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It’s personal

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Though personalised medicines have shown potential in revolutionising medical treatment by making them patient-specific, there is still a long way to go before it makes inroads into the Indian healthcare system. By Sachin Jagdale

From generalised to personalised, medicines have evolved in a big way over the last few years. Target-oriented approach of personalised medicines has not just promised to make the treatments more precise and accurate but at the same time it is going to reduce the duration of medication as well. As evidence of the benefits offered by this new form of healthcare mounts, medical community has also gradually   started rooting for it. However, there are always two sides to a coin. There is a mixed reaction over the cost involved in the use of personalised medicines. Diseases that would be effectively covered under it is also a subject of discussion. As far as India is concerned, besides lagging behind in research, we will have to start with spread awareness about its potential.

Why personalised medicines?

As the term itself indicates, personalised medicines are person-specific. When it comes to the benefits offered by them, till now, this concept has proved beneficial mainly in the treatment of cancer where genetic mutation is the norm. It is always said that  repeated chemotherapy kills the whole body by degrees. This therapy cannot distinguish between what is good and bad. Healthy immune cells and cancerous cells, both multiply rapidly and chemotherapy kills both. Experts sarcastically say that chemotherapy is to kill and not to cure the patient. This scenario can be changed with the help of personalised medicines.

Arunima Patel, Founder and MD, iGenetic Diagnostics, explains, “Personalised medicine has been extremely beneficial in disease categories like cancer. Cancer arises due to a genetic mutation and thus it is important to understand the particular mutation that ails the person. For example, there are more than 50 different types of mutations within the same type of cancer. Thus, it is important for the treating doctor to know the exact character of the disease they are treating and then prescribe medication. The effectiveness of the medicine significantly improves if it is targeted towards a particular genetic mutation. Traditional chemotherapies target every fast growing cell in the body, thus disrupting the immune system and leading to high mortality rates. Personalised medicine targets specific cancerous mutations and hence are more efficacious with limited side effects.”

However, though oncology would be the biggest gainer from personalised medicines, treatment of several other diseases will also enjoy the benefits offered by it. Patel adds, “Other areas where
personalised medicines are being used are transplant cases, infection, neurological disorders and paediatric segments.”

Today, global pharma companies are investing significant resources towards developing these target-specific drugs. However, currently very few of these are commercially launched in India, making them unaffordable for the general population. Patel is optimistic that this scenario will change in the future, leading to a significant decrease in the cost of personalised medication.

“One more important application is for diagnosis of diseases. This could be for confirmation of a diagnosis or differential diagnosis for diseases with overlapping symptoms. Genetic testing could help to conclusively identify the disease. There are instances where genetic testing provided additional information that changed the initial diagnosis by the physician,” informs Satish Sankaran, Lab Director, Strand Center for Genomics and Personalised Medicine, Strand Life Sciences.

Challenges to conquer

Personalised medicines hold the potential to revamp the way medicines are being administered, it has few limitations as well. With the progression of the disease personalised medicines come less handy. Like, in cancer, more the delay more it will be difficult to decide the targeted treatment.

Kapil Mehta, Director R&D, MolQ-Personalised Medicine, explains, “In patients with active or advanced disease, these treatments may have minimal impact on overall survival and quality of life. For example; in case of cancer, genome is highly unstable and mutations are continuously added making it hard to target specific genetic alterations. Moreover, in addition to genetic changes, epigenetic changes and tumour microenvironments have significant impact on disease progression. This would make it even harder to target changes detected by this approach for effective control and treatment.”

Is cost an obstacle?

The concept of personalised medicines is still at a nascent stage in India. So, despite a significant number of cancer patients and those with other serious ailments in the country, personalised medicines haven’t really offered spectacular results. As is the case with a lot of new inventions, this particular form of treatment has its origin in the overseas countries. A good amount of research has been taking place over there. With our limited expertise in this field, if we need to borrow something from our foreign counterparts, it makes the entire process very expensive.

Anu Acharya, CEO, Mapmygenome, India, sheds more light on the topic. She says, “While India has a great genepool of IT and biotech talent, there are some challenges to development of personalised medicine. Machinery and software used are expensive. Moreover, shipping costs and import tariffs add to these costs. Globally, governments are focused on this developing science and are allocating budgets for R&D. We have to see this happening in India too. The Startup India initiative earlier in the year was a good start, but we need more to keep up with the advances in science. Regulations too need to be revamped to allow technology to breathe and grow.”

“It would require exuberant amount of resources, well regulated oversight processes and labs as well as a tightly controlled review process to validate and approve tests before implementation into the clinic,” insists Mehta. Mehta also considers cost as one of the major challenges. He says, “Importantly, due to high cost factor, very few patients in developing countries like India will be able to afford and benefit from genetically-based individualised treatments that are likely to offer only marginal benefit in terms of overall survival and quality of life.”

Sankaran says, “Adoption of the concept of precision medicine is in its infancy in India. There are some physicians who are abreast with the latest scientific developments and see great potential for genetic testing, while others are sceptical about the utility of the test due to the high cost of genetic tests and unavailability of drugs for identified diseases in the local market. Even though certain service providers in India send samples outside the country for testing, certain others like Strand does testing in-house, adopting stringent quality control measures as recommended for such complex tests by national and international regulatory agencies like CAP, ACMG and NABL. This helps in lowering the cost to an extent. However, all the reagents are still imported from companies in the US and Europe. R&D efforts to develop tests with generic reagents would further bring down the cost for testing.”

