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Monday 08:00 - 17:30 Tuesday 08:00 - 17:30 Wednesday 08:00 - 17:30 Thursday 08:00 - 14:30 Saturday 08:00 - 17:30 Sunday 08:00 - 17:30

PDR Pharmaceutical, Unit 17, 3rd Floor, No 14, Yas 3 str, Niayesh Highway, Shahran, 1 Square, Tehran (2026)

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Unit 17, 3rd Floor, No 14, Yas 3 Str, Niayesh Highway, Shahran, 1 Square

07/09/2020

Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread
Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread

Long before the World Health Organization declared Covid-19 a pandemic on March 11, 2020, pharma companies have been ramping up their operations, and utilizing knowledge gained from similar viruses in the past to aid in their research to find a vaccine. Some are looking at compounds formerly tested against viral pathogens such as Ebola and HIV, while others are offering new tech solutions that could combat the spread of coronavirus.
Each week, Pharma IQ will present a round-up of updates on research, treatment options and innovative solutions coming out of the industry as it plays a vital role in fighting the pandemic.
Sensyne Health boosts NHS impact and to help keep pregnant women with diabetes safe at home
AI tech company Sensyne Health has made GDm-Health™ digital, a remote monitoring system for the management of diabetes in pregnancy, available free-of-charge across NHS England in response to the coronavirus pandemic.
Lord Paul Drayson, CEO of Sensyne Health, said, “In light of the UK government’s guidelines around ‘social distancing’ to combat the ongoing Covid-19 pandemic, there is now a greater focus than ever before on the use of remote patient monitoring to reduce the burden on limited NHS resources and help high-risk people stay at home.”
According to the company, the device will give clinicians the opportunity to review changes in symptoms in real time and reduce the cost of what was traditionally a time-consuming method.
The wireless device connects to a smartphone application which monitors glucose levels in the blood of the patient. Using algorithms the device prioritizes patients in need and communicates this information directly to the hospital care teams. Sensyne Health said, this will help improve patient outcomes by keeping high-risk groups safe at home without putting them at unnecessary risk for regular check-ups.
FDA investigates effectiveness of malaria pills and other antiviral drugs to treat Covid-19
The US Food and Drug Administration (FDA) has been working closely with other government agencies to investigate the effectiveness of chloroquine and remdesivir to treat patients with mild-to-moderate Covid-19 symptoms and help prevent further spread of the disease.
Last month, Denis Hinton, Chief Scientist at the FDA, wrote a letter authorizing the emergency use of chloroquine, an approved drug to treat malaria, lupus and rheumatoid arthritis, to treat Covid-19, while the National Institutes of Health began a randomized controlled trial with remdesivir, an antiviral drug developed to treat Ebola, under the FDA’s investigational new drug requirements.
While there are no FDA-approved therapeutics or drugs to currently treat, cure or prevent Covid-19, FDA Commissioner Stephen Hahn, MD, said, “We must ensure these products are effective… [we must also] engage with domestic manufacturers to ramp-up production of products to mitigate any potential supply-chain pressures. If clinical data suggests products may be promising in treating Covid-19, we know there will be increased demand for it.”
The FDA has said it will continue working with innovators to expedite efforts, including leveraging scientific information about the virus and trials currently being conducted in countries including China, Japan, South Korea and Italy.
Cloud-based CTMS supports Covid-19 trials to bring treatments to market faster
Pharmaseal International, a UK-based provider of clinical trials management systems (CTMS), offered life science organizations the opportunity to use its Engility solution free-of-charge to help support moves to bring treatments for Covid-19 to market faster.
The cloud-based solution helps biopharmaceutical organizations and academic institutions manage and centralize their clinical trial lifecycles, regulatory documentation and remote workforce processes.
Daljit Cheema, CEO at Pharmaseal, said, “The team are committed to supporting global life science businesses to improve patients’ lives and would like to further extend this commitment and support during this pandemic to bring treatments to market faster.”
The company claimed, Engibility CTMS facilitates accelerated innovation by delivering new product updates through an intelligent software platform and can adapt to meet the needs of all organizations.
Clinova provides clarity on mask types to minimize risk of contracting Covid-19
In efforts to combat misinformation on mask types, Arsalan Karim, Director of Research and Development at Clinova, makers of the Covaflu Flu Respirator mask, stated, “There’s a lot of talk about different kinds of protective masks, and which one is best.
“While surgical masks protect against infectious agents transmitted by droplets, they do not protect against airborne infectious agents such as viruses, so they will not prevent the wearer from being potentially infected by Covid-19.
“However, the respirator face mask, which protects the wearer from aqueous and oily aerosols, smoke and fine dust, is also more effective at protecting against airborne infectious agents such as Covid-19 and SARS. Respirator masks prevent viruses from entering the body through the mucous membranes of the mouth and nostrils.”
While respiratory masks do not offer wearers 100 per cent protection, Clinova claims the masks will support the efforts of global national health services to combat the spread of the coronavirus.
To take a deeper dive into the effects of the Covid-19 crisis and understand the decisions the pharma industry are taking now to prepare for more resilient supply chains in the future, secure your place at our upcoming expert roundtable in April with Richard Ettl, CEO at SkyCell. Ettl will discuss how to transport pharma goods quickly and safely to patients and tackle the challenges presented by an unprecedented and ever-changing crisis. Sign up now to uncover solutions to shape the future of your supply chain.

