A former sergeant of the Portsmouth Sheriff’s Office (PSO) was sentenced to serve 15 months in prison today for accepting bribes in exchange for favors and referrals. Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and Acting U.S. Attorney Dana J. Boente of the Eastern District of Virginia made the announcement.

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.

Today the Justice Department’s Civil Rights Division announced its letter of findings determining that prison officials at the Alabama Department of Corrections and the Julia Tutwiler Prison for Women violate women prisoners’ constitutional rights by failing to take reasonable steps to protect them from harm due to sexual abuse and sexual harassment caused by correctional staff.

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.

A former correctional officer at the Puerto Rico Department of Corrections was sentenced to serve 37 months in prison for attempting to smuggle heroin into the prison where he worked, Bayamón State Penitentiary, in exchange for a $3,000 payment.

A former state marshal and a correctional officer in Puerto Rico were sentenced today for attempting to smuggle heroin to inmates in exchange for payment.

A former correctional officer in Puerto Rico was sentenced to serve 37 months in prison for attempting to smuggle heroin into state prison by delivering it to an inmate in the parking lot of the Medical Center in San Juan, Puerto Rico.

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.

In a new step to further the Justice Department’s efforts towards enhancing reentry among formerly incarcerated individuals, Attorney General Eric Holder announced Monday that the Bureau of Prisons (BOP) will impose new requirements on federal halfway houses that help inmates transition back into society.

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.

Habtom Merhay, a national of Eritrea and a citizen of the United Kingdom, made his initial appearance today in federal court to face human smuggling charges for his role in smuggling primarily Eritrean and Ethiopian undocumented migrants.

The Justice Department announced today the filing of a lawsuit against the state of Hawaii and the state of Hawaii Department of Transportation Airports Division (HDOT-Airports) alleging that the defendants discriminated against former employee Sherry Valmoja by subjecting her to sexual harassment in violation of Title VII of the Civil Rights Act of 1964.

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.

Four businessmen involved in the development, operation and ownership of restaurants, including Cadillac Ranch restaurants, in Ohio and elsewhere in the United States, pleaded guilty today to tax charges, the Justice Department and Internal Revenue Service announced.

A Texas man pleaded guilty today to conspiring to smuggle and to traffic in counterfeit and misbranded pharmaceuticals, including Viagra tablets, from China.

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.

Zhifei Li, the owner of an antique business in China, was sentenced today to serve 70 months in prison for heading an illegal wildlife smuggling conspiracy in which 30 rhinoceros horns and numerous objects made from rhino horn and elephant ivory worth more than $4.5 million were smuggled from the United States to China.

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.

Ning Qiu, a resident of Frisco, Texas, and an appraiser of Asian art, pleaded guilty today in federal court to participating in an illegal wildlife smuggling conspiracy in which rhinoceros horns and objects made from rhino horn and elephant ivory worth nearly $1 million were smuggled from the United States to China

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).

"The computers of American citizens and businesses are, as we speak, under attack by individual hackers and organized criminal groups using state-of-the-art techniques seemingly drawn straight from a science fiction movie," said Assistant Attorney General Caldwell

An Illinois man, who previously pleaded guilty to trafficking in counterfeit goods and introducing counterfeit drugs into interstate commerce in violation of the Food, Drug and Cosmetic Act, was sentenced today to serve 41 months in prison

As the Secretary has so poignantly described, the conditions for these migrants en route to the United States are horrible. Human smuggling ventures lead to extremely dangerous circumstances that pose a threat to public safety and are serious humanitarian concerns. We have encountered smuggled aliens that have been, kidnapped, taken hostage, beaten, sexually assaulted, threatened with murder or have died as a result of dangerous conditions.

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

Today, the Justice Department asked a federal court to dismiss its case involving Oakley Training School in Raymond, Mississippi, because the state of Mississippi and the Division of Youth Services have significantly improved conditions for confined youth at Oakley. The reforms, implemented under a consent decree, resulted in increased protections to prevent harm to youth, improved suicide prevention practices, improved medical, dental and mental healthcare, increased rehabilitative services and improved special educational services

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

The Justice Department announced today that the owners and operators of the Alger Meadows Apartments in Grand Rapids, Michigan, have agreed to pay $550,000 in damages and civil penalties and to terminate property manager Dale VanderVennen’s role in managing the complex to settle a lawsuit alleging that VanderVennen sexually harassed female tenants in violation of the Fair Housing Act (FHA).

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

Today, the Justice Department asked a federal court to dismiss the injunction to address civil rights violations at Saint Elizabeths Hospital in Washington, D.C., because the District of Columbia and the Department of Behavioral Health have significantly improved the care and treatment of persons confined to Saint Elizabeths Hospital. Saint Elizabeths is the district’s facility for treating individuals with mental health conditions. The reforms, which were implemented following requirements under a court order, have ensured that persons at Saint Elizabeths Hospital are discharged to the community with adequate supports to live in integrated settings. Further, the reforms resulted in important improvements in integrated treatment planning, psychological and psychiatric services, nursing care and protection from assault.

Ahmad Ibrahim Al-Ahmad made his initial appearance today in federal court in Phoenix, Arizona, on federal terrorism offenses, announced John P. Carlin, Assistant Attorney General for National Security.

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.

A Wisconsin pharmacist and a Nevada pharmacologist were arraigned on an indictment today in Federal Court in Central Islip, New York, before United States Magistrate Judge Gary Brown. The defendants are charged with conspiring to supply at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers.

ALEXANDRIA, Va

Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.

DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.

Bergstrom Nutrition, manufacturer of OptiMSM®, a branded form of methylsulfonylmethane (MSM), recently published an article detailing how the small intestine absorbs MSM, particularly in relation to sulfur.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

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 convened this week in Concepcion to talk about one of the most underrepresented but vital business sectors of the region.

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

APEC continues to bolster ethics in the healthcare sector in support of small and medium enterprises (SMEs) and patients, as Chile launches a consensus framework to improve ethical interactions in its healthcare system.

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

On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed…