#FDA Drug Track and Trace Capability

[sgsystemsglobal]

Future Trends in Pharmaceutical Traceability Software: Innovations on the Horizon

The pharmaceutical industry is on the cusp of a digital transformation, with emerging technologies reshaping the way companies manage the safety, quality, and traceability of drugs. At the core of this evolution is pharmaceutical traceability software, which allows manufacturers to track and monitor the movement of products and raw materials across the entire supply chain. With growing regulatory demands and the need for better transparency, pharmaceutical companies must keep pace with innovations that enhance product safety and compliance.

In this blog, we’ll explore the future trends in pharmaceutical traceability software that are set to revolutionize the industry, enabling pharmaceutical companies to meet stringent compliance standards like 21 CFR Part 11, improve operational efficiency, and ensure the safety of their products.

Why Traceability in Pharmaceuticals Matters

Before diving into the future trends, it’s crucial to understand why pharmaceutical traceability is so essential. In the pharmaceutical industry, product safety and quality are paramount. Traceability ensures that every batch of drugs can be traced back to its source, from raw materials to the final product. This is not only important for ensuring the integrity of the product but also for managing recalls, reducing counterfeit drugs, and complying with global regulatory standards.

With regulations such as 21 CFR Part 11 Compliance, which governs the use of electronic records and signatures in the U.S. Food and Drug Administration (FDA) regulated industries, pharmaceutical companies are under pressure to implement robust traceability systems. Compliance with this regulation ensures that electronic records are trustworthy, reliable, and equivalent to paper records. Effective pharmaceutical traceability software is essential to achieving this.

Now, let’s look at the future trends that are shaping the next generation of pharmaceutical traceability.

1. Blockchain Technology for Immutable Records

One of the most exciting innovations on the horizon for pharmaceutical traceability software is the integration of blockchain technology. Blockchain’s ability to create a decentralized, immutable ledger makes it a perfect fit for industries that rely on highly accurate, tamper-proof data.

In the context of pharmaceutical traceability, blockchain can provide real-time visibility into the entire supply chain. From sourcing raw materials to tracking the distribution of the final product, every transaction is recorded in the blockchain, making it impossible to alter without leaving a trace. This level of security is particularly important for combating counterfeit drugs, which continue to be a significant issue in the industry.

Moreover, blockchain offers enhanced transparency and can help pharmaceutical companies demonstrate compliance with 21 CFR Part 11. By providing an indelible audit trail, it becomes easier to prove the integrity of electronic records, ensuring that all actions taken in the drug manufacturing and distribution process are traceable.

2. AI-Powered Predictive Analytics for Quality Control

As pharmaceutical batching and production processes become more complex, predictive analytics powered by artificial intelligence (AI) is becoming a critical component of traceability software. AI can analyze vast amounts of data in real-time, identifying patterns and trends that might indicate potential quality issues or inefficiencies in the supply chain.

For example, AI can monitor environmental conditions during drug manufacturing or shipping and predict when deviations might occur that could compromise product quality. This predictive capability allows pharmaceutical companies to address issues before they escalate, ensuring that only safe, high-quality drugs reach the market.

Additionally, AI-driven analytics can optimize pharmaceutical formulation software, which is responsible for ensuring that drug recipes are consistently followed. By analyzing data from previous batches, AI can suggest adjustments to formulations or processes to improve product consistency and quality.

3. IoT Integration for Real-Time Monitoring

The Internet of Things (IoT) is another technology that is poised to enhance pharmaceutical traceability. IoT devices, such as sensors and RFID tags, can provide real-time monitoring of pharmaceutical products as they move through the supply chain. These devices can track important parameters such as temperature, humidity, and location, ensuring that drugs are stored and transported under the right conditions.

For instance, biologics and other temperature-sensitive medications require strict temperature control during transportation and storage. IoT sensors can continuously monitor the temperature, providing real-time alerts if it goes outside the acceptable range. This ensures that any temperature excursions are immediately addressed, preventing potentially harmful products from reaching patients.

When combined with pharmaceutical traceability software, IoT data can be seamlessly integrated into the traceability system, offering a comprehensive view of the product’s journey from production to patient delivery. This not only enhances safety but also aids in regulatory compliance by providing detailed documentation for audits.

4. Enhanced Data Security and Privacy Features

As pharmaceutical companies increasingly rely on digital systems for traceability, data security and privacy are becoming critical concerns. With the rise in cyberattacks targeting healthcare and pharmaceutical companies, traceability systems must evolve to offer robust security features that protect sensitive data.

Future pharmaceutical traceability software will likely incorporate advanced encryption techniques, multi-factor authentication, and AI-driven security measures to detect and respond to potential threats in real-time. These features will ensure that all traceability data, including electronic records required for 21 CFR Part 11 compliance, are protected from unauthorized access or tampering.

In addition, data privacy regulations, such as the General Data Protection Regulation (GDPR) in Europe, place strict requirements on how companies handle personal data. Traceability software will need to incorporate tools that allow pharmaceutical companies to manage data privacy effectively, ensuring that any patient or product information is stored and transmitted securely.

5. Cloud-Based Traceability Solutions for Scalability and Flexibility

Cloud computing is set to play a significant role in the future of pharmaceutical traceability software. Cloud-based traceability solutions offer scalability, flexibility, and cost-efficiency, making them an attractive option for pharmaceutical companies of all sizes.

By leveraging cloud infrastructure, pharmaceutical manufacturers can scale their traceability systems as needed, accommodating growing production volumes or expanding into new markets. Cloud-based systems also offer the advantage of remote access, allowing teams across different locations to access traceability data in real-time.

Moreover, cloud solutions can streamline compliance with 21 CFR Part 11 by providing secure, centralized storage for electronic records and signatures. Cloud platforms are often equipped with advanced compliance features, such as automated audit trails and secure data backups, helping companies ensure that they meet regulatory requirements.

Conclusion

The future of pharmaceutical traceability software is bright, with innovations like blockchain, AI, IoT, enhanced data security, and cloud-based solutions set to transform the industry. These technologies will enable pharmaceutical companies to improve product safety, streamline compliance, and increase operational efficiency.

By adopting these cutting-edge technologies, companies can not only meet the ever-growing regulatory demands but also enhance the integrity of their supply chains, ensuring that patients receive safe and effective medications. As these trends continue to shape the future of pharmaceutical traceability, businesses must stay ahead of the curve to remain competitive and compliant in an increasingly complex global market.

[interwork2018-blog]

WATCH OUT: DRUG SUPPLY CHAIN SECURITY ACT IS HERE FOR FDA DRUG TRACK AND TRACE. HOW TO KEEP UP WITH THE US PHARMACEUTICAL SERIALIZATION AND TRACEABILITY?

US Pharmaceutical Serialization and Traceability

Status in 2019

The drug supply chain security act, as enacted by the US Congress in 2013, is now maturing into its latter half with a critical goal approaching in 2023. Presently, it is looking for transformational DSCSA compliance changes for US drug market wholesalers. USFDA registered wholesalers are looking for serialization, and verification requirements are due on 27 November 2019.

The manufacturers, repackagers are already on a well-directed path for lot-to-package level pharmaceutical serialization and traceability. The upcoming four years will see some significant changes, integration scenarios, and updates of USFDA DSCSA compliance software. It will help build a highly automated, secured, seamless supply chain.

Critical Steps for

Pharmaceutical Serialization and Traceability

to enhance FDA Drug Track and Trace Capability

(read more about guidelines & deadlines)

Manufacturers

Manufacturers will always have a requirement of GTIN, Serial Number, Lot Number, Expiry Date (in a human-readable format), and GST Datamatrix. Traditional pharma businesses can look to sourcing these requirements cost-effectively. Established ones can always look into building a better cost-effective facility with a dedicated in-house facility.

Pharmaceutical serialization and traceability can only be sustainably achieved with a localized copy of the database. It should be maintained at the manufacturer’s office. It should be verifiable with a decentralized database for printing GTIN, serial number, Lot number, expiry date, and GST data matrix. All this information has to be channeled on a large scale for the packaging and labeling of various prescribed drugs.

Repackagers

All repackagers and white label service beneficiaries are required for drugmakers. There should be just not be passed into the market without serialization. Pharmaceutical Serialization and Traceability can die a miserable death if medicines manufactured at other vendors’ facilities do not get serialized. It is crucial before officially making the first move into before the supply chain, followed by regulatory compliance acknowledgment.

There should be a system of checks, balances, and re-verification to ensure FDA Drug Track and Trace. It is highly advisable to keep a frequently updated secondary database for following up. It should be maintaining a consensus between data flow is drug packages transit.

Wholesalers

Wholesalers have a huge responsibility and verification of transit data packages, the receipt, and checking for many levels. A wholesaler should try to build a dedicated in the house IoT-automation based warehousing system, which taps in continuous data streams.

It will be helpful in automated serialization, authentication based on a barcode, and data received from the actual digital supply chain, and further verification while down the lane distribution.

The inclusion of IoT-based, who has a network of devices, will reduce the human intervention and possibilities of errors. Automation is expected to reduce the overall idle time; shelf-life is critical, challenging to handle the ones that increase the cost of logistics and warehousing due to temperature.

Dispensers

Logistic partner screen tries to infiltrate a culture of the tools that are bumper-to-bumper driving trucks reducing Airdrie again fuel consumption to a great extent. It is known for increasing the overall cost-effectiveness by 31%. The last mile deliveries and end-logistics can be delegated with delivery-tracking and management systems.

Complete supply chain

Pharmaceutical serialization and traceability facilitates FDA Drug Track and Trace. It will increase seamless communication facilities. It is going to be a transitional phase in pharmaceutical serialization and traceability. It will help the FDA maintain and enhance FDA track and trace it through a digital system.

Pro tips for all pharma supply chain partners:

Please keep a secondary database

Always maintain them frequently update consignment details

Be an active partner on your supply chain digital platform

Act accordingly and get the knowledge to hold request that all levels

Conclusion

Pharmaceutical serialization and Traceability endeavors with drug supplies and security act are entirely directed for enabling FDA track and trace. It will reduce the counterfeits, stolen, low activity drug introduction into the supply chain. It requires a reliable DSCSA compliance software that brings a single solution for pharma supply chain partners and regulators to a single platform. Upcoming years will seek technology adoption. There will be essential urgency among US pharmaceutical businesses to choose a technology partner for further compliance, integration, and management.

[healthbetold]

Rare Cannabinoids Are the Next Frontier in the Marijuana Industry

A worker in a cannabis greenhouse. Uriel Sinai / Getty Images

It’s 2021 and regular THC won’t cut it for the burgeoning cannabis industry. Neither does CBD. Instead, many startups are betting that cannabis users are craving for something that nature alone cannot provide.

In Berkeley, California, startup Demetrix is ​​preparing to manufacture “metric tons” of cannabigerol, also known as CBG. CBG is also called “the mother of cannabinoids” because it is chemically a precursor to hundreds of other chemicals found in trace amounts in cannabis plants.

“It’s been a wild ride,” said Cynthia Bryant, Demetrixx’s chief business officer observer. “Three years ago we literally had empty laboratory space. We bought freezers. ”Now they hope to have CBG products ready to go by the end of the year.

Cannabis users are increasingly interested in niche or “rare” cannabinoids, although it is still unclear what these molecules are really capable of. This includes products like Delta 8 THC, which is about half as strong as regular THC and than that. referred to as fastest growing segment the hemp industry. Companies like Demetrix are more interested in “rare” cannabinoids – over 100 compounds in cannabis that only occur in traces in nature but can be produced in abundance in the laboratory.

Demetrix scientists in their laboratory. Demetrix

Demetrix was originally founded by Jay Keasling, a professor at the University of California, Berkeley who focuses on developing microbes, especially yeast, to manufacture other substances: like fuel or an ingredient in anti-malarial drugs called artemisinin. Keasling has since turned to cannabis, where his patented technique equips brewer’s yeast with the ability to make cannabinoids.

“It’s like brewing beer,” says Keasling Observer. “We feed the yeast, the sugar and the yeast, instead of spitting out ethanol, spitting out cannabinoids.”

