Biohealth Innovation
The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.
Image: https://www.biospace.com
In a different year, incoming freshmen would already have in hand a tightly choreographed schedule for late summer and early fall: the move-in date, the orientation and, finally, the first day of classes.
But on the coronavirus pandemic calendar, there are no dates yet for the next academic year. Just scenarios. And that unprecedented uncertainty is fueling a second wave of crisis for schools already plunged into financial distress.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, says “we are not in a situation where we can say we are exactly where we want to be with regard to testing” capacity for COVID-19 in the U.S.
Fauci, in a discussion for TIME 100 Talks: Finding Hope on Thursday, says that the U.S. needs to not only increase the number of tests, which is happening as commercial testing companies increase production and the Food and Drug Administration continues to clear tests using different types of samples (including ones from the nose and saliva, as well as blood). But, he says, we also needs to make sure tests can actually be run the way they should.
Johnson & Johnson (NYSE:JNJ) says it will work with Emergent BioSolutions (NYSE:EBS) to produce more than a billion doses of a COVID-19 vaccine candidate, as it seeks to scale up global manufacturing of its potential treatment.
J&J says it is already preparing for clinical vaccine production at its Leiden facility in the Netherlands, with the aim of starting its Phase 1 clinical trial of its vaccine candidate on humans in September and potentially having it ready under an emergency use authorization next year.
We at Gentian AS believe it is the duty of all companies in the health industry to help combat the ongoing pandemic of COVID-19/Corona virus. High mortality and long hospitalisation are the consequences of the severe cases with COVID-19 pneumonia. Hence, it is important to identify biomarkers that early could aid in rapid and effective identification of the severely affected patients. In the Gentian test portfolio, the two biomarkers, cystatin C and plasma calprotectin, could be useful for the early detection of the severely affected COVID-19 patients. To do our part we are reaching out to research/hospital institutions who want to run a trial to assess whether these biomarkers can make a contribution in the detection of severe COVID-19 cases.
Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.
Even prior to COVID-19, change was afoot in the venture capital industry. Machine learning and algorithms were emerging as new ways to spot winners, and cities like Boston staked out turf as VC hot spots, proving that not all innovation takes place in Silicon Valley.
Most Americans are still stuck at home, but a trio of reports, out from Harvard, Johns Hopkins, and former US Food and Drug Administration Commissioner Scott Gottlieb, are starting to lay a foundation for what reopening the country might look like, if done safely.
Though staying inside is certainly keeping more infections at bay right now, it's not without its costs.
Aside from the strain stay-at-home orders are putting on families, friends and communities, the newfound national quiet means the US is "hemorrhaging $100 billion to $350 billion a month," according to the new Harvard analysis, which was released on Monday.
Image: A worker wears a protective face mask in a factory of roll-forming machine maker Gasparini, in Mirano. Reuters
In the coronavirus era, a host of epidemiological terms have entered common public use. There’s the now-ubiquitous “social distancing,” and the newly politicized “flatten the curve.” And as states and local governments seek a way out of lockdowns that have brought their economies to a near-standstill, “contact tracing” has made its way into everyday conversation as well.
Image: Public health nurse Lee Cherie Booth conducts a test for COVID-19 outside of the Salt Lake City Public Health Center on April 10, 2020, accompanied by Salt Lake County infectious disease nurse Travis Langston. When a swab test comes back positive, contact tracing starts. Scott G Winterton—The Deseret News via AP
Even as the novel coronavirus has derailed daily life and business operations, the life sciences sector continues to see companies make public debuts and ink both financing and partnership deals.
In venture capital, US deal activity in the first quarter tallied 2,300 financings totaling $34.2 billion, according to the latest report by the National Venture Capital Association, which uses data from PitchBook. That’s roughly on track to match the total raised in the past two years, both record-setters in one way or another. But the likelihood of that pace continuing is slim, according to the report.
Image: Sarah de Crescenzo
When a child gets seriously sick, it's up to us to fight for the world that they believe in. Johnson & Johnson Innovation is at the forefront of that fight. Helping to build a better future for the next child battling cancer, fighting the flu or facing the need for surgery.
The JLABS @ Washington, DC Children's QuickFire Challenge invites innovators to submit game changing ideas, technologies, and solutions that have the potential to impact pediatric oncology, pediatric surgery and influenza. The innovator(s) with the best idea(s) will be awarded up to $150,000 in total grant funding; one year of residency at JLABS @ Washington, DC with the use of a bench, workstation, and access to the JLABS @ Washington, DC community; and mentorship from experts at the Johnson & Johnson Family of Companies
Maryland tech companies started the year bringing in a surge of venture capital funding, and three of the state’s top 10 deals were in Baltimore, according to data from the latest PwC/CB Insights MoneyTree report. But a downturn in the last two weeks as the COVID-19 pandemic-caused slowdown took hold is leaving reason to keep celebrations on lockdown for now.
The $227 million that 21 companies raised from investors was a 44% uptick from the $115 million in the fourth quarter of 2019.
