The U.S. Justice Department released the following statement by department spokesman Brian Fallon in response to President Obama’s speech on U.S. signals intelligence.

U.S. Attorney General Eric Holder on Thursday urged Congress to pass the bipartisan Smarter Sentencing Act, introduced by Senators Dick Durbin and Mike Lee.

Dmitry Firtash, 48, a Ukrainian businessman, was arrested Wednesday by Austrian authorities in Vienna on a provisional arrest request based on charges filed in the Northern District of Illinois.

Okland Construction Co. Inc. has agreed to pay the government $928,000 to resolve allegations that it made false statements and submitted false claims under the Small Business Administration’s (SBA) Section 8(a) Program for Small and Disadvantaged Businesses.

Five California-based masonry subcontractors and two individuals paid the government nearly $1.9 million to resolve allegations that they violated the False Claims Act by misrepresenting their disadvantaged small business status in connection with military construction contracts.

Robert C. Sathre was sentenced today to serve 36 months in federal prison for tax evasion by U.S. District Judge Alan B. Johnson in Cheyenne, Wyoming, the Justice Department and Internal Revenue Service (IRS) announced.

Scott B. Miserendino, Sr., 55, a former government contractor who performed work for the United States Navy Military Sealift Command, and Timothy S. Miller, 57, a businessman whose company sought contracting business from the Military Sealift Command, were indicted today on charges including conspiracy and bribery.

A Las Vegas jury returned guilty verdicts yesterday against Alan Rodrigues, a former casino owner from Henderson, Nevada, Weston Coolidge, a former businessman from Las Vegas, and Joseph Prokop, a former National Football League punter from Upland, California, for conspiracy and fraud related to their promotion of a fraudulent tax product through the now-defunct National Audit Defense Network.

A current Puerto Rico Superior Court Judge and Puerto Rico businessman were charged with orchestrating a criminal scheme in which the businessman paid bribes to the judge presiding over the criminal case against the businessman according to an indictment unsealed today.

William P. Danielczyk Jr., formerly of Oakton, Virginia, pleaded guilty to one count of willful failure to collect and pay over employment taxes for the quarter ending Sept. 30, 2010, and one count of theft or embezzlement from an employee benefit plan for the calendar year 2010, the Department of Justice and Internal Revenue Service (IRS) announced today.

Roderick Neal, of Dothan, Alabama, was indicted for stolen identity refund fraud crimes, Deputy Assistant Attorney General Ronald A. Cimino of the Justice Department’s Tax Division and U.S. Attorney George L. Beck Jr. for the Middle District of Alabama announced today following the unsealing of the indictment

Jaime Viteri, a Chicago businessman, pleaded guilty to two counts of willfully failing to file federal individual income tax returns today, announced the Justice Department and the Internal Revenue Service (IRS).

A Puerto Rico businessman pleaded guilty today to bribing Puerto Rico Superior Court Judge Manuel Acevedo-Hernandez, who presided over the businessman’s vehicular homicide trial and acquitted him of all charges

The following statement was released Sunday by Justice Department spokesman Brian Fallon concerning the federal civil rights investigation into the shooting of Michael Brown in Ferguson, Missouri

A Newington, Connecticut, man was indicted last Thursday by a grand jury in the District of Connecticut for one count of corruptly interfering with the due administration of the internal revenue laws, two counts of filing false tax returns and five counts of willfully failing to file tax returns, the Justice Department and Internal Revenue Service (IRS) announced

Adam Michael Webber, of Salt Lake County, Utah, was indicted on Friday by a federal grand jury in the District of Utah, the Justice Department announced. The indictment, which was made public today, charges Webber with one count of dealing in firearms without a license, one count of smuggling goods from the United States and six counts of filing false tax returns

A former salesman at a prominent Los Angeles car dealership and another Southern California man were charged with odometer tampering, the Justice Department announced today.

From access to capital to dispute resolution.

“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

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partenships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.



Strategic Partnerships in Big Pharma: Implications for the Rest
Advantages for one segment of the industry can introduce disadvantages for another.  Alliances among the large players increase competition for top-drawer CRO resources. Smaller sponsors may find it more difficult to receive the quality of service and level of commitment they might otherwise expect.  A large CRO is likely to assign their most talented personnel to projects associated with their strategic partners.  And if a partner study were to run into trouble, it would be hard to fault a CRO for pulling experienced staff members off a smaller project in order to help out with the big client.  Though a reputable CRO wouldn’t jeopardize the relationship with the smaller client, their responsiveness to routine requests might suffer.  It might take longer to get a question answered, receive requested documentation, making the job of vendor oversight difficult.

Though selecting a large, well-established CRO at the outset may have seemed like the safe bet, what do you do if you’re a small sponsor or biotech start-up who is dissatisfied with the level of service you’re receiving?

“Let’s Bring It In-house.”
Put off by a negative experience, many companies decide to curtail outsourcing, and bring functions like monitoring and project management in-house.

This response is understandable, but it rarely goes well.  There’s good reason to outsource study functions to a CRO, especially if you’re small, or new, or both.  Mid-study is a terrible time to realize you’re in over your head.  You may find it difficult to contract with the service providers you want in the timeframe you need them.  Services you would have preferred be performed by a single company may now have to be farmed out piecemeal, which has the overhead of multiple contracts and makes vendor oversight more difficult to manage.  You don’t have time to go through a thorough qualification process.  You’re not in a good bargaining position; you’re trying to buy a new car after they’ve towed away your old one.  And now you have to rely on your new service provider(s) – the ones who may not be your first choice, whom you had to choose in haste, whom you didn’t get to thoroughly vet – to jump in midstream and pick up a study that is already in trouble.

