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Novotech has been engaged by Revive Therapeutics Ltd, a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, to pursue human clinical trials for Bucillamine in the treatment of infectious diseases, including COVID-19.

Novotech, the largest biotech clinical research organization specialist in the Asia-Pacific region, is helping several biotechnology companies in the development of new therapies for the treatment of COVID-19 infections.

Commenting the news, Michael Frank, Revive’s Chief Executive Officer said “We are pleased to have Novotech as part of our team to support us in our global clinical strategy for Bucillamine in infectious diseases, which includes COVID-19”. He also added that Novotech will assist in exploring the potential for a Phase 2 clinical study for Bucillamine in the APAC region.

Most sites still open for biotech clinical activity across Asia-Pacific

Many locations across Asia-Pacific, especially Australia, South Korea, Hong Kong or Taiwan, appear to be managing the crisis well. Sites have changed how they manage trials in line with the most recent health guidelines and a majority are still able to deliver the clinical trial services for biotechnology companies.

Novotech has recently released detailed reviews on the current status of clinical trials in the Asia-Pacific region during the global COVID-19 crisis. This data highlighted that most sites in the region are adapting well to the crisis and are still open for clinical activity and many sites are still very interested in new studies.

In South Korea and Taiwan for example, site initiation, patient recruitment, onsite monitoring and participant visits are proceeding normally across the major biotech sites.

Novotech helps accelerates infectious disease trials in Asia-Pacific

Novotech’s model relies on having experienced local leadership and strong relationships with investigators and sites in the region. Ultimately this benefits biotechnology companies and allows them to accelerate clinical studies.

Novotech undertakes a large number of infectious diseases trials and has strong relationships in this area. Novotech has conducted over 200 projects in infectious diseases and vaccines. Many biotechnology companies look at the Asia-Pacific region for their trials in infectious diseases and vaccines due to the high incidence of conditions such as Hepatitis, HIV and Influenza and other infection types across the region.

Asia-Pacific is recognized by clinical phase biotechnology companies for accelerated patient enrolment especially in rare diseases, metabolic conditions, oncology, immuno-oncology and infectious diseases, and lower clinical research costs.

The Food and Drug Administration (FDA) has released relaxed guidelines for infusion pumps and clinical thermometers due to the COVID-19 pandemic.

The relaxed guidance hopes to increase the availability of these devices which are currently in high demand, and adds to other guidelines recently released by the organisation for medical devices such as ventilators.

Infusion pumps 

The document states that the FDA’s enforcement policy for infusion pumps applies to devices under four different product codes, and more than 20 different types of accessories that are used with infusion pumps.

The FDA says: “Wherever possible, healthcare facilities should use FDA-cleared infusion pumps and accessories to provide infusion therapy, or a device authorised by an Emergency Use Authorisation (EUA).” However, the organisation acknowledges that: “Such devices may not always be available, and to help ensure the availability of the greatest possible number of devices for this purpose, as described in more detail below, FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials of FDA-cleared devices used to support patients who require continuous infusion therapy, without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,12 for the duration of the public health emergency.” 

Under the policy, FDA explains that it will not object to companies making these modifications to already cleared infusion pumps or accessories, so long as the modifications would not “create an undue risk.” The FDA lists examples of these within the document. 

Additionally, the FDA will also allow infusion pump accessories to be used outside their indicated shelf life and duration of use due to the need for these devices during the Coronavirus pandemic. 

Emergency Use Authorisations (EUAs) will be granted by the FDA for infusion pumps that are not currently legally marketed in the US, and to non-medical device manufacturers who may be able to assist in increasing the supply of the devices. 

Clinical thermometers

The new guidelines only apply to certain thermometers: “The enforcement policy in this guidance applies to clinical electronic thermometers, which are regulated as class II devices under 21 CFR 880.2910, product code FLL.” 

In an attempt to ensure supply is able to meet demand, the document also states that the: “FDA does not intend to object to the distribution and use of clinical electronic thermometers that are not currently 510(k) cleared without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency.”

The Iceland-based digital health company Sidekick has adapted its technology to provide remote monitoring, triage and support for COVID-19 patients with the help of the Reykjavik-based computer games firm CCP.

