Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines, and medical devices that are critical to patients

Rockville, MD, July 7, 2021 – United States Pharmacopeia (USP), an independent, scientific nonprofit organization, is pleased to announce the acquisition of Pharmatech Associates, Inc. By adding Pharmatech Associates expertise, USP further advances its more than 200-year mission to help ensure access to quality medicines by extending services that assist manufacturers to meet global quality standards across the drug and product lifecycle.

The global medicine supply chain is a complex marketplace of manufacturers, suppliers, and distributors from many countries.  Making it more resilient requires a multi-faceted approach. The acquisition of Pharmatech supports our commitment to expand our capabilities to strengthen the supply chain of quality medicines, builds on our longstanding work with regulators and manufacturers globally to solve some of the most critical and challenging problems in the industry, and helps ensure patients have access to the medicines that they need.  Pharmatech helps manufacturers satisfy global regulatory requirements to bring products to market, scale up manufacturing, effectively manage quality control, and remediate quality problems in a rapidly changing environment. 

The BioHealth Capital Region Forum is free Virtual 2 Half-Day event for executive-level biotech leaders. The theme of the forum this year is "Big Data...Big Data...Converging" with panels on Big Data in Biotech, nfectious Diseases, Developing Talent, Regional Real Estate, IP Analysis and Protection, Funding, and a Fire Side Chat with Dr. Anthony Fauci, NIAID Director.

The 7th Annual BioHealth capital Region Forum is organized by event partners - Association of University Research Parks, AstraZeneca, BioHealth Innovation, BRAINBox Solutions, Inc, Children’s National Hospital, Emergent BioSolutions, George Mason University, Johnson & Johnson Innovation – JLABS @ Washington, DC, Maryland Department of Commerce, and Virginia Bio. Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. Please join us for our 7th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow. We hope you’re able to join us!

Registration is now open for the BioHealth Capital Region 6^th Annual Crab Trap Competition. The Crab Trap this year will be held virtually in affiliation with the 7^th Annual BioHealth Capital Region Forum with attendees receiving a link to watch live on September, 29^th, 2021. Judges Sally Allain, Head, JLABS @ Washington, DC, Johnson & Johnson Innovation, Andrea Alms, Co-Fund Manager, BioHealth Capital Fund, Troy LeMaile-Stovall, Chief Executive Officer, TEDCO, Conley Jones, Senior Associate, Alexandria Venture Investments, and John Newby, Chief Executive Officer, Virginia Biotechnology Association, join Moderator, Rich Bendis, President and CEO of BHI, to choose one biohealth startup with the most commercial potential.

Companies interested in applying, please visit https://bit.ly/crabtrap2021 today.

ROCKVILLE, MARYLAND, July 6, 2020 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Jeff Boyle as a new board member. Jeff Boyle is the President of Ellume USA LLC and leads the team establishing the manufacturing operation and commercial headquarters in Maryland; and is responsible for all aspects of the North American business operation. Jeff has previously held leadership positions at CSL, Cellestis, and most recently with QIAGEN as a Global Franchise Head.

We are excited to announce a partnership between CEID and CONNECTED DMV. We will be cooperating with CONNECTED DMV in their Pandemic Prevention and Biodefense Initiative and serve as a key partner in the Global Pandemic Prevention and Biodefense Center and AHEAD100 initiative.

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

Today, the FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of four batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.

In Greater Washington, we spotlight these VC firms raising new funds or adding dollars to their existing ones.

Arriving in Washington in the midst of a pandemic, the Biden administration has been laser-focused on funding life sciences, announcing support for the onshoring of crucial manufacturing and proposing vast increases in National Institutes of Health funding and the creation of ARPA-H, a new multibillion-dollar applied research center for the health sciences. 

Image: Courtesy of Central Indiana Corporate Partnership Congress has passed a series of bills that may send billions of dollars of funding to life sciences clusters across the country.

By the end of this week, the world should cross two small but significant milestones on the road to overcoming COVID-19—getting at least 5% of the global population fully vaccinated against SARS-CoV-2, with at least 10% receiving one dose of vaccines that require two.

