Issue No. 3: Can the ‘Pipeline’ of Drug Development Be Reconsidered?

Introduction

This series begins with the recognition that drug development is entering a significant turning point. The main theme is to anticipate the next era from this perspective. Drugs are created by pharmaceutical companies, and their R&D model has been evolving from a self-contained approach to one emphasizing external collaboration in pre-competitive areas, under the banner of Open Collaboration. In Western countries and Japan, which have strong pharmaceutical industries, governments have been placing greater emphasis on Translational Research (TR)—applying the results of basic biomedical research to understanding diseases and drug development. In response to these trends, academia, including universities, has also been engaging more actively in partnerships with pharmaceutical companies, Open Collaboration, and TR-oriented research.

Meanwhile, within pharmaceutical companies, there is a noticeable trend of exploring business models that not only sell “products” like drugs but also provide “solutions” for health. However, it remains unclear what specific challenges need to be addressed to achieve this goal. In this final installment of the series, we will consider these developments and their implications.

Changes in the Pharmaceutical Industry’s Environment: The Structure of the Pharma Crisis

The environment surrounding pharmaceutical companies has undergone drastic changes since the beginning of this century. Around 2001, when the Human Genome Project was nearing completion, there was great optimism about utilizing its results to understand diseases and develop groundbreaking drugs. Drug development began to incorporate genomics, omics, and molecular signaling pathways/networks as foundational techniques for drug target discovery. Additionally, antibody-based drugs garnered significant attention alongside small-molecule drugs. However, the number of newly approved drugs stagnated, regulations became stricter, development timelines grew longer, and development costs soared. By around 2011, it was also evident that many blockbuster drugs—those generating significant sales—would lose patent protection. In response, pharmaceutical executives resorted to strategies such as withdrawing from risky drug development, mergers and acquisitions, downsizing research organizations, and stock buybacks to protect company profits.1) While these measures might ensure corporate survival, they raised fears about the inability to develop the drugs the public genuinely needs.

This sense of crisis among both public and private sectors led to the establishment of initiatives like the Innovative Medicines Initiative (IMI) by the EU and European pharmaceutical companies in 20082) and the National Center for Advancing Translational Sciences (NCATS) under the NIH in the United States in 20113). In Japan, the establishment of the Japan Agency for Medical Research and Development (AMED) as an organization in 2014 followed a similar trajectory. The current emphasis on Open Collaboration and Translational Research reflects this shared sense of urgency, with IMI, NIH/NCATS, and AMED symbolizing saviors poised to address the crisis.

Societal Changes: The Waves of Digitalization and Healthy Longevity Research

The drugs currently in development are unlikely to reach the market until 10 to 15 years from now. For example, immune checkpoint inhibitors, such as anti-PD-1 antibodies, which are now gaining attention in cancer treatment, began research over 20 years ago. Thus, the society where today’s drugs will be used will likely be 15 or even 20 years into the future. What will that era look like?

One clue lies in the societal changes that have occurred over the past 20 years. Today, we live in what is referred to as a “networked society,” a transformation that began in 1993/4 when the Internet was unleashed for public use4). This marked the first revolution of the Internet, which had its origins in the late 1960s. The emergence of new network environments, including smartphones, tablets, and cloud computing, represents the second Internet revolution. Considering the vast number of new services born over the past 20 years, the innovative services that will emerge over the next 10 to 20 years will likely surpass imagination.

Meanwhile, in developed nations and countries like China, the growing population of elderly individuals has become a significant issue. The focus has shifted from merely extending average lifespan to extending healthy lifespan. As a result, pioneers utilizing the outcomes of genome sequencing have embarked on large-scale studies targeting the promotion of healthy longevity through the digitalization (Digital Health) and mobilization (mHealth) of healthcare5). Examples include the Hundred Person Wellness Project (HPWP) led by Leroy Hood at the Institute for Systems Biology in Seattle, the healthy longevity research initiatives by Human Longevity, Inc. (HLI) established by Craig Venter—renowned for the Human Genome Project—and Google’s Baseline Study in collaboration with multiple universities to continuously collect data from healthy individuals and establish baseline metrics.

Such research contrasts with government-supported studies like the UK’s Genomics England project aiming to decode 100,000 genomes for rare diseases and cancer (targeting tens of thousands of patients), the NIH’s cohort study based on genome sequencing with a goal of one million participants, and Japan’s Tohoku Medical Megabank Project, which has registered over 150,000 participants.

