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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.

drugs

WHAT TODAY’S USMCA DEBATE HAS TO DO WITH THE DRUGS OF TOMORROW

The political winds seem to be blowing in favor of a Congressional vote on the U.S.-Mexico-Canada Free Trade Agreement (USMCA) yet this fall. But before they vote, some Members of Congress want to talk over a few issues with the Trump administration’s negotiators. They are pressing the administration to lower intellectual property protections for the U.S. biopharmaceutical industry because they say the agreement’s provisions protecting original data generated by pharmaceutical inventors will drive up the price of prescription drugs.

Their arguments strike a political nerve but don’t offer a complete picture of this complex and evolving industry. The USMCA debate reflects a domestic difference in views. While the United States works to develop its regulatory framework for newer drugs, many other markets are further behind. As important as it is, the issue of data protection for biologic drugs is not well understood. We’ll try to cover the top lines.

Pieces of the Intellectual Property Puzzle

For American innovators of biopharmaceuticals, gaining access to overseas markets requires not only securing regulatory approvals; the policy environment must also be conducive to marketing their products, which includes a value-based approach to pricing, procurement, reimbursement policies – and intellectual property protections.

There are various facets to the intellectual property (IP) protections needed to incentivize massive investments in pharmaceutical innovation and to enable the recovery of those costs once a drug is commercialized. Patents are part of the package and so is the protection of proprietary data, the issue at the fore in discussions about USMCA.

These protections are particularly important to American companies. The intellectual property attached to 57 percent of the world’s new medicines was created in the United States. That’s no accident. Research and development activities flourish in countries where IP frameworks are well developed and enforced.

70% drug dev

What is Data Protection?

To achieve marketing approval from a regulatory oversight agency such as the U.S. Food and Drug Administration and its counterparts in other countries, innovator pharmaceutical companies submit data on the outcomes of their research and years of clinical trials demonstrating the drug is effective and safe. The cost and risks of developing the original data and product fall to the inventor.

When a generic producer or producer of a “biosimilar” seeks approval, they are often afforded the short cut of relying on the inventor’s data. To ensure a balance between incentivizing drug discovery and development while also providing opportunities for lower-cost copies to become available, the inventor’s data may be protected for a period of time against disclosure to generic or biosimilar producer. During this time, any competitor is free to undertake their own data and seek marketing approvals on that basis.

For How Long?

Provisions on data protection are not new in domestic regulations or in trade agreements. Since the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in 1995, World Trade Organization (WTO) members have agreed not to disclose clinical data submitted to regulatory authorities to obtain marketing approval for pharmaceutical products, thereby protecting such data “against unfair commercial use”.

Negotiators of the TRIPS Agreement contemplated specifying that data protection should be no less than five years, but ultimately refrained from including a specific timeframe, leaving it to the discretion of WTO members in their national regulations. NAFTA, which took effect in 1994, provides a minimum of five years.

Enter a New Type of Drug

The timing of these provisions is relevant to the debate today. The TRIPs and NAFTA provisions apply to new “chemical entities,” meaning small molecule drugs – that is, most drugs on the market to date. These types of drugs are capable of being replicated through chemical synthesis to make generic drugs. For this reason, regulators tend to agree that requiring duplicate data from generics would be an inefficient use of resources and unnecessary testing of patients, as long as the generic product is proven “bioequivalent” to its reference product.

Biologics are newer medicines. They are large, complex molecules that are made from living cells to produce the required proteins. This manufacturing process is vastly more complex. A follow-on product is not identical, but rather structurally similar and thus called a “biosimilar”. An exact replica is not possible, and patients cannot automatically be switched from a biologic to its biosimilar without risk of adverse effects.

Given the differences between biologics and small molecule drugs, they are regulated differently, and the IP protections have been applied differently. Biologics are largely defined by their manufacturing processes and regulatory approval of biosimilars does not require identity with the reference product, so biologics must often rely only on process patents versus a product patent. Innovator companies argue a longer term of data protection is needed to bridge the differences in patent protection or to offset the lack of patent protections in some countries, while allowing them to recover the increased cost of generating the original data.

New Trade Provisions for Biologics

Given the longer innovation cycle and the increased cost and complexity of biologics, many governments have provided longer periods of data protection for biologics than for small molecule drugs.

In the United States, the Biologics Price Competition and Innovation Act signed into law by President Obama in 2016, provides for a 12-year period of regulatory data protection for biologics. American companies have sought the same standards from trading partners.

With new agreements in the WTO largely stalled, the focus of trade negotiations over the last decade has shifted to bilateral and regional trade agreements where provisions are often more detailed and tailored. In negotiations toward the Transpacific Partnership Agreement (TPP), the United States pushed for 12 years, but agreed to eight years for biologics from the date of first marketing approval and allowed flexibility in how data protections could be administered. When the United States withdrew from the TPP, the remaining members suspended the relevant provisions.

