AurouSpeak – Newsletter from the Corporate of Aurous HealthCare CRO

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A Century-Old Discovery of a Virus Could Become Our Solution to Antibiotic Resistance

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Antibiotic resistance – the phenomenon in which bacteria stop responding to certain antibiotics – is a growing threat around the world.

It’s expected to kill 10 million people annually by 2050.

And it hasn’t been easy to develop new drugs in order to stay ahead of the problem. Many major pharmaceutical companies have stopped developing new antibiotics, and the drugs that are still in development have faced numerous stumbling blocks toward approval.

So some drugmakers are starting to turn to other solutions, including one that’s actually had a fairly long history: phage therapy.

The treatments are made of bacteria-killing viruses called bacteriophages, or phages for short. Discovered in the early 1900s, bacteriophages have the potential to treat people with bacterial infections.

They’re commonly used in parts of eastern Europe and the former Soviet Union as another way to treat infections that could otherwise be treated by antibiotics. Because they are programmed to fight bacteria, phages don’t pose much of a threat to human safety on a larger scale.

“There’s huge potential there that regular antibiotics don’t have,” NYT columnist Carl Zimmer told Business Insider in 2015. “I think what we’d actually have to work on is how we approve medical treatments to make room for viruses that kill bacteria.”

A conversation about approval pathways is already underway, with a handful of companies starting to get into the space. The trials, while still in early stages, could one day change the way we confront antibiotic resistance.

A need for new options

Dr. Paul Grint, CEO of one small company, AmpliPhi Biosciences, is trying to turn phage therapy into a tool that doctors might be able to one day use alongside antibiotics to treat serious infections.

The company is working on phage-based treatments to treat Staphylococcus aureus, a bug implicated in sinus infections, and Pseudomonas aeruginosa, a bug connected to lung infections in people with cystic fibrosis.

There are a number of reasons why these treatments are gaining some momentum now: for one, there’s a big need for antibiotics. In September, the World Health Organisation warned that the world is running out of antibiotics.

“There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB, otherwise we will be forced back to a time when people feared common infections and risked their lives from minor surgery,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus said in a news release.

For phages in particular, there have been a number of advancements that help make it more straightforward for phage therapy to go through the FDA approval process. Grint told Business Insider that includes being able to sequence the bugs, which would help determine that you’re absolutely getting the right phages in treatment.

AmpliPhi also has a way to manufacture the therapy that’s up to regulatory standards set up by the FDA.

Using phage therapy in the US

While phage therapy has been around for more than a century, Grint said there’s still a lot of education that needs to happen to get doctors and researchers on board, especially in the US. In July, the FDA and National Institutes of Health hosted a workshop regarding bacteriophages, which Ampliphi and others participated in.

There are also some researchers like a group at the University of California at San Diego that are researching phage therapy. In 2016, for example, researchers at UCSD used AmpliPhi’s therapy to treat a professor at the university who had a drug-resistant infection.

Even so, the US is treading carefully into the world of phage therapy. For now, AmpliPhi is able to recruit patients under the FDA’s “compassionate use” pathway, making it mostly a case-by-case situation for now when other antibiotics have failed.

The hope is to use that information, along with some phase 1 studies that are happening in Australia to gear up for a phase 2 trial in the US. The company’s aiming to start that trial in the second half of 2018, meaning it still might be a while before we start using viruses to treat our bacterial infections.

This article was originally published by Business Insider.

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CSIR-NCL inks research pact with Indian Pharmacopoeia Commission on APIs

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CSIR-National Chemical Laboratory (CSIR-NCL), Pune and Indian Pharmacopoeia Commission (IPC) have signed an MoU for the joint research collaboration. This is by combining their respective capabilities in the area of ‘synthesis of impurities of API standards as per requirement of IPC.’

In addition, the IPC, Ghaziabad and the Central Drugs Standard Control Organization (CDSCO), Mumbai are looking to focus on industry and academia participation to spur growth the pharmaceuticals in the country.

At the CSIR-NCL, Pune which conducted an interactive session conducted on October 11, 2017, Dr GN Singh, DCGI & Secretary-cum-Scientific Director, IPC, said that research should be translated to drug discovery.

The regulatory authority should work along with the academia and the industry to work as a team and contribute effectively for the benefit of the common people. We have to come out of our compartments and resolve the issues together that are relevant for the country, stated Dr Singh.

Dr. Pallavi Darade, Commissioner, Food and Drug Administration (FDA), Maharashtra spoke about the achievements of the IPC highlighting its policies regarding clinical trials.

Dr K Bangarurajan, Dy Drug Controller (India), CDSCO, West Zone spoke on the recent regulatory updates in implementation of Drugs and Cosmetics Acts.

Dr. PL Sahu, Pr. Scientific Officer, IPC highlighted the role of IPC and current practices followed. Dr K Raghu Naidu, Head Sitec Labs, Mumbai spoke on the Challenges in Clinical Trial & Bioavailability/Bioequivalence Studies. Dr Bobby George, VP & Head Regulatory Affairs, Reliance Life, Mumbai touched upon the subject ‘Regulatory Requirements for Bio-similars & Stem Cells’.

