covid 19

Johnson & Johnson: Clinical study of potential coronavirus vaccine could start by end of year

Johnson & Johnson (NYSE:JNJ) said today that its Janssen Pharmaceutical Cos. has forged a partnership with the Beth Israel Deaconess Medical Center (BIDMC) to support coronavirus vaccine development.
Janssen and the virology lab led by Dr. Dan Barouch at BIDMC have started preclinical testing of multiple vaccine prospects, with the goal of identifying a COVID-19 vaccine candidate for clinical trials by the end of the month. A Phase 1 clinical study of the potential vaccine candidate could start by the end of the year.

Janssen is already preparing to upscale production and manufacturing capacities to meet global needs once the vaccine is available.
“It is critical to work with the best scientific minds as we look to rapidly identify and develop solutions to the COVID-19 outbreak,” said Dr. Paul Stoffels, executive committee vice chair and chief scientific officer at Johnson & Johnson.
“We are grateful for talented and experienced collaboration partners like Dan Barouch and his team at BIDMC. By mobilizing our collective resources, we believe we can leverage the top science and cutting-edge capabilities to respond to this pandemic,” Stoffels said in a news release.
Janssen’s coronavirus vaccine development will utilize the company’s AdVac and PER.C6 technologies to rapidly upscale production of an optimal vaccine candidate, according to the company. The company has already used the technology to develop its investigational Ebola (which also utilizes its MVA-BN technology), Zika, RSV and HIV vaccines.
The Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center worked closely with Janssen on developing the Zika and HIV vaccines.
“We are currently evaluating a series of potential vaccine candidates for COVID-19,” Barouch said. “This collaboration with Janssen is aimed at the development of a COVID-19 vaccine that would allow for rapid development, large-scale manufacturing, and global delivery.”
Johnson & Johnson’s Janssen has already been collaborating on COVID-19 vaccine development with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.
Janssen is also screening its library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments and provide relief for people around the world.



How is coronavirus vaccine development going in the U.S.?

Researchers in Pittsburgh and Boston are moving forward with research into two separate vaccine programs against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic.
The work of the University of Pittsburgh School of Medicine researchers is detailed in a paper published recently in EBioMedicine, which is published by the Lancet.
Delivery of the vaccine involved a microneedle array to increase potency. The fingertip-sized patch uses dissolvable needles – made of sugar and protein pieces – to deliver the virus’s spike protein into the skin, eliciting an immune response.
Meanwhile, Janssen Pharmaceutical Co, a division of Johnson & Johnson, announced it will partner with Beth Israel Deaconess Medical Center (BIDMC) to support coronavirus vaccine development. Janssen has started preclinical testing of several projects in its work with Dr. Dan Barouch at BIDMC.
They expect to identify a COVID-19 vaccine candidate for clinical trials by the end of the year.
Both programs are benefiting from recent experiences in vaccine development. The Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, for example, worked closely with Janssen on developing Zika and HIV vaccines.
Janssen’s coronavirus vaccine development will utilize the company’s AdVac and PER.C6 technologies to rapidly upscale production of an optimal vaccine candidate, according to the company.
This same technology also had been used to develop its investigational Ebola (which also utilizes its MVA-BN technology), Zika, RSV and HIV vaccines.
“We are currently evaluating a series of potential vaccine candidates for COVID-19,” Barouch said. “This collaboration with Janssen is aimed at the development of a COVID-19 vaccine that would allow for rapid development, large-scale manufacturing, and global delivery.”
Johnson & Johnson’s Janssen has already been collaborating on COVID-19 vaccine development with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response
At the same time, the researchers in Pittsburgh said they were able to act quickly because they had worked with the coronavirus in earlier epidemics.
“We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus,” said co-senior author Dr. Andrea Gambotto, associate professor of surgery at the Pitt School of Medicine. “That’s why it’s important to fund vaccine research. You never know where the next pandemic will come from.”


FOMAT Medical Research announces a partnership with Febo

Febo is a digital upstart, with its sights set on empowering patients by transforming the way they educate themselves.

Febo is an online platform where you can get personalized information about your medical interests and stay updated on the newest developments, news, clinical trials, publications, thoughts from key opinion leaders, treatments, medicines, and more.

We recognize that finding health information that is both reliable and relatable is a serious challenge in today’s digital environment. There is an enormous burden associated with finding content that is specific, timely, accurate, trustworthy, or easily shareable. And yet, this is precisely the type of resource people need if they are going to have a voice in planning their treatment and to empower themselves in managing their condition. This is why Febo was created.

