UNDER the COVID-19 pandemic: Virtual testing rises biotech company I...

In less than a year, biopharmaceuticals and academia have moved from knowing nothing about the SARS-CoV-2 virus to the technology to launch new vaccines to the world.
global pandemic of COVID-19 is making the life sciences industry the focus.
2020, biotech IPOs are booming, and not just those developing COVID-19 drugs are favored by capital, but cancer and rare diseases remain hot investments.
COVID-19 has also changed clinical trials and virtual models have begun to emerge, a necessity for maintaining research and development activities in all disease areas during social isolation.
same time, epidemics, coupled with social justice campaigns, have sparked new interest in drug equity research, and calls from people of color for better testing have led clinical trial recruiters to focus on true diversity.
, the COVID-19 pandemic also caused many problems.
, for example, why are vaccines and infectious diseases being put on the same level until 2020? Rare diseases and cancer treatment have been in the public eye, maintaining a higher level of medical profitability.
the growing political pressure on the U.S. Trump administration has also raised questions about the FDA's operations after the transition. From these perspectives, 2021 will be a year of real change anyway.
regardless of the 2021 COVID-19 pandemic trajectory, it is safe to say that COVID-19 will permanently change the biopharmaceutical industry, just as it does for the rest of the world.
so predictable, what will happen to the pharmaceutical industry in 2021? Predicting the rise of 1 virtual trial model virtual, decentralized or siteless, network-based clinical trial model... No matter how you want to describe it, a new way of doing research will be fully launched in 2020.
Global COVID-19 pandemic has made it a burden for patients to travel to designated medical sites for clinical trials, the emergence of telemedicme has enabled some participants to be assessed at home, which is a key driver in stopping the epidemic.
is a decentralized clinical trial? Essentially, it integrates modern digital health technologies such as mobile devices, mobile applications, remote surveillance devices, and online social platforms into research design.
allows patients to monitor at home and continuously collect endpoint data in real time during the daily lives of trial participants.
idea has been around for years, but most CRO and large pharmaceutical companies prefer traditional methods.
because the virtual test model doesn't work for everyone, some participants have to do some tests in hospitals.
Addition, whether remote health monitoring , often down to video conversations via smartphones , can replace one-on-one contact with medical personnel and how adaptable older people are to the use of modern technology in experiments is also unresolved .
this, one of the great benefits of participating in drug trials at home is to reduce costs and increase hiring and retention rates, a big problem for CRO and biopharmaceutical companies.
This approach has been mixed, but with the FDA announcing new guidelines that say trials should switch to virtual mode where possible to keep research moving forward, companies such as Medable, Science 37, Signant Health/VirTrial have turned to virtual trials and have made unprecedented significant funding and collaboration.
predicts that 2COVID-19 will bring research and development to the spotlight by 2020, with infectious diseases becoming the hottest area on the biopharmaceutical research and development list.
and investors are rethinking this area, and infectious disease research and development is expected to be a fast-growing area in the coming years.
, glaxoSmithKline paid CureVac $294 million to collaborate on research and development of mRNA infectious diseases.
weeks later, Sanofi paid Translate Bio $425 million to expand its gene vaccine partnership for infectious diseases.
effectiveness of the mRNA vaccine in preventing infectious diseases has been confirmed by late COVID-19 trials.
Flagship identified health and safety as a new focus area in the second half of 2019, with technology shifting to more proactive and preventive healthcare.
data also show signs of rising investor interest in infectious diseases.
G-FINDER (Global Fund for Innovation in Neglected Diseases) project shows real and sustained growth in research and development of emerging infectious diseases, two of the main factors being the establishment of the Alliance for Epidemiological Preparedness and Innovation and the outbreak of Ebola and Zika.
Pfizer, which has been a major player in the response to the COVID-19 pandemic, has been pumping money into vaccine research and development, including a Prevnar franchise, and promoting the growth of late-stage vaccines against meningococcal disease, Thyrobacteria and respiratory syncytial viruses.
same time, Gilead and AbCellera are working together to develop antibody therapies for infectious diseases.
and before the pandemic, some drug companies, such as BioNTech and Pfizer, AbCellera and Lilly, had established partnerships.
AbCellera and Lilly had spent months reaching a separate multi-target development agreement, while the anti-SARS-CoV-2 antibody protocol for COVID-19 took only 13 days.
response to COVID-19 suggests that we have other, faster ways to get things done.
in 2021 and beyond, will this work as the new normal, or will it quickly return to its pre-epidemic state? After predicting a short and dramatic term in Office 3, FDA Director Hahn will end a year ago when Stephen Hahn, M.D., was confirmed as FDA Director when e-cigarettes were called the Trump administration's biggest public health crisis at the time.
soon COVID-19 dramatically reversed everything, including Hahn's brief tenure.
criticism of the FDA director peaked in August 2020.
At the time, the regulator issued a press release on the Emergency Use Authorization (EUA) that praised "this authorization as another achievement of the U.S. government in its fight against the influenza pandemic" and led to concerns that Trump would rely on the FDA to approve vaccines prematurely before the November election.
, Hahn appeared at Trump's press conference to point out the benefits of EUA for recovery plasma therapy for COVID-19 patients, made from human blood recovered from a new coronary infection.
35 out of every 100 COVID-19 patients were saved by plasma use," Hahn said at the time.
