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The Life Cycle of Pharmaceutical Drug Discovery From Bench to Bedside

Gaining an appreciation for the drug discovery process and its prospects in a tech-led future.

To meet medical needs, understanding the process of drug discovery is essential for the formulation of pharmaceuticals. In order to bring light to the drug discovery process and how companies are developing their manufacturing and discovery processes as well as ensuring employees have the necessary skillset, APBN was granted an exclusive interview with Dr Tomoyuki Igawa, Director, Chief Executive Officer, and Research Head from Chugai Pharmabody Research to learn more.

 

1. Could you describe what the current process is like for drug discovery from bench to bedside?

Drug discovery activities start by selecting a disease with significant unmet medical need. Then we try to find and validate a target that could potentially solve that need. Targets can be discovered through basic research of mouse genetics, analysis of clinical samples from patients, and translational research. In many cases, pharmaceutical companies collaborate with academia on new targets identified through the basic research at universities. Once we identify a target, we will select the right modality to make the target into a drug. Modality means the shape or type of drug molecule. In the old days, most drugs were made of synthetic small molecules. Although small molecules remain common, proteins and antibodies have become important modalities. Moreover, nucleic acids, viruses and cells can also be used as a modality. Selecting the right modality for the right target is critically important for successful drug discovery. Once the modality is decided, a clinical candidate molecule is selected through the lead identification and lead optimization process. The molecule needs to be optimized in various aspects such as efficacy, pharmacokinetics, safety, formulation stability and manufacturability. Once we confirm the pharmacological effect and safety profile of the molecule, we move on to preclinical development and CMC (Chemistry, Manufacturing, and Controls) development, and eventually move forward to the phase 1 study.

 

2. In what ways could we make the drug discovery process more efficient?

We have ways to make the drug discovery process more efficient and creative.

Firstly, we can collaborate with diverse expertise including other academic fields or industries—teaming up with or involving personnel with different expertise brings us new ideas and new solutions for unfamiliar issues.

Secondly, biomedical experiments require a lot of routine and repetitive experiments, which takes away precious time from the scientists. However, if we can automate those processes with robots and machinery, scientists can use their time to work on more creative things. Actually, the use of technological advancements is expanding beyond such simple tasks. For example, artificial intelligence has started to show great potential in more sophisticated and creative areas including target discovery and de-novo design of new molecular entities – areas where people used to think that machines could not replace human work. These approaches may not only improve efficiency, but also reshape the drug discovery process itself, potentially finding new drugs which conventional approaches cannot achieve.

Thirdly, another approach is to establish closer relationships between academia and industry and share roles between academia and industry more appropriately based on their unique strengths.

 

3. What are some important skillsets that are necessary to drive future growth in the drug discovery industry?

Since drug discovery requires a very broad range of knowledge, skills and experiences, I cannot identify specific skillsets that are necessary. You need biology, biochemistry, chemistry, analytical science, engineering, pharmacokinetics, toxicology, etc. For future growth, additional skills such as data management, machine learning, artificial intelligence and robotics are in high demand as these technologies may change the future of drug discovery.

 

4. What are the current technologies used in the early-stage drug discovery process?

There are too many for me to list out but, at Chugai Pharmabody Research, we conduct research on the generation of new antibody drug clinical candidates focusing on high value First-in-Class and Best-in-Class antibodies. Focusing on a variety of targets and utilizing Chugai’ s proprietary innovative antibody engineering technologies such as the “Recycling Antibody” technology and the “Sweeping Antibody” technology.

 

5. How can pharmaceutical companies further develop and nurture the skills of their employees to better prepare them for the future advancements in the industry and increase efficiency in research activities?

Scientific skills (logical and critical thinking, new ideas, connecting seemingly unrelated things together, communication and discussion skill, etc.), currently required will continue to be even more important, even when many of the experiments can be done by robots. These skills can be developed through engagement in drug discovery projects. In addition to having time for on-going projects, a company should also provide employees with sufficient time for thinking about new ideas and discussing them with others and trying some feasibility studies without any fear of failure. This will foster various skills and the mindset required for drug discovery.

 

6. Currently, are there any ongoing collaborations with Chugai Pharmabody Research and any government body or academia in Asia Pacific?

We are collaborating with A*STAR to discover and develop a therapeutic antibody against Dengue viruses. Also, we are continuously talking with multiple PIs in Singapore academia to identify potential collaborations.

 

7. What are some challenges faced by pharmaceutical companies in the process of drug discovery?

The bar for new drug development is becoming higher because many easily druggable targets have been exhausted, and the remaining unmet medical needs are becoming more difficult to solve. Thus, the success rate of drug discovery is becoming lower. Improving the return on investment or research productivity is required. Cancer immunotherapy is one of the hottest fields in the pharma industry in both discovery research and clinical development. In this field, there’s still a lot of translational gaps in the results between animal models and human patients, and the results in animal models do not often work in human patients, which leads to failure in clinical development. Thus, many companies are working on similar validated target which makes the competition even more severe.

 

8. Could you highlight the areas of study should students focus on to pursue a career in early stage drug discovery?

Since drug discovery requires lots of expertise from different areas, such as biology (immunology, oncology, infection, etc.), biochemistry, genetics, chemistry, omics, analytical science, protein engineering, pharmacokinetics, toxicology, drug delivery, gene editing, cell therapy, and even information technology, students should focus on specific areas of their own interest; becoming truly an expert in their field of interest is the closet way to pursue a career in drug discovery. [APBN]


About the Interviewee

Dr Tomoyuki Igawa

Tomoyuki Igawa, Ph.D., is currently the Chief Executive Officer of Chugai Pharmabody Research in Singapore and is responsible for Chugai group’s antibody/biologics drug discovery research covering all disease area and technology development. He has started working at Chugai Pharmaceutical as Research scientist and had experiences as project leader for emicizumab and satralizumab. He graduated and awarded PhD from University of Tokyo for studies in Engineering, Chemistry and Biotechnology. After a couple of years as Research Scientist working on early CMC development and pharmacokinetics of monoclonal antibodies, he focused on antibody engineering which lead to the discovery of bispecific antibody HEMLIBRA® (emicizumab) for hemophilia A, recycling antibody and sweeping antibody technology for various applications. Dr. Igawa likes to work in the area of interface between antibody technology and disease mechanism especially for unmet needs in the world.