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Keeping tabs on Covid-19: New drug updates from the FDA, free tools to combat diabetes at home and knowing the right mask to combat spread Long before the World Health […]

07/09/2020

Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers
Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers

Following last week’s news that MIT and 3M were collaborating on a paper-based coronavirus diagnostic solution and Pfizer and BioNTech were told they could fast-track two investigational vaccine candidates by the FDA, the global race to develop a vaccine really heated up this week.
Much headway has been over the past seven days by scientists from across the world of pharma, with positive results coming out of studies in the UK and China. Below we present our pick of pharma industry developments in the battle to halt the spread of Covid-19 from over the past week.
Vaccine shows robust immune responses
Interim results from the ongoing Phase I/II COV001 trial led by the University of Oxford has found that a potential vaccine, AZD1222, can be tolerated and generated robust immune responses against the SARS-CoV-2 virus.
The vaccine, which showed the result in all evaluated participants, was co-invented by the University of Oxford and its spin-out company Vaccitech. Phase I/II interim data demonstrated that AZD1222 could generate a rapid antibody and T-cell response against SARS-CoV-2.
The results, which were published in The Lancet, confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95 per cent of participants one month after injection.
Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at the University of Oxford and co-author of the trial, remarked: “The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial program to confirm this.”
Pollard added that the team saw the strongest immune response in participants who had received two doses of the vaccine.
Late-stage Phase II/III trials are now underway in the UK, Brazil and South Africa, and are set to begin in the US.
Regulators will cooperate on Covid-19 vaccine claims WHO scientist
World Health Organization (WHO) chief scientist Soumya Swaminathan has said that country and regional regulators will cooperate and combine efforts to speed through approvals on Covid-19 vaccines when they become available.
With more than 200 Covid-19 vaccines in development, there has been concern about the speed with which the vaccines will be approved and made available to the general public.
Swaminathan warned: “While speed is important, it cannot be at the cost of compromising on the safety or the efficacy standards.”
The scientist’s comments came as animal tests of a potential Covid-19 vaccine being developed by Chinese researchers showed signs that it triggers an immune response against the novel coronavirus.
ARCoV, a messenger RNA vaccine, is the second potential Covid-19 vaccine China’s military-backed research unit has moved to clinical trials.
Prospective study focuses on personalizing treatment of severe Covid-19 patients
Researchers at Israel’s Rabin Medical Center have published prospective data, in collaboration with MeMed, on a host immune biomarker used in managing the care and treatment of patients with severe Covid-19 infection.
The study is the first of its kind to investigate how real-time measurements of IP-10, a host-immune protein biomarker, can be used to monitor and regulate inflammation in severe Covid-19 patients. The researchers used MeMed’s technology platform MeMed Key to conduct the study which revealed that the IP-10 biomarker could be a valuable resource for predicting disease severity and progression.
Dr. Boaz Tadmor, head of Rabin Medical Center’s Central Research Authority explained: “In the majority of Covid-19-positive patients, the host mounts a localized immune response sufficient to clear the virus from the upper airways and possibly the lungs, following which the immune response recedes and the patient recovers. But in some patients, less than 15 per cent, hyperinflammation or a ‘cytokine storm’ is triggered, which has been implicated in acute lung injury, multiple organ failure and mortality.
“A key challenge for clinicians in managing care for these patients is the lack of sufficient data on predictive biomarkers, as well as preventive measures and continuous ways to measure Covid-19-induced hyperinflammation,” Dr. Tadmor added.
Download 4G Clinical’s white paper to understand the challenges associated with basket and umbrella trial design within oncology studies and learn how to innovate your study design strategy to increase trial flexibility and agility during Covid-19.

