COVID-19 wasn’t about to stop the important work being done to meet the large unmet need for pediatric medical devices among patients younger than 18. NCC-PDI’s annual “Make Your Medical Device Pitch for Kids!” pitch competition moved to a 100% virtual event format to keep pediatric medical device innovation moving forward while complying with social distancing recommendations that will help to flatten the curve.

In late March, 30 outstanding companies pitched their pediatric device innovations in cardiovascular, orthopedic, spine and Neonatal Intensive Care Unit (NICU) devices — areas where the need is greatest  — to judges in a virtual meeting room setting. 

Image: https://biobuzz.io

Johns Hopkins President Ronald J. Daniels shared a message with the university community today. The full text of the message is below.

Dear Johns Hopkins Faculty, Students, and Staff:

It has been a long and nerve-wracking month since we began to fully prepare for, and mitigate the impact of, the extraordinary challenges posed by COVID-19. Our colleagues from the Bloomberg School of Public Health remind us that we are still likely a few weeks from the peak of the pandemic in Maryland. For the foreseeable future, we will remain under significant strain as we respond in ways that run counter to our normal course of action and to our community's innate desire to connect in person with each other.

Image: https://president.jhu.edu/

A new coronavirus was spreading in the U.S., and with social distancing orders going into place, talk immediately turned to finding a treatment that could stop the spread. In Maryland, companies jumped into action. Work began on a vaccine at Gaithersburg-based Novavax, and the company partnered with Emergent Biosolutions on initial development and manufacturing. Gaithersburg’s Altimmune is also developing a vaccine, and announced plans last week for a preclinical testing collaboration with the University of Alabama Birmingham.

As the U.S. continues to find its way through a tough fight against this global pandemic, a number of BioHealth Capital Region (BHCR) biotech companies are making significant contributions to stem the COVID-19 pandemic. With people across the U.S. and the world making sacrifices to flatten the curve — along with nurses, doctors and first responders who stand heroically at the front lines — life science companies in our region are doing everything in their power to make COVID-19 vaccine progress with celerity, safety and efficacy top-of-mind.

WASHINGTON (NEXSTAR) ─ Even though he says the worst is yet to come, Dr. Anthony Fauci, the nation’s top infectious-disease expert, has seen signs of progress in the country’s fight against the coronavirus.

“The next week we’re going to see a spike in deaths throughout the country, particularly in the hot spot areas like New York, but simultaneously with that, we’re starting to see some cautiously optimistic type signs,” Fauci said.

Image: https://fox8.com

Like many states across the nation, Maryland is preparing for a possible surge of COVID-19 patients.  Johns Hopkins is working with the state and the University of Maryland to erect an Alternate Care Site at the Baltimore Convention Center (ACS BCC). The ACS BCC is planned to open by mid-April and is intended to be used as a post-acute treatment facility.

Johns Hopkins is working on the recruitment, contracting, and credentialing of temporary Physicians and Advanced Practitioners. Compensation will be provided. We are reaching out to you, as a leader within your organization, in hopes that you might forward this to interested parties who may be willing to temporarily assist in treating patients recovering from COVID-19. Please see the attached job posting for details.

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs through video conference on one of the following dates: 4/22, 5/20. (45 minute blocks of time beginning at 9:00 in the morning.)

Pre-registration is required; sign up here:

For questions/more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..

BioHealth Capital Region COVID19 Resources:

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.