During the interactive sessions two panel discussions were conducted. The first panel discussion comprised of the regulatory bodies including Dr Singh, Prof Ashwini Kumar Nangia, Director, CSIR-NCL Dr Raman Mohan Singh, Director, CDTL, Mumbai, Dr Bangarurajan, Dr Sahu, O S Sadhawani, Joint Commissioner, FDA, Nashik Division and Shri Kale.

The second panel discussion was represented by Dr K. Raghu Naidu, Sitec Labs Ltd., Mumbai, Dr Bobby George, Reliance Life Sciences, Mumbai, Dr Sudhir Pawar, LTM Medical College & General Hospital, Ravi Sekhar Kasibhatta, Lupin Limited, Lupin Bioresearch Center, Dr Mukund Gurjar, Emcure Pharmaceuticals, Dr Mahesh Burande, Institute of Pharmaceutical Education & Research, Pune and Dr Chandra Vishwanathan, Regenerative Medicine.

Earlier, Prof Nangia, introduced the idea behind the interactive session and gave the welcome remarks. Dr Srinivasa Reddy coordinated the programme.

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Hacking Brain Waves Can Give You an Instant Cognitive Boost, Says Study

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Artificially getting activity in certain parts of the brain to sync up can provide a small mental boost when completing tasks or recovering from mistakes, according to new research.

The technique could eventually be used as a safe and simple way to perk up the brain, as well as an option for treating those with psychiatric and neurological disorders, where these types of oscillations are often disrupted.

For the study, a new technique called high-definition transcranial alternating current stimulation (HD-tACS) was used to gently zap the brain using electrodes, with follow-up measurements taken via electroencephalogram (EEG).

The researcher from Boston University concentrated on two brain regions in particular: the medial frontal cortex, which sparks into life when you make a mistake or get surprised, and the lateral prefrontal cortex, which handles rules and goals, and helps us to change our decisions and actions.

“These are maybe the two most fundamental brain areas involved with executive function and self-control,” says Robert Reinhart, the researcher.

aa brain scan 2The large red blob shows increased synchronicity, corresponding to improvements in learning. Credit: Robert Reinhart

Previous studies have looked at the possibility that cells in these brain areas communicate with each other through the timing of their oscillations, but this latest study is the first to look at their effects in detail through the use of HD-tACS.

The study ran through three different sets of tests, each with 30 healthy volunteers asked to carry out a time estimation learning task, pressing a button when they thought 1.7 seconds had elapsed, and getting feedback on whether they’d missed the mark.

In the first set of tests, when HD-tACS was used to increase synchronicity between brain areas, the volunteers learned faster, made fewer errors, and recovered from errors more quickly.

The volunteers themselves didn’t notice any changes in their performance, but the differences were statistically significant.

On the other hand, when the oscillations between the brain regions were disrupted, people in the group made more errors and were slower to learn.

In the second test, each side of the brain was tested independently, with the right hemisphere of the brain shown to be more relevant to changing behaviour.

Finally, in the third set of tests, the oscillations were disrupted then synchronised more quickly than before – during the tasks rather than at the end of each set. They study found that the original thought patterns and levels of learning came back within minutes.

“We were shocked by the results and how quickly the effects of the stimulation could be reversed,” says Reinhart.

While these initial results so far are interesting, researchers have a long way to go to see if these brain sync boosts can be scaled up and are safe enough to be used in the long term, or indeed if they apply beyond the simple task of pressing a button every 1.7 seconds.

But even though it’s early days, the potential is intriguing.

Conditions like anxiety, Parkinson’s, autism, schizophrenia, ADHD, and Alzheimer’s all show signs of disrupted brain oscillations, and a treatment like this could help, as well as being more precise in focus than existing drugs.

Then there’s the question of whether it could give healthy brains a boost in their thought processes – we’re not close to that yet, but it’s a possibility.

“Think about any given workday,” says David Somers, also from Boston University, who wasn’t directly involved in the research. “You need to be really ‘on’ for one meeting, so you set aside some time on your lunch break for some brain stimulation.”

“I think a lot of people would be really into that – it would be like three cups of coffee without the jitters.”

The research has been published in PNAS.

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Chennai CDSCO enters into second phase of e-governance, industry and regulators hail high-tech operations

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As a succession process to the e-governance initiatives of the Central Drugs Standard Control Organization (CDSCO), the Chennai-based south zone office of the central drug regulator has made the process of receiving applications and issuing certificates for ‘Export NoC’ online from October.

This is the second phase of high-tech operations introduced by the south zonal office to help the industry, and that too first in the country, through its online application portal, ‘Sugam’, launched in last year. Sugam portal is a high-tech e-governance system which was introduced by DCGI Dr. G N Singh towards facilitating regulatory-industry relations.