With the ubiquitous nature of the internet as the primary source of information in our lives, paired with the growing share of healthcare costs that falls to patients themselves, individuals now have more ability and motivation to research their own conditions than ever before. At the same time, we have forces such as direct-to-consumer advertising by pharmaceutical companies, misleading media coverage of medical research, and the rise of alternative medicine. making it very difficult for those patients to find reliable, valid information online.
Nicolas Focil

FOMAT Medical Research sees the value in patient education, and we look forward to extending our mission of innovating healthcare for underrepresented populations through our partnership with Febo by bringing knowledge to people around the globe who might not otherwise have access to it.

We want you to be a part of this movement, and to join us in building this groundbreaking new platform.

google play

Download Febo on the Apple App Store and Google Play Store Today!

Learn more visit


eClinical Trials Center of Excellence


    6 ways to prepare your medical practice for coronavirus

    Many physician practices throughout the U.S. are starting to see the impact of the coronavirus(COVID-19).

    As the highly contagious virus is only likely to spread in the weeks ahead, now is the time for leaders to prepare for how they will help diagnose and treat patients and keep their practices running, says Debra A. Cooper, R.N., a senior risk management specialist with Coverys, a medical liability insurer.

    Start planning now for when a patient presents at your practice with symptoms of this novel virus, Cooper said in an interview with FierceHealthcare. She has spent much of her career preventing, treating and educating healthcare organizations about infectious diseases,
    The biggest thing is communication and knowledge,” she says.
    Practices that are affiliated with a hospital or healthcare system may have an advantage, as they can piggyback off their efforts to prepare for coronavirus and get some guidance from them.
    Independent practices may have to work harder to create their own plan, she says.
    “The best thing they can do is just to prepare,” Cooper says, as luckily most areas of the United States have not seen the kind of outbreak that occurred in China, where the pandemic began. However, health experts say the outbreak in the U.S. will be worse before it gets better.
    Hospitals are looking at interim guidelines from the Centers for Disease Control and Prevention (CDC), but many of those guidelines don’t relate to a physician’s office, she says.
    So, where to begin? Here are six recommendations to follow:

    Have a plan to identify patients who may have COVID-19 or be at risk for the virus. Practices should develop triage questions for their employees to use to recognize patients infected with the virus, she says.
    You will want to modify your existing triage questions for staff to use when patients call your practice. Have a standard script for the staff in your office who answers the phone.
    They will want to ask patients if they have traveled to any geographic location in the last 14 days where there is widespread ongoing transmission of the virus. The list of countries is growing. The virus that originated in Wuhan, China is now widespread in Italy, South Korea, Iran and is spreading in other European countries. So-called “hot spots” in the U.S., where the virus has spread, include Washington state, California, and New York.
    Ask patients if they have had contact with a person who has tested positive for coronavirus or is suspected of having the virus. Have they been caring for someone with the virus?

    Ask patients about their symptoms. Do they have respiratory symptoms, a cough, a fever, shortness of breath?
    If patients are at risk of having coronavirus, they will need to get tested. There has been a shortage of coronavirus test kits, but the government says more will be available.
    Be aware of the designated testing facilities in your area, including hospital emergency rooms. Some communities have set up drive-up testing facilities. Before you send a patient to the hospital for testing, your office will want to call and alert them a patient with coronavirus symptoms is on the way, Cooper says.
    The CDC does have a healthcare professional preparedness checklist for the arrival of patients with confirmed or possible coronavirus.

    Be ready for patients who may come to your practice without an appointment. In that case, your staff will have not been able to screen patients to determine if they are at risk of coronavirus. It may be beneficial to post signs at entrances to your practice advising patients that they need to call the office to answer some basic questions associated with the risk of COVID-19 if they don’t have a pre-scheduled appointment.
    Include on that notice that they call the office from their vehicle in the parking lot or from outside the office to answer basic questions to determine their risk before entering the office.

