'We have seen this before.' Global health scholars have issued a clarion call about the needless loss of life expected because of a foreseeable prospect of 'slow and inadequate access to supplies' to control COVID-19 in sub-Saharan Africa. They say what is unfolding now is similar to when lifesaving diagnostics and treatments came to the region long after they were available elsewhere.

The National Venture Capital Association (NVCA) is closely monitoring the outbreak of the coronavirus (COVID-19) and is working diligently to address the VC industry’s needs and provide resources that aim to help firms and portfolio companies during this challenging time. This webpage provides important information and resources to venture-backed companies about the federal response to COVID-19, including tax credits, loan opportunities, and sick leave. NVCA will update this information as it becomes available.

Keep on reading: Coronavirus Information and Resources for VCs and Startups

Safeguarding public health requires rethinking our relationship to the environment and the inequities that drive its destruction

-- Read more on ScientificAmerican.com

“I am pleased to welcome Ignacia back to the Department and the Environment and Natural Resources Division,” said Attorney General Holder.

“The history of the Environment and Natural Resources Division reminds us of the importance of our nation’s public lands and natural resources to the development of this country, and the important role of the division in protecting these resources for future generations,” said Attorney General Holder.

Ignacia S. Moreno, Assistant Attorney General for the Environment and Natural Resources Division, welcomes the members of the division’s senior leadership.

The settlement, which will require legislative and judicial approval to become effective, is fair to the plaintiffs, is responsible for the United States, and provides a path forward for the future.

The Boeing Company has agreed to undertake two significant habitat restoration projects in Washington state to resolve its liability for natural resource damages caused by hazardous substances released from Boeing facilities along the Duwamish Waterway.

The Department of Justice, the Commonwealth of Massachusetts and the state of Rhode Island announced today that Bouchard Transportation Co. Inc. and its affiliates will pay more than $6 million to settle a portion of the federal and state natural resource damages claims for the April 2003 spill of up to 98,000 gallons of oil into Buzzards Bay.

It is always a pleasure for me to see my long-time friends at the D.C. Bar. I have been a D.C. Bar member since 1991 – that is 20 years – and have served on various Bar committees and participated in pro bono activities sponsored by the Bar.

CareSource, CareSource Management Group Co. and CareSource USA Holding Co. have agreed to pay the United States and the state of Ohio $26 million to resolve allegations that they caused Medicaid to make payments for assessments and case managements they failed to provide to children and adults.

Under an unprecedented agreement announced today by the Natural Resource Trustees for the Deepwater Horizon oil spill, BP has agreed to provide $1 billion toward early restoration projects in the Gulf of Mexico to address injuries to natural resources caused by the spill.

Marking the eighth annual Earth Day Service Celebration today, Deputy Attorney General James Cole and Assistant Attorney General Ignacia S. Moreno commended volunteers from the Justice Department’s Environment and Natural Resources Division as they began work on a future Community Greening Center near Marvin Gaye Park in Northeast Washington, D.C.

A $1-million settlement has been reached for natural resource damages (NRD) at the Blackburn & Union Privileges Superfund Site in Walpole, Mass.

As part of Attorney General Eric Holder’s call for cost-cutting measures to streamline operations and reduce spending during a time of constrained funding, the Department of Justice today announced that it will realign functions in various offices, lower lease costs by consolidating or reducing office space and continue to look for ways to more effectively utilize the department’s resources.

“The tragedy at Upper Big Branch will never be forgotten, and the families affected by it will never be made completely whole again. Today’s agreement represents the largest-ever resolution in a criminal investigation of a mine disaster and will ensure appropriate steps are taken to improve mine safety now and will fund research to enhance mine safety in the future,” said Attorney General Holder.

The Department of Justice and the Department of the Interior announced today that Freeport-McMoRan Corporation and Freeport-McMoRan Morenci Inc. have agreed to pay $6.8 million to settle federal and state natural resource damages claims related to the Morenci copper mine in southeastern Arizona.

Direct Resource Inc. has agreed to pay the government $450,000 to resolve allegations that the company falsely claimed payment in violation of the Trade Agreements Act (TAA), which prohibits the sale of products to federal agencies from countries that do not have a reciprocal trade agreement with the United States, the Justice Department announced today. The Columbus, Ohio, company allegedly knowingly sold products from China, a country that does not have such an agreement with the United States.

Pharmacia Corporation and Bayer CropScience Inc. have agreed to pay $4.25 million to federal and state natural resource trustees to resolve claims for natural resource damages connected with the Industri-plex Superfund site located in Woburn, Mass.

The Residential Mortgage-Backed Securities (RMBS) Working Group announced new resources today in the ongoing effort to investigate misconduct, including the launch of a RMBS website to report fraud and the creation of a coordination team to facilitate the various investigations underway around the country.

Northern States Power Co. will begin cleanup of the Ashland/Northern States Power Lakefront Superfund Site in Northwestern Wisconsin under a settlement the Department of Justice and the Environmental Protection Agency (EPA) announced today.

The Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC) today released A Resource Guide to the U.S. Foreign Corrupt Practices Act (the Guide). The 120-page Guide provides a detailed analysis of the U.S. Foreign Corrupt Practices Act (FCPA) and closely examines the DOJ and SEC’s approach to FCPA enforcement.

