The Applied Science Blog

Biotechnology transforms scientific breakthroughs into therapies that save lives, improve health, and redefine how we treat disease. But bringing a biotech product to market is not just about innovation — it’s a marathon involving research, regulation, manufacturing, and teamwork across many disciplines. In the U.S., the process is one of the most regulated, expensive, and high-stakes undertakings in science and business.

This article focuses on the U.S. biotech product development process, with a spotlight on four major categories: pharmaceuticals, biologics, gene therapies, and cell therapies. It outlines the timeline, teams, and regulatory milestones that shape the journey from scientific discovery to market-ready treatment. 

👉 “Our world is built on biology and once we begin to understand it, it then becomes a technology.” — Ryan Bethencourt, Biotech Entrepreneur

Biotech development begins with discovery — often in university labs or research institutes, sometimes within startups or major pharma R&D centers. Scientists identify a biological target, such as a gene mutation or protein malfunction, that contributes to a disease. They then look for molecules (small drugs or biologics) that can modulate or repair that target.

Once a lead candidate is selected, it enters preclinical testing. This includes:

• In vitro studies (test tubes, petri dishes)
• In vivo studies (animal models)
• Toxicology, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (what it does in the body)

Fun fact: Less than 1 in 5,000 compounds tested in discovery research makes it to clinical trials (PhRMA).

Roles involved:

• Molecular Biologists & Biochemists: Identify mechanisms and design molecules.
• Preclinical Pharmacologists: Run drug behaviour and toxicology studies.
• Computational Biologists: Use simulations to predict compound performance.
• Lab Technicians: Conduct cell-based assays and manage animal studies.

👉 “You’re not just making medicine — you’re creating living systems that heal.” —  Senior Process Engineer at Kite Pharma (name anonymized) 

Once preclinical data supports safety and a rationale for efficacy, companies file an Investigational New Drug (IND) application with the FDA. If approved, human clinical trials begin. This process typically takes 6 – 7 years and consumes 60 – 70% of total development costs (Tufts CSDD).

Phase I: First-in-human (20 – 100 volunteers)

• Assess safety, dosage, and side effects
• Usually healthy individuals unless drug is very toxic (e.g. cancer drugs)

Phase II: Efficacy (100 – 500 patients)

• Tests whether the drug works in a target population
• Monitors short-term side effects and optimal dosing

Phase III: Confirmation (1,000+ patients)

• Compares new treatment to standard of care or placebo
• Collects data for FDA review

Fun fact: The probability of a drug progressing from Phase I to approval is just 13.8% (BIO Industry Analysis).

 👉 “The FDA is both a regulator and a partner in advancing public health — their standards push innovation.” — Peter Marks, MD, PhD, Director, CBER

After successful trials, companies submit either:

• New Drug Application (NDA): For small-molecule drugs
• Biologics License Application (BLA): For biologics like antibodies or gene therapies

These applications can exceed 100,000 pages, detailing all preclinical, clinical, and manufacturing data (FDA).

The FDA review process (standard = 10 months; priority = 6 months) includes:

• Statistical review of trial data
• Inspections of manufacturing facilities
• Labelling and risk management plans

Fun fact: The FDA approved 55 new drugs and biologics in 2023.

Roles involved:

• Regulatory Scientists: Write and compile submissions
• CMC Specialists: Ensure that chemistry, manufacturing, and controls data are complete
• Medical Writers: Create patient labelling and physician guides

Biotech is not one-size-fits-all. It encompasses multiple classes of products — each with different scientific principles, production methods, regulatory challenges, and applications. Here's an accessible yet informative breakdown:

💊 Pharmaceuticals (Small Molecules)

These are chemically synthesized compounds, typically taken as pills or injections. They're small enough to enter cells and disrupt disease pathways directly. They're relatively simple to manufacture, store, and test.

Manufacturing: Synthesized in chemical reactors, often outsourced to contract manufacturers.

Example: Gleevec revolutionized treatment for chronic myeloid leukemia by targeting a specific mutation in cancer cells.

Fun fact: Small molecules account for over 90% of all medicines dispensed in the U.S. (FDA).

🧫 Biologics (Large Molecules)

These are protein-based therapies like antibodies or hormones produced using living cells (e.g., CHO cells). Unlike small molecules, they're large, fragile, and must be injected.

Production: Requires bioreactors, sterile facilities, and cold-chain transport.

