IBM Fundamentals of Applying SmartCloud

IBM announces New SmartCloud capabilities, Partnership With Nirvanix | killexams.com existent Questions and Pass4sure dumps

IBM has nowadays increased its cloud computing features for enterprise with the launch of recent IBM SmartCloud capabilities. These new offerings involve SmartCloud utility features, IBM’s new PaaS for enterprise, a portfolio of hardware and software known as SmartCloud basis, and SmartCloud Ecosystem, which comprises new features for IBM companions and ISVs.

The industry plans to back around 200 million clients via the conclusion of 2012.

IBM says that it has ported SAP, ERP and every solitary database functions to its SmartCloud platform. With its new services, it may possibly now automate labor-intensive tasks linked to operating SAP within the cloud, specifically SAP cloning, refreshes and patching. In some circumstances, IBM says the time rate reductions can depart from months or weeks to days or hours, counting on the assignment.

also introduced nowadays is a new partnership with Nirvanix, a cloud storage company. Going forward, Nirvanix’s cloud storage know-how should breathe integrated into IBM’s SmartCloud enterprise storage features, enabling consumers to upload information of any dimension, anyplace in the world, and access them from any place. The storage-as-a-provider providing can champion millions of clients, billions of objects and exabytes of records.

in the meantime, IBM’s new platform-as-a-carrier offering, SmartCloud application functions (SCAS) will launch into beta this yr (q4), offering enterprise–grade protection, open Java and go-platform champion with no vendor lock-in, and a comprehensive set of utility infrastructure and managed services to allow construction and deployment of purposes to the cloud. It will elope on IBM’s SmartCloud commercial enterprise and commercial enterprise+ – the business-type infrastructure-as-a-platform peculiarly designed to elope commercial enterprise workloads at dedicated SLAs (provider degree agreements). IBM SmartCloud enterprise+ is attainable within the U.S., and will breathe deployed international by artery of the conclusion of 2012.

ultimately, the new SmartCloud basis family unit of deepest cloud options goals to champion agencies promptly design and install inner most cloud environments, and includes SmartCloud Entry, prepackaged private cloud software, plus SmartCloud provisioning and monitoring application.

IBM Evolves from On claim to SmartCloud | killexams.com existent Questions and Pass4sure dumps

domestic   →   ERP   →   IBM Evolves from On claim to SmartCloud Posted October 12, 2011 by artery of Sean Michael Kerner     remarks

New IBM application features for cloud consist of middleware, DB2, SAP functions and CRM.

IBM (NYSE: IBM) is rolling out a brand new set of SmartCloud capabilities and application, offering new alternatives for companies to scamper their purposes to a cloud mannequin.

the new offerings consist of the debut of SmartCloud commercial enterprise 2.0, which is a Platform-as-a-provider (PaaS) providing. the brand new SmartCloud will likewise allow IBM DB2 database-as-a-provider as well other IBM functions. IBM isn't just enabling its cloud for IBM software; the SmartCloud likewise has a service for SAP ERP functions.

"This announcement takes their cloud capabilities to the next degree," Lauren States, VP and CTO of Cloud Computing at IBM, told InternetNews.com. "We're adding means to the portfolio for software building and deployment in the cloud with SmartCloud application services."

States referred to SmartCloud application services is IBM's PaaS for the commercial enterprise. She mentioned that initially the software services are concentrated on Java applications and transactional database functions with IBM's DB2. there's additionally an SAP purposes carrier that supplies SAP as a packaged app that will likewise breathe deployed and administered within the cloud.

"We're dawn with what their core customers disburse with their know-how and we'll breathe building that out with other capabilities over time," States noted.

remaining week, Oracle announced its personal public cloud providing, including a database-as-a-carrier providing. States talked about IBM's platform is every solitary about exposing IBM's middleware capabilities as a service. She delivered that programmers who are writing applications for the cloud can simply denomination the provider, whether or not it's database or a further service, and that they will not acquire to breathe troubled concerning the underlying complexity of the stack.

The SmartCloud platform is being delivered on a Linux infrastructure with future plans to expand with windows and IBM's AIX Unix. IBM is the disburse of KVM and pink Hat as the underlying technology seller platform. The platform can likewise breathe used to convey cloud enterprise functions, together with cloud ERP.

IBM is likewise introducing a SmartCloud basis application portfolio for groups trying to deploy on-premise.

"a lot of customers are just getting started with cloud and that they want to center of attention on the merits of virtualization, management and automation for operational effectivity," States mentioned. "This SmartCloud foundation fills a niche in their on-ramp to the cloud and it could actually set the basis for customers that at last want to glean to self-provider, pay-as-you-go infrastructure."

IBM's cloud shove is likewise being prolonged to IBM's latest On claim hosted consumer base. States referred to that IBM already has a huge application on claim internet hosting business. IBM introduced in April that the blueprint became to supply On claim purchasers with cloud capabilities.

"it breathe their aim to deliver a cloud enabled environment inside their software on claim internet hosting industry for those customers that necessity to leverage that operational effectivity," States spoke of.

IBM additionally announced a collaboration with SugarCRM to design its client relationship management (CRM) items accessible on the IBM SmartCloud business. "valued clientele can now consume abilities of advanced CRM solutions, deployable in a count number of minutes, whereas reaching every solitary of the benefits of a non-public cloud ambiance," IBM pointed out in an announcement.

Sean Michael Kerner is a senior editor at InternetNews.com, the information provider of internet.com, the network for technology professionals.

IBM Unveils New ‘DevOps’ CLM tools for the Cloud | killexams.com existent Questions and Pass4sure dumps

IBM the day past unveiled new software and features designed to aid clients streamline the application evolution lifecycle, or what IBM calls “building operations,” or simply DevOps. As fraction of the announcement, which turned into made on the annual Rational Collaborate convention in Florida, parts of Rational’s Collaborative Lifecycle administration (CLM) suite may breathe made obtainable as a DevOps appliance hosted in IBM’s SmartCloud.

The CLM suite, which IBM unveiled ultimately 12 months’s Collaborate reveal, is built on IBM’s open construction platform, known as Jazz, and combines three Rational products, together with necessities Composer, crew live performance, and attribute manager, in a solitary suite that IBM says is easier to buy, deploy, and disburse than separately cobbling the items collectively.

massive Blue yesterday introduced five new CLM products and services as fraction of its shove into DevOps for the cloud. It likewise introduced new cell capabilities in its CLM suite.

the primary DevOps for the Cloud providing bears an unwieldy name: “IBM Rational reply for Collaborative Lifecycle management on IBM SmartCloud enterprise.” This offering is really a slice of IBM’s SmartCloud commercial enterprise that a consumer can disburse as a building and examine atmosphere. SmartCloud enterprise, you will remember, is a public infrastructure as a service (IaaS) offering in line with X86 hardware and the Linux OS. SmartCloud enterprise+ helps energy techniques environments, but now not IBM i.

the brand new IBM SmartCloud application functions (SCAS) platform as a service (PaaS) providing that changed into launched in October 2011 additionally has a role in IBM’s cloud-based mostly DevOps plans. IBM sees SCAS (which comprises a Linux OS, WebSphere became, DB2 database, and SAP purposes) giving consumers a zone the zone they can execute building, build, check, and bring actions.

IBM additionally announced the SmartCloud for executive evolution and glance at various Platform. This providing will give executive organizations a artery to access the CLM suite from a scalable, hosted environment. IBM says this offering will conform to the Federal tips safety management Act (FISMA).

additionally playing into the DevOps cloud is SmartCloud ceaseless delivery, which IBM describes as a set of “choicest drill patterns” designed to aid shoppers disburse CLM tools and IBM’s SmartCloud Provisioning application to exploit the lifecycle of cloud-based mostly functions. SmartCloud continuous birth was at the dawn unveiled in March, and is at present in beta.

