Gujarat is laying stress on biotechnology after seeing states like Karnataka, Maharashtra and Andhra Pradesh reap benefits of investing in the sector. Its government is now working to persuade investors to its Biotech Park at Savli in Vadodara. The move is in sync with the bi-annual Vibrant Gujarat 2017 event to be held from January 10-13.
With the presence of over 180 biotechnology companies, Gujarat has established itself as one of the top five biotechnology hubs in India, stated Dhananjay Trivedi, secretary, department of science & technology, government of Gujarat.
The top five hubs for biotech are Karnataka Maharashtra specifically Mumbai and Pune, Tamil Nadu and Andhra Pradesh. The state is giving a push to biotechnology as a sector for promotion at the Vibrant Gujarat 2017 to be held at Gandhinagar. The eighth edition will draw attention to the fact about Gujarat’s prowess as a manufacturing hub in the country and bring the capability of biotechnology to the fore.
“This has been possible due to the presence of excellent physical and social infrastructure in the form of biotech parks, prominent academic institutions and clinical research organizations. Government of Gujarat has taken multiple initiatives to promote growth of biotech industry such as setting up a bio-incubator at Savli, technology facilitation cell, structured capacity building programmes, Gujarat Biotech Venture Fund etc.,” noted Gujarat S&T secretary Trivedi recently.
The Savli biotech park developed by the Gujarat State Biotechnology Mission (GSBTM) and the Gujarat Industrial Development Corporation (GIDC) spans over an area of 100 acres. The phase I comprises 38 acres of Special Economic Zone (SEZ) and 62 acres of non-SEZ area is now well developed with the basic infrastructure. The officials stated that the park would address the biotech industry’s need for specialized infrastructure. An area of 17.5 acre is earmarked for the Biotech Incubator and Common Equipment Library facilities and various laboratories.
“Adequate thrust has been given to promoting research and development through initiatives such as Gujarat Genomics Initiative, Marine Bio-resource Centre, Biodiversity Gene Bank among others. Going forward, biotechnology sector will remain a thrust area for Gujarat with the aim of making Gujarat the largest and most preferred biotechnology destination for investors,” he added.
Out of the total 1,797 Department of Scientific & Industrial Research recognized biotech companies in India, more than 10 per cent are in Gujarat. At least 50 per cent of the biotech companies in the state are located in and around Ahmedabad followed by 20 per cent companies in Vadodara region making them the major clusters of biotechnology industries, according to Gujarat’s department of Science & Technology.
Presence of a large number of international and domestic biotechnology companies, supplemented by biotech parks, academic institutions and clinical research organizations give it the much-needed impetus. Although a large chunk of companies are in the agricultural biotechnology segment, the contribution of the bio-pharma and bio-services is significant, stated DST.
Researchers have found that placebos can still reduce a patient’s pain, even if they know they’re only taking a placebo – something that goes against the long-held hypothesis that placebos only work when patients are unaware of them.
And it wasn’t a small amount of pain reduction in the study, either. Those who knowingly took a placebo in conjunction with normal pain treatments saw their pain decrease by up to 30 percent, compared to a 16 percent reduction in those who took the regular treatment alone.
“This new research demonstrates that the placebo effect is not necessarily elicited by patients’ conscious expectation that they are getting an active medicine, as long thought,” said senior author Ted Kaptchuk, from Harvard Medical School and the Beth Israel Deaconess Medical Centre.
“Taking a pill in the context of a patient-clinician relationship – even if you know it’s a placebo – is a ritual that changes symptoms and probably activates regions of the brain that modulate symptoms.”
The team gathered 97 individuals who suffer from chronic lower back pain – the world’s leading cause of disability. After evaluating each participant for the amount of pain they currently deal with every day, and explaining what the placebo effect is, they randomly split them up into two groups.
The first group was to continue taking their normal pain treatments, which the team called the ‘treatment-as-usual’ (TAU) group. The second group – known as the ‘open-label placebo’ (OLP) group – was given a bottle of clearly marked placebo pills.
Since both the TAU and OLP groups were already taking non-opioid medications to combat their pain, the researchers had both groups continue their normal medications, but told the OLP group to take two doses of placebo pills per day.
Three weeks later, the team reconvened with both groups to gauge the differences in their pain levels from the start of the experiment to the end. To their surprise, the OLP group reported a whopping 30 percent in pain reduction across two categories: normal pain and maximum pain.
On the other hand, the TAU group reported a 9 percent reduction in normal pain and a 16 percent reduction in maximum pain, meaning that the placebo group experienced about three times less normal pain and half the maximum pain than the TAU group.
“Our findings demonstrate the placebo effect can be elicited without deception,” said lead author Claudia Carvalho, from the Instituto Superior de Psicologia Aplicada (ISPA) in Lisbon, Portugal. “Patients were interested in what would happen and enjoyed this novel approach to their pain. They felt empowered.”
While the team doesn’t offer a complete hypothesis as to why patients seem to take so well to placebo pills, Kaptchuk thinks it could have to do with being immersed in a new treatment.