Example: Humira (used for arthritis and Crohn’s disease) is one of the best-selling biologics globally.

Challenges: Harder to characterize due to molecular complexity; often more expensive.

Fun fact: The average biologic drug is 1,000 times larger than a small molecule in molecular weight.

🧬 Gene Therapies

These therapies introduce, replace, or silence genes to treat diseases at the DNA level. Most use viral vectors like AAV (adeno-associated virus) to deliver genetic material into cells.

Example: Zolgensma, a gene therapy approved in 2019 for spinal muscular atrophy, was the most expensive drug at launch — priced at $2.1 million. But its one-time administration replaces lifelong treatment costs (Novartis).

Production: Requires viral vector manufacturing in specialized cleanrooms.

Fun fact: As of 2024, over 30 gene therapies have received regulatory approval worldwide (Nature).

🧪 Cell Therapies

These involve transplanting living cells into patients. Some are autologous (from the patient), others allogeneic (from donors). CAR-T therapy, for example, uses a patient’s own immune cells, engineered to attack cancer.

Example: Kymriah treats certain leukemias using reprogrammed T-cells.

Challenges: Logistically complex — each batch is personalized, with strict chain-of-custody.

Fun fact: The FDA classifies many cell therapies as both a biologic and a medical procedure.

Each of these product types comes with its own regulatory path, team requirements, and commercial hurdles — yet all share the same foundational goal: translating biology into impactful, often life-saving, treatments.

👉 “Biotech isn't about one superstar; it’s about teams who solve complex problems in parallel.” — Robert Langer, MIT Professor & Moderna Co-Founder

Biotech product development is a deeply collaborative process that brings together a multidisciplinary workforce. From molecular design to commercial launch, the number of people involved—and the range of skills they bring—expands dramatically as the product progresses.

In early discovery, the effort might begin with a small group: 5 – 10 scientists, including molecular biologists, biochemists, and medicinal chemists, who design and test molecules to target specific disease mechanisms. Working in close quarters, they explore how the drug interacts with its target, run in vitro assays, and build early proof of concept in cell models.

As the molecule shows promise, the team grows. Process engineers and development scientists begin optimizing manufacturing, especially if the therapy involves complex biologics. Preclinical pharmacologists and toxicologists design and run animal studies to evaluate safety. By this point, the team may include 15 – 20 internal staff.

When the therapy moves to clinical trials, the scale increases significantly. Clinical operations teams, including clinical trial managers and research associates, coordinate with physicians across hospital sites. Biostatisticians plan data analysis, and regulatory affairs professionals oversee FDA submissions. A Phase III trial, for example, may involve thousands of patients and require coordination between hundreds of clinicians, data managers, and monitoring personnel.

Behind these operations are additional roles:

• QA specialists enforce compliance with GLP and GCP.
• Manufacturing engineers scale the process for clinical and commercial supply.
• Supply chain professionals manage sourcing and logistics, especially for cold-chain biologics.
• Commercial teams prepare for pricing, access, and physician education.
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Most biotech companies use cross-functional product core teams that include members from R&D, clinical, regulatory, manufacturing, quality, and commercial departments. 

Fun fact: A 2023 survey by BIO found that 75% of U.S. biopharma companies outsource part of their clinical operations, increasing team size and complexity dramatically.

👉 “Even fast biotech moves at the pace of biology — and biology doesn’t rush.” —  Program Manager at a U.S.-based oncology biotech company (anonymous) 

The oft-quoted figure for biotech product development is 10 – 15 years from initial concept to product launch (Lindus Health). This cumulative estimate includes a sequence of complex and interdependent phases, each requiring years of planning, execution, and regulatory oversight:

• Discovery & early research (2 – 4 years): This is where scientific ideas are born and tested at the molecular and cellular level. Teams identify promising biological targets and validate lead compounds through lab and computer-based screening.
• Preclinical development (1 – 2 years): Once a candidate shows promise, it undergoes animal testing to assess safety, toxicity, and preliminary efficacy. These studies are essential for securing FDA approval to begin human trials.
• Clinical trials (5 – 7+ years): Human testing proceeds through Phases I, II, and III, each larger and more complex than the last. These phases evaluate safety, dosing, efficacy, and real-world comparisons. It is the longest and most resource-intensive part of the journey.
• Regulatory review (1 – 2 years): Following successful trials, companies submit vast data packages to the FDA. Even with priority review, preparing and responding to regulator questions can stretch over many months.

