Terrifying Reason The UnitedStates Just Approved a Drug For an Eradicated Disease

The report, distributed in June, said that the re-production of known pathogenic infections like smallpox utilizing the procedures of engineered science ought to be of the “most elevated worry” for the US.

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The Food and Drug Administration (FDA) reported on July 13 that it had out of the blue affirmed a medication that could treat smallpox on the off chance that it were ever discharged as a weapon in a fear monger assault. The solution is called TPOXX (tecovirimat).

“To address the danger of bioterrorism, Congress has found a way to empower the improvement and endorsement of countermeasures to frustrate pathogens that could be utilized as weapons,” FDA Commissioner Scott Gottlieb said in an announcement.

“The present endorsement gives an imperative turning point in these endeavors. This new treatment bears us an extra alternative should smallpox ever be utilized as a bioweapon.”

The potential release of smallpox as a weapon is an extremely concerning scenario; many experts think that a weaponised form of disease is one of the biggest risks humanity faces.

The world isn’t prepared for that probability, nor is it prepared to react to a pandemic sickness that happens normally. That implies it’s conceivable that some kind of lethal pathogen – likely an infection – could spread far and wide.

As Bill Gates said in a recent talk, world governments are ill prepared for these sorts of scenarios.

“In the case of biological threats, that sense of urgency is lacking,” Gates said. “The world needs to prepare for pandemics in the same serious way it prepares for war.”

The return of smallpox

There are good reasons to be concerned about a potential smallpox release.

In theory, only two labs in the world are authorised to possess the variola virus: the CDC in Atlanta, and the State Research Center of Virology and Biotechnology in Russia.

But more samples of the virus may be out there. In 2014, vials containing smallpox were found in a cold storage room of an FDA lab at the National Institutes of Health’s campus in Bethesda, Maryland.

The possibility of an accidental release from that kind of forgotten sample is remote but real.

More concerning is the fact that researchers think it wouldn’t be difficult for an ill-intentioned actor to create a version of the smallpox virus – even a more dangerous one – in a lab.

Since smallpox has been “destroyed”, the vast majority never again get an immunization, which means most by far of the world would be helpless against a flare-up.

The Department of Defense as of late appointed a provide details regarding guard against organic weapons from the National Academy of Sciences, Engineering, and Medicine.

The report, distributed in June, said that the re-production of known pathogenic infections like smallpox utilizing the procedures of engineered science ought to be of the “most elevated worry” for the US.

“The US government should give careful consideration to this quickly advancing field, similarly as it did to propels in science and material science amid the Cold War period,” Michael Imperiale, an educator of Microbiology and Immunology at the University of Michigan and the seat of the council that composed the report, said in an announcement.

Last year, a Canadian researcher studying synthetic biology demonstrated that it was possible to create pox viruses related to smallpox from scratch using genetic material purchased through the mail.

Doing that cost the researcher US$100,000 and “did not require exceptional biochemical knowledge or skills, significant funds, or significant time,” according to a World Health Organisation report.

Specialists depend on something beyond [information] for medicinal basic leadership

This instinct assumes a significantly more grounded part amid the main day or two of a patient’s healing center stay, when the measure of information specialists have on patients is not exactly on resulting days.

Numerous innovation organizations are taking a shot at man-made brainpower frameworks that can dissect medicinal information to encourage analyze or treat medical issues. Such frameworks bring up the issue of whether this sort of innovation can execute and additionally a human specialist.

Another investigation from MIT PC researchers proposes that human specialists give a measurement that, so far, man-made reasoning does not. By breaking down specialists’ composed notes on emergency unit, the analysts found that the specialists’ “premonitions” about a specific patient’s condition assumed a huge part in deciding what number of tests they requested for the patient.

“There’s something about a specialist’s involvement, and their long stretches of preparing and practice, that enables them to know in a more thorough sense, past simply the rundown of manifestations, regardless of whether you’re doing great or you’re not,” says Mohammad Ghassemi, an examination offshoot at MIT’s Institute for Medical Engineering and Science (IMES). “They’re taking advantage of something that the machine may not see.”

