DRUG AND TREATMENT TRACKER
Data Sources: Investopedia, North East BioLab, Pacific BioLabs, The Milken Institute, and The New York Times
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Treatment Product Categories
Antibodies are one of your body’s natural defense systems against foreign attackers. When your body detects foreign intruders (like bacteria or viruses), your immune system makes antibodies that recognizes them. These specific antibodies attach to the foreign intruders and target them for destruction.
Antibodies created to attach to different molecules in the body (i.e., not foreign intruders) can also be used to treat disease, for example, by turning down your immune response to stop it from overreacting and causing damage to the body (a phenomenon known as “cytokine storm”).
To treat or prevent disease, scientists can either use antibodies from the blood of people who have recovered from the infection (i.e., “convalescent plasma”) or use antibodies made in a lab that will attach to and stop (“neutralize”) the foreign intruders.
Stages of Development
Phase I - Discovery and Development
Each drug begins with discovery and development in a lab. Pharma companies spend millions of dollars on research and development that includes scientific study and development of drugs for new innovation. Funding can come from several areas including government, grants, and revenues. In 2016, global drug discovery was valued at approximately $35.2 billion worldwide with a growth estimate of up to $71 billion dollars by 2025.
Phase II - Preclinical Research
Once a drug discovery has been made it must go through both preclinical and clinical research with supporting reports tied to its review process. Preclinical research is a basic preliminary phase that involves testing the drug on animals and basic testing for safety flags.
Phase III - Clinical Research
Clinical research can be one of the most important steps in a drug’s development. If a drug is cleared from preclinical trials, it moves on to clinical testing which involves human trials. Drug companies and the FDA have specific standards for clinical trials which include the professionals involved in the scientific testing, the selection criteria of the humans being tested, the setting in which the clinical tests take place, and more. Clinical trial registration is also required and heavily followed by pharma professionals across the sector. Through August 2018, there were over 281,000 registered clinical drug trials worldwide.
Phase IV - FDA Review
The Food and Drug Administration is one of the primary regulators involved in all aspects of the drug market. (See also: How does government regulation impact the drugs sector?) The high standards for drug approval in the U.S. often lead drug development testing in the first three phases to last for approximately 10 to 15 years before approval. In phase four, companies submit fully documented research and findings to the FDA for review. If a submission is accepted, the FDA will provide a response within six to 10 months.
Phase V - FDA Post-Market Safety Monitoring
There are several aspects of post-approval safety monitoring for a marketed drug. The FDA monitors all types of drug advertising for accuracy. It also monitors complaints and problems associated with a drug. As such it has the power to limit drug sales and/or offer warnings. In general, the FDA also does routine manufacturing inspections. Furthermore, the FDA is involved in the patent protections and generic drug transitions of all drugs.
Relevant Drug Development Concepts
Drug Master File
A Drug Master File (DMF) is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of a human drug.
Small Molecule vs. Biologics
Small molecules have a variety of applications or biological functions. Large molecules (also called biologics) are proteins with a therapeutic effect. Small molecules work by cell signaling. Large molecule drugs are complex and may be composed of over 1,300 amino acids. They are identical versions of human proteins.
Drugs for Pediatric Use
Drugs for pediatric use are intended for use in children or youth, generally under the age of 21. In some cases, the American Academy of Pediatrics (AMA) may make exceptions if a pediatrician and family agree on an older age adult.
Drugs for Veterinary Use
Drugs for veterinary use are intended for use in animals, pets, and livestock. However, some veterinary drugs get their start in humans and then change to human and animal drugs.
Process Scale-up Differences & Difficulties
Drug development involves generating progressively larger medicine batch sizes, and changes in processes for different-sized batches may cause unexpected difficulties. Use of the right pharmaceutical equipment can be helpful, as well as the discovery of parameters that affect critical process parameters (CPPs).
New drug development is a highly regulated, complicated process that requires specialists and intense research and development skill sets in the medical research community. All regulations and safety indications must be observed carefully, and human and animal clinical trials subjects treated professionally and with the utmost care. The goal of drug development is to prevent human and animal pain and suffering whenever possible and find and provide new drugs that we can depend on to improve our health and happiness.
COVID-19 Drugs (Medicines) Frequently Asked Questions
What does it mean to be an FDA-approved drug?
FDA approval of a drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. The drug approval process takes place within a structured framework that includes collecting clinical data and submitting an application to the FDA.
What is the FDA’s role in regulating potential treatments during a public health emergency?
The FDA carries out many activities to protect and promote public health during a public health emergency, including helping to accelerate the development and availability of potential treatments, protecting the security of drug supply chains, providing guidance to food and medical device manufacturers, advising developers on clinical trial issues, and keeping the public informed with authoritative health information.
The FDA is committed to supporting the development of new drugs, and the potential repurposing of existing drugs, to address COVID-19 by working with potential drug makers and sponsors to rapidly move products into clinical trials, helping to ensure that trials are properly designed and safe, and protecting the public from potentially unsafe products.
Are there any FDA-approved drugs (medicines) for COVID-19?
Yes, the FDA has approved Veklury (remdesivir) for certain COVID-19 patients. Additionally, during public health emergencies, the FDA may in certain circumstances authorize use of unapproved drugs or unapproved uses of approved drugs for life-threatening conditions when there are no adequate, approved, and available options and other conditions are met. This is called an Emergency Use Authorization (EUA).
Researchers are studying new drugs, and medicines that are already approved for other health conditions, as possible treatments for COVID-19. The FDA created the Coronavirus Treatment Acceleration Program (CTAP) to use every available method to move new treatments to patients. Additionally, the FDA is working with the National Institutes of Health, drug manufacturers, researchers, and other partners to accelerate the development process for COVID-19 treatments. FDA’s Sentinel System is being used to monitor the use of drugs, describe the course of illness among hospitalized patients, and evaluate the treatment impact of therapies actively being used under real-world conditions.