MOVING PAST INNOVATION: THE DRIVE TO CREATE THERAPIES AND VACCINES FOR COVID-19

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By Helen Horvath

 

July 29, 2020 (San Diego) -- Tired of wearing masks and social distancing?  Hoping for a solution to the COVID-19 pandemic?  Confused over what the correct information about COVID-19 may be?  Need money for a life science project for your unique idea?  BIOCOM is the place to go to obtain some solutions as a life science industry association.  In San Diego there are multiple scientific studies through the federal government agencies.   

East County Magazine (ECM) discusses the impact of SARS-CoV-2 or COVID-19 upon the life sciences industry with Carolyn Hawley, Vice President of BIOCOM Communications, the life sciences industry association.

 

What is COVID-19 and how did we get to this point in history?

 

There is a large family of coronaviruses. Most typically cause mild to moderate upper respiratory tract illnesses in humans.  For some, the virus can turn deadly through Acute Respiratory Distress Syndrome (ARDS) that requires hospitalization. 

 

Three serious coronaviruses have emerged over the past 18 years. These viral infections had no cure at the time they appeared. They are SARS coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS), and the final is SARS-CoV2 that causes the coronavirus disease 2019 (COVID-19).   SARS-CoV began in 2002, causing acute respiratory syndrome (SARS) and disappeared by 2004.  MERS was linked to the Arabian Peninsula, where MERS was transmitted from an animal reservoir to camels that then spread to humans according to the NIH.  SARS-CoV-2 or COVID-19 can be considered a viral mutation of SARS and MERS, as they are in the same family of diseases.   

 

Where do these viruses originate?  There are hundreds of animal-based coronaviruses that circulate among bats, pigs, cats, and camels.  As reported by the National Institute of Health (NIH) some of these viruses jump from animals to humans, causing disease in humans. 

 

The CDC recognizes that every year tens of thousands of Americans become ill from diseases sometimes spread between animals and people.  This is known as zoonotic disease that includes Severe Acute Respiratory Syndrome (SARS), influenzas, plague, Middle East Respiratory Syndrome (MERS), Rabies, Brucellosis (caused by unpasteurized milk or undercooked meat), and Lyme disease.  As discussed in previous articles, COVID-19 is a strain of the SARS virus.

 

With six out of ten infectious diseases in people being zoonotic diseases; it is critical that our nation improve and strengthen our capabilities to respond and prevent diseases.  This is accomplished through the One Health method that utilizes the connection between people, animals, plants, and their shared environment.  One Health calls upon experts in animal, human and environmental health in a variety of fields, to include life sciences, to achieve the optimal outcomes for our country.

 

According to the Centers for Disease Control (CDC), dogs, cats, and a few other types of animals can be infected with SARS-CoV-2, the virus that causes COVID-19.  There have been reports of lions and tigers at a New York zoo that tested positive for SARS-CoV-2 (COVID) after a zoo employee with COVID infected the large cats. The CDC does not yet know all species that may become infected.

 

A key element of the life sciences Industry is the creation of unique therapies and vaccines in collaboration with local, state, and federal agencies.  This is done through research, development, and collaboration with non-government organizations such in the pharmaceutical industry, life sciences, and the federal agencies. 

 

Industry associations, such as BIOCOM, provide advocacy for the life sciences industry, bringing products to market, and development of new therapies through membership and networking.  Many may not know that the federal government publishes requests for comment through the federal register on a variety of topics.  BIOCOM members may provide the input to create recommendations to the government for change or improvements through the Federal Register or direct advocacy with legislators.   

 

What is BIOCOM?

 

BIOCOM is headquartered in San Diego. The 501(C)(6) was founded in 1995 with offices in San Francisco, Los Angeles, San Diego, Sacramento, Washington, DC, and Tokyo.  In addition, BIOCOM has strategic partners in Europe, Japan, and Australia.  The organization employs 56 individuals to manage the 1,300+ members and programs.  

 

BIOCOM Institute is the 501(c)(3) non-profit arm of this life sciences industry association. This institute develops and provides high-quality programs and services to speed up the growth of future life science employees and students alike. BIOCOM is unique in that the organization supports STEM educational programs to bring up the next generation of scientists and researchers.  Additionally, BIOCOM and member businesses support veteran mentorship to help veterans’ transition to the life sciences field.  BIOCOM also provides cutting edge human resources and workforce development learning and development. 

