The Layman's Quick Guide to the Drug Research and Development (R&D) Process

Drug research and development (R&D) is a core pharma business area that's time-consuming, costly, and has a low success rate.

Just how costly and time-consuming is it? According to recent food and drug administration (FDA) statistics, the drug development process, from the moment of discovery up to final approval, takes at least 10 years and costs on average USD $2.6 billion.

In addition, less than 10% of drugs make it from discovery to market.

The Complete Drug R&D Process

The complete drug R&D process is divided into five main stages: discovery and development, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring.

Here are the five stages in greater detail:

Stage 1: Discovery and Development

Research for a new drug begins in the laboratory. At this stage in the process, thousands of compounds may be potential candidates for development as medical treatments.

These compounds come from natural sources — compounds extracted from medicinal plants or organisms — and synthetic chemical sources.

After these compounds undergo initial testing, only a select number of the promising compounds are selected for further study. Once researchers identify a promising compound for development, they conduct further experiments to answer key questions such as:

  • How is the compound absorbed, distributed, metabolized, and excreted?
  • What is the best dosage?
  • What is the best way to administer the compound?
  • What are its side effects?
  • How will it interact with other drugs?
Stage 2: Preclinical Research

In this stage, drugs undergo laboratory and animal testing to answer basic questions about safety.

Preclinical research is comprised of two types:

  • in vivo: Latin for "within the living," it involves experimentation conducted on living tissue within living organisms in a controlled environment.
  • in vitro: Latin for "within the glass," it involves experimentation conducted on living tissue outside of living organisms in a controlled environment.

These studies can provide detailed information on dosing and toxicity levels, and help researchers decide whether the drug is safe enough to be tested in people.

Stage 3: Clinical Research

This stage involves the evaluation of drugs tested on people to ensure they are safe and effective.

The clinical research phase is comprised of four sub-phases:

Phase Length of Study Subjects Purpose
Phase I Several months 20 to 100 healthy volunteers Safety and dosage
Phase II Several months up to 2 years Up to several hundred volunteers with the disease/condition Efficacy and side effects
Phase III 1 to 4 years 300 to 3,000 volunteers with the disease/condition Efficacy and monitoring of adverse reactions
Phase IV Post-approval All patients are taking the drug Safety and efficacy
Stage 4: FDA Review

The FDA review teams thoroughly examine all submitted data related to the drug (or device) and make a decision on whether to approve or not to approve it.

Stage 5: FDA Post-market Safety Monitoring

The FDA monitors drug and device safety once products are available for use by the public (e.g. Phase IV clinical research).

The Challenges facing Drug R&D

Drug R & D is essential for the sustainable development of pharmaceutical companies, especially large multinationals. However, the reality is that R&D productivity is declining, costs are rising, and the odds of developing "blockbuster" drugs are becoming increasingly unfavorable.

Pharmas are continuing to adapt to these challenges in a variety of ways including restructuring their operating/business models. However, finding the right solution(s) to the growing problem of R&D productivity is proving as elusive as the quest for the next blockbuster drug.

What do you think are some of the biggest challenges impacting the drug R&D process? Share your thoughts with us by commenting below!

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