We’re taking a closer look at each of the 50 winners of our 2021 Inno on Fire honorees.

Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million.

The FDA's fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.

The 2022 fee for FDA approval applications not requiring clinical data will be about $1.6 million in 2022, which is about $200,000 more than the previous two years.

Drugmakers pay these fees to ensure the FDA responds to applications within 10 months for standard applications and within six months for expedited reviews.

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

On the heels of Silicon Valley’s branding as one of the world’s largest tech hubs, the BioHealth Capital Region aims to brand the DMV region as one of the most prominent BioHealth clusters in the Mid-Atlantic. BioHealth Innovation, Inc. was founded 11 years ago in an effort to drive ideas from labs into markets through innovation-driven economic development organizations and initiatives.

Galvin and Bendis discuss the abundance of opportunities for growth within the region as it is home to a wide variety of research institutions, top scientists, and annual grants. Additionally, they discuss how BioHealth Innovation, Inc. cultivates success for companies within the competitive region.

In this episode of #ThisIsUSG, BioHealth Innovation President and CEO Rich Bendis joins Dr. Anne Khademian for a discussion about BioHealth Innovation's role in advancing the biotechnology/life sciences industry in Montgomery County and the capital region as a whole.

https://www.youtube.com/watch?v=0pe8g47_f-o

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 on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

RIVERDALE, Md., Aug. 12, 2021 /PRNewswire/ -- Medcura, Inc., a commercial-stage medical device company, today announced it has raised $7.4 million in private equity to support its growing product line and development of its lead surgical candidate for clinical evaluation. The financing includes the sale of Series A Preferred stock as well as common stock based, in part, from certain investors benefitting from a Maryland Investment Incentive Program. 

"Medcura has reached a pivotal point in our growth," said Larry Tiffany, CEO of Medcura. "Our products are positively impacting the lives of patients and our community. With these funds we can accelerate product development, expand our commercial footprint and bring the company's potentially lifesaving technology to operating rooms and battlefields worldwide."  

August 11, 2021 (Washington, D.C.) - A bold new public-private partnership to prevent future viral outbreaks from becoming pandemics has moved one step closer to realization, as the Greater Washington cross-sector nonprofit, Connected DMV, has announced the formal launch of a Global Pandemic Prevention and Biodefense Center (GPPBC). The Center will serve as a vehicle to foster greater collaboration among pandemic prevention stakeholders to deliver on strategic projects needed to advance pandemic preparedness and avoidance. The signature initiative of the Center accelerates the development of human monoclonal antibodies (mAbs) to treat the world’s top 100 pathogens across 25 pathogen families most likely to result in disease outbreaks.

One of the top questions that employers in the Life Sciences community within the Capital Region are asking is how companies are approaching bringing employees back to the office. That’s why we asked nearly 30 top employers in the area to share their strategies in a recent survey conducted by BioBuzz Media.

OVERVIEW:

• Free, half-day virtual event.
• Hear from inventors from the National Cancer Institute and the Frederick National Laboratory  about technologies primed for commercialization and/or collaboration; great opportunity for biotech stakeholders and companies of all sizes, including start-ups.
• Panel sessions focused on technology commercialization.
• Lightning Pitch & Poster Session highlighting additional NIH technologies available for licensing and collaborative development presented by the NCI Technology Transfer Ambassadors Program.

As a trifecta of crises upended life in 2020, the need for a diverse scientific and medical community grew ever more clear. George Floyd’s murder elicited worldwide protests against racial injustice. COVID-19 affected all of our lives and had an outsize impact on Black and brown communities. And COVID-19’s economic fallout only exacerbated extreme wealth inequality. 

Brand new office / lab suites. Flexible suites that can be combined for larger uses. Full third floor available for customization.

Approximately 47,000 BRSF.

Click here to download a brochure.

On August 6th, 2021, FDA released an update on various matters related to COVID-19. Among these topics was an update on Emergent BioSolutions, a manufacturer who has come under fire for their mishandling production of COVID-19 vaccines.

However, FDA has now approved certain lots of the AstraZeneca vaccine made at the facility suitable for export. While the AstraZeneca vaccine is not approved for use within the United States, it is used by various countries overseas.

HILDEN, Germany & WALTHAM, Mass. & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) and OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna™ TME panel.