    For patients who are at risk, you will want to take precautions when they come into your practice.
    “This is where the choice of the physician may change,” Cooper says. You will want to make masks available and take any patient at-risk to a private room. You don’t want them to expose other patients or staff members.
    If you have a negative pressure room, that will prevent the spread of germs in your facility. Cooper says she has heard of practices creating a negative pressure room by opening a window and placing a fan so it draws the air outside the building rather than letting it circulate to other areas where it could expose other patients or healthcare staff to the virus.
    Plan ahead with local hospitals. Even if your practice is not affiliated directly with a hospital, practices will have relationships that they have developed. Get into communication with facilities in your area about what to do, including if you are in a rural area without a nearby hospital.
    “The biggest thing is preparation. Where are our resources? Who can we depend on?” Cooper says.
    Practices should also keep in mind their responsibility to notify their local or state public health department if they have a high-risk patient. Have all of those processes in place, she says.
    Follow good infection control practices. Remind staff of proper infection control procedures, including handwashing and appropriate use of personal protective equipment, including masks, gowns and gloves.
    Since there are concerns about possible shortages of PPE, practices may want to take steps to control their supply. For instance, many hospitals are now locking up supplies of masks and dispensing them when requested by healthcare staff.
    You will need to frequently clean high-touch areas using approved cleaning supplies, Cooper says since the virus can survive up to three days on plastic and metal surfaces.
    The CDC has provided recommendations for environmental cleaning and disinfection, along with the FDA which has a list of approved products.
    If you use an outside cleaning company, be sure they are aware of what’s recommended.
    Plan for how your practice will keep running if you are short on staff. Communicate with staff about your practice’s policies and procedures when it comes to illness. Employees who are sick must not come to work.
    Plan now for what you will do if some employees cannot come to work, she says. For a small practice, the loss of one or two employees could mean that half of their workforce is out, she says.
    This is a real possibility as schools around the country close due to the coronavirus outbreak, leaving working parents scrambling to find child care.
    Keep current on the information. It is imperative that practice leaders stay up-to-date on the ever-evolving coronavirus pandemic. There is no shortage of news about the coronavirus, and the CDC provides information about the virus, Cooper says.


    A drug meant for Ebola may also work against coronaviruses

    A drug meant for Ebola may also work against coronaviruses

    Understanding how drugs work is an important step in developing new treatments for COVID-19



    A group of University of Alberta researchers who have discovered why the drug remdesivir is effective in treating the coronaviruses that cause Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) expect it might also be effective for treating patients infected with the new COVID-19 strain.
    “Even if you know a drug works, it can be a red flag if you don’t know how it works,” said virologist Matthias Götte. “It is reassuring if you know exactly how it works against the target.
    “We know the drug works against different coronaviruses, like MERS and SARS, and we know the novel coronavirus is very similar to SARS. So I would say I’m cautiously optimistic that the results our team found with remdesivir and MERS will be similar to COVID-19.”
    The study, published in the Journal of Biological Chemistry this week, is among the first in Canada to discuss the COVID-19 strain.
    Until now, there has not been a published explanation of why remdesivir may work against coronaviruses, said Götte, who added his study is an important step in answering that question.
    Developed by Gilead Sciences as a response to the 2014 West African Ebola virus epidemic, remdesivir was first used on a patient with the novel coronavirus earlier this year in the United States.
    As reported in the New England Journal of Medicine, the patient was given the drug on the seventh day of illness, and showed marked improvement the following day, with symptoms eventually disappearing altogether. And at a recent press conference in Beijing, the assistant director-general of the World Health Organization, Bruce Alyward, said remdesivir is the only drug available that may have real efficacy against COVID-19.
    “What our study showed was that remdesivir essentially mimics one of the natural building blocks for RNA synthesis necessary for genome replication of the virus. Enzymes within the virus are synthesizing the viral RNA genome with these building blocks, but they mix up the bits they need with the drug. Once the drug is incorporated into the growing RNA chain, the virus can no longer replicate,”explained Götte.
    He said the next step is to wait for results from ongoing clinical trials with remdesivir, which are expected by the end of April. Even then, that won’t be the end of the story, he cautioned.
    “It’s likely we’ll need more than one drug to properly fight emerging diseases like COVID-19, as we have with HIV and hepatitis C virus infections,” Götte said.
    “Ideally, we will have a couple of drugs because certain strains could be resistant to certain treatments.”
    Götte’s study was supported by grants from the Canadian Institutes of Health Research and the Alberta Ministry of Economic Development, Trade and Tourism through the Major Innovation Fund Program and Antimicrobial Resistance — One Health Consortium.

    Glaucoma Awareness Week

    Glaucoma Awareness Week

    What is glaucoma?