In the USMCA, American biopharmaceuticals again did not get everything they wanted. Canada and Mexico do not have to match the United States in providing 12 years but agreed to increase the duration of data protection to 10 years from the current standard of five years in Mexico and eight years in Canada.

10 years in USMCA

Why Push Trading Partners to Increase Data Protections?

Beyond North America, the so-called “pharmerging” markets (generally the large developing countries) are growing faster than the stable developed markets. China is by far the largest emerging market for pharmaceuticals. In many developing countries, patent systems are weak or poorly enforced. Regulatory data protection provides some buffer against IP exposure, making it viable and more attractive for companies to introduce their products in that market.

Less data protection and lack of enforcement diminish the potential for U.S. exports. It also leaves the door open for competitors to access unprotected U.S. data without the originator’s authorization. Trade agreement obligations help guard against the unfair commercial use of proprietary data and expand the degree of IP protections in global markets, which is a precursor to greater diffusion of innovative drugs to patients worldwide.

Back to the Core Concerns – Availability and Costs to Patients

Critics of USMCA’s provisions argue data protections keep the prices of biologics high by delaying the introduction of biosimilars. The first biosimilar product was approved in the U.S. market in March 2015. By March 2019, 18 had been approved. Many experts suggest biosimilars have lagged in the U.S. market due to slower changes to the U.S. regulatory system and patent litigation as the industry goes through the same growing pains it did with generic regulation.

As well, drug development is an inherently expensive and risky business, characterized by high failure rates. On average, the process of discovery and commercialization takes 10-15 years at a cost of $2.6 billion. Less than 12 percent of drug candidates make it all the way from lab to patient.

Because of the complexity and high fixed costs required to develop the capacity to manufacture biosimilars, it takes eight to 10 years for biosimilars to come to market, there are fewer entrants than is the case with generics, and the cost savings realized are 10 to 30 percent off the brand, versus an average of 80 percent achievable by generics. Considering the length of time normally required to achieve safe and reliable production of biosimilars, the data protection period in USMCA is unlikely to be a cause of undue delay in getting them to market. Data protection terms are also often less than the remaining patent term.

Your Loss is My Gain

The prominent healthcare research firm, IQVIA, forecasts the biopharmaceutical industry stands to lose $121 billion between 2019 and 2023 as periods of market exclusivity end. Eighty percent of that impact, or loss for innovators, will be in the U.S. market as nearly all of the top branded drugs will have generic or biosimilar competition.

IQVIA says competition among biosimilars is on a path to grow three-times larger in 2023 than it is today. If that’s so, savings over branded biologics could produce approximately $160 billion in lower spending just over the next five years, even as overall spending on biologic drugs grows.

This is part of the business cycle of the pharmaceutical industry and why the innovators maintain strong pipelines because they have limited exclusive time in the market before competitors arrive. That’s good for patients. The data protections in USMCA are not likely to materially impact this cycle or spending. When Canada and Japan lengthened their duration of data protection, drug spending as a percentage of GDP remained nearly flat.

ME losses

Reason for Optimism

Biologics are called the drug of tomorrow. They comprise nearly 70 percent of the innovation pipeline which includes some 4,500 drugs in development in the United States and another 8,000 globally.

Breakthrough products are expected for cancer treatments, autism and diabetes. This is great news, but specialty and niche products tend to come at a higher price so spending may increase as these new drugs enter the market. According to IQVIA, average spending on the brand versions will nonetheless decline from 8.2 percent of the U.S. market to 6.7 percent, a demonstration there’s a healthy market for originals and copies.

There would be no copies without the originals, which is why pharmaceutical regulatory and legal frameworks are full of public policy trade-offs to strike a balance that will support return on innovation while not impeding the availability of affordable drugs. As we make scientific progress, the systems that include IP protections must evolve to accommodate new types of drugs, new capabilities in data analytics and clinical practices, and even changing business models. Not doing so can imperil the pace of progress at precisely the moment when breakthroughs are on the horizon.

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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 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.
CEIV pharma

DACHSER India Branches Boast CEIV Pharma Certification

DACHSER’s Mumbai and Hyderabad branches are among the few companies in India to receive the prestigious Center of Excellence for Independent Validators in Pharmaceutical Logistics certification  recognizing exemplary operations in transporting Life Science and Healthcare (LSH) products. Such products are both temperature and time-sensitive, requiring meticulous, accurate, and high standards in monitoring and handling to ensure product quality.

“Congratulations to DACHSER India on their CEIV Pharma certification. The time and temperature sensitive nature of pharmaceutical products means the highest standards are needed to make sure product integrity is maintained for such shipments,” said Vinoop Goel, IATA’s Regional Director for Airports and External Relations, Asia-Pacific. “With India being a major supplier of pharmaceutical products, DACHSER India’s CEIV Pharma certification will give pharmaceutical companies confidence and assurance that their cold-chain logistics requirements are being met.”

