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Continuous Improvement for Drug Industry: Part 2: Need for Digitalization in Pharmaceutical and Medical Device R&D.

7/6/2021

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Part 1 of this blogpost series introduced Digitalization as one of the important continuous improvement pathways.
continuous improvement for the drug industry_ digitalization in pharmaceutical and medical device R&D
Digitization is conversion of data and processes from analog to digital whereas, digitalization embraces the ability of digital technology to collect data, establish trends, make better business decisions, in toto transform ‘how work happens’.

In this blogpost series, I shall discuss on- Why the need for digitalization in pharma R&D labs?

Need for digitalization in pharma & medical device R&D:

Historically R&Ds regardless of industry sector, were run in an unstructured way. The degree or extent of ‘unstructured-ness’ is different for different industry sectors.

For example, R&D in a metallurgy firm is less sophisticated than in an engineering firm, while R&D labs in the electronic industry may be top class. Similarly, R&D labs in chemical industry, oil & gas industry may be more ‘unstructured’ compared to pharmaceutical or medical device R&Ds.

Then came an era of EVOP (Evolutionary Operations) and Experimental designs or Design of Experiments (DOE). This brought some structure to R&D’s workflow, yet not the desired finesse.

Scientists tend to record results in notebooks, spreadsheets, even on post-it (sticky) notes. Each scientist has his/her unique way of recording experiments, observations and results.

Data is usually decentralized and often buried under a pile of ad hoc experimentation, and this happens even in the most state-of-the-art laboratories. For example, pharma R&D labs have one of the most superior quality assurance norms to comply with. Yet when it comes to pharma R&D’s efficient data capture and data utilization, it has a long way to go!

This is one of the main reasons why pharma R&Ds run on high budget. I shall not take up hi-fi examples but simply put if a product can be developed with 20 experiments instead of 80, cost (of experimentation) will slash to around 1/4th. Now imagine if a product can be developed by mere few experimentations and no clinical trials? Wondering how’s that possible?

Yes, that’s possible- by digitalization!

R&D costs are skyrocketing, while ROI is steadily falling over the last decade. In 2010 the mean cost of bringing a new drug to market was US$1.1 billion ... in 2018 it was US$2.1 billion with clinical trials making up an increasingly large share of this cost. Meanwhile, the mean projected return on R&D investments fell from 10.1% in 2010 to 1.8% in 2019.

Digital transformation could reverse this trend of declining ROI in pharma R&D and improve R&D productivity over the next decade... What will it take to realize this potential?

A recent survey reported opinion of 250 global pharmaceutical and biotechnology leaders on the state of digitalization in biopharmaceutical R&Ds. It was found that some progress is being made, but that there was a greater-than-anticipated gap between the expected value of digital in pharma R&D and actions being taken to realize that value.

In the next part of this blogpost series, I shall discuss on- How to go for digitalization in pharmaceutical and medical device R&Ds.

​Meanwhile, note that there are fifteen different Continuous Improvement pathways for pharmaceutical and medical device R&Ds. Are you planning a Continuous Improvement initiative for your R&D division?
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Upcoming blogposts in this series-

Part 3:  How to go for digitalization in R&D.
Part 4:  Advantages of digitalization in pharmaceutical and medical device R&Ds.
Part 5:  Digitalization in various phases of drug research and development.
Part 6:  Selecting the right R&D digitalization platform.
Part 7:  Six building blocks for digital transformation in pharmaceutical and medical devices R&D.
Part 8:  How to transform existing R&D setup to a digitalized R&D.
Part 9:  Tips and Quick wins of digitalization in pharmaceutical and medical device R&D.
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Related reading:

  1. Kaizen for Pharmaceutical, Medical Device and Biotech Industries. 
  2. Continuous Improvement Tools: 30 Tools to Drive Profitability, Quality and Operational Effectiveness in manufacturing & Service Industry. 
  3. Continuous Improvement for Pharmaceutical R&D.
Keywords and Tags:

#businessprocessimprovement #continuousimprovement #digitalization #digitization #digitaltransformation #digitalizationinpharmaceuticalR&D #digitalizationinmedicaldeviceR&D
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