The SmartCloud application efficiency management offering provides purchasers with entry to Tivoli monitoring and management tools for making improvements to the performance of cloud purposes.

On the cell entrance, IBM introduced that its CLM suite can now labor with the IBM cell foundation. The cell foundation, if you neglected it, combines three tools, together with the IBM Worklight HTML5 mobile software building and runtime environment; the IBM Endpoint supervisor device; and WebSphere cast iron for integration.

the new industry cellular building providing combines CLM, the cellular groundwork, and a yoke of other Rational tools, including the new Rational Developer for vigour techniques edition 8.5 liberate (which that you could examine greater about here), Rational Developer for system z 8.5, Rational application Developer 8.5, and the Android SDK and Emulator. IBM says that with the aid of integrating every solitary these items, consumers can await to velocity up the technique of designing, constructing, checking out, and deploying industry cellular apps, and doing so in a cozy and compliant manner.

It’s a wide, wily cloud world obtainable, and IBM is determined to champion purchasers reduce throughout the litter and control their cloud utility building activities. “nowadays’s industry plight is the artery to wield both the necessity for speedy birth and ample wield in the utility building system,” Dr. Kristof Kloeckner, common manager of IBM Rational, says in an announcement. “We necessity to balance the necessity for velocity and agility with more suitable governance to exploit freight and high-quality, obtain regulatory compliance, breathe positive protection, and acquire some degree of pecuniary predictability.”

connected studies

IBM Puffs Up New Public, inner most SmartCloud Releases

IBM Ships New Collaborative Lifecycle administration Suite

IBM Consolidates Rational crew live performance items, Simplifies Licensing

IBM Unveils change administration utility for device i

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Fundamentals of Applying SmartCloud Control Desk V1

From Gold Bar to Joshua Tree | killexams.com existent questions and Pass4sure dumps

Warning. A lot of climbing talk ahead.

The next morning, they woke up before 9, ate some cereal with mixed fruits, and headed out with some crash pads. Chad, Brooke, Josh, Wendy and I drove about 30 minutes out into the far desert and parked at the Hidden Valley Picnic zone parking lot (big mistake — there’s a parking lot at the Hidden Valley campsite literally across the street).

Just one of the rock formations at Joshua Tree.

(Side note, I grew up in the elevated desert. It doesn’t glance as stunning or pretty as this.)

We got lost for a bit and took a long hike around from the west side but eventually organize a VERY smooth (listed) V1, that was honestly more dote a V0 with a very short top out. Maybe they identified the boulder wrong.

Behind us was White Rastafarian. withhold in irony I acquire no scare doing any V2s at the gym. They’re usually require some technical moves but for the most part, they’re easily doable. White Rastafarian does not ensue suit with that trend: the top-out of the boulder is 25 feet elevated and has a crux about 20 feet up that requires a span from one crack to another.

I ended up being able to design it to a juggy hold about halfway through the problem before I called it quits and decided not to risk injury.

The elusive White Rastafarian. Objects are smaller than they appear — the top of this boulder is 25 feet up!

After this, they headed to Pinhead a smallish boulder about 50 yards or so from White Rastafarian. This had a yoke of powerful routes.

I was able to top out on this route, but due to my destitute choice in footing, I slipped and fell, despite grabbing the juggy topout. I got a shallow scrape near my privilege thumb, and decided forfeit the route in the interest of taping it up and finding something easier. (I now regret not trying the route again after Chad and the others tried it.)

Bandaged up.

I was, however, able to complete the Pinhead Traverse (V0-).

Brooke on the crux of the Pinhead Traverse. Wendy ‘scends the Pinhead Traverse (V0-). Chad using a Double Gaston privilege before he ‘scends Pinhead.

Chad showed us this route that he organize northeast of Pinhead. I’d outcome the gym grading as a V2 or maybe V2+, but outdoors, it’s likely a V0.

Chad’s V0. Josh and Brooke spotting.

I didn’t try it — I wanted to deliver my energy for their last planned route for the day: Hobbit pocket Offwidth.

This offwidth boulder was tucked behind some shave and more rocks, and when they got there, Josh and Chad began to scramble up some surrounding rocks in the area. Wendy took a stab at Patina, a friction V1.I honestly had never really tried a friction climb, and the closest I’d seen at a climbing gym were labeled as VHards…

Wendy makes progress on Patina.

Hobbit pocket is obviously an “Offwidth” problem (see this video for reference on what the offwidth climb would glance like), but I decided to enact a lieback approach. I didn’t want to elope the risk of slipping and jamming my body into the crack — I’ve seen 127 Hours and I’d rather not acquire a similar situation of getting stuck between two rocks.

This problem was a powerful learning experience, but I’ll just bundle in that lesson into the various other lessons I took away from that day’s climbing:1. Learn to scamper your feet alongside your hands. This is something that I often drill to newbie climbers and I needed to re-teach myself when climbing outdoors.2. Feel the rock before attempting to finish it. Unlike gym routes, the routes outdoors don’t acquire colored tape or markings designating where to depart next. You can’t espy that a hold is a sloper. A shelf or crack may not breathe consistently juggy throughout. This is likewise something that I command new climbers when they route me pictures of a route asking, “What enact I enact next?” I can only speculate so much. The best remedy is to just depart out there and try climbing the rock.3. breathe prepared to design risky moves. I mediate this is a bit hypocritical on my part. On one hand, I promised myself that I wouldn’t spoil myself outdoors as to not ruin my trip…but conversely I likewise realized that I would likewise forestall myself from performing moves that were either extremely painful, or performed an action that would require a quick recovery rather than a slow, systematic approach. It made me wonder — how enact climbers really ameliorate their grade at the gym? enact they just glean strong enough (either through repetitive training or focused exercises) to complete higher grades with ease or enact they actually taste the ache of making uncomfortable moves and just live with it? I mediate the privilege reply here is that it’s a balance of the two, but I’ve been ignoring the latter phenomena — when I gain an uncomfortable move, I often summon it quits and then drop down and reassess. Is that what’s selling myself short? enact I scare a minute of ache of which I could possibly labor through and espy success beyond the horizon?

In the end, I feel dote this boils down to a simple principle: bethink your fundamentals. Of course, there are problems outdoors that can’t breathe easily re-created indoors, and there are different risks to take, but I felt that a lot of problem points that emerged when climbing outdoors simply stemmed from losing my icy and remembering my fundamentals even though it seemed dote I was presented with a totally different context.

When they left the park that day, Wendy got several messages from her family and informed us that she needed to head back home for an emergency. As a matter of privacy, I’ll spare the details.

When they got home, they relaxed for a bit, and as the evening emerged, they had some pasta, sat around a fire pit, and chatted.A crescent moon appeared in the distance, under the stars, and above the silhouette of the mountains. It was honestly one of the most pretty scenes I had ever witnessed, and unfortunately I don’t acquire a picture of it. every solitary I can enact is characterize it with words and you’ll just acquire to believe me.

Later, Chad pointed out the International Space Station passing by, which was a knowing light that emerged from the west and traveled in a line slowly to the east. Although it looked dote nothing more than a steady star stirring across the sky, it was exciting and they every solitary chatted about it for quite some time.

Afterwards, Chad brought out his telescope and they got to espy Jupiter and some star clusters. Wendy taught me how to consume long-exposure night photographs, but the light pollution from town definitely caused the pictures to breathe less than perfect. I wish I could drill this more, but I didn’t bring a tripod, and likewise Seattle isn’t exactly primed for clear skies.

Not so powerful for my first long exposure, but it’ll enact for now. Wendy likewise made us s’mores. glance at that presentation!

We went inside afterwards, then played some Monikers. Chad asked if I could sling together an improv DnD session while Wendy and Vincent called it a night.It was fun, and I wish I could enact more sessions dote that.

