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UPS Flight Forward Boasts First-Ever Part 135 Standard Certification

ups flight forward

UPS Flight Forward Boasts First-Ever Part 135 Standard Certification

Drones continue to make news headlines with the latest announcement from UPS Flight Forward, Inc. confirming the first-ever government-approved Part 135 Standard certification awarded by the FAA earlier this week. This certification – which is known as the highest level, supports the UPS subsidiary to further opportunities in drone deliveries including operating drones beyond the visual line of sight (BVLOS).

“This is history in the making, and we aren’t done yet,” said David Abney, UPS chief executive officer. “Our technology is opening doors for UPS and solving problems in unique ways for our customers. We will soon announce other steps to build out our infrastructure, expand services for healthcare customers and put drones to new uses in the future.”

UPS Flight Forward deployed the first BVLOS drone delivery to WakeMed’s hospital in Raleigh, North Carolina shortly after receiving the certification. The government-exempted BVLOS flight was carried out by Matternet’s M2 quadcopter. UPS partnered with drone creator Matternet earlier this year to expand supporting healthcare delivery operations specifically for WakeMed’s hospital campus. These operations further reiterate the demand for efficient, speedy deliveries for the medical industry and its patients.

“UPS Flight Forward is benefitting from our knowledge as one of the world’s leading airlines. The Flight Forward organization is building a full-scale drone operation based on the rigorous reliability, safety, and control requirements of the FAA,” Abney said.

The Part 135 Standard certification carries significant advantages with minimal restrictions to UPS, such as no limits on the scale of operations, unlimited numbers of drones and remote operators, cargo weights exceeding 55 pounds, and more. By obtaining this certification, common barriers associated with drone deliveries are eliminated.

“This is a big step forward in safely integrating unmanned aircraft systems into our airspace, expanding access to healthcare in North Carolina and building on the success of the national UAS Integration Pilot Program to maintain American leadership in unmanned aviation,” said U.S. Secretary of Transportation Elaine L. Chao.

BREAKING BAD TRADE: FENTANYL FROM CHINA

The Real Poison Pill in U.S.-China Trade

Following a historic dinner between President Trump and President Xi last December in Argentina on the margins of the G20 Summit, many of us awaited news on tariffs. We were surprised when, as part of a trade announcement, President Trump hailed a commitment from China to step up its regulatory oversight of fentanyl, the opioid that the Centers for Disease Control says has caused a “third wave” of drug-related overdose deaths in the United States.

It seems the seedy underbelly of e-commerce involves a steady stream of online purchases of deadly variants of the drug fentanyl, made in China and shipped to American doorsteps through the U.S. postal service.

Deadly Parcels from China

Fatal drug overdoses have doubled over the last decade, rising from 36,010 in 2007 to 70,237 in 2017. Synthetic opioids other than methadone – mainly fentanyl – now account for 40 percent of all drug overdose deaths and 60 percent of opioid overdose deaths.

China is the primary source of illicit fentanyl, fentanyl analogues, and fentanyl precursor chemicals in the United States. According to U.S. Customs and Border Protection, almost 80 percent of fentanyl seized in 2017 was interdicted at U.S. Postal Service and express consignment carrier facilities, having been shipped in small quantities from China.

Fentanyl precursors are also shipped from China to Mexico, and to a lesser degree Canada, before being synthesized, often mixed with heroin or cocaine, repackaged, and then trafficked over U.S. land borders in the southwest.

Fentanyl third wave of overdoses

STOP

Last March, the White House stepped up its campaign against opioid abuse, seeking to address factors driving both demand and supply. The Initiative to Stop Opioid Abuse (referred to as STOP) includes education programs, measures to curb over-prescription, expanded access to treatment and recovery, and – a focus on cutting off the flow of illicit drugs from China.

According to Homeland Security, more fentanyl in larger volumes is seized at land crossings, but the fentanyl seized from mail and express consignment carrier facilities is far more potent with purities of over 90 percent versus Mexico-sourced fentanyl that is often diluted to less than 10 percent.