Image: The Huntress team. (Courtesy photo)
Just over three weeks ago the CARES Act, a massive piece of legislation designed to combat the economic havoc being wrought by the coronavirus pandemic, was enacted.
One significant piece of that legislation is the Paycheck Protection Program (PPP), which allows small businesses to borrow funds from the Small Business Administration and affiliated lenders roughly equivalent to 2.5 months of payroll costs. The use of borrowed funds is restricted to “payroll costs” (employee compensation, group health benefits, retirement benefits, state unemployment taxes), rent, mortgage interest, interest on other loans and utilities.
REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today provided additional long-term data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).
"I am impressed by the overall outcomes in patients after a one-time administration of RGX-314. I believe that RGX-314 is the leading gene therapy program for a major retinal disease such as wet AMD and could be an important potential one-time treatment option for AMD patients who require frequent and burdensome anti-VEGF injections. Real-world evidence demonstrates that patients lose vision over time with our current standard of care and incur significant treatment burden with frequent clinic visits and injections," said Allen C. Ho, M.D., Director of Retina Research at Wills Eye Hospital and Mid Atlantic Retina and investigator surgeon in the RGX-314 trial.
Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis. We are dealing with substantial decreases in revenue as well as increased expenses directly tied to addressing this global pandemic. Children's National Hospital is losing $1 million a day. I had a chance to share our challenges with NBC News Reporter Josh Lederman and to spotlight some potential solutions. #covid19 #pediatrics #finances #federalfunding #healthcare #childrenshospital
RESI is planning its first ever, dedicated, digital partnering event on April 29-30th with over 200 investors participating! We’re offering a special opportunity to our tech hubs to help your companies continue their business development in these difficult times. If you are able to promote this event among your constituents, we would like to offer them the possibility to register at a 50% discount, good until April 17th. That means the registration for 2 full days of partnering will cost less than $300!
Special 50% Discount Offer for Tech Hub Constituents (2-Day registration only, ends April 17th) Registration price $595 = $297.50
REGISTER HERE Discount Code: RESITH50
In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19. Please use these links to stay abreast of the last news and resources available for your business.
Maryland
US Small Business Administration
Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? There are a couple openings remaining for tomorrow (Wednesday) ‘s EIR session. Schedule your feedback session with BHI EIRs by videoconference here by 2 p.m. today, Tuesday and forward your power point deck to BHI at that time. Next month’s session is scheduled for May 27th.
Click here to schedule a time with us and send your slide deck to: bhi(at)biohealthinnovation.org.
Contact Judy Costello for more information.
E: jcostello(at)BioHealthInnovation.org
P: 301.637.8854
Bethesda’s Aledade Inc. has done it again.
The fast-growing health tech startup, which helps physician practices cut costs and build accountable care organizations, has raked in a whopping $64 million in Series C financing, after kicking of 2019 with $56 million in then-new investments — and all in a moment of general investor restraint.
The funding will enable Aledade to continue expanding its national network of doctor-led ACOs, the company said Monday. It will also support the addition of more value-based contracts with Medicare, Medicaid and commercial health plans. It comes as Aledade sees annual revenue grow 60% and projects it will surpass $150 million within the next year, it said in an email to the WBJ.
Image: Farzad Mostashari is the CEO and founder of Aledade. JOANNE S. LAWTON
“Nobody knew there’d be a pandemic” … “Nobody has ever seen anything like this before” … “Nobody would have ever thought a thing like this could have happened.”
Those were President Trump’s words in March about the COVID-19 pandemic. Trump’s repeated protestations were questioned by, among others, Trump himself, who told the White House press corps on March 17 that, “I felt it was a pandemic long before it was called a pandemic.”
RIVERDALE, Md., April 17, 2020 /PRNewswire/ -- Medcura, Inc., a commercial-stage medical device company, announced today that it has moved into a new purpose-built facility in Riverdale, Maryland that will support the manufacture and commercialization of its growing product line.
Medcura chose the Discovery District, a growing center for technology and innovation, where high-tech companies can build businesses that develop, manufacture and commercialize disruptive new products. The Company worked with Terrapin Development and St. John Properties to design and deliver a facility that can house product development, manufacturing and leadership functions that will support commercialization of consumer, clinical, surgical and military applications of its proprietary platform. The Company intends to manufacture core cGMP compliant hemostatic and wound treatment materials at a scale necessary for commercial launch and in support of the clinical development of implantable devices.
Image: PRNewsfoto/Medcura, Inc.
QIAGEN N.V. QGEN announces the receipt of the FDA’s approval for its therascreen BRAF V600E RGQ polymerase chain reaction (“PCR”) Kit (therascreen BRAF V600E) as a companion diagnostic to the BRAF inhibitor, BRAFTOVI (encorafenib). The company also announced the subsequent launch of the kit. The FDA approved the use of the PCR kit as a companion diagnostic in combination with cetuximab to treat adult patients, who have metastatic colorectal cancer (“CRC”), with a BRAF V600E mutation after prior therapy. Notably, CRC patients having the mutation will be identified, using an FDA-approved test.