" in a strong and widespread condemnation, Hahn was quick to say that "criticism is entirely justified" and explained to himself that "the data show a decrease in relative risk, not an absolute decrease in risk".
this approach further widens the negative impact.
, Trump accused FDA rules of making it difficult for pharmaceutical companies to recruit participants to test vaccines and therapies.
trump later said the FDA was "like an old, slow turtle" in approving Pfizer's COVID-19 vaccine.
time Hahn's attitude changed, even "threatening" to resign, insisting: "The FDA must adopt a rigorous approach to scrutiny to convince the public who are skeptical about the safety and effectiveness of the vaccine."
" but overall, the pandemic has overshadowed the FDA under government pressure.
and FDA regulatory and approval efforts are tough on day-to-day matters.
not only rejected bioMarin's application for approval for haemophilia A gene therapy, but also asked Sarepta to use additional physiotherapy, delaying the approval of its Duchy muscular dystrophy gene therapy.
.
of course, COVID-19 also brings an additional burden.
"If the vaccine helps safely control the COVID-19 pandemic, then whoever chooses to manage the FDA after the new administration is formed can spend more time on day-to-day matters, such as staffing cell and gene therapy approval teams, rather than dealing with a public health crisis.
forecast 4 Despite the isolation of the COVID-19 pandemic, the number of IPOs in the biotechnology industry is still at record levels When the COVID-19 pandemic broke out, the global IPO market looked lifeless.
social distance and uncertainty have disrupted the functioning of the public market, and some even predict that IPOs will be "nearly stagnant" in the spring of 2020, but ipos by biotech companies will be a 3dring hope in the economic downturn.
they didn't expect much success in the industry.
2020, 102 healthcare companies had IPOs on NASDAQ, raising $23.6 billion.
of the 102 deals, 82 were listed by biotech companies, raising $15 billion, twice as much as the previous year (55 biotech IPOs in 2019 raised $5.6 billion).
these performances are attributable to a number of unique factors in the biotechnology industry.
, biotech investors are investing in capital in the long run, rather than looking at the impact of quarterly sales.
-term nature of healthcare investments does have a flat effect, which is not available in high-tech or consumer-based retail investments, but the creation of long-term value is indeed a return."
another aspect is innovation, and wanting to invest in innovation is essentially in biopharmaceuticals, such as the COVID-19 vaccine developed by Moderna, Pfizer and BioNTech, an innovation that has never been seen before.
about the COVID-19 pandemic, which in itself is the driving force behind investment in biotechnology.
investors are now aware of and interested in PCR testing, molecular biology and vaccines, but a successful IPO in 2020 will not be easy.
ORIC Pharmaceuticals decided to IPO in early 2020, but when the COVID-19 pandemic hit, it caused problems with its plans.
ORIC is watching almost every day to see if it makes sense to go public.
the company, which is developing anti-tumor drugs, has enough cash flow to wait until the outbreak is over.
they don't know how long the outbreak will last and what it will look like after the COVID-19 pandemic.
ORIC's final decision to go public in April, the IPO was priced at $120 million, exceeding its $86 million target set in securities filings, and was successful.
or because of social isolation, ORIC did not complete the two-week roadshow as planned, but condensed it into a four-day video conference.
video or conference call may continue to exist during the IPO process, people may not fully return to the original way after the COVID-19 epidemic, some traditional inefficient habits will change.
say exactly what will happen in 2021.
a large number of biotech IPOs are in the pipeline to keep pace with 2020, but that depends entirely on investor appetite.
estimates that the number of listings in 2021 will be between 55 in 2019 and 85 in 2020.
Forecast 5 has long been seen as a nail in the coffin by big drug companies, but by 2020 it will turn the tide: "If pharmaceutical companies want to treat patients with a disease in each of their new drugs, they should try it in everyone's participants."
" seems to be a question that needs no thought.
this is not always the case today.
the summer of 2020, researchers accused Gilead of failing to equally recruit black, Latino and Native American patients in clinical trials against Veklury, the first FDA-approved drug to treat COVID-19.
researchers analyzed demographic data from several data sets of the drug and found that black Americans accounted for 11 percent of the 397 patients in one study, and 20 percent in a large study involving more than 1,000 patients.
are also chilling compared to U.S. demographics, with blacks accounting for about 13 percent of the U.S. population.
but the COVID-19 pandemic is "equal" for people.
, for example, in Alabama, blacks or African-Americans make up 27 percent of the population, but account for 43 percent of COVID-19 cases.
Shmuel Shoham, M.D., an associate professor at Johns Hopkins University School of Medicine, said: "If clinical trials do not include diversity among participants, results and studies are inaccurate.
clinician or patient may consider the drug's treatment results to be not applicable to them.
despite the challenges that the pharmaceutical industry continues to face, the COVID-19 pandemic could still be a turning point in the diversification of clinical trials," he said.
in the early stages of the pandemic, Genente, like other drugmakers, searched for drugs that could be used to treat COVID-19.
one of the drugs, called Actemra, has been on the market for years to treat rheumatoid arthritis, which the company believes may help suppress inflammation in patients with COVID-19.
results were found in a global, placebo-controlled clinical trial (COVACTA), followed by a second trial aimed at recruiting minority patients (EMPACTA), in which more than 85 percent of participants were minorities to identify minority drug use