    Glaucoma is a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of your eye called the optic nerve.
    The symptoms can start so slowly that you may not notice them. The only way to find out if you have glaucoma is to get a comprehensive dilated eye exam.
    There’s no cure for glaucoma, but early treatment can often stop the damage and protect your vision.

    What are the types of glaucoma?

    There are many different types of glaucoma, but the most common type in the United States is called open-angle glaucoma — that’s what most people mean when they talk about glaucoma. Other types of glaucoma are less common, like angle-closure glaucoma and congenital glaucoma.

    What are the symptoms of glaucoma?

    At first, glaucoma doesn’t usually have any symptoms. That’s why half of the people with glaucoma don’t even know they have it.
    Over time, you may slowly lose vision, usually starting with your side (peripheral) vision — especially the part of your vision that’s closest to your nose. Because it happens so slowly, many people can’t tell that their vision is changing, especially at first.
    But as the disease gets worse, you may start to notice that you can’t see things off to the side anymore. Without treatment, glaucoma can eventually cause blindness.

    What causes glaucoma?

    Scientists aren’t sure what causes the most common types of glaucoma, but many people with glaucoma have high eye pressure (intraocular pressure) — and treatments that lower eye pressure help to slow the disease.
    There’s no way to prevent glaucoma. That’s why eye exams are so important — so you and your doctor can find it before it affects your vision.

    How will my eye doctor check for glaucoma?

    Eye doctors can check for glaucoma as part of a comprehensive dilated eye exam. The exam is simple and painless — your doctor will give you some eye drops to dilate (widen) your pupil and then check your eyes for glaucoma and other eye problems. The exam includes a visual field test to check your peripheral (side) vision.

    What’s the treatment for glaucoma?

    Doctors use a few different types of treatment for glaucoma, including medicines (usually eye drops), laser treatment, and surgery.
    If you have glaucoma, it’s important to start treatment right away. While it won’t undo any damage to your vision, treatment can stop it from getting worse.

    Medicines. Prescription eye drops are the most common treatment. They lower the pressure in your eye and prevent damage to your optic nerve.

    Laser treatment. To lower pressure in your eye, doctors can use lasers to help the fluid drain out of your eye. It’s a simple procedure that your doctor can do in the office.

    Surgery. If medicines and laser treatments don’t work, your doctor might suggest surgery. There are several different types of surgery that can help the fluid drain out of your eye.
    Talk over your options with your doctor. While glaucoma is a serious disease, treatment works well. Remember these tips:

    • If your doctor prescribes medicine, be sure to take it every day
    • Tell your doctor if your treatment causes side effects
    • See your doctor for regular check-ups
    • If you’re having trouble with everyday activities because of your vision loss, ask your doctor about low vision services or devices that could help
    • Encourage family members to get checked for glaucoma, since it can run in families
    Crohn's disease study identifies genetic variant with potential to personalize treatment

    Crohn’s disease study identifies genetic variant with potential to personalize treatment

    The largest study ever to look at why an expensive and commonly used group of drugs fails some patients with Crohn’s disease has identified a genetic marker that could individualize drug treatment.

