By David | Updated October 12, 2026
Biotech R&D (research and development) is the work of discovering a new therapy in the laboratory, testing it for safety, proving it works in people, and getting it reviewed by regulators. In the United States, the FDA breaks the drug development process into five steps: discovery and development, preclinical research, clinical research, FDA review, and post-market safety monitoring.
What Is Biotech R&D?
Biotech R&D covers everything that happens before a medicine reaches patients. For biotech products such as vaccines, monoclonal antibodies and gene therapies, the work often starts with biology: understanding a disease, finding a target, and designing a candidate treatment. If you are new to the products themselves, start with our guide to biotech medicine and how biologics differ from conventional drugs.
The Five Steps of Drug Development
| Step | What happens |
|---|---|
| 1. Discovery and development | Research for a new drug begins in the laboratory |
| 2. Preclinical research | Laboratory and animal testing answers basic questions about safety |
| 3. Clinical research | The drug is tested on people to make sure it is safe and effective |
| 4. FDA review | FDA teams examine all submitted data and decide whether to approve |
| 5. Post-market safety monitoring | The FDA monitors safety once the product is available to the public |
These five steps and their descriptions come from the FDA’s drug development process overview.
Step 1: Discovery and Development
In the discovery stage, researchers may look at thousands of compounds to find candidates that could become a treatment, according to an Avantor Sciences overview. The goal is to find something that can stop or reverse a disease or ailment.
Step 2: Preclinical Research
Before a candidate is tested in people, it goes through laboratory and animal studies. A central aim at this stage is to check whether the drug could cause harm, so toxicity testing is a high priority.
Step 3: Clinical Research
Clinical trials involve people. They are typically run in phases, from small Phase 1 studies to large Phase 3 trials. Before human testing can begin, the developer must submit an Investigational New Drug (IND) application describing the preclinical results, the drug’s composition and manufacturing, and the plan for human testing (Friends of Cancer Research). The FDA review team has 30 days to review the original IND submission (American Pharmaceutical Review).
Phase 3 trials are the largest and often compare the new treatment with a control group (Friends of Cancer Research).
Step 4: FDA Review
After completing the trials, the sponsor submits a New Drug Application (NDA), or a Biologics License Application (BLA) for biological products, formally requesting approval (Friends of Cancer Research). FDA officials then review the data to judge the product’s safety and effectiveness.
Step 5: Post-Market Safety Monitoring
Approval is not the end. The FDA continues to monitor safety once the product is in use by the public.
How Long Does Biotech R&D Take?
Estimates vary by source and by product.
| Source | Estimate |
|---|---|
| Friends of Cancer Research | About 8.5 years on average from early discovery to approval for human use |
| American Pharmaceutical Review | About 10 to 12 years from discovery to approval |
The same American Pharmaceutical Review article reports that only about 8 to 10% of drug products that reach the preclinical phase become FDA-approved products. This is one reason R&D is expensive and risky.
Where Manufacturing Fits In
R&D does not stop at the lab bench. The IND application must describe how the drug is made, and a biologic’s process can affect the product itself. To see how a candidate becomes a consistent medicine at scale, read our guide to biotech manufacturing and how biologic drugs are made.
Frequently Asked Questions
What does R&D mean in biotech? Research and development: discovering a new therapy, testing it, and preparing it for regulatory review.
How many steps are there in drug development? The FDA describes five: discovery and development, preclinical research, clinical research, FDA review, and post-market safety monitoring.
What is an IND application? It is the application a sponsor files with the FDA before human trials, describing preclinical results, the drug’s composition and manufacturing, and the plan for human testing.
What is the difference between an NDA and a BLA? An NDA is the application for a new drug. A BLA is used for biological products.
Why do so few drug candidates reach patients? Candidates must pass safety and effectiveness tests at every step. One review reports that only about 8 to 10% of products entering the preclinical phase end up FDA approved.
This article is for general information only and is not medical advice.
Related Reading
- Biotech Manufacturing Explained: How Biologic Drugs Are Made
- Biotech Medicine Explained: What It Is and How It Works
- Biomanufacturing Updates: [add link when published]
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