FOMAT-Medical-Research-awarded-as-Innovative-Company-of-the-Year

FOMAT Medical Research awarded as “Innovative Company of the Year”

 
 
 

Oxnard, California, October 5th, 2020

FOMAT Medical Research, is a company focused on the pharmaceutical industry, based in Oxnard, California, and has over 10 years of experience in developing clinical trials throughout all phases. Currently, the company is a member of HyperCORE International, and has been selected as a leading company within the industry to participate in clinical trials to help find a potential treatment or vaccine to treat or prevent coronavirus 2 (SARS-CoV-2), which was declared as a pandemic by the World Health Organization (WHO) in March.

 

The Company was awarded “Innovative business of the Year” by the Oxnard Chamber of Commerce due to the work we have carried out at our headquarters. FOMAT, from their facilities, offers the community the opportunity to do a free test to detect COVID-19. Through this study, Nicholas Focil, CEO of FOMAT, wants to not only provide to the community a possibility to diagnose the disease but to help find something that will prevent or treat the coronavirus. Nicholas also ensures that the inclusion of “minorities” in the trials would help with data for future treatments. 

FOMAT Medical Research awarded as “Innovative Company of the Year”
“I could not be more proud of my team, especially with what a rollercoaster of a yearthis has been. One of the most important things that this pandemic has broughtto our attention is the importance of trusting one another and working as ateam to make sure to ensure success in everything we do. Here is a unified teamwith one goal, one mission: To help bring society back to normal.”
Nicholas Focil,
CEO
About Oxnard Chamber:

The Oxnard Chamber of Commerce is the catalyst for business growth, the conveyor of leaders and influencers, and the advocate for the Oxnard community. Its mission is to represent the interests of business and advocate for public policy that promotes a healthy economy. Founded in 1908, the Chamber today empowers 500 enterprises and organizations that employ more than 30,000 people.

 
 

About FOMAT Medical Research:

FOMAT Medical Research is an Integrated Research Organization (IRO), or also known as a Site Management Organization (SMO), focused on innovating healthcare throughout the Americas. With over 10 years of experience in participating in Phase 1 through Phase 4 clinical trials in a wide variety of therapeutic areas, we rely on a highly experienced clinical research team that has the professional expertise necessary to assist Sponsors and Contract Research Organizations (CRO) with reaching their project goals quickly and effectively.

Our mission is to diversify clinical trials throughout the Americas and innovating healthcare for underrepresented populations while ensuring that we uphold Good Clinical Practice standards and ethics are upheld. We find itIt is essential that high-quality data is contributed to the scientific community to create better treatments.

 
 
 

COVID-19

Trump Recibe Tratamientos a Base de “Anticuerpos”

Donald Trump ha recibido un tratamiento a base de anticuerpos monoclonal que aún se encuentra en fase experimental y promete beneficios. Nicholas Focil CEO de la compañía FOMAT Medical Research, es uno de los centros en llevar a cabo un estudio clínico de dicho tratamiento, comenta que el presidente Trump, podría salir adelante y recuperarse muy

pronto “… esta medicina hace que entre más rápido te tomas el medicamento, más rápido el cuerpo humano comienza a reaccionar…las posibilidades de mejoría aumentan exponencialmente…”.

 
 

 
Compañía de Oxnard intenta encontrar un tratamiento efectivo para el COVID-19

Compañía de Oxnard intenta encontrar un tratamiento efectivo para el COVID-19

Compañía de Oxnard intenta encontrar un tratamiento efectivo para el COVID-19

“Es la última etapa previo a ser aprobada por el gobierno americano y la FDA para su venta”, dijo Nicholas Focil, CEO de FOMAT.

La lucha contra el COVID-19 continua y una compañía en Oxnard está a la vanguardia, realizando pruebas para encontrar un tratamiento efectivo para ayudar a los enfermos y una vacuna para proteger contra el virus.

FOMAT es el nombre de la compañía de investigación médica que realiza pruebas con medicamentos proporcionados por compañías farmacéuticas y muy pronto por la Organización Mundial de la Salud para encontrar lo más rápido posible un tratamiento y vacuna contra el COVID-19. 

En un edificio en el corazón de Oxnard, que fácilmente puede pasar desapercibido, se lleva a cabo un estudio médico histórico.

