Oncology Drug Development Process: Every Stage, and Where Manufacturing Fits In

So let’s walk through the oncology drug development process properly: every stage, what actually happens in it, how long it tends to take, and the part most guides skip, which is when and how the drug has to be made. If you are a biotech founder, a sponsor, or someone who just got handed a CDMO shortlist, this is meant to save you a few painful lessons.

The oncology drug development process at a glance

The US FDA describes drug development as five steps. Oncology follows the same backbone, but with its own twists: toxic compounds, patient-based early trials, and a lot of use of expedited review routes. Here is the map before we zoom in.

1. DiscoveryTarget and lead compound
2. PreclinicalLab and animal studies
3. IND filingFDA clearance to test in people
4. Clinical trialsPhase 1, 2 and 3
5. Regulatory reviewNDA or BLA
6. Post-marketPhase 4 and safety tracking

Figure 1: The stages of oncology drug development. Clinical trials (highlighted) are where most of the time and risk sit.

Stage 1: Discovery, where the idea starts

Everything begins with biology. Researchers look for a target, usually a protein or pathway that helps a tumor grow or survive. Then they screen large libraries of compounds to find ones that hit that target. According to the FDA, thousands of compounds may be potential candidates at this point, and only a small number look promising enough to move forward.

The survivors get tweaked. Chemists adjust the structure to improve potency, reduce side effects and make the molecule behave better in the body. This is also the first moment a smart team starts asking a question that will matter for years: can this molecule be made consistently, at scale, in a form patients can take?

Stage 2: Preclinical research and the IND application

Before a single patient is dosed, the compound goes through laboratory and animal studies. The goals are simple to say and hard to achieve. How does the body absorb, distribute, metabolize and clear it? What is the toxicity? What dose might be safe to start with?

When that package looks solid, the sponsor files an Investigational New Drug (IND) application. Per the FDA, it must include animal study and toxicity data, manufacturing information, clinical protocols and details on the investigators. The FDA then has 30 days to review it. Note that “manufacturing information” is part of the list. Regulators want to know how the drug is made before anyone takes it.

Stage 3: Clinical trials, the long and risky middle

This is where programs win or lose. Oncology trials often enroll patients with the disease right from the early phases, because many cancer drugs are too toxic to test on healthy volunteers. Here is how the three phases line up, using the FDA’s published ranges.

Table 1: Clinical phases and their typical scale. Source: US FDA, Step 3: Clinical Research.

Why so many oncology programs fail

The numbers are sobering. A well-known analysis by Wong, Siah and Lo, covering more than 24,000 oncology development programs between 2000 and 2018, put the chance of moving through each phase like this:

Figure 2: Probability of success by phase for oncology programs. The authors used a path-by-path method, so the phase figures do not multiply neatly into the overall number. Source: DIA Global Forum.

The takeaway is not “give up”. It is that every avoidable delay costs real money in a field where most candidates will not make it. A drug supply problem that stalls a trial for six months is an expensive way to lose.

Stage 4: Regulatory review

After Phase 3, the sponsor submits a New Drug Application (NDA), or a Biologics License Application (BLA) for biologics. The package covers everything from preclinical data to Phase 3 results, plus proposed labeling and manufacturing details. Once the FDA accepts the application as complete, the review team has 6 to 10 months to decide.

Oncology drugs frequently qualify for expedited routes such as fast track, breakthrough therapy designation, accelerated approval and priority review. These can shorten the path, but they also compress the time you have to get commercial manufacturing ready. Teams that wait for approval before thinking about scale-up find that out the hard way.

Stage 5: Post-market monitoring

Approval is not the finish line. Phase 4 studies and ongoing safety monitoring continue once the drug is in real-world use, often involving several thousand patients. Rare side effects and long-term outcomes only show up at that scale. This is also when reliable, consistent supply becomes a patient issue, because people on cancer therapy cannot simply skip a month.

Where manufacturing fits into every stage

Here is the part that often gets treated as a footnote. The drug has to be made at every step, and the requirements change as you go. This is exactly where a CDMO earns its place, taking on development and manufacturing work so the sponsor can focus on the science and the trials.

Table 2: How manufacturing needs change across development stages.