R&D for personalised medicines is a very expensive proposition and hence only large global pharma companies are undertaking this type of research currently. As mentioned before, normally such medicines are launched in developed countries. Patel informs that  in the developed countries affordability is higher and also can get reimbursed under insurance schemes.

With our limited strength in the field of personalised medicine it is imperative for Indian operators to have tie-ups with established players from overseas countries. Unless efforts are made to be self – sufficient in this regard the cost factor will always remain a deterrent for the patients. But there is a silver lining to the cloud as well. Companies such as iGenetic are collaborating with global providers of personalised diagnostics to make these tests available at affordable rates in India.

Patel states, “Cross-border collaboration should largely be in the R&D space. Indian biotech companies can collaborate with global peers in developing indigenous drugs in this space at lower costs in order to cater to Indian and developing world population.”

Acharya also believes in the same theory and informs that Mapmygenome is on the right track. She says, “Cross-border agreements are a rapid-expansion strategy that can be of immense value – introducing tests and services to the Indian market can be economically viable. Mapmygenome has several such strategic partnerships – with Brain Resource, and other diagnostic companies.” She informed that they also have organisations that offer their personal genomics services in Latin America, Asia, etc.

While pointing out that collaborations with drug companies conducting clinical trials and accessibility of patients from India to these drug trials would really help patients to try out experimental drugs, Sankaran echoes what Patel said before. He says, “Efforts by government agencies to facilitate import and sale of approved drugs and mandate insurance companies to provide coverage for treatment of genetic disorders would considerably help in better adoption of personalised medicine.”

Pharma perspective

New discovery is the norm in the pharma industry. The survival and growth of any pharma company depends on its ability and willingness to accept the latest advances in the market. Though the concept of personalised medicines has not yet gained significant ground in India, it will happen sooner or later. Pharma companies will be left with no option but to accept this new form of healthcare. Till now personalised medicines have showed potential in the treatment of diseases like cancer. A lot of research is still going on in the overseas market. As far as India is concerned, there are a few developments taking place, but nothing noteworthy has been achieved yet.

Sankaran feels that advances in the field of genetics have pharma companies more opportunities to develop new drugs. “The pharma industry is driven by market requirement. There is a huge requirement for discovery of new drugs for cancer and rare diseases. Data from genetic profiling would definitely be a rich source for discovery of new drug targets. Drug re-purposing, yet another outcome of genetic profiling, has opened the doors for pharma companies to conduct trials of drugs in non-approved diseases and get approvals from FDA and EPA,” says Sankaran.

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However, is it easy for pharma companies to achieve  Sankaran’s expectations? Perhaps not. Mehta explains, “High costs and high failure rates in drug development are major impediments in bringing effective therapies to the clinic. So far, the general approach by pharma manufacturers has been to develop inhibitors against single target (targeted therapies), which have sky-rocketed the costs with minimal survival benefits. Cancer is a multi-gene disease and only few drugs are available to target selected mutations. It will required to develop many more drugs against remaining target genes to reap potential benefits of personalised medicine (for example in lung cancer 8-10 driver genes have been identified whereas only two genes can be targeted by available drugs). It will take enormous effort, time and resources to develop effective drugs against remainder targets before this technology can be applied for identifying right drugs for right patients, that too implying that epigenetic and micro-environmental changes do not have significant impact in disease progression.”

Despite having done considerable work in the field of personalised medicines, overseas researchers too have a lot of ground to cover. So, India lags way behind in this sphere. As mentioned before by Mehta, even today there is a very limited success and a lot of time and efforts needed to be devoted to take a real leap. In comparison with their overseas counterparts, Indian researchers’ work and achievements are miniscule. So, in the near future, Indian pharma companies are less likely to have strategies/ business plans developed around personalised medicines.

Pranav Anam, Co-Founder and CEO, The Gene Box, takes a cautious approach. He says, “The field of personalised medicine will help pharma companies. It is very essential we understand that with the right data, they will be able to make better targeted drugs for people with various conditions. Having said that it is a long way away.”

Need for awareness

India has one of the largest patient pools in the world but lack of awareness is going to affect the growth of personalised medicines in the country. However, according to Sankaran, Internet savvy population is keeping themselves updated with the latest development. Sankaran narrates, “It is interesting to mention here that I was asked by a cancer patient about a year back as to why we do not use liquid biopsy instead of tumour blocks for testing; the test was not even being offered in the US at that time! The utility of personalised medicine in diagnosis of rare inherited diseases is steadily being recognised and accepted by physicians. They are excited about new non-invasive technologies like liquid biopsy and its utility in testing tumours that are inaccessible and tracking disease progression and recurrence.”

When it comes to patient awareness, the physician’s role proves detrimental. He is the connect between the patient and the medicine producer. Educating general population is important but educating the physician is perhaps more important. As Acharya opines, “One factor that holds sway here is the medical fraternity’s opinion. There is a need to educate doctors about the clinical value of this service.”

Patel sums up saying, “There are early adopters, especially in metros; however the pick up is slow. Also, there is a thought process on changing treatment protocols to incorporate personalised medicines. As soon as prices reduce, clinicians and patients will shift towards personalised medicine.”

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