The startup is now looking for a lead investor for its Series A round to fund the company’s go-to market roadmap.

Image: Sam Owen is founder and CEO of D.C.-based Otolith Labs ALEXANDRA WHITNEY PHOTOGRAPHY

Introduction

The UK formally left the EU on 31^st January  2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31^st December  2020. During this transition period the UK has continued to remain under EU pharmaceutical law.

From 1^st January 2021 the UK will be able to adopt an independent regulatory framework with the Medicines and Healthcare products Regulatory Agency (MHRA) positioned as the stand-alone regulator for medicines and medical devices.

Negotiations between the EU and UK are still ongoing to define the future relationship and with only a matter of months left before the end of the transition period there has been no formal agreement. For the pharmaceutical industry this presents numerous challenges as companies prepare to continue supply of medicines that comply with new legislation. The preferred outcome for many within the industry will be to implement a mutual recognition agreement for areas such as GMP certification, batch testing, etc. between the UK and EU.  It is unclear at this stage if an encompassing mutual recognition agreement is achievable so all involved parties should be preparing for a ‘no deal’ scenario and review existing guidance to understand risk exposure and mitigating actions.

Real estate investment trusts (REITs) have done an excellent job creating outsized wealth for their investors over the years. From 1972 through the end of last year, REITs generated an average annual total return of 13.3%, which outperformed the S&P 500's 12.1% total return. Those higher long-term returns mean REITs have turned small initial investments into big-time paydays at a faster pace than the S&P 500.

New Enterprise Associates Inc., one of the world’s largest venture capital firms, is in talks to sell a minority stake in itself, according to people with knowledge of the matter.

The Silicon Valley firm has held discussions with several potential investors, said the people, who requested anonymity because the talks are private. No deal has been reached, and it’s possible one won’t materialize. Representatives for NEA didn’t immediately respond to requests for comment.

Image: NEA’s Scott Sandell Photographer: David Paul Morris/Bloomberg

Johns Hopkins moved up a spot to No. 10 in the annual U.S. News & World Report Best Global University Rankings released today, a year after moving up to No. 11 from No. 12 in the 2020 rankings.

Johns Hopkins also ranks among the top 10 universities in the world in 15 subject areas and among the top 20 in 19 subject areas. Ten new subject area rankings were added to the list this year, bringing the total to 38.

Image: https://hub.jhu.edu

In a long-awaited meeting on America’s crash program to deliver vaccines against the Covid-19 coronavirus, leaders of the program reviewed the measures they have taken to assure the effectiveness and safety of the vaccines. The U.S. Food and Drug Administration convened a panel of independent vaccine experts to ask questions during the Thursday online session. The meeting was designed to reassure the public on the integrity and transparency of the FDA’s vaccine oversight, as the agency has wrestled with political pressure and pockets of public vaccine hesitancy.

MARSEILLE, France, Oct. 23, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors (“IO-pretreated”). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

She said the Rockville research company is set to grow and details Covid’s larger impact on research.

Image: Dr. Christine Dingivan took over as president and CEO of Rockville contract research organization Emmes at the end of September. COURTESY EMMES

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer.

Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps on board full time. This comes two months after it nabbed U.K. government funding for a COVID-19 vaccine it thinks can improve on first-generation prospects, including the AstraZeneca vaccine it helped develop.

Image: Vaccitech's headquarters in Oxford, England (Jun via Flickr/CC-by-SA 2.0)

America’s long-term economic growth demands a stepped-up commitment to promoting the innovation impact of the nation’s top-tier universities and other research institutions.

For research institutions themselves, this commitment means prioritizing research, empowering great researchers, building efficient and outcomes-focused technology transfer operations, instilling cultures of innovation and entrepreneurship, and engaging with surrounding business and innovation communities. For America as a whole, it means funding more research resources and paying more attention to the worldwide competition for human talent, including high-skilled immigrants.

BLUEPRINT FOR ECONOMIC RECOVERY BEYOND THE TRIANGLE: Most experts agree Raleigh and Durham are well positioned for a strong recovery from the pandemic, but what about the areas well beyond the Triangle's core?