The president’s initiative would require the postal service to provide advance electronic data for 90 percent of all international mail shipments within the next two years, offering data that will help law enforcement identify and seize illegal substances shipped through mail. Private shippers such as UPS and FedEx routinely require such electronic data.

The administration is also scaling up the Department of Justice’s “darknet” enforcement efforts. Fentanyl in its various forms is relatively cheap and easy to buy from China online paying with cryptocurrencies, or even credit cards or money transfers.

fentanyl shipments from China

Over One Million Pills a Day – In One Factory in China

China has grown to become the largest mass producer of generic drugs and pharmaceutical ingredients in the world with over 5,000 pharmaceutical manufacturers. Upwards of 90 percent of the active pharmaceutical ingredients used in U.S. production of finished dosage forms of medical pharmaceuticals is imported from just two countries: India and China.

In addition, China has over 160,000 chemical producers and hundreds of thousands of pharmaceutical and chemicals distributors. The explosion in volume and number of producers has far outstripped China’s FDA (CFDA) from adequately regulating and monitoring them.

Faster Than Can Be Regulated

Unlike opioids derived from the poppy plant, fentanyl is a synthetic painkiller produced in a laboratory. It is 50 times more potent than heroine and 50-100 times more potent than morphine. Inhaling just two milligrams of pure fentanyl can be lethal.

In the United States, most fentanyl products are classified either as Schedule I chemicals, those that have no accepted medical use and high potential for abuse, or as Schedule II chemicals, those with medical use but only available through a non-refillable prescription.

Fentanyl’s molecular structure can be easily modified to create new derivatives, putting regulators constantly behind in evaluating and classifying each new variant one-by-one. From furanyl fentanyl, acetyl fentanyl, acryl fentanyl, to carfentanil — to name just a few — fentanyl has hundreds of analogues that differ slightly from the original, enabling criminal producers to operate in a gray territory while regulators struggle to ban the new substances. Legislation passed in 2017 now allows U.S. FDA to schedule fentanyl analogues immediately on a temporary basis while the agency conducts its investigations.

President Trump has urged President Xi to implement a similar approach. China currently controls around 25 types of fentanyl-related products. President Trump wants China to establish fentanyl as its own class of controlled substances, restricting all fentanyl analogues, including future fentanyl-like substances. Doing so would be a start.

Busting Drug Trade

Such a commitment by China is not, however, likely to put a dent in its fentanyl exports to the United States absent real enforcement. In recent years, CFDA has imposed stricter licensing requirements for pharmaceutical and chemical producers, but diversion, adulteration, and clandestine production remain significant problems.

“Chinese chemical manufacturers export a range of fentanyl products to the United States, including raw fentanyl, fentanyl precursors, fentanyl analogues, fentanyl-laced counterfeit prescription drugs like oxycodone, and pill presses and other machinery necessary for fentanyl production.” — U.S China Economic and Security Review Commission Staff Research Report

CFDA has undergone several reorganizations in the last few years. In the most recent, some of its regulatory responsibilities have devolved to provinces and counties with little accountability. Pre-marketing approvals will be managed separately from post-market inspections and surveillance. With just a little over 2,000 inspectors, authorities have little hope of effectively overseeing legal compliance, let alone spotting even a fraction of criminal activity.

The central government has assisted U.S. drug and law enforcement agencies, sharing information and intelligence that helps U.S. agencies target Chinese nationals trafficking illicit drugs in the United States. To alleviate the free flow of fentanyl from China, the Chinese government should also prosecute transnational criminals operating in China in high-profile cases with severe penalties.

Soybeans, Tech Transfer, and Fentanyl

Trade talks over soybeans and intellectual property protections for American technologies seem an unlikely setting for addressing illicit trade in deadly fentanyl.

There are some in the United States who are frustrated with this administration’s willingness to toss out the traditional trade policy playbook, but this is one case where it can welcomed by everyone.

 

 

Interested to read about fentanyl trade in more detail?