The Role of Consumers and Patients as Stakeholders in Drug Development

When considering the future of drug development, addressing the needs of patients is paramount. In Western countries, a paradigm shift is rapidly occurring, recognizing consumers and patients as stakeholders in drug development. There is growing advocacy for listening to patient voices, encouraging their participation, and evaluating the benefits and risks of drugs from their perspective. This movement has led to extensive discussions and experimental projects funded by both public and private sectors6). The concept is encapsulated in the phrase, “Patient involvement will be the blockbuster of drug development.”7)

In biomedical research, the idea that humans are not merely large guinea pigs but partners is already widely accepted among genome researchers8). Genome sequence interpretations become more reliable with larger comparative datasets, while individual participants in large-scale testing may also benefit directly. This is a significant departure from traditional population-based testing versus genome-based testing. For rare diseases, where patient numbers are limited, advocacy organizations often act as intermediaries between researchers and healthcare providers9). Such organizations are also critical in supporting the construction of biobanks for research purposes.

Historically, medical research has simply categorized individuals as either patients or healthy subjects. However, research aimed at personalized or precision medicine seeks to stratify both patients and healthy individuals into more nuanced groups. This requires diverse types of testing, including genetic and genomic analyses, biochemical tests like bloodwork, microbiome and pathogen studies, biomechanical or electrophysiological assessments, and biomarker-based diagnostics for suspected conditions. While these tests have traditionally been conducted in medical institutions, some are now being replaced by Direct-to-Consumer (DTC) services or portable, user-friendly measurement devices such as wearable or wireless sensors10). The latter is known as Point of Procedure or Point of Care technology.

Empowered and Proactive Consumers

This trend is significantly transforming consumer perceptions of healthcare. Consumers are increasingly realizing that they can evaluate the effectiveness of non-prescription interventions—such as diet, supplements, exercise, sleep, breathing techniques, meditation, mindfulness, and other lifestyle modifications—without relying on medical institutions. Among these, the rapid advances in detecting and analyzing the roles of the gut microbiota have opened new dimensions in assessing the effects of diet. Additionally, the proliferation of portable sensors, imaging devices, and micro-blood testing services is raising expectations for the continuous collection of personal health data, potentially surpassing the discrete measurements typically conducted in medical institutions.

A more fundamental change accompanying this trend is the open access to specialized biomedical information on the Internet. This is supported by policies in the United States and the United Kingdom that mandate the public dissemination of research funded by public grants. As a result, the latest biomedical research findings are now easily accessible to the general public, particularly in English. This has led to a rapid increase in the number of Wise/Empowered Consumers11).

Major pharmaceutical companies in Western countries are now actively engaging in initiatives to make these empowered consumers and patients better partners in drug development. One example of such initiatives is the implementation of long-term patient education programs12).

Impact of New Discoveries and Technologies on the Pipeline

To summarize the points discussed so far, the current focus on Open Collaboration and Translational Research (TR) defines the present state of drug development. The next generation of healthcare, where pharmaceutical companies move beyond selling “products” to providing “solutions” for health, represents a significant shift. In this next-generation healthcare, likely between 2023 and 2030 (7 to 14 years from now), digitalization will advance, and an increasing number of consumers and patients will continuously monitor their health using simple measurement devices and DTC services. Preventive and predictive measures will become more critical, and the management of chronic disease progression will increasingly involve non-pharmaceutical interventions. Furthermore, treatments will become more tailored to the unique characteristics of individuals13).

During this transition, how will the R&D environment for pharmaceutical companies evolve? The first consideration is the impact of new discoveries in biomedical fields, emerging analytical and measurement technologies, and ICT/IoT advancements influencing all these areas. While the expectation of breakthrough drug developments following the Human Genome Project remains unmet, the pace of foundational discoveries and technologies is accelerating.

Even focusing solely on TR, numerous examples stand out: ultra-high-speed sequencing (NGS), advanced omics, extracellular RNA communication (exRNA), single-cell analysis, genome editing, embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), iPS cells, organ-on-a-chip technologies, molecular and cellular imaging, and brain imaging technologies like brain scans. Additionally, these wet-lab technologies are increasingly combined with ICT advancements, including supercomputers, big data, artificial intelligence (AI)—particularly deep learning and natural language processing (NLP).

