BIOPHARMACEUTICAL
"Worldwide prescription drug sales are expected to rise from US$900 billion in 2019 to US$1.2 trillion by 2024."- Deloitte
What is Biotechnology?
Biotechnology is the manipulation, through genetic engineering, of living organisms or their components to produce useful, usually commercial, products such as pest resistant crops, new bacterial strains, or ground breaking pharmaceuticals.
Since DNA, the self-replicating material present in nearly all living organisms as the main constituent of chromosomes, was discovered in 1953, there have been inexhaustible advances and discoveries in the wide range of biotechnologies such as food alterations, genetic research and cloning, human and animal health care, pharmaceuticals and the environment.
Biological processes of microorganisms have been used for more than 6,000 years to make useful food products and to preserve dairy. There are currently more than 13 million farmers across the world who use agricultural biotechnology to increase yields, prevent damage from insects and pests and to improves the overall efficacy and harm reduction of farming's impact on the environment. By harnessing the cellular and bio-molecular processes, biotechnology aims to develop products and technologies that help improve our lives and the health and long term outlook of our planet.
Whether combating debilitating and rare diseases, feeding the hungry, creating more efficient and cleaner energy, reducing our environmental footprint or greatly increasing the manufacturing processes we possess and their overall impact on our world, biotechnologies are our key to unlocking a safe and sustainable future for our race, our planet and most of all our children.
What is a Pharmaceutical?
A Pharmaceutical is a compound manufactured for use as a medicinal drug, used to diagnose, cure, treat or prevent disease. These drugs include any substance, other than food that provides nutritional support, that when inhaled, injected, smoked, consumed, absorbed via a patch on the skin or dissolved under the tongue causes a temporary or long term physiological (and sometimes psychological) change in the body.
Pharmaceutical companies discover, develop, produce and market these medicinal drugs as generic or brand pharmaceuticals that can be classified as controlled prescription drugs or over the counter medications.
All pharmaceuticals are subject to local, national and international laws and regulations that govern the testing, safety, efficacy, patenting and marketing of drugs. In general governments will regulate what drugs can be marketed, how they can be marketed and in certain cases they will also regulate the individual drug pricing. Due to the complex and expensive path from drug discovery, to development and eventually marketing, it is essential to have strong industry partnerships to help bring companies and their drugs through the development cycle.
As drug development is such an important aspect of biotechnology, it is important to understand the full process of drug approvals. While specific requirements of each individual country may vary, the USA's Food & Drug Administration (FDA) provides a general description of the approval process for new drug compounds and studies as follows:
Discovery and Development - Research for a new drug compound begins in a laboratory.
Pre-Clinical Research - This phase tests new drugs on non-human subjects to gather toxicity, efficacy and pharmacokinetic information.
Clinical Phase 0 Research - Pharmacokinetics, specifically oral bio-availability and half-life of the drug. This phase requires about 10-15 participants, and is referred to as human micro-dosing studies, but is often skipped in favor of going directly to Phase I.
Clinical Phase I Research (~1yr) - This is testing done on 20-80 healthy individuals for the purpose of dosage and safety of the drug.
Clinical Phase II Research (~1-3yrs) - This phase determines the effectiveness and potential side effects of the drug through testing of about 100-300 patients suffering from the particular disease or condition.
Clinical Phase III Research (~2-3yrs) - Testing is carried out on 1000-5000 patients suffering from the disease or condition and monitors the side effects brought on by long-term usage. This phase is extremely rigorous and detailed, and often some patients will receive the drug while others receive a placebo (sugar pill) to determine the drugs effectiveness.
FDA Review - After Phase III is complete the FDA, or other local governing body, will thoroughly examine all data related to the drug and the completed clinical studies to determine whether to approve or reject the drug compound and requested indication use.
Commercialization - At this stage drugs have received their regulatory (FDA or other) approval and are ready to be brought to market and commercialized for general sale and use.
Clinical Phase IV Research - This phase takes place after the FDA approves the marketing of a new drug and is conducted to identify and evaluate the longer-term effects of a drug for a greater number of patients.
Whether a phase IV study is required or not, the FDA or other local governing body, monitors all drugs on an ongoing basis once they are available for use by the public. It is important to note that about 5-10% of drugs that enter the FDA testing process actually gain final approval.
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