This instinct assumes a significantly more grounded part amid the main day or two of a patient’s healing center stay, when the measure of information specialists have on patients is not exactly on resulting days.

Ghassemi and software engineering graduate understudy Tuka Alhanai are the lead creators of the paper, which will be introduced at the IEEE Engineering in Medicine and Biology Society meeting on July 20. Other MIT creators of the paper are Jesse Raffa, an IMES inquire about researcher, and Roger Mark, a teacher of wellbeing sciences and innovation and of electrical building and software engineering. Shamim Nemati and Falgun Chokshi of Emory University are additionally creators of the examination.

The most effective method to quantify emotions

Specialists consider an enormous number of elements — including indications, seriousness of ailment, family history, and way of life propensities — when choosing what sorts of exams to arrange for their patients. Notwithstanding those elements, Ghassemi, Alhanai, and their partners pondered whether a specialist’s “hunches” about a patient additionally assumes a part in their basic leadership.

“That premonition is most likely educated by a background marked by encounter that specialists have,” Ghassemi says. “It’s similar to how when I was a child, my mother could simply take a gander at me and tell that I had accomplished something incorrectly. That is not a direct result of something mysterious, but rather in light of the fact that she had so much experience managing me when I had accomplished something incorrectly that a basic look had a few information in it.”

To attempt to uncover whether this sort of instinct assumes a part in specialists’ choices, the scientists performed opinion examination of specialists’ composed notes. Conclusion examination, which is frequently utilized for measuring purchaser states of mind, depends on PC calculations that look at composed dialect and count positive or negative estimations related with words utilized as a part of the content.

The specialists played out their investigation on the MIMIC database, an accumulation of restorative records from 60,000 ICU patients admitted to Beth Israel Deaconess Medical Center in Boston over a 10-year time span. This database incorporates specialists’ notes on the patients and also seriousness of sickness, indicative imaging exams, and a few different components.

The specialists needed to figure out what, on the off chance that anything, the specialists’ notes included best of the data accessible in the therapeutic records. They processed assumption scores from the notes to check whether there was any connection with what number of symptomatic imaging tests the specialists requested for patients.

In the event that restorative information alone was driving specialists’ choices, at that point opinion would not have any connection with the quantity of tests requested. Notwithstanding, the specialists found that when they represented every single other factor, the specialists’ estimations did to be sure help foresee what number of tests they would arrange. This impact was most grounded toward the start of a patient’s clinic stay, when specialists had less therapeutic data to go on, and after that declined as time passed by.

They additionally found that when specialists felt more negative about a patient’s condition, they requested all the more testing, yet just up to a specific point. On the off chance that they felt contrarily about the patient’s condition, they requested less tests.

“Unmistakably the doctors are utilizing something that isn’t in the information to drive some portion of their basic leadership,” Alhanai says. “What’s essential is that a portion of those concealed impacts are reflected by their slant.”

Nostalgic machines

Next, the scientists want to take in more about exactly what factors add to specialists’ premonitions. That could conceivably prompt the improvement of computerized reasoning frameworks that could figure out how to consolidate a similar data that specialists are utilizing to assess patients.

“The inquiry is, would you be able to get the machine to accomplish something to that effect? It would be extremely fascinating to train the machine to rough what the specialist encodes in their assessment by utilizing information not as of now caught by electronic wellbeing frameworks, for example, their discourse,” Alhanai says.

The exploration was financed by the National Institutes of Health (NIH) Neuroimaging Training Grant, the Abu Dhabi Education Council, the NIH Critical Care Informatics Grant, and the NIH Research Resource for Complex Physiologic Signals Grant.

Having a [baby] is exorbitant and befuddling, notwithstanding for a wellbeing approach master

Which we utilized for every one of one moment, cost about $7,000. Food and lodging for my significant other for 48 hours cost simply finished $3,100. Two Tylenols for my significant other: $25. Research center work: $1,200.

It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is unbelievable is the fact that I am still receiving bills for his birth.

Of course, I “knew” what was going to happen when we found out that my wife was pregnant. I study health policy for a living, and I have written extensively about the American health care system. Yet for all the reading and writing, experiencing health care in America personally is a rather shocking experience. Keep in mind, our birthing experience was without any complications and we have health insurance.