Virginia Governor Ralph Northam on Monday issued an order to residents stay at home until June 10, part of expanded efforts to curtail the coronavirus pandemic that continues to spread across the country.
“I want to be clear: Do not go out unless you need to go out. This is very different than wanting to go out,” the Democratic governor said in announcing the order.
Northam noted that “some of our beaches and other recreational areas were literally packed” over the weekend, and warned that, “everyone who is gathering in a crowd is putting themselves and others at risk.”
ABBOTT PARK, Ill., April 15, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) announced today the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.
This antibody test adds to Abbott's existing COVID-19 tests that are already being used, including its m2000™ molecular laboratory system and its ID NOW™ molecular point-of-care device.
GERMANTOWN, Md., April 20, 2020 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I/II trial for Precigen's PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse™ platform designed to activate the immune system to recognize and target HPV+ solid tumors. HPV+ cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.
It was a year ago this month that Johnson & Johnson Innovation first unveiled plans to launch a healthcare innovation facility in Washington, D.C., in collaboration with BARDA—also known as the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
BARDA's mission: the innovation, advanced research and development, acquisition and manufacturing of medical countermeasures—vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceutical products—needed to protect us from chemical, biological, radiological and nuclear (CBRN) health security threats, as well as pandemic influenza and emerging infectious diseases.
Image: Photo courtesy of Children’s National Hospital
The push for convalescent plasma and hyperimmune globulin immunotherapies to use against COVID-19 continues at the federal level, with the U.S. Department of Health and Human Services (HHS) touting collaboration with non-governmental entities to see it done.
GlaxoSmithKline CEO Emma Walmsley on Tuesday told CNBC’s Jim Cramer that her company’s newly announced partnership with industry peer Sanofi is an “unprecedented collaboration” between competitors.
The European pharmaceutical giants are combining their resources to develop a Covid-19 vaccine and aim to produce a batch within the next 20 months.
Image: https://www.cnbc.com
Iceland has 364,000 inhabitants. Currently, roughly 10% of them are aware of whether or not they have COVID-19. This is due to a massive undertaking by Kári Stefánsson, MD, Dr. Med., the co-founder, president, and CEO of deCODE genetics—a population genetics powerhouse that has routinely produced new discoveries in fields such as genomic architecture, cancer genetics, and mental illness. Now, deCODE has combined the most intensive targeted testing and general screening of any population to date for SARS-CoV-2.
Direct Relief today announced a donation from AstraZeneca of 3 million surgical masks for US healthcare workers battling Covid-19.
“For the dedicated and courageous healthcare workers across this country treating Covid-19 and non-Covid19 patients, working without an adequate supply of face masks and other protective equipment is like going into battle without body armor,” said Direct Relief CEO Thomas Tighe. “This generous and timely donation from AstraZeneca will make a substantial difference in keeping these vital workers safe and able to continue providing care for us all.”
Image: Pallets of surgical masks, donated by AstraZeneca, are prepared at Direct Relief's global distribution facility in California for delivery via FedEx to health workers battling Covid-19 across the United States. (Photo: Direct Relief)
Summary: Droplets from a cough travel at a speed of 1.2 meters per second at peak velocity. Findings reveal that there is no logical reason to suggest 6 foot of physical distance is substantial at reducing coronavirus transmission.
Source: Western University
A recent Western-led study says two meters might not be far enough away if someone lets an uncovered cough loose in your direction – meaning sneeze and cough etiquette is more than a simple social nicety, but a key to stopping the spread of diseases like COVID-19.
Image: Western Engineering’s cough chamber is a two-metre enclosed cube with an opening and chin rest in the front, which is used as an access point for study participants to cough. Within the cube, a camera and a laser are used to determine the velocity of the expelled droplets from the cough. The image is credited to Frank Neufeld.
TENANT AMENITIES
Johns Hopkins University, whose global count of COVID-19 cases and deaths has become one of the most popular sources for information about the disease, has unveiled a new United States map that dives into the pandemic on a county level.
The U.S. map provides information about counties’ health infrastructure, population and policies and cases related to COVID-19, the disease caused by the coronavirus.
Image: Johns Hopkins University’s map tracking the COVID-19 has added county data, including snapshot infographics, like this one of Prince George’s County, for every county in the country. (Johns Hopkins University)
Sanofi and GSK, two of the biggest names in vaccine development, are joining forces on creating a coronavirus vaccine, the companies announced Tuesday.
Sanofi launched the project in February; what’s new is GSK’s contribution of an adjuvant — a substance that is added to a vaccine to enhance people’s immune responses.
Image: JOSEPH N. DISTEFANO
Current COVID-19 tests detect the presence of the SARS-CoV-2 viral RNA genome in patients’ samples through RT-PCR. They are designed to identify who has the virus in their system, at the time of testing. But, testing in the United States has been inadequate on multiple levels. There are not enough tests, leaving some patients waiting in long lines outside of the hospital and others sleeping overnight in their cars, waiting to be tested. Also, the tests’ levels of sensitivity (identifying those with the disease correctly) and specificity (identifying those without the disease) have been called into question.