    A UK wide collaboration led by the University of Exeter, Royal Devon & Exeter NHS Foundation Trust and the Wellcome Sanger Institute, has demonstrated that a genetic variant carried by 40% of the population explains why some patients develop antibodies against the anti-TNF drugs, infliximab, and adalimumab and lose response. The authors conclude that a further trial is required to confirm that genetic testing prior to treatment will reduce the rate of treatment failure by facilitating the most effective choice of therapy for individual patients. The research, part-funded by Wellcome, Crohn’s & Colitis UK, Guts UK, Cure Crohn’s Colitis and supported by the NIHR, is part of a program of work committed to finding the right drug for the right patient first time.
    Anti-tumor necrosis factor (TNF) drugs, infliximab, and adalimumab are used to treat patients with moderate to severe Crohn’s disease and ulcerative colitis when other treatments have not worked. Also known as biological medicines, these drugs work by blocking TNF, a protein that drives persistent gut inflammation. Introduced in the 1990s, anti-TNF drugs now rank in the top five by drug spend in the NHS.
    Published in Gastroenterology, the Personalised anti-TNF therapy in Crohn’s disease study (PANTS) looked at the clinical data and genetics of 1,240 patients with Crohn’s disease starting anti-TNF treatment at 120 UK hospitals — the largest cohort of its kind.
    Although anti-TNF drugs have given new hope for people with Crohn’s and Colitis and provided an important treatment option, many patients lose response over time. One of the major reasons patients lose response is the development of an immune response to the drug (immunogenicity). Anti-TNF drugs are large, complex molecules, made inside living cells. Repeated administration causes the immune system to recognize the drug as a potential threat rather than a medicine, leading to the production of antibodies against the drug. These antibodies increase the rate at which the drugs are removed from the body. As well as reducing the effectiveness of treatment, antibodies may also cause adverse drug reactions at the time of injection or infusion. This research identified a genetic marker HLA-DQA1*05, carried by 40 percent of the European population that increases the risk of development of antibodies against infliximab and adalimumab 2-fold.
    Crohn’s disease is a lifelong illness that causes inflammation and ulceration of the digestive system. There are approximately 160,000 patients with Crohn’s disease in the UK and this number is growing — it is a hidden health crisis. The disease most commonly presents in young adults, adolescents, and children. Symptoms include urgent diarrhea, rectal bleeding, abdominal pain, profound fatigue, and weight loss.
    PANTS study investigator Professor Tariq Ahmad, Head of the Inflammatory Bowel Disease and Pharmacogenetics Research Group at the University of Exeter, and consultant gastroenterologist at the Royal Devon and Exeter Hospital, U.K said: “We strongly believe that this type of research is essential to developing cost-effective, treatment strategies for patients with inflammatory bowel disease.”
    Helen Terry, Director of Research, Crohn’s and Colitis UK said: “The future of Crohn’s and Colitis treatment is personalized medicine, so the identification of a genetic marker that explains why anti-TNF drugs don’t work for some people with Crohn’s is highly significant. These results are extremely promising and further research could lead to individualized treatment and better outcomes for the people living with these debilitating conditions.”
    Funding information: Guts UK, Crohn’s & Colitis UK, Cure Crohn’s Colitis, Wellcome. Unrestricted grants: Abbvie, Merck Sharp & Dohme, NAPP, Pfizer, Celltrion.


    FOMAT Makes Waves at SCRS 19

    FOMAT Makes Waves at SCRS 19 

    Last weekend several prominent members of the clinical research industry gathered at the 2019 Global Site Solutions Summit hosted at the Diplomat Beach Resort in Hollywood Florida. This marks the 14th year in a row that the event has been held, and it once again served as a space for sites, CRO’s, and other industry professionals to build their business, establish connections, discover innovations, and discuss best practices in the field of clinical research. 
    To commemorate the passing of SCRS founder and CEO Christine Pierre last year, a special tribute and commemorative pin bearing her iconic red glasses were handed out to members of the event. Throughout the weekend, the expo halls rang with nostalgia as countless stories of Christine’s contributions to the industry and legacy as a trailblazer for global clinical research sites were exchanged between guests.  A special tribute was held at the event on October 11 on the main stage from 4:15-4:30 to honor her memory.
    After the hard launch of HyperCORE at DIA in June, SCRS 2019 was the first definitive outing for the alliance that showcased the unity of its eight members. The level of respect and comradery in the organization was at an all-time high during the event. In addition to rekindling old friendships, new relationships between sites, SMO’s and key figures were established. Invaluable feedback was collected from visitors to the HyperCORE booth which will be used to shape future projects and events moving forward. Over the weekend a party for HyperCORE was held at which Executive Director Michael Casey performed an entire magic show and it was a magical evening, to say the least.

    FOMAT CEO Nicholas Focil spoke on October 12th at the “A Shared Vision: Boosting Your Research Operations” panel on October 12 from 4:30 pm – 5:30 pm. The focus of the panel was on operations. How to best optimize practices within a clinical trial and how to establish a shared vision for clinical research on an organizational level. The speakers provided an administrative overview of the clinical, regulatory, and financial risks of research and also discussed how to best determine current and future research staffing models used to drive up quality and profitability. The event was moderated by Tristen Richins (QCare Head of Business Development, IQVIA) with other panelists Hans Christian Hoeck (CEO, TrialCare Research) and Lestter Cruz Serrano (Medical Affairs Advisor, Cognizant) all greatly contributing to the conversation. All three panelists provided insightful commentary and answered questions from the crowd which ranged from university professionals to industry veterans. The panel was overall successful and provided critical insight for the crowd and panelists alike. Overall, SCRS19 was a tremendous success for both HyperCORE and FOMAT. New memories and bonds have been forged that will carry over well after next year’s event.