I cannot imagine how overwhelming the experience must be for someone with fewer resources and less of an understanding about health care in America.

Being pregnant and giving birth: Not what it used to be

From the main medical checkup, we were acquainted with what’s in store: heaps of printed material and loads of bills. There are obviously all the month to month, at that point every other week, and after that week after week specialist’s visits with the comparing bills.

In West Virginia, due to the opioid plague, most specialists will likewise demand a medication screen.

As it turned out, my better half’s specialist requested plentiful measures of blood work and ultrasounds – “outpatient indicative administrations,” totaling a large number of dollars. It is difficult to scrutinize any of these when all you need is a sound child – and your specialist is the special case who knows which tests are vital.

Like most guardians, we additionally needed to know whether our child would have been solid. Here is the aggregate sum of the bill for hereditary testing sent to our insurance agency: US$26,755.

Bringing forth our first child, Nico, had been a significant laborious affair for my better half. She worked for over 30 hours. Decided not to invest hours in the healing center, my better half essentially conceived an offspring this time in the front seat of our auto. Eventually, I could toss my better half onto a bed in the maternity ward, and Lukas popped ideal out.

I kidded to my significant other: “In any event they can’t charge us for conveyance.” At the plain minimum, I should document a claim with our insurance agency.

I am as yet not exactly beyond any doubt how wrong I was, on the grounds that each time I request a nitty gritty bill, new things show up while others inexplicably vanish.

The conveyance room, which we utilized for every one of one moment, cost about $7,000. Food and lodging for my significant other for 48 hours cost simply finished $3,100. Two Tylenols for my significant other: $25. Research center work: $1,200.

That does not represent Lukas. Food and lodging for him was simply finished $1,500. Different research center work charges included another $1,400 or somewhere in the vicinity. The hearing test cost $260.

I endeavored to monitor all the therapeutic work force going back and forth, however sooner or later everything turned into an obscure. The specialist, who was absent during childbirth, charged $4,200 for conveyance and care. Pediatricians ceased by a couple of times to keep an eye on Lukas for $150 per look.

We were not able to take advantage of a tax-favored flexible spending account for most of these expenses, because “being pregnant” does not count as a “life event.” While “giving birth” does count, the added contributions cannot be applied to previous costs associated with the birth.

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Forget Hackers And Cyberwarfare, Rising Sea Levels Could Pose The Biggest Threat To The Internet

The results aren’t great. Within 15 years as many as 6,500 kilometers (4,000 miles) of buried fiber optic conduit could be submerged and 1,100 traffic hubs could be besieged by water.

Forget about Internet on Mars and Li-Fi, the Internet we rely on to run our hospitals, feed our cities, tweet celebrities, and watch animals do stupid things here on Earth could be at risk – and rising sea levels are to blame.

The Internet relies on a large physical network combining colossal data centers and thousands of kilometers of fiber optic cable buried underground. If this was to somehow falter (whether through cyberwarfare, space weather, or climate change), things could get bad pretty quick.

As a recent peer-reviewed study highlights, this infrastructure (the so-called “physical Internet”) is not currently built to withstand significant changes in sea level. Even more worryingly, we could see the consequences of this as soon as 2033.

Quite a bit of this framework is covered and takes after since quite a while ago settled privileges of way, ordinarily paralleling thruways and coastlines, Paul Barford, a University of Wisconsin-Madison teacher of software engineering and an expert on the “physical Internet”, said in an announcement.

“When it was fabricated 20-25 years back, no contemplation was given to environmental change.”

Barford introduced the investigation at a gathering of the Association for Computing Machinery, the Internet Society. what’s more, the Institute of Electrical and Electronics Engineers on July 16. While there has been look into rising ocean levels and urban foundations, for example, streets, lodging, and even whole islands, this has all the earmarks of being the principal evaluation analyzing the hazard that rising ocean levels posture to the Internet.

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The results aren’t great. Within 15 years as many as 6,500 kilometers (4,000 miles) of buried fiber optic conduit could be submerged and 1,100 traffic hubs could be besieged by water.