Sidekick is providing the country’s emergency management authorities with a national COVID-19 programme to help manage infected individuals in their homes.

The Sidekick COVID-19 programme is a CE-marked medical device allowing patients to self-report on a panel of symptoms and measurements on a predefined schedule several times a day if needed.

It is backed by an advisory board of nine infectious disease specialist doctors, as well as data and AI expertise from Apple and Google’s Assistant.

Sidekick said it had put the technology together in a matter of days and had borrowed resources from CCP, famous for producing the massively multiplayer online role playing space game Eve Online, to create an algorithm that classifies patients by disease severity.

It then alerts healthcare professionals from Iceland’s emergency services if their condition deteriorates.

The technology gives an aggregate score used to stratify patients into four categories ranging from “okay” to “critical”, using a symptom assessment scale from zero to 25.

Sidekick, which already works on gamified digital health products with companies including Bayer and Pfizer, is working on an updated version of the algorithm drawing on data from a development cohort of 450 different people.

This will be used to create an artificial neural network classifier that will be validated in 150 new patients randomly selected from the same national Icelandic cohort.

An application has been filed for an expedited ethics approval from the Icelandic National Bioethics Committee and Sidekick expect this validated model to be live next week..

Results will be submitted for publication in a peer-reviewed journal.

The remote care solution hopes to save hours of phone calls for symptom evaluation, allowing healthcare professionals to focus their efforts on the most urgent cases.

Patients also receive targeted information and support such as videos and messages from their clinical teams and prompts to hydrate and manage their medication.

Sidekick estimates that the programme, including integration into healthcare processes, programme content, and the clinical algorithm, can be adapted to different communities within one or two weeks.

Dr Ragnar Ingvarsson, chief physician of Iceland’s COVID-19 Response Unit said:  “We have been carefully planning for the worst-case scenario possible, which is why all the relevant stakeholders in Iceland agreed that we should explore all possibilities to reduce the pressure on our healthcare resources and at the same time deliver quality care to patients.

“Sidekick‘s response has been excellent and within ten days they have delivered a very impressive remote care platform, which allows us to closely monitor patients diagnosed with COVID-19 in home isolation. This gives us that extra buffer needed in case of a sharp rise in cases in Iceland, allowing us to focus our resources on those patients who most urgently need it.”

GlaxoSmithKline has announced plans to collaborate with China’s Xiamen Innovex on a potential vaccine to treat the COVID-19 coronavirus.

The companies are testing a recombinant protein-based coronavirus vaccine candidate, known as COVID-19 XWG-03, which is being developed by Innovax with Xiamen University.

GSK will provide Innovax with the adjuvant need for a preclinical test of the vaccine which is based on a series of truncated S (spike) proteins from the novel coronavirus SARS-CoV-2 that causes the respiratory disease known as COVID-19.

Like many of the other vaccines in development the vaccine uses a version of the spike proteins seen on the surface of the coronavirus to prime the body’s immune system.

GSK said that preclinical data from one of its collaborations has suggested that the adjuvant may have a benefit.

Adjuvants are important in vaccines as they boost the body’s reaction to the vaccine and reduce the amount of antigen needed to produce a therapeutic effect.

In the case of COVID-19, this would help the manufacturer of a successful vaccine keep pace with demand.

GSK expects data to be reported from the various collaborations over the next 3 months and these data will inform next steps for clinical development of the candidate vaccines.

CEO Emma Walmsley said the company is looking at further collaboration opportunities with companies and institutions.

It is also exploring options to share manufacturing capacity and provide large-scale manufacturing for any vaccine that makes it through the clinical development process.

At the beginning of February GlaxoSmithKline joined with the not-for-profit organisation, the Coalition for Epidemic Preparedness Innovations (CEPI) to supply adjuvants in the effort to find a vaccine against the coronavirus.

According to the latest information published by the World Health Organization, there are two vaccines in clinical trials against coronavirus.

These are an adenovirus vector-based vaccine being developed in China by CanSino Biologics and the Beijing Institute of Biotechnology, and Moderna’s mRNA vaccine that is being developed in partnership with the US-government backed NIAID.