If you are still deciding whether to build capacity yourself or outsource, this breakdown of CDMO versus in-house manufacturing is worth a read. And for the broader picture of how outsourcing works, our plain guide to pharmaceutical contract manufacturing covers the basics.

Why oral oncology drugs need special handling

A lot of modern cancer treatment comes as a tablet or capsule: kinase inhibitors, hormone therapies and similar targeted drugs. They are convenient for patients, but the active ingredients are often highly potent. A tiny amount of airborne powder can be a real exposure risk for the people making them.

That is why high-potency manufacturing relies on containment ratings known as occupational exposure bands, or OEBs. Facilities built for the top band need engineered controls through the entire process, not just a good set of gloves. If you want the detail, we explain it in our guide to OEB Level-5 containment in oncology manufacturing.

How Pinnacle Life Science supports the manufacturing side

To be clear about scope: Pinnacle Life Science focuses on the manufacturing end of this journey, specifically oral solid dosage oncology products, rather than on discovery or clinical research. It is a subsidiary of Aarti Drugs Ltd. and makes its products in Baddi, Himachal Pradesh. For the wider context on that region, see our look at Baddi as a pharma manufacturing hub.

Figure 3: Pinnacle Life Science at a glance. Source: Pinnacle’s About us page.

A few specifics, all drawn from Pinnacle’s own published information:

• Oncology block with high-potency containment. The Baddi facilities are described as equipped for OEB Level-5 oncology oral solid dosage programs, with dispensing, granulation, compression, film coating and primary packaging running inside isolator systems. See the infrastructure page for the facility overview.
• Regulatory track record. Pinnacle reports that it completed a US FDA audit of its oncology block in April 2023 and a UK MHRA audit in June 2023.
• R&D support. The R&D division supports patent non-infringing formulations, as well as immediate-release and modified-release products.
• Supply continuity. Pinnacle says its link with Aarti Drugs Ltd. supports API supply resilience, which matters most in the post-market row of Table 2, when supply cannot afford to wobble.

Oral oncology products on Pinnacle’s list

Here are the oncology molecules currently listed on the products page, along with what they are used for.

Table 3: Oncology products listed by Pinnacle Life Science. Check the product pages for current strengths and dosage forms.

What to ask before you pick a manufacturing partner

Whichever stage you are at, a few questions separate a reliable partner from a risky one. Can they show containment evidence, not just claim it? Can they take you from development to commercial scale? Have they handled technology transfer before? Do they have real capacity right now? We cover each of these in our 7-point checklist for choosing an oncology CDMO, and if you are comparing options in the region, what to know before partnering with a CDMO in India is a useful companion read.

Frequently asked questions

What are the main stages of the oncology drug development process?

Discovery, preclinical research (including the IND application), clinical trials in three phases, regulatory review through an NDA or BLA, and post-market monitoring. Manufacturing runs alongside all of them.

How long does oncology drug development take?

There is no single number, because it varies a lot by drug. The FDA’s own ranges give a feel for it: Phase 1 takes several months, Phase 2 takes several months to 2 years, Phase 3 takes 1 to 4 years, and the FDA review adds 6 to 10 months once the application is accepted. Discovery and preclinical work come on top of that.

Why do so many oncology drugs fail in clinical trials?

Cancer is biologically complex, and a drug that shrinks tumors in the lab may not work, or may be too toxic, in people. In one large analysis, only about 3.3% of oncology programs went from Phase 1 all the way to approval.

What is an IND application?

It is the filing a sponsor submits to the FDA before starting human trials. It includes animal and toxicity data, manufacturing information, clinical protocols and investigator details. The FDA has 30 days to review it.

When should a company involve a CDMO?

Earlier than most teams expect. Clinical supply, formulation work and technology transfer all need planning well before Phase 3, and expedited approval routes leave little room for catching up on scale-up after the fact.

What makes oral oncology drug manufacturing different?

Many oral cancer drugs are highly potent, so facilities need strict containment to protect workers and prevent cross-contamination. That usually means engineered controls such as isolators, along with tightly managed documentation and quality systems.

Sources: US FDA, Step 3: Clinical Research; US FDA, Step 4: FDA Drug Review; US FDA, Step 1: Discovery and Development; DIA Global Forum, What Are the Chances of Getting a Cancer Drug Approved?. This article is for general information and is not medical advice.