"This is USG" is a video podcast series launched by the Universities at Shady Grove (USG) in October 2020. The series features Dr. Anne Khademian, USG's Executive Director, interviewing guests who are closely connected to USG and the greater community. Guests include students; alumni; staff; faculty; members of the USG Board of Advisors; business, community and university leaders; and others.

https://youtu.be/0pe8g47_f-o

ARLINGTON, Va., Aug. 9, 2021 /PRNewswire/ -- Sands Capital held a first and final closing of its second life sciences dedicated fund, Sands Capital Life Sciences Pulse Fund II, L.P. ("Pulse II"), raising $560 million. This close increases total Pulse Strategy assets under management to more than $950 million, including Sands Capital Life Sciences Pulse Fund, L.P. ("Pulse I") and related vehicles. The team will continue investing with the same emphasis on private therapeutics, diagnostics, and life sciences tools businesses. The strategy's mission is to help transform how diseases are defined, diagnosed, and treated.

Jeff Galvin, CEO of American Gene Technologies and Rich Bendis, CEO and President of BioHealth Innovation, Inc. have a fireside chat about the rapid evolution of the BioHealth Capital Region.

You can also listen to the audio only version via Apple https://apple.co/37wc6Kk, Google https://bit.ly/2XbLe0v, Spotify https://spoti.fi/3yCWhxE, and TuneIn https://bit.ly/3AqYkoR.

Click here to view the video interview between Jeff and Rich.

GAITHERSBURG, MD, 9 August 2021 - MaxCyte, Inc. (Nasdaq: MXCT) (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the signing of a clinical and commercial license with Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on creating and delivering engineered cells as medicines.

Under the terms of the agreement, Sana Biotechnology obtains non-exclusive clinical and commercial rights to use MaxCyte's Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

The FAES Academic Programs at NIH offers a unique Advanced Studies in Technology Transfer to persons with a Bachelor’s degree in science or engineering or a related field. Courses are offered in the evenings, making it convenient for working professionals and postgraduate Fellows to gain expertise and experience in patenting, licensing, collaborative agreements, and other fundamental intellectual property transactions. The technology transfer profession field employs more than 10,000 professionals in the U.S., with many practicing their trade in the greater Washington, D.C. metro area.The course instructors are leading practitioners in the field, so students can simultaneously gain the necessary knowledge and build professional networks.

Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 - UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

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 on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

Hospitals and health systems across the U.S. are pushing forward digital transformation efforts by creating new tools and launching innovative programs. 

Here are the organizations that announced pilots of new innovation programs or expansions to existing programs during June and July, as reported by Becker's Hospital Review.

1. Worcester, Mass.-based UMass Memorial Health expanded care beyond hospital walls with the recent rollout of its tech-powered hospital-at-home program. 

The Bacteriophage (Phage) Therapy (PT) market is growing rapidly in the U.S. The rise of antibiotic resistant bacteria and multidrug-resistant bacteria (MDRs) across the globe has increased the value and industry acceptance of a phage approach, which can help combat bacteria that cannot be effectively treated by antibiotics. What’s more, the phage modality is a great fit for targeted personalized medicine approaches.

ROCKVILLE, Md.--(BUSINESS WIRE)--Aug. 4, 2021-- GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King. Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company’s pipeline.

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques. People both inside the pharmaceutical industry and outside share many common concerns about the state of the pharma supply chain. Interruptions caused by the COVID-19 pandemic, global unrest, severe weather catastrophes, and other events stand to disrupt the supply of essential ingredients and products; these challenges have pharma professionals, government leaders, and others looking for ways to shore up the supply chain and avoid interruptions.

COLLEGE PARK, Md. – The Quantum Startup Foundry (QSF) at the University of Maryland (UMD) today announced that Ernst & Young LLP (EY US) is a founding member of the QSF and will help the foundry advance its mission of accelerating leading-edge quantum technologies and driving the second quantum revolution.

EY is the first professional services firm and overall organization to work with the foundry on programs that connect the virtual and physical resources needed to support quantum entrepreneurs and startups. Additionally, EY will provide insight, mentorship, customer and investor introductions, and other services to companies cultivated through the QSF.

The chief executive of AstraZeneca has underscored the importance of multilateral cooperation in the fight against COVID-19 as well as other systemic global challenges such as climate change, calling global warming “the biggest threat to humanity”.

In a wide-ranging and exclusive interview, Pascal Soriot expressed unease over what he saw as an excessive focus on Western nations in the context of vaccinations. He told IMD’s President Jean-François Manzoni: “The whole discussion is about [the] US and Europe, but there are 7 billion people outside of those two regions.”

