The Justice Department announced today that it reached a settlement with the Delran Township School District in New Jersey under Title II of the Americans with Disabilities Act (ADA).

Attorney General Eric Holder and United States Attorney for the Southern District of New York Preet Bharara announced today the completion of the Justice Department’s multi-year civil investigation pursuant to the Civil Rights of Institutionalized Persons Act (“CRIPA”) into the conditions of confinement of adolescent male inmates on Rikers Island. The investigation, which focused on use of force by staff, inmate-on-inmate violence, and use of punitive segregation during the period 2011-2013, concluded that there is a pattern and practice of conduct at Rikers Island that violates the rights of adolescents protected by the Eighth Amendment and the Due Process Clause of the Fourteenth Amendment of the United States Constitution. The investigation found that adolescent inmates are not adequately protected from physical harm due to the rampant use of unnecessary and excessive force by New York City Department of Correction (“DOC”) staff and violence inflicted by other inmates

The following statement is attributable to Justice Department spokesman Brian Fallon regarding Attorney General Eric Holder’s visit to Mexico City today to meet with his fellow attorneys general from across Central America to discuss the situation involving migrant children.

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

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

Media Registration is Open for the APEC Informal Senior Officials’ Meeting

Broaden opportunities for people and ensure more inclusive growth across the Asia-Pacific, urged the 2020 Chair of APEC Senior Officials, host of the Asia-Pacific Economic Cooperation in 2020.

Media registration is open for the First APEC Senior Officials’ Meeting (SOM1) and related meetings in Putrajaya, Malaysia from 3 February to 22 February 2020.

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

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,…

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

Ethan Perlstein, founder of Perlstein Lab, asked a question on Twitter and got some great answers from David Grainger, partner at Index Ventures and Katrine Bosley, CEO of Editas Medicine. (You can read the whole thread by clicking through.) @LifeSciVC @sciencescanner @ksbosley @scientre what's the burn rate distribution of biotech NewCos in for the first year of

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

The move is seen to make the fundraising process easier and cost-effective for startups.

The post SC Malaysia eases norms for firms issuing convertible notes to VC, PE firms appeared first on DealStreetAsia.

About CNU
Capital Normal University (CNU) was founded in 1954. Being a national “Double-First Class” university and “Province-Ministry Co-sponsored” (Beijing and the Education Ministry) university, CNU has extensively broad disciplines including literature, sciences, engineering, management, law, education, foreign languages and arts. For over 60 years, CNU has cultivated more than 200 thousand graduates specializing in various fields. Currently, CNU is an important talent training base of Be…

About CNU
Capital Normal University (CNU) was founded in 1954. Being a national “Double-First Class” university and “Province-Ministry Co-sponsored” (Beijing and the Education Ministry) university, CNU has extensively broad disciplines including literature, sciences, engineering, management, law, education, foreign languages and arts. For over 60 years, CNU has cultivated more than 200 thousand graduates specializing in various fields. Currently, CNU is an important talent training base of Be…

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

Tumor cell and mouse studies suggest tetravalent antibodies that target four different antigens could help treat cancers resistant to HER-targeted therapies.

Genocea has identified an immunological imprint in patients with malaria and is using a $1.2 million grant from the Gates Foundation to turn the findings into a vaccine.

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.