BARDA Industry Day 2019

What is BARDA Industry Day?

BARDA Industry Day is the annual meeting held to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space. This year,  BARDA Industry Day 2020 will be virtual and will feature one day of exciting speakers, breakout sessions, and valuable networking opportunities!

 

sirnaomics logo

After posting positive results from a midstage test for its RNAi candidate back in the spring, Sirnaomics has grabbed a $105 million series D round.

The cash boost, co-led by existing investor Rotating Boulder Fund, new investor Walvax Biotechnology Co. Ltd. and Sunshine Riverhead Capital, will go toward the biotech seeking to push deeper into the clinic and one day follow rival and RNA pioneer Alnylam to regulatory approval.

The $105 million will be put toward that R&D process for its RNAi therapeutics, which are on tap to treat a diverse range of diseases including cancers, fibrosis diseases, metabolic diseases and viral infections.

 

TrueGenomix - Charles Cathlin

What happens when you fund Black Founders? With $100K funding & support from Google for Startups Black Founders Fund, TruGenomix plans to further advance its efforts to bring earlier diagnosis & treatment for behavioral health disorders like PTSD to military, veterans, first responders, healthcare workers & trauma-exposed communities at large. This is why the initiative matters: https://goo.gle/2SqjS10

 

ASME logo

Last week, the Department of Defense (DOD) announced a seven-year award of $87 million for a new Manufacturing USA institute: BioMADE. The BioIndustrial Manufacturing and Design Ecosystem (BioMADE) institute joins a network of 8 other DOD institutes, making for a total of 16 institutes supported across the federal government in the Manufacturing USA program. ASME has been a long-time supporter and advocate of the Manufacturing USA program.

 

ITIF Logo

Different geographies and jurisdictions play different roles in the global economy. Some specialize in what economists call “seedbed” functions—generating new products and firms, often through cutting-edge innovation. Others specialize in corporate functions by offering attractive environments for company headquarters or other management activities. Still others specialize in more routine production functions for goods or services, handling aspects of the work that involve less innovation and have lower skill requirements. Finally, some regions specialize in resource production tied to geographical endowments, such as minerals, arable land, or lumber.

 

Cover Page from the Report

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look at COVID-19’s impact on Medicare telehealth. Other articles include: the next installment in the series of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for entrepreneurs; the Bayh-Dole Act turns 40; and the lack of public guidance available regarding COVID-19 related apps.

 

Global Startup Ecosystem Report GSER 2020 pdf

A few months ago, we all woke up to a new reality as COVID-19 changed everything. Personally, I shut down one of my startups while one of my portfolio’s startups boomed and a close friend — who had closed a large Series B in January — fired a third of her employees.

Then I saw community members rise to the occasion, taking action to help others, and governments acting faster than ever to enact bold and effective policy. Clearly, we are the ones we’ve been waiting for. It’s in our hands as a global community to shape how this will play out.

Autonomous Therapeutics Inc

Rockville, Md.—Autonomous Therapeutics, Inc. (ATI), a rapidly growing antivirals company, has chosen Montgomery County’s Rockville, Maryland, for its new headquarters. ATI chose to relocate from New York City to take advantage of Rockville’s proximity to leading U.S. researchers, regulators, and funders. Their new 17,700 SF home at 1530 E. Jefferson Street is also in an Opportunity Zone, which offers an advantage for the company in attracting future investment.  

ATI is developing a suite of first-in-class “Therapeutic Interfering Particles” (TIPs) to prevent respiratory pandemics, including influenza and COVID-19. The company’s lead candidates include therapeutics that are designed to prevent infections by any coronavirus strain—from COVID-19 to the next pandemic. ATI has raised millions of dollars in capital from public and private partners to transition its antiviral candidates into first-in-human clinical trials.

 

Brexit Logo

Introduction

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

From 1st 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.

Alexandria® Building the Future of Life Science™

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.

 

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

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

NewImage

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