Deundra Milhouse and Fredrick Hill, both residents of Alabama, were sentenced today in separate stolen identity refund fraud (SIRF) cases, announced Acting Assistant Attorney General Tamara Ashford of the Justice Department’s Tax Division and U.S. Attorney George L. Beck Jr. for the Middle District of Alabama. Milhouse was sentenced to serve 81 months in prison and Hill was sentenced to serve 74 months in prison

This fourth annual report to Congress describes efforts to collect and improve data on crime and justice in Indian country, as required by the Tribal Law and Order Act of 2010. The report details the number of tribal law enforcement agencies reporting crime data to the FBI’s Uniform Crime Reporting program. It describes BJS’s first National Survey of Tribal Court Systems which will collect data on tribal courts in the lower 48 states and Alaska covering 566 tribes

The Justice Department announced today that it has released a Best Practices Guide to Reform HIV-Specific Criminal Laws to Align with Scientifically-Supported Factors . This guide provides technical assistance regarding state laws that criminalize engaging in certain behaviors without disclosing known HIV-positive status

“If an institution is unwilling to admit its wrongful conduct in a statement of facts; or balks at paying a substantial penalty that reflects that conduct; or refuses to do right by those affected, then we will not shrink from litigating as long as we must to fulfill our law enforcement mandate.”

Attorney General Eric Holder today released the following statement regarding the U.S. Sentencing Commission vote approving retroactivity of sentence reductions for drug offenses

Attorney General Eric Holder announced today that the Justice Department has submitted filings in voting rights cases in Wisconsin and Ohio. The department’s involvement in these two cases represents its latest steps to enforce the remaining parts of the Voting Rights Act against restrictive state laws, following up on the department’s lawsuits last year against similar measures in Texas and North Carolina

Kelvin L. Brown, aka “Doom,” 34, of Newport News, Virginia, was convicted yesterday by a federal jury of participating in a drug conspiracy in the Newport News area, from the early 2000’s through September 2013. Brown was also convicted of distribution of cocaine, possession with intent to distribute cocaine, two counts of possession of firearms in furtherance of a drug trafficking crime and felon in possession of a firearm

Today, a federal grand jury in Milwaukee returned a 15-count superseding indictment charging two Milwaukee men, Paul Carter aka “Pimpin’ Paul” and David Moore aka “King David” with conspiracy, sex trafficking and related offenses spanning from the years 2007 to 2013

The United States filed a complaint in federal court in Chicago to bar Laurie G. Helfer, aka Laurie G. Powell, individually and through her businesses Laurie’s Freelance & Tax Preparation Services and Tax Lady Laurie Inc., from preparing federal tax returns for others, the Justice Department announced today

The Department of Justice released today its second report to Congress entitled Indian Country Investigations and Prosecutions, which provides a range of enforcement statistics required under the Tribal Law and Order Act of 2010, as well as information about the progress of the Attorney General’s initiatives to reduce violent crime and strengthen tribal justice systems

Attorney General Eric Holder, Assistant Attorney General for National Security John Carlin and U.S. Attorney William J. Hochul Jr. for the Western District of New York announced today that a federal grand jury in Rochester has returned a seven-count indictment charging Mufid A. Elfgeeh, 30, of Rochester, with three counts of attempting to provide material support and resources to the Islamic State of Iraq and the Levant (ISIL), aka the Islamic State of Iraq and Syria (ISIS), a designated foreign terrorist organization. In addition, Elfgeeh is also charged with one count of attempted murder of current and former members of the United States military, one count of possessing firearms equipped with silencers in furtherance of a crime of violence, and two counts of receipt and possession of unregistered firearm silencers.

The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

At Engredea 2018 in March in Anaheim, CA, OmniActive will be highlighting the latest addition to its ginger ingredient range, Gingever 10% powder, expanding its application to tablets, capsules and beverages.

“Ten, twenty, thirty years ago, you were in the best position to go global if you were a large company and had a lot of resources and access to a lot of attorneys and advisors who could help you navigate regulations and issues that get more complicated as you go abroad.”

Ministers in charge of small and medium enterprises (SMEs) in the APEC region issued a statement following their meeting in Concepcion, Chile, on 5-6 September 2019.

We need it for inclusive policymaking

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.



Standard Operating Procedures (SOPs)
It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)

Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.

A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.

Training
Training can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.

The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.

It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. 

Trial Master Files (TMFs)
Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder.


Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication.

The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.

Technology to the Rescue?
No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?

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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

April saw the company add new CEO, receive approval for lead ADC drug, and launch a public offering of stock.

Moderna announces it has partnered with Lonza with the aim of producing one billion doses annually.

Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...]

Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations. Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price. But researchers (in [...]

Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association.

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NHS England has advised pharmacies to risk assess staff who may be particularly vulnerable to COVID-19, including those from a black, Asian or minority ethnic background.

To read the whole article click on the headline

April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]

Tough times at Orchard Therapeutics as it swings the ax across staffers and facilities, phases in new pipeline advances and reduces interest in others.

Researchers working with a group of postmenopausal women found that a technology using casein to encapsulate calcium nanoparticles reduced GI issues compared with more conventional calcium carbonate or calcium citrate supplements.

President Trump wants businesses to start reopening after the coronavirus forced shutdowns. Here's what the White House task force recommends for states.

In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.

Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66.

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.

Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday.

The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds.

Amid a plateau in the number of new coronavirus-related deaths in Los Angeles County, officials Friday were easing into an economic recovery plan.

Orange County continues to confirm more coronavirus cases. Here's the latest community breakdown.

In the past week, Orange County has announced 21 deaths linked to COVID-19, pushing the total since the pandemic began to 71.

By Rachael E. Hunt —

U.S. health officials are monitoring for cases in the United States.

Track the latest numbers on deaths in U.S. states and territories. Updated daily.

From New York to Washington, see the per-day count of new, confirmed COVID-19 cases in each state. Updated daily.

Cancellation of the ceremony was the second blow to Putin, who was forced to call off a referendum extending his time in power.

Yokogawa Electric Corporation (TOKYO: 6841) announces the November 15 release of ProSafe-RS R4.05.00, an enhanced version of the ProSafe-RS safety instrumented system. ProSafe-RS is a core product of the OpreX Control and Safety System family.

Yokogawa Electric Corporation (TOKYO: 6841) announces the November 14 release of Plant Resource Manager (PRM) R4.03, the latest version of a software package in the OpreX Asset Management and Integrity family that facilitates the monitoring and control of plant operations by centralizing the management of large volumes of data from instrumentation and manufacturing equipment. PRM R4.03 features powerful device diagnostic functions that help to optimize plant maintenance and ensure safe operations.