How The mRNA Vaccines Were Made: Halting Progress and Happy Accidents

The stunning Covid vaccines manufactured by Pfizer-BioNTech and Moderna drew upon long-buried discoveries made in the hopes of ending past epidemics.

#acquired-immune-deficiency-syndrome, #clinical-trials, #coronavirus-2019-ncov, #fauci-anthony-s, #graham-barney-s-1953, #kariko-katalin-1955, #mers-middle-east-respiratory-syndrome, #national-institutes-of-health, #vaccination-and-immunization, #weissman-drew-1961, #your-feed-science

How Psychedelic Drugs Can Be Used for Mental Health

Many recreational drugs known for mind-altering trips are being studied to treat depression, substance use and other disorders. Here’s what you need to know.

#alternative-and-complementary-medicine, #anxiety-and-stress, #brain, #clinical-trials, #depression-mental, #ecstasy-drug, #ketamine-drug, #lsd-lysergic-acid-diethylamide, #mental-health-and-disorders, #psychedelic-and-hallucinogenic-drugs, #psychiatry-and-psychiatrists, #serotonin-chemical

Cannabis to Help You Diet? One Edibles Company Thinks So

An edibles company says one of its products will lead not to the “the munchies” but to weight loss. There’s just one problem: the science.

#advertising-and-marketing, #cannabis-foods-and-products, #clinical-trials, #colorado, #drug-enforcement-administration, #food-and-drug-administration, #marijuana, #medical-marijuana, #national-institutes-of-health, #science-and-technology, #university-of-mississippi

J. & J. Booster Protects Against Severe Omicron, Study Says

Two shots of the vaccine reduced the risk of hospitalization from the fast-spreading variant by 85 percent, a clinical trial found.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #johnsonjohnson, #research, #south-africa, #vaccination-and-immunization

Israel Study Will Test Effectiveness of 4th Vaccine Dose

A decision on whether to offer the additional shot, and for whom, is expected within days.

#clinical-trials, #coronavirus-2019-ncov, #israel, #vaccination-and-immunization

F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older

The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.

#clinical-trials, #coronavirus-delta-variant, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #molnupiravir-drug, #paxlovid-drug, #pfizer-inc, #your-feed-science

A Popular Test Claims to Boost I.V.F. Success. The Science Is Unclear.

I.V.F. patients are faced with a growing list of costly “add-ons.” For one such test, some say more robust research is needed to support its effectiveness.

#clinical-trials, #in-vitro-fertilization, #infertility, #pregnancy-and-childbirth, #reproduction-biological, #research, #tests-medical

Pfizer’s Covid Pill Works Well, Company Confirms in Final Analysis

The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.

#clinical-trials, #coronavirus-delta-variant, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #molnupiravir-drug, #paxlovid-drug, #pfizer-inc, #your-feed-science

New Covid Antiviral Pills Offer Hope as Omicron Looms

Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #molnupiravir-drug, #research, #your-feed-science

Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel

The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #food-and-drug-administration, #merckcompany-inc, #molnupiravir-drug

A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.

A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.

#clinical-trials, #diabetes, #harvard-university, #insulin, #melton-douglas, #pagliuca-felicia, #research, #semma, #stem-cells-embryonic, #vertex-pharmaceuticals-inc

Merck Says Its Covid Pill Is Less Effective in a Final Analysis

The drug, molnupiravir, reduced the risk of hospitalization and death in high-risk Covid patients by 30 percent. An earlier analysis had found a 50 percent reduction.

#clinical-trials, #coronavirus-2019-ncov, #merckcompany-inc, #molnupiravir-drug, #united-states

Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug

Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #brain, #clinical-trials, #deaths-fatalities, #drugs-pharmaceuticals, #elderly, #food-and-drug-administration, #jama-neurology-journal, #labeling-and-labels-product, #rbc-capital-markets, #research, #your-feed-science

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties

Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.

#appointments-and-executive-changes, #biden-joseph-r-jr, #califf-robert-m, #clinical-trials, #conflicts-of-interest, #drugs-pharmaceuticals, #duke-university, #food-and-drug-administration, #manchin-joe-iii, #regulation-and-deregulation-of-industry, #united-states-politics-and-government

The Ketamine Cure

The once-taboo drug has been repurposed to treat depression and is even available for delivery. But how safe is it?

