Cloud Hosting

Best listening experience is on Chrome, Firefox or Safari. Subscribe to Federal Drives daily audio interviews onApple PodcastsorPodcastOne.

One might be surprised to learn the FBI has opened more than two dozen grand jury investigations this year alone related to federal contracting fraud. Its Procurement Collusion Strike Force is using some up to date techniques like data mining for contractors honest ones, that is it all means the need for strong compliance programs. For more,Federal Drive with Tom Temin spoke to Jon Jacobs and Alex Canizares, partner and senior counsel, respectively, from the law firm Perkins Coie.

Tom Temin: And lets begin at the beginning here, and tell me a little bit about this phenomenon of contracting fraud. Is this mostly something that happens with collusion among contractors? Or is it something that happens between the government and contractors as a rule?

Jon Jacobs:Yeah, the kind of fraud were talking about here, Tom, is contractor-to-contractor collusion. So what the Strike Force is focusing on is bid rigging, price fixing or market allocation among contractors who are bidding for federal contracts. They will get together beforehand, and they will decide who is going to win a particular bid, the one whos going to submit a higher or complimentary bid will know what the prearranged winner is going to bid. And so its all set up so competition is eliminated. The agency, the federal government is not involved. So this is very different than say kickbacks to federal contractors in order to steer contracts a certain way.

Tom Temin:Sure. And then I guess, for the contractors involved, the ones who agree to lose then get some sort of consideration, I guess, for the winners in general?

Jon Jacobs:They do. These bid-rigging conspiracies are often set up so that if Alex and I are the two natural bidders for a contract, well get together and Ill say, Alex, let me have this one, please bid above this certain price, and the next ones yours.

Tom Temin:And I guess the question is, how often does this happen? I mean, theres a couple of dozen out of what 15- 20,000 contracting actions a year and 2,000 of them roughly are protested. I mean, this is a big business. So I guess Im asking in general, is the system in the United States corruption-free with exceptions? Or is it tend to be maybe the noncorrupt ones are the exceptions?

Alex Canizares: According to the FBI, which issued a report in March of this year, this is a significant issue. They cite a study that says that about 20% of procurement is tainted by some sort of bid rigging. And whether or not that study is true, if you think about $500 billion-plus of federal procurement activity every year, this is something that is going to have a significant impact. And this Procurement Collusion Strike Force recognizes that, kind of renews the focus that the law enforcement community has.

Tom Temin:By the way, your numbers a little out of date during the pandemic, it was more like $639 billion. So theres a lot of room for collusion I guess, drug companies and mask companies or whatever. And is it generally more on to the extent we know, on the DoD side or the civilian side?

Alex Canizares:Well, its really everything. I mean, I think the areas of focus for this particular Interagency Task Force include Defense. There was just another indictment announced last week in the Defense context, but also health care. And you mentioned the pandemic, and I think the significant increase in federal spending and response to the pandemic heightens the concern. And its not specific to COVID but if you think about infrastructure, thats another area I think well see renewed focus on, especially with talks underway about increased spending on transportation and infrastructure. But really, its not agency-specific, its not just DoD. These are many, many law enforcement agencies, and inspectors general and different agencies that are now on heightened alert for this issue.

Tom Temin:And, Jon, you did have experience in the Justice Department earlier in your career. Is there any clue that a contracting officer can discern that might tip him or her off that somethings un-kosher going on here?

Jon Jacobs:Yes. And actually, the Antitrust Division as a part of this new initiative has published the so-called red flags of collusion on their website. And the red flags are designed for contracting officers to know what to look for. Its not completely comprehensive, but some of the examples are, are there a small number of bidders for this particular kind of contract? Because obviously, its easier to collude if you dont have a large number. Are there similar-looking bid proposals? Is there similar handwriting, similar typographical errors? Does it look like the different bids were prepared by the same person because believe it or not, sometimes these conspirators arent careful enough. And its very suspicious when you lay them all out in the table. And then take a look at the patterns not only the prices, but the patterns of winning. As I said before, the way these bid rigging conspiracies usually work is, if Alex and I are supposedly competing, were rotating. And so if it looks like Alex is winning about 50%, Im winning about 50% thats a red flag.

Tom Temin:Sounds like high school construction contract. Were speaking with Jon Jacobs and Alex Canizares. They are partner and senior counsel at the law firm Perkins Coie. And tell us more about the FBI task force. Its an interagency affair. Whos involved and maybe a little bit about the data mining and data experts theyve gotten on board?

