Last year, when GEN prepared an editorial titled Eight Biopharma Trends to Watch in 2020, who could have foreseen COVID-19 and the deaths, illnesses, and economic disruption that the disease would wreak? And who could have foreseen how armies of industry and academic researchers would race to develop hundreds of new and repositioned vaccines and drugs? (GEN tracks more than 300 on its COVID-19 Drug and Vaccine Tracker webpage).

While biopharma was dominated by COVID-19, which prompted a surge of research and business activity, the industry also saw developments that will position it for further growth even after the virus is brought under control.

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that long-time employee, Dr. Paul VanVeldhuisen, has been named President of Emmes Public Sector.

Emmes is now organized into two business groups:  Emmes Public Sector and Emmes Biopharma.  The public sector group includes all the company's existing federal government clients and contracts, as well as work for foundations, public/private sector partnerships, and not-for-profit organizations.

Image: Paul VanVeldhuisen - PRNewsfoto/Emmes

Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate. 

Click here to schedule a time.

Wednesday, January 13, 2021

Are you an early stage company with innovative biohealth technology? Have you considered non-dilutive funding to advance your technology? Do you want to know if federal or state non-dilutive funding makes sense for you? Sign up for a free 1:1 advice and feedback session regarding non-dilutive funding applications with BHI’s expert grant strategists. Learn more about funding sources and discuss potential strategies for success. BHI has worked with over 100 companies, helping them secure SBIR/STTR and other federal awards —at twice the national average win rate. 

Click here to schedule a time.

Wednesday, January 27, 2021

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.

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

The National Institute of Allergy and Infectious Diseases (NIAID) announced the commencement of the Phase III trial (NCT04611802) of the Novavax investigational COVID-19 vaccine, in a press release issued on Monday, December 28, 2020. The trial will evaluate the effectiveness, immune response, and safety of a COVID-19 vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland, called NVX-CoV2373, and is estimated to complete data collection by March 31, 2021.

I’ve been reluctant to write this blog post because historically I don’t like talking about weight. But I’ve been promising to publish how I lost 65 pounds in the past 18 months without any fad diets or gimmicks to try and be helpful to others. I have a plan,

I know it works and for the friends and family who have followed what I’ve done they’ve equally lost a lot of weight.

We are now only a few weeks out from Biotech Showcase and excited to launch the Spotlight Sessions on our on-demand hub on partneringONE.

We have also posted several Digital Medicine and Medtech Showcase sessions this week. Sponsor Insight content, on-demand public and private company presentations as well as Investor strategy videos are available for you to watch on demand.

Be sure to look at the sessions we have planned for the weeks of January 5 and 11.

Maryland is home to one of the largest life science clusters in the United States with more than 500 biotech companies. In addition to several state-of-the-art labs, Maryland is home to the NIH in Bethesda. Research opportunities, as well as BS and MS degree programs, are offered at Johns Hopkins in Baltimore and the University of Maryland in College Park. Montgomery College in Germantown offers the AAS degree and certificate programs in biotech. World-class training by companies like BioTrac and Biotech Primer attracts an international audience of professionals.

Image: https://www.americangene.com

ROCKVILLE, Md., Dec. 30, 2020 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Neox s.r.o., a European-based CRO.  Neox will add over 150 employees who support biotechnology, pharmaceutical, and medical device companies.

"This is an important and exciting step for Emmes, demonstrating significant progress on our strategic plans to grow our biopharmaceutical business," said Dr. Christine Dingivan, Chief Executive Officer of Emmes. "Neox adds a sizable, well-established biopharmaceutical research services business to Emmes and significantly expands our international presence."

LONDON — Britain on Wednesday became the first country to give emergency authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, clearing the path for a cheap and easy-to-store shot that much of the world will rely on to help end the pandemic.

Image: https://www.nytimes.com - From Video

GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- 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 announced that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- 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 announced that it has entered into an agreement to sell a portion of the royalty rights due to REGENXBIO from Novartis Gene Therapies from the net sales of Zolgensma® to entities managed by Healthcare Royalty Management, LLC (HCR) for a gross purchase price of $200 million. This transaction provides immediate, non-dilutive capital to REGENXBIO for continued innovation in the development of potential breakthrough gene therapies for patients and completion of its internal manufacturing capabilities.