District of Columbia 

Maryland

• Governor's Update - https://governor.maryland.gov/coronavirus/
• General Update - https://coronavirus.maryland.gov/
• Business Resources - https://govstatus.egov.com/md-coronavirus-business\

Montgomery County, MD

Virginia

US Small Business Administration 

Volunteers

Sean M. Kirk, Executive Vice President, Manufacturing and Technical Operations at Emergent BioSolutions joins Rich Bendis to discuss the COVID-19 Health Crisis, Emergent’s Capabilities in Manufacturing in the BioHealth Capital Region and Beyond

Mr. Kirk joined Emergent BioSolutions in 2003 and has served as executive vice president, manufacturing and technical operations since April 2019. Prior to this position, Mr. Kirk has held various senior leadership roles including senior vice president, manufacturing operations and contract development and manufacturing operations (CDMO) business unit lead from April 2017 to March 2019, senior vice president, biodefense operations from November 2015 to March 2017, senior vice president, biosciences operations from February 2014 to November 2015 and senior vice president, biodefense vaccines and therapeutics development from March 2012 to February 2014. Mr. Kirk also served in multiple roles of increasing responsibility at Emergent’s manufacturing operations site in Lansing, Michigan.

Before joining Emergent, Mr. Kirk worked at Merial, a multinational animal health company, serving in various positions from 1996 to 2001. Mr. Kirk received both an M.B.A. and B.S. in Microbiology from the University of Georgia.

New Members Continue GSK and NEA’s commitment to the BHI mission and the BioHealth Capital Region

ROCKVILLE, MARYLAND, April 6, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of two new board members, Rebecca Farkas, PhD, Director, External R&D, Scientific Collaborations at GSK, and Sara Nayeem, M.D., Partner at New Enterprise Associates (NEA). BHI’s leadership also thanked outgoing Board of Directors members Rip Ballou of GSK and David Mott of NEA for their contributions to the organization and friendship of many years.

 “I am honored to welcome both Rebecca and Sara to our Board of Directors,” said Richard Bendis, BHI President and CEO. “They both bring a combination of experience and fresh vision to our already robust collection of industry leaders. We are excited to to work with them to help grow the BioHealth Capital Region industry cluster.”

Immunomic Therapeutics Inc. is pivoting, as many are, in this new era to work on a vaccine for the novel coronavirus. But it’s also pursuing goals that would be considered ambitious even before the world changed: It’s closing in on a $50 million raise, advancing its brain cancer program — and positioning itself for an initial public offering.

The Rockville vaccine maker secured the first $10 million of this latest fundraising round at the end of January from Korean investment group HLB, and it expects to close on another $40 million-plus in the next couple of weeks, said Bill Hearl, founder and CEO of ITI. That capital would support the immuno-oncology company’s therapy for glioblastoma, an aggressive brain cancer, now heading into a phase 2 clinical trial after a successful phase 1 study that extended the typical 14- to 16-month median survival rate to 41 months.

Image: Bill Hearl is CEO and founder of Immunomic Therapeutics in Rockville. COURTESY IMMUNOMIC THERAPEUTICS

Not long ago, working from home was an option for some of us.

Today, it’s the norm for nearly all of us. 

Unless your job absolutely requires you to be on the front lines, the coronavirus pandemic has caused us all to set up home offices and social distance ourselves from coworkers and clients alike. 

That shift has likely carried some stumbling blocks, something even the most seasoned remote worker can attest to.

Image: https://www.bizjournals.com

GlaxoSmithKline and AstraZeneca are considering forming a joint laboratory to help the U.K. government stretch and expand its supplies for COVID-19 diagnostic tests, according to a report from Bloomberg.

Even though diagnostics are not their core efforts, the plan is for the two Big Pharmas to test a range of different reagents, chemical mixtures and other materials for new ways to help detect the spreading novel coronavirus. Successes would be provided to other manufacturers or the U.K.’s National Health Service.

Image: Global supplies of testing reagents and other materials, including swabs, have been faced with overwhelming demand in recent weeks. (NIAID - Rocky Mountain Laboratories)

We're currently tracking 95 potential treatments and 52 potential vaccines in the pipeline to combat hashtag#COVID19.

There are thousands of researchers all over the world racing to get a treatment or vaccine to market.

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. Due to the potential exceptional impact, we want to assure our recipient community that NIH will be doing our part to help you continue your research.