According to Our World in Data, a collaboration of the Oxford Martin Programme on Global Development at the University of Oxford and the nonprofit Global Change Data Lab, 376,173,766 people were fully vaccinated as of May 20 (4.8% of global population), while 739,208,299 people had received one dose (9.5%).

The companion diagnostics market is on track to reach $6.8 billion by 2025 (from $3.7 billion in 2020), according to a Markets and Markets report , driven by the growing need for targeted therapy, the rising importance of personalized medicine, the increasing global incidence of cancer, and a raging demand for next-generation sequencing (NGS). So it's not surprising to see more and more alliances between pharmaceutical companies and diagnostics companies.

LEIDEN, The Netherlands, July 06, 2021 / B3C newswire / -- MIMETAS, a leader in organ-on-chip-based disease models and technology, and Roche, a world-leading pharmaceutical company, announced today that they have entered into a collaboration to develop human disease models to characterize novel compounds in inflammatory bowel disease (IBD) and hepatitis B virus infections (HBV). Under the terms of the agreement, MIMETAS is eligible to receive an upfront payment and milestone payments from Roche.

MIMETAS will be responsible for developing tissue-based disease models and assays in the OrganoPlate, its proprietary organ-on-chip platform that increases predictability of biomarkers and reduces animal use in scientific testing. Roche will gain access to technology, disease models, and scientific results. Roche will also receive an option to exclusively license specific disease models and assays for use in drug discovery.

Howard Carolan, Co-Founder and CEO  of CoapTech, Inc., and Neil Davis, Program Director of the Biomedical Entrepreneurship Graduate Certificate program at the University of Maryland Baltimore (UMB), joins Rich Bendis to discuss Startups, Tech Transfer, and the Funding.

Listen now on Google https://bit.ly/36fStWr, Apple https://apple.co/2UpA0UO, Spotify https://spoti.fi/36igrjG, and TuneIn https://bit.ly/3hpCRpT.

Mr. Davis is currently Program Director of the Biomedical Entrepreneurship graduate certificate program at the University of Maryland Baltimore (UMB).  This unique 12 credit graduate certificate provides the student with an opportunity to learn the process of creating valuable intellectual property (IP) and moving it into commercial application.  This process begins with the creation of IP, continues to its licensing and the formation of a venture through the growth of the venture, and culminates with the monetization of that venture.

Thanks to unprecedented development speed and mostly strong safety and efficacy data, vaccines have dominated the response to COVID-19. But ending the pandemic will also require development of numerous therapeutics.

Seven COVID-19 drugs have shown promise recently. Positive signs include the accumulation of encouraging data, participation in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trials, and/or progress toward regulatory authorizations.

• This  document  has been  redacted by  Sam Collaudin, Kinexum Business Strategy  Consultant, independently  from any  pharmaceutical and  biotech companies 
• It synthesizes  selected  data presented  during  the  ATTD 2021  conference 
• Grey  rectangles  are  personal  comments and  opinions,  underlined  words are clickable  links  to other  slides  or  external  references 
• If  you  have comments, please  contact me by  email (This email address is being protected from spambots. You need JavaScript enabled to view it.) 
• Disclosure: Business  strategy consultant  at Modular  Medical,  CEO  of Abvance Kinexum ,  consultant  for Therapeutics, chairman  of  a non  for profit French health  care  insurance company  (Groupe Operating  Since  2003 Uitsem)

This week, a pair of Frederick companies raised millions in new investment, offering evidence of the Maryland city’s growing role as one of the region’s tech hubs. Check out the specifics on those companies and more:

Image: Frederick, Maryland. (Courtesy photo)

Johns Hopkins University's board of trustees has voted unanimously to add a new five-year term to the presidential tenure of Ron Daniels, an extension through June 2029 that "reflects the board's full and unwavering confidence in the trajectory of our institution and its remarkable people—our students, faculty, staff, alumni, and friends—supported and sustained by President Daniels' able leadership," Lou Forster, the board's chair, wrote in a message to the Hopkins community today.

