FDA proposes delayed track and trace rollout; GSK forays into artificial intelligence-aided drug research

This week, Phispers brings you news on an apex court ruling in Canada that overhauls its patent law and makes it more NAFTA-friendly. While a new director-general took office at the WHO, malware Petya stalled operations at Merck. We also report on a warning letter to a heparin testing laboratory in China, and how the FDA has proposed a delayed enforcement of new serialized product identifier on drug packages by one year.

Heparin testing laboratory in China receives FDA warning letter

In early 2008, ‘fake’ heparin-based medicines caused deaths in the US and other parts of the world. In a bid to realize cost-saving opportunities, Chinese producers had added a potentially toxic substance — known as ‘over-sulphated chondroitin sulphate’ (OSCS) — to pharmaceutical grade heparin.

The counterfeit product was cheaper to manufacture, did not offer the intended therapeutic effect and was difficult to differentiate from heparin using the existing test methods.

After the 2008 heparin crisis, the analysis of heparin and heparin-related drugs has become of prime importance to the FDA.

Shandong Analysis and Test Center, a contract testing lab situated in Shandong in China that analyzes samples of heparin and heparin-related drugs for the presence of OSCS using nuclear magnetic resonance (NMR) spectroscopy, received a warning letter after a January 2017 FDA inspection.

The inspectors found the laboratory routinely failed to establish analytical system suitability while testing samples for OSCS. In one instance, when the system suitability test failed, the lab did not investigate why the equipment failed system suitability for detection of OSCS. It also did not determine the reliability of other OSCS tests conducted prior to the system suitability failure.

The warning letter said: “System suitability testing determines whether requirements for precision are satisfied and ensures the NMR spectrometer is fit for the intended testing before analyzing samples. It is critical that your system be demonstrated as suitable for detecting OSCS contamination in heparin to avoid the possibility of samples erroneously passing when an instrument is not working properly.”

In addition, analysts were unable to retrieve original electronic data for analysis of heparin and heparin-related drug samples. During the inspection, access to information necessary to conduct the inspection was also restricted.

FDA proposes delayed enforcement of DSCSA (track and trace /serialization)

The US Food and Drug Administration (FDA) has proposed a delayed enforcement of new serialized product identifier on drug packages and verification requirements by one year. This draft guidance, published by the FDA last week, could have major ramifications for the industry.

As part of the Drug Supply Chain Security Act (DSCSA) requirements, referred within some parts of the industry as either ‘track and trace’ or ‘serialization’, all drug manufacturers are required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce no later than November 27, 2017. Repackagers are required to do the same no later than November 27, 2018.

In the draft guidance, the FDA says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products before November 26, 2018.

“This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that manufacturers introduce in a transaction into commerce before November 26, 2018, without a product identifier, FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level,” the draft guidance said.

“Almost all of the manufacturer requirements set to go into effect on November 27, 2017 would not be enforced” due to this proposed one year delay, an industry analysis said.

A delayed rollout will, however, still require “manufacturers to provide the transaction information, transaction history and transaction statement in electronic format only, except when selling directly to a licensed healthcare practitioner who is authorized to prescribe medication under State law, or to other licensed individuals who are under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice,” it added.

BASF announces significant enhancements in ibuprofen manufacturing capacity

BASF is building a new plant to manufacture the active pharmaceutical ingredient (API) — ibuprofen — in Ludwigshafen, Germany. The plant is scheduled to come onstream in 2021.

The company is also expanding its ibuprofen capacities at its production site in the US, situated at Bishop (Texas), to fill the existing supply gaps for ibuprofen in the market. The expansion will come onstream in early 2018. The company is investing around US$ 226 million (€200 million) in both these projects.

Ibuprofen is used to treat pain, fever, and inflammation. The Ludwigshafen plant will be “the first world-scale ibuprofen plant in Europe,” Dr Markus Kamieth, member of the board of executive directors, BASF SE, said. With this investment, BASF aims to ensure high supply security for its customers and meet the growing global demand for the API.

After Sanofi, GSK forays into artificial intelligence by tying up with Exscientia

An increasing number of companies on both sides of the Atlantic are applying artificial intelligence (AI) to drug research. The latest to join the bandwagon is British drug major GlaxoSmithKline — the company unveiled a US$ 43 million strategic drug discovery deal with Exscientia on July 1.

As per this tie-up, Scotland-based Exscientia will leverage its AI-enabled platform with the expertise of GSK, in order to discover novel and selective small molecules for up to 10 disease-related targets. In May, Exscientia had signed a similar deal with Sanofi.