The house before playing Monikers. A bit blurry, but maybe preempt given the circumstances…

Why the Harper Majority is a Step Back for Science – Let Us count the Ways | killexams.com existent questions and Pass4sure dumps

This is a guest post by David Ng, a science literacy academic at the Michael Smith Laboratories of the University of British Columbia.

In case you missed it, last night saw the Canada election deliver a Conservative majority. It was an provocative and historic vote for a variety of reasons, but the bottom line is that now the Harper government is in a position to enact pretty much as it pleases, given its position of majority power in both the House of Commons and the Canadian Senate.

As is the norm for any democratic action, this is estimable and harmful depending on your perspective and ideals. Those who design their homes in the industry or economic front generally espy the result as a positive; whereas those who value fairness, ethical government practices, and convivial issues minister to glance upon the election as a daunting and frustrating setback. In this mix, however, is the scientific point of view. And speaking as a Canadian scientist, I want to disburse this space to design the case that every solitary things being considered, this is a fundamentally harmful minute in history for Canadian science.

To enact this, let’s access how the Harper government (not the “Government of Canada” as it was once officially called) has performed so far (in the science context anyway).

And let’s wrangle for this in a rational way. They are after every solitary scientific folk. In fact, let’s apply the estimable outmoded rubric of looking at the claim, providing a reason, and then presenting the evidence for this stance.

First up is their claim: let’s just depart with something direct:

The Harper Government is harmful for Science.

As for coming up with a reason, it’s actually fairly straightforward. Here, we’ve seen repeated examples that would demonstrate a clear necessity of understanding science culture, as well as actions that often undermine the very notion of scientific literacy. Sometimes, you glean the sense that science just isn’t vital to this government, and on occasion it even feels downright inconsequential.

But, of course, this wordy judgement can’t stand on its own verbiage. They necessity concrete evidence for their claim, and to enact this, it’s probably easiest to focus on a number of key points that demonstrate Harper’s modus operandi.

Point 1. The Harper government is not terribly scientifically literate.

There’s a few examples of this (also espy point 2), but let’s simply draw attention to the appointment of a Minister of Industry, Science and Technology who waffles on the science of evolution. In case you don’t know his name, it’s Gary Goodyear: and in essence, his role in government is meant to breathe the primary driver on pushing and representing how science is funded, courted, guided, and basically done in Canada. Although an architect of many a reduce to science funding in times that arguably necessity more scientific innovation (see 4 for more), he was and silent is preeminent as a controversial pattern when in 2009, the Globe and Mail asked him to partake his stance regarding evolution. To this, he replied, “I’m a Christian, and I don’t mediate anybody asking a question about my religion is appropriate.”

Now from a scientific point of view, this ilk of statement is mildly troubling – you would hope that at least the Minister representing science would acquire more eloquent words to suppose on this subject. Unfortunately, this wasn’t the case as illustrated with his further comments on the matter when pressed again during a television interview. During this incident, he chose to proclaim his credit in evolution, but continued with this very odd and ludicrous description of what evolution is:

“We are evolving, every year, every decade. That’s a fact. Whether it’s to the intensity of the sun, whether it’s to, as a chiropractor, walking on cement versus anything else, whether it’s running shoes or elevated heels, of course, they are evolving to their environment.”

2. The Harper government has managed to design Climate Change science an ideological issue.

You’ve actually seen a lot of this already in American politics, but nowadays there’s likewise a Canadian version. Here’s how it works:

In general, science is fairly particular about the artery it is done. The fashion is built to thrive on objectivity and it is ultimately based on the things they see, record, and analyze. It isn’t perfect, since the concept of a paradigm can exert influence, but the evidence it builds on silent has to meet some pretty tough criteria – certainly much more stringent than other epistemologies, or other ways of knowing. outcome another way, scientific evidence is not suppose to breathe swayed by ideological or partisan lines.

Despite this, Harper’s politics acquire warped the science of climate change into one of partisan debate. every solitary other Canadian political parties consume the science at face value, and build from it. Not so with the Conservatives. This is inherently disrespectful to the scientific community, as it suggests that they can design decisions concerning climate change in a zone where scientific literacy has no currency, whereby the overwhelming scientific consensus is treated as nothing more than an provocative and suspicious footnote.

As a result, Harper runs the country on the pretense of whether one can dependence or distrust the scientific evidence, without actually debating the actual technical strengths and weaknesses of the climate science data currently presented. Harper runs the country based on messages that economically sound promising, but are environmentally unsustainable, and acquire strong repercussions which conveniently will consume form long after he is retired. Above all, he places an accent on nurturing a subtle form of climate change denialism and has made it fraction of the conservative ideology. From a scientist’s point of view, this is probably not the best artery to formulate vital policies – on “feelings” as contest to concrete evidence. In essence, they can suppose that I may not breathe a betting man: but if I was, I’m pretty positive that the scientific community is the best zone to glean their odds.

Now, one might wrangle that this is not Harper’s stance at all. It would materialize that the official consume would proclaim the government’s official backing of the “fundamentals of climate change science.” However, as always is the case, actions speak louder than words. As evidence of this, you only necessity to withhold track of the Harper’s record on climate change. Since obtaining its first minority government in 2006, the Conservatives acquire essentially moved away from Canada’s commitment to Kyoto, and has repeatedly undermine climate change talks (to the point of being consistent winners of the “Fossil of the Day” award), fraction of which involves the ceaseless setting up of disappointing emission targets.

In 2009 the goal was to reduce carbon emissions by 20% below 2006 levels by 2020; an equivalent of 3% below 1990 levels by 2020. The goal was later changed in early 2010 to 17% of 2005 levels by 2020; an equivalent of 2.5% above 1990 levels.

The three most populous provinces disagree with the federal government goal and announced more ambitious targets on their jurisdictions. Quebec, Ontario and British Columbia announced respectively 20%, 15% and 14% reduction target below their 1990 levels while Alberta is expecting a 58% extend in emissions. (Wikipedia, April 2011)

More troubling, is that Harper appears to not acquire any qualms about pushing his agenda in any artery possible, and does so in a artery that draws clear distinctions between party lines. In particular, is his egregious misuse of Senate power to depart against the democratic passing of a Climate Change Bill (Bill C-311).

Here, a quick lesson in Canadian government procedures might help. Essentially, when Canadian laws or Bills are outcome on the table, they necessity to depart through a vote in the House of Commons. This is represented by elected members of government, such that the voting here is inherently meant to picture the “will of the people.” However, if passed, the law then needs to depart through the Canadian Senate. This flat of government is suppose to reflect a zone of “sober second thought,” but historically, the Senate very rarely goes against the decisions made in the House of Commons. This is because Senate members are appointed, and therefore in principle are there to silent respect the democratic underpinning of the House of Commons’ vote. However, in December 2008, Harper filled 18 vacant Senate spots with Conservative appointments, and has used this Senate majority in undemocratic ways – including the killing of the Climate Change Bill.

Still, there are other ways to compel an ideology along: which brings us to point number three.

3. The Harper government has demonstrated a willingness to “muzzle” science.

In 2010, the release of Environment Canada documents showed that new media rules introduced by the Harper Government in 2007, with the aim to control the skill for Federal climate scientists to interact with media, had been responsible for what many of these scientists acquire called a “muzzling” effect.

“Scientists acquire noticed a major reduction in the number of requests, particularly from elevated profile media, who often acquire same-day deadlines,” said the Environment Canada document. “Media coverage of climate change science, their most high-profile issue, has been reduced by over 80 per cent.”

The analysis reviewed the repercussion of a new federal communications policy at Environment Canada, which required senior federal scientists to search authorization from the government prior to giving interviews.

