Clinical Research Organisation India

Ayush ministry directs Ayush SLAs to register at e-aushadhi portal for consistent supply of medicines

Posted on Updated on

In order to expedite the operationalisation of e-aushadhi portal for consistent supply of medicines, the Union Ayush Ministry has directed all state licensing authorities (SLAs) of Ayurveda, Siddha, Unani and Homoeopathy to expedite the process of registering on the portal on priority basis.

The main aim of e-aushadhi portal is to ascertain the needs of various district drug warehouses so that all the required drugs are constantly available to the user district drug warehouses without delay.

The portal deals with the management of stock of various drugs, sutures and surgical items. This includes classification and categorisation of items, codification of items, quality check of these items and finally medicines at the point of care or to the patient.

According to the Union Ayush Ministry notice, many of the state licensing authorities have not registered themselves in the e-aushadhi portal due to which registration of drug inspectors and manufacturers have not been initiated.

The key benefit of the portal is to implement a transparent system for procurement, storage and distribution of quality drugs, supply equipment required for the hospitals at a reasonable price.

It is also meant to ensure adequate savings in the budget for medicines by scientific forecasting system based on the preparation of essential drug list and its actual consumption.

The portal will also monitor the budget and drug consumption pattern by introducing a pass book system.

It will also be instrumental in improving infrastructure of the existing drug warehouse in district and further streamline the drug warehouse management, quality management, equipment inventory management, equipment complaint chain management, equipment auction life cycle, human resource and finance management in an efficient manner.

The e-aushadhi application is divided into layers. The layering model of the application is based on a responsibility layering strategy that associates each layer with a particular responsibility.

This strategy has been chosen because it isolates various system responsibilities from one another, so that it improves both system development and maintenance.

Each layer has specific responsibilities. The presentation layer deals with the presentation logic and rendering of the pages. The control layer manages access to the business logics layer.

The data access layer is responsible for the access to the enterprise information system (databases or other sources of information).

While the business logics layer is related to the business logic and manages the access to the data access layer, the helper layer supports the presentation layer as per the system protocols.

Source: 1

We Just Got Closer Than Ever to a Working Chlamydia Vaccine

Posted on Updated on

main article image

After more than fifty years of trying, a potential new chlamydia vaccine has at last reached phase 1 clinical trials. Not only was the vaccine found to be safe and well-tolerated when administered to humans, it was also able to provoke a distinct immune response.

While this does not necessarily suggest full protection from chlamydia, researchers say these are promising early signs.

“Given the impact of the chlamydia epidemic on women’s health, reproductive health, infant health through vertical transmission, and increased susceptibility to other sexually transmitted diseases, a global unmet medical need exists for a vaccine against genital chlamydia,” says immunologist Peter Andersen from the Statens Serum Institut in Denmark.

This is a hole that scientists have been trying to fill for decades with no success. The first attempts to create a chlamydia vaccine began way back in the 1960s, when researchers tried to produce a number of vaccines using the bacterium itself, Chlamydia trachomatis.

These studies unfortunately backfired, with some patients becoming more susceptible to the infection after vaccination. Without a clue as to what was going on, the idea was largely abandoned until recently.

Today, chlamydia is the most common sexually transmitted bacterial infection in the world and a growing threat to female fertility, despite antibiotic treatments and screening programs.

Over the past decade, as the number of infections continues to grow, chlamydia vaccine research has picked up steam, with a dozen studies published each year on average.

In all that time, only one of these vaccines has had enough potential to make it to human clinical trials. After conducting studies on animals, researchers from Imperial College London and Statens Serum Institut were at last given permission to conduct a randomised trial of 32 healthy women between the ages of 19 and 45.

These participants were split into three groups; the first of which was given a placebo vaccine three times at 0, 1 and 4 months apart. In the same way, the second and the third group were given a chlamydia vaccine that contained either added liposomes (CTH522:CAF01) or added aluminum hydroxide (CTH522:AH).

These two different combinations were selected in previous trials on mice and guinea pigs. At 4.5 and 5 months, participants were then given intranasal boosts of the vaccine, receiving five doses in total.

The sample size is admittedly small, as is typical at this stage of trials, but the results are cause for optimism. Phase I clinical trials are primarily designed to test for safety, and in the study no serious adverse events were reported, which means the research can continue on to larger trials (which may or may not reveal less common reactions). Any local reactions to the vaccine were mild and comparable to the hepatitis B vaccine.

Testing the immune response was only a secondary goal, but that’s where this medicine really shines. While no participant in the placebo group received an immune response, every participant who received the vaccines showed a strong immune response, and this was boosted with every subsequent jab.

Interestingly, the vaccine with liposomes was consistently better at increasing serum antibodies, inducing a 5.6 higher response in immunoglobulins following intramuscular injection. What’s more, these added liposomes also showed a stronger mucosal and cell-mediated immune response, both of which are important for an infection that lives within cells of the mucus.

In fact, the amount of immunoglobulins produced by this vaccine are similar to those induced by other licensed vaccines like the one for hepatitis B. In contrast, the intranasal doses didn’t seem to add much at all.