SAN FRANCISCO--(BUSINESS WIRE)-- venBio Partners LLC today announced the closing of venBio Global Strategic Fund III (“venBio Fund III”), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

ROCKVILLE, Md., April 6, 2020 /PRNewswire/ -- Emmes today announced that Heather Hill, Dr. Adam Mendizabal and Dr. Nilay Shah have been promoted to vice president.  According to Dr. Anne Lindblad, president and chief executive officer, "These promotions reflect their talent and value to the organization.  Heather, Adam and Nilay demonstrate our commitment to developing staff and promoting from within.  They will strengthen and add great value to our leadership team and will support our plans to grow both internally and externally."

Heather Hill

Dr. Adam Mendizabal

Dr. Nilay Shah

One of America’s biggest companies has teamed up with one of the country’s least-known federal agencies to make doses of a coronavirus vaccine. Lots of them. 

The deal underscores the important role that the U.S. Biomedical Advanced Research and Development Authority, or BARDA, plays behind the scenes in protecting Americans—and everyone, really—from pandemics.

A few weeks ago, I was in New Orleans for a jam-packed wedding weekend, complete with a crawfish boil, second line parade, Hawaii-themed 30th birthday luau for the bride-to-be, and more gumbo and jambalaya than we could eat (and guys, we’re talking authentic Louisiana Creole, which was just delicious.)

Image: Image via the Business Journals

Last week, we spoke to the head of Emergent BioSolutions’ Therapeutics Business Unit Dr. Laura Saward about her company’s work developing plasma-based potential treatments for COVID-19. Now, the company announced that it has received $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS), to speed the development of one of its treatment candidates.

The U.S. Food and Drug Administration approved a clinical trial Friday that will allow Johns Hopkins University researchers to test a therapy for COVID-19 that uses plasma from recovering patients.

Arturo Casadevall, a Johns Hopkins infectious disease expert, proposed the use of convalescent plasma to treat critically ill COVID-19 patients and to boost the immune systems of health care providers and first responders. He assembled a team of physicians and scientists from around the United States to establish a network of hospitals and blood banks that can collect, isolate, and process blood plasma from COVID-19 survivors

COVID-19 Notice for Maryland SBDC Clients, Stakeholders, and Partners

We are committed to serving our clients during the COVID-19 (Coronavirus) health emergency.

Consulting Services - New clients already in business can request COVID consulting assistance by clicking on the "I'M IN BUSINESS- GET CONSULTING" on our home page. The link is right below this notice towards the right side of the page. Continuing clients may continue to contact their consultant by phone, web conference, or email.

Training - All in-person training scheduled during the month of April has been canceled, postponed or offered online. If a paid training class is canceled or postponed, participants may request a refund or apply the funds to another class. If the class will be offered online, registered participants will receive an email with instructions for participating in the online class.

We're proud to announce a partnership with the U.S. Government on a comprehensive response to expedite development of our plasma-derived therapy to address hashtag#COVID19. https://lnkd.in/eHGC5F6

hashtag#toprotectandenhance hashtag#emergentbiosolutions hashtag#COVID19 hashtag#coronavirus

Image: https://www.linkedin.com

Information regarding the hashtag#montgomerycountymd Public Health Emergency Grant Program passed by County Council yesterday. The County Executive's staff is preparing regulations and plans to implement the program as quickly as possible. Businesses may submit questions about the program to: This email address is being protected from spambots. You need JavaScript enabled to view it.. More info to come! hashtag#covid19response hashtag#moco

Image: https://www.linkedin.com

Solicitations play an important role in making the general public aware of funding opportunities available to the small businesses of the nation. Participating Federal Agencies post these funding opportunities on a regular periodic basis throughout the year associated to SBIR/STTR.

To become involved with the Small Business Innovation Research (SBIR) or the Small Business Technology Transfer (STTR) program, small businesses can compete by submitting solicited proposals to these agencies. A winner in the competitive solicitation process is awarded a grant or contract. The SBIR/STTR program does not fund unsolicited proposals (proposals that do not refer to and address a specific topic in a current agency SBIR/STTR solicitation).