There are 60 more vaccine candidates in preclinical testing, using a variety of different approaches including DNA, viral vectors, protein subunits, and live attenuated viruses.

France’s Servier has signed a deal to buy the Danish biotech Symphogen, which specialises in antibody-based therapies for cancer.

Neither party disclosed financial details of the deal, which involves a straight transaction where Servier will buy all of the Copenhagen-based biotech’s shares.

The companies have been in talks for several months, and Servier said the deal will strengthen its offering in antibody technology, while ensuring Symphogen’s antibody and early-development technology is fully used.

Servier will gain full ownership of Symphogen’s pipeline of oncology and immune-oncology drug candidates, as well as the antibody discovery and development platform.

Once the transaction is complete, Symphogen will become Servier’s antibody “centre of excellence” for its therapeutic areas.

Symphogen will operate as a standalone organisation with Servier, maintain its headquarters in Ballerup, Denmark, and “continue to rely on its current and experienced employees”.

Servier’s president Olivier Laureau said: “The acquisition of Symphogen is an important step for Servier to meet its strategic ambitions to become a recognised player in oncology.

“Antibody-based therapies remain a key therapeutic modality within oncology and immuno-oncology, and with Symphogen’s strong antibody capabilities, this acquisition will boost significantly our R&D in oncology and in our other therapeutic areas.

“Our goal is to bring life-saving treatments to greater numbers of patients around the world.”

Servier is trying to reinvent itself following the safety scandal centred around its home market in France, and the weight loss drug Mediator (benfluorex).

In September, Servier finally went on trial focusing on why the drug was allowed to stay on the market in France from 1976 until 2009 despite the fact it was suspected of causing heart and pulmonary failure.

Over the period Mediator is thought to have caused between 500 and 2,000 deaths because of its cardiovascular side effects, and is thought to have left thousands of other people with debilitating health problems.

Servier has already paid more than a hundred million euros in compensation to patients affected by the scandal and offered compensation to thousands more people who took the drug.

Recruitment for a patient registry app for COVID-19 is underway, which could help governments find their way out of lockdown by remote monitoring of symptomatic and asymptomatic patients following diagnosis.

Digital research company ObvioHealth has launched the Obvio-19 platform, which will use an app to monitor 10,000 Americans during the coronavirus pandemic.

The registry will remotely enrol and collect data on medical history, immune response and symptoms in the general population over a period of six months for each participant.

It’s hoped that the study will offer insights on evolution of symptoms, flag risk factors associated with infection, and provide further information on how the immune system responds to the SARS-CoV-2 virus that causes the disease.

Data collected could be useful as governments across the world look for exit strategies for the lockdowns that are helping to suppress the virus but causing economic misery across the globe, with millions of people stuck at home unable to work.

ObvioHealth began recruitment yesterday while awaiting final app approval from Google and Apple.

Once the app goes live participants will receive an email with instructions on how to download it, and will complete a questionnaire on demographics, medical history, contact with infected individuals and daily symptoms related to COVID-19.

Those who have previously tested positive or show or develop symptoms may receive a finger-prick test to assess their immune response and report results via the app.

ObvioHealth was founded in 2017 by health consulting agency SPRIM and is backed by Tikehau Capital and life sciences contract research and services firm IQVIA.

In a separate development, digital health firm Ada Health has launched a COVID-19 assessment and screening app.

Ada’s existing services use artificial intelligence to assess symptoms and this has now been expanded to cover COVID-19.

The new screener is available on the company’s website and is free to use and can be embedded by partners, health systems and care providers to support efforts against the disease.

Ada said the app will be regularly updated and will enable users to receive more personalised and regionally-specific guidance, advice, and care navigation.

It is currently available in English, but will be made available in French, German, Italian, Portuguese, Spanish, Arabic and other languages in the coming days.

The European drugs regulator has stopped short of granting widespread use of the drug chloroquine against COVID-19, days after the FDA said it could be used under emergency measures to fight the outbreak.

An unproven medicine against COVID-19, chloroquine and the less toxic hydroxychloroquine are currently licensed to treat malaria and autoimmune diseases such as lupus.

Most of the evidence to support use of chloroquine or the less toxic hydroxychloroquine against the disease comes from a small trial in France.

