Nov 26, 2019:
The past couple of years have seen multiple transformative changes in the Life Sciences industry due to scientific advancement and emerging technologies. Some key drivers and trends that are steadily gaining a strong foothold in the industry are discussed below.
AI and ML:
Artificial Intelligence (AI) and Machine Learning (ML) have been spear heading data driven decisions, which could help automate as well as streamline processes. Tech giants like Microsoft, IBM and Google have been designing tools for healthcare that are being incorporated into regulatory services.
Recently, Google designed a tool that can recognize heart attacks about 48 hours before it occurs, and another that can detect diabetes merely by scanning an individual’s photograph. Such advancements in artificial intelligence also play an important role in acquisitions. A case in point Is the acquisition of Flatiron Health by Roche in 2018. The oncology specific Electronic Health Record (EHR) designed by Flatiron Health can now be leveraged by Roche for better drug development.
Drug developers are constantly utilizing AI to improve their R&D in terms of cost and quality. Navitas Life Sciences’ OneClinical platform is an AI/ML driven system that enables clinical trial sponsor companies to detect issues quickly and take proactive action to rectify. This results in reduced cost of running the trial due to fewer feet on the ground, as well as improves the quality of the trial due to reduced errors. The benefits that AI and ML exert in the pharmaceutical industry are extensive, with newer applications emerging in the healthcare landscape daily.
Biologics have been facing stiff competition from biosimilars due to revenue threats and patent lifts. Biologics are drugs that are developed from living organisms or their components and they enjoy a fair share of the pharmaceutical market. The lack of affordability and access to biologics are driving the adoption of biosimilars, which are an almost identical copy of the original biological molecule. With biosimilars costing 30% less (on average) than biologics, these molecules are being rapidly adopted by payers and national health services across the globe. Clinical testing of biosimilars requires extensive expertise and biosimilars developers need a strong partner to bring such products to market. Navitas Life Sciences has conducted 8% of all Biosimilars studies in India in 2018 and has proven expertise in this area.
Another sector that benefits from the patent lift off is the generic industry. Generic drugs have the same pharmaceutical capacity as innovator drugs. Needless to add, they are cheaper than the original drugs, resulting in their becoming the drug of choice for payers and national healthcare systems worldwide. While USA is the largest market for generic drugs, India accounts for nearly 20% of global generics output. Generic drugs are pharmaceutical equivalents of innovator drugs. They require the same standards of testing and manufacture as do innovator products. Complex generics are also coming into the market. These drugs require specialized testing and expertise. Navitas Life Sciences has conducted over 1000 bioavailability & bioequivalence studies, including support for complex generics to help generics companies bring their drugs to market quickly and effectively.
The clinical trials sector is another facet of the pharmaceutical industry that has witnessed considerable innovations. The first stage of a clinical trial, and one of the biggest impediments, is patient recruitment. AI has provided ways to sieve through medical records and identify patients who would best suit the trial and who are more likely to take part in the study! Technology has even provided ways to identify patients who are more likely to drop out of a trial, which means that preventive measures can be put in place to continue the trial.
Another startling trend is the way clinical trials are being conducted. Virtual trials are moving away from the drawing board and into reality, which will augment patient comfort and reduce the time taken to develop a drug. There has been a lot of attention recently on a study conducted by Stanford University called the Apple watch heart study which included 400,000 people. The real time data provided from such a study will elevate the understanding of the science of heart health, providing key insights that were not available before.
The virtualization of research has brought in better connectivity, helping labs and data centers access data faster and more efficiently. Cloud computing is free from large capital investments or higher costs required for customizations. Tech giants like Google, Alibaba and Amazon provide reliable and safe storage services with superlative supporting technology. Cloud computing has also helped in levelling the playing field in the pharmaceutical industry, with even smaller companies implementing such data storage services as their larger counterparts.
An onus on data privacy and data protection has brought into focus EU’s General Data Protection Regulation (GDPR), the U.S.’s Health Insurance Portability and Accountability Act (HIPAA), the EU-U.S. Privacy Shield Framework and the California Consumer Privacy Act (CCPA). Steep fines have been put in place for non-compliance with data privacy laws, with the GDPR allowing fines amounting to 20 million Euros or 4% of the company’s revenue. With effect from Jan 1, 2020, European consumers will have the right to seek compensation from organizations that fail to protect their data.
Another focus of regulatory affairs is improving patient safety. While health authorities are constantly updating their regulations to ensure improved quality of medicines and drug safety via pharmacovigilance, other avenues of intervention include ensuring the safety of the drug supply chain to limit spurious drugs on the market.
Personalized medicine is the process of tailoring treatment based on the unique molecular and genetic profile of an individual. This will help in improving the ability to identify if specific treatment will help the individual and are safe.
Personalized medicine is expected to help physicians select therapy or treatment that are precise and better suited to the needs of the patient. It will also help in lowering the risk of side effects. A trial and error approach or a generalized approach that is commonly used today results in increased costs incurred with lower chances of a better outcome when compared to personalized treatment.
This area of Life Science will help in changing the way we think about health conditions and the methods used to treat them. One of the earliest examples of personalized medicine is in breast cancer. About 30% of patients with breast cancer over express HER2 protein. The use of a drug called trastuzumab, in combination with chemotherapy, is found to lower recurrence by 52%. People who overexpress this protein are found to be non-responsive to standard therapy. Therefore, a test to identify the expression levels of the protein will help in catering to the specific needs of the patient.
Another poignant example is that of personalized treatment for heart transplant patients. Earlier, an expression profiling test was carried out to identify the risk of organ rejection. This involved an invasive endomyocardial or heart biopsy. Now a simple genetic test can be used to determine the probability of rejection and it can also be used for personalized immunosuppressive drug dosages. Personalized medicine, therefore, promises to herald in a very exciting phase of treatment and care.
Wearable technology has so effortlessly woven into the fabric of our society that fitness devices like Fitbit and smartwatches have become an integral part of our lives. According to Accenture, the use of wearables in the US has increased from 4% in 2014 to 33% in 2018. The information collected from such devices are also being put to good use, like in the Apple watch study.
Wearable ECG monitors are stepping up the heat on improved heart care. These devices are equipped to send electrocardiogram (ECG) to the patient’s doctor and to even detect atrial fibrillation. Similarly, there are wearable blood pressure monitors that can store up to 100 readings. This information can then be transferred to an App on a phone for reference. Wearable technology has, thus, eliminated the gap between science and usability.
The realm of Life Sciences is an exciting place to be in, as it is constantly evolving with a focus on improving the quality of life of people. The industry is making concerted efforts to be more patient- centric and relevant, paving the way for innovative measures that foster better care. With a pulse on the needs of patients, we look forward to significantly improving human health through technology and scientific breakthroughs.
|Dr Ayaaz Hussain Khan
Global Head, Generics,
Navitas Life Sciences