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Keeping tabs on Covid-19: Vaccine results show encouraging signs in UK and China, as Israeli study offers hope to severe sufferers Following last week’s news that MIT and 3M were […]

07/09/2020

Patent and know-how licensing: Going beyond the textbooks
Patent and know-how licensing: Going beyond the textbooks

Practitioners working with patents and know-how licenses - in-house and in private practices - face a number of challenges. In this article, key concerns are addressed relating to ownership, royalties, visibility and protecting licensed IP.

Identifying the know-how
How to clearly identify the licensed know-how while not compromising its confidentiality is a top issue. In Europe, this also feeds into the need to describe know-how in sufficient detail to comply with European competition law[i]. A common solution is to use a general description, referring to a separate, confidential document. Alternatively, the names or titles of particular methodologies or procedures could be listed where these refer to specific elements of know-how. Care is needed, however, to ensure that documents are drafted precisely enough to cover the full range of the know-how, and technical input was crucial in this respect.

Ownership
Clearly defining the intellectual property (IP) owned by each party is key to avoiding misunderstandings and disputes. The licensor must be clear about the extent to which it will offer its own future improvements to the licensee. Assignment or exclusive grant-back of the licensee’s improvements is not generally acceptable under EU competition law, but the licensor may require a non-exclusive licence back, and such clauses are commonly included. Particular consideration of IP ownership provisions is needed in collaboration type agreements, where more than one party will be creating and cross-licensing foreground IP. Upfront thought and discussions are needed to prevent dispute and avoid the need for jointly-owned IP. A point sometimes overlooked is whether a Supplementary Protection Certificate (SPC) would be applied for; as this can result in up to five years of extra patent protection, it is a subject that should be included upfront in negotiations.

Royalties and payments
Payment structures are becoming increasingly complex. Payment terms usually comprise a mixture of initial payments, milestone payments and royalty payments. Royalties are often structured with one rate for patents and another, lower, rate for know-how once the patents have expired. There may also be provisions to calculate reduced rates where there are combination products or antibody-drug conjugates. As most modern drug products are complex and require multiple licences, the licensee may wish to deduct third party royalties when working out the Net Sales on which royalties are paid, and the licensor may want an overall royalty ‘floor’. Where royalties depend on whether the licensee’s product falls within a valid claim, the parties should remember that the scope of claims may vary between countries.

Protecting licensed IP
Participants at the recent Life Sciences Patent Network Europe conference highlighted the importance of licensors carrying out robust due diligence. Many licensors remain nervous about protection in countries where IP and trade secret protection are perceived as weak, such as China and South Korea, and this is becoming an increasing problem as their biotech/drug production markets grow. Due diligence may include visiting the production facilities where the licensed materials will be used. This issue of trust in relation to how technology will be used may also affect the licensor’s approach to allowing assignment, sub-licensing and sub-contracting. In a market characterised by frequent consolidation and business sales, licensors may be wary of allowing licensees to share licensed technology with new business partners who could be or become competitors.