Options for Small Sponsors and Start-ups
So what’s the answer?  You have several good options we’ve seen work well for smaller organizations.

(1) Go smaller.  Look beyond traditional outsourcing choices and consider selecting smaller vendors who may well be in a better position to focus on individual projects and give priority to shorter term engagements.  After all, a project that’s small to a big CRO will be comparatively big to a small CRO.

(2) Go long-term.  Consider establishing strategic partnerships of your own.   Doing so would increase the expertise and technology to which you’d have ready access, and could extend your global reach.

(3) Go big, but go vigilantly.  There’s a reason companies hire big, reputable CROs.  ‘Big’ means the CRO has an impressive set of resources at its disposal.  ‘Reputable’ means it has a proven record of successfully completing studies, producing reliable data, and preserving subject safety.  Smaller sponsors can still take advantage of everything a big CRO offers if they can commit to conducting very strict vendor oversight.  They need to closely monitor the quality of the work the CRO performs, frequently assess adherence to the many written study plans, and make sure deadlines are being met.  Service contracts should guarantee a certain level of responsiveness (by specifying maximum turn-around times, for example), especially for those requests that enable these oversight activities.


Qualification is Key
While the key to Option 3 is effective vendor management, the key to Options 1 and 2 is effective vendor qualification.  Resources are tight in a small company, so you need to direct them where your exposure is greatest, where they’ll do the most good.  What could be more essential to the success of your study than choosing the right company to conduct it?   Many sponsors conduct on-site vendor audits.  That’s good.  That’s necessary.  But it’s not sufficient.  To consistently choose the best possible CRO for your study, sponsors need to:

• Formally document and maintain vendor selection criteria and qualification process
• Form selection committees that represent all sides of your business – finance, contracting, operations, finance, QA, data management, pharmacovigilance, biostatistics, etc.
• Conduct on-site audits with well-trained, well-prepared QA auditors
• Track the resulting CAPA activities
• Ensure outstanding issues are resolved before the contract is signed
• Periodically re-evaluate vendors to make sure they can continue to deliver the same level of quality they’ve delivered in the past

Strategic partnerships among large companies have reshaped the research environment for industry players of every size.  Small and mid-sized companies who take the time to review current outsourcing arrangements, assess alternative models, and thoroughly qualify new vendors and partners will fare the best.

Photo Credit: FreeImages.com/Svilen Milev

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

Takeda in global licensing agreement with ProThera to develop plasma-based therapies for inflammatory conditions.

Biotech venture funding metrics continue at historic highs, highlighting that the robust financing environment in the public markets continues to fuel the private markets as well.  – Bruce Booth, partner Atlas Venture in Data Snapshot: Venture-Backed Biotech Financing Riding High, April 2015 Here in Madison, Wisconsin, you might not know that was true if you

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of artificial intelligence (AI)-enabled versions of the GX series panel-mount type paperless recorders, GP series portable paperless recorders, and GA10 data logging software, which are components of the highly operable and expandable SMARTDAC+data acquisition and control system. This new AI functionality includes the future pen, a function developed by Yokogawa that enables the drawing of predicted waveforms. Yokogawa is also releasing a new CPU module for the e-RT3 Plus edge computing platform that is environmentally robust and Python compatible. The GX/GP and e-RT3 release is set for April 8, and the GA10 software will be released on May 13. The SMARTDAC+ system is a product in the OpreX Data Acquisition family, and the e-RT3 Plus is part of the OpreX Control Devices family.

He became a pioneer of salsa music and was renowned for hits such as Puerto Rico, Adoracion, No se compara and Maestro rumbero.

Genomewide association studies identified four genes that could serve as diagnostic markers and/or therapeutic targets for EoE.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

May 7, 2020

During times of crisis, the most effective leaders are those who can build solidarity by educating the public about its own interests. Sadly, in the case of COVID-19, the leaders of the world's two largest economies have gone in the opposite direction, all but ensuring that the crisis will deepen.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

May 7, 2020

During times of crisis, the most effective leaders are those who can build solidarity by educating the public about its own interests. Sadly, in the case of COVID-19, the leaders of the world's two largest economies have gone in the opposite direction, all but ensuring that the crisis will deepen.

May 7, 2020

During times of crisis, the most effective leaders are those who can build solidarity by educating the public about its own interests. Sadly, in the case of COVID-19, the leaders of the world's two largest economies have gone in the opposite direction, all but ensuring that the crisis will deepen.

May 7, 2020

During times of crisis, the most effective leaders are those who can build solidarity by educating the public about its own interests. Sadly, in the case of COVID-19, the leaders of the world's two largest economies have gone in the opposite direction, all but ensuring that the crisis will deepen.

May 7, 2020

During times of crisis, the most effective leaders are those who can build solidarity by educating the public about its own interests. Sadly, in the case of COVID-19, the leaders of the world's two largest economies have gone in the opposite direction, all but ensuring that the crisis will deepen.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.

Apr 17, 2020

This episode of Horns of a Dilemma touches on whether the failure to properly anticipate and warn about the novel coronavirus constitutes an intelligence failure, what changes might be required in the intelligence community in the wake of the pandemic, and what type of investigation or inquiry might be appropriate in order to learn lessons and incorporate changes for both the intelligence community and the whole of government moving forward.