Beyond brick and mortar

The biopharmaceutical industry has developed vaccines to protect against more than 30 diseases, including the ones to help prevent COVID-19, meningococcal diseases, Ebola, malaria, and human papillomavirus (HPV). Research-based companies have also developed more than 470 medicines for cancer, cardiovascular diseases, and diabetes in the last 10 years, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in a 2023 report.

The IFPMA added that today, there are more than 9,000 medicines in development across all therapeutic fields and about 260 vaccines in the pipeline.

The biopharmaceutical industry has consistently invested in research and development. It is estimated that it spent about $198 billion globally, even at the height of the pandemic in 2020. Compared with other high-technology industries, the annual spending by the biopharmaceutical industry is 8.1 times greater than that of the aerospace and defense industries. Investments in pharmaceutical R&D are also 7.2 times more than that of the chemicals industry, and 1.2 times more than that of the software and computer services industry.

R&D involves screening compounds that exhibit the potential for treating new or existing conditions or protecting against specific diseases. On average, researchers identify one promising compound among 5,000 to 10,000 screened. Researchers then extensively test the compound to ensure its efficacy and safety, a process that can take 10 to 15 years for both a medicine and a vaccine.

Most of the R&D process — in terms of investments and duration — happens during the clinical trial process. Clinical trials refer to studies where people participate as patients or healthy volunteers, the US Food and Drug Administration (FDA) explained. The Pharmaceutical Research Manufacturers of America (PhRMA) said clinical trials are carefully designed studies that establish the benefits and risks of a medical treatment or intervention.

Following a rigorous screening and preclinical testing process, PhRMA said the company will file an Investigational New Drug (IND) with regulators. This application will allow investigational medicine to be tested on human volunteers in clinical trials. In every clinical trial, respecting as well as protecting the safety of volunteers are of the highest importance.

There are different phases in a clinical trial. The UK National Institutes for Health (NIH) explained that a Phase I trial tests an investigational drug on a small group of often healthy people to determine its safety and side effects, as well as find the correct drug dosage. A Phase II clinical trial, on the other hand, has participants up to 300 people. The emphasis at this stage is to establish the efficacy of the investigational drug on people who have a certain disease or condition. A Phase III clinical trial, meanwhile, gathers about 3,000 people to study different populations and different dosages. Under Phase III, investigational medicines are studied in combination with other drugs.

The primary value of clinical trials is focused on health and science. The FDA said some people participate in clinical trials because none of the approved treatment options have worked or they are unable to tolerate certain side effects. Trials also contribute to the advancement of medical knowledge.

While the drug discovery and pre-clinical trial steps last for three to six years and make up 14.9% of total R&D expenditures, the clinical trial process lasts for about six to seven years and makes up 49.2% of total R&D spending.

A quick search on the clinicaltrials.gov portal indicated that in the Philippines, there are at least 200 active and/or recruiting clinical trials. The majority of this is being carried out by global pharmaceutical companies that are also currently operating in the country.

In the Philippines, clinical trial investments are estimated to be at P29-30 billion annually, ranging from non-physical assets, soft infrastructure, human capital development, and scientific and medical knowledge transfer.

It is also to be noted that the conduct of clinical research requires highly technical and qualified personnel — ranging from doctors, nurses, pharmacists, biostatisticians, and many others. With these, the conduct of clinical trials in the country is a huge investment opportunity that yields jobs and fosters a culture and environment of innovation.

The Philippines once ranked second to Singapore in the number of clinical trials conducted in 2010. Beyond brick-and-mortar manufacturing, the country can seriously consider clinical trials as one of the low hanging fruits or ways by which it could potentially bring about health, innovation and progress.

 

Teodoro B. Padilla is the executive director of Pharmaceutical and Healthcare Association of the Philippines (PHAP). PHAP represents the biopharmaceutical medicines and vaccines industry in the country. Its members are in the forefront of research and development efforts for COVID-19 and other diseases that affect Filipinos.

Beyond brick and mortar
Philippines Pandemic