Challenging validity
A patent licensee working with the patented technology may be more knowledgeable than the patentee about patent vulnerabilities, and licensors will wish to prevent such a licensee from using their knowledge to challenge the patent. Under EU law, the licensor may not generally ban the licensee from challenging the patent, and this is sometimes cited as a major obstacle impeding access to new technologies. However, a provision in an exclusive licence that permits its termination by the licensor in the event of such a challenge is often acceptable, and obliges the licensee to ‘put his money where his mouth is’ and risk termination if he believes the patent is invalid.

Increasingly important
Given the increasing sophistication of modern drugs and healthcare solutions, it seems inevitable that sophisticated licensing is on the rise as multiple licences are needed for complex products. The playing field is ever-changing as new technologies emerge and markets evolve rapidly.

[i] Under the Technology Transfer Block Exemption 316/214 or EU Commission guidelines under Article 101, Treaty of Rome

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Patent and know-how licensing: Going beyond the textbooks Practitioners working with patents and know-how licenses – in-house and in private practices – face a number of challenges. In this article, […]

07/09/2020

Keeping tabs on Covid-19: AstraZeneca ups nasal-spray vaccine production and air cargo industry preps vaccine distribution
With the World Health Organization this week publishing a list of the latest Covid-19 candidate vaccines from around the world, Pharma IQ’s weekly round-up looks at developments from the past seven days including news on how the pharma industry plans to handle vaccine disruption and flu season.

New pharma partnership prepares air cargo industry for Covid-19 vaccine distribution

The International Air Cargo Association (TIACA) and Pharma.Aero have joined forces to develop global guidance for the air cargo industry designed to optimize transportation of a Covid-19 vaccine.

To address concerns around how a vaccine would affect global supply chain operations, the joint working group has implemented a program involving key industry stakeholders, including pharma manufacturers and logistics firms, which will manage the knock-on effects of vaccine distribution.

The aim of the program will be to provide the air cargo industry with more clarity on the demands, expectations and quality supply chain requirements, including critical trade lanes, air cargo capacity, handling and storage, track and trace requirements for the transportation of a vaccine.

Neel Jones Shah, TIACA board member and Global Head of Airfreight at Flexport, said: “Covid-19 vaccine delivery will be one of the biggest logistical challenges in modern history.

“No one company can own the end-to-end vaccine supply chain. We need to start working together now to ensure the industry is prepared when the time comes,” he added.

Nathan De Valck, chairman of Pharma.Aero., commented: “Setting up reliable end-to-end air transportation for pharma shippers is part of the vision and mission of Pharma.Aero. Among our members, [which include] life sciences and pharmaceutical shippers, certified airport communities and air cargo operators, we have a track record of project-based collaboration.

“As a result, Pharma.Aero is well-positioned to make a valuable contribution in preparing the air cargo industry for this immense challenge,” De Valck, added.

AstraZeneca to ramp up production of nasal-spray vaccine in case of a Covid-19 resurgence

AstraZeneca has announced the production volume of Flumist, a nasal-spray vaccine to fight influenza, has been increased in anticipation of higher demand due to Covid-19.

In a statement, AstraZeneca claimed more than 25 per cent more doses than previously planned of the nasal spray vaccine would be available to the commercial market in the US as early as September 2020. The increased production of the nasal spray is part of the pharma industry’s efforts to help reduce the burden on the healthcare system and ensure resources are available should there be a resurgence or continuation at present levels of Covid-19.

Mina Makar, SVP, US Respiratory and Immunology at AstraZeneca, said: “AstraZeneca has increased manufacturing capacity and accelerated vaccine development to ensure we can confidently meet the needs of consumers and the healthcare system.

“We are proud to provide Flumist – the only nasal-spray flu vaccine – which helps play a key role in the fight against flu in the US.”