 

As an industry association, BIOCOM is unique in that the organization is able to impact public policy in the life sciences industry.  From medical devices to gene therapies to COVID-19 therapies and vaccines, member firms within BIOCOM have developed unique products that resolve the nation’s various healthcare issues.  BIOCOM is there to represent the needs of the industry through advocacy and collaboration with State and Federal governments.  BIOCOM impacts current California and national COVID-19 research and development process.  Many of the BIOCOM member businesses are involved in creating COVID-19 therapies and vaccines.

 

BIOCOM has advocated for Medicare patients through support of Congressional legislation to ensure that Medicare covers key new and innovative medical devices and drugs approved under the Food and Drug Administration. Various legislation permits the life sciences industry to have either permanent or temporary payment for the devices through Medicare (US House of Representatives bill HR-5333 and HR 4393).  HR 3771 which establishes and interagency One Health Program as examples of efforts by BIOCOM to support the life sciences community in an ongoing effort to bring products to market.

 

BIOCOM also ensures that member firms use ethical guidelines in research.  This knowledge  helps the life science and general community to feel a measure of safety when a drug or vaccine is approved, or advocacy is sought within the legislative offices.  Ethical guidelines and methods of research involve an institutional review board (IRB), clearly defined methods, and special permission to have the human subject trials.

 

Interview with Carolyn Hawley, Vice President, BIOCOM Communications and Canales Communication

 

One of the greatest challenges in this COVID-19 environment is the development of therapies through research and development to meet the needs of the public for a potential vaccine and treatments for COVID-19.  Although announced that rapid research trials are being done for a vaccine; there are ethical considerations for this process that must be considered.  The COVID-19 pandemic has also become a political football that is impacting how the therapies and vaccines are developed.  As with many government programs, our nation throws money at a problem.  Yet, where is our nation in the scientific discovery and development of a true medical solution to COVID-19 and other medical treatments?  

 

According to Hawley, “Testing and therapies to detect COVID-19 antibodies will hopefully help make COVID-19 treatable.  Yet, nothing is there yet “ Firms are “continuing to put more in the funnel” for treatments, she says, adding, “The COVID-19 vaccine is so far down the road. The tracing research must be completed as part of the vaccine development.  In the end, we may have multiple vaccines.”  

 

BIOCOM is busier than ever as a result of the pandemic, says Hawley. “Our work has sped up, not slowed down.” As part of that increased business, CEO Joseph Panetta met with 50-60 CEOs across California asking what was needed, she adds. “Our industry had lower numbers of furloughs and layoffs since the start of the pandemic.  The role (of BIOCOM) is to listen to our members' needs always; yet the reality is that we also work collaboratively to create industry solutions; advocacy is critical. Two-thirds of our member firms are exceedingly small, early stage firms (start up businesses), sometimes less than 10 people.  We provide a variety of funding opportunities that include access to technology funding and angel investors.”

 

Ironically, Governor Newsom’s stay at home order impacted the research and development of vaccines and therapies needed to stop COVID-19, says Hawley. “The quarantine order only had a few job categories that were considered vital.  These included firefighters, law enforcement, doctors, and nurses as vital. Lab employees were not able to go to work”  to research solutions to COVID-19 due to “murky language” in the Governor’s order pertaining to lab workers.

 

In a lab, “cells need feeding, or they will die,” she explains. The protocol for therapy development requires a completely sterile environment.   

 

“If a research lab has a viviarium onsite, the lab had to quickly respond to the study and participation…Non-compliance with research protocols means that if labs remain empty today, no therapy (or COVID-19 treatment) will be available tomorrow.  Labs needed to continue to operate full throttle.  Without lab workers, who would work to resolve COVID-19?”  

 

With the media focus on COVID-19, many people may have thought that other diseases were not still being researched.  Yet, that is far from true. Hawley indicates that the stay at home order had a broad impact. “Labs across the country were still working on solutions to other diseases such as diabetes, cancer, and heart disease.” When the lab employees were not included in the essential workers list, this created problems far beyond COVID-19 research.  “Labs and employees needed to go forward.  When elective surgeries and procedures were delayed, the research community must be careful.  For example, when brain surgery research trials began, surgery could not stop, since the surgery results impacted the overall outcome of the research.  Research requires fast responses to outcome,” Hawley notes.

