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5 Ways WMS can Benefit the Pharmaceutical Supply Chain

pharmaceutical

5 Ways WMS can Benefit the Pharmaceutical Supply Chain

Warehouse management software is a must for every supply chain, but for some industries, it can provide additional benefits. Craig Powell, Managing Director of Balloon One, shares his insight into how warehouse management software can be used to optimize pharmaceutical logistics.

Every supply chain is dependent on effective warehouse management, but for the pharmaceutical industry, there are additionally complex challenges to be overcome. Fortunately, many of the unique issues that handling drugs and medical equipment present may be benefitted by the implementation of warehouse management software (WMS).

Below, I’ll take you through just some of the ways that WMS can benefit your pharmaceutical warehouse.

FMD compliance

With WMS technology, it’s easier to process and securely transfer digital information so that transparency across the whole supply chain can be achieved. This is crucial for compliance with the Falsified Medicines Directive (FMD). The FMD states that every pharmaceutical package must have a unique barcode, containing the batch number, expiry date, and a unique serial number. WMS can read these and keep track of this information, improving efficiency. This also ensures that SecurMed UK, the national medicine verification organization, can be informed when stock is received, moved, and picked for dispatch — again, in compliance with the FMD.

Time sensitivity

One of the most important elements of pharmaceutical supply is tracking drug expiry dates. WMS can keep dates and product locations to hand, along with other important digital information, to help optimize your first expired, first-out (FEFO) system of inventory management. Not only will this further ensure the goods you store and move are safer, but it can drastically decrease what slips through the cracks and needs to be thrown away once expired. This can help you keep to waste output targets and saves your clients money too, and fewer resources are wasted. It also helps ensure that stock spends as little time in transit and storage as possible, so efficiency is further improved.

Pharmaceutical maintenance

According to the MHRA, almost one-third of critical and major deficiencies are due to improper storage temperatures (ABB). WMS can help you keep track of complicated storage information such as the need for temperature or climate-controlled warehousing, as well as contamination control. It can even alert you to urgent issues such as faulty fridges. All this can prevent medicines from spoiling, keeping wasted stock to a minimum, and accurate temperature control can help save energy while lowering heating and cooling costs too.

Eliminating security concerns

With data and information, such as stock levels, presented in a visual, easy-to-digest format, you can also far more effectively manage security issues such as theft. Digitizing processes such as vendor tracking and labeling can prevent both accidental and criminal mislabelling, reducing the risk of ‘salting’; monitoring motion-detection alarms and cameras can prevent tampering and criminal activity, and logging each step of your safe disposal practices can prove useful for meeting regulations — or if you come across any legal or environmental trouble.

Customizable solutions

WMS is designed to be customizable to suit all kinds of projects, so no matter what your needs are, you’ll likely find the technology or be able to personalize your software to better streamline your processes. For example, if you need tailored traceability and storage monitoring, or personalized picking and packing systems, don’t make do — research the options that are available to you. If you can’t find a solution for a particularly complex warehousing requirement, speak to your WMS provider about what packages, add-ons, and personalized services they can provide.

These are just some of the ways WMS is elevating the pharmaceutical supply chain. If your warehouse has complex requirements, you may be surprised by how easily you can streamline your processes with this technology.

pharma pharmaceutical

Resilience of Pharma Supply Chains and the Impact of Covid-19 Pandemic

How is the COVID-19 crisis influencing pharma supply chains for the future? Is the global pharma supply chain under sustained threat? And what about Asia and its dominance in the supply chain? These are all valid questions considering recent and current events.

It is generally agreed that COVID-19 marks a point in the understanding of medicine supply risks, but will it fuel efforts to establish local supplies of chemicals and APIs as a “matter of national security”? In the last 12 months, Pharma companies have become acutely aware of their dependency on complex supply chains. As the result, the pandemic has finally convinced all stakeholders to build more resilience into their supply chains going forward.

In the last 10 years or so, lower costs have been a key decider in relocating a significant share of manufacturing capabilities to China and India. We have, therefore, seen a large increase in production volumes in these countries where we know that almost 40% of registered sites for APIs were located in India or China, according to FDA data published in 2019.

The relocation of manufacturing to Asia has a direct impact on supply chain reliability and has led to drug shortages.

Believe it or not, drug shortages are not rare events and don’t just happen when there are worldwide pandemics. The average drug shortage in the US lasts 14 months…some last for years.

Before COVID-19, the FDA had already placed 145 pharmaceutical products on its drug shortages list. In April 2021, there were 175 drugs on the FDA drug shortages list.

Covid-19 didn’t have the foreseen catastrophic effect. There are several reasons for this:

-The pharma industry had a sufficient inventory buffer (average inventory is about 180 days for the entire industry)

-Drug manufacturing has long lead times, so the effect of 1-2 weeks manufacturing cessation in China would take some time to cycle through the supply chain.

-Supply disruptions of APIs or finished products made in China were not hugely prolonged, otherwise, the effects would have been more severe.

-Regulatory challenges for medicines were largely overcome, where required, by flexibilities introduced by regulators to fast-track regulatory processes. For example,

-Fast-tracking approvals to alternative sources of supply of reagents

-Ensuring availability of GMP certification to manufacture and import

-Remote auditing options

-Labelling and Packaging flexibility

Switching sources of supply (which is not straightforward in the pharmaceutical industry) was not extensively required…

-There was a relatively short period of logistical and distribution challenge. Demand spikes for transportation capacity was placed under enormous strain compounded by (i) surge in international demand for PPE, sanitiser, critical care medicine and medical devices (ii) Disruptions at ports (iii) Decreased capacity on Air Freight (iv) Re-routing of transportation (v) Personnel availability constraints due to lockdowns/quarantine (vi) Increased prices. Routes have already opened, and lockdowns are slowly being phased out.

