The Global Stage: Q&A with EVERSANA’s Vikram Anand

Vikram Anand
president, compliance services
EVERSANA

As technology continues to connect people and improve processes, pharma and life sciences companies and more often required to learn how to operate on a global stage. Vikram Anand, president of compliance services at EVERSANA, recently spoke with Pharmaceutical Executive about the company’s recent expansion into new global markets and other regulatory issues.

Pharmaceutical Executive: What trends are you seeing with pharmacovigilance/medical information?
Vikram Anand: We’re observing several key trends globally. Firstly, the integration of advanced technologies like AI and advanced analytics is transforming pharmacovigilance (PV) and medical information (MI). Automation of process-oriented tasks and the implementation of robust workflows and systems are becoming essential. Our collaboration with Oracle exemplifies this shift.

Secondly, the rise of machine learning and AI in drug development is notable. These technologies are increasingly used to predict safety issues, optimize treatment plans, and ensure compliance, enhancing overall efficiency and effectiveness.

In the realm of medical information, Contact Center as a Service (CCaaS) platforms are making a significant impact. AI applications such as chatbots, agent assist tools, sentiment analysis, live voice and text translation, and automated quality checks are revolutionizing customer interactions. These technologies enhance response times, improve accuracy, and ensure a higher quality of service.

Lastly, there’s a significant move towards consolidation. Our customers are seeking unified vendors to manage global operations seamlessly, a true partner who can jointly own their vision and drive the required results. This approach simplifies management and ensures that the needs of doctors and patients are met effectively, with localized support and a deep understanding of market conditions.

Additionally, there’s a growing emphasis on real-world evidence (RWE) to support regulatory decisions and improve patient outcomes. The use of RWE is becoming a cornerstone in demonstrating the value and safety of new therapies.

PE: What is the importance of global hubs?
Anand: Global hubs in the drug safety space are essential for delivering consistent, high-quality care to patients and doctors in their native languages and time zones. They offer significant value to clients with multinational operations by providing a single vendor with interconnected systems and processes worldwide. This approach eliminates the need for multiple vendors across different regions, ensuring seamless support for global drug safety needs. In today’s world, having global interconnected systems and streamlined processes is crucial for driving the right ROI from investments like Artificial Intelligence. Moreover, AI can deliver maximum impact only when integrated within such a cohesive and unified framework.

Local regulatory demands vary significantly from country to country. Having local teams is crucial for navigating these diverse regulatory landscapes effectively. Local teams possess the necessary expertise to comply with regional regulations, ensuring that drug safety practices meet all local requirements. This localized approach not only enhances compliance but also ensures that the specific needs of each market are addressed efficiently.

PE: What trends did you notice at the World Drug Safety Conference?
Vikram Anand: At the World Drug Safety Conference, several key trends stood out. The increasing use of big data and artificial intelligence in pharmacovigilance was a major focus, highlighting how these technologies can enhance drug safety monitoring and risk management. There was also a strong emphasis on patient-centric approaches, ensuring that drug safety measures align with patient needs and experiences. Additionally, the conference addressed the challenges posed by social media in drug safety and the evolving global drug safety legislation.

This conference is one of our biggest events each year. Witnessing its growth and seeing like-minded professionals from around the globe come together to discuss how we can ensure drugs come to market safely and prioritize patients is incredibly powerful. We had incredible participation, including a great panel on “The Subtle Art of Simplifying Pharmacovigilance” and a track on “AI or Not to AI.”

Just before the World Drug Safety Event, we were at the Oracle Safety Consortium Innovation Summit Europe 2024 in Utrecht and presented a case study with the Global Chief Medical Officer from a leading global biopharmaceutical company. This showcased the mutual success of a unified and strategic pharmacovigilance partnership in supporting global growth in more than 100 countries. We look forward to an equally engaging participation at the World Drug Safety Summit in the United State on October 29 and 30.

PE: How can companies looking to build a global footprint navigate the varying regulatory bodies they must interact with?
Anand: Navigating the complex landscape of global regulatory bodies is challenging. For example, Europe has over 20 countries, several of them with its own regulatory guidelines and local demands. Similar challenges exist in the Asia Pacific region, and even within North America, the regulatory complexities between the United States and Canada differ significantly.

Manufacturers entering new markets or launching products must have a deep understanding of regulatory requirements. This can be achieved by building internal expertise or partnering with experienced entities. Having teams with strong market knowledge and a proven track record in bringing drugs to market is crucial.

Another critical component is establishing clear communication channels and implementing robust compliance monitoring systems. Regulations can change rapidly, so pharma companies need to stay ahead of these changes and have the right systems and people in place to adapt swiftly.