CRO in chennai

Australia Is Set to Become The First Country to Completely Eliminate One Type of Cancer

Posted on Updated on

main article image

The International Papillomavirus Society has announced that Australia could become the first country to eliminate cervical cancer entirely.

According to a new study, Australia’s efforts to distribute a human papillomavirus (HPV) vaccine for free in schools have been a resounding success.

The sexually transmitted infection causes 99.9 percent of cases of cervical cancer.

In 2007, the Australian federal government began offering the vaccine to girls aged 12-13, and in 2013 it was made available to boys, too. Girls and boys outside of that age bracket but under nineteen are also entitled to two free doses of the vaccine.

Between 2005 and 2015, the percentage of Australian women aged between 18 and 24 who had HPV dropped from 22.7 percent to just 1.1 percent.

Immunization rates have increased further since 2015, contributing to what’s being described as a “herd protection” effect.

The world isn’t catching up

In the US, the HPV vaccine is not free. It can cost as much as US$450 for the full regimen, according to the Association of Reproductive Health Professionals, although financial assistance is often available.

In 2016, 78.6 percent of 15-year-old Australian girls, and 72.9 percent of 15-year-old Australian boys were vaccinated – but only 50 percent of American girls between 13 and 17, and 38 percent of American boys between 13 and 17 had received the vaccination, as per data published by the Henry J. Kaiser Family Foundation.

The situation is much worse in the developing world, where papillomavirus incidence rate remains high.

“Two-thirds of the world’s population of women don’t get access to what Australian women do,” said Joe Tooma, the chief executive of the Australian Cervical Cancer Foundation.

“Unless we do something, it will still be one of the major cancer killers in developing countries.”

Administering the HPV vaccine in schools has also proven to be effective in a trial that took place in Bhutan.

Offering this kind of free access to the vaccine in other developing countries may seem like an expensive measure, but as the Australian example shows, it could ease the burden of cervical cancer down the line.

This article was originally published by Futurism. Read the original article.

Source: 1


CDSCO issues guidance document to streamline approval process for conducting BA/BE studies for export

Posted on Updated on

The Central Drugs Standard Control Organisation (CDSCO) has come out with a comprehensive draft guidance document to streamline the approval process for conducting bioequivalence (BE) and bioavailability (BA) studies with human participants in India for export purposes.

BE studies are conducted to establish that two medicines, usually the original patented drug and a generic version, have the same biological equivalence, which means they work the same way and are interchangeable. The study is crucial for ensuring the safety and tolerability of generics against corresponding innovator drugs.

BA refers to the relative amount of drug from an administered dosage that enters the systemic circulation and the rate at which the drug appears in the systemic circulation.

The ministry of health and family welfare has recently amended the Drugs and Cosmetics Rules, 2017, to make BE studies compulsory for certain classes of generic drugs manufactured in India. However, those drug makers exporting to the US and the European Union are required to conduct these studies to gain marketing approval for those jurisdictions as BA and BE studies are recognised globally as an effective method to ensure therapeutic equivalence between a pharmaceutical equivalent test product and a reference drug.

According to industry sources, since the amendment to regulations, the number of pharmaceutical companies approaching the regulators to get approval for BE and BA studies has increased manifold.

The government has decided to come out with a draft guidance document to make the application process smooth-running. According to an official source, many applications get unnecessarily delayed in the absence of a detailed checklist. The new draft is expected to harmonise the submission process, shorten clearance time and help examiners reach quick and uniform decisions.

As per the guidance document, any firm that wants to conduct a BA and BE study should submit detailed study protocol, details of Ethics Committee registration, BA/BE Centre approval copy and other relevant documents mentioned in the checklist.

To obtain the CDSCO nod for the study of a new chemical entity not approved in India but cleared in other countries, an undertaking letter from the sponsor stating that he/she will provide complete medical care as well as compensation for the injury or death should be provided. Published reports of Pharmacokinetic and Pharmacodynamics studies carried out in healthy subjects demonstrating safety and tolerability of the molecule are also necessary.

For cytotoxic drugs, hormonal preparations, narcotic and psychotropic substances etc to be tested in healthy human subjects, a scientific justification with special emphasis on safety of subjects with a proper risk evaluation and mitigation strategy should be submitted. The guidance document also states that the firm should submit separate applications for different protocols along with requisite fee.