However, despite all of this, local, regional, shorter supply routes are preferred in the current crisis and the environmental agenda is driving this theme globally.

Even if the manufacture of APIs or fine chemicals was more regionally dispersed or locally based, the raw materials for these manufacturers may not be available in these locations anyway.

It appears that we will have to manage the reality that raw material availability and cost are critical factors in where pharmaceutical manufacturing resides. As a result, increased resilience will need to be factored into our supply chains which will include sourcing, at some level, from Asia and the ROW. Moving production closer to home markets would be costly and would take years to accomplish. The smarter approach is to build resilience into the supply chain. How is this achieved?

The key is to ensure there is a risk management plan in place that focuses on the evaluation of potential issues arising from the loss of a supply chain partner or a region. This requires

-Alternate supply arrangements

-Inventory levels to provide a potential buffer

-Agile Manufacturing

This is infinitely more challenging than it seems. It means that organizations need to precisely know the quantity of each raw material or medicinal product in the supply chain and where it is at any given moment. This leads to hyper-complexity where advanced algorithms (and data analytics/AI) will be required to help design supply chains with greater resilience and risk monitoring capability.

Designing resiliency into the supply chain should incorporate placing inventory at the right points of the supply chain network (i.e., the right inventory commensurate to the risk at that point in the supply chain).

Investment in real-time production monitoring systems and integrated planning and scheduling tools (LEAN tools) could increase the agility of existing manufacturing sites to speed up supply and reduce requirements for additional expensive production equipment.

The pharmaceutical industry will continue to build resilience and secure itself against volatility in supply from Asia…perhaps at a faster pace than before.

Next time… could it be another virus, a mosquito, or a resistant bacterium?

However, we should not lose focus on the immediate supply chain challenge.

Supply chains need to plan now for resilience to navigate the current turbulent market.

CEIV

Dachser Air Receives CEIV Pharma Certification Expanding Companies Network Services Globally

In March 2021, Dachser’s fifth location, Shanghai, is to receive the Center of Excellence for Independent Validators in Pharmaceutical Logistics certification (CEIV Pharma) that will expand the company’s network services for its customers, specifically in the life sciences and healthcare (LSH) sectors. Following the Frankfurt, Atlanta, Mumbai, and Hyderabad locations, Shanghai is their most recent CEIV certification from the International Air Transport Association (IATA).

The CEIV Pharma certification ensures compliance to international standards including European Union and World Health Organization Good Distribution Practices (GDP), United States Pharmacopeia, and IATA temperature control regulations. The standards insist on secure, compliant, and efficient air-freight services, which Dachser successfully displayed.

“At Dachser, the safe and efficient transportation of pharma products is a key priority for us, and our CEIV Pharma certified locations in Germany, the US and Asia enables us to serve our customers in the key regions around the world,” says Ralph Riehl, Managing Director Americas at Dachser Air & Sea Logistics. “With this latest certification, we are demonstrating our continued emphasis on constantly enhancing our service quality as well as showcasing we are a reliable partner for transporting vital and temperature-sensitive products.”

In 2018, Dachser received its first CEIV Pharma certification for their Frankfurt branch in Germany. By 2019, their United States branch in Atlanta and two Indian branches – Mumbai and Hyderabad, had received the CEIV Pharma certificates. The certificates highlight Dachser’s commitment to LSH logistics excellence in delivering high-value, time-sensitive, temperature-controlled products leveraged by  Dachser’s global network of speed, consistency, and efficacy.

“A resilient and highly efficient transport network, tailored to the specific needs of the LSH industry, has never been more crucial than today. Dachser is committed to superior service and further confirms our exceptional competence in the handling of sensitive life-saving pharmaceutical products based on the highest international standards quality standards,” added Mr. Riehl.

Responding to the globally growing demand, Dachser invested its services in the field of life sciences and healthcare to substantially provide efficient air-freight services globally leading to CEIV Pharma certified facilities. With this certification, Dachser Shanghai now joins a limited number of logistics companies in Asia to be recognized by IATA.

life sciences therapy

Life Sciences Real Estate in the Time of COVID-19

Increased funding plus employees that need an office makes the Life Sciences real estate sector resilient in a global pandemic.

The life sciences industry has become one of the most talked-about sectors as the entire world races to find a vaccine for COVID-19. In the first six months of 2020, investors have spent more than $16 billion on life sciences, while the National Institutes of Health (NIH) continues to increase its grants. In 1994, NIH gave out $11 billion in grants, and by the end of 2019, that number jumped to $39.1 billion – fueled by COVID-19-related therapeutics, antibody tests, and vaccines. Additionally, the aging U.S. population needing life-sustaining care, wellness-conscious millennials, and a prescription drug market on track to reach $1 trillion by 2022 has also played a part.

In an effort to continue research, development, and production, life sciences companies, owners, and operators of laboratories and office space are fast-tracking the use of current and new technologies.

The Importance of Technology

Over the years, technology has improved the R&D landscape of life sciences by significantly reducing costs. Connections between tech and biotech are creating more targeted drug development, replacing the previous time-consuming theories. Nowadays, interaction simulations can be run at the click of a button, and clinical trials can be done quicker and cheaper through technology efficiencies. Artificial Intelligence (AI) has become so valuable in finding links in the ever-growing global data resources. Also, it has created more platforms and business opportunities for biotech companies to utilize.