The document suggests the new communications policy has practically eliminated senior federal scientists from media coverage of climate-change science issues, leaving them frustrated that the government was trying to “muzzle” them. (Montreal Gazette, March 15, 2010)

This facet of Harper’s strategy is especially troubling. Science, as a whole, is a venture that best works when there is fluidity and an openness in how information is shared. Whether that is within the scientific community in the form of expert peer review, or back and forth between scientists and the generic public or the policy makers as a dialogue of civic consequence, there is simply no commendable judgement for this form of control. It should breathe obvious that discussions on Climate Change, which has obvious public importance, things shouldn’t breathe elope dote a corporation protecting its secrets and/or hiding information that veers away from the desired message.

4. The Harper Government is out of paw with science culture: scientists are driven by many things, and not always by the industry/business/corporate mentality.

Over the last yoke years, we’ve seen examples where the Harper Government has consistently pushed research towards a cumbersome accent for applied sciences and industry, often at the expense of basic science. Whether this is via funding cuts to granting agencies such as the Natural Sciences and Engineering Research Council (a bastion of basic science research), diverting such monies towards projects where business-related objectives are encouraged, or via restructuring of the National Research Council such that industry-related projects are given priorities, there’s definitely a fashion to his ways. Overall, this indicates a generic ignorance of how scientific progress works – that is, it is almost always the discoveries born from basic research that fuel the future innovation necessary for applied benefits. outcome another way, if Harper continues on this track to give himself quick political gain, he does so at the expense of future Canadian science. Even a minute lull in basic research in the present could result in a significant lull in applied and economic potentials in the future.

As well, this constant patronage towards the industry side of science likewise doesn’t necessarily reflect the intentions of the scientists themselves. Money and economics may breathe desirable things for scientists, but most often there are other stronger motivations at stake – including an aspiration to bring about positive change in the world, as well as unpretentious outmoded intellectual curiosity.

An illustration of Harper’s willingness to always give credence to the corporate line, is his Government’s destitute handling of the recently diposed Bill C-393. Essentially, this is an episode where harmful politics trumped estimable science. The estimable science in this case is the fact that there are very efficient antiretroviral drug out there, which design HIV/AIDS a treatable disorder. Unfortunately, these are mostly priced too elevated for individuals in developing countries – countries where unnecessary death from HIV/AIDS is catastrophically high. The harmful politics concerns a frustrating sequence of events that saw a Bill (C-393), designed to fairly and with monitoring facilitate production of generic drugs, glean passed in the House of Commons (i.e. democratically given the green light); then was taken to Senate, where it was deliberately stalled for five days, in an atmosphere where delusory information provided by the pharmaceutical industry was being distributed to the Tory Senators; such that it was ultimately killed by default when the new election was called. The fact that the judgement for this was ultimately because of the Harper’s Government willingness to patronize substantial Pharma is extremely galling, especially when so many lives were literally at stake.

Conclusion

It’s vital to note that science culture isn’t the only thing that drives a civil society. However, as a conduit for reasoned discourse and apposite information that affects local and global concerns, it’s obvious that science must not breathe taken for granted. Based on last night’s election results, they acquire every judgement to worry about the Conservative majority, as the Harper Government has repeatedly demonstrated past activities that not only consume science for granted, but treat it with a form of contempt. The Harper government has consistently ignored whatever sound utility the scientific endeavor can provide, and by doing so, has outcome the future of Canadian science at risk, as well as the elements of society that would acquire otherwise benefited from it.

In the end, this means that they must watch the actions of this Harper Government more closely; and to breathe vocal, to breathe active, and to enact their best to hold them to account for their actions. Democracy has given Harper a mandate to govern as he sees fit, and for this there should breathe an component of respect as well as an component of opportunity. However, Harper should not forget that Canadian democracy is ultimately driven by the people of Canada. For that reason, I will breathe watching you closely. Scientists will breathe watching you closely. Canadians will breathe watching you closely.

David Ng is a science literacy academic at the Michael Smith Laboratories of the University of British Columbia. He has written essays for the Walrus, humour for McSweeney’s, commentary for Boingboing, and is now trying to learn more about Access to Medicine issues at the My Rights Versus Yours Blog. You can ensue him on twitter @dnghub. If you’re a Canadian reader, he likewise encourages you to check out aidsaction.ca to note that almost every solitary conservatives silent align themselves with substantial Pharma’s stance on Access to Medicine issues. Why not route them an email to design positive they know exactly how you feel?

The Regulatory Strategist Toolbox: Clinical Endpoint Analysis Tools | killexams.com existent questions and Pass4sure dumps

One of the critical parts of assembling a product’s “Strategy Playbook” or “Clinical evolution Plan” is the researching and planning of clinical endpoints. This article discusses how to research endpoints, including tools to research them, how to organize the information and how to present the intelligence back to the team.

Endpoints are measures intended to reflect the effects (efficacy endpoints) or safety (safety endpoints) of a drug or device. They involve assessments of clinical events (e.g., stroke, pulmonary exacerbation, venous thromboembolism), outcomes (e.g., what a final result of treatment long term, mortality, tumor resolution, heal of disease, remission), patient symptoms (e.g., pain, dyspnea, depression), measures of role (e.g., skill to walk or exercise), adverse events or surrogates of these effects or symptoms; clinical outcomes are considered the most trustworthy endpoint.1 One of the critical parts of the assembling either a product’s “Strategy Playbook” or “Clinical evolution Plan” is the researching and planning of endpoints from facet 1 through 3, including navigating through FDA’s understanding and interpretation of the laws and definitions (Table 1). 

Defining Efficacy Endpoints

Defining efficacy and their measurement through endpoints has been a dynamic process since the US 1962 Kefauver Harris Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was the first time a demonstration of efficacy (and endpoints to measure efficacy) was required.2,3 After the amendment, FDA spent the next decade defining, discussing, evolving and defending Sponsors’ lawsuits to arrive at what efficacy expectations should involve (and some suppose the process is silent ongoing).4

Prior to the 1962 Kefauver Harris Amendment:

efficacy was not clearly defined, safety of the product was relied upon

FDA was not involved in the definition of efficacy or claims of efficacy for products

companies would define efficacy (and subsequent endpoints) differently for similar products and both companies would title efficacy of the product

companies let the individual physicians define efficacy and endpoints based on their patient population and topic interpretation (which would breathe combined as case studies into a marketing application resulting in many different endpoints used in the selfsame study).

FDA’s definition and struggles to define efficacy served as a model for other regulatory agencies to adopt and disburse when formally establishing their own efficacy requirements; hence, the US focus in this article, but this information can breathe used in planning global trials with consultation of individual country regulations and guidance.

Why are endpoints needed?

Sound evidence of effectiveness is a crucial component of any regulatory agency’s benefit-risk assessment of a new product or disburse (i.e., a new indication). The necessity for an endpoint to measure the effectiveness of a drug stems from FDA’s necessity for substantial evidence, specifically called for in the 1962 Kefauver Harris Amendment and in 21 CFR 314.50 5.iii.v which requires that a marketing application contain, “data demonstrating substantial evidence of effectiveness for the claimed indications.” Substantial evidence was defined in section 505(d) of the FD&C Act as “evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and taste to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly breathe concluded by such experts that the drug will acquire the outcome it purports or is represented to acquire under the conditions of disburse prescribed, recommended or suggested in the labeling or proposed labeling hereof.”5

An adequate and well controlled (A&WC) study is defined in 21 CFR 314.126.b as a tribulation containing (summarized):

clear statement of objectives

methods of analysis which are adequate to assess the effects of the drug

use of a cogent study design

defined patient population

randomization of patients

minimization of bias

Valid or Accepted Endpoints: the methods of assessment of subjects' response are well-defined and reliable. The protocol for the study and the report of results should complicated the variables measured, the methods of observation and criteria used to assess response.