The team came to this conclusion after overlaying Sea Level Rise Inundation data on the Internet Atlas, which allowed them to compare the forecasted sea level rises with a map detailing the Internet’s physical network.

The system has been intended to endure some water, yet it is just water-safe, not waterproof. This implies the determined level of flooding could represent a genuine hazard to the working of the Internet as we utilize it today. The tempest surges that took after Hurricane Sandy and Hurricane Katrina indicate the issues to come, Barford included.

The most exceedingly terrible influenced regions will be low-lying beach front urban areas. The analysts particularly named New York, Miami, and Seattle as high hazard. Be that as it may, if the system in these regions is harmed the impacts will “swell” over the Internet, Barford says. This is on the grounds that these urban areas are the place transoceanic marine links come aground and it is these transoceanic marine links that connection the US to whatever remains of the world, in any event from an online perspective.

Things being what they are, what would we be able to do? Solidifying the framework may defer the inescapable yet it won’t be compelling over the long haul, Barford clarified. This examination ought to be viewed as a “reminder”.

“The vast majority of the harm that will be done in the following 100 years will be done sooner than later,” cautioned Barford.

“That amazed us. The desire was that we’d have 50 years to get ready for it. We don’t have 50 years.”

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What Big Pharma pays your doctor

It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

Members of Innovative Medicines Canada (IMC), the lobby group for the large pharmaceutical companies, recently released their voluntary reports of payments to health-care professionals and health-care organizations.

Altogether, the 10 reporting companies paid out more than $75 million in 2017.

This is the second year of these disclosures. When they started, Russell Williams, then the IMC president, said on CBC’s The Current: “We’re open to continually improving and monitoring” the disclosures. According to the new president, Pamela Fralick, the 2016 revelations were only a first step and she expected more companies to disclose payments in 2017.

Come the 2017 disclosures, and there are still the same 10 companies. Moreover, the disclosures are actually not on the IMC website, they are on the individual companies’ websites and are not easy to find. It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

IMC touts these disclosures as “part of our commitment to high ethical standards and enhancing trust.”

But all that the companies have disclosed are gross figures — with no information about what they paid for.

Paid to promote opioids?

Why did Purdue Pharma, makers of OxyContin and a host of other opioid products, give almost $1.9 million to health-care professionals in 2017?

All Purdue’s website says is that the money was for “services.” Were some of those services speeches made by doctors on behalf of Purdue? In the past Purdue has paid doctors $2,000 a talk.

Amgen Canada gave more than $6 million to health-care organizations, but we don’t know what these organizations did with that money.

Novartis spent $350,000 on travel expenses so that doctors and possibly other professionals could go to international congresses and/or global stand-alone meetings.

Who were these health-care professionals? What meetings did they go to? Where were the meetings?

Canada lags behind

Big Pharma here in Canada is far behind the curve when it comes to disclosing where the money is going. The federal government doesn’t seem to be in any hurry to force the companies to make more information public either.

Just over a year ago, then Health Minister Jane Philpott’s position was that forcing the disclosure of payments to individual doctors was, “in principle…an important concept” but should be left to the provinces.

In the United States, companies have had to disclose any payment of more than $10 to a doctor since 2013. The doctors are named.

In Australia, an analysis of information that companies must disclose found that, from October 2011 to September 2015, 42 companies sponsored 116,845 events for health professionals.

In nine European countries, disclosure is either mandatory or voluntary. Many of the European voluntary codes allow doctors to opt out of having their names disclosed.

IMC justified not linking doctors’ names to payments on the grounds of Canadian privacy laws but Ontario’s recently passed legislation will require disclosures to include the names of all health-care professionals who receive money or any other “transfer of value.”

Later this summer, British Columbia will hold public consultations about the same type of legislation.

4 Things We Now Know About [Treatment] Resistant Depression

Imagine being depressed and trying medication after medication—only to find none work. That’s the plight of people with treatment-resistant depression. We look at this little-understood condition, and how researchers are working to crack its code.

For many people coping with major depressive disorder—which includes different types of depression that persist for at least two weeks—antidepressants can play an invaluable role in helping relieve symptoms, enabling them to resume the life they once enjoyed. But for those who experience a form known as treatment-resistant depression (TRD), standard medications tend to provide little to no relief.