Source: Telemundo

Empresa-de-latinos-en-California-trabaja-con-la-OMS-para-encontrar-la-posible-cura-para-el-coronavirus

Empresa de latinos en California trabaja con la OMS para encontrar la posible cura para el coronavirus

Empresa de latinos en California trabaja con la OMS para encontrar la posible cura para el Coronavirus

Nicholas Focil, un bioquímico de origen ecuatoriano, lidera ensayos clínicos para encontrar un posible tratamiento y vacuna del coronavirus en Oxnard, California, con un medicamento considerado “prometedor”.

LOS ÁNGELES, California.– Centro de investigaciones creado por un latino en California trabaja con la Organización Mundial de la Salud (OMS) para encontrar un posible tratamiento y vacuna contra el coronavirus.

“Se ve muy prometedor”, dijo Nicholas Focil a Univision Los Ángeles sobre el cóctel de anticuerpos llamado REGN-COV2, que ha estado ganando atención a nivel nacional como una posible forma de tratar y prevenir la infección causada por el coronavirus.

Focil está al frente de FOMAT Medical Research una empresa de investigación médica, fundada por Nicholas Focil, un bioquímico de origen ecuatoriano, que trabaja en la carrera mundial contrarreloj para comprobar un potencial tratamiento contra el COVID-19.

“La gente piensa que son conejillos de india”, dijo el doctor Augusto Focil a cargo de realizar los ensayos clínicos en la sede de FOMAT en Oxnard, California.

El ecuatoriano explica que cualquier medicamento que hoy en día existe en el mercado debió pasar por una fase experimental como la que ahora ellos realizan para corroborar la efectividad del medicamento que tiene un alto potencial de convertirse en la salida a la crisis de salud mundial que se vive hoy.

Unos 150 centros en Norteamérica y Sudamérica llevarán a cabo una prueba para confirmar si el tratamiento de anticuerpos ofrece un resultado efectivo para las personas que d ieron positivo al virus y la empresa del bioquímico ecuatoriano es una de ellos.

De acuerdo con Nicholas Focil, los fondos para las pruebas provienen del proyecto “Operation Warp Speed” del gobierno federal. Su objetivo es entregar vacunas COVID-19 seguras y efectivas para enero de 2020.

La empresa del latinoamericáno trabaja con la empresa farmacéutica, Regeneron, para llevar a cabo dos ensayos clínicos para un medicamento de anticuerpos (REGN-COV2) que posiblemente pueda tratar, y prevenir el COVID-19. En un segundo estudio, las personas sanas con alto riesgo tomarán el medicamento para medir su efectividad.

Como parte de los ensayos médicos, se habilitó un sitio de pruebas de coronavirus gratuita en un estacionamiento en la calle A, cerca de la Biblioteca Principal de Oxnard, California. A los participantes se les entregarán los resultados de sus prueba en 45 minutos. Las personas que dan positivo, podrían calificar para el ensayo del medicamento, mientras que las personas que dan negativo, pero que han estado expuestas recientemente, pueden calificar para la vacuna.

FOMAT también participará en un proyecto global, llamado Solidarity, qué consiste de ensayos clínicos que involucran a la Organización Mundial de la Salud y la prueba de vacunas.

Source: Univision

aids

Ending AIDS: World Will Fall Short of 2020 Targets

The 2020 targets set by UNAIDS to control global HIV/AIDS infection will not be met with “COVID-19 risks blowing HIV progress way off course,” officials reported.
According to the 2020 Global AIDS Update, 1.7 million people worldwide were newly infected in 2019 with HIV, and that was three times higher than the 500,000 targets for 2020, according to the report at the International AIDS Conference virtual meeting.
“We see that 62% of these infections are among marginalized people: This is about men who have sex with men, sex workers, gay men, prisoners, people who inject drugs,” said UNAIDS Executive Director Winnie Byanyima of Uganda during a media briefing. “These are people whose rights are denied; it is about lifting their human rights violations and restrictions so that we give the opportunity to benefit from science. In at least 73 countries, there are laws that criminalize same-sex relationships; in 106 countries we have laws that criminalize personal drug use.”