Image: Johns Hopkins University President Ron Daniels speaks at the 10,000 Small Businesses graduation ceremony in Baltimore in November 2019. CREDIT:WILL KIRK / JOHNS HOPKINS UNIVERSITY

The firm helps gene therapy and vaccine companies develop and manufacture products for rare diseases.

Image: Vigene Biosciences, led by CEO Zairen Sun, right, and Chief Commercial Officer Jeffrey Hung, has been acquired. EMAN MOHAMMED

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced the appointment of Evan Loh, M.D., CEO of Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK), Jonathan Leff, Partner at Deerfield Management, and Jana Jensen, Ph.D., Chief Operating Officer at Deerfield Discovery and Development, to the company’s Board of Directors.

Go pakh your cahr, Boston. Grab some granola, California. It’s D.C.’s moment in life sciences. 

For years, the Washington metropolitan area has been one of the nation’s fastest-growing and largest life sciences markets. Growth during the pandemic and the market’s singular location are launching it into a whole other stratosphere. 

Image: ST. JOHN PROPERTIES’ MATT HOLBROOK AT RIVERSIDE TECH PARK IN FREDERICK. PHOTO: BY ST. JOHN PROPERTIES 

Entrepreneurs who require funding for their startup have long counted on self-accredited high net worth individuals (“angels”) to fill their needs, after friends and family, and before they qualify for institutional investments (“VCs”). The many crowd funding platforms on the Internet, led still by Kickstarter and IndieGoGo, were expected by many to put regular people in charge of funding new opportunities, and kill the need for angel groups.

Image: https://blog.startupprofessionals.com

Since 2005, the Small Business Capital Investment Incentive has generated early-stage funding for more than 200 Arizona businesses, including my company, Qwick. I moved from California to Arizona to launch Qwick, an on-demand staffing platform for the service industry, because I know that new companies need these early investments to succeed.

As Arizona lawmakers finalize the fiscal 2022 budget, they can support new businesses by extending this incentive that’s commonly known as the angel investor tax credit. The program has made a $1.38 billion economic impact over the past six years alone.

Of the nearly 3 billion base pairs in the human genome, about 99% are the same in every human being — however, it is the sequence of these DNA pairs that makes each of us who we are genetically.

It’s like that with entrepreneurial DNA — every state has it.

Our country was built by entrepreneurs. It’s just that from state to state, our DNA is “sequenced” differently.

In Oklahoma, our entrepreneurial DNA isn’t channeled from one dominant industry — or from a particular type of entrepreneur. Our state heroes of innovation have impacted industries across the board — from human flight to rock and roll. From changing the way that people drive to changing the way the way people exercise. From making it easier to shop to making it easier to park. From digging ditches to accessing the Internet.

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Dr. Murat Kalayoglu, President and CEO at Cartesian Therapeutics, provides an update since his last visit on their cell and gene therapies, as well as fundraising successes.

Listen now on Apple https://apple.co/2SuVe2M, Google https://bit.ly/35Uq6wV, Spotify https://spoti.fi/3w3d7nd, or TuneIn https://bit.ly/2U9zYjL

Delta customers now have more ways to meet COVID-19 test requirements introduced by the U.S. Centers for Disease Control and many international governments during the pandemic. Convenient and accurate in-home rapid antigen tests that can be shipped directly to a home address or picked up locally are now available for purchase on delta.com.

“Even as the U.S. achieves widespread immunity through vaccinations, many international countries lag behind the U.S. in vaccination rates. Testing and proof of a negative test result within 72 hours of travel remain core components for entry to many international destinations as well as to return to the U.S. during the global pandemic,” said Henry Ting – S.V.P. & Chief Health Officer. “These new purchase and pack COVID-19 tests offer a convenient option to provide proof of a negative test result and enable a seamless experience for our customers.”

Moderna CEO Stéphane Bancel made the decision to build his mRNA research-and-development platform on public cloud to create what he calls “software for life.”1 He used the cloud as a means to accelerate therapeutic discovery and development. When the COVID-19 pandemic hit, this strategy proved prescient. The company was well positioned to quickly design research experiments and to harness its automated laboratory and manufacturing processes and enhanced drug-discovery pipeline.