The disorder isn’t rare: Up to one-third of adults with major depression battle symptoms—such as persistent feelings of sadness, sleep disturbances, low energy and thoughts of death or suicide—that don’t respond to treatment.

“In spite of the fact that there is some difference with respect to how to characterize treatment-safe despondency, a patient is by and large considered to have it if the individual hasn’t reacted to satisfactory measurements of two unique antidepressants taken for an adequate span of time, which is normally a month and a half,” clarifies Jaskaran Singh, M.D Senior Director of Neuroscience, Janssen Pharmaceuticals, some portion of the Johnson and Johnson group of organizations.

While there’s still much to learn, several recent and promising advances are shedding new light on how to understand and manage TRD. Recently, for Mental Health Month, we highlighted some of the most important findings—and why there may be new hope for people who’ve been living with the disorder for far too long.

Your age, gender and health status may increase your risk for treatment-resistant depression.

There’s no way to predict for sure who with depression will be unresponsive to treatment, but researchers have observed that certain populations are more vulnerable than others. Women and senior citizens, for example, seem to experience TRD at higher rates, for reasons that are likely both biological and psychological. Individuals who endure severe or frequently recurring bouts of depression also appear to be more susceptible.

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A depressed person’s overall health can also play a role.

“Patients with depression who have some medical illnesses—such as thyroid disease and chronic pain—are at greater risk for TRD,” says Alexander Papp, M.D., a psychiatrist at UC San Diego Health.

Other conditions associated with TRD include substance abuse and eating and sleep disorders, which have the potential to make you more prone to being resistant to treatment with antidepressants.

Depression may have causes we don’t yet understand—which may be why antidepressants don’t work for everyone.

While the science of sadness is still to a great extent a secret, the most prevalent hypothesis is that it’s caused by low cerebrum levels of such neurotransmitters as serotonin and norepinephrine, which are related with sentiments of satisfaction and prosperity. In any case, late research recommends that these neurotransmitters may not be the solitary guilty party—so antidepressants, which work to expand serotonin or norepinephrine levels, may not be a one-estimate fits-all treatment.

“One of the more present day speculations is that discouragement makes irritation in the mind, or that aggravation in the cerebrum makes sorrow,” Dr. Papp says. “Customary antidepressants just influence neurotransmitters, so this might be the reason a few patients don’t react to them.”

Regardless of whether this ends up being valid, what we do know is there’s still no ensured settle for the issue—which can be baffling for the two patients and their friends and family.

“When I had a clinical practice, I saw numerous patients with treatment-safe gloom who disclosed to me that loved ones trusted they favored being discouraged, or weren’t making enough of an effort to enhance, on the grounds that their antidepressants weren’t working,” Dr. Singh says. “This isn’t about an absence of inspiration. I’ve never met a patient who would not like to improve.”

There are established methods for managing treatment-resistant depression.

While the words “treatment-resistant” might seem synonymous with “no hope,” the reality is that tools do currently exist to help people with TRD. A 2012 study published in the journal Patient Preference and Adherence identified five main treatment strategies—optimization, switching, combination, augmentation and somatic therapies—that psychiatrists can use to create a personalized plan for patients.

Improvement, for example, implies that “a few people with TRD may profit essentially from giving their upper more opportunity to work or by taking a bigger measurements,” Dr. Papp says.

For others, changing to an alternate class of upper—or adding one to the present treatment for a consolidated approach—may prompt reduction. Also, growth may include utilizing pharmaceuticals that were produced for different utilizations, however that have since been endorsed for the treatment of TRD.

There are additionally physical (nondrug) treatments, including transcranial attractive incitement—which targets nerve cells in the district of the cerebrum associated with mind-set control and gloom—and electroconvulsive treatment (ECT), which prompts changes in mind science to help turn around side effects of TRD.

ECT—which individuals regularly allude to erroneously as “electroshock treatment”— “is exceptionally trashed, to a great extent because of how it was depicted in the motion picture One Flew Over the Cuckoo’s Nest,” Dr. Singh says. In any case, the system is significantly more secure and more bearable today, he notes, and regularly saved for individuals with extreme, tranquilize safe discouragement. “It’s not for everybody, but rather it might be powerful in 70 to 80% of patients,” he includes.