Another important step toward cleaning up the Quanta Resources Superfund site in Edgewater, N.J., was announced today by the Department of Justice and the U.S. Environmental Protection Agency.

Assistant Attorney General Ignacia S. Moreno announced today the publication of the Environment and Natural Resources Division’s (ENRD) Fiscal Year 2012 Accomplishments Report. The full report, which details the division’s work across the nation during FY2012, is posted at www.justice.gov/enrd/Current_topics.html.

The Department of Justice’s Office on Violence Against Women today announced a new Mentor Court Initiative to support criminal and civil domestic violence courts across the country.

The Justice Department today announced an enhanced online resource designed to support American victims of overseas terrorism.

Attorney General Eric Holder announced today that the Justice Department’s Bureau of Justice Assistance (BJA) will provide $150,000 in Fiscal Year 2013 funding to Newtown, Conn., to fund two positions to ensure school safety, such as school resource officers.

Tonawanda Coke Corporation was sentenced in federal court in Buffalo, N.Y., Wednesday to pay a $12.5 million penalty and $12.2 million in community service payments for criminal violations of the Clean Air Act (CAA) and the Resource Conservation and Recovery Act (RCRA).

The Justice Department’s Environment and Natural Resources Division (ENRD) today released its Fiscal Year (FY) 2013 Accomplishments Report detailing its work alongside other federal agencies.

"Earth Day is another reminder to me of that commitment, a commitment that the Department of Justice is dedicated not only to protecting the people of our country, but also to protecting its natural resources."

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.

M&A is an omnipresent reality in the biopharma industry, from Big Pharma mega-mergers to smaller acquisitions of emerging startups. We’ve recently witnessed several large M&A transactions get closed or announced, including BMS-Celgene, Takeda-Shire, and AbbVie-Allergan; according to BMO Capital Markets

The post BioPharma M&A Drives More Efficient Resource Allocation appeared first on LifeSciVC.

Emport LLC is pleased to introduce new training programs and materials to augment its food safety and allergen control portfolio.

True or False:

(1) eSource in clinical trials means eliminating the possibility for transcription errors.

(2) Data collected in Electronic Data Capture (EDC) systems is eSource.

Strictly speaking, both statements are false. If that surprises you, it’s probably because many casual uses of the term “eSource” actually differ from the formal definition laid out by FDA. If the participants in any discussion share the same interpretation of “eSource”, or if it’s clear from context how “eSource” is being used, then no harm, no foul. (Contemporary translation: “Meh.”) BUT…and you know where we’re going with this…when a term can be interpreted in multiple ways, there’s always a possibility for miscommunication and cross talk.



FDA Guidance on eSource in Clinical Investigations
FDA defines eSource as *any* data initially recorded in electronic format. That’s a broad definition, one that includes:
     a) equipment-generated data, such as digital imaging and labs
     b) electronic Patient Reported Outcome (ePRO) transmissions
     c) data streams from mobile health devices, such as Apple ResearchKit
     d) data entered directly into an EDC, known as Direct-Data-Entry (DDE) solutions
     e) data entered into an Electronic Health Record (EHR) or electronic Medical Record (EMR) system


Discussion of Direct-Data-Entry (DDE)
DDE systems allow research staff members to use portable devices to enter study data directly into an EDC system. DDEs have been garnering a lot of industry attention of late, and a number of companies offer solutions that offer a DDE data flow. As independent 3rd party auditors, we don’t want to play favorites by mentioning specific systems as examples, but if your company sells or uses a DDE system that you want to highlight, feel free to add a comment below to give it a shout out.

Discussion of EMR/EDC Integration
Not long after finalizing its e-Source guidance, FDA hosted a webinar that encouraged companies to explore direct EMR/EDC integration. While a few industry players have taken up the effort, movement has been slow. One difficulty: generally EMRs are built with healthcare in mind, not clinical research. Secondly, with so many EMR and EDC vendors, ensuring that EMR data from one system is mapped to appropriate EDC fields in another system relies heavily on data standards that are still being defined and need to be implemented on both sides. 

Source Data Verification (SDV)
If data is transmitted directly from the source system to an Electronic Data Collection (EDC) system, SDV is not required, since the source data isn’t being transcribed manually. (Note: other types of Source Data Review (SDR) activities are still necessary, even if SDV isn’t. SDR must be conducted to verify ALCOA-C data principles such as attribution, originality, accuracy, completeness, etc.) Direct transmission from source system to EDC system is the typical pathway for items (a) – (d) above, and so SDV is not required for these types of eSource.


Common Confusions
SDV. Unless there is EMR/EDC integration – Item (e) above – source data from an EMR system needs to be manually transcribed. This is what makes T/F question #1 false. Just because source data originates in an EMR, it does *not* suggest SDV checks are superfluous. You could argue, as many have, that SDV is not a high-value activity and uncovers only a small percent of data error. That argument may well influence how much SDV is conducted, but whenever data is transcribed from original source into an EDC system, SDV is a relevant discussion.

EDC Data. It’s not unusual for someone to refer to data stored in EDCs as eSource. Data stored in EDCs are electronic, and may be source, but only if the EDC is the first place the data is recorded. This is what makes T/F question #2 false.

In Summary
If you’re ever in a discussion about eSource and things start going sideways, it may be time to haul out the formal definition of eSource -- in all its tedious detail -- to make sure everyone is using the term the same way. 

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Image Credit: Paradox by Brett Jordan

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