The promise of the R&D pipeline

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Medicine Cabinet

GROWING scientific knowledge and the rapidly increasing pace of technological advances are ushering in an era of endless possibilities for the prevention, treatment, and management of diseases and conditions affecting patients and their families.

Fueled by the commitment to bring new medicines from laboratory to patients around the world, biopharmaceutical companies are working on a robust pipeline of medicines currently in development.

The publication Biopharmaceutical Research Industry Profile said that there are more than 7,000 potential medicines in clinical development around the world. These are medicines in development for a wide array of diseases and conditions targeting both non-communicable and infectious diseases.

Leading the strong pipeline are medicines for cancers with 1,909 potential treatments in development, followed by neurological disorders at 1,308; infectious diseases, 1,261; immunological disorders, 1,123; cardiovascular, 563; mental disorders, 510; diabetes, 401; and HIV/ AIDS, 208.

Experts said that more than 70% of medicines in development are potential first-in-class medicines with a mechanism of action distinct from any other available drug. These medicines are beneficial to patients who may not have responded to existing treatments, or have no therapy options available at present. First-in-class medicines could also bring in greater efficacy, improved delivery, or fewer side effects.

Equipped with deeper understanding of the molecular underpinnings of a disease, researchers are also developing a new wave of targeted therapies. The said biopharmaceutical report disclosed that 42% of medicines in development have the potential to be personalized medicines while 73% of cancer medicines have the potential to be personalized.

Personalized medicine is sometimes referred to as precision or individualized medicine. It is often associated with convenience and distinct service, according to one’s preferences. However, personalized medicines do more than that, as they attempt to meet an individual requirement and customize a unique solution, one patient at a time.

The publication Value of Personalized Medicine said that it is “an emerging field of medicine that uses diagnostic tools to identify specific biological markers to help assess which medical treatments and procedures will be best for each patient.” This is a revolutionary approach as an individual’s response to any medicine is highly dependent on his own molecular profile. It has been found that small differences such as in formulation or dosing can also affect the way the medicine works for a particular patient, its impact adherence, and ultimately a patient’s quality of life.

A biological marker or biomarker is “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, disease processes, or biological responses to a therapeutic intervention.” Biomarkers can be used to reduce uncertainty and guide clinical care as biomarkers are detected from a patient’s protein analysis, biopsy, and gene sequencing, among others.

Personalized medicine is here to stay. In 2015, more than 25% of new drug approvals were personalized medicines. In the same year, 35% of cancer approvals were personalized medicines, the Pharmaceutical Research and Manufacturers of America reported.

Personalized medicines, along with the thousands of medicines and vaccines in development, do not only offer the best treatment for each patient. They also provide hope, one of the essential ingredients needed not just to survive but to lead a quality life.

Medicine Cabinet is a column of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), representing the research-based medicines and vaccines sector in the country. The author is the executive director of PHAP.