See two key reports produced by U.S.-China Economic and Security Review Commission analyst Sean O’Connor: Fentanyl: China’s Deadly Export to the United States, February 2017 and Fentanyl Flows from China: An Update, November 2018

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 fourteen years as an Adjunct Professor at Georgetown University’s Master of Science in Foreign Service program.

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

How Drones Could Transform Biopharmaceutical Supply Chain Innovation

Drones have made the news once again. This time, to aid in swift and reliable delivery of life-saving temperature-controlled medications required in emergency situations. A collaboration between Direct Relief, Merck (MSD outside the U.S. and Canada), Softbox, AT&T and Volans-i is pushing the boundaries and capabilities of UAVs- also known as drones, and confirmed a successful fourth pilot proof-of-concept mission was conducted in the Bahamas last week.

“This successful pilot demonstrates the potential of innovative UAV technology to aid in delivery of temperature-dependent medicines and vaccines to people who critically need them,” said Craig Kennedy, senior vice president, Supply Chain, at Merck. “The potential of UAV technology is just one of the many areas in which we are innovating across our business and our supply chain to maximize our ability to save and improve lives around the world.”

As the partners focus on biopharmaceutical supply chain innovation and strengthening humanitarian efforts,  concerns on how to  overcome challenges in global regulations are considered in order to solidify official application in various global markets. Previous test flights were conducted in Switzerland and Puerto Rico.

“Experience and research consistently show that those most at risk of health crisis in disasters live in communities which are likely to be cut off from essential health care due to disruption of transportation and communications,” said Andrew Schroeder, who, among other responsibilities, leads analytics programs, data visualization, and geospatial analytics for Direct Relief.

“Drone delivery is one of the most promising answers to this problem. More remains to be done to operationalize medical cargo drones in emergencies. But successful tests like this one demonstrate that remarkable new humanitarian capabilities are emerging quickly.”

Real-time data analysis and collection in conjunction with fully autonomous controlling enabled test flight success. Additionally, the cold-chain technology ensured temperatures as low as -70 degrees Celsius were maintained, all while providing accurate temperature tracking and reporting.

Photo credit: Direct Relief

“Our goal is to revolutionize the way goods and people move in the world,” said Hannan Parvizian, CEO and Co-Founder of Volans-i, in San Francisco. “Successfully demonstrating our ability to make temperature-controlled drone deliveries in various climate and terrain conditions across these pilots is a first step towards realizing our vision for a world in which no one should be deprived of access to life-saving medical supplies and vaccination due to lack of infrastructure and responsiveness of the transportation ecosystem.”

“This most recent proof-of-concept test has once again demonstrated the capabilities of the Softbox SKYPOD for the transportation of life saving medicines, this time at ultra-low temperatures,” added Richard Wood, Director, Digital Connected Technologies at Softbox. “To ensure full track and trace throughout the test flight Softbox utilized Internet of Things (IoT) technologies and data dashboard services provided by AT&T. The data collected during the successful flights has shown everybody involved the power of IoT to provide full visibility of the Cold Chain, even in the most extreme environments while using innovative transportation modes.”

“Through close collaboration with Direct Relief, Merck, Volans-I and AT&T, we have successfully proven the capabilities of this unique and ground-breaking combination of cutting-edge technologies and now will focus our efforts on completing subsequent pilot projects,” Wood concluded.

United Cargo Earns “Best Air Cargo Carrier – North America” Award

During this year’s annual Asian Freight, Logistics and Supply Chain (AFLAS) Awards in Hong Kong, United Cargo was recognized as the “Best Air Cargo Carrier” for the North American region.

Hosted annually by Asia Cargo News, selected nominees and winners are determined through a different approach with the help of more than 15,000 reader and e-subscriber votes. Consistency in service, innovation, customer relations, and management are all taken into consideration when vetting winners for the annual awards.

“United Cargo’s primary goal is to build and sustain long-term relationships of mutual benefit with our customer partners,” said United Cargo President Jan Krems. “Our team is especially proud to again receive this award representing the voice of our customers, because it confirms we are delivering a consistently excellent level of service worldwide and enhancing our partners’ success. I salute United Cargo team members in more than 300 locations around the globe for their commitment to quality.”