Emmes today announced that it was selected as one of the best places to work in the greater Washington area. This is the fifth time that the company has been chosen as a top workplace by The Washington Post, whose rankings are based on the highest employee engagement ratings.

The Post’s 2021 Top Workplaces list included a wide range of organizations, including government contractors, law and real estate firms, professional and business services firms, and technology companies.

The Post partnered with employee engagement firm Energage, LLC, to conduct the survey, asking employees about the companies they work for on topics ranging from employee development to innovation. More than 3,500 area companies were invited to participate, representing over 65,500 employees. Emmes was selected as a top workplace in the large company category.

Many of you are following the ongoing effort by some political leaders to strip our scientific intellectual property rights pertaining to vaccines and treatments for COVID-19. This proprietary science and technology was developed by our scientists working day and night at great financial risk to our companies.

A diverse, global team of scientists, led by University College of London and Children’s National Hospital/George Washington University, has been selected for the final stages of Cancer Grand Challenges – and is in with a chance of securing a share of £80 million (c.$111 million) of funding to take on one of cancer’s toughest problems.

Nearly 170 teams submitted ideas for this round of awards, and the NGTC team, which stands for ‘Next Generation T-cell therapies for childhood cancers, led by Martin Pule, Ph.D., University College of London, and Catherine Bollard, M.B.Ch.B., M.D., Children’s National Hospital and George Washington University, is one of 11 shortlisted groups.

It is with enormous pride and excitement that we announce that Aifred Health is #2 in the WORLD in the Global @IBM Watson AI XPRIZE!  

I could not be prouder of the entire Aifred Health team and especially the four co-Founders Robert Fratila, Kelly Perlman, Sonia Israel and David Benrimoh, MD.,CM., MSc. whose vision and passion started us on this journey. 

The US$1M prize will be used to accelerate the delivery of our AI technology in the field of #depression and to begin the work to apply our tech to other disease indications where personalize treatment choice is needed to deliver better outcomes to patients. 

UNITE, A comprehensive immuno-oncology approach

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Three Surprising Lessons for Other Cities and Regions. Download the PDF: http://share.endeavor.org/pdf/HDSVBSV.pdf

The life sciences industry has been asked to play the lead role in delivering innovative solutions to the world’s pandemic challenges; but like other sectors, is not insulated from these disruptive societal and workplace impacts. And while far from finished, the industry is meeting the moment—delivering on biomedical innovations to mitigate and ultimately end the global pandemic; continuing its role as economic stalwart countering economic downturns with hiring and continued growth; adjusting to the turmoil of remote operations; advancing varied and creative diversity and inclusion initiatives; and partnering with educators to advance the science, technology, engineering, and math, or “STEM” talent needs of the industry as well as enhancing its diversity. This is a daunting agenda for any industry, let alone in a single year, and this report works to take stock of the industry’s position and strategic priorities in 2021, with a primary focus on its demands for workforce and talent, arguably the most critical ingredient for addressing this bold agenda.

TEDCO recently launched ‘TEDCO Talks’, a series featuring thought leaders in economic development across the State of Maryland. On May 28th, TEDCO CEO & Executive Director, Troy LeMaile-Stovall interviewed Sally Allain, Head of JLABS @ Washington DC, about the future of the innovation ecosystem and the crucial role that JLABS will play in advancing the BioHealth Capital Region. It was extremely uplifting to hear the leaders of the two powerhouses discuss solutions on issues ranging from pandemic preparedness and healthcare inequality to diversity in the workforce.

Coastal resources - including fish, minerals and energy - are critical to people, nature and the economy, and are a focus for the emerging sustainable blue economy agenda. It has long been recognized that a particular challenge in coastal areas is the management of land-based activities that generate detrimental impacts on coastal resources in the marine environment. Many of these pressures are negative externalities of land-based human activities that are not taken into account within existing resource-governance frameworks. Therefore, the development of improved approaches to land-sea governance that take account of how land-based activities affect the quality and availability of coastal resources is the focus of this report.