Demetrix is ​​just one of a handful of startups poised to embark on a new path in the cannabis industry similar to the path taken by CBD or, more recently, Delta-8 THC. Dennis O’Neill, the president of Biomedican, another California-based startup, estimates that the rare cannabinoid industry could be worth it $ 25 billion by 2025.

Biomedican also uses proprietary yeasts to mass-produce rare cannabinoids like CBG and has amassed $ 4.1 million in funding to date.

“There’s a percentage of CBD people who are looking for the next best thing,” says O’Neille Observer. “All of the data points show that we have a demand tsunami that will hit this market. There will be a lot of money to be made. ”

Where do the rare cannabinoids come from?

It’s not that we didn’t know these molecules existed in cannabis, but that they were historically inaccessible. Molecules like CBG are usually only present in traces in natural plants – although some varieties can be bred contain more of a certain rare cannabinoid.

The biosynthetic approach excludes the plant from the equation and focuses on the molecular machinery of cannabis to boost the production of rare cannabinoids.

The end result is an isolated form of a rare cannabinoid. It’s the same product that would naturally exist, but without the extra terpenes or other molecules present in a plant (a disadvantage some weed connoisseurs might say but seen as an advantage by emerging industries) .

The idea that scientists succeeded in developing yeast to produce rare cannabinoids, thereby circumventing the scarcity of nature, has existed for several years. Keasling first published a piece of paper on the subject in 2019, but at that point it was not clear whether the process could be scaled up enough to support a new industry.

Bryant says that through faster math, advances in microorganism engineering, and a better understanding of cannabis, Demetrix went from zero liters of CBG to 15,000 in three years. In February, Demetrix also signed an agreement with a commercial manufacturer promising to supply these “metric tons” of CBG.

Fermentation tanks on a laboratory scale. Demetrix

Biomedican also expanded its operations this year, says O’Neill. Covid-19 has delayed the arrival of the equipment, but it expects it will be operational by the end of the year. “Our plan is to manufacture here in the US and then build a plant in Mexico, Europe and then Asia,” he says.

However, if everything stays on track, he expects to be in high-volume production of rare cannabinoid products – mostly CBG – by 2023 (they have already moved into pilot production). Biomedican already plans to distribute its products in Mexico.

That could range from cosmetics and lotions to granola bars, chocolates, or pet care products – the same products that became breeding grounds for CBD. This also means that it is possible that rare cannabinoids, once they are as freely available as CBD, fall into the same traps as CBD.

CBD has medicinal benefits. It forms the basis of the FDA-approved epilepsy drug Epidiolex and is used to treat pain. But it has also built a reputation for treating conditions from anxiety to erectile dysfunction. according to an analysis of the posts on the r / CBD subreddit.

As the introduction of CBD demonstrated, the novelty of certain cannabinoid products can create both an exciting and chaotic experience for people watching new products arrive on store shelves. CBD products are not reviewed by the FDA before they go on sale, nor are companies may say CBD products can treat any diagnosable condition. However, you can make “general wellness” claims.

“There is so much going on for the individual consumer,” says Paul Seaborne, professor of commerce at the University of Virginia. “They don’t necessarily have the same support and guidance from their GP or from normal sources.”

Keasling admits that the CBD industry has some element of the “snake oil” sales art. The rare cannabinoid industry could very well go this route. Rare cannabinoids have their share of the hype, and as manufacturing increases, they will hit consumers in successive waves, with science lagging behind as to what they can actually achieve.

“I would like these companies that work with technical microbes to deal with them a little better,” says Keasling.

Research to date on rare cannabinoids is sparse at the moment. This is mainly because it was nearly impossible to isolate these compounds in large quantities, and because marijuana’s status as a List I drug has made such studies difficult to conduct. Seaborne estimates that thanks to this planning, the pace of cannabis research has stalled by 30-50 years.

So far, research into rare cannabinoids contains some nuggets of information that allude to certain health effects. Previous studies on CBG suggest that it may show promise as a treatment Glioblastoma, psoriasis, or Neurodegenerative Diseases to like AS (these studies were carried out on mice and cells). Another one is running clinical study on the effects of cannabigerol on human diseases, which is registered on Clinicaltrials.gov at the time of writing.

Rodent studies on THCV, another rare cannabinoid, have suggested that it can decrease appetite and upregulate metabolism (again, no ongoing clinical trials are registered on this at this time). There are three clinical trials of THCV on Clinicaltrials.gov – one has published results and suggests it could help people with type II diabetes control blood sugar levels.

But these rodent studies are enough for O’Neill to predict that THCV will be the next rare cannabinoid to boom.

Incidentally, Demetrix and Biomedican are betting that these rare molecules have previously undiscovered effects. Even Keasling suggests that once the research is done, we might find that some rare cannabinoids are “worthless”, but not much of that research has happened yet.

Both companies also plan to support them by making rare cannabinoids available for clinical trials.

“We do our own basic research to understand these cannabinoids, but we also look for others to help us figure out what each of these cannabinoids can be of benefit to consumers,” says Bryant. “This is a class of compounds that modern scientific evaluation has completely skipped.

“I don’t think there are many connections we can say that about.”

In the meantime, companies plan to venture into even darker areas of cannabinoid manufacturing – ones that don’t even exist in natural plants.

Keasling’s original work suggests that his method could be used to cultivate “unnatural cannabinoids”. Biomedican announced the synthesis of a type of cannabinoid called Sesqui-CBG, a chemical variation of regular CBG.

A biomedical scientist Press release suggests that sesqui cannabinoids contain properties of many other cannabinoids combined, but Biomedican CEO Maxim Mikheev warns that we don’t know much about them.

“Sesqui cannabinoids haven’t been studied very well,” he says Observer.

Fear of the unknown doesn’t seem to be a problem that affects most cannabis users. Despite ongoing research into what cannabinoids can and can’t do, these molecules still have the enticing appeal of untapped potential. After 50 years of hesitant research, nobody knows exactly what we might find.

“Despite all this confusion, despite the fast pace of things, consumers are giving” [cannabis products] give it a try, ”says Seaborne. “This is proof of how much desire there is.”

The post Rare Cannabinoids Are the Next Frontier in the Marijuana Industry first appeared on Health be Told.

source https://healthbetold.com/rare-cannabinoids-are-the-next-frontier-in-the-marijuana-industry/

[1stnewslink]

Rare Cannabinoids Are the Next Frontier in the Marijuana Industry

A worker in a cannabis greenhouse. Uriel Sinai / Getty Images

It’s 2021 and regular THC won’t cut it for the burgeoning cannabis industry. Neither does CBD. Instead, many startups are betting that cannabis users are craving for something that nature alone cannot provide.

In Berkeley, California, startup Demetrix is ​​preparing to manufacture “metric tons” of cannabigerol, also known as CBG. CBG is also called “the mother of cannabinoids” because it is chemically a precursor to hundreds of other chemicals found in trace amounts in cannabis plants.

“It’s been a wild ride,” said Cynthia Bryant, Demetrixx’s chief business officer observer. “Three years ago we literally had empty laboratory space. We bought freezers. ”Now they hope to have CBG products ready to go by the end of the year.

Cannabis users are increasingly interested in niche or “rare” cannabinoids, although it is still unclear what these molecules are really capable of. This includes products like Delta 8 THC, which is about half as strong as regular THC and than that. referred to as fastest growing segment the hemp industry. Companies like Demetrix are more interested in “rare” cannabinoids – over 100 compounds in cannabis that only occur in traces in nature but can be produced in abundance in the laboratory.

Demetrix scientists in their laboratory. Demetrix

Demetrix was originally founded by Jay Keasling, a professor at the University of California, Berkeley who focuses on developing microbes, especially yeast, to manufacture other substances: like fuel or an ingredient in anti-malarial drugs called artemisinin. Keasling has since turned to cannabis, where his patented technique equips brewer’s yeast with the ability to make cannabinoids.

“It’s like brewing beer,” says Keasling Observer. “We feed the yeast, the sugar and the yeast, instead of spitting out ethanol, spitting out cannabinoids.”

Demetrix is ​​just one of a handful of startups poised to embark on a new path in the cannabis industry similar to the path taken by CBD or, more recently, Delta-8 THC. Dennis O’Neill, the president of Biomedican, another California-based startup, estimates that the rare cannabinoid industry could be worth it $ 25 billion by 2025.

Biomedican also uses proprietary yeasts to mass-produce rare cannabinoids like CBG and has amassed $ 4.1 million in funding to date.

“There’s a percentage of CBD people who are looking for the next best thing,” says O’Neille Observer. “All of the data points show that we have a demand tsunami that will hit this market. There will be a lot of money to be made. ”

Where do the rare cannabinoids come from?

It’s not that we didn’t know these molecules existed in cannabis, but that they were historically inaccessible. Molecules like CBG are usually only present in traces in natural plants – although some varieties can be bred contain more of a certain rare cannabinoid.

The biosynthetic approach excludes the plant from the equation and focuses on the molecular machinery of cannabis to boost the production of rare cannabinoids.

The end result is an isolated form of a rare cannabinoid. It’s the same product that would naturally exist, but without the extra terpenes or other molecules present in a plant (a disadvantage some weed connoisseurs might say but seen as an advantage by emerging industries) .

The idea that scientists succeeded in developing yeast to produce rare cannabinoids, thereby circumventing the scarcity of nature, has existed for several years. Keasling first published a piece of paper on the subject in 2019, but at that point it was not clear whether the process could be scaled up enough to support a new industry.

Bryant says that through faster math, advances in microorganism engineering, and a better understanding of cannabis, Demetrix went from zero liters of CBG to 15,000 in three years. In February, Demetrix also signed an agreement with a commercial manufacturer promising to supply these “metric tons” of CBG.

Fermentation tanks on a laboratory scale. Demetrix

Biomedican also expanded its operations this year, says O’Neill. Covid-19 has delayed the arrival of the equipment, but it expects it will be operational by the end of the year. “Our plan is to manufacture here in the US and then build a plant in Mexico, Europe and then Asia,” he says.

However, if everything stays on track, he expects to be in high-volume production of rare cannabinoid products – mostly CBG – by 2023 (they have already moved into pilot production). Biomedican already plans to distribute its products in Mexico.

That could range from cosmetics and lotions to granola bars, chocolates, or pet care products – the same products that became breeding grounds for CBD. This also means that it is possible that rare cannabinoids, once they are as freely available as CBD, fall into the same traps as CBD.

CBD has medicinal benefits. It forms the basis of the FDA-approved epilepsy drug Epidiolex and is used to treat pain. But it has also built a reputation for treating conditions from anxiety to erectile dysfunction. according to an analysis of the posts on the r / CBD subreddit.

As the introduction of CBD demonstrated, the novelty of certain cannabinoid products can create both an exciting and chaotic experience for people watching new products arrive on store shelves. CBD products are not reviewed by the FDA before they go on sale, nor are companies may say CBD products can treat any diagnosable condition. However, you can make “general wellness” claims.

“There is so much going on for the individual consumer,” says Paul Seaborne, professor of commerce at the University of Virginia. “They don’t necessarily have the same support and guidance from their GP or from normal sources.”

Keasling admits that the CBD industry has some element of the “snake oil” sales art. The rare cannabinoid industry could very well go this route. Rare cannabinoids have their share of the hype, and as manufacturing increases, they will hit consumers in successive waves, with science lagging behind as to what they can actually achieve.

“I would like these companies that work with technical microbes to deal with them a little better,” says Keasling.

Research to date on rare cannabinoids is sparse at the moment. This is mainly because it was nearly impossible to isolate these compounds in large quantities, and because marijuana’s status as a List I drug has made such studies difficult to conduct. Seaborne estimates that thanks to this planning, the pace of cannabis research has stalled by 30-50 years.

So far, research into rare cannabinoids contains some nuggets of information that allude to certain health effects. Previous studies on CBG suggest that it may show promise as a treatment Glioblastoma, psoriasis, or Neurodegenerative Diseases to like AS (these studies were carried out on mice and cells). Another one is running clinical study on the effects of cannabigerol on human diseases, which is registered on Clinicaltrials.gov at the time of writing.

Rodent studies on THCV, another rare cannabinoid, have suggested that it can decrease appetite and upregulate metabolism (again, no ongoing clinical trials are registered on this at this time). There are three clinical trials of THCV on Clinicaltrials.gov – one has published results and suggests it could help people with type II diabetes control blood sugar levels.