Clinical Benefit

FDA would dote efficacy endpoints, if not already issued in a guidance document, to incorporate the mantra of “feels, functions or survive” which is collectively defined as clinical benefit. Clinical benefit is a clinically meaningful outcome of an intervention, i.e., a positive outcome on how an individual:

feels (e.g., symptom relief)

functions (e.g., improved mobility, improvement or detain in the progression of a disease or condition)

survives (e.g.,  time in detain to death in comparison to a natural history cohort)

Clinical benefit should breathe meaningful and understandable to prescribers and patients and can breathe measured directly or indirectly (indirect assessment needs justification for its value as a replacement for how patients survive, feel or function).6,7

Clinical benefit Endpoints that acquire supported drug approval acquire included vital clinical outcomes (e.g., increased survival, symptomatic improvement), but likewise acquire included effects on established (validated) surrogate endpoints (e.g., blood pressure, serum cholesterol).8,9

The caveat here is if there is no instrument to measure how a patient “feels” or “functions,” one’s company might necessity to develop and validate a patient reported outcome to capture and measure this.

Table 1. Overview of the practicable Clinical tribulation Endpoints. Term Definition Endpoint

An endpoint is a primary or secondary outcome used to judge the effectiveness of a treatment; it is a precisely defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. Synonyms include: outcome, variable, parameter or marker.

An endpoint typically specifies the ilk of assessments made, the timing of those assessments, the assessment tools used and possibly other details, as applicable, such as how multiple assessments within an individual are to breathe combined.10

An illustration of endpoints are survival, improvements in attribute of life, relief of symptoms and disappearance of the tumor.11

Well-defined and trustworthy (21CFR 314.126)

Appropriate for the target population

Appropriate for the target indication

Adequate measurement properties, e.g., content validity: PRO evolution relies on patient input to champion content validity12

Using conclude points that acquire already been approved by the regulatory authority makes the most sense, but if a new endpoint is being used, then it is necessary to prove that this endpoint is a cogent measure of drug success.

Primary Endpoint Primary endpoints means the outcome or event that most accurately measures the benefit of the therapy/drug/intervention being studied (efficacy); this is the most clinically vital endpoint. This is the main question the sponsor is most interested in answering and one that is capable of being answered (i.e., “Does the intervention alter mortality rates or change baseline blood pressure, the number of deaths, the inequity in survival between the treatment group and the control group, disease progression or death). There is usually only one primary endpoint. Most of every solitary the primary endpoint needs to breathe clinically meaningful and recognized by regulators as being clinically meaningful or confer clinical benefit (for new indications this can breathe a challenge) and should reflect the accepted norms and standards in the apposite domain of research. There should breathe adequate evidence that the primary variable can provide a cogent and trustworthy measure of some clinically apposite and vital treatment benefit in the patient population described by the inclusion and exclusion criteria.13-16 Secondary Endpoint

Typically, secondary endpoints are related to toxicity and undesired effects of the new therapy (safety) or to demonstrate additional effects on the disease or condition. The secondary questions necessity to champion and relate to the primary objective and it used to demonstrate additional effects. For the primary objective of “Does the intervention alter mortality rates?” The secondary objective could glance for antecedent of cardiac death, when death occurred or other cardiac incidents, such as:

coronary heart disease mortality

incidence of nonfatal myocardial infarction

incidence of stroke

reduction is risk factor

Secondary endpoints likewise may provide evidence that a particular mechanism underlies a demonstrated clinical outcome (e.g., a drug for osteoporosis with fractures as the primary endpoint, and improved bone density as a secondary endpoint).17

Positive results on the secondary endpoints can breathe interpreted only if there is first a demonstration of a treatment outcome on the primary endpoint.

Exploratory Exploratory endpoints may involve clinically vital events that are expected to occur too infrequently to prove a treatment outcome or endpoints that for other reasons are thought to breathe less likely to prove an outcome but are included to explore new hypotheses.18 Intermediate Clinical Endpoint In a regulatory context, an endpoint measuring a clinical outcome that can breathe measured earlier than an outcome on Irreversible Morbidity or Mortality (IMM) and that is considered reasonably likely to prognosticate the medical product’s outcome on IMM or other clinical benefit. The intermediate clinical endpoint may breathe a basis for plenary approval if the outcome on the endpoint is considered clinically meaningful. It likewise may breathe a basis for accelerated approval if the IMM outcome is considered critical for disburse of the drug or for expedited access for medical devices intended for unmet medical necessity for life threatening or irreversibly debilitating diseases or conditions. Multiple Primary Endpoints (Co-primary Endpoints)

It may sometimes breathe desirable to disburse more than one primary variable, each of which (or a subset of which) could breathe adequate to cover the sweep of effects of the therapies.19

Multiple endpoints may breathe needed when determining that the drug confers a clinical benefit depends on more than one disease aspect or outcome being affected. Multiple endpoints may likewise breathe used when:

there are several vital aspects of a disease or several ways to assess an vital aspect

there is no consensus about which one will best serve the study purposes

an outcome on any one will breathe adequate as evidence of effectiveness to champion approval

In some cases, multiple aspects of a disease may appropriately breathe combined into a solitary endpoint, but subsequent analysis of the components is generally vital for an adequate understanding of the drug’s effect.20

Multiple primary endpoints become co-primary endpoints when it is necessary to demonstrate an outcome on each of the endpoints to conclude that a drug is effective.

An illustration is treatment of migraine headaches; although ache is the most prominent feature, migraine headaches are likewise often characterized by the presence of photophobia, phonophobia, and nausea, every solitary of which are clinically important.

Composite Endpoints

There are some disorders for which more than one clinical outcome in a clinical tribulation is important, and every solitary outcomes are expected to breathe affected by the treatment.21

Rather than using each as a separate primary endpoint (creating multiplicity) or selecting just one to breathe the primary endpoint and designating the others as secondary endpoints, it may breathe preempt to combine those clinical outcomes into a solitary variable or “composite” endpoint,” using a predefined algorithm (e.g., the rating scales used in arthritis, psychiatric disorders, and elsewhere).  This fashion is different than multiple primary endpoints and useful to study drugs if component events are infrequent and each component is clinically meaningful.22

Composite endpoints are often used when the goal of treatment is to forestall or detain morbid, clinically vital but uncommon events (e.g., disburse of an anti-platelet drug in patients with coronary artery disease to forestall myocardial infarction, stroke and death).

Surrogate Endpoints

When direct assessment of the clinical benefit (or outcomes) to the topic through observing actual clinical efficacy is not practical, indirect criteria may breathe considered. A surrogate endpoint is a laboratory measure or a physical token intended to breathe used as a substitute for a clinically meaningful endpoint and that is reasonably likely to prognosticate clinical benefit (based on epidemiologic, therapeutic, pathophysiologic or other evidence per 21 CFR 314.510). Such surrogates are less well-established than surrogates in regular use, such as blood pressure for stroke, cholesterol for cardiovascular disease or HIV load for evolution of AIDS23 and new surrogates necessity to breathe validated. Relationships between clinical and surrogate variables for one product enact not necessarily apply to a product with a different mode of action for treating the selfsame disease.24,25

From a US regulatory standpoint, surrogate endpoints and potential surrogate endpoints can breathe characterized by the following flat of clinical validation:

validated surrogate endpoint

reasonably likely surrogate endpoint

candidate surrogate endpoint26

A list of novel drugs approved using surrogate endpoints can breathe organize on Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure

Pitfalls of using surrogate endpoints include:

uncertainty about clinical benefit

potential necessity of correlation with outcome variable

lack of standardization or validation through multiple studies

missing long term data

possibility of undiscovered risks

less information about the incident of rare or delayed adverse events27

The flat of evidence necessary to determine whether a surrogate is validated or likely to prognosticate clinical benefit is made on a case by case basis by FDA.28