But the evidence has shown toxicity issues with chloroquine, also used in lupus and rheumatoid arthritis, which can permanently damage the eye and cause vision loss if used in the long term.

While the FDA and the French regulator have granted a wide emergency licence for chloroquine for COVID-19, the EMA has made no such decision, instead leaving it to national regulators to make decisions on implementing such programmes.

In a statement the EMA noted that while studies of chloroquine and hydroxychloroquine are ongoing in COVID-19, the drugs must not be used outside their authorised uses except in clinical trials or nationally agreed protocols.

The EMA noted that the drugs are vital medicines for patients with autoimmune conditions and warned that they should not be denied access to them because of stockpiling for COVID-19.

Paul Hudson, CEO of France’s Sanofi, has told Reuters in an interview that the company is capable of producing millions of doses of hydroxychloroquine for COVID-19.

According to Hudson, the company has made a choice to “overproduce” drugs to ensure hospitals in the Europe and US can keep pace with demand.

Hospital executives and doctors from nine European countries warned in an open letter on Wednesday that they only had up to two weeks’ worth of some medicines used in intensive care units.

However Sanofi is running at 93% capacity according to Hudson, as staff with coronavirus symptoms such as fever and any employee who has been in close contact with them are sent home for two weeks.

Fate Therapeutics, the company announced a multi-billion dollar deal with Janssen Biotech to develop cell therapies for the treatment of cancer.

The partnership will leverage San Diego-based Fate Therapeutics’ induced pluripotent stem cell (iPSC) product platform and Janssen’s proprietary tumor-targeting antigen binders to create novel CAR NK and CAR T-Cell product candidates that will be developed against up to four tumor-associated antigens for hematologic malignancies and solid tumors. Fate will advance the different candidates through preclinical studies to the point of the filing of an Investigational New Drug Application with the U.S. Food and Drug Administration. When that time comes, Janssen will have the right to exercise its option for an exclusive license for the development and commercialization of collaboration candidates targeting the tumor-associated antigens.

Fate’s iPSC platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses, according to the company. The company’s approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass-produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment, the company said.

Under terms of the agreement, Fate will receive $50 million in upfront cash, as well as a $50 million equity investment by Janssen. Janssen will also cover the funding costs of the R&D of the collaboration candidates. Once Janssen takes over the program, Fate will then be eligible to receive payments of up to $1.8 billion upon the achievement of development and regulatory milestones and up to $1.2 billion upon the achievement of commercial milestones. Fate will also be eligible to receive double-digit royalties on worldwide commercial sales of products targeting the antigens. Additionally, Fate has the right to co-commercialize the candidates should they be approved and share equally in profits and losses, the company said in its announcement.

Scott Wolchko, president and chief executive officer of Fate Therapeutics, touted the partnership with Janssen. He said the collaboration combines Janssen’s “deep domain expertise in oncology,” along with their proprietary technologies for targeting and binding certain tumors with Fate’s iPSC product platform to develop novel off-the-shelf CAR NK and T-cell cancer immunotherapies.

“The collaboration strengthens our financial and operating position through a focused effort of developing cell-based cancer immunotherapies utilizing Janssen’s proprietary antigen-binding domains while enabling us to continue to exploit our deep pipeline of wholly-owned product candidates and further develop our off-the-shelf, iPSC-derived cell-based immunotherapies,” Wolchko said in a statement.

The alarming worldwide diffusion of COVID-19 has inspired numerous governments to intervene to counter the spread of the disease. For their part, regulatory bodies that govern medical devices have taken steps to ease import restrictions and expedite registration processes for needed goods, seeking to ensure that regulations do not block the development or supply of devices that could save lives. What follows is a roundup of regulatory updates from the Asia-Pacific region pertaining to the outbreak.