These days, many work-from-home policies are hard to apply to the work done in labs. So, life sciences companies have relied on scheduling and remote communication tech to coordinate calendars for on-site employees to conduct activities that cannot be done at home. Calendar tools with features that allow all employees access to real-time scheduling software have also become more widespread. And some companies have even sped up the integration of cloud-based platforms into ongoing research. This movement toward remote research tools has been inspired by the pandemic, allowing researchers to analyze data from home and focus during their time in the lab.

Market Applications

The pandemic has forced pharmaceutical companies to confront new challenges to traditional methods when conducting clinical trials. Many life sciences companies have had to ramp up fast, integrate virtual engagement into their clinical trial protocols, all while using telehealth technologies to connect with trial participants more widely than ever before.

In fact, in March 2020, the U.S. Food and Drug Administration issued guidance bolstering clinical trial sponsors to “evaluate whether alternative methods for safety assessments (phone contact, virtual visit, alternative location for the assessment…) could be implemented if necessary.  Some industry experts this transition to more tech-focused engagement would have taken many more years without the momentum ignited by the pandemic.

Additionally, COVID-19 has had a monumental impact on how technology is used in today’s drug development and drug applications. Many life sciences companies are increasing the use of AI in the search for a vaccine and identifying existing drugs that may be repurposed for therapeutic solutions. AI can make data collection and analysis so much more efficient in clinical trials and can be used to synthesize data too fast to determine drug candidates’ safety and efficacy.

Who’s Investing?

Today, with a significant focus on health and wellness, life science companies expand with large investments from financial and corporate venture capital groups. As a result, investment capital is surging into the life science market. The U.S. is the leader for investment by a lot, with China right behind it, having had some large investment rounds. While the life science market is healthy, other industries are in distress. As we all know, retail is in trouble, and corporate offices are struggling, especially in the wake of COVID-19. With the increased telecommuting, the future of the office sector is uncertain. So, life sciences have become a focus in the real estate industry, making it attractive to investors looking for an opportunity.

There is a lot of VC money being invested in life sciences, so these companies are well-capitalized. This sector has traditionally weathered economic challenges well. Think tech crash of the early 2000s and the Great Recession as examples. Since life science companies like to invest in their premises and stay long term, rents are higher, making life sciences a really attractive investment opportunity right now. Rents are continuing to increase, with sustained growth in most areas, and that growth has been consistent over time, making for a smart investment.

Key Issues to Watch For

To manage the impact of the COVID-19 pandemic, owners and managers of properties that house life sciences offices, manufacturing, and laboratory space have been able to apply many of the pandemic-related solutions that they have used elsewhere. Given that many labs are typically single-tenant buildings, landlords can cater to unique concerns. However, life sciences tenants can be less experienced than others, presenting landlords and property managers with an opportunity to add value by providing tenants with advice on the solutions they have seen work effectively across the buildings they own and manage, such as sanitization and touchless technologies.

Long term, some see the pandemic and corresponding focus on the design and repositioning of spaces for tenants as a continuing driver toward developing healthy buildings. The users of life science office and lab space are more than likely to be some of the most highly-educated consumers of real estate in any market. For them, the management of space in a sustainable way has become an expectation instead of a plus. Moving forward, competitive advantage will be the integration of health and wellness facilities and technologies as we enter the post-COVID-19 “new normal.”

Where Do We Go From Here?

Looking into the future, as the life sciences boom continues in the real estate industry, owners and operators must be aware of how they and their tenants can harness the right technology to address the obstacles from the pandemic. To successfully market spaces to biotech, pharmaceutical, and medical device companies, real estate developers must be mindful of this challenge, as their users are likely to be more tech-savvy than the average real estate consumer. On the other hand, owners of older spaces hoping to reposition them as an office or lab space must convince potential tenants to integrate innovative technologies as effectively as developers of new modern spaces.

As real estate owners, investors, and operators move into the post-COVID-19 world with a focus on life sciences, they will need to demonstrate to the market that they have a keen understanding of current issues and solutions applicable to life sciences tenants and how the right technology can solve them.

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Louis Lehot is the founder of L2 Counsel. Louis is a corporate, securities, and M & A lawyer, and he helps his clients, whether they be public or private companies, financial sponsors, venture capitalists, investors or investment banks, in forming, financing, governing, buying and selling companies. He is formerly the co-managing partner of DLA Piper’s Silicon Valley office and co-chair of its leading venture capital and emerging growth company team. 

L2 Counsel, P.C. is an elite boutique law firm based in Silicon Valley designed to serve entrepreneurs, innovative companies and investors with sound legal strategies and solutions. 

supplies

FREE TRADE IN MEDICINES AND SUPPLIES IS THE HEALTHIEST APPROACH

What Does Trade Have to Do with the Pandemic?

pandemic is a type of epidemic, wherein an outbreak of a disease not only affects a high proportion of the population at the same time, but also spreads quickly over a wide geographic area.

As the novel coronavirus jumped continents, governments in countries yet unaffected or with low incidence rates moved to prevent “importing” the virus through individual travel. Simultaneously, governments acted to create diagnostic kits and treatments for those with the virus – all praise our frontline healthcare workers.

Unfortunately, what could worsen the situation is a policy practice that seems to be infectious. More than 20 governments are banning the export of needed supplies, a prescription for shortages and higher prices. What the crisis also lays bare is that key countries and many important healthcare products remain outside a WTO agreement that would otherwise enable duty-free trade in the medicines and supplies we need on a regular basis.