Image: Ben Holmes is co-founder and CEO of Nanochon. COURTESY BEN HOLMES

The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET'S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

The U.S. Food and Drug Administration (FDA) has approved the second-ever genetically modified subtype of pig for human consumption. But there are no plans to raise this pig for meat or other foodstuffs—the use case is actually much, much cooler.

Get unlimited access to the weird world of Pop Mech. LET'S GET WEIRD. By adjusting the pig’s genes so it doesn’t produce a particular sugar called galactose-alpha-1,3-galactose (alpha-gal), scientists can make medicines that are safe for a group of people who suffer from a peculiar, little-understood allergy. And while this certification isn’t planned for meat, that could be next.

Image: TIM MACPHERSON

The latest on the innovations that will let us go back to normal. This has been a devastating year. More than 1.6 million people have died in the COVID-19 pandemic, with more than 75 million cases and tens of trillions of dollars in economic damages. Millions of people are out of work and struggling to pay their bills, and more than a billion children are missing out on crucial time in school. In the U.S., this year also saw the horrifying killings of George Floyd and Breonna Taylor, ruinous wildfires, and a presidential election unlike any other in modern times.

RICHMOND, Va.--(BUSINESS WIRE)--Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).

At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.

SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

Advances in technology that shape the future come in different forms. Some help us realize possibilities of systems that already exist. Others allow us to reframe what’s possible.

Take computing, for instance. Advances in transistors over time have produced more powerful processors that can fit into ever smaller and more affordable packages. This has made it possible to do computing tasks more efficiently and conveniently, but in the end these improvements apply the same principles of classical computing that were used when there were room-sized mainframes.

Image: Sarah Kreikemeier tunes an optical assembly at IonQ's offices. (Photo courtesy IonQ/Erin Scott)

It’s tempting to look forward to the new year — especially after such an abysmal 2020 for so many.

But before we do, let’s not forget all that happened in the region’s innovation ecosystem this year. It wasn’t all bad.

Here, we recap some of the top trends, events and topics over the last 12 months.

Image: Husband-wife co-founders Matthew and Marnel Goins run Puzzle Huddle, which saw increased demand amid stay-at-home orders, school closures and the refocus on supporting Black-owned businesses. Puzzle Huddle

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best-laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C., and Maryland. 

Image: https://biobuzz.io

A biotechnology company whose research and intellectual property has helped to create the Oxford-AstraZeneca Covid vaccine has raised new investment from venture capitalists.

Oxford-based Vaccitech has agreed the funds – understood to be as much as £10million – from Future Planet Capital which also invests in health, climate change and education projects.

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

BALTIMORE (WJZ) — A team from Johns Hopkins University won a global mask design challenge.

Two dozen undergraduates from the university make up Team Polair. Together, they created a clear mask they said people would want to wear.

Image: https://baltimore.cbslocal.com

ROCKVILLE, MD, Dec. 18, 2020 (GLOBE NEWSWIRE) --  

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced today a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics' proprietary DART® platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology.

Sykesville, MD, and Fairfax, VA, December 21, 2020 - Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.    

The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

The BioTalk with Rich Bedis Podcast created by the BHI President & CEO and Andy Eckert was awarded the 1st Annual BioBuzz Media Award. This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns.

BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1^st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region.  This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.

BHI’s Managing Director, Economic Development, Judy Costello was recognized by voters in the 1^st Annual BioBuzz awards this past week as the top Community Builder in the BioHealth Capital Region.  This award honors someone in the region who has gone above and beyond their responsibilities to make an impact on the ecosystem by being a thoughtful community builder who fosters intentional collaborations and meaningful contributions of their time, energy, and expertise to support the biohealth community. This person is a servant leader who sees beyond their job description or the balance sheet and strives to create a rising tide for all across the BioHealth Capital Region so that we can collectively make a greater impact on public health and patients around the world.