For more on how to improve your manufacturing operations from the ground up download Pharma IQ’s Guide to maximizing operational efficiency in pharma manufacturing. Discover best practices from industry leading experts for leveraging next-generation tools and solutions to increase your product’s speed to market and to meet customer demand.

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With the World Health Organization this week publishing a list of the latest Covid-19 candidate vaccines from around the world, Pharma IQ’s weekly round-up looks at developments from the past […]

07/09/2020

Digitalization pyramid: How stakeholder interests can lead to a data-driven business
Digitalization pyramid: How stakeholder interests can lead to a data-driven business

Digitalization has been defined by Gartner as, “the use of digital technologies to change a business model and provide new revenue and value-producing opportunities; it is the process of moving to a digital business.”
Digital businesses have never been so important to the effectiveness of creating business continuity than in the current global health pandemic. With local grocers, hospitals and traditional manufacturing suffering from the worst economic circumstances in a decade, digital businesses like Amazon, Teladoc Health, and Zoom are registering stock evaluations.
A recent report by Accenture demonstrates that only digitally mature companies are resilient enough to maintain full operations in this and future crisis. For example, Google’s Deepmind has recently contributed to scientific efforts to combat Covid-19 by using its artificial intelligence application to release virtual structure predications of several under-studied proteins associated with SARS-Cov-2.
With increasing healthcare offerings supported by Accenture and Mayo clinic, Google Cloud is setting a powerful new paradigm for how life science companies are using technology to detect, diagnose and treat diseases. In an effort to meet the increased demands of the market, life science organizations are starting to turn to these new digital health solutions, however, the definition of digitalization, its imminent impact and the associated urgency often remain misunderstood and underappreciated by the relevant stakeholders in life science companies. These stakeholders are focused on their current business needs, and while they can see some benefit in technology, their real-life problems and stressful schedules prevent them from identifying what initiatives are best to scale up and what digital success will look like in the future.
This blog is intended to help life science organizations understand how digitalization is achieved and the benefits it will bring to their part of the organization.