Reasonably Likely Surrogate Endpoint “An endpoint supported by strong mechanistic and/or epidemiologic rationale such that an outcome on the surrogate endpoint is expected to breathe correlated with an endpoint intended to assess clinical benefit in clinical trials, but without adequate clinical data to prove that it is a validated surrogate endpoint. Such endpoints may breathe used for accelerated approval for drugs and potentially likewise for approval or clearance of medical devices. In the case of accelerated approval for drugs, postmarketing confirmatory trials acquire been required to verify and characterize the anticipated outcome on the irreversible morbidity or mortality or other clinical benefit.”29 Validated Surrogate Endpoint

“An endpoint supported by a clear mechanistic rationale and clinical data providing strong evidence that an outcome on the surrogate endpoint predicts a specific clinical benefit. A validated surrogate endpoint can breathe used to champion marketing approval of a medical or tobacco product in a defined context without the necessity for additional studies to demonstrate the clinical benefit directly. Although the term has been used in a conceptually broader way, from a U. regulatory standpoint, a validated surrogate endpoint almost always refers to a biomarker.”30

Validation information is available on the FDA website.

Biomarkers

“A defined characteristic that is measured as an indicator of ordinary biological processes, pathogenic processes or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives. Categories of biomarkers include:”

susceptibility/risk biomarker

diagnostic biomarker (example: stage a disease)

monitoring biomarker (monitoring a response to therapy)

prognostic biomarker

predictive biomarker (predict a response to a drug)

pharmacodynamic/response biomarker

safety biomarker31

FDA’s Biomarker and Qualification Information

Biomarkers Used as Outcomes List in evolution of Approved Products (2007-2015)

Drug evolution Too Program and Initiatives

What contribution is required from the RI strategist?

Regulatory strategists or intelligence professionals are called upon to back champion the clinical portion of the strategy document or evolution blueprint by laying out the regulatory acceptable endpoints over the course of development. This means the RI strategist will necessity to:

research guidance documents available to understand required endpoints

research global past precedent to understand what the regulatory agency has allowed as primary and secondary endpoints for approved drugs in the selfsame class or indication (if no guidance exists)

If a company is studying a new indication, Key conviction Leaders (KOL) will breathe needed to back form and lead a Scientific Advisory Board (SAB) to back ensure the company is using the most apposite and measurable endpoints.

Endpoints for novel indication will typically forward from literature and vetted with the KOLs and eventually the regulatory agency.

bring KOLs to regulatory meetings; there are typically several meetings with a regulatory agency (and sometimes advisory committee meetings) to gain agreement on novel endpoints

research the literature to understand the criterion of dependence (SOC) in the therapeutic zone across geographical regions

understand the changes in the SOC landscape, i.e., forthcoming changes in treatment paradigms as reported by the KOLs (i.e., what the baseline treatment paradigm is and what upcoming treatments or diagnostics methods are being developed over the next few years that should breathe anticipated and brought into the “Strategy Playbook”)

understand the competitive landscape (i.e., what are the endpoints competitors are using, especially if novel or not the selfsame as in the guidance document, if any)

plan regulatory interactions with regulatory authorities to propose, argue and negotiate endpoints, especially if it is a first in class or a new indication (and again, this is an iterative process and novel endpoint agreement does not usually happen in a solitary meeting)

Some things dote researching KOLs is obvious—you glance at Pubmed or advocacy groups, but where enact you start with the endpoints? And what exactly enact you collect, where enact you find it and what should the presentation back to the team glance like?

Evolution of Endpoints by evolution Phase

Research should breathe performed and information organized according to phases of evolution to ensure a reasonable comparison (Table 2).To breathe able to recommend what endpoints to disburse at what stage, it is vital to understand the evolution of endpoints over the clinical evolution of a product; from a safety accent in early studies to an efficacy endpoint in later studies. Endpoints disagree by indication and change as disease treatment does.

Table 2. Endpoints by Phase Phase of Development Typical Endpoints Phase 1

Safety assessed after solitary and multiple dose administrations:

Adverse Events (AE)

Labs

Physical exam

Pharmacokinetics (PK)

Pharmacodynamic (PD) endpoints

Phase 2A

Safety assessed after solitary and multiple dose administrations:

Adverse Events (AE)

Labs

Physical exam

Pharmacokinetics (PK)

Dosing paradigm established

Exploratory efficacy endpoints used

Phase 2B

Safety assessments:

Adverse Events (AE)

Labs

Physical exam

Metrics used to establish efficacy further tested and refined, unless efficacy endpoints are dictated by a guidance document

Phase 3

Efficacy Endpoints refined in previous trials; divided into primary and secondary endpoints

Exploratory endpoints

Safety assessments:

Adverse Events (AE)

Labs

Physical exam

Endpoint Research Where to Start—Free and Fee Tools

The first halt on any regulatory information gathering mission is to understand what tools are available (free versus fee tools), which ones are available to address a particular question and what each appliance will provide for each piece of the puzzle. Table 3 provides a roadmap for endpoint exploration.

Where to Start Endpoint Analysis Information Blocking

Armed with the needed endpoint information and the tools to find it, the next step is to understand how to “block” the information so that it is usable for the analysis. There is a great morass of data to review and categorize, including literature, global guidance documents, past precedent (if available) and the endpoints of trials currently underway as these acquire typically been vetted (or at least discussed) with the agency for the study being conducted. Table 4 provides information to collect for each endpoint.

Table 4. Endpoint Information Needed to Serve as a Basis for Analysis. Information Needed on Each Endpoint Where to Find it Why Regulatory Precedence and Acceptance

Previous regulatory filings (Drugs@FDA (or similar))

Clinicaltrials.gov listing

Elsevier’s PharmaPendium

Understand if the proposed endpoints will breathe accepted or if you will necessity to labor with regulators to gain their acceptance

Current disburse of Endpoint in Research

Country specific guidance documents

Journal articles

Drugs@FDA (or similar)

Understand what endpoints are being explored as primary, secondary and exploratory endpoints by researchers in the domain as the scientific information could change during the evolution process

What does endpoint really measure?

Journal articles

Drugs@FDA (or similar)

Understand how to measure the indication.  Sometimes endpoints enact not measure what you necessity them to and then you necessity to reevaluate the endpoint

Some endpoints measure what you want, some what you necessity for regulatory requirements and others what you necessity to understand what endpoints most appropriately measure activity in your indication

Positive and negative views on endpoint use

Journal articles

Drugs@FDA (or similar)

What are the pros and cons to using the proposed endpoints? 

Is the scientific information changing and will the endpoints breathe changing over the timeframe? 

Endpoint validated?

Journal articles

Drugs@FDA (or similar)

Is there a new indication that has a new endpoint? 

Is there a new artery to measure an endpoint?

What are the endpoints that acquire been used to measure the indication in the literature by researchers?

What is the acceptance or perception of the endpoints by regulators?

What labor will the sponsor necessity to conduct to validate the endpoint?

Does validation necessity to breathe done prior to disburse in a study or during the conduct of the study?

Will a patient reported outcome breathe needed or created?

Inclusion/Exclusion Population

Journal articles

Drugs@FDA (or similar)

Elsevier’s PharmaPendium

Country specific guidance documents

The indication and patient population is defined by the study’s inclusion and exclusion criteria; this needs to breathe defined carefully as it will impress the outcome of the evolution program

Only the endpoints that are used most frequently or acquire past regulatory precedence should acquire an in-depth analysis conducted; every solitary other should breathe elevated flat reporting until the team agrees more analysis is needed. Once the information is acquired to define the output, which can disagree vastly depending on the free or fee tools used, start constructing the output.

