All drugs approved in the U.S. marketplace over the past 30 years, whether over-the-counter or prescription, went through an extensive, multi-year, multi-million dollar journey before being available to patients. It’s a significant undertaking, riddled with risk, oversight, and regulation. To bring a new drug to the marketplace requires extensive resources, technical acumen, and an unwavering commitment to the goal: approval. By choosing the right partnerships, you can give your drug development program the competitive advantage it needs to reach the marketplace.
Below, I’ve broken down the U.S. drug development cycle.
What is a Drug Development Cycle?
The U.S. drug development process, as outlined by the FDA includes five steps:
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- FDA Post-Market Safety Monitoring
Let’s take a look at each step in a bit more detail.
Discovery and Development
The discovery and development phase is where new drugs and medications are discovered. The source of inspiration behind drug discovery is wide and varied. Some common origins include:
- Creation of new chemical or organic compounds
- New insights about an existing disease
- Molecular compound testing as a means to use existing drugs to treat additional diseases
- Alternative options to existing treatments
- New technologies for delivery, like innovative complex drug delivery systems including transdermal patches and oral thin films
Developing the formulation is an essential component of researching and developing a new drug. At Tapemark, we rely on our onsite formulation laboratory and subject matter experts to develop drug formulations for transdermal, thin film, or topical drug delivery system.
Our formulation process is supported by state-of-the-art equipment and industry-leading experts. Below is a sample of our formulation process at Tapemark.
- Active Pharmaceutical Ingredient (API) solubility testing
- Blending of formulation components using high/low shear homogenizer
- Coating of blend using casting knife on a release liner
- Lamination of coated film with backing (for patches)
- Die cutting of laminate
- Franz cell testing and assay analysis
- Pouching of the die cuts in pouch material
- Stability testing of the formulation
Identifying and Validating Targets
Drug discovery includes identifying and validating targets and may include thousands of compounds as potential candidates. Of these, the most promising compounds are those selected for development.
Once a compound is selected, development includes a series of information-gathering experiments. Some of the data points researchers hope to uncover are:
- Details on absorption, metabolization, and excretion
- Potential benefits and mechanisms of action
- Best delivery modality
- Potential side effects
Throughout drug development, researchers test and retest compounds, recording therapeutic characteristics and following leads to identify the most promising compound.
At Tapemark, we support the drug development process with our cGMP compliant laboratories. Capable of providing full analytical support in-house, we are able to shave approximately 10-15 days off of each batch cycle.
Staffed with well-rounded experts and equipped with some of the best equipment available, our analytical capabilities are extensive to support clients. Our analytical capabilities include:
- Method development, transfer, verification, & validation
- In-Process testing on blends and laminates
- Final product release testing
- ICH stability storage and testing
- Microscopy capabilities
- Controlled substance storage and handling
- Cleaning methods
- Compendial raw material testing
- HPLC and GC (Empower 3 Software)
- TOC, Karl Fischer moisture, Instron, viscosity, texture analyzer
- Dissolution apparatus (App 1,2,5,6,7) equipped with autosamplers
Another essential part of drug development is blending. Blending involves developing a stable, consistent mixture for the drug. Here at Tapemark, we specialize in transdermal, oral thin film, and unit dose semi-solid drug delivery. As such, our blending services are all about mixing a drug for its specific delivery method.
In the blending process, the first steps include defining the preliminary blending process and selecting the vessels for pre-mixes. Once we establish the blending parameters, we begin blending of the batch, sampling our blends at each step of the process.
During preclinical research, researchers work to determine a compound's toxicity by testing it in vitro and in vivo. Scientists perform preclinical research without dosage restrictions, advancing those molecules which yield promising results.
Unlike preclinical research, which focuses on answering basic questions about a drug’s safety, clinical research studies the way a drug will interact with the human body. As such, clinical research in pharmaceutical drug development refers to trials performed on people or animals.
The clinical research phase is composed of four phases, each with its own purpose:
- Phase 1, Safety and dosage
- Phase 2, Efficacy and side effects
- Phase 3, Efficacy and monitoring of adverse reactions
- Phase 4, Safety and efficacy
All phases combined, clinical research trials span several years.
FDA Drug Review
After clinical research, the next step in the drug development process is FDA drug review. When a company’s research and trials have determined their drug is safe and effective in its intended use, they can file for FDA review and approval.
In their application, drug developers must include every bit of information they’ve discovered about the drug. This includes reporting on all studies, data, analyses, and clinical results. The FDA also requires submission of proposed labeling, patent information, directions for use, and any data from studies conducted outside the U.S.
Once submitted, it is up to the FDA to file the application or reject it. Once filed, the FDA review team has less than a year to make a decision on the drug’s approval. During this time, the FDA may:
- Work with the applicant to develop and refine the drug’s labeling
- Ask questions based on existing data
- Require additional studies
If approved, the company obtains the right to market the drug.
FDA Post-Market Safety Monitoring
Even after FDA approval and entry into the marketplace, drugs are still subject to FDA monitoring and evaluation. This is to ensure drug safety and efficacy throughout its time in the marketplace.
Problems with both prescription and over-the-counter drugs are reported to and reviewed by the FDA. Common amendments to a drug that’s already reached the marketplace include dosage cautions and usage information.
Also, if a drug company wishes to change their drug post-market, they must receive FDA approval. Examples of post-market changes include formulation changes, labeling changes, new indications, and dosage strength changes.
The FDA also conducts routine inspections of drug manufacturing facilities to validate good manufacturing practices are being employed. The FDA also regulates prescription drug advertisements and promotional labeling. False or misleading advertisements or statements, whether online, via sales personnel, in print, on television, or by any other avenue are subject to FDA scrutiny.
As you can see, bringing a drug to the U.S. market is complex. It’s a massive investment of time, resources, and capital. When you choose a drug development partner, you’re deciding who will be by your side every step of the way. Be sure to select a partner with the technical expertise, facilities, resources, and relationship skills to help maximize your success.