Today's Daily Dose brings you news about the revised FDA decision date for Bristol Myers' CAR T cell therapy for refractory large B-cell lymphoma; Enanta Pharma's primary biliary cholangitis trial results; MacroGenics' anticipated clinical data read-outs and regulatory event for this year and Trovagene's name change.

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.

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.

Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion.

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous For device-lead drug combination products, is there any difference in the quality (grade) of API used compared to a pure drug product? The cGMP guidance for combination products does not seem to specify, and since drug claims cannot be made on device-lead drug combination products, it was not clear what quality of drug is required. Thank you!

From : Communities>>Regulatory Open Forum
​I doubt FDA would have any willingness to change the requirements or expectations for a drug product based on whether it is in a strictly drug product versus in a combination product.  The fact also that there is not a published allowance for this is further evidence that FDA expects that the drug will meet the requirements as expected for drug products without providing any allowed changes or classes of changes.  Remember, FDA expects that drug products meet specific requirements.  Things like [More]

In an effort to tease out the priorities of a clinical study site audit, I asked six of our most experienced GCP auditors the following question:

If you only had one hour to conduct a study site audit,
what would you look at?
[Obligatory warnings:  Do not try this at home. This is just a simulation. Caveat lectorem. Dinosaurs in the mirror are bigger than they appear. Et cetera.]

Of course it’s not possible to conduct any kind of meaningful audit in so short a time, but it’s an interesting thought exercise because it gets to the heart of study site risk.
In order to respond to this question, the auditors needed to ask themselves:

(1) What are the greatest site risks to a study?
(2) Where can evidence be found that those risks are being managed?

Answering the first question is pretty easy. The very first paragraph of ICH E6(R2) tells us “Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected…and that the clinical trial data are credible.” So there it is: the reason GCP exists. When we conduct clinical research, our highest priorities are human subject protection and data integrity. It follows, then, that jeopardizing these obligations is our greatest risk.

So with only an hour to evaluate whether a study site is managing these risks, we can move on to the second question. What would our audit (now referred to as “hour audit”) look like?

IRB Approvals

Hour Auditor has decided to spend the first twenty minutes at the site reviewing IRB approvals. Are all of the IRB approval letters in the Investigator Site Files (ISF)? Is the protocol that’s being executed the same version that the IRB approved? Have the protocol amendments and all of the associated Informed Consent Forms (ICFs) also been approved?

Missing approval letters aren’t necessarily the end of the world. It’s quite possible that the required approvals are sitting on the sponsor portal, having been received from a central IRB. Their absence from the ISF could just be a clerical error. However, it’s a first-order finding if the site was responsible for getting approval from its local IRB and failed to do so. The IRB would have to be notified. The FDA would have to be notified. Without review and approval from an ethics body, the safety of study participants is jeopardized and their rights violated. Everything stops.


Informed Consent

With forty minutes left to go, Hour Auditor spends the next twenty minutes reviewing participants’ ICFs. The selection of these participants may be random or targeted, depending on the results of the IRB approval review. Has each participant signed every applicable version of the ICF? Were they signed before any associated study procedures were conducted? If not, was the delay noted in the subject notes? How was the situation remedied? Was there a CAPA to ensure that any other incidents were corrected and future occurrences prevented? Was the IRB informed?


Inclusion/Exclusion Criteria

Now down to the final twenty minutes, Hour Auditor asks to see the Inclusion/Exclusion (I/E) criteria for two screened and enrolled participants. Most likely, the particulars of the study -- the vulnerability of the patient population, the therapeutic area, and the protocol complexity, among other things -- would drive the selection.

We’re running out of time, and this could be our final stop. With so much else to look at, including source data, IP accountability, staff qualification and training, and Adverse Events reporting, why focus on I/E criteria? Because they give us a glimpse of many aspects of study conduct all at once. When a site can assess complex I/E criteria correctly, it demonstrates protocol compliance and a commitment to producing reliable study data. Examining I/E criteria also gives Hour Auditor a chance to assess source data quality and provides further assurance of subject safety.

Best Laid Plans
As with any audit, particular findings at any step could (and should) alter the plans for this one-hour visit. If the ICF review left Hour Auditor concerned about fundamental flaws in the IC process, the rest of the audit might be spent trying to determine the extent of the problem. An incidental discussion could raise red flags about staff proficiency that may have Hour Auditor poring through protocol training records or scrutinizing the Delegation of Authority log. (Plus, Hour Auditor really, really wants to take a peek at the IP accountability records, and so may find a reason to do so*.)

