Pharmaceutical experts are of the view that Pharmacokinetic-Pharmacodynamic (PK/PD) modeling and simulation would be the better answer for the uncertainty in translational and biologics drug discovery programmes to tackle issues through algorithmic approach.

The technology, for finding out the success rate of various methods of research through mathematical relations, has proved to solve various efficacy issues in the process of drug discovery and development research. The method could be more used in translational research and biological research where a large number of attrition problems persist, suggested Dr Balaji Agoram, senior principal scientist, PDM, Pfizer Global R&D, UK.

The modeling and simulation will support the industry to integrate all the information available on a research project into one platform and make a decision on the whole mechanism or the characteristics of a best-in-class molecule. The model would be effective to solve various issues including the identification of target in high risk biologics, where most of the drugs are developed from small molecules.

"PK/PD modeling and simulation is identified as one of the key source that could be leveraged to find the pathway of the research in a better manner," said Dr Agoram. The method has already proved its merits in testing the efficacy of the molecule in new drug research. The PK/PD modeling and simulation can accelerate the process of testing best-in-class molecules, which will save time and money of the investor. However, there are very less case studies available in proving pharmacological and safety parts of translational research.

"In the next five years, we may have more case studies and a proven ground in the pharmacological and safety sides of the translational research. We already have some information on the pharmacology studies on some antibodies," he added.

The method is gaining more relevance in the current scenario, while the drug regulators in developed countries disclosed their concerns over the failure of drugs after entering global market. The PK/PD modeling would cut down the attrition rate in clinical trial of the drug compounds and will gather more information from the attrition so that the same mistake can be avoided in the next step of research.

The technology would also help the companies to come out with well designed pre-clinical trials, which will result in reduction of duration of studies. With this, the companies can expect early entry of their molecule in clinical trials which will cut the overall cost of research.

Another advantage of the method is that it ensures a better communication between each department involved in drug discovery and development to bring in more team effort in the project. It will also systematically integrate the diverse knowledge base to help documentation of processes in the whole research project.

However, the PK/PD modeling and simulation needs investment of money and time in the early stage of research, for which no absolutely clear returns could be assured. Lack of sure returns is the major limitation that holds the pharma research companies from conducting the simulation studies even though it offers all those advantages, said Dr Agoram.