Pandemic Proportions

In the history of pandemics, there has been none more deadly than the infamous Bubonic Plague which took 200 million lives in the mid-14th century, wiping out half the population on the European Continent. The pathogen spread through infected fleas carried by rodents, frequent travelers on trading ships. The practice of quarantine began in the seaport of Venice, which required any ships arriving from infected ports to sit at anchor for 40 days — quaranta giorni — before landing. Two centuries later, Small Pox took 56 million lives. In the modern era, some 40 to 50 million succumbed to the Spanish Flu of 1918 and HIV/AIDS has claimed 25-35 million lives since 1981.

For perspective, and not to minimize its severe toll, the number of fatalities from novel coronavirus will likely exceed 10,000 by the time of this writing. COVID-19, as it is currently known, is a reminder that we live with the ongoing threat from many types of both known infectious diseases like cholera, Zika and Avian flu, as well as diseases yet unknown to us. Although we can more rapidly detect, contain and treat epidemics, diseases now travel at the speed of a person on board an international flight. Our cities are bigger and denser, further enabling rapid transmission.

Pandemic Prepping Includes Trade

Because we are interconnected, we share the health risks, but we can also problem-solve as a global community. Scientists in international labs share insights to identify viruses, swap guidance on how to conduct confirmatory tests, and quickly communicate best practices for containment.

Outside times of crisis, global trade in health-related products and services has laid the foundation for faster medical breakthroughs through international research and development projects, and by diversifying the capability to produce medical supplies, devices, diagnostics and pharmaceuticals.

Innovation thrives in the United States like nowhere else. Yet, no single country, not even the United States, can discover, produce and distribute diagnostics, vaccines and cures for everything that ails us — or invent every medical intervention that improves the productivity and quality of our lives.

One Quarter of medicines have tariffs

A Dose of Foresight

As the Uruguay Round of multilateral trade negotiations were drawing to a close in 1994, a group of countries representing (at the time) 90 percent of total pharmaceutical production came to an agreement. Each government would eliminate customs duties on pharmaceutical products and avoid trade-restrictive or trade-distorting measures that would otherwise frustrate the objective of duty-free trade in medicines.

The WTO’s Pharmaceutical Tariff Elimination Agreement, which entered into force on January 1, 1995, is known as a “zero-for-zero initiative” to eliminate duties reciprocally in a particular industrial sector. Signed onto over subsequent years by the United States, Europe’s 28 member states, Japan, Canada, Norway, Switzerland, Australia and handful of others, the agreement initially covered approximately 7,000 items that included formulated or dosed medicines, medicines traded in bulk, active pharmaceutical ingredients (APIs) and other chemical intermediaries in finished pharmaceuticals.

Signatories agreed to expand the list in 1996, 1998, 2006 and 2010 so it now covers more than 10,000 products. Tariffs were eliminated on a most-favored-nation basis, meaning it was extended to imports from all WTO members, not just parties to the agreement.

Maintenance Drugs

Though an important start, the agreement has not been updated in a decade. Trade in products covered by the WTO agreement has risen from $1.3 trillion in 2009 to $1.9 trillion in 2018. Yet, some 1,000 finished products and 700 ingredients are not covered under the agreement, leaving pharmaceutical trade subject to hundreds of millions in customs duties. With China and India increasing manufacturing over the last decade, the value of global trade included in duty-free treatment decreased from 90 percent in 1995 to 81 percent in 2009 to 78 percent in 2018.

It is challenging to chart trade statistics and tariffs on health-related products, particularly since many chemical ingredients have both medical and non-medical uses. Here we have attempted to reproduce tables developed by the WTO in 2010, but we do not include a large number of chemicals that have general use whose tariff lines were not enumerated in the WTO’s analysis.

Health Product Import Shares

In 2010, the European Union and the United States together accounted for almost half of all world imports of health-related products. Europe has become a much larger importer while U.S. imports have decreased slightly as a percentage of global imports. Imports by many big emerging markets including Brazil, Mexico, China, India and Turkey, have increased along with their purchasing power. These countries benefit from zero duties when importing from countries that signed on to the WTO Pharmaceutical Trade Agreement.

Health Product Export Shares

On the export side, Europe dramatically increased its share of global exports while the United States dropped across the board compared to 2010, particularly in medical products and supplies. China shows significant growth in exports of inputs specific to the pharmaceutical industry – including antibiotics, hormones and vitamins – as well as medical equipment including diagnostic reagents, gloves, syringes and medical devices. India also increased its exports of all types of pharmaceuticals, particularly ingredients, but did not drive up its share across all types of exported health-related products. China and India would benefit from zero duties without having to reciprocate for exports from countries that signed on to the WTO agreement.

That said, according to the trade data, China and India still only account for 5.4 percent of global exports in health-related products covered by the agreement. Therefore, simply expanding membership to include these countries is not sufficient to enlarge duty-free trade – the number of tariff lines covered by the agreement would also need to expand to capture a significant portion of traded healthcare products.

Emerging Market Pharm Trade

Tariffs as a Symptom

The final price of a pharmaceutical is determined by many factors that differ by country. Costs and markups occur along the distribution chain from port charges to warehousing, to local government taxes, distribution charges, and hospital or retailer markups. Tariffs may seem a relatively small component of the final price, but the effect is compounded as all of these “internal” costs accumulate and they are symptomatic of complex regulatory systems.

A 2017 study by the European Centre for International Political Economy determined that tariffs on final prices add an annual burden of up to $6.2 billion in China. In Brazil and India, tariffs on medicines may increase the final price by up to 80 percent of the ex-factory sales price. Imported pharmaceuticals are at a clear disadvantage and patients bear the burden in cost and diminished availability.