The point of this thought exercise was to consider (1) the obligations of the clinical research industry to protect subjects and produce reliable data, (2) where the biggest risks to that obligation lie, and (3) how site audits should be prioritized to ensure those obligations are being met and those risks are being managed.

_________________________________________________________________________

*The auditors involved in this discussion did their best to honor the absurdly artificial time constraint I gave them. That meant foregoing activities no self-respecting auditor could bear to forego. This paragraph recognizes some of those activities. (Thank you all. I know this hurt.)

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

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The likelihood of an effective vaccine being developed and scaled up in less than 12 months is unrealistic, suggests GlobalData analyst.

by Justin Elliott, Paul Kiel and Lydia DePillis

Through programs like the Small Business Administration’s Paycheck Protection Program and the Federal Reserve’s Main Street Lending Program, the federal government is deploying hundreds of billions of dollars in grants, loans and bond purchases to help businesses amid the coronavirus-sparked economic crisis. Each program comes with different strings, but their basic purpose is to keep workers on the payroll.

We want to know what this means for your workplace. How has your company treated its workers during the crisis? Have you or your colleagues been laid off, furloughed or otherwise affected? Have you seen money used in surprising ways? What do you think we should be reporting on?

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A third of pharmacists cannot obtain continuous supplies of personal protective equipment, according to a survey conducted by the Royal Pharmaceutical Society.

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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

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]

With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]

As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe.

The coronavirus outbreak makes finding jobs more difficult for everyone. College seniors face unique career challenges.

The NHL announces it is postponing the Global Series games that were scheduled to be held in the Czech Republic and Finland in the 2020-21 season.

Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans.

For the high school and college classes of 2020 — and their families — the coronavirus outbreak has left a large, empty space where signature coming-of-age moments should be.

U.S. and U.K. intel agencies are reviewing the private report, but intel analysts examined and couldn't confirm a similar theory previously.

In March 2019, Yokogawa completed a demonstration project for the Optimization of the Operation Control of Oil Refining Plants in Indonesia. The New Energy and Industrial Technology Development Organization (NEDO) awarded this project to Yokogawa in 2013.

These polyketides, which occur naturally in a myxobacterial species, stabilize microtubule polymers and are therefore being investigated as potential anticancer agents.

2012 XA133 or city killer as it is being called is the third asteroid heading towards the Earth.

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

It is a home telephone service which gives users unlimited local and nationwide calling in the US. For international calls, users will get the same rates used as the Google Voice service.

NTA NEET 2020 has been postponed amid the coronavirus (COVID-19) pandemic. 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.

Ruangguru CEO Adamas Belva Syah Devara has resigned from its role as the government's special staff.

The post Indonesia Digest: Ruangguru CEO quits govt role; Gojek partners Paxel appeared first on DealStreetAsia.

It's SG growth & marketing director, Sarah Tan, will take over the reins as interim general manager.

The post Deliveroo’s Singapore GM departs, one quarter of employees in city-state laid off appeared first on DealStreetAsia.

Wihardja’s appointment comes nine months after his predecessor, former MDI Ventures CEO Nicko Widjaja, quit to join BRI Ventures.

The post Indonesia’s MDI Ventures appoints former AC Ventures partner Donald Wihardja as CEO appeared first on DealStreetAsia.

RBI Assistant Scorecard 2020 of prelims exam released @ rbi.org.in. Check your marks here on the direct link and download your marksheet. RBI Mains exam date postponed by Reserve Bank of India. The new exam date of RBI Assistant Mains 2020 will be revealed soon.

IBPS PO/IBPS Clerk Results 2019-2020 postponed due to Coronavirus outbreak in India. IBPS Recruitment 2020 Provisional Allotment merit list will now be released on new dates. Check Notification PDF Details here.

Indogen is working with its portfolio firms to explore opportunities in Greater China and Japan.

The post Indonesian VC firm Indogen Capital eyes succour in East Asia amid virus crisis appeared first on DealStreetAsia.

ESB claims to be enabling restaurants to transition to the cloud-kitchen model amid the COVID-19 outbreak.

The post AC Ventures leads seed round of Indonesian restaurant ERP startup ESB appeared first on DealStreetAsia.

People dump their exotic animals for logical, if not good, reasons