“It’s the benefit of being immersed in treatment: interacting with a physician or nurse, taking pills, all the rituals and symbols of our healthcare system,” he said. “The body responds to that.”
“You’re never going to shrink a tumour or unclog an artery with placebo intervention. It’s not a cure-all, but it makes people feel better, for sure.”
While there’s still a lot of work to do to understand the underlying factors of how the placebo effect operates and what triggers it – even when the patient is aware – the team’s findings will hopefully benefit those suffering from chronic pain issues by offering up new treatments for the future.
The team’s work was published in the journal Pain.
Source : University of California – San Diego
Summary : In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experienced measurable decreases in a set of blood-based metabolites associated with inflammation, cardiovascular disease risk and cholesterol regulation.
In a novel controlled clinical trial, participants in a six-day Ayurvedic-based well-being program that featured a vegetarian diet, meditation, yoga and massages experienced measurable decreases in a set of blood-based metabolites associated with inflammation, cardiovascular disease risk and cholesterol regulation.
The findings, published in the September 9 issue of Scientific Reports, represent a rare attempt to use metabolic biomarkers to assess the reported health benefits of integrative medicine and holistic practices. Senior author of the study, which included researchers from multiple institutions, was Deepak Chopra, MD, clinical professor in the Department of Family Medicine and Public Health at University of California San Diego School of Medicine and a noted proponent of integrative medicine.
“It appears that a one-week Panchakarma program can significantly alter the metabolic profile of the person undergoing it,” said Chopra, whose foundation provided and managed funding for the study. “As part of our strategy to create a framework for whole systems biology research, our next step will be to correlate these changes with both gene expression and psychological health.”
Study co-author Paul J. Mills, PhD, professor of family medicine and public health and director of the Center of Excellence for Research and Training in Integrative Health, both at UC San Diego School of Medicine, noted that alternative and integrative medicine practices, such as meditation and Ayurveda, are extremely popular, but their effects on the human microbiome, genome and physiology are not fully understood. “Our program of research is dedicated to addressing these gaps in the literature.”
“The researchers looked at the effects of a Panchakarma-based Ayurvedic intervention on plasma metabolites in a controlled clinical trial,” said first author Christine Tara Peterson, PhD, a postdoctoral fellow at UC San Diego School of Medicine. “Panchakarma refers to a detoxification and rejuvenation protocol involving massage, herbal therapy and other procedures to help strengthen and rejuvenate the body.”
The study involved 119 healthy male and female participants between 30 and 80 years of age who stayed at the Chopra Center for Wellbeing in Carlsbad, Calif. Slightly more than half were assigned to the Panchakarma intervention (the Chopra Center’s Perfect Health program, which typically costs $2,865 for a six-day treatment). The remainder to a control group. Blood plasma analyses, using liquid chromatography and mass spectrometry, were taken before and after the six-day testing period.
The researchers found that in the Panchakarma group there was a measurable decrease in 12 specific cell-membrane chemicals (phosphatidylcholines) correlating with serum cholesterol and inversely related to Type 2 diabetes risk.
“These phospholipids exert broad effects on pathways related to inflammation and cholesterol metabolism,” said Peterson. “Plasma and serum levels of the metabolites of phosphatidylcholine are highly predictive of cardiovascular disease risk.”
Application of a less stringent measurement standard identified 57 additional metabolites differentially abundant between the two groups of participants. The authors suggested that given the very short duration of the trial, the serum profile changes were likely driven by the vegetarian diet component of Panchakarma. They said further studies were needed to more fully understand the processes and mechanisms involved.
- Christine Tara Peterson, Joseph Lucas, Lisa St. John-Williams, J. Will Thompson, M. Arthur Moseley, Sheila Patel, Scott N. Peterson, Valencia Porter, Eric E. Schadt, Paul J. Mills, Rudolph E. Tanzi, P. Murali Doraiswamy, Deepak Chopra. Identification of Altered Metabolomic Profiles Following a Panchakarma-based Ayurvedic Intervention in Healthy Subjects: The Self-Directed Biological Transformation Initiative (SBTI). Scientific Reports, 2016; 6: 32609 DOI: 10.1038/srep32609
The clinical trial research industry in India is moving from traditional pen and paper and using the cloud to make research cost-effective and transparent.
India is turning out to be an attractive international hub for conducting clinical trials. The industry saw a steep increase from 0.9 percent in 2008 to 5 percent in 2013.
Along with growth has come evolution. While electronic data capture (EDC) for clinical trial research is not a new phenomenon in India, the cloud is giving it a boost. This means that costs are manageable, which makes it viable for researchers and sponsors. But costs do vary from study-to-study on the basis of the volume and duration.
“Out of 600 such studies, only 50-60 of our old research studies are still on paper. For each study, we were paying at least Rs 3 to 4 lakh. This expense has come down for us significantly,” says Archana Bhattacharya, database manager and curator at the Public Health Foundation of India (PFHI).