Side Effects

According to the U.S. International Trade Commission, the U.S. pharmaceutical industry historically shipped bulk APIs from foreign production sites to the United States before formulating into dosed products. After the WTO agreement, it became viable to import more finished products duty-free. Over the years, a failure to add more APIs to the duty-free list reinforced this trend. The U.S. Food and Drug Administration also allows firms to import formulated products prior to receiving marketing approval to prepare for a new product launch but does not allow bulk API importation before market approval.

The urgency to accrue adequate supplies and treatments for COVID-19 has reignited a debate on U.S. over-reliance on China and India for antibiotics, among other medicines. What if factories must close? What if China and India withhold supplies? If raw materials and ingredients are derived in those countries, would the United States be able to ramp up domestic production? The White House is considering incentives and Buy America government procurement requirements to stimulate demand for U.S. production and in the meanwhile has temporarily reduced tariffs on medical supplies such as disposable gloves, face masks and other common hospital items from China.

20 Countries Ban Medical Exports

A Cure Worse Than the Disease

Removing barriers to trade in essential products is a healthier approach than imposing restrictions that could exacerbate potential shortages.

Nonetheless, some 20 countries have announced a ban on the export of medical gear – masks, gloves, and protective suits worn by medical professionals. They include Germany, France, Turkey, Russia, South Korea, India, Taiwan, Thailand and Kazakhstan.

Governments generally do maintain national stocks of critical items to enable manufacturers to ramp up production in cases of health emergencies or address unexpected gaps in their supply chains. But when major producers withhold global supply, importing countries face shortages and higher prices. Dangerously, India’s trade restrictions go beyond medical gear to restrict export of 26 pharmaceutical ingredients. India, however, relies heavily on APIs imported from China for their medicines, much of it originating from factories in Hubei province where the outbreak emerged.

Bans tend to beget more bans, potentially wreaking havoc on pharmaceutical and medical product supply chains, making it more difficult for healthcare workers to stem spread of the virus. Poorer countries with already fragile and underfunded healthcare systems are left in an even more vulnerable position.

A Test for Public-Private Collaboration

Instead of export restrictions, governments can expedite purchase orders and otherwise support industry efforts to ramp up production for domestic and global use. Most global manufacturers are operating at several times their usual capacity since the initial outbreak in China. Private labs are utilizing high-throughput platforms to conduct more tests faster but require trade in the chemical reagents needed to start up and run the tests.

Biopharmaceutical firms are applying their scientific expertise to accelerate the development of a vaccine and treatments for COVID-19. They are reviewing their research portfolios, investigating previously approved medicines that have potential to treat the virus, and donating approved investigational medicines to the global research effort. Internationally, scientists are collaborating through a Norway-based nonprofit called the Coalition for Epidemic Preparedness Innovations on COVID-19 vaccine development. They know that the more options, the better – most drug candidates will not get through all three phases of clinical trials.

Recovery

Epidemic diseases evolve and they do not respect borders. Treating them, as well as the myriad chronic diseases and other ailments that affect us more routinely, requires new and adapted medical technologies arising from innovation made widely available through trade.

While there’s nothing inherently wrong with providing incentives to encourage domestic production, it should not come at the expense of free trade in health-related products. Tariffs should be eliminated on life-saving medicines and their ingredients. Governments must impose restrictions on exports temporarily and only when absolutely necessary. In this way, openness in trade will help promote the recovery of both our health and our economies.

Many thanks to economist and contributor Alice Calder for running all the trade numbers in this article. Full data tables may be accessed here.

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Andrea Durkin is the Editor-in-Chief of TradeVistas and Founder of Sparkplug, LLC. Ms. Durkin previously served as a U.S. Government trade negotiator and has proudly taught international trade policy and negotiations for the last fifteen years as an Adjunct Professor at Georgetown University’s Master of Science in Foreign Service program.

Alice Calder

Alice Calder received her MA in Applied Economics at GMU. Originally from the UK, where she received her BA in Philosophy and Political Economy from the University of Exeter, living and working internationally sparked her interest in trade issues as well as the intersection of economics and culture.

This article originally appeared on TradeVistas.org. Republished with permission.

medical equipment

Guide to Preparing Medical Equipment for Shipping

Shipping medical equipment is inseparable from diverse challenges shippers have to face and overcome to orchestrate and eventually conduct the process without any difficulties. The most common challenges refer to the efforts to provide these items with utmost security through each and every stage of the process. Should any of the items get damaged or destroyed, the party in charge will have to deal with costly repairs or, even worse, complete replacement of the item.

The most viable solution lies in preparing medical equipment for shipping properly so as to minimize the chances of an accident. Here is what you have to bear in mind before you start negotiating shipping terms.

Evaluation prior to packing

What inevitably precedes the process of packing and preparing medical equipment for shipping is a thorough evaluation. This step is necessary because these items vary considerably in terms of size, shape, fragility, and weight. Consequently, to be able to complete the task efficiently and successfully, one has to know precisely the type and amount of equipment that is to be shipped.

Medical equipment should be handled with the utmost care and by experts who possess the expertise, experience, and appropriate equipment to respond to the demands of the task accordingly. An amateur cannot understand the delicacy of the process, which further results in increasing the risks of damage or even destruction to some of the medical equipment during the shipping process.