Difficult to obtain, the CEIV Pharma certification is earned by companies implementing efficient, safe, and excellence in transporting LSH products. Currently, DACHSER’s Hyderabad branch is one of two companies in the region to boast the accreditation. Through a strenuous audit ensuring compliance among all all facilities, equipment, operations and staff, DACHSER applied for the certification with the goal of adding to its already extensive history in handling pharma products.

“Obtaining the CEIV Pharma certification is an important milestone for DACHSER India. It emphasizes our continued focus for providing highly reliable logistic services to our valued customers in the LSH segment”, said Huned Gandhi, Managing Director, Air & Sea Logistics for the Indian Subcontinent. “Quality and efficiency have always been the cornerstones for our success and our teams are extremely proud to receive this accreditation from IATA.”
“By way of CEIV certification at our Mumbai and Hyderabad branches, DACHSER India has made a big step forward to further enhance its operational and technical competencies in serving our LSH customers,” concluded Zarksis Munshi, Head of Air Freight, Air & Sea Logistics India Subcontinent.

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.

Dublin Network Station Opened for Peli BioThermal

In an effort to support the company goal to exceed 100 network stations and drop points in 2019, Peli BioThermal announced the opening of its most recent network station strategically located next to the Dublin Airport in Ireland.

With a primary focus on the Crēdo on Demand rental program, the network station will act as a service center to refurbish, repair, condition, and service the reusable Crēdo shippers.

“Dublin is a key logistics location hub and Ireland’s life sciences sector and bio-pharmaceutical industry is increasing at a rapid rate,” said Dominic Hyde, vice president of Crēdo™ on Demand. “As we continue to expand our Crēdo on Demand rental program, the Dublin network station and service centre puts customers in closer proximity to more convenient and flexible shipping options.”

The Crēdo on Demand rental program enables organizations to select the best shipping applications and provides high performance, temperature-controlled containers including the Crēdo Cargo, Crēdo™ Xtreme and Crēdo™ Cube.

For more information on the company’s temperature-controlled solutions profile, visit: www.pelibiothermal.com

Turkish Airlines and DoKaSch Temperature Solutions Join Forces

A Master Rental Agreement between Turkish Airlines and DoKaSch Temperature Solutions will provide support for Turkish Airlines leading efforts in transporting temperature-sensitive products such as vaccines and other pharmaceuticals, according to a release from the companies this week.

DoKaSch Temperature Solutions – a Germany-based, air cargo temperature-controlled solutions provider confirmed it will supply its Opticooler solution to the airline. The Opticooler is known to be one of the safest containers in the temperature-controlled container market. Its features include an electric air-conditioned container equipped to maintain precise temperature ranges, regardless of tropical or arctic conditions.

“Turkish Airlines serves more destinations than any other airline. This means that our Opticoolers are now available to many more clients that need reliable temperature-controlled air freight,” said Andreas Seitz, Managing Director of DoKaSch Temperature Solutions.

“As one of the leading airlines of the world, we provide our cargo clients with the best quality services to transport high-value pharma products. So the Opticooler is one of the natural choices and the Master Rental Agreement confirms that we have all the necessary procedures in place,” said Fatih Cigal, Turkish Cargo’s Senior Vice President for Marketing.

 

Source: Reinhardtstrasse 55

Middle East Facility Opens for Peli Biothermal

Global temperature controlled packaging company, Peli Biothermal, announced next steps in its global expansion efforts with the opening of the Jeddah, Saudi Arabia drop point. The announcement follows the companies goals of expanding its global footprint, primarily in the Middle Eastern region.
Additionally, the new drop point puts the company one step closer to meeting their goal to exceed 100 network stations and drop points for its rental program for 2019.
“Our Crēdoon Demand rental program is designed to provide our customers with options,” said Dominic Hyde, vice president of Crēdo on Demand. “Adding another drop point in key logistics hubs in the Middle East will allow our customers in pharmaceutical distribution the flexibility and convenience to choose the best drop-off location for their business needs.”
The new location benefits PeliBio Thermal’s Crēdo™ on Demand rental program by increasing available drop points, providing opportunities for growth in the region. The new facility will provide protection for globally transported payloads containing life sciences and pharmaceuticals.

Source: Peli Biothermal

Biotech & Pharmaceuticals Post-Brexit

Alacrita consulting released an infographic detailing insight from  leaders in the pharma and biotech industries and what their predictions are for a post-Brexit market. Survey results indicate what’s to come for leaders and industry players and how attitudes are predicting to change.
Some of the findings may come as a surprise for some, while other results can only be confirmed with time. For example, 98 percent of pharma execs say that Europe is an important market for their products. At the end of the day, the environment for clinical research, pharma companies and products could very well take a substantial shift.
The Special Pharma Relationship
Provided by Alacrita