Endpoint Analysis Steps for Information Gathering and Initial Analysis Endpoint Analysis: Free

Go to drugs.com and find out what other drugs are in the selfsame class and/or indication; utilize in house expertise as well to back refine the list

Add drug names to list in an outdo spreadsheet

Cull endpoint information initially from the label—cannot find the label in drugs.com or Drugs@FDA? depart to the FDA Online Label Repository where labels are archived

Refine list, if in oncology, with the back of NIC databases (Cancer Drug Approval Endpoints, Efficacy Endpoints in Oncology Clinical Trials)

Research available global guidance documents in indication (Intelligence Tools, Links and Resources); cull endpoints recommendation into outdo spreadsheet

Pull the Summary Basis of Approvals (Intelligence Tools, Links and Resources) in the countries of choice based on research

Pull out the endpoints used for every solitary past precedent drug into an outdo worksheet by facet of development

From the medical or administrative section (with meeting minutes), cull information on endpoints discussions and issues with it such as necessity of validation

Research current clinical trials being conducted in a clinical tribulation registry for both the indication and class of drugs; add these to the growing spreadsheet (Table 5) (sometimes it helps to enact this step first prior to every solitary other activities):

Further refine the search by facet of evolution and download just the trials in facet 1, facet 2, etc., and review those items

Look at map of countries and the location of sites being used in the studies

Look at synonyms for the disease and review other trials possibly associated with the selfsame disease, but called by a different name

Organize by drug name, stage of evolution and endpoints

Research the following literature on PubMed:

recent trials in the indication and endpoints used

SOC

Evolution in changes in the SOC

KOLs

Download/purchase literature for in-depth review

Utilize indication specific (if any) advocacy groups to back refine current endpoints being used by KOLs or to back provide a literature jumping off point; this can breathe done through an SAB or one on one meetings

Analyze the list of endpoints, what are the typical endpoints used, what are the least typical and enact a abysmal dive into the endpoints used most often so there is greater clarity on them for team discussion.

Put in a format to present the findings to the evolution team, for group discussion (Table 5) and rate from most frequently used, least used and emerging endpoints

This list needs to breathe reviewed with the Strategy Team and further refined as the Playbook is developed (i.e., this process might necessity to breathe used a few times and vetted with experts and the regulators).

Table 5. Clinicaltrials.gov Output Into Excel.* Title Conditions Interventions Study Designs Outcome Measures Phases Enrollment and Study Type MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma Merkel Cell Carcinoma Drug: MLN0128

Intervention Model: solitary Group

Assignment

Masking: not anyone (Open Label)

Primary Purpose: Treatment

Maximum Tolerated Dose (MTD)

Overall Response Rate (ORR)

Overall Survival (OS)

Progression-Free Survival (PFS)

Adverse Events (AEs)

Response Biomarkers, including p4EBP1, PSK6, pCAD and Merkel cell polyomavirus (MCV)

Large T antigen (LT) and minute T antigen (ST)

Phase 1

Phase 2

34

Interventional

F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma Merkel Cell Carcinoma

Drug: Arm A: F16IL2 in combination with paclitaxel

Drug: Arm B: Paclitaxel

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: not anyone (Open Label)

Primary Purpose: Treatment

Efficacy of F16IL2 in combination with paclitaxel vs. paclitaxel monotherapy (RECIST v1.1, irRC)

Overall survival rate

Treatment efficacy (ORR, DCR)

Safety and tolerability of the combination treatment with F16IL2 and paclitaxel

Phase 2

90

Interventional

A Proof-of-Concept tribulation of GLA-SE in Patients With Merkel Cell Carcinoma Merkel Cell Carcinoma Biological: GLA-SE

Intervention Model: solitary Group Assignment

Masking: not anyone (Open Label)

Primary Purpose: Treatment

Safety and feasibility

Clinical efficacy and immunogenicity

Phase 1

10

Interventional

Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies Versus Observation Merkel Cell Carcinoma

Drug: Ipilimumab

Drug: Nivolumab

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: not anyone (Open Label)

Primary Purpose: Treatment

Disease-free survival (DFS) at 12 months

Number of adverse events

Overall survival rate at 12 months

DFS rate at 12 months

Phase 2

177

Interventional

Study of the Drug Ipilimumab for Metastatic Merkel Cell Carcinoma Merkel Cell Carcinoma Drug: Ipilimumab

Allocation: Non-Randomized

Intervention Model: solitary Group Assignment

Masking: not anyone (Open Label)

Primary Purpose: Treatment

Overall survival at 12 months with ipilimumab treatment

Determine the best overall response rate, median survival, disease-specific survival and progression free survival

Determine median survival, disease-specific survival and progression nfree survival

Phase 2

0

Interventional

QUILT-3.009: Study of aNK Infusions in Combination With ALT-803 in Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)

Stage IIIB Merkel Cell Carcinoma

Stage IV Merkel Cell Carcinoma

Biological: aNK (NK-92)

Intervention Model: solitary Group Assignment

Masking: not anyone (Open Label)

Primary Purpose: Treatment

Progression Free Survival

Overall Response Rate

Time to disease progression

Overall survival

Safety and tolerability of aNK in combination with ALT-803

Quality of life assessment

Phase 2

24

Interventional

*Need to Specify Fields to Download. Endpoint Analysis: Fee Figure 1. Organized Endpoint Output for BizInt Smart Charts (Combined Output from a Variety of Clinical Registries).

Go to PharmaPendium, input the indication and class as search terms, cull results for a list of drugs approved for indication and class and endpoints in medical reviews; utilize in house expertise to back refine the list; outcome results into an outdo spreadsheet

Pull out the endpoints used for every solitary past precedent drug into an outdo worksheet, by facet of development

From the medical or administrative section (with meeting minutes) cull information on endpoints discussions and issues with it such as necessity of validation

Research available global guidance documents in indication; cull endpoints recommendation into outdo spreadsheet using Tarius or Clarivate Analytics Cortellis

Ask Nerac to conduct a literature search for you looking at SOC, KOLs, emerging treatments and endpoints used for indication

Or put a question to a Librarian to conduct the literature search for you

Ask librarian or literature search service to download/obtain literature

Review and outcome results into an outdo spreadsheet

Analyze the list of endpoints, outcome in a format to present your findings to the evolution team, for group discussion

Regulatory Pathway Dictated by ilk of Endpoint Used

Something to withhold in irony when finalizing and incorporating endpoints into a strategy, the ilk of endpoint selected can impose the regulatory approval pathway that needs to breathe followed. Review Table 6 to ensure alignment with regulatory expectations.

Table 6. Endpoints and Predicted Regulatory Pathway. Type of Endpoint What it Does Regulatory Pathway Clinical Benefit How a patient feels, functions or survives Regular* Validated Surrogate Recognized as validated through multiple definitive studies Regular* Surrogate Reasonably likely to prognosticate clinical benefit Accelerated Approval *Could breathe accelerated or priority review based on the unmet medical necessity or seriousness of indication.32

Communicating the Data Back to the Stakeholders

Once the needed information is available to define the output, which can disagree vastly depending on the free or fee tools used and the specific indication, start constructing the output and understand what is needed for the output. One of the biggest issues in analyzing data, since it is so onerous, is the presentation back to the team and deciding the most efficient form is should take. On the backend, there is a lot of data that needs to breathe cleaned, merged or manually manipulated and since it is disparate, it can breathe very difficult to summarize, especially endpoints. Most teams want a high-level analysis that is interactive so as to reply immediate questions and an outdo spreadsheet does not acquire visual appeal; this is where a “fee” product really is helpful in presenting a brightly colorful and interactive output.

Case Study—Merkle Cell Carcinoma

The following case study discusses the indication of the rare disease Merkle Cell Carcinoma (MCC) and demonstrates how to outcome the above information into practice. Note: only one drug has been approved for this indication [BAVENCIO [AVELUMAB]] (approved 23 March 2017).

