Research
Medical science continues to evolve at an extraordinary rate, opening whole new horizons for discovery research and product development and innovation in all manner of treatment and therapies. Janssen-Cilag is part of an international network of research based companies and markets these products on behalf of the group in Australia.
To maximize their future opportunities in the exciting field of healthcare, the group invested about $7.68 billion USD worldwide on R&D in 2007, putting the corporation in the top 20 companies in the world. One of the key focus areas is biotechnology, which represents the promise of entirely new and highly targeted therapies for a range of diseases. At the same time, amazing genomics tools are already beginning to revolutionize and speed up the discovery of traditional pharmaceutical medicines.
From Idea to Medicine
Medicines are the culmination of a long and costly process of research and development, where creativity, serendipity and insight are vital elements. Our researchers create new molecules and discover new assays to test them. Accurate interpretation of the results leads them to creation of even more effective compounds.
This research is the basis of drug development. Although technology has improved investigations, it is still a time consuming process, which can only be fulfilled by the commitment of our researchers to the patients. After all, the objective of our research is to improve quantity and quality of life.
Dr. Paul Janssen said:
The birth of a new drug
The birth of a new drug is rather like a knock-out competition. Each year thousands of new chemical substances are discovered by pharmaceutical research teams. Eventually, one of these molecules will become a new drug.
In the years before automation and computer technology were available, each development phase took months or years to complete. Today, automation and computer assisted techniques can reduce the time taken to develop a new molecular entity. Even so, it takes around thirteen years to advance a new molecule to a drug the doctors can prescribe.
In those thirteen years, the drug goes through several phases:
- Desk research
- Molecular modelling
- Synthesis and analysis
- Pharmacology
- Pharmacokinetics and toxicology
- Clinical research
- Production research
- Registration
- Information and marketing
- Postmarketing surveillance
- Compliance, quality control & assurance
Desk Research
At the beginning of any project to synthesise a new molecule, we need accurate information about currently available knowledge in the particular field of research. More recently, we are using information technology to survey thousands of research reports published around the world every month. Key advances are highlighted and hundreds of items are collated before being brought automatically to the attention of our researchers.
Molecular Modelling
Employing the very latest techniques means new drug developments can begin on the screen of a computer. We are using a deep understanding of the molecular functioning of drugs and their sites of action to design molecules that fit the therapeutic profiles we seek. It is now possible to put such theoretical molecules through preliminary checks, before they have even been synthesised.
Synthesis and Analysis
The synthesis departments maintain a constant supply of new, original molecules with interesting biological activity, based on the creative process of molecular modelling. Each year several thousands of compounds embark on this exhaustive research programme.
Pharmacology
Pharmacology is the vital part of pharmaceutical research. Although a certain activity might be expected, it has to be proven in pharmacological experiments. In former times activity had to be screened using animals, but later on new techniques using smaller organisms and cultures of cells or subcellular structures could be used increasingly, thereby reducing the need for laboratory animals.
Pharmacokinetics and Toxicology
We want to know exactly what happens to a prospective drug when it enters the body of humans or animals, plants or the environment; and if a substance is safe for these organisms. The study of pharmacokinetics is to answer the first part: how much of this drug is absorbed into the blood, how quickly does it reach the target; does it reach the brain as well; does it accumulate in certain tissues; how is it broken down by the body and how does it leave the body again?
Toxicologists look for possible undesirable side-effects, ranging from the extremely poisonous to mildly irritant, and for both short and long-term effects.
Clinical Research
When a compound has passed the laboratory hurdles, it becomes the subject of clinical trials: investigating its effect in patients. This stage in the development of a drug, which consists of four phases, is by far the longest and the most expensive. It takes about five years, as each drug needs to be tested in 2000-4000 patients in order to prove its efficacy and safety. Clinical research with patients takes place in accredited hospitals world-wide according to the stringent rules of Good Clinical Practice. These rules ensure the safety and well being of the patients and ensure the reliability of the test results. Only about one in every five drugs will pass this testing phase.
Janssen-Cilag Australia is conducting clinical research in a variety of therapeutic areas.
Production Research
Even during the research stage we have to find out the best production methods. The chemical production departments have to find a safe and economically viable method of producing the effective substance drug in large quantities, while still maintaining the high quality of the product.
Our pharmaceutical production departments manufacture the drugs in their ultimate form - tablets, suppositories, drops, ointments, powders, ampoules, etc. - after serious research to find the most suitable and effective form. The production of drugs must comply with the most stringent standards of purity, safety and quality.
Registration
All data are eventually reviewed by regulatory authorities worldwide, which involves a significant amount of time and effort from our Medical and Regulatory Teams.
Information and Education
During the drug's R&D stages, detailed information is being prepared on the new drug, in order to supply physicians with evidence-based data and tools for their patients that help use the drug properly.
Postmarketing Surveillance
Once a drug is on the market, the company's task is by no means finished. The results from use in actual practice are continually evaluated and communicated to the company. Furthermore, research into the drug's efficacy and possible new uses is performed on an ongoing basis. Data gathering continues long after the compound has become a successful new drug, combining information on a global scale, monitoring performance and often identifying potential further valuable applications.
Compliance, Quality Control & Assurance
In almost no other industry are the products and production processes subjected to such thorough checks as in the pharmaceutical industry. The ultimate goal of all this effort is the manufacture of pure and safe drugs. Research and production are both subject to very strict rules of Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice.
TOP