#alternative-and-complementary-medicine, #anxiety-and-stress, #clinical-trials, #depression-mental, #ketamine-drug, #mental-health-and-disorders, #psychedelic-and-hallucinogenic-drugs, #therapy-and-rehabilitation

C.D.C. Recommends Covid Vaccine for Younger Children

With the agency director’s sign-off, children ages 5 to 11 could begin to receive the shots this week.

#biontech-se, #centers-for-disease-control-and-prevention, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #disease-rates, #heart, #pediatric-inflammatory-multisystem-syndrome-pims, #pfizer-inc, #united-states, #vaccination-and-immunization, #your-feed-science

COVID trial using antidepressant cut short due to apparent effectiveness

Image of a female pharmacist wearing a face mask.

Enlarge (credit: FG Trade / Getty Images)

Despite the wide availability of vaccines, the most recent surge in COVID-19 cases left several US states struggling to provide adequate health care to their citizens. The situation reinforces the potential value of drugs like molnupiravir, which reduce the need for hospitalization among those with COVID-19. But monupiravir will be expensive and will likely be difficult to supply globally for some time. So ongoing trials that test existing drugs for effectiveness against COVID-19 can still provide significant value.

One of those trials has just produced some promising results. A cheap generic drug, developed as an antidepressant, appears to reduce hospitalization rates. While the effect was limited, it was clear enough to cause the trial to be cut short.

A decent trial

The drug in question is called fluvoxamine and is part of the class of drugs known as selective serotonin reuptake inhibitors, which are used to treat depression. There is absolutely no reason to expect that fluvoxamine would be effective against SARS-CoV-2, but a small trial tested it anyway, and the study looked promising. So the drug was picked up by a project called the TOGETHER trial, which is running a series of clinical trials using cheap drugs that are already approved for use.

Read 9 remaining paragraphs | Comments

#clinical-trials, #covid-19, #drugs, #medicine, #pandemic, #science, #treatments

F.D.A. Says Pfizer Vaccine’s Benefits Outweigh Key Risks in Children 5 to 11

The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps as early as next week, a long-awaited development that would affect 28 million children.

#biontech-se, #centers-for-disease-control-and-prevention, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

Why Is Good Medical Advice for Pregnant Women So Hard to Find?

A recent warning about the pain reliever acetaminophen is a reminder that health risks in pregnancy remain maddeningly, dangerously understudied.

#clinical-trials, #drugs-pharmaceuticals, #pregnancy-and-childbirth, #research, #tylenol-drug, #women-and-girls

Mix-and-Match Covid Boosters: Why They Just Might Work

The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #immune-system, #johnsonjohnson, #moderna-inc, #pfizer-inc, #vaccination-and-immunization

Would You Let a Scientist Infect You With Covid?

The controversial history of human challenge trials.

#clinical-trials, #colds, #coronavirus-2019-ncov, #imperial-college-london, #national-institute-of-allergy-and-infectious-diseases

Data from Federal Scientists Raise Questions About J.&J. Booster Shots

People who have received the company’s one-shot vaccine may benefit from a booster with another brand. F.D.A. advisers will discuss the data on Friday.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-delta-variant, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #national-institutes-of-health, #pfizer-inc, #research, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

First, Impressive Vaccines for Covid. Next Up: The Flu.

Vaccine makers are betting that the mRNA technology powering two successful Covid vaccines will help curb the tragic global death toll from the flu.

#clinical-trials, #coronavirus-2019-ncov, #influenza, #research, #rna-ribonucleic-acid, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.

#children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-delta-variant, #disease-rates, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #regulation-and-deregulation-of-industry, #united-states-politics-and-government, #vaccination-and-immunization

Merck’s Covid Treatment Pill: What to Know About Molnupiravir

The pills are effective and relatively cheap, but they are unlikely to be available for everyone with Covid.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #merckcompany-inc, #molnupiravir

Merck Says It Has the First Antiviral Pill Found to Be Effective Against Covid

The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #merckcompany-inc, #molnupiravir, #ridgeback-biotherapeutics

Merck Says It Has First Effective Antiviral Pill for Covid

The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #merckcompany-inc, #united-states

Pfizer and BioNTech Submit Data on Vaccine for Kids 5 to 11

The companies said that their vaccine was safe and effective in that age group, and that they would submit a formal request in the coming weeks to U.S. regulators to allow a pediatric dose.