This news follows an announcement made earlier this month confirming the carrier will begin transporting and leasing Swiss-based temperature-controlled containers provided by SkyCell. United Cargo will be the first U.S. carrier of SkyCell’s containers, enabling safe and effective logistics for biopharmaceuticals and temperature-sensitive items.

“TempControl’s transport of vaccines and other high-value biopharmaceutical shipments is increasing rapidly,” said Jan Krems, President of United Cargo. “Extremely precise, long-duration temperature control is required for the safe transport of these highly-sensitive shipments. 

“SkyCell is excited to partner with United to increase the availability of SkyCell containers for the U.S. pharma industry,” said Richard Ettl, CEO of SkyCell. “United and SkyCell share the goal of eliminating temperature excursions and reducing the CO2 footprint in global pharma transportation.” 

Source: United Cargo

SkyCell & Air France KLM Martinair Cargo Extend Collaboration for Pharma Logistics

In an effort to extend improved and innovative services for clients, SkyCell – known as the fourth largest pharma airfreight container provider, and
Air France KLM Martinair Cargo, confirmed they will extend their collaboration globally with plans to present it to the global AF KLM network. Air France KLM Martinair Cargo boasts one of the largest and densest global networks.

“Air France KLM Martinair Cargo values of Transparency, Innovation and Care match the values of SkyCell: we are both committed to provide the highest quality standards to our clients in the most transparent and innovative way. SkyCell is driven by technological innovation in pharma transport technology and that is why we want to work very close together,” said Enrica Calonghi, Global Head of Pharmaceutical Logistics at Air France KLM Martinair Cargo.

In a recent evaluation from one of the Big Four international audit companies, SkyCell’s shipments from the last 12 months showed a
0.1 percent of the transports involved a temperature excursion with their containers. The companies share a common theme in transparency in addition to customer-driven services.

“Air France KLM Martinair Cargo is a pioneer in pharma airfreight services and has an extensive network. With a shared vision of innovation in the supply chain of temperature-sensitive products, our collaboration will ensure that consumers are guaranteed a safe and sustainable service. We will also further improve our services through SkyCell’s data-driven approach,” said Richard Ettl, CEO of SkyCell.

Cathay Pacific Confirms Pharma.Aero Membership

Pharma.Aero announced during this year’s IATA World Cargo Symposium that Cathay Pacific – a CEIV Pharma certified company, is now a full member supporting the shipping of time-sensitive pharmaceutical products.

“We are excited about Cathay Pacific joining our collaboration group as a full member. Their active involvement in the pilot of the pharma corridor project is a clear added value,” said Nathan De Valck, Chairman of Pharma.Aero. “In collaboration with Pharma.Aero and our pharma shipper members, key performance indicators of the pharma corridor will be clearly defined, targeting to set A2A pharma handling standards.”

With Pharma.Aero’s goal to provide excellence in end-to-end air transportation of pharma products, the Cathay membership is given the assurance of a streamlined and accurate method for airport-to-airport (A2A) temperature-controlled handling.

“India and Bangladesh are both big markets for Cathay Pacific, especially when it comes to shipments of pharmaceutical products. Hyderabad, Bangalore and Mumbai followed by Dhaka have always had large number of pharma shipments and this continues to grow,” said Cathay Pacific Regional Head of Cargo for South Asia, Middle East and Africa, Rajesh Menon.

“United States, Canada and Australia are key trade lanes for India and Bangladesh. PharmaLIFT is an important product and our handling expertise is a key USP we provide to our agents. Collaborating with Pharma.Aero, this offering will only become stronger to provide quality in the transportation and expert handling of valuable and sensitive pharmaceutical products,” he concluded.

Peli Biothermal Making Moves in Los Angeles

Peli Biothermal makes the news again with the recent announcement confirming the Los Angeles-based network station this week. The purpose of the new location is to serve as a service station, offering repairs and refurbishing for the company’s reusable Crēdo on Demand shippers. This expansion also confirms the company’s plan to exceed 100 network stations and drop points for early 2019.