The AI-based drug discovery process harnesses modern supercomputers and machine learning systems to predict how molecules will behave, and how they could make a useful drug, thereby saving time and money on unnecessary tests. AI systems already play a central role in other high-tech areas such as the development of driverless cars and facial recognition software.

Besides Sanofi and GSK, Merck and Johnson & Johnson are also exploring the potential of AI to help streamline the drug discovery process.

Andrew Hopkins, CEO of Exscientia, said: “This agreement with GSK is the second we have signed in recent months with a top global pharma company. The alliance provides further validation of our AI-driven platform and its potential to accelerate the discovery of novel, high-quality drug candidates.”

However, big pharma is treading cautiously when it comes to AI. “It's still to be proven, but we definitely think we should do the experiment,” John Baldoni, GSK's head of platform technology and science, said.

Canada overhauls patent law; multinationals favored over startups

A Supreme Court ruling in Canada last week overhauled its patent law. And now, the law will largely favor multinational patent holders over Canada’s own startups. According to news reports, the step may ease North American Free Trade Agreement (NAFTA) talks, due to begin in August.

This decision, aimed at reshaping intellectual property rights in Canada, effectively lowers the bar to receive and defend a patent in the country, tilting the playing field in favor of existing patent holders.

However, though the larger firms may have lauded the ruling, it threatens to hurt the domestic technology sector and undercut Prime Minister Justin Trudeau’s vision of reshaping Canada as a leader in innovative industries.

The Supreme Court ruled that a current standard, known as the “promise doctrine,” goes too far, because it allows for patents to be invalidated if an invention doesn’t do any of the things it promised.

The decision resolves an issue that had been flagged by the US in the NAFTA talks. The Supreme Court decision came after another ruling last week that ordered Alphabet’s Google to remove search results from websites offering goods that infringe on intellectual property.

The ruling “removes a key irritant,” Michael Geist, a law professor at the University of Ottawa, said in a written statement. “Combined with the Google case from earlier this week, Canada is now home to some of the toughest anti-piracy laws in the world along with some of the friendliest patent rules for patent holders,” Geist added.

Merck’s operations shutdown due to computer malware Petya

Last week, Petya/NotPetya cyberattack hit Merck and several other companies. The cyberattack, known as ransomware, works by locking users out of their computers and demanding a ransom in order to regain entry.

New Jersey-based Merck made the announcement of the attack last week. Internal communications instructed employees to disconnect mobile devices from the network and refrain from posting on social media.

The core technology in Petya is called ETERNALBLUE. According to news reports, it was developed by American spy agencies. It relied on bugs in Windows that Microsoft presumably wasn’t aware of until earlier this year.

Merck missed two critical opportunities earlier this year to inoculate itself from this vicious cyberattack. In March, Microsoft had issued a critical bulletin advising IT administrators of the steps needed to prevent hackers from using the ETERNALBLUE technology to gain unauthorized access into their networks.

Then in May, the first global attack based on this exploit, known as WannaCry, had spread widely, shutting down 16 hospitals in the UK. In the aftermath of WannaCry, Microsoft issued yet another patch. In fact, most prominent security firms worldwide asked companies to immediately employ these crucial patches to prevent unauthorized access to private networks.

A Merck spokesperson said: “We have made good progress in our response to the June 27 global cyber attack…Government authorities working with us have confirmed that the malware responsible for the attack contained a unique combination of characteristics that enabled it to infect company systems despite installation of recent software patches.”

The Petya attack hit at least five other countries. In Ukraine, the attack was being described as the biggest in the country's history.

Tedros Adhanom Ghebreyesus takes office as the new WHO director-general

On July 1, Dr Tedros Adhanom Ghebreyesus took over as director-general of the World Health Organization (WHO). He succeeded Dr Margaret Chan.

Tedros was elected on May 23, 2017, by vote of WHO member states at the 70th World Health Assembly. The director-general is WHO’s chief technical and administrative officer and oversees the policy for WHO’s international health work.

This is the first time that member states at the World Health Assembly selected a director-general from among multiple candidates. In previous elections, a single nominee was forwarded by the WHO executive board to the World Health Assembly for consideration, a statement said.

Prior to his election as the director-general of WHO, Tedros served as minister of foreign affairs of Ethiopia from 2012 to 2016. He also served as the minister of health of Ethiopia from 2005 to 2012 where Tedros led a comprehensive reform effort of the country’s health system, including the expansion of the country’s health infrastructure.

“The right of every individual to basic health services will be my top priority. I will champion mechanisms to meaningfully listen to, learn from and engage people and communities — including migrant, displaced and disabled individuals; people living in rural, urban slum and low-income areas; and other vulnerable populations,” Tedros said in his vision statement.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : Delayed by Jordiet. is licensed under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”