10 successive steps of drug development in videos, walk and app
Starting at fundamental research and drug discovery at Leiden University and the LUMC, the Leiden Red carpet successively highlights different stages of the product development process. The stages covered in this series are: testing of drug efficacy, safety and stability, manufacturing of drug compounds, its clinical investigation and ultimately prescribing the new drug for treating patients in the hospital.
You can can also download the Leiden Red Carpet brochure (in Dutch) accompanying the tour, for extra information.
The Leiden Red Carpet films are an initiative of the Entrepreneurs Association of Leiden Bio Science Park (OV BSP).
Drug development at Leiden Bio Science Park in 10 short films
At Leiden Bio Science Park both biotech companies and research institutes are active across all phases of the chain of drug development. The mayor of Leiden, mr Henri Lenferink, and Harry Flore (chairman of the entrepreneurial society OV BSP) welcome you at the Red Loop walking tour and films.
1. Fundamental research
Fundamental research is often the first step in the R&D trajectory that leads to new drugs. The Leiden Academic Centre of Drug Research (LACDR) is a modern knowledge centre of Leiden University dedicated to improving patient care through scientific research. Understanding diseases better often leads to identification of new drug targets.
2. Vaccine development
After the drug target discovery phase, drug candidates move into various development phases at companies and knowledge institutes at Leiden Bio Science Park. For example, Janssen Vaccines (formerly Crucell) develops vaccines against infectious diseases including Hepatitis, Ebola and travellers diseases.
3. DNA research
Through the use of genomics (advanced DNA analysis technologies) the efficacy of specific drugs can be determined, for example to identify antibiotic resistance of certain bacteria. Also in other disease areas, like cancer, genomics play an increasingly important role in identifying patients that will benefit from (newly developed) drugs. BaseClear is a laboratory with a focus on genomics, synthetic biology and forensic research.
4. Clinical Trials
Safety and efficacy of novel drugs must ultimately be demonstrated in patient studies. The Centre for Human Drug Research (CHDR) is dedicated to organizing and managing early stage clinical trials with healthy volunteers and patients to understand the drugs pharmacology in humans.
5. Drug formulation
After efficacy and other important properties of the drug have been established, all required substances are combined into a single pharmaceutical product – like a pill or fluid. This step in the process is called drug formulation. In Leiden, the company Dr. Reddy's (formerly OctoPlus) researches methods to develop drugs for administration by injection.
6. Drug delivery
In order to deliver the drug at the right site in the human body, effective drug delivery technologies are essential. The blood brain barrier is one of the most challenging hurdles in treating brain diseases. 2-BBB is dedicated to overcome this challenge, by specializing in drug delivery technologies that allow drugs to penetrate the human brain.
7. Drug stability
The drug also needs to be proven stable under all real life conditions, as drugs may be used under tropic or arctic circumstances. Eurofins | PROXY Laboratories at Leiden Bio Science Park tests the stability of drugs in climate chambers and performs quality control tests of (bio)pharmaceutical raw materials.
Janssen Biologics is subsidiary of one of the largest pharmaceutical companies in the world, Johnson & Johnson. At Leiden Bio Science Park, Janssen Biologics has a large facility that produces Remicade, a medicine against autoimmune disorders such as rheumatoid arthritis, Crohn´s disease and psoriasis. Upon manufacturing in Leiden, Remicade is sold worldwide.
9. Administration to the patient and clinical research
The final stage of the development process often takes place in hospitals. Medicines under development are offered to selected patient cohorts in academic centres such as the LUMC. The LUMC takes part in both early research into diseases and in clinical trials in the later stage of the development of the potential medicine. After some 10 to 15 years of research and development proving the drug’s safety and efficacy, the product is made commercially available to the patient.
All 10 Leiden Red Carpet films together in one file can be found here.