400th Edition – April 7, 2020

On April 3rd, 2020, DLA Piper and BioHealth Innovation, Inc. (BHI) presented an overview of the key provisions for BioHealth Capital Region Life Sciences companies in the $2 trillion Coronavirus Aid, Relief, and Economic Security Act stimulus package via webinar.

The hour-long review and discussion was recorded and is NOW AVAILABLE to access online.

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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.”

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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.

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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 BHI.

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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

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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

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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.

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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.

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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.

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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.

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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

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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)

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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).

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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)

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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

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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.

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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

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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

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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.

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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: BizinfoCovid19@montgomerycountymd.gov. More info to come! hashtag#covid19response hashtag#moco

Image: https://www.linkedin.com

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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

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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

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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

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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

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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.

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Anthony Fauci has been an extraordinary presence during the COVID-19 crisis: calm yet urgent, informative yet plain-spoken. Along the way, he’s doing something even more difficult than explaining COVID-19. He’s providing insight about the role of the scientific expert in a liberal democracy.

Image: https://en.wikipedia.org/wiki/Anthony_Fauci

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WASHINGTON — Nearly 300 children have now been tested in the District’s first drive-thru COVID-19 coronavirus test site, with no kids in the nation’s capital needing life-saving ventilators as the virus wreaks havoc on older populations.

But after the first American infant died of coronavirus in Chicago on Saturday, a new focus on testing children has entered the national conversation – with treatment for the youngest coronavirus patients potentially playing a key role in fighting the outbreak.

Image: https://www.wusa9.com

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Emergent BioSolutions (EBS) – Get Report may be a small company up against the heavy hitters, but it has a plan for a coronavirus treatment, one indication that many players are taking their shot at a vaccine, as the world eagerly waits a solution.

Monday, Johnson & Johnson (JNJ) – Get Report said it will start human testing of a vaccine for the Coronavirus as early as September. The company joins Gilead Sciences (GILD) – Get Report, which the World Health Organization says is a front-runner in making a viable drug, in finding a solution to Covid-19.

Image: https://www.thestreet.com

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The massive bailout package that the U.S. government passed last week to stave off an economic collapse from measures put in place to mitigate the spread of the COVID-19 epidemic is giving out billions to American small businesses. But startups that received venture capital money could be left out.

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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.

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GAITHERSBURG, Md., March 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (EBS) today announced an agreement with Novavax, Inc. (NVAX) whereby Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older.

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A small study reported by researchers in Beijing and the United States found that 50% of patients treated for COVID-19 infection still carried the virus for up to eight days after their symptoms had disappeared. The authors, reporting their results in American Journal of Respiratory and Critical Care Medicine, say they don’t yet know whether the virus might still be capable of transmission at the late stages of disease. However, the results indicate that quarantine periods might need to be lengthened in some recovered patients.

Image: NIAID

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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.

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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

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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).

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