As exciting as these long-awaited results are, they are only indicative of immune protection; they don’t guarantee that this vaccine can stop a chlamydia infection. But even still, there’s good reason to think that it might.

“Studies of antibodies in mice have found that antibodies in the vagina are the first line of defence against chlamydia infection, which suggests they are key to how effective the new vaccine may be,” explains clinical development researcher Helene Juel from the Statens Serum Institut.

In other words, if these antibodies can target the bacteria before it enters the genital tract, it might be able to halt the progression of the infection, reducing future fertility issues.

More years of research will be needed before this vaccine is shown to be effective and marketable, but the work is already under way. The authors say they are planning phase II of their clinical trials, which is set to test the efficacy of the vaccine sometime this autumn.

“It’s exciting for us just to be off the starting block with doing human clinical trials,” Shattock told Time. “We need to encourage more trials to be done in this space, because it’s such an important infection with such a big potential public-health gain.”

For many, the dream is to one day combine the chlamydia vaccine with the HPV vaccine, so that we can protect young females from cancer and infertility at the same time.

The research has been published in The Lancet Infectious Diseases.

Source: 1

India and US soon to begin collaborative research on vaccine adjuvant development

Posted on Updated on

In order to foster collaborations between Indian and US investigators to accelerate vaccine adjuvant research, the Department of Biotechnology (DBT) has invited applications from eligible candidates for collaborative research under the India-US Collaborative Research Grants on Vaccine Adjuvant Development.

This programme will support collaborations, both between academic institutions as well as between academia and industry partners. The aim is to build capacity for discovering and developing new adjuvants that can improve vaccine efficacy and also enhance career development.

Activities associated with adjuvant discovery include: the screening of compound libraries, in vitro or in silico, to identify molecules capable of stimulating (human) cellular receptors or pathways that result in enhanced innate/adaptive immune responses; identification of molecular or cellular mechanisms-ofaction of novel adjuvants; optimisation of novel adjuvants through structure-activityrelationship (SAR) studies, involving medicinal chemistry approaches; and preclinical testing of novel adjuvants in animal models with pathogen-derived antigens or licensed vaccines to determine the safety, immunogenicity and efficacy of the novel combination.

The goal of adjuvant development is to advance novel vaccine-adjuvant combinations towards licensure for clinical use. Adjuvant development activities include: characterisation of immune profiles and potential immunotoxicity induced by vaccines formulated with novel adjuvants; improvement of an adjuvant’s in vivo efficacy and reduction of reactogenicity through formulation or modification of delivery routes; toxicology, stability testing, pharmacokinetics or adsorption, distribution, metabolism and excretion studies to generate data required for initiating clinical testing of novel adjuvanted-vaccines. Adjuvant research also encompasses the development and evaluation of combination adjuvants, such as: the systematic pairing of novel or previously described adjuvants to identify highly synergistic combinations; identification of molecular or cellular mechanisms underlying synergistic adjuvant action in such combinations; or development of approaches to optimise the co-delivery of multiple adjuvants, either through carriers or other formulations, or chemical linkers. This new programme supports a wide variety of adjuvant research activities conducted collaboratively by Indian and US investigators.

Areas of collaborative research will include discovery of novel compounds with adjuvant activity; systematic optimisation of lead adjuvant compound(s); in vitro or in vivo (animals) evaluation of novel adjuvants (single compounds or combinations) combined with antigens associated with pathogenic infections, candidate vaccines, or licensed vaccines; mechanism-of-action studies of adjuvants, including identification of molecular targets, signaling pathways, or immune effector functions (e.g., soluble mediators, cellular targets); formulation/ optimisation of novel adjuvanted vaccines, including those for at-risk populations; and systematic side-by-side in vitro and/or in vivo (animal) comparison of adjuvants to down-select for subsequent product development.

However, this programme will not support cancer-related adjuvant discovery/development; and clinical trials.

From this Joint Call, the DBT seeks new innovative approaches that have the potential to transform the vaccine sector on a national or global scale by identifying and filling gaps in knowledge on the discovery/ development of novel adjuvants that enhance vaccine performance without interfering in its activity. This Joint Call is aimed to support collaborative proposals that combine complementary and synergistic research strengths in any of the aforementioned areas. This call invites consortia-based concept proposals from academia (with/without industry) with already established/identified leads and explicitly outlined deliverables for further validation.

This call for proposals will close on 7th October, 2019.

Source: 1

Alzheimer’s Appears to Attack The Neurons That Keep Us Awake

Posted on Updated on

main article image

Alzheimer’s is an insidious disease. Long before even the earliest symptoms begin to show, plaques of amyloid beta proteins and tangles of tau proteins are already building up in the brain.

Excessive daytime napping is one of the earliest outward signs, but exactly why that might be is hard to say. Some have suggested that Alzheimer’s disease (AD) disrupts sleep-promoting brain regions, while others say a lack of sleep is what drives cognitive decline.

Researchers at the University of California San Francisco (UCSF) have now put forward a new explanation. Analysing postmortem brain tissues from 13 patients with AD and 7 healthy controls, the team suggests that Alzheimer’s disease directly attacks brain regions that keep us awake during the day.