Alex Canizares:Well, its not just the FBI, its actually led by the Antitrust Division within the Department of Justice. FBI is a principal law enforcement agency thats involved. But youve actually got a total of 29 either U.S. attorneys offices or agencies, and that includes the inspectors general who already have their own oversight function looking for this sort of conduct. I do want to mention one aspect of the red flags, which is important here, too, which is contracting officers that conduct competitive procurements are already required by statute and regulation to be on the lookout for this sort of antitrust activity. And so when they are reviewing contract proposals in a procurement, theyre already supposed to notify the Department of Justice for this sort of thing. What this particular task force does, is really two things. One is bring new cases. And the other part is really bring about more awareness, educate people, and train people, and theyve done a significant amount of training in that regard.

Tom Temin:Alright, so lets get to some of the advice your law firm has put forth for contractors that dont want to be seen as doing this. And also, I guess theres the situation where it could occur because of some employees, but you can protect the corporation, even if those people get punished and go to jail somehow. So what should contractors do to stay out of this?

Jon Jacobs:Yeah, the very first thing I would advise is to update your compliance program. That is particularly important for avoiding any kind of antitrust offense and particularly recently, given some DOJ guidance, and theres at least a couple of reasons for this. I mentioned the so-called leniency program and then Alex, maybe you can describe the recent availability of deferred prosecution agreements that are available to those with otherwise effective compliance programs. So the Antitrust Division has a leniency program. And what that is, is if you are the very first individual or company to notify the Antitrust Division of a conspiracy that it has not heard about before, you get complete immunity. You will not be charged, you wont be fined, your executives wont go to jail. Remember, the antitrust laws do involve jail terms, potentially, for executives that participate in this activity. Now, youre still going to have to cooperate and that can be quite an effort. Youre going to have to hire a lawyer, unfortunately, youre going to have to proffer your facts of your internal investigation, youre going to have to produce documents and make your executives available for an interview with the criminal prosecutors. But its also available only for the first to contact the DOJ. There is a race for leniency. So its important if you see something right away, say something.

Tom Temin:Is there, by the way, any qui tam possibility for someone that might be lower down in the company that blows the whistle on this?

Jon Jacobs:There absolutely is and some of my criminal cases started with a qui tam complaint.

Tom Temin:Got it, okay and what else?

Alex Canizares:Well, one of the things that contractors can really do to kind of mitigate the risk of this sort of enforcement activity is to, as Jon says, build a robust compliance program, have those internal controls in place, but also be specifically aware of the risks that the DOJ is looking at. These same red flags of collusion are things that companies within their own company can sensitize their employees to. Thats the procurement folks, thats the people who are doing the business development and that sort of thing. And it also means having a very specific reporting mechanism. So if people see something, they can bring it to the attention of the appropriate person. The False Claims Act, in terms of qui tam is another aspect of this. Its not particularly within the purview of this program. But its certainly reasonable to expect that if people are identifying potential fraudulent activity that could result in a False Claims Act matter.

Tom Temin:Alright, and a couple of lightning round questions here at the end, does this tend to be as far as you can tell more in the services or in the products acquisition area?

Alex Canizares:I would say its not limited to either one. I think that the areas that were looking at now, in terms of recent announcements, we had one very recently in the infrastructure sector that was more service oriented. But really, I think theres likely to be cases on both sides of that fence.

Tom Temin:And the second question is, more and more contracting dollars are going through government wide acquisition contracts as GWACs as task orders, as opposed to full an open. And so is it more an occurrence in full and open competition, or do you find it in the GWAC task orders also?

Alex Canizares:Its an interesting question. I dont think its off the table in terms of a GWAC context. I mean, as you say, there are situations and its not limited to the GWACs but where sole source contracting is perfectly permissible. The concern in this particular area is where competition is required. And I think thats where companies, particularly if theyre engaged in teaming arrangements, need to be very sensitized to what the risks are.

Tom Temin:Alex Canizares is senior counsel at the law firm Perkins Coie, thanks so much.

Alex Canizares:Thank you.

Tom Temin:And Jon Jacobs is a partner there. Thank you very much.

Jon Jacobs: Thank you, Tom.

Go here to read the rest:

Federal procurement fraud occurs more often than you might think - Federal News Network

On June 28, shares ofCel-Sci (NYSEMKT:CVM) plunged nearly 70% peak-to-trough before recovering. The reason behind the wild price action couldn't be more obvious -- the company's pivotal phase 3 study involving its Multikine immunotherapy did not meet its primary endpoint of improving the overall survival (OS) of head and neck cancer patients.

Cel-Sci had been extremely popular among traders of the r/WallStreetBets community due to its short interest -- standing as high as 24% before the data release. The stock also has a cult following outside of that. There is even a website with detailed instructions on how to make short-sellers cover all of their bets. Is there any hope left for shareholders?