#biontech-se, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

Moderna vs. Pfizer: Both Knockouts, but One Seems to Have the Edge

A series of studies found that the Moderna vaccine seemed to be more protective over the long term than the Pfizer-BioNTech vaccine. Here’s why.

#biontech-se, #clinical-trials, #coronavirus-2019-ncov, #immune-system, #johnsonjohnson, #journal-of-the-american-medical-assn, #moderna-inc, #pfizer-inc, #united-states, #vaccination-and-immunization, #your-feed-science

Pioneering Gene Therapy Freed Her of Sickle Cell. Is a Cure at Hand?

Such treatments are extraordinarily promising and costly. Will the Biden administration commit to spending that could speed clinical trial results?

#clinical-trials, #drugs-pharmaceuticals, #genetic-engineering, #genetics-and-heredity, #race-and-ethnicity, #research, #sickle-cell-anemia

Parents Find Ways to Get Their Youngest Children Covid Vaccines

Schools have reopened around the country, and families with those under 12 are finding ways to get their kids inoculated, even though they’re not officially eligible yet.

#children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #parenting, #pfizer-inc, #vaccination-and-immunization, #your-feed-healthcare

America Desperately Needs a Much Better F.D.A.

The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.

#clinical-trials, #drugs-pharmaceuticals, #empire-of-pain-the-secret-history-of-the-sackler-dynasty-book, #food-and-drug-administration, #kelsey-frances-oldham, #purdue-pharma, #regulation-and-deregulation-of-industry

An Experimental H.I.V. Vaccine Fails in Africa

Researchers ended a large trial in South Africa after finding that an experimental vaccine offered little protection.

#acquired-immune-deficiency-syndrome, #africa, #clinical-trials, #drugs-pharmaceuticals, #johnsonjohnson, #south-africa, #vaccination-and-immunization, #your-feed-science

The Intolerable Wait for a Kids’ Vaccine

As children’s hospital beds fill up, the F.D.A. shouldn’t delay. 

#children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #education-k-12, #food-and-drug-administration, #medicine-and-health, #united-states-politics-and-government, #vaccination-and-immunization

Ivermectin Demand Surges Though It Doesn’t Work for Covid-19

Prescriptions for ivermectin have jumped to more than 88,000 per week, some pharmacists are reporting shortages and people are overdosing on forms of the drug meant for horses.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #ivermectin, #poisoning-and-poisons, #research, #your-feed-healthcare, #your-feed-science

How the Delta Variant Infiltrated an Elementary School Classroom

A detailed study in California found that the variant easily spread from an unvaccinated teacher to children and, in a few cases, their families.

#california, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-risks-and-safety-concerns, #deaths-fatalities, #disease-rates, #education-k-12, #los-angeles-county-calif, #marin-county-calif, #united-states, #vaccination-and-immunization, #youth

Modern Love Season 2: An Interview with Mary Elizabeth Williams

When Mary Elizabeth Williams got back together with her husband, she didn’t expect a cancer diagnosis — or for her story to inspire a television episode.

#clinical-trials, #love-emotion, #melanomas, #modern-love-tv-program, #television, #williams-mary-elizabeth

BioNTech founder Uğur Şahin and Mayfield’s Ursheet Parikh are coming to Disrupt

It’s hard to argue that any technology company has had a greater impact in the past decade than BioNTech, the mRNA-based therapeutics pioneer behind the world’s most widely-used COVID-19 vaccine. Developed in record time in partnership with Pfizer, thanks to an existing partnership to work on immunization for the common flu, BioNTech’s mRNA inoculation is without a doubt one of the biggest medical innovations of the past century.

BioNTech co-founder and CEO Uğur Şahin isn’t stopping there, of course: the company recently announced that it would be developing an mRNA-based vaccine targeting malaria, an illness that still kills more than 400,000 people per year. It also has treatments for a range of cancers in process in its development pipeline, and has announced plans to address HIV and tuberculosis with future candidates.