Life science industry with Digital Technology (Rebooting)

Digital technology is connecting genetic information with real world data and companies are already combining drugs, advanced application devices, and apps to be more patient-centric.

Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.

Data collection and visualization for decision making to improve the overall performance of themanufacturing supply chain is a huge opportunity for the life science industry, however it’s not about being new – it’s about using proven solutions andapproaches to decision making to improve quality, reliability and reducing waste.

Businesses across the life science industry have been collecting data using large historian systems for years. Many currently have so much data arising from different sources it can be hard to focus on what is important. Right now, almost every device in a GMP manufacturing facility collects data and our clients have been completing projects to physically connect all these devices and systems for many years. The drive to physically connect the systems has come from many strategic objectives, including serialization.

All this excellent work has put the industry in a great position to use the data it is currently collecting in the best possible way.Although the robotics and automotive industries may be in a better position to use Artificial Intelligence (AI) and self-learning systems to improve manufacturing in efforts linked to Industry 4.0 – the life science industry has been using data and evidence to improve its manufacturing for nearly forty years.

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New tools and processes are emerging that can enable smart, decentralized production, with intelligent factories, integrated IT systems, the Internet of Things (IoT), and flexible, highly integrated manufacturing systems. In addition, future developments may mean that machine learning algorithms will be able to quickly adjust manufacturing lines and production scheduling. New developments will also pave the way for predictive maintenance and the opportunity to identify and correct issues before they happen.

Integrating with single use systems
The adoption of single-use technologies, such as single-use bioreactors and other unit operations is on the rise. Fueled by the growing pipeline of high potency and biological drugs and coinciding with the growth in personalized medicine and its inherent need for smaller batches, single-use technology will play an increasingly important role in the coming years.

Both upstream and downstream manufacturing processes benefit from single-use systems. During this manufacturing method the biopharma process system is disposed of after use as opposed to being cleaned, enabling quick set up while reducing cleaning and validation need.

Currently,the integration of manufacturing execution system (MES) solutions with start-to-finish technologies and single-use manufacturing platforms is helping the industry to deploy biopharmaceutical manufacturing with increased productivity and efficiency.The upshot is that manufacturers can significantly reduce the time-to-market for new products.

Single-use components are also an enabling technology for smaller scale production of biopharmaceuticals, including antibodies, proteins, vaccines and cell therapies, which would otherwise be much more difficult to produce. Increased productivity and efficiency are also a necessity when it comes to manufacturing smaller batches and a wider range of product. In this environment, single-use technology will naturally flourish as a simple, cost-effective solution.

Digital manufacturing
The first steps towards fully connected, self-optimizing production processes have been taken – the advent of digital manufacturing is on the horizon. Enterprise Manufacturing Intelligence (MI) involves accessing more meaningful data to give a better, more holistic view of operations and allowing for improved analytics and real-time responsive decision-making to drive continuous improvement.

Access to this data, or Big data, also allows for the creation of digital twins. A digital twin can be made up of data captured from the entireend-to-end manufacturing process of a product – this twin can then be used to find invaluable insights. Extension of the traditional ‘golden batch’, where data was very much process control-based, will be supplemented and surrounded with environmental data, raw material data, training data and any other digital data available that goes towards influencing the golden batch.

With this digital information available across multiple
Sites, batches and suppliers, sophisticated analytics can provide a digital twin that best represents the golden batch and alerts controllers to any problems based on these specific data sets.

Patient centricity
Digital technology is connecting genetic information with real world data and companies are already combining drugs, advanced application devices, and apps to be more patient-centric. This push towards customized medicines solutions, driven by technological advances and pressure from patients who want to be more involved in their own care, will take the market in new directions.

The impact on the market, and more notably manufacturers, is that there will be a growing demand for smaller batches which will highlight any inflexibility in a manufacturer’s supply chain.

The propagation of product variants and smaller batch sizes will mean that launch approaches, process technologies and validation concepts will need to be overhauled.

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