A new report released Wednesday from RTI International is meant to address that very question. The Innovation Corridor Blueprintincludes 12 areas of focus for leaders and stakeholders to tackle in a 100-mile radius around the Triangle. Topics range from digital infrastructure and affordable housing to biohealth technology and addressing systemic racism.

Image: An illustration of the Raleigh-Durham skylines. SEANPAVONEPHOTO

By Brian Darmody 

Seventy-five years ago, Vannevar Bush, an electrical engineer who directed government research during the Second World War, authored Science—The Endless Frontier. His report called for a centralized approach to government research, which led to the creation of the National Science Foundation in 1950 and is credited as a path breaking roadmap for US science policy.  

Over the next 75 years, the federal government invested billions of dollars of research, creating the world’s leading research universities, while places like Stanford University and state of North Carolina launched research parks; tech transfer programs stimulated by the Bayh-Dole Act flourished; and reforms in SEC regulations created the venture capital sector. 

Download the PDF

– Winning company has FDA cleared device to rapidly and objectively assess brain injury at point of care.

ROCKVILLE, MARYLAND, October 26, 2020 – BrainScope, a medical neurotechnology company that is a pioneer in the use of A.I. and machine learning in the creation of biomarkers of brain injuries and disease was selected from five finalists as the company with the most commercial potential at the 5th Annual BioHealth Capital Region Crab Trap Competition. The Bethesda, Maryland based company is helping hospital Emergency Departments (EDs) objectively triage the almost five million patients that present each year with suspected mild traumatic brain injuries. BrainScope’s FDA-cleared decision support tool provides a rapid and accurate assessment of the likelihood of a brain bleed and a concussion, at the point of care.

BrainScope’s outstanding 99% sensitivity to a head CT scan is performed without the use of radiation, in a fraction of the time, and can improve ED efficiency and increase patient satisfaction. Clinical studies have demonstrated that when BrainScope is used in triage, hospitals can reduce the number of patients being sent for head CT by about a third. According to BrainScope CEO Susan Hertzberg, “We are honored to have been chosen from this exceptional group of companies and are very excited by the early reception we are receiving from the emergency medical community.  Now more than ever in this COVID-19 world, emergency departments need to have fast, accurate, objective tools to rapidly assess patient status and needed care.”

The Sixth Annual BioHealth Capital Region Forum brought together industry leaders from across the region who discussed the accomplishments and strengths of the region as its member companies continue to innovate new therapies and medicines in one of the strongest bio-hub regions in the United States.

The forum, which drew more than 1,100 registrants and included 59 world-class speakers and panelists, had a different look this year due to the ongoing COVID-19 pandemic. Instead of gathering together in the heart of the BioHealth Capital Region at AstraZeneca’s Gaithersburg facility, the forum was held virtually. The event offered multiple panels and keynotes that highlighted advancements made in the region across several areas, including cell and gene therapies, the use of artificial intelligence and the ongoing battle against COVID-19.

Image: https://biobuzz.io

Maryland is on pace to see its second-largest funding year ever.

VC investment dollars hit a seven-quarter high in the U.S. in the third quarter of 2020: A total of $36.5 billion was invested in U.S. tech and healthcare companies, according to data from the MoneyTree Report by PwC/CB Insights. That’s up 30% from the second quarter. The total number of deals rose to 1,461 investments in companies, up 1% over the prior quarter.

It’s the second straight quarter of growth, indicating that a slowdown toward the end of March as the pandemic set in didn’t become the norm.

“Things are still going gangbusters,” said Brad Phillips, a director in PwC’s Emerging Company Services practice. “It’s been a relief for a lot of people that were in the market and just didn’t know what was going to happen.”

Image: Whitebox's Baltimore team inside its Curtis Bay HQ. (Courtesy photo)

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions Martha Schoonmaker, Executive Director, Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC).

Martha Schoonmaker is the first Executive Director for the PIC MC Foundation, the entity that develops, manages, and markets the Germantown campus on behalf of Montgomery College for company locations. PIC MC is an integrated academic, business, and research campus and is the only community college with a hospital, Holy Cross Germantown Hospital, located as the anchor resident partner.