“Los Angeles is a major logistics hub for sea and air carriers as well as a hot spot for pharmaceutical innovation,” said Dominic Hyde, vice president of Crēdo on Demand. “As we continue to expand our Crēdo on Demand rental program, the LA network station and service centre puts customers in Asia and elsewhere in the world in closer proximity to more convenient and flexible shipping options.”

Located next to the Port of Long Beach and LAX, the network station provides competitive access to the 1,570 biotech and pharmaceutical companies in the state of California.

About Peli BioThermal
Peli BioThermal Ltd. offers the widest range of temperature controlled packaging and service solutions to the global life sciences industry. The company is the recipient of two Queen’s Awards for Enterprise: International Trade in 2018 and Innovation in 2017.  The company’s products ensure that delicate biological materials arrive intact and effective, despite exterior environments.  Peli BioThermal is dedicated to developing innovative products designed to fulfil the complex needs of the global life sciences industry. The company’s customers benefit from its extensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. The company also offers a complete portfolio of services and software to support end-to-end temperature-controlled packaging asset management. Outside of Europe, the company does business under the name Pelican BioThermal LLC. For more information, visit pelibiothermal.com.

Source: Peli Biothermal

Dubai Customs Thwarts Attempt to Smuggle 5m Captagon Pills

Cooperation between different customs departments and good planning have led to thwarting an attempt to smuggle large number of Captagon pills at Jebel Ali & Tecom Customs Center, just a few days before 2019 unfolds.

The illegal shipment was tracked by customs intelligence personnel who shared the information and images of the shipment through the Regional Intelligence Liaison Office (RILO).

The Regional Intelligence Liaison Office (RILO) is a regional centre for collecting and analyzing data, which also disseminates information throughout the global customs network. As a fundamental pillar of the World Customs Organization (WCO)’s Enforcement Strategy, Intelligence and Information Exchange is facilitated through eleven (11) RILOs covering the six (6) regions of the WCO.

The RILO informed of a drug shipment in a nearby country, and by analyzing and comparing the data, the team at Jebel Ali & TECOM Customs Center decided to track similar shipment coming into Dubai in a container that had vehicle spare parts from a country that doesn’t normally trade with spare parts. The container was tracked through the smart Vessel Tracking System, developed by Dubai Customs.

The container was scanned, and with the help of the customs K-9 Dog unit, 5 million Captagon pills that weighed 500 kg were seized. This raises the number of Captagon pills seized since January 2018 to 15 million pills.

Jebel Ali & TECOM Customs Center has made 19 seizures between 2016 and 2019. These included 225 million narcotic pills and 51 kg of other drugs.

Commenting on the seizure, Director of Dubai Customs Ahmed Mahboob Musabih pointed out all customs departments work and coordinate together to combat illegitimate trade and thwart any narcotic drugs smuggling attempt.

“We are vigilant and well prepared to all attempts of bringing these illegal contrabands into the UAE through Dubai entry points. The high sophisticated level that Dubai Customs reached in terms of infrastructure, equipment and the skills of their customs officers have led to more control over the emirate’s entry points and borders following the vision of His Highness Sheikh Mohammed Bin Rashid Al Maktoum, Vice President, Prime Minister and Ruler of Dubai” says Musabih.

Shuaib Al SuwaidiCustoms Intelligence Director at Dubai Customs revealed they track shipments on their way to Dubai’s entry points based on numerous data and intelligence resources.

Captagon was first manufactured in 1961. It stimulates the central nervous system, increases alertness, boosts concentration and physical performance, and provides a feeling of well-being. It was earlier prescribed to treat narcolepsy and depression, but the medical community determined that Captagon’s addictive properties outweighed its clinical benefits in 1980.

It was then banned in several countries, particularly after it was found, as is the case with long-term amphetamine users, to lead to extreme depression, malnutrition, heart and blood vessel toxicity, and sleep deprivation.

 

 

Leadership Shifts to Support Global Logistics Expansion Efforts

Increasing growth in Europe and India is the primary driver behind recent leadership changes for the global innovation and provider of temperature control packaging for life science and logistics company, Softbox.

