Improving patient engagement and drug development through AI and enhanced medical affairs roles

Although it might seem like AI is the newest and hottest innovation in the industry, medical affairs professionals have been using some form of it for decades. We in the industry characterise AI's history by several key milestones, from its initial use in diagnosing illnesses in the 1960s to its present-day application of sophisticated machine learning algorithms and drug development. Today, this technology is critical in countless healthcare decision-making processes, but especially medical affairs, which relies heavily on evidence.

The pharmaceutical drug development and commercialisation landscape is undergoing a profound transformation, fuelled by rapid advancements in AI and the evolving andincreasing role of medical affairs. These changes are reshaping how new drugs and therapies make it to market, streamlining pharmaceutical development and clinical testing, while enhancing patient outcomes and revolutionising the healthcare ecosystem. The adoption of AI technology, both predictive and analytical, within medical affairs, signifies a strategic shift towards prioritising enhanced clinical and scientific information, better patient care, and medical intelligence.

Unlike conventional approaches, where technology adoption might be superficial, pharmaceutical companies should align AI solutions with clear objectives to improve patient outcomes and streamline drug development. Additionally, both the AI and human elements must effectively understand what a successful medical affairs campaign looks like and its impact. When those requirements are satisfied, we can use those insights to inform future decisions, leading to smarter, faster patient outcomes.

Early integration: Enhancing clinical trials with AI

AI's role in enhancing clinical trial recruitment represents a significant advancement in drug development. By leveraging algorithms to identify suitable patient populations and recruitment strategies, AI facilitates more effective enrolment and optimises the appropriate target patient population to ensure better patient outcomes and chances of clinical success. Particularly in the realm of rare diseases, AI's ability to parse through real-world data, like electronic health records, ensures that trials for orphan drugs are well-informed, enhancing the likelihood of regulatory approval.

In the realm of rare diseases, AI's advanced analytics play a pivotal role in the synthesis of study arms from real-world data sources, such as electronic health records. This innovative approach facilitates the creation of virtual comparators, thereby enriching the design and conduct of orphan drug trials. The integration of synthetic control arms not only streamlines the trial process, but also amplifies the probability of achieving regulatory approval by providing robust, data-driven insights into drug efficacy and safety.

The evolving role of medical affairs and AI's integration

While AI offers many opportunities to support medical affairs professionals' work, its ability to support patient engagement will have a significant impact. Rather than simply adopting technology for technology's sake, medical affairs professionals need clear objectives and goals for AI's use in patient engagement improvement.

When implemented correctly, and with vast data, AI algorithms help provide an unbiased view of patients' and healthcare professionals' (HCPs) unmet needs and the educational or research gaps needed to accommodate them. For example, AI's language processing and sentiment analysis function should review patient feedback, social media interactions, and online patient forums. By understanding patient sentiments, preferences, and concerns from these data sources, medical affairs teams can personalise educational materials, support programs, and communication strategies to better meet patient needs. Additionally, AI's predictive capabilities can help identify potential gaps in patient care or education and provide recommended proactive interventions and targeted outreach initiatives to ensure these patients have access to a specific clinical trial or product in the market.

In the contemporary pharmaceutical industry, the spotlight often falls on specialised clinical products, such as cell and gene therapies, shifting the commercialisation paradigm beyond traditional strategies. Medical affairs professionals now emerge as key figures in this landscape, driving the commercial value of innovations and addressing the unmet needs of patients and HCPs. Their expertise is crucial in conveying the scientific merit of new treatments and ensuring these innovations meet the stringent requirements of various healthcare stakeholders.

Global trends from regulatory agencies are influencing the escalating costs of innovative treatments, necessitating a shift towards new evidence generation that captures the societal burden, patient-reported outcomes (PROs), and quality of life (QoL) improvements. Legislative actions, such as the Inflation Reduction Act in the US and various EU initiatives aimed at curbing healthcare costs, emphasise the need for comprehensive data that extends beyond traditional randomised controlled trials (RCTs).

Real-world evidence (RWE) is becoming increasingly pivotal in this context, offering a broader understanding of a treatment's impact. Engaging with stakeholders - including payers, HCPs, and internal teams like medical affairs and value access groups - from early development stages is critical. This collaboration ensures that product positioning is finely tuned to demonstrate the clinical value and societal benefits to patients, investors, and regulators, thereby securing market success.

AI’s broad impact and looking ahead

The incorporation of AI into life sciences heralds a promising future, not just in automating tasks, but in enriching medical affairs efforts and patient care. The fusion of AI's analytical prowess with the clinical acumen and empathy of medical affairs professionals offers a powerful tool for unlocking new insights and accelerating drug development. This collaboration is key to navigating the complexities of modern healthcare, ensuring innovative treatments align with patient needs.

The proactive deployment of AI in early development stages is essential, allowing medical affairs teams to harness the technology's full potential. Proper implementation facilitates pharmacovigilance, regulatory compliance, and monitoring for adverse drug effects, ensuring economic and efficient operations.

Looking ahead, the synergy between AI and human expertise is set to redefine the pharmaceutical and biotech industries, enhancing drug development, commercialisation, and patient engagement. This partnership promises to unlock previously unimaginable insights, paving the way for a new era of pharmaceutical innovation centred on patient-centricity and medical intelligence.

About the authors

Dr Yahya Anvar serves as chief AI science & insights officer at Envision Pharma Group and OKRA Technologies. During his tenure at OKRA.ai, he oversaw the implementation and productisation of a wide range of AI capabilities to address industry needs across the drug development continuum, covering RWE, value & access, medical, and commercialisation. He has over 15 years of experience in the healthcare sector and is the author of over 30 peer-reviewed scientific articles. Dr Anvar holds a PhD in Medicine, with a focus on Bioinformatics and Computational Biology, from Leiden University and an MSc in Bioinformatics and Artificial Intelligence from Brunel University.

Dominic (Nick) Marasco is the executive president and chief commercialisation officer at Envision Pharma Group, a global technology-enabled strategic solutions partner for the life sciences industry. With over 25 years of industry experience, he has a wealth of expertise in C-suite strategic management and planning, mergers and acquisitions, commercial operations, and global business development for life science companies. Marasco is a board member/board advisor to numerous public and private, for and not-for-profit life-sciences and academic organisations. Additionally, Dominic is a Health Policy and Management Executive Council member at the Harvard T.H. Chan School of Public Health. He received his BSc in Pharmacy from the Philadelphia College of Pharmacy and Science and graduated from Harvard Business School's 2022 Advanced Management Program.