Today, Attorney General Eric Holder met with campus leadership from eight Washington, D.C.-area colleges and universities: American University; Catholic University of America; Gallaudet University; Georgetown University; George Washington University; Howard University; Trinity University; and University of the District of Columbia, to discuss how administrations are addressing sexual assault on campus.

Since 1940, LDF has performed critical work to rally Americans from all backgrounds to the unifying cause of justice – standing on the front lines of our fight to guarantee security, advance opportunity, and ensure equal treatment under law.

Guadalupe Escamilla, 72, of Weslaco, Texas, pleaded guilty to one count of vote-buying before Chief U.S. District Judge Ricardo Hinojosa in the Southern District of Texas, McAllen Division.

Deputy Assistant Attorney General Ronald A. Cimino for the Tax Division of the Department of Justice and U.S. Attorney Preet Bharara for the Southern District of New York announced that Paul M. Daugerdas, 63, a tax attorney and certified public accountant, was sentenced today in Manhattan federal court to serve 15 years in prison for orchestrating a massive fraudulent tax shelter scheme in which he and his co-conspirators designed, marketed and implemented fraudulent tax shelters used by wealthy individuals to evade over $1.6 billion in taxes owed to the Internal Revenue Service (IRS).

"These groundbreaking efforts [Smart on Crime, Federal Interagency Reentry Council] are enabling us to tear down unnecessary barriers to opportunity and independence – while building up programs and policies that enable returning individuals to successfully reintegrate into their communities."

"Five decades after its passage, the Civil Rights Act continues to touch the lives of Americans across the country – and to serve as a potent tool for combating discrimination. As we contemplate a half-century of progress—and look to the work that remains—the Civil Rights Division remains committed to its mission to protect, defend and advance civil rights in our nation."

A former Northfield, New Hampshire, man was indicted on three counts of tax evasion for tax years 2008, 2009 and 2010, the Justice Department and Internal Revenue Service (IRS) announced today

Political consultant Gregory Naylor, 66, of Philadelphia, pleaded guilty today to making false statements to federal agents and misprision of a felony in connection with his role in attempting to conceal two campaign finance-related fraud schemes

A former Iowa State Senator pleaded guilty today to concealing payments he received from a presidential campaign in exchange for switching his support and services from one candidate to another and to obstructing a subsequent investigation into his conduct.

The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end.

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.

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.

Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.

Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.




Trialed Drug vs Marketed Drug


Once researchers are satisfied that animal studies show that an Active Pharmaceutical Ingredient (API) is effective and nontoxic at initial doses, there’s an urgency to get it into the clinic and begin human studies as soon as possible. Though the ultimate product may be marketed in one form, a different form may take less time to manufacture, and so would be the form given to human volunteers in earlier clinical trials.

A tablet, for example, is much harder to manufacture than a 2-piece hard shell capsule because determining the appropriate compression for a tablet takes time. (Tablets that aren’t sufficiently compressed will break apart in the bottle; tablets compressed too tightly may not dissolve as they should, earning themselves the entertainingly accurate moniker “bedpan bullets.”) Rather than wait until a tablet form of the drug can be fully developed, to save time, sponsors would likely begin human studies using a hard shell capsule version.*

To ensure that clinical trial data for the Investigational Product (IP) are applicable to the ultimately marketed product, clinicians run bioequivalence for dosage form studies. These small pharmacokinetics studies may result in changes, such as dosage amount or frequency, if people do not metabolize the studied formulation and the final formulation the same way.


Stability Test Failures

When we hear of a pharmaceutical company having to “pull its product,” we typically think of a recall scenario that involves consumers, distributers, and retailers.  Recall procedures fall under the GMP umbrella, and are spelled out in great detail in 21 CFR Part 211. However, similar procedures may very well be required of clinical site staff, long before the product ever sees its first drugstore.


Before any clinical trials begin on a drug, manufacturers would have been conducting stability tests for months. But stability testing may continue for years after the start of human trials, and analysts could detect a variety of troubling conditions in the course of their work. Product can change color or break apart. Capsules can crack and leak. Microbes could begin to grow, especially in moister product. The container closure system itself could be problematic; it could leech contaminating material into the product, introducing impurities, or it could extract material from the product, diminishing its potency. Any of these finding could mean that study drug would need to be pulled from clinical sites.

No one expects site staff to have detailed quarantining and recall procedures; the Sponsor will tell site staff exactly what they need to do. But what would this look like?

(1) Adulterated product that cannot be dispensed will need to be moved to a separate, secure area so it won’t be confused with good product. It might need to be stored there for a period of time or shipped back to the Sponsor.

(2) For certain, a site’s drug accountability procedures will be center stage. The only way a site can successfully recall bad product is if it has -- all along -- closely tracked the amount of IP it has received, dispensed, and still has on hand.

(3) Study participants who have any quantity of the bad product will need to be contacted, told not to use it, and told how to return it. (Note that this pertains to participants on the placebo arm as well, otherwise the blind will be broken.) Phone calls may not be sufficient; sites may need to invoke lost-to-follow-up procedures, such as sending registered letters. Remote, virtual trials, which often ship IP to participants, need to be designed to allow for the tracking and retrieval of bad product.