“We have work to do,” she stated.
In the report’s forward, Byanyima noted that “The COVID-19 pandemic has changed our world immeasurably over the past six months,” but she also pointed out that “Our progress towards ending AIDS as a public health threat by 2030 was already off track before the COVID-19 outbreak…Modelling conducted on behalf of UNAIDS and the World Health Organization [WHO] has shown that a six-month disruption to medical supplies could result in an additional 500 000 AIDS-related deaths in sub-Saharan Africa alone by the end of 2021.”
She also stressed that closed borders and lockdowns, as well as restrictions on travel, are “dismantling the community operations built up over years to bring HIV medicine to patients who need therapy.”
“One disease should not be sacrificed for another,” Byanyima said.
WHO Director-General Tedros Adhanom Ghebreyesus, PhD, agreed: “While tackling COVID-19 is a global emergency, we must not turn out backs on the 38 million people living with HIV and the millions more at risk of infection.”
“WHO is deeply concerned about the impact COVID-19 has had on the global response to HIV. A new WHO survey shows that access to HIV medicines has been significantly curtailed as reason of the COVID pandemic,” Tedros stated.
He said that 73 countries have reported that they are running out of HIV medications. “To mitigate the impact of the pandemic on antiretroviral access, WHO recommended that all countries prescribe antiretrovirals for longer periods time — up to 6 months,” Tedros said. He also suggested stockpiling condoms and drugs used for pre-exposure prophylaxis.
The UNAIDS program has three objectives, known as the 90-90-90 targets:

  • Diagnosis 90% of individuals with an HIV infection in each country
  • Start 90% of these diagnosed patients with antiretroviral therapy (ART)
  • Get 90% of the patients on medication to reduce their HIV viral load to undetectable levels

Currently, 38 million people worldwide have HIV infections, and 25.4 million of them are on treatment, according to the report, yet 12.6 million are not treated.
Additionally, HIV still impacts girls and women disproportionately. “I am sad to say that women and girls in Africa continue to be the most affected with 59% of all new infection, and we know why: It is caused by gender inequalities, gender-based violence, it is structural barriers that limit girls’ safety; they are not safe in school; they are not safe at home. We can do more for women and girls,” Byanyima emphasized.
Byanyima pointed out that the report does show progress in terms of expanding access to ART, with sub-Saharan Africa showing the most improvement.
“Infections in sub-Saharan Africa has been reduced by 38% in the last 10 years, which is above the global average of a reduction of 23%,” she said. “But we see other regions where the direction of infections is in the other direction: Eastern Europe and Central Asia is going up by 72%, and in Latin America the infection rate is up 21%.”

The 2020 targets set by UNAIDS to control global HIV infection will not be met with “COVID-19 risks blowing HIV progress way off course,” officials reported.
According to the 2020 Global AIDS Update, 1.7 million people worldwide were newly infected in 2019 with HIV, and that was three times higher than the 500,000 targets for 2020, according to the report at the International AIDS Conference virtual meeting.
“We see that 62% of these infections are among marginalized people: This is about men who have sex with men, sex workers, gay men, prisoners, people who inject drugs,” said UNAIDS Executive Director Winnie Byanyima of Uganda during a media briefing. “These are people whose rights are denied; it is about lifting their human rights violations and restrictions so that we give the the opportunity to benefit from science. In at least 73 countries, there are laws that criminalize same sex relationships; in 106 countries we have laws that criminalize personal drug use.”
“We have work to do,” she stated.
In the report’s forward, Byanyima noted that “The COVID-19 pandemic has changed our world immeasurably over the past six months,” but she also pointed out that “Our progress towards ending AIDS as a public health threat by 2030 was already off track before the COVID-19 outbreak…Modelling conducted on behalf of UNAIDS and the World Health Organization [WHO] has shown that a six-month disruption to medical supplies could result in an additional 500 000 AIDS-related deaths in sub-Saharan Africa alone by the end of 2021.”
She also stressed that closed borders and lockdowns, as well as restrictions on travel, are “dismantling the community operations built up over years to bring HIV medicine to patients who need therapy.”
“One disease should not be sacrificed for another,” Byanyima said.
WHO Director-General Tedros Adhanom Ghebreyesus, PhD, agreed: “While tackling COVID-19 is a global emergency, we must not turn out backs on the 38 million people living with HIV and the millions more at risk of infection.”
“WHO is deeply concerned about the impact COVID-19 has had on the global response to HIV. A new WHO survey shows that access to HIV medicines has been significantly curtailed as reason of the COVID pandemic,” Tedros stated.
He said that 73 countries have reported that they are running out of HIV medications. “To mitigate the impact of the pandemic on antiretroviral access, WHO recommended that all countries prescribe antiretrovirals for longer periods time — up to 6 months,” Tedros said. He also suggested stockpiling condoms and drugs used for pre-exposure prophylaxis.
The UNAIDS program has three objectives, known as the 90-90-90 targets:

  • Diagnosis 90% of individuals with an HIV infection in each country
  • Start 90% of these diagnosed patients with antiretroviral therapy (ART)
  • Get 90% of the patients on medication to reduce their HIV viral load to undetectable levels

Currently, 38 million people worldwide have HIV infections, and 25.4 million of them are on treatment, according to the report, yet 12.6 million are not treated.
Additionally, HIV still impacts girls and women disproportionately. “I am sad to say that women and girls in Africa continue to be the most affected with 59% of all new infection, and we know why: It is caused by gender inequalities, gender-based violence, it is structural barriers that limit girls’ safety; they are not safe in school; they are not safe at home. We can do more for women and girls,” Byanyima emphasized.
Byanyima pointed out that the report does show progress in terms of expanding access to ART, with sub-Saharan Africa showing the most improvement.
“Infections in sub-Saharan Africa has been reduced by 38% in the last 10 years, which is above the global average of a reduction of 23%,” she said. “But we see other regions where the direction of infections is in the other direction: Eastern Europe and Central Asia is going up by 72%, and in Latin America the infection rate is up 21%.”
And the African nation of Eswatini, formerly known as Swaziland, has achieved its 90-90-90 targets along with its 95-95-95 targets, Byanyima said.
Another sign of hope: In 2019, Botswana decriminalized same sex relationships, and laws are moving forward in Gabon to do the same.
“So there is progress, but not enough,” Byanyima stated.

Source – https://www.medpagetoday.com/meetingcoverage/iac/87431

FMR

FOMAT Medical Research

FOMAT Medical Research an organization with more than 10 years of experience in the pharmaceutical industry seeks to conduct clinical trials in a wide variety of therapeutic areas.

Currently, we are collaborating with pharmaceuticals and health organizations to conduct clinical trials for possible treatment or vaccines to treat COVID-19 (SARS-CoV-2).

During our recent media exposure, some of our responses have been edited to sound like we create the medication. We would like to clarify that our work is focused on the research through clinical trials of these medical solutions.

 
FOMAT Medical Research es una empresa con más de 10 años de experiencia en la industria farmacéutica, teniendo como objetivo realizar estudios clínicos en las múltiples áreas terapéuticas.

Actualmente nos encontramos colaborando junto a farmacéuticas y Organizaciones de la Salud, realizando estudios clínicos para un posible tratamiento o vacuna para tratar el COVID-19 (SARS-CoV-2).

En la reciente aparición en los medios de comunicación, algunas de nuestras respuestas han sido editadas por lo que dieron a entender de forma equivocada que hemos creado la medicación para curar el COVID-19. Nos gustaría aclarar que nuestro trabajo se centra en la investigación a través de ensayos clínicos de estas soluciones médicas.

novavax

Novavax Secures $1.6 Billion from U.S. Government for COVID-19 Vaccine Program

With rising numbers of COVID-19 infections and as the fight against the novel coronavirus continues, Novavax received $1.6 billion in federal funding to support the clinical development of the company’s vaccine candidate, NVX‑CoV2373.
Gaithersburg, Md.-based Novavax said the funding will allow the company to participate in Operation Warp Speed, the government’s program that has a goal of supporting the development of hundreds of millions of vaccine doses by 2021. The funding granted to Novavax will support the late-stage clinical development of the vaccine candidate, including a pivotal Phase III study. Additionally, the funds will be used to establish large-scale manufacturing in order to deliver 100 million doses of NVX‑CoV2373 by the end of the year.
Stanley C. Erck, president, and chief executive officer of Novavax, said the company was honored to partner with Operation Warp Speed, a program that is supporting multiple shots on goal against COVID-19 by backing multiple vaccine projects, including Moderna’s mRNA program and AstraZeneca’s vaccine candidate.
“The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government, and funding entities join forces to defeat the novel coronavirus together. We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis,” Erck said in a statement.
In April, Novavax identifiedits vaccine candidate for COVID-19, NVX-CoV2373. The vaccine candidate has been developed from Novavax’s proprietary nanoparticle technology and includes the company’s proprietary Matrix-M adjuvant in order to enhance immune responses and stimulate high levels of neutralizing antibodies. NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant.
In preclinical trials, NVX‑CoV2373 demonstrated the indication of antibodies that block the binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. The company initiated a Phase I/II trial in May, with preliminary immunogenicity and safety results expected at the end of July. The Phase II portion of the trial, which will assess immunity, safety, and COVID-19 disease reduction is expected to begin thereafter. The $1.6 billion agreement with the U.S. government will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase III clinical trial with up to 30,000 subjects beginning in the fall of 2020.
The Phase I/II clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI). The company’s vaccine development program also received $60 million from the U.S. Department of Defense.
U.S. Health and Human Services Secretary Alex Azar said including Novavax’s vaccine candidate to Operation Warp Speed increases the odds of having a safe and effective vaccine by the end of 2020.
The Operation Warp Speed agreement also allows for a follow-on agreement with the U.S. government for additional production of the vaccine candidate for U.S. stockpiles. This latest federal funding supports Novavax plans to file submissions for licensure with the U.S. Food and Drug Administration.