This year at Disrupt 2021, Şahin will join us along with Mayfield Fund Partner Ursheet Parikh, a key investor in BioNTech. Both Şahin and Parikh will be talking to us about how the COVID-19 vaccine came to be, but more importantly, about what the future holds for mRNA technology and its potential to address a wide range of chronic healthcare problems that have been tough challenges to solve for decades or even centuries. We’ll also be talking about what it means to build a biotech startup with true platform potential, and how that might differ now as compared to what investors were looking for just a few short years ago.

Şahin and Parikh are just two of the many high-profile speakers who will be on our Disrupt Stage and the Extra Crunch Stage. During the three-day event, writer, director, actor and Houseplant co-founder Seth Rogen will be joined by Houseplant Chief Commercial Officer Haneen Davies and co-founder and CEO Michael Mohr to talk about the business of weed, Secretary of Transportation Pete Buttigieg will talk about the future of getting around and the government’s role in partnering with startups, and Coinbase CEO Brian Armstrong will dig into the volatile world of cryptocurrency and his company’s massive direct listing earlier this year.

Disrupt 2021 wouldn’t be complete without Startup Battlefield, the competition that launched some of the world’s biggest tech companies, including Cloudflare and Dropbox. Join Secretary Buttigieg and over 10,000 of the startup world’s most influential people at Disrupt 2021 online this September 21-23. Check out the Disrupt 2021 agenda. We’ll add even more speakers.

Buy your Disrupt pass before July 30 at 11:59 pm (PT), and get ready to join the big, bold and influential — for less than $100.

Get your pass to attend now for under $99 for a limited time!

#articles, #biontech, #brian-armstrong, #ceo, #clinical-trials, #cloudflare, #coinbase, #dropbox, #events, #hiv, #illness, #life-sciences, #malaria, #mayfield-fund, #medical-research, #pete-buttigieg, #pfizer, #secretary, #tc, #tc-disrupt, #tc-disrupt-2021, #technology, #ugur-sahin, #ursheet-parikh

Biden Officials Now Expect Vulnerable Americans to Need Booster Shots

The growing consensus that at least some Americans will need a booster is partly tied to research suggesting that Pfizer’s vaccine is less effective after about six months.

#centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #offit-paul-a, #pfizer-inc, #vaccination-and-immunization

Headache Research Advances Though Cures Are Elusive

Research into these often mysterious and debilitating disorders has languished. That’s changing.

#amgen-inc, #brain, #clinical-trials, #denmark, #drugs-pharmaceuticals, #eli-lilly-and-company, #food-and-drug-administration, #headaches, #health-insurance-and-managed-care, #migraine-headaches, #national-institutes-of-health, #nerves-and-nervous-system, #pain, #research, #science-and-technology, #united-states

Castor, a clinical trial process company, raises $45M to create more human-centered research

Castor is on a mission to make every clinical trial faster and patient-focused. The clinical trial software company announced Wednesday it raised $45 million in Series B funding to continue modernizing the process as the industry shifts to decentralized clinical trials.

Eight Roads Ventures and F-Prime Capital co-led the round and were joined by existing investors Two Sigma Ventures and Inkef Capital. The Series B brings Castor’s total funding to $65 million since it was founded in 2012.

Clinical trials are “stuck in a rut,” Derk Arts, M.D., co-founder and CEO of Castor told TechCrunch. Currently, they take a long time to set up and don’t involve continuous data monitoring.

They also require patient participants to travel to a research site that could be hours away from their home. As a result, slow enrollment accounts for nearly 40% of terminated trials, and an inconvenient process inhibits researchers from attracting a diverse group of patients, he said.

Castor, which is remote first, but has offices in New York and Amsterdam, is one of several companies bringing technology to a process that is largely still done on paper. Its software provides a self-service version enabling researchers to design studies and integrate in-person and remote patient data from any source in real time. Patients interested in joining trials can enroll and share their data via a mobile app.

The global pandemic pushed innovation forward at an accelerated pace, and Castor responded in turn, making its software free for COVID-19 research.

It then saw an influx of users and new customers like the World Health Organization. WHO used Castor for its “Solidarity Trial,” which was identifying how existing medications might improve outcomes compared to standard of care alone. The study included over 10,000 patients across 553 sites in 30 countries, Arts said.