While briefing Pharmabiz about the operational process of the portal, Dr S Manivannan, deputy director of drugs control in Chennai CDSCO, said all the activities for Form level licensing were made operational within two days of its launching in last year. Now, we have entered into the second stage of the high-tech revolution in the CDSCO with online activities for the ‘Export NoC’. He hopes that this development will largely help the pharma manufacturers, traders and exporters in Tamil Nadu, Pondicherry and Kerala.

The online process for ‘Export NoC’ became live on October 6, and the office received four applications on October 9. All applications were processed on the same day and issued licences on the next day. The DDC said his office has stopped receiving any application in hard copy and the licenses are certified by digital signature. He further said Chennai CDSCO office is the first zonal office in the country that has made this remarkable thing within a short time.

In last year, the operations of the portal started on June 15 and receiving and issuing of Form 11 licences started on the next day itself.

Elaborating on the activities of the central regulatory office, Dr. Manivannan said CDSCO is mainly concentrating on four regulatory approvals such as issuing dual use licences (for import of chemicals and pharmaceuticals), issuing NoC in Form 29 for manufacturers, ‘Export NoC’ and Form level licensing. Out of these, Form level licensing were started online through Sugam portal in last year, and the ‘Export NoC’ has been made applicable now. The remaining two approvals will be made online by December.

To a question he said the office of Chennai CDSCO is transparent in all spheres of activities and also in coordinating with state drugs control department. The industry and trade sector show a healthy cooperation towards the central regulator’s office.

When asked about the CDSCO’s coordination work in the state, S. Sivabalan, director of Tamil Nadu drugs control department, said very good support is getting from the central office for coordination work and immediate action is taken on all files.

Responding to the new initiatives of the CDSCO in Chennai, the Kerala state drugs controller, Revi S Menon, said no file from Kerala is pending with the central office in Chennai. The DDC is giving full support to all regulatory activities that require the cooperation of CDSCO.

Commenting on industry side, the chairman of Tamil Nadu Pharmaceutical Manufacturers Association, J Jayaseelan said no industrial unit is facing any kind of difficulty in clearing a file from the CDSCO office. A healthy industry-regulatory relation is maintained in between the regulator’s office and the industry leaders.

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There’s a New Method For Fixing Broken Bones Using Pieces of Other People’s Bones

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Sometimes, the only way to patch up a fracture is to use surgical screws that keep everything in place while the bone is healing.

But sticking a piece of metal inside the body can lead to various complications. Now surgeons have come up with a novel type of screw that’s fashioned out of human bone – and it’s already being used in several hospitals.

Typical surgical screws are made either out of titanium or stainless steel, and together with metal plates they are a common way to stabilise certain fractures, especially if the broken bone is in a foot or an ankle.

The procedure can lead to a range of complications, though – the body can try to reject the foreign object, causing inflammation and pain, or the patient can have an allergy to the metal, or it can even lead to bacterial infection in the bone.

Worst of all, this type of ‘orthopedic hardware’ sometimes needs to be removed after the bone has healed, which means a second surgery on top of the first one that got those screws in.

That’s why Austrian orthopaedist Klaus Pastl wanted to experiment with new materials for surgical screws, eventually patenting a design for a screw that’s made out of… human bone. Because why not?

The Shark Screw, as it’s called, is made out of the super-sturdy hard middle layer of the femur or thigh bone – the strongest, hardest, and longest bone in the human body.

If you have opted to donate your body to medicine once you die, this offering can include bones as well. In fact, donated material from bone banks is already used in orthopaedic procedures, typically transplants.

In collaboration with researchers from Graz University of Technology (TU Graz), Pastl came up with a unique surgical screw design whittled out of donated bone material.

Even though the first attempts to make screws out of human bone were done in the mid-90s, his design is considered to be the first functional human bone screw graft, and last year it was approved for official use by Austrian and Swiss medical authorities.

Unlike metal, these bone screws don’t have to be removed – in fact, after about six weeks, the graft gets incorporated into the patient’s own bone tissue, greatly reducing the potential for infection or rejection. According to the team, after a year the transplant can’t even be detected on an X-ray.

Currently, the Shark Screw is produced by Pastl’s tissue bank startup surgebright, but the researchers are now working on developing specialised screws for foot and jaw surgeries, where these grafts could be especially useful.

“In [jaw] surgery, extremely small screws are necessary, approximately 20 mm long, which have to withstand great stresses,” says biomechanics researcher Gerhard Sommer from TU Graz.

“Because relative to size, the jaw muscle is the most powerful muscle in the human body.”

The team is now investigating what forces affect bones specifically in feet and the jaw, so that they can customise new human bone grafts for these types of body repairs.

“In general there is a big difference between working with metal screws and screws made of biomaterial,” says Sommer.

“The mechanical principles are the same, but we also have to consider that donated bone material shrinks somewhat during sterilisation and two hours after the operation expands again in the body and becomes more elastic.

“For this reason, we are carrying out extensive investigations and tests – both in dry and rehydrated states.”

Let’s hope their experiments are successful and the Shark Screw catches on in other parts of the world, because it sounds pretty damn awesome.

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