Dear Colleagues! This is Asrar Qureshi’s Blog Post #669 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
Continued from Previous……
Let us talk about the international trends and compare these to our industry status. A number of reports are available that show the trends, however, Pharma Trend Report by StartUS Insights is quite pertinent to understand where the pharma industry is going. Although they review a very large number of startups and scaleups globally, for this report they analyzed a sample of 1745 startups and scaleups and identified the top ten trends. It must be emphasized that the new trends are being led by startups, not by the large pharmaceutical companies. The startups work with greater agility and focus as compared to established behemoths.
Trend #1 – Artificial Intelligence
Pharmaceutical industry has traditionally shunned early adoption of technology, partly due to strict adherence to SOPs, and partly due to regulatory constraints. The industry cannot be too progressive if the regulatory authorities are regressive. Internationally, the regulatory framework is now allowing use of advanced technology.
Use of artificial intelligence and machine learning is helping to accelerate drug discovery and development process. A big part of drug discovery after it shows promise, is clinical trials. Several studies are required to establish the safety and efficacy of the trial drug in human beings. The patients are enrolled under strict inclusion/exclusion criteria, demographics, ethnicity, age, gender, etc. Based on similarities, patient cohorts are developed. During the trial, huge amount of data is generated about adverse reactions and efficacy, some of which must be analyzed immediately to decide whether to continue in the patients or drop. AI is making it faster, more accurate and cheaper.
AI use is also being investigated to automate manufacturing processes, designing effective marketing strategies and post-launch activities. Manufacturing processes are mostly repetitive, and AI can easily handle it. Marketing strategies are based on studying competitors, market development, and growth trends, AI can help greatly.
Pakistan does not do drug discovery and development, very few clinical trials are conducted here, and traditional marketing strategies are employed by all companies. We are therefore miles away from AI and machine learning in pharma industry.
Trend #2 – Big Data and Analytics
To understand how much data is being generated every day, we may have a cursory look at Google. Google Data Centers are where the data is stored. No one knows the exact number of servers in Google data centers, but a report by Gartner in July 2016 estimated that Google was using approximately 2.5 million servers. Another estimate says that 400-500 servers are added daily to Google storage. For understanding, your office serving one hundred staff with computers may have 1 – 2 servers only. Google is just one; among the large players we have Microsoft and Amazon, and thousands of other sites offering storage.
The summary is that billions of bytes of data is generated every hour. This is the magnitude of what we call Big Data. Data is useless if it is not analyzed to draw actionable inferences. Big Data requires a different kind of expertise, and people have learned to become experts. At present pharma companies do not have inhouse expertise to analyze big data. Even the data generated from clinical trials is partially analyzed and submitted. Startups are offering to do the job more efficiently. There is a big concern however, about the confidentiality of sensitive data. A Belgian startup is offering platform to build applications on sensitive data and create a synthetic version which could be shared with the third parties.
In Pakistan, we are also generating data from businesses, government, education, safe-city projects, road cameras, and so on, but we do not have tools and expertise to analyze big data. Our internet speed is limited due to narrow bandwidth for which we pay, outdated hardware and pirated software. With every passing day, we are falling further behind.
Trend #3 – Flexible Production
People in the pharma industry know that the pharma production runs in batches which are based on number of tablets, capsules, liters of solution for injections etc. The batch sizes are standardized and optimized for cost-effectiveness and efficiency. Over time, experience has dictated that larger batch sizes are better in consistency and economy. The regulatory bodies also insist on following the batch sizes and prefer larger batch sizes. No good company violates the standard batch sizes. Pharma companies have upgraded production equipment and are going for larger batch sizes in Pakistan also. But what do you do about new products, highly specialized, low use products? Their quantities may be so small that these may not fit into existing equipment.
Certain startups are now offering technologies which can make smaller production within the existing setup possible. It is already being offered in biopharmaceuticals and chemicals, and it will come to regular pharma also.
In Pakistan, we use some innovative ‘Jugaad’ type things to handle off-size and smaller batches, the detail of which can be ignored.
Trend #4 – Precision Medicine
The use of targeted therapies is already becoming popular. Targeted therapy targets the disease area/cells more specifically and spares the healthy ones. This leads to better cure rates and less side effects. The next target being chased is to customize medicine to the individual, specific needs of the patients. This is the field of precision medicine.
A French start up offers a software solution which simulates the effects of drugs in a patient’s body based on personal characteristics. In simple words, it can predict in real time about the efficacy and drug interaction in each individual. It is an amazing development.
A Swiss startup offers platform technologies which can provide patients with individualized therapeutic vaccines for treating their conditions.
I mentioned in one of my blogposts about a Novartis drug ZolgenSMA which is single-dose treatment for Spinal Muscular Atrophy, a genetic disorder. The cost is astronomical, but it is a cure for an otherwise incurable, progressive, debilitating, fatal disease. Even this is not precision medicine, which is many steps ahead of this.
In Pakistan, we have no way of getting into these things. We do not have the resources, technology, expertise, and above all, desire to develop ourselves.
To be Continued……
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