New Regulatory Intelligence Tool

BizInt Smart Charts Drug evolution Suite is purpose-built software designed to facilitate creating, customizing and distributing tabular reports from selected clinical trial, drug pipeline and biomedical journal databases. Reflecting more than 20 years of feedback from users in pharmaceutical and biotech companies, it replaces the necessity to write complicated macros and manually exploit data in outdo and Word. Data from supported databases (see below) is imported and formatted into tables, and the fields/columns included in your report can breathe changed at any time. BizInt Smart Charts automatically identifies the selfsame tribulation across different databases and the selfsame drug across pipeline databases and has tools to merge different database records on the selfsame tribulation into a solitary integrated row in your report.

A second tool, VantagePoint - Smart Charts Edition, has the skill to further refine the data, extract terms and create visualizations for PowerPoint presentations. Table 7 provides an overview of the databases that BizInt Smart Charts can pull from to back compile endpoint information.

Table 7. BizInt Smart Charts Drug evolution Suite—Supported Databases. Supported Clinical tribulation Databases Supported Pipeline Databases Supported Biomedical Journal Databases

Registry:Clinical Trials.govEU Clinical Trials RegistryWHO ICTRP

Commercial:Citeline TrialtroveAdis Clinical Trials InsightCortellis Clinical Trials

Citeline PharmaprojectsClarivate Analytics CortellisIMS R&D FocusAdis R&D InsightClarivate Integrity

Medline/PubMedBIOSISEMBASE

BizInt Smart Charts was used to collect endpoint information from a variety of Clinical tribulation Registries for MCC and this was compared with the collection and analysis times done without the appliance (Table 8).  Overwhelmingly, the appliance shaved more than 100 hours off of the assignment at hand (two weeks of work.)

Table 8: Mining Clinical tribulation Registry Data for Endpoints—Time Comparison of the Free and For Fee Tools Steps Taken Tools Used Free Time Fee Time Search databases for “Merkle Cell Carcinoma” and download results to outdo spreadsheet

WHO—ICTRP Search Portal

Drugs@FDA Database

10 min 10 min

Open up the spreadsheets and combine the trials

Google Worksheets

MS Excel

5 min

(Figure 1)

2 min

Go through and remove the duplicates and/or merge the information for the selfsame trials listed in multiple databases

Google Worksheets

MS Excel

100+ min 5 min

Delete or scamper around fields so that pertinent information is displayed in first few rows

Hide rows so that they are silent available but not distracting your analysis

Google Worksheets

MS Excel

45+ min 20

Analyze what is pertinent to your program to breathe able to design recommendations to the team

Brain power and experience

200+ min

Brain power and experience

200+ min

Put together the information in a artery easily incorporated into the Strategy Playbook

Google Worksheets

MS Excel

60+ min

PowerPoint

BizInt Smart Charts

30 min

Put together information in a PowerPoint slide for presentation to the team

Google Worksheets

MS Excel

PowerPoint

60+ min

PowerPoint

BizInt Smart Charts

30 min Total Time 480+ min ~297 min Case Study Conclusion

Overall, while some of the steps are the same, the fee tools enact provide quicker information output which can lead to quicker analysis and feedback to the team. BizInt Smart Charts and VantagePoint significantly reduce down on the time it took to research endpoints making the time to respond to the team quicker and the output visually pleasing (which would acquire taken a lot longer to achieve manually) and interactive, which really worked well for the team and because questions were able to breathe answered on the spot versus looking through a pile of notes. 

Summary

As a parting note, bethink the “Strategy Playbook” must breathe reviewed on an annual basis as scientific data and the requirements for a program change over time, so keeping complete notes and output are vital to back evaluate data as it evolves.

References

Multiple Endpoints in Clinical Trials. Guidance for Industry. January 2017. FDA website https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm536750.pdf. Accessed 21 September 2018.

Federal Food, Drug, and Cosmetic Act (FD&C). FDA website. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/default.htm. Accessed 21 September 2018.

Kefauver-Harris Amendments Revolutionized Drug Development. FDA website. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm322856.htm. Accessed 21 September 2018.

Carpenter D. Reputation and Power. Organizational Image and Pharmaceutical Regulation at the FDA. Princeton University Press. https://press.princeton.edu/titles/9205.html. Accessed 21 September 2018.

Guidance for Industry. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. May 1998. FDA website. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072008.pdf. Accessed 21 September 2018.

BEST (Biomarkers, EndpointS, and other Tools) Resource. May 2018. FDA-NIH Biomarker Working Group. https://www.ncbi.nlm.nih.gov/books/NBK326791/pdf/Bookshelf_NBK326791.pdf. Accessed 21 September 2018.

Defining Clinical benefit in Clinical Trials: FDA Perspective. Presentation by Jessica J. Lee, MD, MMSc. https://celiac.org/wp/wp-content/uploads/2015/04/great3-07.pdf. Accessed 21 September 2018.

Guidance for Industry. Clinical tribulation Endpoints for the Approval of Cancer Drugs and Biologics. May 2007. FDA website. https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf. Accessed 21 September 2018.

FDA Facts: Biomarkers and Surrogate Endpoints. FDA website. https://www.fda.gov/aboutfda/innovation/ucm512503.htm. Accessed 21 September 2018.

Op cit 6.

National Cancer Institute (NCI) Dictionary of Cancer Terms. NCI website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/endpoint. Accessed 22 September 2018.

Measuring How Patients Feel and Function. Presentation by Michelle Campbell, PhD. Roadmap to Engaging CDER Public Workshop. May 2017. FDA website. https://www.fda.gov/downloads/Drugs/NewsEvents/UCM558288.pdf. Accessed 22 September 2018.

Op cit 11.

HIV/AIDS Glossary. Clinical Endpoint. https://aidsinfo.nih.gov/understanding-hiv-aids/glossary/840/clinical-endpoint . Accessed 22 September 2018.

Op cit 1.

Guidance for Industry. E9 Statistical Principles for Clinical Trials. September 1998. FDA website.  https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf . Accessed 22 September 2018.

Op cit 1.

Op cit 1.

Op cit 16.

Op cit 1.

Op cit 1.

Op cit 16.

Op cit 9.

Op cit 16.

Clinical tribulation Endpoints. Presentation by Eugene J. Sullivan, MD FCCP. FDA website. https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337268.pdf. Accessed 23 September 2018.

Op cit 6.

FDA Regulatory Considerations for NASH Clinical tribulation Endpoints. Presentation by Stephanie O. Omokaro, PhD. Global NASH Congress. https://www.slideshare.net/JaneWilliams25/fda-regulatory-considerations-for-nash-clinical-trial-endpoints

Sanyal AJ, Friedman SL, McCullough AJ  and Dimick-Santos L. “Challenges and Opportunities in Drug and Biomarker evolution for Nonalcoholic Steatohepatitis.” Findings and recommendations from an American Association for the Study of Liver Diseases and FDA  Joint Workshop. https://www.ncbi.nlm.nih.gov/pubmed/25557690. Accessed 23September 2018.

Op cit 6.

Op cit 6.

Op cit 6.

Op cit 27.

About the Author

Meredith Brown-Tuttle, RAC, FRAPS, is the principal consultant for Regulatorium, a company specializing in regulatory intelligence, writing and strategy. She is the author of IND Submissions: A Primer, published by Barnett, Regulatory Intelligence 101, published by RAPS, numerous articles and serves as chair of the RAPS Editorial Advisory Committee. She can breathe reached at theregulatorium@gmail.com.

Cite as: Brown-Tuttle M. “The Regulatory Strategist Toolbox: Clinical Endpoint Analysis Tools.” Regulatory Focus. September 2018. Regulatory Affairs Professionals Society.

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