But these rodent studies are enough for O’Neill to predict that THCV will be the next rare cannabinoid to boom.

Incidentally, Demetrix and Biomedican are betting that these rare molecules have previously undiscovered effects. Even Keasling suggests that once the research is done, we might find that some rare cannabinoids are “worthless”, but not much of that research has happened yet.

Both companies also plan to support them by making rare cannabinoids available for clinical trials.

“We do our own basic research to understand these cannabinoids, but we also look for others to help us figure out what each of these cannabinoids can be of benefit to consumers,” says Bryant. “This is a class of compounds that modern scientific evaluation has completely skipped.

“I don’t think there are many connections we can say that about.”

In the meantime, companies plan to venture into even darker areas of cannabinoid manufacturing – ones that don’t even exist in natural plants.

Keasling’s original work suggests that his method could be used to cultivate “unnatural cannabinoids”. Biomedican announced the synthesis of a type of cannabinoid called Sesqui-CBG, a chemical variation of regular CBG.

A biomedical scientist Press release suggests that sesqui cannabinoids contain properties of many other cannabinoids combined, but Biomedican CEO Maxim Mikheev warns that we don’t know much about them.

“Sesqui cannabinoids haven’t been studied very well,” he says Observer.

Fear of the unknown doesn’t seem to be a problem that affects most cannabis users. Despite ongoing research into what cannabinoids can and can’t do, these molecules still have the enticing appeal of untapped potential. After 50 years of hesitant research, nobody knows exactly what we might find.

“Despite all this confusion, despite the fast pace of things, consumers are giving” [cannabis products] give it a try, ”says Seaborne. “This is proof of how much desire there is.”

The post Rare Cannabinoids Are the Next Frontier in the Marijuana Industry first appeared on 1st News Link.

source https://1stnewslink.com/rare-cannabinoids-are-the-next-frontier-in-the-marijuana-industry/

[gordonwilliamsweb]

Have a Case of a Covid Variant? No One Is Going to Tell You

This story also ran on NBC News. It can be republished for free.

Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.

Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs ― meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.

Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That’s worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.

Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants ― in accordance with arcane regulations governing clinical labs ― could hamper efforts to investigate pressing questions about the variants.

The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to “urgently” relax certain rules that apply to clinical labs.

Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn’t provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, “legally we can’t” tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.

“However, we are actively looking into what we can do,” she said.

Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a covid-19 diagnostic test was delayed while the virus spread undetected.

The limitations also put lab professionals and epidemiologists in a bind as public health officials attempt to trace contacts of those infected with more contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. “You want to be able to tell [patients] a variant was detected,” he said.

Complying with the lab rules “is not feasible in the timeline that a rapidly evolving virus and responsive public health system requires,” the organizations wrote.

Hamilton also said telling patients they have a novel strain could be another tool to encourage cooperation ― which is waning ― with efforts to trace and sample their contacts. She said notifications might also further encourage patients to take the advice to remain isolated seriously.

“Can our investigations be better if we can disclose that information to the patient?” she said. “I think the answer is yes.”

Public health experts have predicted that the B117 variant, first found in the United Kingdom, could be the predominant variant strain of the coronavirus in the U.S. by March.

As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, which was first identified in South Africa, in 14 states; and five cases of the P.1 variant initially detected in Brazil in four states, Dr. Rochelle Walensky, the CDC director, told reporters Wednesday.

A Feb. 12 memo from North Carolina public health officials to clinicians stated that because genome sequencing at the CDC is done for surveillance purposes and is not an approved test under the Clinical Laboratory Improvement Amendments program ― which is overseen by the U.S. Centers for Medicare & Medicaid Services ― “results from sequencing will not be communicated back to the provider.”

Earlier this week, the topic came up in Illinois as well. Notifying patients that they are positive for a covid variant is “not allowed currently” because the test is not CLIA-approved, said Judy Kauerauf, section chief of the Illinois Department of Public Health communicable disease program, according to a record obtained by the Documenting COVID-19 project of Columbia University’s Brown Institute for Media Innovation.

The CDC has scaled up its genomic sequencing in recent weeks, with Walensky saying the agency was conducting it on only 400 samples weekly when she began as director compared with more than 9,000 samples the week of Feb. 20.

The Biden administration has committed nearly $200 million to expand the federal government’s genomic sequencing capacity in hopes it will be able to test 25,000 samples per week.

“We’ll identify covid variants sooner and better target our efforts to stop the spread. We’re quickly infusing targeted resources here because the time is critical when it comes to these fast-moving variants,” Carole Johnson, testing coordinator for President Joe Biden’s covid-19 response team, said on a call with reporters this month.

Hospitals get high-level information about whether a sample submitted for sequencing tested positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Yet patients and their doctors will remain in the dark about who exactly was infected.

“It’s relevant from a systems-based perspective,” Gilpin said. “If we have a bunch of B117 in my backyard, that’s going to make me think a little differently about how we do business.”

It’s the same in Washington state, McCallion said. Health officials may share general numbers, such as 14 out of 16 outbreak specimens at a facility were identified as B117 ― but not who those 14 patients were.

There are arguments for and against notifying patients. On one hand, being infected with a variant won’t affect patient care, public health officials and clinicians say. And individuals who test positive would still be advised to take the same precautions of isolation, mask-wearing and hand-washing regardless of which strain they carried.

“There wouldn’t be any difference in medical treatment whether they have the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that “in a public health emergency it’s really important for doctors to know this information.”

Pandori estimated there may be only 10 or 20 labs in the U.S. capable of validating their laboratory-based variant tests. One of them doing so is the lab at the University of Washington in Seattle.

Dr. Alex Greninger, assistant director of the clinical virology laboratories there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing tests last fall.

Within the next few weeks, he said, he anticipates having a federally authorized test for whole-genome sequencing of covid. “So all the issues you note on notifying patients and using [the] results will not be a problem,” he said in an email.

Companies including San Diego-based Illumina have approved covid-testing machines that can also detect a variant. However, since the add-on sequencing capability wasn’t specifically approved by the FDA, the results can be shared with public health officials ― but not patients and their doctors, said Dr. Phil Febbo, Illumina’s chief medical officer.

He said they haven’t asked the FDA for further approval but could if variants start to pose greater concern, like escaping vaccine protection.

“I think right now there’s no need for individuals to know their strains,” he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Have a Case of a Covid Variant? No One Is Going to Tell You published first on https://nootropicspowdersupplier.tumblr.com/

[stephenmccull]

Have a Case of a Covid Variant? No One Is Going to Tell You

This story also ran on NBC News. It can be republished for free.

Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.

Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs ― meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.

Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That’s worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.

Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants ― in accordance with arcane regulations governing clinical labs ― could hamper efforts to investigate pressing questions about the variants.

The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to “urgently” relax certain rules that apply to clinical labs.

Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn’t provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, “legally we can’t” tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.

“However, we are actively looking into what we can do,” she said.

Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a covid-19 diagnostic test was delayed while the virus spread undetected.

The limitations also put lab professionals and epidemiologists in a bind as public health officials attempt to trace contacts of those infected with more contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. “You want to be able to tell [patients] a variant was detected,” he said.

Complying with the lab rules “is not feasible in the timeline that a rapidly evolving virus and responsive public health system requires,” the organizations wrote.

Hamilton also said telling patients they have a novel strain could be another tool to encourage cooperation ― which is waning ― with efforts to trace and sample their contacts. She said notifications might also further encourage patients to take the advice to remain isolated seriously.

“Can our investigations be better if we can disclose that information to the patient?” she said. “I think the answer is yes.”

Public health experts have predicted that the B117 variant, first found in the United Kingdom, could be the predominant variant strain of the coronavirus in the U.S. by March.

As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, which was first identified in South Africa, in 14 states; and five cases of the P.1 variant initially detected in Brazil in four states, Dr. Rochelle Walensky, the CDC director, told reporters Wednesday.

A Feb. 12 memo from North Carolina public health officials to clinicians stated that because genome sequencing at the CDC is done for surveillance purposes and is not an approved test under the Clinical Laboratory Improvement Amendments program ― which is overseen by the U.S. Centers for Medicare & Medicaid Services ― “results from sequencing will not be communicated back to the provider.”

Earlier this week, the topic came up in Illinois as well. Notifying patients that they are positive for a covid variant is “not allowed currently” because the test is not CLIA-approved, said Judy Kauerauf, section chief of the Illinois Department of Public Health communicable disease program, according to a record obtained by the Documenting COVID-19 project of Columbia University’s Brown Institute for Media Innovation.

The CDC has scaled up its genomic sequencing in recent weeks, with Walensky saying the agency was conducting it on only 400 samples weekly when she began as director compared with more than 9,000 samples the week of Feb. 20.

The Biden administration has committed nearly $200 million to expand the federal government’s genomic sequencing capacity in hopes it will be able to test 25,000 samples per week.

“We’ll identify covid variants sooner and better target our efforts to stop the spread. We’re quickly infusing targeted resources here because the time is critical when it comes to these fast-moving variants,” Carole Johnson, testing coordinator for President Joe Biden’s covid-19 response team, said on a call with reporters this month.

Hospitals get high-level information about whether a sample submitted for sequencing tested positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Yet patients and their doctors will remain in the dark about who exactly was infected.

“It’s relevant from a systems-based perspective,” Gilpin said. “If we have a bunch of B117 in my backyard, that’s going to make me think a little differently about how we do business.”

It’s the same in Washington state, McCallion said. Health officials may share general numbers, such as 14 out of 16 outbreak specimens at a facility were identified as B117 ― but not who those 14 patients were.

There are arguments for and against notifying patients. On one hand, being infected with a variant won’t affect patient care, public health officials and clinicians say. And individuals who test positive would still be advised to take the same precautions of isolation, mask-wearing and hand-washing regardless of which strain they carried.

“There wouldn’t be any difference in medical treatment whether they have the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that “in a public health emergency it’s really important for doctors to know this information.”

Pandori estimated there may be only 10 or 20 labs in the U.S. capable of validating their laboratory-based variant tests. One of them doing so is the lab at the University of Washington in Seattle.

Dr. Alex Greninger, assistant director of the clinical virology laboratories there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing tests last fall.

Within the next few weeks, he said, he anticipates having a federally authorized test for whole-genome sequencing of covid. “So all the issues you note on notifying patients and using [the] results will not be a problem,” he said in an email.

Companies including San Diego-based Illumina have approved covid-testing machines that can also detect a variant. However, since the add-on sequencing capability wasn’t specifically approved by the FDA, the results can be shared with public health officials ― but not patients and their doctors, said Dr. Phil Febbo, Illumina’s chief medical officer.

He said they haven’t asked the FDA for further approval but could if variants start to pose greater concern, like escaping vaccine protection.

“I think right now there’s no need for individuals to know their strains,” he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

Have a Case of a Covid Variant? No One Is Going to Tell You published first on https://smartdrinkingweb.weebly.com/

[amshrihari]

RFID IN HEALTHCARE MARKET ANALYSIS

RFID in Healthcare Market, By Product Type (Tags (Passive, Active), Readers, Middleware), and By Region (North America, Latin America, Europe) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027

Press Release :  RFID in Healthcare Market

Request Free Sample                                                                 Download PDF

RFID is a system based on wireless technology (non-contact system) which utilizes radio-frequency electromagnetic fields for transferring data from a tag attached to an object, for various purposes like automatic identification and tracking of objects. RFID enables identification from a distance, unlike earlier bar-code technology.

Statistics:

The global RFID in healthcare market is estimated to account for US$ 16,756.6 Mn in terms of value by the end of 2027.

Global RFID in Healthcare Market: Drivers

Concerns over drug counterfeiting in healthcare is expected to hinder growth of the global RFID in healthcare market over the forecast period. Patient safety is affected by counterfeit pharmaceuticals and biologics which is a growing problem. Specific technology is needed to deter this drug counterfeiting. RFID minimizes the risk of counterfeited, unacceptable, adulterated or tampered with and diverted drugs.