Tailored packing is crucial

While ordinary packing supplies will undeniably be suitable for some medical equipment, there are those items that require using custom-built crates or specific packaging solutions for impeccable security. The above-mentioned evaluation, hence, proves to be crucial for this purpose. Once you know exactly the size of items and when you analyze those which are awkwardly-shaped or extremely heavy, you will be able to request engineering of the crates that guarantee protection from abrasion, shock, moisture, temperature change, and vibration.

What packing supplies are necessary?

When preparing medical equipment for shipping, using specialized packing materials is a must. Understandably, for some pieces of equipment, you can use standard cardboard or plastic boxes, but generally, the most sensitive pieces require the already mentioned custom-built crates for excellent protection. In addition, using premium-quality cushioning materials is the strategy you need when eliminating any chances of damage is what you strive for.

If you opt for maritime shipping after analyzing the pros and cons of this decision, looking for vapor barrier packaging solutions becomes inevitable. In these circumstances, it is of utmost importance to use moisture and vapor-proof packaging to prevent corrosion on metal surfaces that can seriously harm the functionality of the equipment.

Professional assistance is mandatory when preparing medical equipment for shipping

There are numerous, respectable companies in the shipping industry that offer their impeccable service to various clients. Regardless of the airfreight vs. sea freight dilemma you might be experiencing, there is no place for questioning your decision to hire professionals for this task. However, to be able to monitor the process and assess the quality of the service you get, it is critical to get an insight into the usual practice when preparing medical equipment for shipping is in question.

Conduct detailed research before you find the shipping company you can trust. You need one which employs genuine professionals who know how to pack diagnostic, surgical and lab equipment, CT scanners, lasers, X-ray devices, and MRI machines. They need to be reliable and competent to dismantle these pieces of equipment, secure all the parts, pack, and, finally, load these into a shipping container. Online reviews are a good starting point for your search. Requesting free no-obligation cost estimates can help you know what budget you will need for this endeavor.

Obtain insurance

An essential step in the process of preparing medical equipment for shipping is getting the proper insurance by all means. No matter how well the preparations have been conducted, there is always a risk of unforeseen accidents that might endanger the safety of equipment in the shipping process. Concerning the value of the items you want to ship, obtaining proper insurance must not be neglected. It is important to be entitled to a reasonable compensation should some of your pieces of equipment get damaged or destroyed on the way to their final destination. This is the only solution that guarantees you peace of mind and the knowledge that you have covered all the potential scenarios of the upcoming shipping process.

Preparing medical equipment for shipping requires time

Time is what you need to handle each task with utmost commitment and undivided attention and finally prepare medical equipment for shipping well enough. Starting well in advance means an opportunity to reconsider some decisions before you make them final. If you understand how delicate this process is, you will understand how important it is to bring all the potential difficulties to a minimum. Professional assistance is the core of this process because you need the expertise to complete the process successfully.

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Ian Miller has devoted his time to studying shipping industry challenges and he frequently writes articles on this subject for companies such as Four Winds Bahrain. Ian has cooperated with many shipping companies and is now writing a study on the effects of technology on the shipping industry.

pancreas

First-of-its-Kind Bio-Artificial Pancreas on Track for Type-I Diabetes Cure

Imagine a world where those living with Type 1 Diabetes, a chronic illness affecting more than 60 million adults globally, no longer had to deal with regular blood glucose monitoring, daily insulin injections or life-threatening nighttime hypoglycemic events, but instead could eat, exercise and sleep worry-free. That’s the kind of future an up-and-coming breakthrough technology is on track to creating.

Beta-O2 Technologies, a privately held biomedical company headquartered in Israel with research and industry affiliates across the U.S., is working to deliver a first-of-its-kind bio-artificial pancreas as a safe, effective and long-term cure for the disease. With preliminary animal trials showing promising results for its second generation breakthrough device, called Bio-artificial Pancreas (ßAir), the company is planning to begin human clinical trials within the year.

“We have strong pre-clinical evidence to prove the safe operation of our device on animals,” said Beta-O2 CEO Amir Lichter, noting that the second generation ßAir is performing well in ongoing animal studies. “It’s an enormous achievement that is paving the road for human trials.”

Measuring approximately 2.5 by 2.5 inches, ßAir is made of titanium. It has two components: a macrocapsule that contains pancreatic cells and an oxygen tank equipped with an external port, so patients can easily refresh oxygen levels weekly. Once implanted under a patient’s skin, it becomes a natural source of insulin, sensing blood glucose levels and delivering insulin as required.

While there are a couple of other artificial pancreatic solutions being explored by different industry players, Beta-O2’s disruptive technology is the only bio-artificial pancreas to incorporate an active oxygen supply, necessary to keep the pancreas cells in the implanted device functional and viable over the long term. Other solutions are demonstrating limited success because they rely on a patient’s bloodstream to deliver enough oxygen to keep the transplanted cells viable, which is problematic, Lichter explained.

“Pancreas cells (islets) are extremely delicate,” he said. “We solve the problem by proactively supplying oxygen through an external source, providing a superior solution.”

Lichter said the beauty of the Beta-O2 solution — which holds 10 global patents for its exclusive immune protection capabilities and oxygen supply mechanisms — is that it’s very generic, meaning “it can contain cells from a human donor, cells from the pancreas of a pig, or cells derived in a lab from stem cells.” Other advantages are that Beta-O2’s bio-artificial pancreas does not require a patient to take intensive immunosuppression therapies after implant due to its protective encapsulation capabilities, and the device can quickly be retrieved from a patient if necessary due to malfunction or other health concerns, he explained.