QIAGEN (Hilden, Germany) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus. The EUA approval status comes after QIAGEN recently began shipping QIAstat-Dx SARS-CoV-2 test kits to the US under a new FDA Policy allowing the kits to be made commercially available.

Image: QIAstat-Dx Respiratory SARS-CoV-2 Panel test (Photo courtesy of QIAGEN)

GAITHERSBURG, Md., April 02, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

Steve Bulger has heard all the complaints.

The acting director for the U.S. Small Business Administration’s Mid-Atlantic region knows about the technical issues that applicants for the agency’s Economic Injury Disaster Loans (EIDL) faced last week.

He’s received questions about why those loans come with interest rates well above the Federal Reserve’s current standard rate.

Image: Steve Bulger, acting director for the U.S. Small Business Administration’s Mid-Atlantic region, has been dealing with an overflow of loan applications from small businesses struggling amid the COVID-19 crisis. U.S. SMALL BUSINESS ADMINISTRATION

The agency said it had redeployed some staff and streamlined processes to enable it to review clinical trial protocols faster and respond faster to companies and scientists developing new drugs for the disease.

The Food and Drug Administration hopes to expedite development of treatments for Covid-19 under a new program that the agency announced Tuesday.

The FDA said that under the Coronavirus Treatment Acceleration Program, or CTAP, it is redeploying staff and streamlining processes with the goal of speeding up reviews of clinical trial protocols and single-patient expanded-access requests.

Image: https://medcitynews.com

In the middle of a hand-sanitizer shortage caused by the coronavirus pandemic, Johns Hopkins and Baltimore distillery Sagamore Spirit are working together to manufacture the disinfectant for use by the Johns Hopkins Health System.

The collaboration came together in less than 10 days, with Sagamore Spirit converting 100% of its distillation processes from rye whiskey mash bills to corn ethanol in support of the effort.

Image: IMAGE CREDIT: WILL KIRK / JOHNS HOPKINS UNIVERSITY

The number-one pressure on small-business owners right now is payroll. Whether you’re a sole proprietor one-person-show or a company with 500 employees, you’ve certainly felt the pressure. Maybe you’ve already stopped paying yourself, have laid off workers or cut hours. Well, you can thank your federal government for the best aid program recently offered for small business, the Paycheck Protection Program loan (aka Coronavirus Stimulus Loan, or PPP Loan).

Prominent research universities and government agencies are keeping the public abreast of the scope of the coronavirus pandemic as well as the reported outcomes of identified cases.

Major media outlets are doing their best to share information in real-time, but often portray spiking case numbers in hotspots like New York City as the accelerating spread of COVID-19. The reality, in many states across the U.S., is that COVID-19 has already infected large swaths of the population, so the coronavirus is not necessarily “spiking” but rather being revealed through better diagnostics and wider access to COVID-19 testing. 

Image: https://biobuzz.io

Newswise — When T.C. Wu, M.D., Ph.D., M.P.H., and Chien-Fu Hung, Ph.D., heard earlier this year about a new coronavirus that was spreading in China, their pathology labs immediately started developing a vaccine. That’s because nearly 20 years ago, Wu and Hung worked on a vaccine for another coronavirus that originated in China — severe acute respiratory syndrome, or SARS. So far, Wu and Hung have observed that the new coronavirus is “smarter” and “sneakier” than SARS, and they are concerned it will not go away like SARS did. Wu and Hung can discuss how their lab administered the new coronavirus vaccine to mice, and that preliminary results should be back by the end of the month. Watch this video and read this story about their efforts.

WASHINGTON – Following President Trump’s signing of the historic Coronavirus Aid, Relief, and Economic Security (CARES) Act, SBA Administrator Jovita Carranza and Treasury Secretary Steven T. Mnuchin today announced that the SBA and Treasury Department have initiated a robust mobilization effort of banks and other lending institutions to provide small businesses with the capital they need.