While these breakthroughs and technologies are revolutionary, they are likely to be absorbed into existing drug development pipelines in specific areas. For instance, iPS cells and genome editing could create human cell models for specific diseases using cells derived from patients to explore drug targets14). Similarly, differentiated cells such as hepatocytes or cardiomyocytes from iPS cells could evaluate the safety of drug candidates15). Supercomputers, AI, or deep learning can be applied to massive combinations of target proteins and drug candidates to predict binding16), assess drug-likeness of compounds17), and estimate the success probability of clinical trials18). These innovations can make pipelines more efficient and improve success rates, as proposed in various studies.

Table 1. Innovation Challenges for Pharmaceutical Companies Transitioning to Health Solution Providers
EpG: Epigenetics, GxE: Genome-Environment Interactions, GOP/N: Genome-Omics-Pathway/Network, PHR: Personal Health Record, EMR: Electronic Medical Record.
Innovation Challenges Specific Tasks Biomedical Issues Information and Computational Techniques
Adaptation to Open Innovation Building platforms to quickly respond to new discoveries and technologies Absorption and utilization of new discoveries and technologies
Transition from Genome to EpG and GxE studies
Development of highly human-relevant model systems
Establishing co-creation platforms
Sharing information and knowledge
Supporting human resource development
Research on Proper Use of Drugs Selection of drugs tailored to individuals
Research on optimal timing and dosage
PGx, TGx studies
Biomarker discovery
Research on appropriate polypharmacy
Chronobiology research
N of 1 studies, dissemination of Point of Care
GOP/N approaches
Integration of PHR and EMR
Data analysis and pattern recognition
Knowledge processing and cognitive computational techniques
Natural language processing, control theory
Research on Non-Pharmaceutical Interventions Studies on the molecular basis of the effects and risks of lifestyle modifications (diet, exercise, sleep, etc.) PGx, TGx, NGx studies
Biomarker and health marker discovery
Chronobiology research
N of 1 studies, dissemination of Point of Care
GOP/N approaches
Integration of PHR and EMR
Data analysis and pattern recognition
Knowledge processing and cognitive computational techniques
Natural language processing, control theory
Establishing New Relationships with Consumers and Patients Encouraging patient involvement in drug R&D
Supporting participatory healthcare
Reducing participation barriers
Addressing ethical, legal, and social issues
Establishing co-creation platforms
Point of Care + N of 1 studies
Establishing co-creation platforms
Sharing information and knowledge
Providing learning opportunities
Data analysis and pattern recognition
Pipeline Reassessment Collaboration with external organizations Innovations in specific areas Full adaptation to ICT/IoT

Figure 1. Schematic representation of the current one-way pipeline
Figure 1. Schematic representation of the current one-way pipeline

Innovation in Drug Development for the Next Generation

However, efforts to adapt to these new discoveries and technologies will not automatically transform pharmaceutical companies into health solution providers. It is well-known that Japanese companies are adept at absorbing new scientific and technological advancements and turning them into innovative products for the market. Yet, for pharmaceutical companies to evolve into health solution providers, they must create new systems and develop new services. This requires a shift in values.

Of course, the specific innovations required will differ for each company, as differentiation and competition are fundamental principles in business. However, there are common challenges. Below is a brief list of these innovation challenges:

  1. Adapting to Open Collaboration
  2. Research on Proper Drug Usage
  3. Research on Non-Pharmaceutical Interventions
  4. Establishing New Relationships with Consumers and Patients
  5. Reassessing the Pipeline

Table 1 provides an overview of these challenges. Due to space constraints, detailed explanations are omitted, but it is important to note that these challenges are not independent; they are deeply interconnected. At the core of these connections lies the concept of patient-centered care in healthcare.

Open Collaboration

First, regarding open collaboration, one of the most significant missing elements in Japan’s current efforts is the participation of consumers and patients as active stakeholders in drug development. There are barriers to patients, as recipients of healthcare services, participating in research and development as equal partners. Foundational platforms must be established to lower these barriers. For instance, agreements on managing personal health records must be defined19), and educational programs for consumers and patients must be made available. In practice, open research initiatives with a translational research (TR) focus in Western countries place great importance on patient participation. For example, NIH/NCATS has established a framework called PCOR (Patient-Centered Outcomes Research) to support such involvement. The importance of patient participation is also widely recognized in drug development. In the EU, big pharma companies are exploring cross-disciplinary initiatives in this direction20). The importance of cancer patient participation is also a topic of discussion21). For example, understanding how patients perceive anticancer drugs is critical, as it has been pointed out that such insights are valuable. In Japan, it has even been reported that the side effects of anticancer drugs are often experienced at home22).