“It’s remarkable because it’s not just a single brain nucleus that’s degenerating, but the whole wakefulness-promoting network,” says lead author Jun Oh, who researches memory and ageing at UCSF.

“Crucially this means that the brain has no way to compensate because all of these functionally related cell types are being destroyed at the same time.”

Disrupted sleep has been associated with β-amyloid plaques before, but so far, little is known about the role of the other main AD marker, the tau protein tangles. Mounting evidence in the past few years has suggested this is an important avenue to explore.

While both tau and β-amyloid are hallmarks of Alzheimer’s disease, an overabundance of the former might contribute more to brain degeneration, directly driving symptoms like fragmented sleep.

study published earlier this year, for example, found that older people who display less slow-wave sleep have higher levels of the brain protein tau. At the time, the authors suggested that while these patients were sleeping for longer, the disrupted nature of this sleep was causing excessive daytime napping.

Oh and his colleagues have a different theory. Rather than stemming from a lack of sleep from the night before, they suggest that excessive daytime sleepiness is caused by direct degeneration of wake-promoting neurons.

Looking at brain tissue, the team found a significant tau buildup in three wakefulness-promoting brain centres, including the locus coeruleus (LC), the lateral hypothalamic area (LHA), and the tuberomammillary nucleus (TMN). Remarkably, this complex system had lost as many as 75 percent of its neurons.

“Our work shows definitive evidence that the brain areas promoting wakefulness degenerate due to accumulation of tau – not amyloid protein – from the very earliest stages of the disease,” says senior author Lea Grinberg, a neurologist and pathologist at UCSF.

Among the many fatalities was a type of neuron in the LHA that produces a neuropeptide called orexin. This neuron plays a crucial role in wakefulness; when it is deleted in mouse models, the animals show similar patterns to human narcolepsy – a chronic sleep disorder characterised by daytime drowsiness.

In the brains of patients with AD, UCSF researchers found orexin practically annihilated. In fact, the abundance of these orexin-producing neurons had decreased by more than 71 percent.

“To put this into another perspective, patients with narcolepsy .. have been reported to show 85-95 [percent] reduction in the number of orexinergic neurons, almost comparable to what we see in patients with AD,” the authors write.

While Alzheimer’s is most often associated with memory problems, sleep problems are a common complaint that can show up much sooner. As such, scientists are now curious if excessive napping can somehow help us diagnose Alzheimer’s earlier and more effectively.

“The study supports the idea that sleep dysfunction is a manifestation of Alzheimer’s pathology buildup in the brain, rather than a risk factor,” Ginberg told Newsweek.

“It opens opportunities to treat the cause rather than the symptoms.”

The findings have been published in Alzheimer’s & Dementia.

Source: 1

Indian healthcare industry focuses on technology to propel accurate clinical outcomes: Amit Sharma

Posted on Updated on

Indian healthcare industry is focusing on clinical outcome through innovation with technology automation to bring in the much-needed patient convenience. This is because patients too, and primarily the medical tourism segment, prefer the hospitals that are able to provide complete services under one roof, said Amit Sharma, founder and CEO of eExpedise Healthcare.

Medical tourists usually decide to travel when they can achieve savings of more than 30 per cent of the cost they have to bear in their home country. For instance, as per information published by OECD, patients in the US save between 30 per cent and 50 per cent of the cost of treatment for common ailments such as heart issues, if they travel to Asia or Latin America for the same treatment.

Expectations of consumers are changing rapidly so is the demand and supply process across the industry, and healthcare is no different. Co-ordinated Healthcare is driving the current healthcare industry, he added.

In an interaction with Pharmabiz on how integrated healthcare solutions are changing the face of economy, Sharma said that the healthcare institutions have understood the consumer expectations and started expanding horizontally and vertically and trying to having all the services under one umbrella or provide the platform where customer can access other required services at its own ease. Some of the large institutes has opened a dedicated concierge department which focus on arrangement of services which are not offered inhouse.

The solution provides consolidating resources for efficiency, expanding access points and market presence, adding resources to assist population health management, acquiring facilities for expansion or diversification, creating a means to recruit and retain physicians … the list goes on.

The integrated and co-ordinated services are not necessarily being related to medical but other services such as for outstation patient and attendants hotel or accommodation near the Hospital or food options as for attendants. In fact it is this service that has made

India a preferred medical tourism destination globally. Patients travelling for medical care look forward to hassle free treatment and post treatment care, this is only possible through integrated healthcare solution, said Sharma

The global medical tourism market was valued at $53,768 million in 2017, and is estimated to reach at $143,461 million by 2025, registering a CAGR of 12.9 per cent from 2018 to 2025. The most frequently availed services via medical tourism route include cancer, orthopaedic, neurological disease, elective surgery, among others.

Affordability and accessibility of good quality healthcare services along with assistance from tourism departments and local governments are the factors that drive the growth of the global medical tourism market. In addition, availability of latest medical technologies in medical tourism hubs, throughout the world, is expected to fuel the market growth, he said.

Source: 1