Source: 1

A New Study Shows Why You Really Need to Look After Your Brain Cells

Posted on Updated on

main article image

Up until a few years ago, it was widely accepted that the neurons you’re born with are pretty much all you get. Then a handful of studies made us think we had it all wrong and neurogenesis continued throughout our adult years.

Now a study just published in Nature has found that our ability to grow new neurons does indeed slow to a crawl in our youth – so maybe we need to look after our brain cells more than we thought.

Let’s just get one thing out of the way: neuroscience is hard. Really hard. Discovering new brain cells isn’t as simple as digging out a chunk of grey matter and looking at it under a microscope.

Over the past few years, a number of studies have come out enthusiastically overturning the old adage that our brains stop growing new cells long before we hit adulthood.

To get around many of the practical and ethical challenges that come with studying human nervous systems, a number of the researchers based their conclusions on signs of new growth in rodents.

While these kinds of methods come with the usual caveat ‘mouse brains aren’t human brains’, the excitement of challenging the status quo can often overshadow the need for caution.

This latest study led by researchers from the University of California, San Francisco, identified the maturity of a type of brain cell taken from a mix of 59 deceased and living patients, and used this to estimate when we stop growing new neurons.

Specifically, the team focussed on cells taken from the dentate gyrus, an area of the hippocampus which previous research had found could be growing as many as 700 new brain cells every day.

The specimens were taken from individuals ranging from a 14-week-old foetus to a 77-year-old male, providing the team with a spectrum of neurological development.

What they found showed a timeline of development that slowed after birth and stopped in adolescence.

Samples taken from the 14-week-old foetus contained precursor cells, proliferating neurons, and mature tissue migrating towards the dentate gyrus.

By age one, it seemed as if new nerve growth in this area was slowing, with far fewer precursor cells.

Beyond age 13 there were no proliferating neurons to be seen in the hippocampus, contradicting previous research.

There are a couple of take-home messages from this study.

Firstly, we might have been right all along – human brains really don’t generate new neurons into adulthood.

Secondly, taking prior studies on mice into account, it seems as if human brains are more unique than we ever suspected.

This leaves us with a fascinating question – why do some animals grow new brain cells when we don’t?

Answering this question could point the way to novel treatments for degenerative brain conditions, if not show us why they arise in the first place.

It’s easy to be cynical and wonder why science simply can’t make up its mind, but as frustrating as it seems, this is the methodology of science in action.

No doubt this research is far from the final word on the matter, as the back-and-forth continues to add ever more detail to what is probably the most complicated organ in the human body.

This research was published in Nature.

Source: 1

Aidan approaches DTAB to remove non-experts from FDC panel, seeks more time to submit data

Posted on Updated on

As a sub-committee of the Drugs Technical Advisory Board (DTAB) gets ready to examine the ban on 300-plus fixed dose combination (FDC) drugs, All India Drug Action Network (Aidan), a petitioner in the case, has come out against the presence of ‘non-expert’ members in the panel and the tight deadline set by the government to make submissions.

In a letter written on March 15 to DTAB chairman Dr BD Athani, which has been reviewed by Pharmabiz, Aidan sought the removal of ‘non-expert’ industry body representatives and professional association members from the sub-committee citing credibility issues and conflict of interest. The group, a network of NGOs in the health sector, called for the reconstitution of the panel to increase its reliability.

The non-profit organisation also wanted the technical advisory board to extend the deadline for submissions by another month as more than 1,000 formulations related to the 344 impugned FDCs need to be scrutinised.

The health ministry last year had banned these FDCs — drugs containing two or more active ingredients — after an expert committee headed by Prof CK Kokate declared them unsafe. Drug makers challenged the ban in high courts across the country. In January this year, the ministry moved the apex court challenging a Delhi high court order that quashed the ban. Aidan had also filed a petition in the top court against the Delhi High Court order.

The DTAB panel, constituted in accordance with the Supreme Court order to re-examine the issue, is headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai. President of Indian Pharmaceutical Association Telangana Dr Rao VSV Vadlamudi, Maharashtra FDA Joint Commissioner OS Sadhwani, one representative each from Indian Medical Association’s New Delhi and Mumbai chapters and a clinical pharmacologist are the other members. DDC (I) CDSCO (HQ) Sanjeev Kumar Gupta is the convener. The committee, which was given three months to finalise the report, last week directed Aidan and other industry stakeholders to make their submissions regarding the FDCs in question before April 7.