U.S. affiliates helping to bring product to market

Beta-O2 is currently collaborating with several U.S.-based pharmaceutical companies and academics, including researchers from Harvard University, MIT, University of Virginia and Cornell University, to further enhance the ßAir oxygen supply and its ability to measure glucose levels and secrete insulin once implanted. The company is also in negotiations to solidify its collaboration with several stem cell providers as it looks to secure an additional $15 million in investment funds to support its aggressive go-to-market strategy.

“The active oxygen supply used by Beta-O2 is currently the best and most advanced technique for maintaining viability and function of large numbers of pancreatic islets (or stem cell-derived islets) in an encapsulation transplantation device,” said Clark K. Colton of the Department of Chemical Engineering at MIT and Beta-O2 Scientific Advisory Board member.

Calling the Beta-O2 device a “next-gen treatment option,” Dr. José Oberholzer, Professor of Surgery, Biomedical Engineering and Experimental Pathology at the University of Virginia and Beta-O2 Scientific Advisory Board member, explained that “after years of insulin injections and ‘closed-loop’ insulin pumps and glucose sensors, patients will finally have access to a biological device solution to treat the most brittle forms of diabetes. The Beta-O2 device is the only implant that has shown reproducible results in humans with diabetes, with measurable insulin production originating from human islet cells within the device without the need for recipients to take any immunosuppressive drugs.”

An earlier safety trial involving four patients in Sweden, supported by New York-based JDRF (Juvenile Diabetes Research Foundation), successfully demonstrated that Beta-O2’s device is fully safe for use. No side effects were observed in patients who carried the device for up to 10 months, and the cells remained viable and functional.

Now, current animal trials underway at Beta-O2 are focused on extending the life of functional cells even further, with promising early results showing that rats implanted with ßAir are maintaining normal glucose levels.

“With tangible evidence that we can maintain the viability and functionality of our cells for a long duration in rats, which have an immune system very similar to humans, we are looking forward to moving ahead with our second round of human clinical trials,” Lichter said, noting that the company aims to be first to show that implanted biological pancreatic cells can successfully achieve normal blood sugar levels in diabetic patients without the need for immunosuppression therapy.

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About Beta-O2 Technologies Ltd. (www.beta-o2.com)

Beta-O2 Technologies Ltd. is a biomedical company developing a proprietary implantable bioreactor, the ßAir, for the treatment of Type 1 Diabetes. ßAir is designed to address the main problems of the otherwise successful procedures in which islets of Langerhans (i.e. pancreatic endocrine cells) are transplanted in diabetic patients, such as the need for life-long immunosuppressive pharmacological treatment and limited functionality of the transplanted islets over time due to an insufficient oxygen supply. Beta-O2 investors include SCP Vitalife Partners, Sherpa Ventures, Aurum Ventures, Pitango Venture Capital, Saints Capital, Japanese and Chinese private investors.

Special Report: How to Keep Shipments Moving Forward During a Global Health Emergency

Delayed start to the new year
The coronavirus outbreak has prompted an official global health emergency that is severely affecting business operations not only in China but also around the globe. With any kind of widespread health outbreak, global importers and exporters are dealing with unpredictable logistics concerns that require a proactive approach to keep business running as usual.

It’s important to note that any cargo from the Wuhan, Hubei Province (the origin of the outbreak), and other quarantine zones, are restricted from leaving the province, which includes full container loads (FCL), less than container loads (LCL), as well as air freight. There will also be delays in factories re-opening, and a reduction of exports from China due to Wuhan residents not returning to work until February 17th, 2020 and other municipalities extending Chinese New Year until February 9th, 2020, including:

-Shanghai Municipality

-Chongqing Municipality

-Jiangsu Province

-Zhejiang Province

-Guangdong Province

-Fujian Province

The latest in air and ocean travel

In general, there has been an increased reduction in travel in and out of China. In areas where travel is permitted, strict health checks are causing significant delays at main air and ocean terminals, to ensure the safety of all travelers and workers. While the Wuhan port is closed, the other ports continue to operate. We also continue to see several airlines canceling flights in and out of China which can have an impact on cargo capacity.

Below are important considerations that will help keep your supply chain moving and better navigate any shipping challenges associated with the latest travel restrictions and schedule shifts.

Assessment of inventory levels

Having an accurate assessment of your inventory is expected, but it’s important to understand how restrictions on imports from China will impact your current inventory and regular shipping cadence. Look ahead to determine if the demand for your product may change in the next few weeks and if you have a need for expedited shipping. Starting those conversations now and establishing a plan are important as air capacity falls due to canceled passenger flights and higher demand.

Planning ahead in production

There are numerous variables to consider when planning for production. Working through these with a supply chain expert will help you be prepared and proactive as the uncertainty around the virus continues.

-What will production look like and has there been any discussion with the vendors and factories?

-How are existing inventories compared to sales projections?

-What plans are in place in case there is a shortage of workers in China or the demands are not being met within a specific window of time?

-Has there been a discussion about how the backlog will be addressed?

Backup sourcing options

When there is any kind of delayed start to production, keeping up with the workload poses a challenge, and so you may need to consider backup sources. Backup sourcing options are not always easy to find and keeping up with the sheer demand and quality controls can be a challenge. Connecting with a global supply chain expert to vet reliable options is important to ensure success.

While we may not know how long this global health emergency will last, C.H. Robinson’s global network of experts are dedicated to helping you get your shipments where they need to be. We continue to closely monitor the situation and provide updates through our client advisories as needed.

genetic testing

Global Genetic Testing Market to Hit $25 Billion by 2025

Genetic Testing Market is expected to exceed USD 25 billion by 2025. Growing incidences of genetic diseases coupled with the rising availability of advanced genetic tests will augment the industry growth.