(4) What should be done if it turns out some participants have already used the bad product? Unfortunately, that’s one SOP you can’t write in advance; it would completely depend on the nature of the IP and the problem it has, the vulnerability of the patient population, the protocol, the participant’s proximity to the site, etc. Perhaps a careful case review to look for AEs associated with affected participants would suffice. More critical situations may require participants to undergo physical examinations or special testing. In many cases, study data associated with the use of the tainted IP would need to be identified and removed from the efficacy analysis.

(5) These quarantining and recall activities must be carefully recorded. IRBs and regulators will want written proof that all suspect IP has been accounted for. Sponsors might consider sending a CRA to ensure adequate documentation.


Re-labeling

Stability tests don’t have to fail to trigger action for clinical staff. Should a chemist discover a condition that requires a labeling modification -- a new expiry date**, for example – all the labels on existing product held at clinical study sites would need to be replaced. In these situations, the Sponsor may dispatch CRAs to replace the labels themselves, or negotiate with individual site staffs to do it instead. 


No GxP is an Island…

GMP professionals manufacture, package, and label biopharmaceutical products. GCP professionals conduct clinical trials on those same products. These roles are very different from each other, yet they don’t work in isolation. Formulation changes, stability testing, and re-labeling requirements represent three examples in which activities performed by GMP folks impact their GCP counterparts. Have you experienced any additional examples? Feel free to share them in the Comments section.

In case you missed it, our last post was about how attributes of the Study Drug influence the Site Selection and Feasibility process.

___________________________________________________________

* “By the time clinical trials start, they know what ingredients go in the cookie, they just don’t know how the cookie is going to turn out yet.”
       - Rosanne Sylvia-Heeter, Polaris Director of GMP Compliance and phenomenal cook

** Expiry dates are not required but are sometimes included on IP labels.

J&J agrees a manufacturing partnership with Emergent, as it looks to hit its target of one billion doses.

As the industry shifts gears to combat the novel coronavirus, a number of leadership changes have taken place.

Catalent announces partnership with J&J to manufacture lead COVID-19 vaccine candidate, plans to hire 300 staff and manufacture 24/7.

The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.

Snake Oil & Enforcement

Off-Label Promotion & Outbreaks

Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere.

Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19.

Eli Lilly has teamed with China’s Junshi Biosciences in the U.S., marking the company's second COVID-19 pact to develop neutralizing antibodies against the virus. It promises to be a faster approach than designing a new small-molecule drug would be, but getting from idea to an effective product may not be so simple.

Following in the footsteps of an increasing number of biopharmas that want to use data to get more bang for their buck in R&D, J&J has promoted Najat Khan, Ph.D., to the role of chief data science officer.

Johnson & Johnson taps Khan for chief data role; Icon poaches AstraZeneca vet Buck as CMO; Intellia signs on Lebwohl as CMO.

Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns.

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.

Roy Horn, the dark-haired half of Siegfried & Roy, raised the white tigers and other animals in the duo's extravagant shows that were one of the biggest draws on the Las Vegas Strip.

The committee will examine the merits and demerits of various dates for the commencement of the its report by 31 December 2016.

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Check important government schemes launched by the Ministry of Health & Family Welfare which are important to study for the UPSC (IAS) Prelims 2020 exam.

CBSE Result 2020: Amid COVID - 19 pandemic & lockdown, Kendriya Vidyalaya Sangathan (KVS) and many state boards (like Gujarat, Haryana, Puducherry) have decided to promote school students (Classes 1st to 9th & Class 11th). After this, many students & parents are seeking clarity from the Central Board of Secondary Education (CBSE). Check updates.

Former CEO Achmad Zaky stepped down from his position, in a surprise move, in December 2019.

The post Indonesian unicorn Bukalapak’s co-founder & CTO Herucahyono exits appeared first on DealStreetAsia.

IBPS RRB Provisional Allotment List & Final Result 2019-2020 out @ ibps.in. Check your result on direct link provided here. IBPS conducted the RRB Office Assistant & Officer Scale I, II & III recruitment exam in August 2019.

SBI Clerk Prelims Exam Analysis & Review 2020 is shared here for all days and all shifts. Check here the detailed analysis and review of the SBI Clerk Prelims 2020 exam held on 22nd February, 29th February and 1st March 2020. Know questions asked and their difficulty level. 

RBI Assistant Result 2020 out @ rbi.co.in of the prelims exam held for the recruitment of over 900 vacancies in central bank. Check your result on direct link here and know your marks of RBI Assistant Prelims 2020. Know RBI Assistant cut off marks and Mains Exam Date.

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IBPS Exam Calendar 2020-21 released @ ibps.in in PDF Download format. Check here exam dates and schedule of IBPS Recruitment 2020 of IBPS PO, IBPS Clerk, IBPS RRB and IBPS SO 2020 in banks. Download IBPS Calendar 2020 here. 

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