Source – https://www.biospace.com/article/operation-warp-speed-backs-novavax-covid-19-vaccine-program-with-1-6-billion-funding/

COVID 19

Want to reopen your pharma lab amid COVID-19? Consider these strategies first

COVID-19 has unleashed a logistical conundrum for pharmaceutical leaders: How do you keep momentum in therapeutics development, when, like all workplaces, most labs have had to either restrict use or close altogether? The answer lies, at least in part, in what companies do now to prepare for a safe, effective reopening.
It won’t be easy, given the pandemic’s colossal impact. Every company will have its own best path to reopening, based on variances in local regulations and capital flow. But there are four key real estate and facility management strategies that can support leaders through this crisis:

1. Harness the power of data to support social distancing and space planning.

To make the best use of your facility, while safeguarding employees, understand first how your people interact with the lab space itself. Do they typically work side by side on benches? How much space is already designated for more private work?
While the average lab is less dense than the average office space, social distancing will still prove challenging given the collaborative nature of pharmaceutical development and production. Therefore, it’s important to lay out criteria for social distancing floorplans that reflect real-world employee space demand, and also accommodate both epidemiological guidelines and employee comfort levels.
With data-driven insights, you can evaluate occupancy and/or space planning strategies based on how they affect safety and business. For example, rotating staffing may help limit the number of staff on-site at any one time, but it may also compromise productivity. Or, if you’re in a position to grow, you may want to consider how a shorter, flexible lease could support rapid upsizing and downsizing as conditions evolve.

2. Ramp up health, quality and safety procedures.

Of all industries, the pharmaceutical world is perhaps best-equipped when it comes to meeting COVID-19 safety standards. After all, what lab doesn’t already have robust guidelines for handwashing and personal protective equipment like lab coats, gloves and eyewear?
In addition to updating standard practices, your company must ensure all personnel–from scientists to facility managers–understand and adhere to them. Janitorial teams will need to perform intensive cleaning even more regularly. HVAC maintenance teams will need to monitor air quality and heating, ventilation and air conditioning operations more closely to curb contagion risk. Human resources teams may need to devise a means of checking temperatures at all entry points.

3. Use technology to drive efficiency in your post-COVID-19 workplace.

To help facilitate social distancing requirements, you might incorporate real-time WiFi login and security badge data, along with data from heat and motion sensors. In turn, data from these occupancy planning tools, together with predictive analytics tools, can help you better assess future needs.
On the facility management side, consider deploying smart building systems and wireless equipment sensors to better manage indoor air quality, supporting employee health while also reducing energy costs and overall operating expenses.

4. Consider how remote work could eventually become more viable.

Already, as more and more data scientists enter the R&D process, we’ve seen an industry shift from mostly wet lab space, to a more even mix of wet lab, flex lab and computational science space. Such teams, who can function effectively in an office-like space, may also be able to work remotely without too much disruption.
Enabling some amount of virtual lab work could be a boon for some companies even beyond COVID-19. Leasing, for instance, could become more viable, giving firms the flexibility to expand or contract as market conditions change. Conversely, larger companies with their own large campuses could consider sale/leasebacks to monetize their space and/or exit some of it if not needed.

What’s beyond the pandemic for research facilities?

No one has a crystal ball for how this–or any industry for that matter–will emerge on the other side of COVID-19. Now is the time to take a fresh, holistic approach at your portfolio. How can you best support your workforce with safe, effective work environments? How might more comprehensive facilities management support health, in addition to productivity?
By considering these questions through a post-COVID-19 lens, pharmaceutical leaders can help keep the industry ahead of even the most challenging of curves.

Source – https://www.drugdiscoverytrends.com/want-to-reopen-your-pharma-lab-amid-covid-19-consider-these-strategies-first/