Michael Treskow, partner at Eight Roads Ventures, called Arts “a straight shooter” who knows the industry’s pain points and is bringing the clinical trials industry into the modern age.

“Technology is making a real impact,” Treskow added. “Castor is so driven to dramatically improve clinical trials, and with its work with WHO has a significant use case of how this is important. As we have seen with the rapid development of COVID vaccines, this is what the industry is able to do.”

The clinical trial market is valued at around $16 billion and is growing rapidly at 16% per year, Arts says. A market that big is also attracting companies that want to innovate it. He cites Science 37 and Medable, which recently pulled in a $78 million extension to its $91 million Series C.

The Series B enables Castor to have teams in place to respond to the fast-growing industry. Last year, the company nearly tripled in revenue growth and is on course to do the same in 2021. Castor has 150 employees currently and expects to hit 200 by the end of the year.

Arts, who has a background in software programming and in medicine, said the new funds will go toward continued product development, interoperability and collecting real-world evidence from decentralized trials. The company is focusing on the United States for now, but sees potential in moving into the Asia region later this year.

“Patients deserve to have an amazing service, and it is up to us to deliver on that,” he said.

#castor, #clinical-trials, #derk-arts, #eight-roads-ventures, #f-prime-capital, #funding, #health, #inkef-capital, #medable, #michael-treskow, #recent-funding, #science-37, #startups, #tc, #two-sigma-ventures, #world-health-organization

Citing the Delta Variant, Pfizer Will Pursue Booster Shots and a New Vaccine

Scientists were critical of the announcement, pointing to evidence that the current two-dose regimen is powerfully effective against the coronavirus.

#astrazeneca-plc, #biontech-se, #clinical-trials, #coronavirus-2019-ncov, #disease-rates, #drugs-pharmaceuticals, #immune-system, #pfizer-inc, #stockpiling, #vaccination-and-immunization, #your-feed-science

In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the drug be given only to patients with mild symptoms.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #clinical-trials, #drugs-pharmaceuticals, #food-and-drug-administration, #labeling-and-labels-product

Pfizer Vaccine in Israel: How It Works Against Delta Variant

Israel reported that the Pfizer vaccine was 64 percent effective against the Delta variant. Other studies suggest a higher rate.

#clinical-trials, #coronavirus-2019-ncov, #disease-rates, #drugs-pharmaceuticals, #vaccination-and-immunization

Should People With Immune Problems Get Third Vaccine Doses?

France is handing out third shots of the two-dose vaccines to cancer patients and others with immune system impairments. In the United States, patients like these are on their own.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #disease-rates, #drugs-pharmaceuticals, #france, #immune-system, #influenza, #moderna-inc, #research, #transplants, #united-states, #vaccination-and-immunization, #your-feed-science

Johnson & Johnson Vaccine Protects Against Delta Variant, Company Reports

The vaccine also produced long-lasting immune responses, researchers said. Booster shots seem unnecessary, at least for now.

#clinical-trials, #coronavirus-2019-ncov, #immune-system, #johnsonjohnson, #moderna-inc, #pfizer-inc, #united-states, #vaccination-and-immunization, #your-feed-science

4G Clinical’s clinical trial management software attracts over $200M in new funding

The pandemic significantly changed how we do medical research, and now companies are trying to figure out what trends will stay and which ones will go. One that 4G Clinical is hoping will survive the pandemic is a need for speed and flexibility in therapeutics trials. 

4G Clinical creates software to run the back-end of a clinical trial. That means randomizing patients into treatment and placebo groups, locating medicines and placebos, keeping the supply of those medicines stocked, and, at least during the pandemic, delivering those medicines to patients. All of these tasks fall under the umbrella of Randomized Trial Supply Management, or RTSM for short. 

Specifically, 4G Clinical’s software, called Prancer, uses natural language processing to take specific requirements needed to manage a clinical trial, which are often written in long, complex documents, and configures them into a platform.

The fastest the company has been able to move from a phone call to the first dose in a clinical trial was 6 days – a sprint that created the software needed for a COVID-19 study during the pandemic. That was an exceptionally fast case, but in general, 4G Clinical says it can beat standard timelines by considerable margins.

“Most vendors in the world would say that they are probably, you know, between 10 and 16 weeks from, you know, from the kicking off a study until they can dose a patient,” says Dave Kelleher, a company co-founder. “Our typical timeline is generally four to six weeks post spec signature.” 