 

These restrictions to research and employment initially caused major problems creating the empty lab syndrome.  BICOM’s advocacy response included communication with key legislators, the Governor’s office, and the use of experts to outline a case to have laboratory employees listed as “essential workers” under Governor Newsom’s quarantine orders.

 

As part of BIOCOM’s advocacy,  Hawley states, “BICOM worked with the Governor’s office to obtain personal protective equipment for labs, first responders, and other key employees and employers in our community.  The PPE issue has also been an issue that faced the non-medical community.”  Ms. Hawley stated that her “daughter was immunocompromised and mask wearing is required in my home along with social distancing. Being in the BICOM industry, how could I not wear a mask?” 

 

Helping businesses during the pandemic

 

With the on again, off again aspect of COVID-19 due to higher numbers of infected people, Hawley discusses methods that employees and business owners could use to open businesses safely.  “BICOM reached out to members that led to a 30-40 member panel of experts who came together to discuss what it mean to reopen in a COVID-19 environment.  These experts were composed of human resources personnel, attorneys, communication experts, and testing.  These experts asked the life sciences industry to comment on the specific recommendations of the experts.”

 

Through the subject matter experts work at BIOCOM, one of the most informative guides available to reopen businesses online is “the BIOCOM Path Forward for California’s Life Science Industry.  This free resource outlines industry standards for transitioning the BICOM community back to the workplace,” according to Hawley.  The resource is designed to prevent and lessen exposure and spread of the novel coronavirus (COVID-19).  This return to work guide also has a free checklist for risk assessment of businesses.  Both documents are free to the public and can be downloaded and modified for other industries use as foundational documents.  

 

Going Digital

 

BIOCOM, like other industries, has been hit hard by loss of opportunities to have face to face meetings, conferences, and events.  This industry association typically has large scale annual conferences around the country.  Just as with every business in the nation, BIOCOM has lost revenue as a result of cancellation of face to face conferences and events. To continue the industry association’s commitment to networking and product development, “BIOCOM went virtual with “Digital BIOCOM in mid-June.  This is important because the scientific community and business community needs to find methods to interact and discuss ideas and solutions to improve human health,” Hawley says. 

 

She adds, “ This is not an alone-in-the-room activity.  Small companies need the interaction and access to capital.  Business funders need to be able to vet firms based upon specific research.” Without the interaction, developing new products, therapies, and treatments becomes more difficult.  There is also a loss of psychological sense of community when interactions do not occur. 

 

Social Media and COVID-19 

 

Hawley is an expert in communications.  “As a communicator, it fascinates me at times when people use social media as their sole source of information,” she says.  Often, rumors may harm the BIOCOM industry through misleading statements. Hawley advises, “Look for truth in reporting – not misinformation.  Think about the media statement that ”if chemicals kills COVID-19, then drink it.” (do not do this – example purpose only).  How many people believed the statement without examining the facts? How many were injured?  Sometimes common sense goes out the window in social media environments, she observes.

 

Social media can be great; yet Hawley states that her fascination with social media also goes to the actual research that is tied to social media posts.  “If an inflammatory statement happens,” she urges people to please “cross reference with multiple sources.  I have older teenagers; I tell them to find several references in multiple sources with multiple perspectives in order to learn the truth…False (or misleading) information is not helpful.”

 

Further, she notes that as a general guideline, “The less words that can be used, the more the message is skewed; 140 characters is not sufficient to explain highly technical information. This becomes a declaration not a statement.  Readers should use peer review journals.  Do not try to paraphrase a 20 page technical paper into 140 characters.  Instead, point to the research as a tool instead of paraphrasing a billboard statement using 140 characters that may not factually represent the truth.”

 

For instance,  Moderna’s first phase trial is an example where only eight people were tested. “From a scientific point of view, eight people does not make a representative sample necessary to validate a vaccine or other product,” Hawley points out.   

 

“False information in the media is huge,” says Hawley. “True, good science is through peer review,” which means experts with professional experience in the specific field read and comment on research. “Research does not guarantee that the problem will stop; yet, understanding COVID-19 creates the knowledge to create solutions.”

 

Hawley suggests that a  “great sources for COVID-19 research and information can be found at “STATNews, Biocentury, and BIOCOM’s COVID-19 research documents found in the BIOCOM COVID-19 Resource Center.  STATNews and Biocentury are paid services that offer free access to up to date research in the COVID-19 research arena.”