Research on Proper Drug Usage and Non-Pharmaceutical Interventions

Next, let us consider research on proper drug usage and non-pharmaceutical interventions together. While diet is the primary focus of non-pharmaceutical interventions, the ultimate goal of such research is to uncover the molecular basis of these interventions. Consequently, research on proper drug usage and non-pharmaceutical interventions, particularly diet, overlap significantly at the molecular level23). Both fields fundamentally investigate how the body responds to externally introduced compounds, and the underlying response pathways overlap substantially24). Moreover, both drugs and diet are influenced by gut microbiota. As the precision of microbiota testing improves, individual differences become more pronounced. Additionally, both humans and gut microbiota operate under circadian rhythms25). To consider personalized medicine and personalized nutrition, such conditions must be taken into account. In research, stratification of subjects that reflects these differences is necessary.

To broadly conduct such studies, it would be prudent to establish an open platform where stakeholders from various perspectives can participate, rather than having pharmaceutical and food companies isolate patients and consumers. Ultimately, this direction leads to research aimed at maintaining individual health through personalized medicine and personalized nutrition. Such advanced research is referred to as N-of-1 studies26), which represent a more refined methodology compared to current clinical trials. On the other hand, providing dietary advice tailored to individuals—diet being the most familiar non-pharmaceutical intervention—also converges on N-of-1 studies. The same applies to other interventions. However, it is unlikely that such research can be left solely to healthcare providers, including doctors and medical staff. Therefore, the participation of consumers and patients is a prerequisite for N-of-1 studies. Considering the interaction between diet and drugs, the same can be said about the proper use of drugs. Ultimately, research on diet, drugs, and toxins must be integrated into a unified health science.

What Types of Professionals Are Needed?

When considering healthcare innovation from the perspective of utilizing current and future ICT, a critical challenge is how to nurture or secure ICT professionals who will lead these efforts. These professionals will be involved in advising physicians and medical staff on decisions and actions to improve the quality of care. At the core of their responsibilities is the task of extracting knowledge from healthcare-related data (from data to knowledge; D2K) and translating it into actionable services. This advanced, experience-based work could be referred to as Translational Data Science—an art that involves high-level judgment. It encompasses various techniques in data handling, analysis, and modeling within computational science. Future hospitals will likely need to either employ many such data science professionals as full-time staff or establish stable, ongoing collaborations with groups of these specialists.

These professionals will work closely with healthcare providers, particularly physicians, to support decision-making in areas such as Evidence-Based Medicine (EBM) and Evidence-Based Supplements (EBS). These are essential for clinical medicine, drug development, preventive medicine, and research on health foods and supplements, often regarded as the “Holy Grail” of these fields. Thus, these professionals must possess sufficient biomedical knowledge and communication skills to engage in meaningful dialogue with clinicians and basic researchers. Unlike fields like number theory, where young geniuses such as Abel and Galois have historically emerged, statistics rarely produces prodigies; it requires extensive experience. Similarly, training the data science professionals mentioned above cannot be rushed. Like clinicians, they need time to accumulate experience.

Such professionals will likely be needed in all areas related to healthcare, not just in clinical settings. They might be referred to as D2K scientists for BioMedPharma & Nutrition. To drive the pull-type innovation in healthcare discussed earlier, it is essential to train these professionals as quickly as possible while also creating attractive career opportunities for them.

Reassessing the Pipeline

Drug development requires substantial investment, long development timelines, and efforts to meet increasingly stringent regulations. The pipeline represents the pharmaceutical industry’s accumulated wisdom in R&D management, aimed at mitigating these risks. Reassessing the pipeline highlights the critical role of consumer and patient participation27),28). For example, in the early stages of target discovery, the ability to gather more patients with the relevant condition improves the accuracy of the search. Similarly, in clinical trials, and even after market launch, patient and consumer collaboration can increase the number of participants and enable the collection of real-world data (RWD). This includes not only data from controlled environments like medical facilities but also self-reported data collected by patients themselves. Such data reflects how medications are actually used, providing insights into their real-world effectiveness. Efforts to use this data for the next generation of drug development are likely to increase.