Generally, large pharmaceutical companies are capable of creating these trial management systems internally. Small companies, however, may not have the capability to do so. 4G Clinical goal is to provide a service that can be of use to both. 4G Clinical has currently designed systems for over 230 companies – though the company would not disclose the specific trials in which its systems are being used. 

4G clinical is also announcing over $200 million in a growth equity round led by Goldman Sachs. Before Goldman, the primary investment came from Boston-based Schooner Capital and First Analysis, a VC firm out of Chicago. 

Kelleher declined to say what the plans for the round were, other than company has plans to pursue more go-to-market strategies and R&D, and ultimately aims to “take up as much air” in the eClinical and RTSM space as possible. 

The eClinical market is expected to reach about $14.7 billion by 2027. RTSM made up about 17 percent of market share in 2020. With the complexity of clinical trials increasing, and the number of trials growing – even after COVID-19 related issues shut many trials down in 2020 – there may be room for more growth. 

Before COVID-19, there was evidence that the amount of clinical trials had steadily been increasing. In 2000, there were 2,119 clinical trials registered at Clinicaltrials.gov. By 2010, 100,208, and by 2020, 362,532 registered by the end of the year (that includes massive slowdowns created by the pandemic for non-COVID research). 

Within that landscape, there is some evidence that sponsors of clinical trials are using more external applications to manage those clinical trials. Of 500 clinical operations professionals respondents surveyed by Veeva (another eClinical company, keep in mind) found that 63 percent were using an RTSM system, up from about 43 percent in 2017. 

4G Clinical, generally, is looking to benefit from the increased public attention to the clinical trials process, and the flexibility that the pandemic has created for sponsors to get creative with clinical trial designs. 

The pandemic did encourage some innovation in this regard. Take, for example, the World Health Organization’s SOLIDARITY trial, which used an adaptive trial design in which multiple drugs could be tested at once. Drugs that showed no promise mid-way through the trial could be dropped (as hydroxychloroquine was in June 2020). The adaptive part, in short, allows for mid-trial tweaks. 

It’s not the traditional design of the gold-standard randomized controlled clinical trial, but it did glean a significant amount of knowledge in a short period of time. After seven months, three of four drugs tested showed no effect on mortality, whereas the fifth remdesivir, showed some limited promise. 

Adaptive trial designs weren’t unheard of before the pandemic – the FDA had actually released guidance on adaptive clinical trials in 2019. But the post-pandemic landscape might encourage more flexibility in this regard, and with it, increase a need for software that can be tweaked to accommodate such changes. 

“I think that we saw some regulatory hurdles reduced as part of this process that allows for more creativity in study design,” says Kelleher. “Probably the most important thing for us is our flexibility, we can make changes to studies very rapidly – to live studies.” 

4G Clinical and other RTSM software like it, are looking to hone tools that already exist within clinical trials – specifically software used to actually run them. It’s an area of research that the team itself has both a personal stake in, and strong industry knowledge. 

Kelleher was diagnosed with Multiple Sclerosis at the age of 23 (a disease to which there is still no definitive cure), and previously founded the Portland-based ACME business consulting. His co-founder Ed Tourtellotte, lost his wife to breast cancer around the same time. Neither have a background in pharmacology, but rather, the team is tackling drug development through streamlining clinical trial software. 

By contrast, other companies aim to streamline clinical trial processes through A.I-based drug target identification, an especially hype-induced area of the space in which investment quadrupled to $13.9 billion between 2019 and 2020. Clinical trial management software may seem more mundane, but it’s still an essential part of running Phase III and most Phase II studies. 

Tourtellotte has designed bespoke software systems for major drug developers, including Pfizer’s Impala system (used in 80 percent of Pfizer’s clinical trials for the past 20 years, says Kelleher) and another system Trident, which was sold to Bioclinica in 2009 (along with Tourtoulette’s company, Tourtellotte Solutions). Trident was utilized by GlaxoSmithKlein for clinical trials in 2010. 

At this point, the company has declined to confirm a total amount of funding, but in 2020, revenue grew 110 percent with just ten percent of its portfolio focused on COVID-19 related projects. 

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