 

Biocentury is unique in that online resource lists, working on aspects of a disease along with STATNews, providing updated research to the community, she says, adding, “These legitimate and scientific information sources are just a small part of legitimate research results available to the public.”

 

She went on to state, “One of the downfalls of social media in report COVID-19 is that many media outlets lack the scientific “disciplined thinking and use hyperbole” or inflated results.  “Science requires a measured approach to research.  Reporting of COVID-19 and other illnesses require a more scientific side instead of a business side. The technical results will help the community decide on facts versus a slanted fiction.”

 

Present knowledge about COVID-19 with unique potential solutions

 

All areas of life sciences are impacted by COVID-19.  The industry continues to struggle to keep up with the ever changing and new developments in the COVID-19 research and development arena.  Hawley reiterated that “in this current environment, we are learning as we go.”  

 

The BIOCOM industry examines COVID-19 from a “cellular level to develop therapies.  It is so interesting how the COVID-19 cell is shaped like a crown.  Our industry examines the cell from different angles,” Hawley explains. This permits the researcher to determine how the cells interact for COVID-19 treatments in different situations.  

 

“Early in the pandemic, we started noticing that a person loses their sense of smell.  Industry and the community said that this loss was not associated with COVID-19.  Not long after, the loss of the sense of smell became known as a precursor to COVID,”  Hawley recalls.

 

Patients with  COVID-19 also experience neurological and physiological changes in patients with COVID-19.  According to the Stanford Medicine News Center, there is a relationship between the gut and the neurological ties going directly to the brain.  The COVID-19 gastrointestinal symptoms included nausea/vomiting, diarrhea, and loss of appetite in addition to respiratory complications and development of Acute Respiratory Distress Syndrome (ARDS) in the most serious cases.  People with serious ARDS may feel as if they are drowning in water even with the use of the ventilator due to the inability of the blood to circulate oxygen properly.

 

Ms. Hawley reiterated that in the research, “We are learning as we go in the current COVID-19 environment” and the situation is constantly changing as the search continues for antiviral drugs, other therapies or vaccines against COVID-19 infection.  

 

A National Institute of Health article states that the “only current option available is the use of broad-spectrum antiviral drugs.  Anti-inflammatory drugs (such as hormones and other molecules), as well as Chinese traditional medicines, such as ShuFengJieDu capsules and Lianhuaqingwen capsules, have also been used (Ji et al. 2020; Ding et al. 2017). All of the current COVID-19 drug options come from past experience in treating SARS, MERS, or some other new influenza viruses previously, and are aiming to address active symptoms. (remembering that SARS and MERS are directly tied to the current SARS-CoV-2 or COVID-19.  COVID-19 would be considered a mutation of the original SARS virus from 18 years ago).”  

 

In addition to airborne transmission and droplet spread which can be minimized by wearing masks, novel COVID-19 uses the skin to transmit the virus. The virus is very thin skinned when it comes to soap; soap will kill the virus rapidly.  The mucus membrane of the mouth, nose, eyes, and potentially the ears creates opportunities to have the virus enter the body. Twenty to thirty seconds of handwashing can avoid a lot of health problems with COVID-19 and other diseases in our communities.

 

For more information about COVID-19, follow Dr. Horvath on East County Magazine’s website.  Or go to BIOCOM.org, STATNews, Biocentury, Center for Disease Control, or NIH’s NIAID website for the latest fact based and updated COVID-19 research and information. 

 

Dr. Helen Horvath is a psychologist, organizational development consultant and published author on a variety of psychology and business topics. As a speaker, she has presented at the American Psychological Association Annual Conference, Society of Industrial and Organizational Psychology, and other key professional organizations.  She is a former marriage and family therapist and published a relationship book entitled “Put a Period to IT: When Divorce is the Option”.   Dr. Horvath writes for East County Magazine on COVID-19 topics in business, healthcare, and research as part of the Facebook Grant Project.

East County Magazine gratefully acknowledges the Facebook Journalism Project for its COVID-19 Relief Fund grant to support our local news reporting including impacts on vulnerable communities during the COVID-19 pandemic. Learn more: #FacebookJournalismProject and https://www.facebook.com/fbjournalismproject/.

You can donate to support our local journalism efforts during the pandemic at https://www.EastCountyMedia.org/donate.

 

 

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