Moreover, improved operational efficiency with RFID is also expected to aid in growth of the global RFID in healthcare market. To get an accurate account of inventory, manufacturers, and distributors have to improve visibility throughout the supply chain management. Lack of visibility of customer orders and available stock will lead to increased inventory and locks finances unnecessarily as healthcare practitioners often keep buffer stocks to avoid stocks out situation. As RFID enables increased visibility of the inventory, it will reduce buffer stocks by substituting knowledge of inventory and thereby reducing inventory cost.

Statistics:

North America held dominant position in the global RFID in healthcare market in 2019, accounting for 49.5% share in terms of value, followed by Europe and Asia Pacific, respectively.

Figure 1: Global RFID in Healthcare Market Share (%) Value, By Region, 2019

Global RFID in Healthcare Market: Restraints

High cost of the system is expected to hinder growth of the global RFID in healthcare market. The cost of an RFID tag can range from four cents per tag to upwards of US$ 50.00 per tag depending on the capabilities. The RFID tag readers can range from US$ 1,000.00 to US$ 3,000.00 per reader.

Moreover, lack of standardization in technology is also expected to limit growth of the market.

Statistics:

The global RFID in healthcare market was valued at US$ 4,004.0 Mn in 2019 and is forecast to reach a value of US$ 16,756.6 Mn by 2027 at a CAGR of 19.6% between 2020 and 2027.

Figure 2: Global RFID in Healthcare Market Value (US$ Mn), 2016 – 2027

Market Trends/Key Takeaways

Medication shortages in pharmacies is expected to propel growth of the global RFID in healthcare market. For instance, according to an annual survey published in August 2020 by Kit Check, around 60% of pharmacy staff reported dealing with up to 20 medication shortages at a time. More than 72 of respondents reported spending up to 15 staff hours to reconcile each medication shortage.

Moreover, launch of medical devices with RFID scanners is expected to propel growth of the global RFID in healthcare market. For instance, in August 2020, JADAK, a business unit of Novanta Corporation, launched HS-1RS Secure Access Handheld Barcode Scanner, enabled with software from Imprivata and HID. The HS-1RS integrates 1D and 2D barcode scanning with LF/HF RFID smartcard/contact-less and prox card reading functionality.

Regulations

U.S.

FDA intends to exercise enforcement discretion as described below for studies that fall within all of the following parameters:

A manufacturer, repackager, relabeler, distributor, retailer, or others acting at their direction will attach RFID tags (chips and antennae) to only immediate containers, secondary packaging, shipping containers, and/or pallets of drugs that are being placed into commerce. There is no limit to the number of tags or readers that may be used in the study.

The drugs involved will be limited to prescription or over-the-counter finished products. The drugs involved will not include those approved under a Biologics License Application or protein drugs covered by a New Drug Application. The study need not have a pre-determined time limit or endpoint, except that tag placement for the study will be completed by December 31, 2007.

RFID will be used only for inventory control, tracking and tracing of products, verification of shipment and receipt of such products, or finished product authentication.

RFID will not be used to fulfill existing FDA regulatory requirements (e.g., fulfillment of labeling or Current Good Manufacturing Practice requirements, provision of chemistry, manufacture, and control information, storage of information in fulfillment of a regulatory requirement, or performance of label and product reconciliation).

RFID will not be used in lieu of current labeling control systems to ensure correct labeling processes.

The study will use "passive," "semi-active," or "active" tags.3

Information will be written to the tag at the time that the tag is manufactured (e.g., "read only" tags), after the tag is manufactured but before it is affixed to a drug's container (e.g., "read-write tags"), or after the tag is affixed to a drug's container.4 The tags will contain a serial number (e.g., an electronic product code) that uniquely identifies the object to which the tag is attached, and may also contain other information such as storage and handling conditions, information from the FDA approved label and labeling, lot number, and product expiration date

The tags will not contain or transmit information for the healthcare practitioner.

The tags will not contain or transmit information for the consumer.

The tags will not contain or transmit advertisements or information about product indications or off-label product uses.

A seal containing a logo, an inventory control message unrelated to the product (e.g., a message informing the custodian that the package contains an RFID tag), and/or a unique serial number may be placed over the RFID tag or elsewhere on a drug's immediate container, secondary packaging, and/or shipping container.

The addition of the RFID tag and seal will not block, obscure, or alter any of the product's existing and approved label and labeling information.

The RFID tag will not substitute for, replace, or interfere with a linear bar code required pursuant to 21 C.F.R. § 201.25.

Participants will "read" the tags as needed to identify the product and/or conduct the study.

The tag readers will work by emitting electromagnetic energy at radio frequencies of 13.56 megahertz, 902-928 megahertz, or 2.4 gigahertz, and at powers in compliance with regulatory requirements of the Federal Communications Commission (i.e., 1-4 watts effective isotropically radiated power).

Global RFID in Healthcare Market: Competitive Landscape

Major players operating in the global RFID in healthcare market include, Microchip Technology, Accenture plc, Hitachi, IBM, 3M, AeroScout Inc., Know Labs, Inc., Kit Check, Fresenius Kabi, and Siemens Healthcare.

Global RFID in Healthcare Market: Key Developments

Major players in the global RFID in healthcare market are focused on adopting partnership strategies to enhance their market share. For instance, in September 2020, Kit Check announced that Premier Inc. has extended its sole source partnership with the company for its Blue sight for Controlled Substances (BCS) solution as well as its namesake kit and tray processing system.

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Customized     Market Research Services

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[lauramalchowblog]

The False Choice Between Science And Economics

By DAVID SHAYWITZ, MD, PhD

As the nation wrestles with how best to return to normalcy, there’s a tension, largely but not entirely contrived, emerging between health experts—who are generally focused on maintaining social distancing and avoiding “preventable deaths”—and some economists, who point to the deep structural harm being caused by these policies.

Some, including many on the Trumpist-right, are consumed by the impact of the economic pain, and tend to cast themselves as sensible pragmatists trying to recapture the country from catastrophizing, pointy-headed academic scientists who never much liked the president anyway.

This concern isn’t intrinsically unreasonable. Most academics neither like nor trust the president. There is also a natural tendency for physicians to prioritize conditions they encounter frequently—or which hold particular saliency because of their devastating impact—and pay less attention to conditions or recommendations that may be more relevant to a population as a whole.

Even so, there are very, very few people on what we will call, for lack of a better term, “Team Health,” who do not appreciate, at least at some level, the ongoing economic devastation. There may be literally no one—I have yet to see or hear anyone who does not have a deep appreciation for how serious our economic problems are, and I know of a number of previously-successful medical practices which are suddenly struggling to stay afloat amidst this epidemic.

In contrast, at least some on—again, for lack of a better term—“Team Economy” seem to believe that the threat posed by the coronavirus is wildly overblown, and perhaps even part of an elaborate, ongoing effort to destroy Trump.

Yet even if some partisans are intrinsically unpersuadable, I suspect that if Team Economy had a more nuanced understanding of Team Health, this could facilitate a more productive dialog and catalyze the rapid development and effective implementation of a sustainable solution to our current national crisis.

For starters, it might help Team Economy to know that even pointy-headed academics appreciate that science is (or at least should be) a process we use, not an ideology we worship. Most researchers recognize every day how difficult it is to figure out biological relationships, and to make even the most basic predictions in the highly reductionist systems of a petri dish or a test tube.

Under typical conditions, scientists tend to do an exceptional amount of study before they cautiously suggest a new insight. It’s really hard to figure out how nature works, and each time we think we’ve understood even some tiny aspect of it, nature tends to surprise us again with an unexpected twist. While often maddening, this complexity is also what makes science so captivating, engaging, and intellectually seductive.

In the context of COVID-19, it is incredibly, absurdly challenging for anyone—including scientists—to get their heads around the rapidly evolving knowledge that is, in any case, preliminary and is being collected under difficult conditions.

This is not an environment conducive to understanding exactly what’s going on at a system-wide level, let alone a molecular one.

And yet, that’s what Team Health is trying to manage. They’re working to understand the very basic characteristics of SARS-CoV-2 (the virus that causes COVID-19), while simultaneously extrapolating from the data in order to make recommendations that are going to impact the lives of billions of people.

There is a saving grace: researchers aren’t starting from scratch. They are informed by studies of related pandemics—the influenza pandemic of 1917-1918, the SARS outbreak of 2002-2004, and the 2009 swine flu pandemic, for starters. Investigators are also leveraging all they’ve learned about the biology of related viruses to make educated guesses about how to approach the current threat, and using recently-acquired knowledge of how to harness the immune system in cancer to think about how we might help the immune system respond more effectively to a virus.

Most scientists recognize the limitations of their knowledge, and realize just how hard it is to extrapolate—which is why they tend to avoid doing so. But they also appreciate that even if understanding is difficult and prediction even harder, the process of science—the meticulous collection and analysis of data, the constructing, testing, and reformation of hypotheses—has proven phenomenally effective over the long haul. It has enabled us to better understand illness and disease, and to provide humanity with the opportunity for longer and less miserable lives than ever in the history of our species.

And even if this potential is not realized either universally, nor as frequently as we might wish, it’s still the best construct we have.

It beats, for instance, hoping that a disease will simply disappear, like a miracle. Hope is not a method.

The Trump administration ought to listen to scientists, but it need not accept their advice uncritically. And that’s because behind closed doors, scientists never (well, hardly ever) accept the advice—or data—from other researchers at face value. They invariably question techniques, approaches, and conclusions.

The foundational training course my classmates and I took in grad school in biology at MIT essentially ripped apart classic papers week after week, exposing the flaws, and highlighting the implicit assumptions—and these were generally top-tier pieces of work by legendary scientists. I came away from the course with a powerful sense of the fragility of knowledge, the difficulty of proof, and a deep respect for the researchers who are driven to pursue, persist, and publish—despite these intrinsic challenges.

No individual or organization should be so revered that their findings are beyond scrutiny or evaluation, whether he or she works for a drug company, an academic institution, or an NGO.

But what rankles people on Team Health isn’t thoughtful skepticism from Trump about a particular piece of data (if only!), but rather Trump’s apparent indifference to science as a whole, and the ease with which he casts it aside if it fails to comport with his narrative-of-the-moment.

Trump seems to treat science like just another point of view, embracing it when convenient, ignoring it when not. This sort of casual indifference rattles the people on Team Health because, for all their disagreements, researchers tend to believe that there is an objective reality they are attempting to describe and understand, however imperfectly.

The notion that a scientist’s inevitably hazy view of a real phenomenon—drawn from well-described, ideally reproducible techniques—is indistinguishable from a “perspective” that some presidential advisor, or morning cable host, or guy on Twitter pulls out of . . . well, let’s say thin air . . . seems irresponsible.

And that’s because it is.

The good news is that Trump has a real opportunity in the coming days to leverage the advice of both scientists and policy makers, should he choose to listen.

In the last week, two important reports were published, each by a cross-functional team of experts. One was organized by the Margolis Center for Health Policy at Duke, and includes Trump’s former FDA Commissioner, Dr. Scott Gottlieb, and one of Obama’s national health technology leaders, Dr. Farzad Mostashari. The other is from the Johns Hopkins Center for Health Security. Both groups suggest that transition to normalcy will require an exquisite ability to rapidly identify new outbreaks and track down and quarantine individuals who are likely afflicted—the ability to test-and-trace.

The idea is that our country needs the ability to conduct something close to a precision quarantine, where we constrain the activity only of those likely exposed — which requires, of course, accurately determining who those people are.

To their credit, both groups focus not on high-tech solutions that might be challenging to implement and potentially threatening to individual privacy (most Americans are not looking to emulate the policies of South Korea or China), but rather on extensive contact tracing involving a lot of individual effort. In other words: good old-fashioned disease hunter shoe-leather.

This approach requires not just a lot of dedicated people, but also a testing capability that we are hopefully developing, but clearly don’t yet possess. For example, a recent Wall Street Journal article quoted New Hampshire’s Republican governor Chris Sununu complaining that his state received 15 of the much-anticipated Abbot testing machines Trump recently demonstrated at the White House—but only enough cartridges for about 100 tests. “It’s incredibly frustrating,” Sununu vented. “I’m banging my head against the wall.”

The reason all this matters (at least if, like me, you believe the health experts) is that the rate at which the population is developing immunity to SARS-CoV-2 is remarkably low, according to UCSF epidemiologist Dr. George Rutherford. He estimates the rate of population immunity in the United States is around 1 percent, and notes that it’s apparently only 2 percent to 3 percent in Wuhan—the center of the original outbreak.