In its letter, Aidan objected to the inclusion of industry representatives in the expert panel. “It is clear from this (Supreme Court) judgment that the task assigned to the DTAB or the sub-committee appointed by it is of the nature of an expert review of the report of the Kokate Committee in order that an analysis of these be made in greater depth. Therefore it has to be an expert review committee, the members of which have to be selected on the basis of their expertise in medicine, pharmacology, rational therapeutics and regulation of health care,” Dr Mira Shiva, co-convener of Aidan, wrote in the letter.

While welcoming the appointment of Dr Kshirsagar as its chairperson, the NGO expressed its disagreement with the appointment of industry association members to the panel. “Representatives of the Indian Pharmaceutical Association (IPA) are representatives of a professional association and not any expert body. Similarly, representatives of the Indian Medical Association (IMA) represent an association of medical professionals and not any expert body. The appointments of these three members, on the basis of their membership in professional associations, do not meet the criteria of expertise and objectivity required for deciding on the findings of another expert body — the Kokate Committee,” the letter stated.

“Many members of the IPA are affiliated with the pharma industry. There are thus clear, organic conflicts of interest. Further, the IMA is a body particularly known for its conflict of interest with respect to commercial endorsements and vis-a-vis the pharma industry. The sub-committee report headed by Dr Kshirsagar will therefore lack credibility in a matter of grave public health interest if it includes such members,” Dr Shiva added. Aidan also wants the members of the re-constituted committee to declare their conflicts of interest to boost transparency.

Source: 1

Elephants Are Strangely Resistant to Cancer – And We May Finally Know Why

Posted on Updated on

main article image

A research team peering into the relatively underexplored “junk” DNA of mammals has found more clues as to elephants’ extraordinary ability to evade cancer – and determined that the genes responsible for mitigating damage in elephant cells can also be found in humans.

Most of the world’s mammals are prone to cancer, but elephants are strangely resistant. They’re not completely immune, but compared to humans, they get it surprisingly rarely – especially considering that they have 100 times the number of cells that humans do.

Cancer occurs when a cell randomly mutates during division, so the fact that only around 1 in 20 elephants develops cancer, compared to 1 in 5 humans, is extremely curious.

Researchers had been trying to figure out why this was the case for decades, but it was only a few years ago that a team of researchers narrowed this incredible trait down to an overabundance of a gene called p53, which suppresses tumours. African elephants have 40 copies of p53. Humans have just one.

But now a team of researchers at the University of Utah has found more clues as to how it occurs, and it’s not just down to p53.

They studied what had been known for several decades since the 1960s as “junk DNA” – DNA that does not code for proteins. That doesn’t make it useless, however – recent studies have found that it performs other functions, such as being able to control when and where genes are expressed.

“People used to call the noncoding regions ‘junk DNA’, but I see it as a jungle that has not been explored,” said neurobiologist Christopher Gregg from the University of Utah.

“We are exploring the noncoding regions to try to discover new parts of the genome that might control different diseases.”

The team searched the parts of the elephant genome that are common to all vertebrates, but specifically evolved more rapidly in elephants. They were scanning these regions for elements that help resist mutation – and therefore cancer.

They identified three genes in the elephants’ DNA – FANCL, VRK2 and BCL11A – after exposing the DNA to gamma radiation and observing how it responded to damage. These genes in particular are involved in DNA repair that guards against mutations – and they’re strongly associated with elephant accelerations.

Because vertebrates have so much DNA in common – having evolved from a common ancestor – many other mammals have these genes, too. The human versions don’t protect us from cancer in the same way that they seem to do in elephants, but just knowing what these genes are can help us narrow down their evolution in elephants, and determine if we can effect a similar change in our own genes.

Other animals the team studied were the hibernating bat, to study limb abnormalities; orca and dolphin, to study eye and corneal development, as well as adaptation to high pressure environments to study blood clotting disorders; naked mole rat, to study eye development and glaucoma; and thirteen-lined ground squirrel, to study albinism and leopard syndrome.

Future research will be needed to determine whether these accelerated regions in other mammals could be applied therapeutically to help control diseases in humans.

“We are staring at uncharted territory,” Gregg said. “This method gives us a new way to explore the genome and potentially uncover new approaches to identify, diagnose and treat disease.”

The paper can be read in full in the journal Cell Reports.

Source: 1