Why Innovation in Big Pharma Is So Slow: Insights from BMS

At the 2023 DPHARM conference, Hassan Kadhim from Bristol-Myers Squibb offered an insightful look into the challenges driving innovation in Big Pharma. His presentation, “Addressing the Innovation Gap,” shed light on the slow adoption of new technologies in clinical trials and the internal processes pharmaceutical companies use to navigate their complex, highly regulated landscape. Kadhim’s focus on structured frameworks, established capabilities, and industry collaboration gave the audience a better understanding of the forces shaping pharma innovation.

The Innovation Paradox in Pharma

Kadhim began by addressing the widespread frustration within the industry over the slow pace of technological adoption. He noted that technology vendors and Big Pharma colleagues often express impatience with how long new tools take to be integrated into clinical trials. The slow speed, however, stems from the industry’s complex regulatory environment. Innovations must comply with standards like Good Clinical Practice (GCP), which requires extensive validation and cautious implementation, making adopting technology time-consuming and resource-intensive.

He further emphasized the stakes in pharma, where innovation can mean the difference between life and death for patients. This heightened responsibility necessitates a careful approach, where even promising technologies, such as AI for analyzing clinical trial data, need thorough validation to ensure they meet regulatory and safety standards.

Defining Innovation in Pharma

To establish common ground, Kadhim offered a broad definition of innovation, describing it as the “production, adoption, assimilation, and exploitation of value-added novelty.” This applies to various innovations—developing new drugs, adopting external technologies, or improving internal processes. Kadhim cited the implementation of electronic data capture (EDC) systems as a key innovation that replaced paper-based methods, reducing errors and speeding up clinical trial data collection.

Kadhim highlighted that while DCTs offer great potential for improving patient access and recruitment by allowing trials to be conducted remotely, they also introduce new complexities. Ensuring data integrity and maintaining regulatory compliance requires robust planning and coordination. For example, while digital tools can streamline patient engagement, they must be fully validated to ensure they can securely handle sensitive data and maintain trial integrity.

The Dichotomy of Innovation in Pharma

Kadhim described a dichotomy within the pharmaceutical industry: early-stage drug discovery tends to attract significant attention, with breakthroughs like gene therapy and CRISPR technologies generating excitement. In contrast, innovation during clinical trials (phases II, III, and IV) is often more incremental due to the stringent regulatory environment and established protocols. The emphasis during the clinical phases shifts to safety, efficacy, and adherence to established protocols, which makes it challenging to introduce radical innovations at these stages.

The Innovation Lifecycle

Kadhim illustrated the biopharma drug lifecycle, which spans approximately 14 years and costs around $2 billion from discovery to market. The profit window, typically lasting three to four years, is brief, further adding pressure on companies to innovate efficiently during this time. He explained that the initial stages of drug development—discovery and preclinical testing—are resource-heavy and time-consuming. Once a drug reaches clinical trials, the focus becomes ensuring safety and efficacy, which involves meticulous planning and data analysis across multiple phases.

He also touched on the cyclic nature of innovation in Big Pharma. After a drug’s approval, companies enter a short period where they can recoup their investment and allocate resources for further innovations. However, this period is limited, as they must soon begin the process anew for the next drug in their pipeline. Kadhim highlighted that this cyclical nature often results in incremental innovations rather than disruptive changes, as companies must balance the need to innovate with maintaining financial stability.

Pillars of Sustained Innovation

Kadhim emphasized three key pillars for sustained innovation in clinical operations: incubation frameworks, established capabilities, and industry collaborations.

1. Incubation Frameworks: These structured processes encourage collecting, qualifying, and piloting new ideas. He provided an example from Bristol-Myers Squibb, where dedicated teams are tasked with scouting new technologies and evaluating their potential in controlled environments before broader implementation.
2. Established Capabilities: Kadhim noted that robust, documented processes, along with the right technologies and talent, are critical for maintaining operational efficiency while integrating innovations. Bristol-Myers Squibb, for instance, has invested in comprehensive clinical trial management systems (CTMS), which incorporate technologies like EDC and risk-based monitoring (RBM), creating a cohesive ecosystem to support trial management.
3. Industry Collaborations: Partnerships are essential for fostering innovation and bringing new capabilities into the company. Kadhim mentioned collaborations with organizations such as TransCelerate BioPharma and the Clinical Trials Transformation Initiative (CTTI), which provide valuable opportunities for knowledge-sharing and co-development of solutions.

Interaction of the Pillars

Kadhim explained how these pillars interact to support innovation within Bristol-Myers Squibb. The incubation framework collects and pilots new ideas, while collaborations provide additional insights and opportunities. These efforts are then integrated into the company’s established capabilities, guided by governance processes to ensure they deliver value.

For example, Bristol-Myers Squibb conducts internal innovation campaigns, encouraging employees to propose ideas for improving clinical trial processes. Once an idea is selected, it undergoes a thorough evaluation, including building a business case and developing a change management plan. If successful, the idea is piloted and, if viable, scaled up to become part of the company’s operational capabilities.

The Complexity of Clinical Trials

Kadhim presented a “snake diagram” to showcase the complexity of clinical trials, highlighting various capabilities such as patient engagement, digital data flow, trial master files, and decentralized trials. He explained that each of these capabilities requires coordination across different organizational groups, and any innovation must be carefully assessed to ensure it fits within these established processes.

For instance, digital data flow—enabled by tools like electronic health records (EHRs) and wearable devices—has revolutionized real-time data analysis in trials. Yet, these tools must be integrated seamlessly into the broader trial infrastructure to maintain data integrity and compliance. Similarly, the trial master file (TMF), a repository of essential trial documents, must be managed carefully to ensure regulatory compliance. Bristol-Myers Squibb’s electronic TMF (eTMF) systems exemplify how innovation can streamline these traditionally manual processes while maintaining rigorous standards.

Aligning Innovation with Corporate Strategy

Kadhim emphasized the need to align innovation efforts with broader corporate strategies. This involves creating multi-year roadmaps, building strong business cases, and ensuring the innovations deliver measurable value. Metrics are established to track progress and ensure innovations align with company objectives.

He shared Bristol-Myers Squibb’s roadmap for implementing decentralized clinical trials, detailing the necessary steps for technology adoption, training, and regulatory compliance. By integrating DCTs into its existing processes, the company ensures these efforts align with its long-term strategic goals.

Embracing Uncertainty in Innovation

Kadhim concluded by acknowledging the inherent uncertainty in innovation. He urged the audience to view uncertainty as a risk and an opportunity. Innovation, by its nature, involves venturing into unknown territory, which can be daunting but is also where significant breakthroughs occur. He encouraged embracing this uncertainty while applying strategic planning and risk management to navigate it.

Bristol-Myers Squibb’s approach to managing uncertainty involves thorough risk assessments and developing contingency plans for innovation initiatives. By balancing strategic oversight with a willingness to experiment and learn from failures, the company has successfully implemented valuable innovations that enhance clinical trial processes.

Summary

In summary, Kadhim’s presentation at DPHARM 2023 offered a comprehensive view of the intricate processes and challenges that drive innovation within Big Pharma. Through structured frameworks, established capabilities, and strategic collaborations, pharmaceutical companies like Bristol-Myers Squibb are navigating the complexities of clinical trials to bring new technologies to the forefront.