Herd immunity—the ability of a population’s background level of immunity to protect the occasional vulnerable individual—requires levels more than 10 fold above this (the actual figure depends on the infectivity of the virus; for ultra-infectious conditions like measles, more than 90% of a population must be immune; for the flu, which is less infectious, the figure is closer to 60%; SARS-CoV-2 is likely to be around this range). This means that, in Rutherford’s words, “herd immunity for this disease is mythic”—until there’s an effective vaccine.

Translation: For the foreseeable future, almost all of us are vulnerable. And we will remain vulnerable until therapies emerge.

Health experts worry that without a transition that includes provisions for meticulous contact tracing, rushing headlong back to a vision of normalcy would likely result in a rapid reemergence of the pandemic, and potentially, a need for more wide-spread quarantines—which would drive a stake into the heart of any economic recovery.

The truth here is that Team Economy doesn’t need to push against Team Health, because they’re after the same thing. If Trump embraces a transition that recognizes both the economic needs of the country and the wisdom of leading health experts and policy makers, he may succeed in leading a weary but irrepressibly resilient nation out of our current crisis, and into a durably healthy, economically promising future.

David Shaywitz, a physician-scientist, is the founder of Astounding HealthTech, a Silicon Valley advisory service, and an adjunct scholar at the American Enterprise Institute.

This article originally appeared on The Bulwark here.

The post The False Choice Between Science And Economics appeared first on The Health Care Blog.

The False Choice Between Science And Economics published first on https://venabeahan.tumblr.com

[kristinsimmons]

The False Choice Between Science And Economics

By DAVID SHAYWITZ

As the nation wrestles with how best to return to normalcy, there’s a tension, largely but not entirely contrived, emerging between health experts—who are generally focused on maintaining social distancing and avoiding “preventable deaths”—and some economists, who point to the deep structural harm being caused by these policies.

Some, including many on the Trumpist-right, are consumed by the impact of the economic pain, and tend to cast themselves as sensible pragmatists trying to recapture the country from catastrophizing, pointy-headed academic scientists who never much liked the president anyway.

This concern isn’t intrinsically unreasonable. Most academics neither like nor trust the president. There is also a natural tendency for physicians to prioritize conditions they encounter frequently—or which hold particular saliency because of their devastating impact—and pay less attention to conditions or recommendations that may be more relevant to a population as a whole.

Even so, there are very, very few people on what we will call, for lack of a better term, “Team Health,” who do not appreciate, at least at some level, the ongoing economic devastation. There may be literally no one—I have yet to see or hear anyone who does not have a deep appreciation for how serious our economic problems are, and I know of a number of previously-successful medical practices which are suddenly struggling to stay afloat amidst this epidemic.

In contrast, at least some on—again, for lack of a better term—“Team Economy” seem to believe that the threat posed by the coronavirus is wildly overblown, and perhaps even part of an elaborate, ongoing effort to destroy Trump.

Yet even if some partisans are intrinsically unpersuadable, I suspect that if Team Economy had a more nuanced understanding of Team Health, this could facilitate a more productive dialog and catalyze the rapid development and effective implementation of a sustainable solution to our current national crisis.

For starters, it might help Team Economy to know that even pointy-headed academics appreciate that science is (or at least should be) a process we use, not an ideology we worship. Most researchers recognize every day how difficult it is to figure out biological relationships, and to make even the most basic predictions in the highly reductionist systems of a petri dish or a test tube.

Under typical conditions, scientists tend to do an exceptional amount of study before they cautiously suggest a new insight. It’s really hard to figure out how nature works, and each time we think we’ve understood even some tiny aspect of it, nature tends to surprise us again with an unexpected twist. While often maddening, this complexity is also what makes science so captivating, engaging, and intellectually seductive.

In the context of COVID-19, it is incredibly, absurdly challenging for anyone—including scientists—to get their heads around the rapidly evolving knowledge that is, in any case, preliminary and is being collected under difficult conditions.

This is not an environment conducive to understanding exactly what’s going on at a system-wide level, let alone a molecular one.

And yet, that’s what Team Health is trying to manage. They’re working to understand the very basic characteristics of SARS-CoV-2 (the virus that causes COVID-19), while simultaneously extrapolating from the data in order to make recommendations that are going to impact the lives of billions of people.

There is a saving grace: researchers aren’t starting from scratch. They are informed by studies of related pandemics—the influenza pandemic of 1917-1918, the SARS outbreak of 2002-2004, and the 2009 swine flu pandemic, for starters. Investigators are also leveraging all they’ve learned about the biology of related viruses to make educated guesses about how to approach the current threat, and using recently-acquired knowledge of how to harness the immune system in cancer to think about how we might help the immune system respond more effectively to a virus.

Most scientists recognize the limitations of their knowledge, and realize just how hard it is to extrapolate—which is why they tend to avoid doing so. But they also appreciate that even if understanding is difficult and prediction even harder, the process of science—the meticulous collection and analysis of data, the constructing, testing, and reformation of hypotheses—has proven phenomenally effective over the long haul. It has enabled us to better understand illness and disease, and to provide humanity with the opportunity for longer and less miserable lives than ever in the history of our species.

And even if this potential is not realized either universally, nor as frequently as we might wish, it’s still the best construct we have.

It beats, for instance, hoping that a disease will simply disappear, like a miracle. Hope is not a method.

The Trump administration ought to listen to scientists, but it need not accept their advice uncritically. And that’s because behind closed doors, scientists never (well, hardly ever) accept the advice—or data—from other researchers at face value. They invariably question techniques, approaches, and conclusions.

The foundational training course my classmates and I took in grad school in biology at MIT essentially ripped apart classic papers week after week, exposing the flaws, and highlighting the implicit assumptions—and these were generally top-tier pieces of work by legendary scientists. I came away from the course with a powerful sense of the fragility of knowledge, the difficulty of proof, and a deep respect for the researchers who are driven to pursue, persist, and publish—despite these intrinsic challenges.

No individual or organization should be so revered that their findings are beyond scrutiny or evaluation, whether he or she works for a drug company, an academic institution, or an NGO.

But what rankles people on Team Health isn’t thoughtful skepticism from Trump about a particular piece of data (if only!), but rather Trump’s apparent indifference to science as a whole, and the ease with which he casts it aside if it fails to comport with his narrative-of-the-moment.

Trump seems to treat science like just another point of view, embracing it when convenient, ignoring it when not. This sort of casual indifference rattles the people on Team Health because, for all their disagreements, researchers tend to believe that there is an objective reality they are attempting to describe and understand, however imperfectly.

The notion that a scientist’s inevitably hazy view of a real phenomenon—drawn from well-described, ideally reproducible techniques—is indistinguishable from a “perspective” that some presidential advisor, or morning cable host, or guy on Twitter pulls out of . . . well, let’s say thin air . . . seems irresponsible.

And that’s because it is.

The good news is that Trump has a real opportunity in the coming days to leverage the advice of both scientists and policy makers, should he choose to listen.

In the last week, two important reports were published, each by a cross-functional team of experts. One was organized by the Margolis Center for Health Policy at Duke, and includes Trump’s former FDA Commissioner, Dr. Scott Gottlieb, and one of Obama’s national health technology leaders, Dr. Farzad Mostashari. The other is from the Johns Hopkins Center for Health Security. Both groups suggest that transition to normalcy will require an exquisite ability to rapidly identify new outbreaks and track down and quarantine individuals who are likely afflicted—the ability to test-and-trace.

The idea is that our country needs the ability to conduct something close to a precision quarantine, where we constrain the activity only of those likely exposed — which requires, of course, accurately determining who those people are.

To their credit, both groups focus not on high-tech solutions that might be challenging to implement and potentially threatening to individual privacy (most Americans are not looking to emulate the policies of South Korea or China), but rather on extensive contact tracing involving a lot of individual effort. In other words: good old-fashioned disease hunter shoe-leather.

This approach requires not just a lot of dedicated people, but also a testing capability that we are hopefully developing, but clearly don’t yet possess. For example, a recent Wall Street Journal article quoted New Hampshire’s Republican governor Chris Sununu complaining that his state received 15 of the much-anticipated Abbot testing machines Trump recently demonstrated at the White House—but only enough cartridges for about 100 tests. “It’s incredibly frustrating,” Sununu vented. “I’m banging my head against the wall.”

The reason all this matters (at least if, like me, you believe the health experts) is that the rate at which the population is developing immunity to SARS-CoV-2 is remarkably low, according to UCSF epidemiologist Dr. George Rutherford. He estimates the rate of population immunity in the United States is around 1 percent, and notes that it’s apparently only 2 percent to 3 percent in Wuhan—the center of the original outbreak.

Herd immunity—the ability of a population’s background level of immunity to protect the occasional vulnerable individual—requires levels more than 10 fold above this (the actual figure depends on the infectivity of the virus; for ultra-infectious conditions like measles, more than 90% of a population must be immune; for the flu, which is less infectious, the figure is closer to 60%; SARS-CoV-2 is likely to be around this range). This means that, in Rutherford’s words, “herd immunity for this disease is mythic”—until there’s an effective vaccine.

Translation: For the foreseeable future, almost all of us are vulnerable. And we will remain vulnerable until therapies emerge.

Health experts worry that without a transition that includes provisions for meticulous contact tracing, rushing headlong back to a vision of normalcy would likely result in a rapid reemergence of the pandemic, and potentially, a need for more wide-spread quarantines—which would drive a stake into the heart of any economic recovery.

The truth here is that Team Economy doesn’t need to push against Team Health, because they’re after the same thing. If Trump embraces a transition that recognizes both the economic needs of the country and the wisdom of leading health experts and policy makers, he may succeed in leading a weary but irrepressibly resilient nation out of our current crisis, and into a durably healthy, economically promising future.

David Shaywitz, a physician-scientist, is the founder of Astounding HealthTech, a Silicon Valley advisory service, and an adjunct scholar at the American Enterprise Institute.

This article originally appeared on The Bulwark here.

The post The False Choice Between Science And Economics appeared first on The Health Care Blog.

The False Choice Between Science And Economics published first on https://wittooth.tumblr.com/

[interwork2018-blog]

THE MOST INNOVATIVE THINGS ARE HAPPENING WITH BLOCKCHAIN FOR DSCSA DRUG SERIALIZATION

The Dynamic Duo: Blockchain for DSCSA Drug Serialization

The US Congress has enacted the drug supply chain security act 2013. Since then, technology businesses have aggressively explored all possible permutations and combinations of technology. The objective has been to build solutions to build a highly reliable system that closely works to help companies seamlessly scale without worrying about DSCSA serialization compliance.

The motive behind Blockchain for DSCSA Drug Serialization is to counter increasing time-material costs of supply chain operations, restricted supplies due to the productivity of employees, and excessively increase turnaround time in fulfilling requirements at the bulk level in the pharmaceutical supply chain. Ultimately, a sustainable Solution of Blockchain for DSCSA Drug Serialization has turned out to be the most beneficial one. Let us see how.

Innovations with Blockchain for DSCSA Drugs Serialization

While there are some changes to the Blockchain for Drug Serialization for DSCSA, the most primitive ones are:

A Single Solution, Double Purpose

One of the significant problems is that it is not able to seamlessly integrate with existing technology resources. Blockchain is capable of offering an all-round supply chain management solution instead of just focusing on Blockchain for DSCSA Serialization requirements. If the adoption of Blockchain for DSCSA Drug Serialization is Strategic, it offers the completeness of solutions for long-term stellar growth.

Multi-stakeholder operations

Other solutions just offer convincing answers to one, two, or a maximum of three stakeholders who are the primary supply chain partners. But according to US FDA, DSCSA serialization requires a top-notch level of communication in a highly secured environment for efficiently curbing drug counterfeiting. The dire need for enhancing drug track and trace capability is promoting Blockchain for DSCSA Drug Serialization.

Best use of Decentralized Database

A Blockchain for DSCSA Serialization offers a decentralized database accessible to all supply chain partners enhancing Blockchain-Based Drug Track and Trace. It also comes with an added innovation which lets regulatory bodies and US FDA regulators to conveniently fetch the transacting drug lot database from any timeline during the passage of the lots between any two supply chain partners.