Paul Rennie OBE, Counsellor for Global Issues in the Global Economy Group at the British Embassy, Washington DC, and Professor Jason Snape, Head of Environmental Protection within AstraZeneca’s Global Sustainability Team, join Rich Bendis to Discuss Life Sciences, Climate Change, COP26 - UN Climate Change Conference, and The Race to Zero Campaign.

Listen now via Apple https://apple.co/3ls3EEp, Google https://bit.ly/3liTlSU, Spotify https://spoti.fi/3ylxair, and TuneIn https://bit.ly/3rS9Giz.

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 on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

GAITHERSBURG, Md., July 29, 2021 /PRNewswire/ -- MaxCyte, Inc., (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, today announced the pricing of its upsized offering of 13,500,000 shares of common stock at an initial offering price of US$13.00 per share (the "Offering").

MaxCyte has granted the underwriters a 30-day option to purchase up to 2,025,000 additional shares of common stock at the initial offering price per share of common stock less underwriting discounts and commissions.

The closing of the Offering is expected to occur on August 3, 2021, subject to customary closing conditions.

Maryland biotech company Emergent BioSolutions said on Thursday that it was approved by the U.S. Food and Drug Administration (FDA) to resume manufacturing of Johnson & Johnson’s COVID-19 vaccine at its Bayview plant in East Baltimore. The Gaithersburg-based company, which serves as a contract manufacturer for pharma companies, has an agreement with J&J to provide doses of its one-shot vaccine.

Image: Emergent Biosolutions' Bayview facility. (Courtesy photo)

ROCKVILLE, Md., July 29, 2021 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc (Shuttle Pharma), a Maryland-based developer of new drugs for cancer treatment, was awarded US Patent No.: 11,034,667 B2 for "Selective Histone Deacetylase Inhibitors for the treatment of Human Disease." These non-cytotoxic, highly selective inhibitors target the histone deacetylase 6 (HDAC6) enzyme to stimulate the immune system for applications in the treatment of cancers, neurological diseases and immunological disorders.

Lead inventor Scott Grindrod, PhD describes histone deacetylase (HDAC) inhibitors as "a novel class of drugs that target enzymes involved in regulation of critical cellular functions that can inhibit cancer growth and activate cellular immunity. These are key target functions to improve cancer treatment. HDAC6 regulates the innate immune system and will be tested to activate an anti-cancer immune response to increase the effectiveness of chemotherapy and radiation therapy. The molecules in this patent enhance Shuttle Pharma's platform technology of selective inhibitor discovery for cancer treatment."

GAITHERSBURG, Md., July 29, 2021 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent’s Bayview manufacturing facility to resume production of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan.

“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” said Emergent chief executive officer, Robert Kramer. “We are in the unique business of producing life-saving medications for catastrophes that we hope never occur like anthrax attacks, opioid overdoses, and Covid-19.”

Emergent Biosolutions’ vaccine manufacturing plant in Baltimore has been the subject of many headlines this past year for its’ role in producing several COVID-19 Vaccines.  However, the history of this facility goes back more than two decades.

For the past 25 years, this Baltimore biopharmaceutical facility has played a significant role in Maryland’s life sciences ecosystem. Over the course of its life, the building has gone from being home to vaccine and small molecule manufacturing to the development of countermeasures for biologic threats, including COVID-19.

Image: https://biobuzz.io

Boston Properties (BXP) is set to acquire the Shady Grove Bio+Tech Campus, a seven-building, 435,000-square-foot office park in Rockville, Md., for $116.5 million, from Lantian, the company announced. 

The deal is expected to close in the third quarter of this year. 

The 31-acre property, located at 9600 Gudelsky Drive, is situated within the Shady Grove life sciences cluster, home to a host of companies in the biotechnology sector. It is also currently home to the Universities at Shady Grove, a biomedical and tech-focused university that is part of the University System of Maryland.

Image: PETE OTTENI. PHOTO: BY BXP

The rapidly spreading Delta variant is forcing employers to rethink their strategies for handling the pandemic. Policies they should reconsider include encouraging or requiring employees to be vaccinated, whether to hold off on having remote workers return to company facilities, rules for social distancing and wearing masks at job sites, ventilation, testing, travel restrictions, communicating exposures, and support for mental health care. This article offers advice on how to think through these issues.close