Mac Conwell hopes to raise an initial fund worth about $10 million for his new investment firm RareBreed Ventures.

Image: McKeever “Mac” Conwell, a local entrepreneur and investor, has launched his own venture fund called RareBreed Ventures. KAITLIN NEWMAN FOR BBJ

Recordings of Keynotes, Panels and the Fireside Chat Available Online

The 6^th Annual BioHealth Capital Region (BHCR) Forum like many events in 2020, went virtual this year with over 1,200 online registrants and 59 speakers coming together. The Forum, which has been held at AstraZeneca (Formerly MedImmune) since 2014 in Gaithersburg, MD, brought together the BioHealth Industry with a full slate featuring leaders of industry, academia, and government. The common message throughout the entire agenda was how this region has continued to operate and innovate while working to help the world solve the COVID-19 Pandemic.

The 2020 Crab Trap Competition, typically held during the Forum, will take place at Noon on October 21^st. The Crab Trap focuses on companies in therapeutics, diagnostics, medical devices, healthcare services, e-health, mobile health, electronic medical records, health informatics, and BioHealth cyber security. This years’ finalists include BrainScope, CARRTECH, Creative Bio-Peptides, innara HEALTH, and KaloCyte.

The entire 6^th Annual BioHealth Capital Region is currently available by visiting https://eventmobi.com/biohealth2020.

NOTE: If you haven’t already registered, please enter your information for immediate access. Click on the “Agenda” line to browser all the videos now available.

This event is free for biotech leaders is presented by BioHealth Innovation, VirginiaBio, Children’s National Health System, Deloitte, JLABS @ Washington D.C., Johns Hopkins University, Maryland Department of Commerce, Quality Biologics, George Mason University, University System of Maryland and AstraZeneca. Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. Please join us for our Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

 New Members Continue BHI’s Commitment and Mission in the BioHealth Capital Region

ROCKVILLE, MARYLAND, October 20, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointments of three new board members, Sally Allain, Head of JLABS @ Washington, DC, Joseph F. Sanchez, PhD,  Director, Science Engagement, R&D North America, AstraZeneca, and Robert Silverman, Chief Business Officer, Alloy Therapeutics, Inc. BHI’s leadership also thanked outgoing Board of Director member Tracey Vetterick, formally of AstraZeneca for her contributions to the organization and support of many years.

PALO ALTO — A big Southern California real estate and investment firm has gobbled up its latest in a string of Palo Alto office property purchases, a deal that extends a buying spree in the Silicon Valley tech hub that now tops $850 million.

Alexandria Real Estate, acting through an affiliate, has bought two Palo Alto office buildings on Hillview Avenue near Arastradero Road, acquiring a site that’s in the famed Stanford Research Park.

The deal suggests investors still seek to collect commercial properties in choice and prestigious locations despite the economic uncertainties that the coronavirus has triggered.

Image: https://www.mercurynews.com

The U.S. government is providing roughly $486 million to AstraZeneca to accelerate the Big Pharma company’s experimental Covid-19 therapy.

The funds will be used to advance AstraZeneca’s antibody combination, AZD7442, into two phase-III clinical trials. The last-stage studies, expected to begin later this month or early next month, will involve more than 6,000 study participants at sites in and outside the United States. (Phase-III clinical trials are typically the last hurdle a pharmaceutical company must successfully clear before seeking approval for a new drug candidate.)

Thank you for your interest in the 6th Annual BioHealth Capital Region Forum on Monday, October 19, 2020 that will highlight the accomplishments of today and chart our successes of tomorrow.

We are thrilled to welcome executive-level biohealth industry leaders from across the country and overseas. To make the best use of your time and enable you to network with our 1000+ registrants and learn from the 58+ industry speakers, please use the instructions below to join our virtual event platform, https://eventmobi.com/biohealth2020

She aims to have a big presence in the local business community.

Image: Paula Sorrell is the new associate vice president of innovation and economic development at George Mason University. GEORGE MASON UNIVERSITY

Adaptive Phage Therapeutics can take its therapy for superbugs to human trials.