Counterfeit Detection System

The newest innovations in the blockchain for DSCSA drug serialization make blockchain-based drug track and trace solutions highly capable of implementing improve counterfeit detection systems. Any discrepancies or a non-uniformity is in redirected transactions from different stakeholders down the line of all Pharma supply chain critically flagged for scrutiny by supply chain partners and regulatory bodies.

Real-Time Transaction and Notification System

Blockchain-Based Drug Track and Trace has greatly innovated to make life easier for major Pharma supply chain partners in the US market. They are doing so by helping suppliers and partners receive notifications of all transactions anywhere in the supply chain, which they can acknowledge after verification with all serialization relevant data. These notifications capable of driving positive attention of all regulatory bodies and supply chain partners to leave no scope for uncontrolled introduction of counterfeit into the mainstream supply chain.

Seamless Database Migration & Adoption

Innovative use of Blockchain for DSCSA Drug Serialization opens up the unlimited scope of migration and adoption of a new database as per DSCSA serialization standards. According to the DSCSA, all suppliers and partners are expected to maintain a highly active database, including all details like:

What to Expect From the Future?

Supply chain components like third party verification

The localization of a database copy

Integration scenarios like ERP-SCM

Data interoperability

AI-IoT based systems for warehousing, counterfeit, SCM operations

Conclusion

As the essential deadline for DSCSA full completion of serialization infrastructure set up nears, Blockchain-Based Drug Track and Trace will become an inevitable part of US-based pharmaceutical supply chain management business. Businesses that will pay required attention to proper efforts with Blockchain for DSCSA Drug Serialization with the right blockchain-based drug track and track solution will reach excellent benefits with an unbeatable advantage over others. In the future, USFDA takes strict measures and issue sanctions for tightening screws on drug counterfeiting in the upcoming years.

[iotconnectedsmartproducts]

Electronic Labeling For Food Traceability And Fresh Produce Integrity

The year 2018 saw North America reeling under multiple E.coli outbreaks, with the Center for Disease Control and Prevention issuing a blanket warning against consuming the suspected source - romaine lettuce. The agency along with the Food and Drug Administration struggled to pinpoint the source for the outbreak. Similar outbreaks of foodborne illnesses like Vibrio parahaemolyticus and Salmonella have also littered the past year affecting hundreds of people.  Foodborne illnesses cause millions of dollars worth in losses from recalls, loss in sales and damage to brand reputation.  Money needs to also be spent on notifying retailers, regulatory bodies and storing or disposing of affected products and government fines.

So, what steps are the government agencies and enterprises taking to reduce the impact of such outbreaks in the future? The CDC and FDA are encouraging labels on susceptible fresh produce which clearly state the origin of the product as well as when it was harvested so that consumers can take a more informed decision while purchasing. In fact, product labels can go a long way in boosting food safety and accurately locating the ground zero for outbreaks. With digitization gaining momentum everywhere, electronic packaging and labeling solutions are the key to delivering consistent and reliable data of each product’s journey from farm to shelves.

Simplifying Complex Food Systems with Reliable Data

Food systems are highly complex. A restaurant may have bought tomatoes from multiple distributors, who themselves may have repackaged their products after sourcing them from a variety of farms. We can see how it becomes a challenge to trace the origins of each item back to its source. It is thus important to link all the diverse participants within a supply chain. Reliable and consistent data is the indispensable factor that decides the integrity of food quality and helps quickly locate the ground zero during recall situations.

The challenge presents itself in the collection, management and analysis of such a large amount of data without suffering any damage to its quality. Much of this data is maintained by distributors in their respective PIMs, but they are neither in congruence with each other nor exposed to the end consumer. But technology has advanced in leaps and bounds making it possible to transform everyday items, even fresh produce into active and intelligent objects. Bringing electronic labeling solutions and cloud computing into the fold makes it simpler to record each and every event occurring to a product. Digital tags (RFID, NFC, QR codes, data matrix codes, barcodes) on packaging and labels can be used as the medium to link fresh produce to the internet, essentially giving them a unique identity or digital twin that is capable of collecting and relaying information about itself (origins, current location, previous stops in the supply chain etc.). Thus, by converting fresh produce and all food products into connected smart products and bringing all partners within the supply chain into a shared system to maintain integrity, the end result on the shelf will be capable of accurately describing its journey to a potential buyer.

Minimizing Impact of Contaminated Food with Traceability

With certain fresh produce, foodborne illnesses are unavoidable. The least we can do is to look for innovative solutions in order to contain their spread and minimize their impact. The detective work that goes into identifying the source farms for the outbreak of foodborne illness is exhaustive and time consuming. By the time government officials figure out the origin, the contaminated produce has already covered a lot of ground and affected hundreds of people. Entire supplies of the suspected produce gets halted resulting in severe losses and prices of similar produce shooting up. Brands associated with the produce take a hit to their reputation.

But fresh produce powered by electronic labels can show exactly which farm or distributor it has traveled from via it’s digital twin on the web. With a far more uncluttered food supply chain to sieve through, the investigative tasks for regulators becomes much more simpler. Product recalls become more straightforward by targeting only the suspected farms, instead of banning the supply of the entire range of the produce. Traceability is thus the key to tackling and understanding the causes for such frequent outbreaks.

But better management of foodborne illnesses is just one of the advantages of going digital.

Increased Visibility means fewer mishaps down the Supply Chain

Retailers, distributors, manufacturers and farmers can all benefit hugely from smart packaging and electronic labels. The digital transformation of very complex supply chains afford more transparency into all events that are a part of it and make available data of higher quality to work with. From producers to distributors, packaging companies and retailers, each participant can know the exact actions of a particular item within the supply chain. When you have a complete and accurate record of each product’s journey at both SKU and batch levels from all active participants, processes that focus on narrowing down sources for inadequacies or anomalies in events of a product recall situation become faster and simpler - more powerful.

Enterprises can keep track of harvest dates and accordingly plan logistics to ship items to locations depending on their freshness. A digital record via the digital twin of each item on the web enables far better stock keeping. These digital twins ensure that store employees are alerted to produce that are nearing their expiry dates or use-by dates . With a clearer view of items in their inventory that might soon be going bad, companies can plan for and take definite stems in offloading these items through multiple channels; for example sell them at cheaper rates or donate them to food banks.

Product Data is equally valuable to Consumers and Enterprises

It is not just enterprises who benefit from traceability and the expanded product information afforded by electronic labels. Consumers today are looking for more than an ingredient list on product labels. They want to know use-by and expiry dates, ingredients, allergen information, instructions for storage and preparation, advisory and warning statements, country of origin and much more. Savvy consumers are conscious of how their lifestyle choices and purchase decisions impact the world. Not only are they more aware of environmental and social issues, they want each aspect of their lives to contribute to the betterment of the world. This involves their purchase decisions being more responsible, sustainable and ethical. Brands would be unwise to ignore this shift in mindset and would do well to deliver more visibility into their products to build richer relations with their customers.

But there is only so much that the physical surface of a product can manage to cram into its limited confines! But the digital space is not bound by such confines. It can contain an endless amount of data, can capture and store changes in real time, distribute relevant data into multiple channels as deemed necessary and enable a user friendly interface to display the data, reducing unnecessary confusion caused by overcrowded text on product labels.

Electronic labels leverage the universal presence of smartphone technology in our daily lives to enable access to expanded product information at the point of consideration for a sale. Not only can brands utilize e-labels for the purposes of ensuring higher consumer transparency, it could be an opportunity for some innovation in packaging and branding. Smart packaging and interactive product labels can lead to a more personalized, interesting and fun shopping experience for richer, smarter and thoughtful customer engagement and experiences.

Electronic labels can reinvent smaller enterprises and farmers

There are plenty of smaller enterprises that pride over their organic produce. Fresh produce from such farms generally do not carry any outer packaging, save for a tiny sticker. These enterprises can capitalize on these tiny stickers to deliver rich content to their consumers. A single data matrix code on a sticker can elevate a orange into a connect smart product. Scanning its sticker will tell the potential buyer how and where the single orange was grown, the date it was harvested, temperature and storage conditions it was under as well as the locations it has passed through before reaching a local supermarket. It can carry information verifying its organic nature and lack of any bio-engineered content through certifications. Electronic labels can help smaller enterprises and farmers reimagine their business practices by appealing to a more technologically savvy market base.

And that is not all that a simple data matrix code can do. Its traceability feature will also  help smaller enterprises come onto a shared system of collaborators in events of contaminated and poisoned food circulating the market.

It is the responsibility of every enterprise which works to grow and distribute food, to ensure a bountiful supply of safe and fresh produce to the mass. Meshing the digital and physical world is the key to securing the integrity of the fresh food supply chain.

[newstechreviews]

President Donald Trump declared Tuesday that the U.S. will be able to carry out five million coronavirus tests per day, but the top official overseeing testing strategy told TIME earlier in the day that goal wasn’t feasible given current technology.

Admiral Brett Giroir, the assistant secretary of health who is in charge of the government’s testing response, said during an interview on Tuesday morning that “there is absolutely no way on Earth, on this planet or any other planet, that we can do 20 million tests a day, or even five million tests a day.”

Since the beginning of the year, the Administration has conducted 5.7 million tests in total, he said. And while the government has made strides in increasing the number of tests being performed in recent months, the White House’s new “blueprint” for testing, rolled out on Monday, currently plans to double current COVID-19 testing. Giroir plans to hit 8 million per month by next month.

The tally would still fall short of what a Harvard University study said is necessary to safely restart public life. The 56-page “roadmap” published last week by a group of experts said the U.S. needed to be capable of carrying out at least 5 million tests a day by early June, and 20 million per day by late July, in order to reopen the economy. Giroir called the assessment “an Ivory Tower, unreasonable benchmark,” that wasn’t needed, based upon current modeling projections, and that couldn’t be supported by current technology.

Five hours later, when a reporter asked Trump at the White House if the country would reach five million daily tests, as the Harvard study recommended, Trump responded: “We’ll increase it, and it’ll increase it by much more than that in the very near future.” Asked to clarify if he meant the U.S. would “surpass 5 million tests per day”, Trump said, “We’re going to be there very soon.”

The largest number of tests conducted by the U.S. in a single day was 314,182, according to Covid Tracking Project data. Trump didn’t offer how his Administration was going to account for the 1,500% increase, but assured those at the briefing: “If you look at the numbers, it could be that we’re getting very close.”

Keep up to date on the growing threat to global health by signing up for our daily coronavirus newsletter.

Trump’s assertion was the latest in a series of inaccurate and misleading statements made by the president about the COVID-19 crisis that have often placed him at odds with the experts advising him. On Feb. 28, speaking about the new coronavirus, he declared “like a miracle, it will disappear.” On March 6 he said that “anybody that wants a test can get a test”. Last week, bizarrely, he speculated that “ultraviolet” light or the injecting of disinfectants might serve as treatments.

In the absence of a vaccine or effective treatment of the new coronavirus, testing is a crucial element in any plan to allow Americans to return to their normal lives, experts say. Trump’s apparent lack of familiarity with his own Administration’s testing plans is the latest of a series of costly missteps on that front. In January, the Centers for Disease Control and Prevention distributed hundreds of faulty diagnostic test kits. Then in February, the Federal Food and Drug Administration was too sluggish in approving tests developed by hospital, university and private laboratories, creating a bottleneck.

The Administration has been able to streamline those processes over the last two months and build up capacity, but as labs and states now compete for the same equipment, a new problem has emerged: a scarcity of supplies.

The White House has repeatedly celebrated advances in boosting U.S. testing capacity and expressed confidence about states’ ability to do more in hopes of getting closer to Trump’s foremost goal: a phased reopening of the economy. As state and local governments consider re-opening, public health experts agree it will take meticulous and widespread testing to identify people who might be infected, trace their contacts, test those individuals who came in contact with an infected person and isolate them from the public to reduce the chances they will spread the virus.

The 5.7 million tests conducted in the U.S. so far are much more than any other country, but represent less than 2% percent of the total U.S. population. The Administration’s testing blueprint, announced Monday by the President in the White House Rose Garden, outlines how the federal government aims to help all 50 states.