Some projects move faster. Therapies for urgent unmet needs may qualify for breakthrough designation or accelerated approval pathways from the FDA. The most dramatic example: The Pfizer–BioNTech COVID-19 vaccine progressed from first human dosing (April 2020) to Phase III results (November 2020) in just 7 months, a feat made possible by global collaboration and overlapping trial phases (FDA).

More commonly, biotech companies spend years raising funding, refining their strategy, and adjusting to trial data. As StarFish Medical notes, small companies often underestimate how long it takes to move from preclinical proof to clinical readiness — a process slowed not just by science, but by regulatory prep, hiring, and manufacturing readiness (Starfish Medical).

👉 “Every successful drug has a quiet army behind it — scientists, clinicians, logisticians, all pushing forward for years.” — Carl June, developer of CAR-T therapy

Let’s consider a hypothetical oncology biotech startup:

Years 1 – 2: A team of 5 – 10 scientists identifies a promising molecule targeting a cancer-related protein. They confirm activity in vitro and in mice, while process engineers begin pilot manufacturing studies using CHO cells.

Year 3: The company files an Investigational New Drug (IND) application. FDA approval allows them to begin a Phase I trial in 20 – 50 patients with late-stage cancer. The company hires clinical trial managers, a QA lead, and adds 10 – 15 staff.

Years 4 – 6: A Phase II trial involves 150 patients across multiple hospitals. The team now includes 30+ internal employees coordinating with dozens of clinicians and CROs.

Years 7 – 9: A Phase III trial recruits over 1,000 patients across hundreds of sites globally. The regulatory affairs team prepares the New Drug Application (NDA) — a submission often exceeding 100,000 pages.

Year 10: After regulatory review and manufacturing scale-up, the drug is approved. The commercial team launches outreach to oncologists and insurers. Total direct team size: 80+ internal; 200+ external.

Biotech product development demands long-term vision, deep technical skill, and an unwavering commitment to detail. Projects are lengthy, costly, and often uncertain — but for those who succeed, the reward isn’t just financial. It’s measured in lives changed, diseases cured, and a scientific legacy that echoes far beyond the lab bench.

The real heroes of biotech are the teams who show up every day, balancing precision with creativity, rigour with resilience. It’s a space where biology becomes medicine, and medicine becomes hope.

👉 “The next decade will redefine medicine—not just how we treat disease, but how we understand the body as a programmable system.” — George Church, Geneticist and Biotech Visionary

The next chapter of biotech is already unfolding, driven by radical breakthroughs and an urgency to do better, faster, and more affordably:

CRISPR Comes of Age: With the 2023 approval of Casgevy for sickle cell disease and beta thalassemia, gene editing is no longer just a laboratory marvel — it’s a clinical reality (FDA). These approvals signal a shift where programmable gene repair may soon be applied to a wider range of conditions, from rare inherited disorders to certain cancers.

mRNA Therapies Beyond COVID: Building on the success of COVID vaccines, mRNA is being reimagined for everything from personalized cancer vaccines to therapies for rare metabolic diseases. Moderna, BioNTech, and others are already in human trials for these next-generation applications. The promise? Designing a new therapy in weeks, not years.

AI-Powered Drug Discovery: Biotech startups like Recursion and Insilico Medicine are pairing machine learning with biological data to predict drug candidates, optimize molecular design, and repurpose old drugs for new uses. The AI revolution may not replace scientists — but it’s becoming their most powerful lab partner.

Decentralized Clinical Trials: The pandemic accelerated a shift toward remote and hybrid clinical trials. With wearable devices, mobile apps, and home nursing, patients can now participate in research without frequent hospital visits. This model increases accessibility and diversity in trials — two longstanding challenges in clinical research.

Together, these advances hint at a future where biotech products are safer, smarter, and more tailored to individuals. The vision is bold: cures instead of treatments, precision instead of probability, and access without delay.

Biotech product development may take a decade or more and cost billions of dollars, but its value is immense: it improves our health, extends our lives, and builds a quiet trust in the invisible systems that protect us. When we take a pill, receive a vaccine, or undergo a gene therapy, we rarely think of the teams and trials behind it — yet we rely on their care, precision, and science to make sure we recover, not suffer. We are no longer paralyzed by fear of disease; we are inspired by the progress that makes healing possible. That is the quiet power of biotech — and the promise it continues to deliver.