Increasing awareness regarding the availability of genetic tests should escalate the genetic testing market growth throughout the forecast years. Industry players implement several promotional activities that raise awareness amongst the people. Moreover, due to increasing internet penetration in developing economies, individuals are becoming aware of the benefits of early diagnosis of genetic diseases. Above mentioned factors should surge the industry growth. However, the high cost of genetic testing may affect industry growth to some extent.

The unprecedented growth pace of the genetic testing market is rather evident from 23andMe’s recent launch of a grant program as a part of its Genotyping services for the research platform. A significant market contributor globally, through this invention, aims at promoting research studies with the intent to increase the revenue shares in the upcoming years. This trend itself bears testimony to the fact that the chief market players are opting for strategic moves to strengthen their position in the global genetic testing market share.

A business vertical of high repute, thriving extensively on personalized medicines, genetic testing market as of today stands as one of the outpaced, profitable industry spheres there is. Endorsed by the availability of technologically sound gene diagnosing kits and elevating cognizance regarding the use of personalized medicines, the commercialization potential of the genetic testing industry has surged immensely in the past few years.

Speaking of the test type spectrum, the carrier testing segment has stood tall during the past few years and is likely to develop at an appreciable pace during 2019-2025. For the records, the carrier testing segment accounted for USD 460 million in 2018. These tests find large scale use among couples to determine the chances of having a child with genetic disorders.

Also, they focus on detecting the probability of a healthy person carrying mutated genes. These factors have prompted healthcare professionals to recommend required treatments for the individuals comprising mutated genes thereby adding an impetus to genetic testing market trends.

North America’s genetic testing market will foresee over 10% growth throughout the forecast years. Increasing prevalence of genetic diseases will prove beneficial for regional growth. Cystic fibrosis, sickle cell anemia, thalassemia, and other genetic disorders affect millions of individuals in the U.S. annually that should spur the demand for upgraded genetic tests. Moreover, favorable regulatory scenario for genetic tests will further positively influence regional growth.

Companies are undertaking several initiatives to add innovations in the genetic testing market. Additionally, industry players such as 23andMe, BGI, BioMerieux, Cepheid, Counsyl and others have implemented several strategic initiatives such as mergers, acquisitions and product launches for gaining competitive advantage. For instance, in October 2016, 23andMe announced the launch of a grant program as part of its Genotyping Services for Research platform. The program is aimed at promoting research studies and obtaining proposals in which 23andMe experience is likely to garner more customers. This strategy will enhance 23andMe’s business grow

Source: https://www.gminsights.com/industry-analysis/genetic-testing-market,m

vaccines

Report: Global Vaccines Market

The U.S. vaccine market is anticipated to experience growth of 8.9% CAGR during the forecast timeframe. The high adoption rate of vaccines to reduce the incidence of infectious diseases along with several initiatives undertaken by government by increasing immunization rates and recommendations should stimulate business growth.

Japan’s vaccine market will grow significantly over the coming years to reach over USD 6.0 billion by 2025. Introduction of the routine vaccination program in October 2016 leading to the introduction of numerous important and routine vaccines having a higher rate of administration as compared to voluntary vaccines should drive the Japan vaccine market.

Increasing demand for preventive vaccines, the rising number of people suffering from infectious as well as non-infectious diseases globally will drive the vaccine market over the forecast timeframe. Increasing government funding for vaccine development will further boost industry growth.

Widespread routine vaccination programs and numerous initiatives undertaken by governments to encourage vaccine administration especially in developing and underdeveloped countries will positively impact industry growth. Growing awareness about reduced mortality due to immunization should propel vaccines industry growth over the forecast period.

High adoption of new vaccines coupled with technological advancements should stimulate business growth. Moreover, a strong product pipeline of leading companies such as Merck, Novavax, Emergent BioSolutions will lead to industry expansion over the coming years. However, high costs associated with transportation and storage of vaccines will limit the vaccines market growth to a certain extent over the foreseeable future.

Each time a nation is hit by an epidemic wave, children are one of the groups that take the deadliest hit. According to the Centers for Disease Control and Prevention, 1 or 2 of every 1,000 children who are diagnosed with measles die. During the nation’s recently witnessed measles outbreak, around 92 percent of children received a combination vaccine that prevents measles, rubella, and mumps. Immunization programs prevent and protect toddlers and infants from dangerous complications and failing to vaccinate may certainly put them at risk for fatal diseases. This has escalated the demand for vaccines for kids, which has subsequently influenced the growth curve of the vaccines market from the pediatric populace.

As per estimates, vaccines industry size from the pediatric age group is set to witness a CAGR of 9.1% over 2019-2025, given the high vulnerability of kids to infectious diseases along with the increasing implementation of pediatric immunization programs.

Driven by the ongoing pace of urbanization and the rising awareness regarding the potential dangers a pandemic can inculcate, the global vaccines industry is gaining increased attention. According to a new research report by Global Market Insights, Inc., the overall vaccines market size is anticipated to surpass $70 billion by 2025.

Some of the major market players involved in the global vaccines market are Merck, AstraZeneca, Johnson & Johnson, Novartis, Bristol-Myers Squibb, Abbott, Sanofi Pasteur, GlaxoSmithKline, Pfizer, Emergent BioSolutions, CSL, Astellas Pharma and Novavax. Firms are focusing on product launch to fortify their product base and market reach over the coming years.

Source: Global Market Insights, Inc.