The first thing to realize is that we are all trying to do our best. Even though friction between different organizations and their respective goals seem inevitable, there is a common destination to be reached. This destination is a newly transformed business that results from synchronized innovation in all respective organizational units, focused on solving the current stakeholders needs.
In simple terms, if every part of the organization addresses their current challenges and embraces novel technological opportunities, their progress can merge into a unified whole. Regrettably, this is not apparent to all stakeholders, due to an effect a German idiom coins: The forest being disguised by trees.
Source: Adobe Stock
Let us look at some of the common challenges of stakeholders in life science businesses that could be solved by today’s technology. As examples, we will put ourselves into the shoes of a laboratory head, a quality control (QC) manager, a regulatory affairs representative and a collaboration manager. We will see that extrapolating only a few steps will merge all stakeholder’s interests in the same final outcome: the foundation of a digital business
Laboratory head
With Eroom’s law working against them, laboratory heads are mainly interested in finding better, safer and more cost-effective drugs. In order to make good decisions, they need to be able to find and access all relevant information related to a specific project.
In most companies, it is currently not possible to retrieve all digital information for a specific product through a simple search. Therefore, much effort is being spent on breaking up data silos and providing basic search and retrieval function to laboratories. Once this problem is solved, the desire will arise to not only find specific data sets, but also to interrelate them with other projects in the company.
The idea to increase efficiency by making better decisions on which drugs to promote and which projects to stop will result in greater quality and higher throughput. This can only be achieved if data is harmonized and transformed into information by adding descriptive metadata.
A main bottleneck of integrating information are the incompatible data formats that digital information is often stored in. Leveraging data standards like Allotrope will enable future reuse of data. A set of well-curated, long-term usable information packages is the foundation of any digital business. The path of the lab head will inevitably lead to this stage.
QC and compliance manager
QC managers have one major concern in a world of rapidly advancing technologies that regulatory officials will require access to legacy data a company cannot provide.
Warning letters are detrimental to any life science company and need to be avoided. The main reason for warning letters issued over the last few years is missing data integrity. While paper prints and file backup solutions have sufficed in the past, current audits require frequent access to reintegrable data. It is, therefore, an eminent challenge for QC managers to put into place archiving solutions that keep data in a fully compliant storage.
Once the problem of storing measurements has been solved, however, a new challenge can be foreseen. How can the process that leads to a specific released batch be made visible and how can a drill down into the data genealogy be made possible?
The ability to reconstruct a human readable process description and all relevant descriptive information on the fly will become the next object of desire. Standardized data models and process descriptions integrated into the data storage solution will form the basis of what can be coined a streamlined audit.
No more mountain archive explorations or calling people out from retirement will be necessary. All information will be available with the push of a button.
Consider the system necessary to achieve this; it has to collect, harmonize, store and reprocess digital information. Similar to the lab head, this system forms the foundation of a digital business as the logical destination for the QC manager.
Regulatory affairs manager
A crucial task to bring a product to market is proving the safety and effectiveness of a drug to regulatory authorities. Wagon loads of documentation has to be prepared, in agreement with minute specifications that vary between countries.
Today, a plethora of data management systems needs to be consulted to retrieve all the information necessary to produce the desired submission documents. Unfortunately, these systems do not communicate well with each other and require much manual effort to operate.
It is, therefore, a high priority item for all regulatory affairs managers to increase efficiency and reduce errors using automation of manual efforts in data digitalization and transfer between systems.
A key component to ensure the integrity of data is through implementing master data systems that hold definitions of contextual metadata to be assigned to individual information packages. Every data package created needs to be tagged with a set of mandatory and optional metadata.
If such automation is fully deployed the resulting data packages will be connected on their metadata level. This means that a foundation is laid for completely automatic creation of submission material. It is clear to see that the need for automation, coupled with connecting data, can result in substantial time savings during the submission process, which equals millions of dollars per day for a block buster drug.
While the desired outcome is very different from the one of the lab head and QC manager, the enabling technology has many parallels and again provides the basis of a digital business.
Collaboration manager
A collaboration manager has the responsibility to ensure that contract research organizations (CRO) and contract manufacturing organizations (CMO) receive and deliver information of the highest quality. While it has been an established practice to subcontract parts of the drug discovery and development pipeline to third party companies, never before has the need for digital exchange of data been greater.
With the previously described needs for standardized and well curated data from all other units in the organization, the collaboration manager needs to make sure that the CROs and CMOs submit data according to required standards. A secure data transfer is only the first part of the pipeline, because even more important are automatic quality checks to guarantee data integrity and compliance. While these abilities are currently under development in many companies, it can be conjectured that the next big leap will be an automatic monitoring and performance scoring of CROs and CMOs.
Such a metric, completely data driven, will enable life science companies to go beyond trust and identify the best partners in the industry. The gained transparency will result in cost savings and higher product quality. Furthermore, the system necessary to accomplish this data exchange, quality checking and performance scoring will have to rely heavily on standardized and contextualized data packages. As in our previous examples, this will be the foundation for a data-driven, digital business.

In conclusion, every life science company has to successfully go through the process of digitalization or risks being overtaken. While many stakeholders do not grasp the full picture, their individual interests will lead them to contribute to the foundation of a data-driven business.
If management encourages a synchronized effort to build a system capable of transforming the organization, all stakeholders will instantly gain valuable business benefits. At ZONTAL, we believe that technology holds the key to unprecedented productivity. Together with our top 20 pharma partners, we have developed ZONTAL – a space to guide digital transformation and bring immediate business benefits to important stakeholders. Join us for our educational webinar on May 28 to learn how we can transform the industry together.

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Digitalization pyramid: How stakeholder interests can lead to a data-driven business Digitalization has been defined by Gartner as, “the use of digital technologies to change a business model and provide […]

PDR Pharmaceutical

07/09/2020

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