Giroir, a pediatric critical care specialist who previously served in roles at the Defense Department, said all states require a tailored strategy and that their individual testing plans will be dependent on a range of factors, including the “virus circulating within their states as well as the particular demographics.” The goal is for each state to be able to screen at least 2% of their residents, he said.

The Administration works with states on a weekly basis to discuss their specific needs, review the testing strategies, and follow-up on any additional requests they may need. “If we do testing in a smart way, like all those who were symptomatic and contact-traced and you targeted asymptomatic screening, that’s really the way to go,” Giroir said.

Experts say the U.S. has not done enough testing to yield an accurate and actionable picture of the epidemic for states to come up with effective plans. “If a state misjudges its true underlying infection trajectory, it may suffer large flare-ups of the disease, necessitating a long and painful lockdown again,” wrote Dr. Ashish Jha, director of the Harvard Global Health Institute. “Yet most states are long way from adequate testing—and the tracing of contacts that must follow.”

The U.S. has increased the number of tests as commercial testing companies increase production and the Food and Drug Administration continues to approve tests using different types of samples, including ones from the nose and saliva, as well as blood. States are responsible for developing their own plans to secure those tests from companies, Giroir said, while the federal government should be the “supplier of last resort.”

“It’s horribly inefficient to say that the government is going to buy all the supplies, recreate a distribution center, do 5,000 hospitals, maybe 10,000 laboratories in academic centers,” Giroir said. “What we really want to do is use the commercial supply chain.”

Senator Patty Murray of Washington, the top Democrat on the Health Committee, took issue with this aspect of the Administration’s testing blueprint because individual states are already fighting with one another to obtain much needed medical supplies. The Trump approach doesn’t “identify ways to fix our broken supply chain, or offer any details whatsoever on expanding lab capacity or activating needed manufacturing capacity,” she said in a statement on Monday. “Perhaps most pathetically, it attempts to shirk obvious federal responsibilities by assigning them solely to states instead,” she said.

Governors from the hardest-hit states say they’re locked into counter-productive bidding wars with one another to acquire certain supplies, including tests. Maryland Governor Larry Hogan was so desperate for diagnostic testing kits, he bought half a million kits from a South Korean company. Politicians, medical professionals and hospital officials have criticized Trump’s reticence to ease the supply shortage by using presidential authorities under the Defense Production Act (DPA) to compel U.S. private production capacity to manufacture the supplies.

Giroir said that kind of criticism is “based on very little knowledge of how this works.” For instance, testing swabs have been in short supply since March. The swabs—which resemble oversized Q-tips and are inserted into the nose to sample mucus at the top of the throat—are manufactured in northern Italy and China, where production was decimated due to coronavirus outbreaks. “Like if you were relying on one swab type that’s only made in Italy, because that’s what the FDA does, it doesn’t matter what I do [in the U.S.] until you open the market and have different swab types,” Giroir said.

Due to the scarcity of key testing components like swabs, chemical reagents and tubes, Giroir acknowledges that the federal government needs to help steer some critical parts of the supply chain to increase the number of tests being done. In May and June, the federal government plans to purchase the components necessary to meet all the states’ plans and distribute them to central locations in each state.

“For swabs and tubes, it’s really the heaviest hand of the federal government,” he said. “We buy it, we procure it, we know it’s there, we ship it. But over the course of the summer, by July, we think we’re going to move even the swabs and the tubes into a more directed traffic-controlled free market system, where we don’t buy it, but we assure the states can purchase what they need for every single line.”

Come this summer, he said, “We’ll be swimming in swabs.”

When reached after the President’s comments, Giroir’s staff said the Administration is always looking for ways to ramp up testing but maintained that—barring technological breakthrough—5 million tests could not be supported.

Please send tips, leads, and stories from the frontlines to virus@time.com.

[coinfirst]

Blockchain Can Save Pharmaceutical Industry $180 Million, Study Says

UCLA Health and LedgerDomain, a blockchain development platform, announced a new study revealing that blockchain technology would save the United States pharmaceutical industry over $180 million each year.

The study was launched as part of the U.S. Food and Drug Administration’s Drug Supply Chain Security Act Pilot Project Program. The program is part of a broader effort to develop an electronic, interoperable system to track prescription drugs throughout the U.S. 

According to the Drug Supply Chain Security Act enacted in 2013, by 2023, pharmacists in the U.S. will be required to verify prescription drugs before they are dispensed. This is problematic, however, because verifying drugs has never been a requirement for U.S. pharmacies. 

LedgerDomain CEO and Founder Ben Taylor told Cointelegraph during an interview at the Hyperledger Global Forum that 17% of prescription drugs in the U.S. are counterfeit. He explained that drug verification must be achieved in real-time to comply with DSCSA’s new standards, adding:

“In today’s drug supply chain, DSCSA-compliant verification is rare; in three years, it will be required. Without a real-time system that allows for single scans and near-instant verification, pharmacies will bear a massive regulatory burden.”

Blockchain as a solution for tracking prescription drugs

In order to solve this problem, LedgerDomain has partnered with UCLA Health — a leading U.S. dispensary that consists of five distinct pharmacies and over 200 clinics — to apply DSCSA requirements within one pharmacy located at one of the nation’s busiest hospitals. 

One of the Pilot Project Program’s objectives was to focus on enhanced requirements for package tracking. In turn, UCLA Health leveraged LedgerDomain’s blockchain-based mobile application, “BRUINchain,” to track a prescription drug called Spinraza. Created by biotechnology company Biogen, Spinraza acts as a treatment for children and adults with spinal muscular atrophy and is a critical, life-saving medication.

According to Taylor, BRUINchain is built on Hyperledger Fabric, an enterprise-grade, open-source distributed ledger. He explained how the platform operates:

“By leveraging blockchain technology, BRUINchain is able to track and trace drugs as they move through a pharmacy while verifying the legitimacy of the drug with the manufacturer before being administered.”

Taylor further noted that the application is designed as a shared, permissioned blockchain-based system where membership and participation in the network are controlled, rather than open to the public. This makes it possible for multiple parties to track and verify drugs using BRUINchain while preserving data integrity and security.

During the trial, UCLA Health officials used cell phones to scan FDA-stipulated two-dimensional barcodes placed on the bottom of Spinraza boxes. This allowed them to check for possible duplicates and to update the drug’s custody, allowing real-time reporting of inventory counts and locations within the UCLA pharmacy system. According to a report submitted to a peer-reviewed journal:

“The BRUINchain system requirements include scanning the drug package for a correctly formatted 2D barcode, flagging expired product, verifying the product with the manufacturer, and quarantining suspect and illegitimate products at the last mile: pharmacist to patient, the most complex area of the drug supply chain.”

Taylor also noted that BRUINchain can turn over data in real-time, in about 50 milliseconds. This is important, as drugs should be verified instantly, otherwise, dispensers would need to scan the packaging twice. 

Leveraging blockchain technology means that only a single scan is required, saving the U.S. pharmaceutical industry $180 million each year in labor costs alone. Blockchain technology would also reduce the need for pharmacies to hoard safety stock, resulting in $3.5 billion per year in savings.

While this may be the case, Taylor mentioned that the cost to implement a solution such as BRUINchain would result in a multi-billion dollar challenge for the pharmaceutical industry. “We learned that this current work process would cost UCLA about $5 million a year to comply with this system,” he explained. 

Blockchain for supply chain management

Although a blockchain-based solution such as BRUINchain could be costly to implement, it was nevertheless impressive during the trial, as Biogen, Spinraza’s manufacturer, never once had to scan a single product for verification. LedgerDomain made it easy to access Biogen’s relational database by loading it directly onto the BRUINchain blockchain.

The senior manager of clinical supply capabilities of Biogen, Imran Shakur, told Cointelegraph that blockchain technology has great potential to bring clarity to pharmaceutical supply chains, adding:

“Managing a global network of rare and specialty treatment requires a tremendous level of collaboration across different systems, people and processes. Each component is focused on ensuring that treatment is brought to a patient with care and assuredness. But, we have to ask ourselves: How do we manage the responsibility that our patients receive the right medication across all these various networks?” 

Shakur explained that while existing systems can help ensure patients receive correct, authentic medications, operational teams often work in silos. He noted that blockchain technology can seamlessly bring teams together to help deliver proper care to patients.

Moreover, the results of the study suggest how the BRUINchain can be effective. During the trial, a 100% success rate was observed across scanning, expiration detection and counterfeit detection. The paperwork was also reduced from approximately 1 hour to less than a minute.

Can this be applied to coronavirus test kits?

Given that the BRUINchain leverages blockchain technology to detect counterfeit prescription drugs, it may be possible to apply the same technology to ensure that coronavirus testing kits are authentic. A recent article from ABC News reported that fake home-testing kits for the coronavirus were seized at the Los Angeles International Airport. When asked if BRUINchain could be used to determine authentic coronavirus test kits in the future, Taylor responded:

“If you believe that the coronavirus pandemic is the new normal, supply chain assurance is more important than ever. Blockchain can provide an overlay that helps all stakeholders. Our goal is to apply blockchain in real-time to provide a single version of truth for everyone.”

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[valdamarkdirect]

New High Accuracy Barcode Printer Is Perfect For Medical Device Packaging | Valdamark

See on Scoop.it - Packaging

The new Toshiba thermal barcode printer and scanner is perfect for small labels and medical device packaging!

Jake Whitfield's insight:

New high end precision printer makes the job of compliance in Medical Packaging much easier!

This is the latest thermal barcode printer from Toshiba which brings together their high resolution capabilities with a highly precise small label feeder. 

  Regulations aimed at tracking and tracing products through the distribution and supply chains can be difficult to comply with at the best of times! 

  One issue facing pharmaceutical manufacturers is the difficulty in fitting all the required information onto the surface area of one small label. 

  Toshiba has debuted its new thermal barcode printer that is able to print at very high resolutions but also solves the problem of 'media shift' whilst printing. This makes for much better quality print in general - particularly for small labels. 

  The Toshiba B-EX473HS prints 600 dpi up to 6 inches per second. The labels can be as small as 0.51 x 0.12 inches with guaranteed accuracy. The machine focuses on maintaining center of alignment which does away with the frustrating 'media shifts that many operators can experience. 

  This makes for very consistent printing which can place barcode data on labels with a very small surface area. 

  This kind of capability will mean that many manufacturers will be able to print specialist labels in house in turn lowering their costs whilst maintaining control of compliance issues. 

  It is thought this will be particularly useful when considering the new rules introduced by the U.S. Food & Drug Administration (FDA) that state medical device packaging must contain a unique device identifier (UDI) with many product requiring it to be printed on the device itself. The high resolution required here is the perfect job for the new Toshiba printer. 

  Take a look at other printer and impulse heat sealer machines suitable for medical device packaging!

[kristinsimmons]

The False Choice Between Science And Economics

By DAVID SHAYWITZ

As the nation wrestles with how best to return to normalcy, there’s a tension, largely but not entirely contrived, emerging between health experts—who are generally focused on maintaining social distancing and avoiding “preventable deaths”—and some economists, who point to the deep structural harm being caused by these policies.

Some, including many on the Trumpist-right, are consumed by the impact of the economic pain, and tend to cast themselves as sensible pragmatists trying to recapture the country from catastrophizing, pointy-headed academic scientists who never much liked the president anyway.

This concern isn’t intrinsically unreasonable. Most academics neither like nor trust the president. There is also a natural tendency for physicians to prioritize conditions they encounter frequently—or which hold particular saliency because of their devastating impact—and pay less attention to conditions or recommendations that may be more relevant to a population as a whole.

Even so, there are very, very few people on what we will call, for lack of a better term, “Team Health,” who do not appreciate, at least at some level, the ongoing economic devastation. There may be literally no one—I have yet to see or hear anyone who does not have a deep appreciation for how serious our economic problems are, and I know of a number of previously-successful medical practices which are suddenly struggling to stay afloat amidst this epidemic.

In contrast, at least some on—again, for lack of a better term—“Team Economy” seem to believe that the threat posed by the coronavirus is wildly overblown, and perhaps even part of an elaborate, ongoing effort to destroy Trump.

Yet even if some partisans are intrinsically unpersuadable, I suspect that if Team Economy had a more nuanced understanding of Team Health, this could facilitate a more productive dialog and catalyze the rapid development and effective implementation of a sustainable solution to our current national crisis.