Chinese regulatory bodies roll out numerous emergency regulatory changes

• The National Medical Products Administration (NMPA) announced that they will expedite the registration of medical protective clothing devices that meet relevant standards from the EU, US, or Japan, as well as the Chinese standard GB 19082-2009 (Technical Requirements for Single-Use Protective Clothing for Medical Use), as a temporary emergency measure.
• The Center for Medical Device Evaluation (CMDE) announced adjustments to their medical device application acceptance and consultation services, beginning on February 3. The CMDE encourages the use of their online eRPS system and will temporarily suspend on-site acceptance of applications and consultation services.
• The CMDE published two new technical review guidelines on nucleic acid detection reagents and antigen/antibody detection reagents designed for IVDs that will detect coronavirus.
• The CMDE announced extensions for renewals and data correction requests due to delays caused by the COVID-19 outbreak. Extensions for renewal applications can now be filed within three months of the date the outbreak dissipates. Applications that have been notified to submit additional technical reviews or data corrections from February 12, 2019 to the end of the outbreak will be given an additional year to submit the information.
• The CMDE published a guidance document on registering devices that use deep learning technology to identify lung abnormalities caused by pneumonia based on CT images of the lungs to evaluate people infected with coronavirus. The guidance specifies the basic requirements, as well as the requirements for risk management, software research materials, clinical trials, instructions, and software updates for these devices.
• Due to a shortage of medical masks in Hubei province, the provincial NMPA office will allow importation of unregistered masks as an emergency measure. While the measure is in effect, only an import authorization is needed for qualifying products. Manufacturers will need to work with licensed distributors in Hubei in order to import under this allowance.

Singapore names devices temporarily exempt from registration requirements

The Singapore Health Sciences Authority (HSA) issued the Health Products (Import, Wholesale and Supply of Medical Devices — Exemption) Order 2020 on January 31. The Order exempts specified devices (particulate respirators, protective gear, surgical masks, and thermometers for measuring human body temperature) from registration requirements, and it exempts importers and wholesalers of those devices from establishment licensing requirements.

During the time when the Exemption Order is in effect, the named devices can be imported for commercial (or other non-personal) purposes through a simplified notification route, which is outlined on the HSA website.

Malaysia provides application for face mask registration exemption

In order to safeguard an adequate supply of face masks, the Malaysian Medical Device Authority (MDA) announced that companies can apply for exemption from registration for these devices through a Notification of Medical Device for Special Access. Devices that have obtained this exemption are not permitted to be advertised.

Australia provides registration exemption for specified goods from authorized laboratories

Australia’s Therapeutic Goods Administration (TGA) issued the Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020 on January 31 for devices used for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of the novel coronavirus infection. The exemption is available for those devices imported, exported, manufactured, or supplied by a laboratory that is a member of the Public Health Laboratory Network. Devices supplied for purposes relevant to the public health threat posed by the COVID-19 emergency will circumvent several registration requirements, including the Essential Principles, conformity assessment procedures, and inclusion in the Australian Register of Therapeutic Goods (ARTG).

Thailand reclassifies alcohol-containing gel products as cosmetic goods

In order to avoid shortages, the Thai Food and Drug Administration (FDA) announced on March 11 that it would remove alcohol-containing gel products such as hand sanitizers from the category of regulated medical devices. These products were formerly regulated as cosmetic goods and will be legally defined as such again. This step will allow such products to reach the public considerably faster.

By GR-CIS  | April 03, 2020  – GR-CIS, a scientifically backed Regulatory service organization actively advise stakeholders on potentials COVID-19 vaccines and treatment studies. The organization has also taken significant  steps over the past few months to ensure that the organizations’s existing structure continue as possible in this challenging environment.

This challenging environment has forced GR-CIS teams to swiftly adapt and apply learnings to trials in other locations as pandemic spread brings new challenges to ongoing clinical trials.

GRCIS is deeply committed to driving research into COVID-19 and our experts are currently advising sponsors and industry stakeholders on swift, safe and efficient conduct of potential and treatment studies for COVID-19. GR-CIS expert also supporting companies for Registration and Importing new Diagnostic devices in India.

In response of the COVID-19 outbreak, many Regulatory agencies has intervene to counter the spread of the disease. For their part, regulatory bodies have taken steps to ease import restrictions and expedite registration processes for needed goods, seeking to ensure that regulations do not block the development or supply of devices that could save lives.

We continue to assess the ever-changing impact of COVID-19 on our operations and we are committed to keeping clients regularly updated on the latest developments.