This suggests that evaluating R&D departments by the proportion of candidate compounds they pass to the next stage will become an outdated and irrational approach. The current “Go” or “No Go” decisions at various pipeline stages may be unavoidable from a business perspective but increasingly questionable scientifically. Reforming this approach might require cross-functional organizations involving government, competitors, and academia.

In summary, new discoveries and technologies are absorbed into various interconnected steps within the pipeline. Each step is increasingly conducted in collaboration with external partners rather than entirely in-house. From a patent perspective, aspects beyond compound structure design can be advanced through external collaboration. Additionally, many stages involve research elements, creating iterative loops rather than linear workflows. The most evident examples are target discovery at the beginning and the refinement of patient selection, dosage adjustments, and timing during real-world use.

In 21st-century medicine, individualization (Personalized Medicine) and precision (Precision Medicine) have become the “Holy Grail” goals. Detailed analysis of human effects is now the most critical task. The challenge lies in how much can be understood about human effects before market launch and how effectively post-market data can validate initial hypotheses.

At this stage, the connection between pre-approval research and post-market studies should be strengthened, as should collaboration with healthcare providers, including clinicians. Additionally, in Japan, smoother coordination between administrative bodies overseeing pharmacists (responsible for drug regulation) and those influencing physicians is essential. Ultimately, the goal is to create a system focused on “patient-centered healthcare services,” breaking down barriers. Advances in the Internet and related technologies already provide the tools and environment to make this possible, leaving psychological resistance among stakeholders as the primary obstacle.

Currently, drugs emerge from the pipelines of individual pharmaceutical companies. For pharmaceutical companies to evolve into health solution providers, the existing pipeline model may need to be reconsidered. However, this entails challenges distinct from merely adapting to new technologies.

Figure 2. A pipeline including parallel processes and loops, with significant collaboration with external parties
Figure 2. A pipeline including parallel processes and loops, with significant collaboration with external parties.

Conclusion

At the beginning of this discussion, the pharmaceutical crisis was described as a crisis for the executives of major pharmaceutical companies. These executives attempted to navigate the crisis by employing various strategies: moving away from self-contained operations, withdrawing from high-risk therapeutic areas, engaging in mergers and acquisitions, closing R&D divisions, and buying back shares with surplus funds. Governments have supported the exploration of treatments for challenging diseases through translational research, areas where pharmaceutical companies are reluctant to take risks. The bipartisan 21st Century Cures initiative launched by the U.S. House of Representatives in 2014 is an excellent example of what politicians can achieve in addressing these challenges. Similarly, NIH and its NCATS patient-centered evaluation research, as well as the European pharmaceutical industry’s IMI programs to educate patients as “smart partners,” are refreshing experiments aimed at making patients partners in drug development for the next generation. These examples underscore the critical roles politicians and citizens can play in next-generation healthcare and new drug development.

Universities and academia are, of course, essential partners for pharmaceutical companies in next-generation healthcare. The challenge, however, is that politicians and citizens in Japan are not fulfilling roles similar to those in Europe and the United States29). The question is how to address this gap.

I believe that creating a community where nations, academia, pharmaceutical companies, analytical and measurement equipment manufacturers, information technology companies, researchers, engineers, and other stakeholders involved in drug development can share candid opinions and learn from each other is the first step toward a solution. This is because, while it is not often discussed, the pharmaceutical crisis is not only a crisis for executives with tenures of less than a decade but also a crisis for researchers and technical experts who are likely to be involved in this field for much longer.

Figure 3. The drug lifecycle. Is current research funding too concentrated on pre-market phases?
Figure 3. The drug lifecycle. Is current research funding too concentrated on pre-market phases?


References

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PROFILE
Tsuguchika Kaminuma

Tsuguchika Kaminuma

Born in Kanagawa Prefecture, Japan, in 1940. Educated at International Christian University, Yale University, and the University of Hawaii. Received a Ph.D. in Physics. Since 1971, has worked at Hitachi Information Systems Research Institute, the Tokyo Metropolitan Institute of Medical Science, and the National Institute of Health Sciences. Conducted research in pattern recognition, medical artificial intelligence, medical information systems, bioinformatics, and chemical safety. In 1981, founded an industry-government-academia research exchange organization (now CBI Society) aimed at theoretical drug design. Later engaged in interdisciplinary human resource development at Hiroshima University and Tokyo Medical and Dental University. Established the NPO Cyber Bond Research Institute in 2011.

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