For starters, it might help Team Economy to know that even pointy-headed academics appreciate that science is (or at least should be) a process we use, not an ideology we worship. Most researchers recognize every day how difficult it is to figure out biological relationships, and to make even the most basic predictions in the highly reductionist systems of a petri dish or a test tube.

Under typical conditions, scientists tend to do an exceptional amount of study before they cautiously suggest a new insight. It’s really hard to figure out how nature works, and each time we think we’ve understood even some tiny aspect of it, nature tends to surprise us again with an unexpected twist. While often maddening, this complexity is also what makes science so captivating, engaging, and intellectually seductive.

In the context of COVID-19, it is incredibly, absurdly challenging for anyone—including scientists—to get their heads around the rapidly evolving knowledge that is, in any case, preliminary and is being collected under difficult conditions.

This is not an environment conducive to understanding exactly what’s going on at a system-wide level, let alone a molecular one.

And yet, that’s what Team Health is trying to manage. They’re working to understand the very basic characteristics of SARS-CoV-2 (the virus that causes COVID-19), while simultaneously extrapolating from the data in order to make recommendations that are going to impact the lives of billions of people.

There is a saving grace: researchers aren’t starting from scratch. They are informed by studies of related pandemics—the influenza pandemic of 1917-1918, the SARS outbreak of 2002-2004, and the 2009 swine flu pandemic, for starters. Investigators are also leveraging all they’ve learned about the biology of related viruses to make educated guesses about how to approach the current threat, and using recently-acquired knowledge of how to harness the immune system in cancer to think about how we might help the immune system respond more effectively to a virus.

Most scientists recognize the limitations of their knowledge, and realize just how hard it is to extrapolate—which is why they tend to avoid doing so. But they also appreciate that even if understanding is difficult and prediction even harder, the process of science—the meticulous collection and analysis of data, the constructing, testing, and reformation of hypotheses—has proven phenomenally effective over the long haul. It has enabled us to better understand illness and disease, and to provide humanity with the opportunity for longer and less miserable lives than ever in the history of our species.

And even if this potential is not realized either universally, nor as frequently as we might wish, it’s still the best construct we have.

It beats, for instance, hoping that a disease will simply disappear, like a miracle. Hope is not a method.

The Trump administration ought to listen to scientists, but it need not accept their advice uncritically. And that’s because behind closed doors, scientists never (well, hardly ever) accept the advice—or data—from other researchers at face value. They invariably question techniques, approaches, and conclusions.

The foundational training course my classmates and I took in grad school in biology at MIT essentially ripped apart classic papers week after week, exposing the flaws, and highlighting the implicit assumptions—and these were generally top-tier pieces of work by legendary scientists. I came away from the course with a powerful sense of the fragility of knowledge, the difficulty of proof, and a deep respect for the researchers who are driven to pursue, persist, and publish—despite these intrinsic challenges.

No individual or organization should be so revered that their findings are beyond scrutiny or evaluation, whether he or she works for a drug company, an academic institution, or an NGO.

But what rankles people on Team Health isn’t thoughtful skepticism from Trump about a particular piece of data (if only!), but rather Trump’s apparent indifference to science as a whole, and the ease with which he casts it aside if it fails to comport with his narrative-of-the-moment.

Trump seems to treat science like just another point of view, embracing it when convenient, ignoring it when not. This sort of casual indifference rattles the people on Team Health because, for all their disagreements, researchers tend to believe that there is an objective reality they are attempting to describe and understand, however imperfectly.

The notion that a scientist’s inevitably hazy view of a real phenomenon—drawn from well-described, ideally reproducible techniques—is indistinguishable from a “perspective” that some presidential advisor, or morning cable host, or guy on Twitter pulls out of . . . well, let’s say thin air . . . seems irresponsible.

And that’s because it is.

The good news is that Trump has a real opportunity in the coming days to leverage the advice of both scientists and policy makers, should he choose to listen.

In the last week, two important reports were published, each by a cross-functional team of experts. One was organized by the Margolis Center for Health Policy at Duke, and includes Trump’s former FDA Commissioner, Dr. Scott Gottlieb, and one of Obama’s national health technology leaders, Dr. Farzad Mostashari. The other is from the Johns Hopkins Center for Health Security. Both groups suggest that transition to normalcy will require an exquisite ability to rapidly identify new outbreaks and track down and quarantine individuals who are likely afflicted—the ability to test-and-trace.

The idea is that our country needs the ability to conduct something close to a precision quarantine, where we constrain the activity only of those likely exposed — which requires, of course, accurately determining who those people are.

To their credit, both groups focus not on high-tech solutions that might be challenging to implement and potentially threatening to individual privacy (most Americans are not looking to emulate the policies of South Korea or China), but rather on extensive contact tracing involving a lot of individual effort. In other words: good old-fashioned disease hunter shoe-leather.

This approach requires not just a lot of dedicated people, but also a testing capability that we are hopefully developing, but clearly don’t yet possess. For example, a recent Wall Street Journal article quoted New Hampshire’s Republican governor Chris Sununu complaining that his state received 15 of the much-anticipated Abbot testing machines Trump recently demonstrated at the White House—but only enough cartridges for about 100 tests. “It’s incredibly frustrating,” Sununu vented. “I’m banging my head against the wall.”

The reason all this matters (at least if, like me, you believe the health experts) is that the rate at which the population is developing immunity to SARS-CoV-2 is remarkably low, according to UCSF epidemiologist Dr. George Rutherford. He estimates the rate of population immunity in the United States is around 1 percent, and notes that it’s apparently only 2 percent to 3 percent in Wuhan—the center of the original outbreak.

Herd immunity—the ability of a population’s background level of immunity to protect the occasional vulnerable individual—requires levels more than 10 fold above this (the actual figure depends on the infectivity of the virus; for ultra-infectious conditions like measles, more than 90% of a population must be immune; for the flu, which is less infectious, the figure is closer to 60%; SARS-CoV-2 is likely to be around this range). This means that, in Rutherford’s words, “herd immunity for this disease is mythic”—until there’s an effective vaccine.

Translation: For the foreseeable future, almost all of us are vulnerable. And we will remain vulnerable until therapies emerge.

Health experts worry that without a transition that includes provisions for meticulous contact tracing, rushing headlong back to a vision of normalcy would likely result in a rapid reemergence of the pandemic, and potentially, a need for more wide-spread quarantines—which would drive a stake into the heart of any economic recovery.

The truth here is that Team Economy doesn’t need to push against Team Health, because they’re after the same thing. If Trump embraces a transition that recognizes both the economic needs of the country and the wisdom of leading health experts and policy makers, he may succeed in leading a weary but irrepressibly resilient nation out of our current crisis, and into a durably healthy, economically promising future.

David Shaywitz, a physician-scientist, is the founder of Astounding HealthTech, a Silicon Valley advisory service, and an adjunct scholar at the American Enterprise Institute.

This article originally appeared on The Bulwark here.

The post The False Choice Between Science And Economics appeared first on The Health Care Blog.

The False Choice Between Science And Economics published first on https://wittooth.tumblr.com/

[interwork2018-blog]

DRUG SUPPLY CHAIN SECURITY ACT: COMPLIANCE IS NOT AS DIFFICULT AS YOU THINK

DSCSA Compliance, Difficulties, and Solutions

Among a lot of reasons that are presently surfacing around FDA track and trace capability, most primitive ones are misconceptions around the definition of product identification and verification. The other is financial, commercial, and infrastructural gaps between large, small, and mid-size companies.

Verification? Product Identification? Definitions Under DSCSA

There are essential issues in how the modern pharmaceutical industry interprets product identification and verification. It is often misunderstood that verification of product identification means that the manufacturer, repackager, is expected to verify whether they make the product. Or there is an identification on the counterfeit in a particular Pharma supply chain automatically point in time.

As per DSCSA identification and verification definition, the manufacturers and the higher-level partners in a supply chain have been bound to ensure (at any time) that a particular request a product verification helps them verify that the product. It includes an identification number, lot number, and other details that are the same as available on the human-readable label and the one submitted to the USFDA regulators.

Resource & Commercial Gaps Among Companies

The commercial, financial, and business capabilities of a well-established pharmaceutical giant, a mid-scale company, or a freshly approved Pharma company would be different. DSCSA compliance is facing significant hurdles. The large-cap companies are capable of undertaking the serialization process and make the necessary changes in their production facilities. But, they are lacking the right business leadership and the required information for successfully carrying out the compliance process. The mid-scale and small pharmaceutical companies are having significant trouble in building a commercially feasible manufacturing and supply chain model. The focus is on embedding the serialization process via contacted manufacturers or a portion of it that remains in the house.

No Standardization of the Serialization Process

One of the hurdles faced by the DSCSA serialization process is that there is no standardization of the serialization process. New-age startups and well-established companies and their CMOS or CIOs are coming out with consultancy services ‘Serialisation as a Service’ concept consulting the short, less resourceful time to managing to get through these processes. Industry experts and thought leaders have outrightly dishonored the idea of one to one consultancy on a global matter, and it is not advisable.

Benefits of

DSCSA Compliance

and Why Every US Pharma Business Needs It?What Is The Real Solution?

DSCSA Compliance can be best managed with strategized, well-structured intervention of technology product that is capable of foolproof security, safety, and data security compromise concerns. It should be bringing all the primary and secondary stakeholders of a farmer supply chain to a single solution. Standardization of the serialization process and decentralization of information is a must. The centralization of vigilance should tope it and policing efforts. They are more critical for a sustainable, successful stride of DSCSA Compliance with the help of DSCSA Software.

What Makes DSCSA Compliance More Feasible?

There have been various entrant Technology Solutions that are getting on and off the Pharmaceutical Landscape. A completely foolproof, robust Blockchain-Based Serialization Solution, DSCSA Software is all you need. Fortunately, the Blockchain is one Technology that is capable of documenting Transactions on a Decentralized database with 99.99% data immutability at all ends. It is the perfect solution allowing a vast number of private or permissioned vendors to register over a Blockchain Platform voluntarily.

It verifies the profile and makes them a part of a wholly secured, highly transparent Pharma Supply Chain Solution. It is a great Solution that Allows Real-time Transactions and foolproof consensus management across all regulators and the leading supply chain partners. It helps in executing supplies across the pharmaceutical consumer base.

Business Benefits of using a

DSCSA Compliance Software

No FDA penalties

Keeping all Pharmaceutical Supply Chain operations abiding by the Serialization process drastically reduces the chances of ending up FDA sanctions and suspension of Services.

Complete Security

Blockchain day, The Traceability Solutions, and DSCSA Software bring SCM operations a lot closer to the SCM compliance eliminating all possibilities of stolen, counter feet, and low activity Drugs.

Secured Scalability

Expanding wide across more Rx rugs for Manufacturing deep down the consumer base is more affordable and feasible with an end to end Serialization Solution.

Business Beyond Boundaries

The power of Blockchain-Based Private and Formation Registries over the Blockchain Platform to successfully impaneled vendors and officially communicate with other partners in the Supply Chain anywhere across the world.

Bulletproof data security

Blockchain Technology is capable of building a decent life Database with imitable Data records in the form of Smart Contracts. All the product-related information and Realtime Transactions are highly secured.

Reduced Compliance Costs

DSCSA Software Solution is capable of drastically reducing the overall compliance cost, which in turn causes higher profitability in the long run.

Eight Times Better Fault Tolerance

Blockchain-Based DSCSA Software enables suppliers and partners and regulators to identify notice, red flag, quarantine that are passed into the Supply Chain just with the help of a click.

Cost-Effective SCM

The high efficient DSCSA Compliance Software enables companies to focus on cutting costs department wise.

Higher Productivity

The Highly Secured and process includes resource utilization rates and makes the human resource capital way more efficient than ever before.

Conclusion

Forceful intrusions of Technology in Pharmaceutical Traceability and Serialization can make DSCSA Compliance way more comfortable than it looks from the outside. Highly robust, new-age Blockchain-Based DSCSA Software eliminates the hassles of building and managing a Technology Platform. Now you can Setup Serialization Solutions with leading Blockchain Development Companies that are making efforts towards standardizing the process Drug Serialization on a Global Scale.