Image: Dr. Carl Merril, third from right, with his son Greg, CEO and co-founder of Adaptive Phage Therapeutics, and other members of the team. ADAPTIVE PHAGE THERAPEUTICS INC.

October 14, 2020 – Johnson & Johnson Innovation announced today at the virtual 2020 HLTH conference the awardees for the JLABS @ Washington, DC Children’s, Maternal Health, and Diversity in Innovation QuickFire Challenges, which respectively aimed to catalyze pediatric innovation, improve maternal health in the United States, and support diverse innovators. These challenges embody Johnson & Johnson Innovation’s commitment to catalyzing potential solutions to today’s greatest healthcare challenges.

At BioBuzz, we’re dedicated to bringing you interesting and important stories that emerge from the thriving life sciences ecosystem that is the BioHealth Capital Region (BHCR). 

The heart of the BHCR biohealth cluster is Maryland, with its vast network of government research agencies, the strong university system, and a deep network of established, emerging, and startup life science companies across a wide range of fields, including cell and gene therapy, advanced biomanufacturing, phage therapy, medical devices and more traditional biotech and pharma organizations. That’s not even to mention the remarkable efforts of myriad Maryland vaccine companies to develop the first approved, safe, and efficacious SARS-CoV-2 vaccine.

Emmes today announced that it was selected as one of the best places to work in the greater Washington area. The Washington Post’s 2020 Top Workplaces list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees. The Washington Post partnered with employee research and consulting firm Energage, and the process is based on a scientific survey of employees who rate their workplace culture.

The Post’s annual survey honored 200 organizations as Top Workplaces. Emmes was selected in the large company category, which included organizations with between 500 and 999 employees. More than 3,600 area companies were invited to have their employees take the survey.

If you’re located in New York City or the Silicon Valley, venture capital firms are abundant and well covered by the media — you can’t escape them. But entrepreneurs in the Baltimore-D.C. region don’t need to go so far to find a firm that could propel their startup to growth.

The local venture capital community is robust, with dozens of firms that invest in all sorts of industries, from healthcare to fintech to cybersecurity. And it’s part of the reason that in 2016, approximately $1.09 billion was invested in local high-tech startups by VC firms, placing the region in the top 10 funded clusters in the U.S.

What is MedTech Color?

MedTech Color is a non-profit organization focused on ensuring people of color enter, remain, and flourish in the medtech industry. There is immense untapped potential from people of color, and we’re committed to providing and promoting opportunities for them to make a meaningful contribution to the industry.

JOHN WHYTE: You're watching "Coronavirus in Context." I'm Dr. John Whyte, chief medical officer at WebMD. Today I'm joined by Dr. Stephen Hahn. He's the commissioner of the US Food and Drug Administration. Dr. Hahn, thanks for joining me.

STEPHEN M HAHN: John, thank you. Really appreciate the opportunity, and it's great to be part of this webcast.

Image: Stephen M. Hahn M.D.

To meet the Trump Administration’s Operation Warp Speed goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) today announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing  of the company’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent infection with SARS-CoV-2, the coronavirus that causes COVID-19.

Not every research project succeeds. And not every company survives. However, the ones that align with the culture of winning and sign up and adopt the community charter are opting in for a much higher chance of disrupting their industry and changing the rules of the game.

So, you are probably thinking it’s not important, right?

But it is... At the Virginia Tech Corporate Research Center, we have the unique ability to witness effective project teams daily. With over 200 companies creating breakthroughs from nanomaterials to self-driving vehicles, we have a ready-made ‘team laboratory’ to understand what works and how to scale.

Image: Brett Malone, Ph.D., President & CEO Virginia Tech Corporate Research Center

Montgomery County Executive Marc Elrich joins BioTalk to discuss his Career Path, the BioHealth Industry and plans to support the Industry in MoCo.

Listen now on Apple https://apple.co/37dYS5Z, Google https://bit.ly/2IC4eOp, Spotify https://spoti.fi/2IDpN11, TuneIn https://bit.ly/31cjHuZ, and YouTube (Audio) https://bit.ly/31bsiho.