life sciences industry. Smart devices, telehealth, and AI are transforming healthcare delivery and research. However, as mentioned, these technologies also create new entry points for cyber threats.  

"AI technology will likely affect pharmaceutical research and development with applications for drug design and screening," said Ampulski. "But with that potential comes the risk of a potential cyber attack or data contamination," emphasizing the dual-edged nature of these emerging technologies. 

Proactive Risk Management 

Ampulski shared several proactive measures that life sciences companies can take to manage risks effectively, including the following. 

• Manufacturing Capacity Expansion: Manage supply chains, quality control, and backup plans for manufacturing capacity expansion. 
• Technological Security: Address data exposures, comply with cyber regulations, train staff, and obtain cyber insurance for technological security. 
• Post-Market Surveillance: Implement surveillance programs to monitor product performance and safety, issuing timely field notifications for post-market surveillance. 
• Team Scaling: Develop training programs to ensure employees are versed in operations and safety as the team scales. 

Partnerships with Insurance Providers 

Collaborating with insurance providers and legal experts is essential for navigating the life sciences industry's complex risk landscape. Ampulski emphasized the importance of specialized insurance programs tailored to the unique needs of life sciences companies.  

"Having expertise in understanding the life sciences industry aligns with ensuring the risks are mitigated," she noted. 

Insurance providers with experience in life sciences can offer critical support in identifying and managing potential risks. By working closely with insurers and legal counsel, life sciences firms can develop a comprehensive risk management strategy to protect their operations, assets, and — most importantly — patient safety. 

Emerging Risks 

Looking ahead, Ampulski identified several emerging risks that life sciences companies need to prepare for, including the following:  

• Off-label use of products 
• Supply chain disruptions 
• Sustainability challenges 

She also highlighted the shifting workforce dynamics, noting that "employees in their first year on the job are the most vulnerable to injury," underscoring the importance of robust training programs. 

Encouraging Collaboration 

Despite the proprietary nature of the life sciences industry, Ampulski has observed a significant degree of collaboration among regulatory bodies, life sciences companies, and insurance providers. This collaboration is driven by a shared goal of improving patient health and safety. "It is one of the reasons why it is so important for life sciences companies to have an insurance partner that specializes in the industry and understands the shifting landscape," she said. Such partnerships facilitate sharing insights and best practices, ultimately enhancing risk management efforts. 

The evolving risk landscape in life sciences presents numerous challenges for healthcare technology professionals. By staying informed about regulatory changes, implementing proactive risk management strategies, and fostering collaboration with specialized insurance providers, life sciences companies can effectively navigate these challenges. Ampulski's insights underscore the importance of vigilance, continuous improvement, and strategic partnerships in ensuring the safety and success of innovative healthcare technologies.