Pharma industry has begun to witness major transformation with the evolution of Virtual Man that is seen to decrease clinical trials and enable researchers understand the biology of diseases. Some companies using Virtual Man have been able to reduce clinical trials by 40 per cent and decrease the number of patients participate in human studies by two thirds, said Prof Prakash V Mallya, director, Centre for Pharmaceutical Professional Advancement, Krupanidhi College of Pharmacy.

Virtual Man is a 3D scan of the human  body.  Now new technologies like the Virtual Man are a catalyst for an R&D overhaul.  In the competitive landscape of pharmaceutical marketing, drug delivery devices are product differentiators.

Drug companies are adopting virtual R&D to increase innovation, have an in-depth knowledge about the human body and the pathophysiology of disease.

“Now the Virtual Man would enable researchers predict the effects of new drug candidates before human studies. Models of the heart organ, cell systems and musculoskeletal architecture are already developed by the academia globally.  These are used to simulate the psychological effects of drug interactions and identify those which have an efficacy to treat diseases. Thus, the Virtual Man can be connected in the innovative way”, stated Prof Mallya in an article titled ‘Brave new world of pharma emergence: Be future ready’ brought in a journal published by Krupanidhi College of Pharmacy.

There is rapid progress in drug research, increase in generic production, availability of high potency active pharmaceutical ingredients (HPAPIs) and innovation in production processes.  Biologics and personalised medicine have brought to the fore targeted therapies, he stated.

A prevailing global trend is to combine pharmaceuticals with medical technology for the development of drug delivery devices using nanotechnology to help pass the blood brain barrier. Already, Inhalers, insulin pens, skin patches have brought considerable convenience to patients.

In order to sustain innovation, there is demand for engineering expertise not just for manufacture but to generate novel concepts in packaging of pharmaceuticals, biologics, vaccines, anti-viral drugs and HPAPIs. For liquid formulations in syringes, vials, ampoules, and solid formulations like tablets-capsules, there is use of static division (SD) technology. It operates on light transmission to detect static particles to measure dynamic light fluctuations to differentiate ‘static’ from moving objects. High speed cameras allow reliable identification of particle and container defects. Novel imaging software detects quality features of capsules-tablets in terms of weight, foreign particles, deformation in shape-length and deformation in real-time at high throughput rates.   In order to ensure quality and safety, industry mandates Overall Equipment Effectiveness (OEE) Process Analytical Technology (PAT, Quality by Design (QbD) and current Good Manufacturing Practices (cGMP).

With pharma industry’s futuristic and exponential changes, academic programmes at pharmacy colleges need to gear up full throttle to keep pace in the dynamic decade of Brave new world of pharma emergence, stated Prof Mallya.