A transition from paper to software has brought in more than one benefit. For a foundation that carries out hundreds of studies, transparency and quality drug development is of utmost importance. The range of studies include trials for mental health, cardiovascular diseases, tuberculosis, health financing, health economics, child health and pollution, cancer, and diabetes, among others.
This research is crucial, so down-time is a big no-no. With the cloud, this is minimized and as an additional advantage, transparency is ensured. “EDC comes with geo-tagging, which means the location of the data entry is tracked. This way, some data validation is done as well,” says Bhattacharya.
Cloud has proven to be a boon when compared to traditional computing because it has reduced costs. “Our costs came down by 40 percent after we switched to cloud from third-party servers,” says Manuj Vangipurapu, CEO, Quad One Technologies. This decision helped him cut down costs for his clients who conduct clinical research.
Vangipurapu says that it was easier to develop a credible system with electronic case research form on Amazon’s AWS cloud for his clients. “Our product, Clinion is handling 30 studies as of today and is looking to migrate 155 studies from PHFI,” he says. Since cloud works on a ‘pay per use’ model, it is economical for bulk studies.
First-timers to EDC like Dabur Research and Development Centre (DRDC) and the Target Institute of Medical Education and Research (Mumbai), are positive about the transition. “The cost of the clinical trial has reduced remarkably due to remote monitoring, fewer site visits, reduction (or elimination) of printing costs, faster data entry, and lower data cleaning costs,” Sunil Kumar, research scientist from DRDC, medical affairs and clinical research says.
Target Institute of Medical Education and Research has been working on one study using the EDC platform. Its CEO, Sanjay Tamoli, says that the real-time data entry feature is the main feature of the software based data management system. Tamoli says EDC has reduced the time gap between data entry and its review, accelerating the monitoring process.
However, there are a few concerns that have come up. Tamoli speaks of the verification and back-up process that requires some more work. Apart from the source study document, the direct data entered requires a robust back-up as well. The cloud server speed is another issue to be tackled, notes Kumar.
A section of the industry still remains resistant to the use of technology. “At least 30 to 40 percent of researchers still stick to paper files,” says Vangipurapu. This is more so with the public health sector, which struggles with limited spending in the union budgets—as of March 2016, the health budget has remained stagnant at Rs 19,000 crore. Though India is the third-largest economy in the world, it only spends 1 percent of its GDP on public health, reports Reuters.
“Public health budgets have been a problem. So, there is a very slow transition. It is probably only in the last year or so that researchers are looking at EDC,” says Bhattacharya. Some SMEs have funding issues, so they can’t invest in IT. But slowly and steadily, cloud is making an impact on clinical research.
India has begun to bounce back in clinical trials with the new regulations issued at frequent intervals. This has enabled global pharma and clinical research organisations (CROs) to re-consider conduct of human studies in the country, said Naz Haji, SVP and head of India, Indonesia, Malaysia and Singapore operations, Quintiles.
“This change in regulations specific to clinical trials is progressive for both Indian companies and its patient population. Big pharma has evinced interest and is comfortable to kick start human studies once again in India which was considered a promising hub until end of 2012,” he added.
“However, the government along with the industry will need to reinstate efforts to ensure that the regulatory enforcement system in the country is able to step up the pace of approvals and provide the required clearances in a time bound manner. Clinical trials are important in patient care and therefore we are educating our customers internally that human studies are expected to surge supported by adequate assistance from the Indian regulators,” Haji told Pharmabiz at the sidelines of the DIA Life Sciences IT-enabled business conference held here in Bengaluru.
“Our strategy from a company perspective is to capture new opportunities driven by the government’s regulations and create a patient awareness to opt for clinical trials for their medical needs. So long the global companies whose trials constituted a substantial chunk of India’s clinical research business were unsure of India. The lack of regulations and uncertainty on the required approvals were looming large. But now we are convincing them that the environment is conducive and appropriate for clinical trials”, stated Haji adding that all Indian clinical research companies would need to move on similar lines to convince both multinational majors and the Indian patient population.
As it stands, regulations in India are adequate to ensure traction in clinical trials. There is enough momentum in the last nine months to ensure the prevalence of a comfort zone. Now with the latest guidance issued the Union health ministry early this month permitting clinical trials at hospitals with less than 50 beds and with no restriction on the number of clinical trials an investigator could take up at a time in the country, are expected to give a big impetus to growth, he said.
India is much-sought-after by international drug majors and CROs for human studies. The big benefits in this country are the combination of qualified doctors and patient pool along with the hospital infrastructure. Now with implementation of ICT (information and communication technology), the infrastructure needs are evolving with wireless networks, mobiles, higher-quality video viewing and broader bandwidth connections. For Quintiles too, India is key in its future game plan as we continue to invest in both individuals and infrastructure to serve companies here, said Haji.
Furthermore, global pharma and CROs too are beginning trust the reliability on the Indian regulatory system. Another positive for India is that the government itself is reaching out facilitate partnerships and collaborations. “Therefore, this country is bouncing back as it has emerged out of the dark phase of decline in human studies. We foresee 2017 to be more positive as sponsors making a big comeback,” he noted.