Kevin Valentine will now hold the title of General Manager for Softbox Europe and brings with him over  25 years of industry experience, specifically pertaining to the leadership experience in the science and production of advanced temperature controlled packaging solutions and thermal covers for pharmaceuticals. Valentine will focus primarily on quality of innovation and client services in his new role.

Additionally, Dharmesh Chauhan, who will report directly to Valentine, will take on the role of Sales Director for Softbox Europe. and will provide support to the newly-combined Softbox and TP3 Global sales teams to further efforts of temperature control packaging and thermal cover portfolios for global pharmaceutical customers.

A third player in the industry, Dinesh Patki, will lead efforts towards growth with the full integration of TP3 Global/CLI and Softbox in India through his role as General Manager of Softbox India. Patki provides strong relationships with the Indian market that will assist in the expansion of company growth in the region.

 “Kevin, Dharmesh and Dinesh are very experienced industry leaders and I’m delighted to welcome them in their new roles within the Softbox leadership team,” Wayne Langlois, President at Softbox, said.  “By leveraging the best possible talent from within our organisation, it enables us to integrate and grow Softbox to further growth success.”

Source: Softbox Systems

 

 

First-of-its-Kind Brain Health Supplement Aims to Improve Cognition, Memory

America’s newest brain health supplement may come in a small capsule, but according to scientific studies, its benefits could be huge. Sophrosyne, a first-of-its-kind breakthrough product launched this month, has a unique combination of four mind-boosting ingredients clinically proven to improve cognition and memory.

“This is great news for seniors and anyone looking to sharpen their memory, and also for military veterans or athletes who may experience frequent hits to the head,” said Dr. Daryl Rhys Jones, a top neuroscientist formerly with the Mayo Clinic and current CEO of Jonescientific, who led the development of Sophrosyne after years of research and testing. “With its unique mix of ingredients present at clinically active doses, there is nothing as effective as Sophroshyne on the market.”

In fact, no other known brain health product in the U.S. has been developed by a neuroscientist – an expert in the development and function of the nervous system, including the brain. Dr. Jones – who has done extensive research on Alzheimer’s and Chronic Traumatic Encephalopathy (CTE) – and his team scientifically evaluated hundreds of ingredients for their memory and cognition-building properties and produced the supplement using what they found to be the four most effective ones: withania somnifera, curcumin, bacopa monnieri and hericium erinaceus.

What sets these ingredients apart? Here’s a breakdown from Dr. Jones:

Withania somnifera. This plant – commonly known as Indian ginseng, Ashwagandha or winter cherry – has been proven to regenerate damaged brain cells.

Curcumin. A natural chemical produced by some plants, featuring antioxidant properties, this ingredient has shown to help maintain a healthy environment within the brain by removing unwanted proteins. An 18-month UCLA human clinical trial confirmed that consuming 180 mg of curcumin per day led to significantly enhanced memory and focus.

Bacopa monnieri. In at least four randomized, double-blind, placebo-controlled human trials, this herb has been demonstrated to enhance cognition and memory, and decrease the rate of forgetting newly-acquired information. It was shown to prevent the breakdown of neurotransmitters essential for cognition and memory.

Hericium erinaceus. Also known as Lion’s mane due to its unique appearance, this medicinal mushroom has been found to increase levels of peptides essential for the survival of brain cells. In a 16-week double-blind, parallel-group, placebo-controlled human trial, a high dose of this ingredient was found to improve cognitive function in seniors.

“Our research shows that these four nootropic (cognitive enhancing) ingredients, consumed in a daily capsule, deliver the most impressive results in improving cognition and memory compared to any other supplement available on the market,” said Dr. Jones, who cautions against taking other brands of supplements with a large ingredient list, due to the danger of losing the protective effects of a product that likely contains only minimal amounts of each ingredient crammed into one capsule.

A daily dose of Sophrosyne contains science-backed, clinically active doses of 500 mg of withania somnifera, 180 mg of curcumin, 300 mg of bacopa monnieri and 500 mg of hericium erinaceus.

For more information, please visit: Www.jonescientific.com