Image source: Getty Images.

Unfortunately (or rather, fortunately, depending on the lens one looks through), it looks like the shorts have won, and the hunters have now become the hunted. Despite the clinical trial lasting 9.5 years, Multikine was unable to demonstrate a 10% benefit in improving patients' OS.

This is the company's flagship drug candidate. Cel-Sci has no product revenues and only around $50 million in liquid assets. By all measures, the stock should be going to zero after the plunge from its $1 billion market cap before the data readout.

It took over a year for results to come out after the trial finished. In retrospect, that gave the company ample time to data-mine and look for "potential" therapeutic signals.

Via a post-hoc subgroup analysis, the company uncovered that patients who received Multikine followed by surgery and radiotherapy, but not chemotherapy, had an OS improvement of 14.1% after five years, compared to those who just received surgery and radiotherapy. The survival benefit disappeared after accounting for patients who also received chemotherapy. Based on this, the company anticipates that it can meet regulatory requirements for a Biologics Licensing Application (BLA) submission.

If the data mining here seems confusing, consider this analogy. A political candidate lost in the midterm elections. Instead of acknowledging defeat, he instead cites data from one sub-district that overwhelmingly voted for him as evidence that he actually "won."

Let's think about Cel-Sci's story for a minute. Its plan to seek approval for Multikine effectively suggests that patients would need to forgo chemotherapy for Multikine to have a significant effect. I do not think that the U.S. Food and Drug Administration (FDA) could ever approve a drug based on such a scheme, but Cel-Sci is going ahead with its FDA filing anyway.

The stock has attracted a huge meme following, and it has not tanked to single digits after the disappointing data readout. Some investors probably moved all-in and are hoping for a good river card (the FDA submission) to complete a busted hand (reverse their fortunes).

At this point, however, it's almost a given that Multikine will go nowhere. The data says it all. In addition, while the Multikine trial was still ongoing, next-generation immunotherapy checkpoint inhibitors like Opdivo and Keytruda entered the market. In the case of the former, it reduced the risk of death in patients with head and neck cancer by 30%. On a side note, it did not take a decade for Opdivo to achieve that efficacy. All of this makes it pretty clear that for investors thinking about the long term, Cel-Sci is a biotech to avoid.

This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

Read more from the original source:

Will All End Well for This Popular Reddit Biotech? - Motley Fool

This article was originally published here

Cell Death Dis. 2021 Jul 1;12(7):661. doi: 10.1038/s41419-021-03947-7.

ABSTRACT

Bladder cancer is one of the most common malignant tumors in the urinary system. The development and improvement of treatment efficiency require the deepening of the understanding of its molecular mechanism. This study investigated the role of ALPK2, which is rarely studied in malignant tumors, in the development of bladder cancer. Our results showed the upregulation of ALPK2 in bladder cancer, and data mining of TCGA database showed the association between ALPK2 and pathological parameters of patients with bladder cancer. In vitro and in vivo experiments demonstrated that knockdown of ALPK2 could inhibit bladder cancer development through regulating cell proliferation, cell apoptosis, and cell migration. Additionally, DEPDC1A is identified as a potential downstream of ALPK2 with direct interaction, whose overexpression/downregulation can inhibit/promote the malignant behavioral of bladder cancer cells. Moreover, the overexpression of DEPDC1A can rescue the inhibitory effects of ALPK2 knockdown on bladder cancer. In conclusion, ALPK2 exerts a cancer-promoting role in the development of bladder cancer by regulating DEPDC1A, which may become a promising target to improve the treatment strategy of bladder cancer.

PMID:34210956 | DOI:10.1038/s41419-021-03947-7

See the rest here:

ALPK2 acts as tumor promotor in development of bladder cancer through targeting DEPDC1A - DocWire News

Increasingly, companies are looking to adopt smart technologies to optimise production and decision-making in order to create businesses of the future. However, as reliance on autonomous and digital technology grows, so too does the risk of cyber-attacks, says professional services firm PwC.

As technologies become more interconnected, the potential cybersecurity threats and attack vectors are growing. The consequences of these threats can be severe, resulting in production and revenue losses, regulatory fines, reputational damage, as well as the shutdown of critical infrastructures.

This has been further compounded by the complexities and uptake of smart systems that use advanced technologies such as machine learning and the Internet of Things (IoT).

Termed Smart Manufacturing/Smart Mining, South African industry leaders recognise that the terms encompass everything from Artificial Intelligence (AI) to robotics and cyber-security.

PwC said it has issued a point of view on emerging cyber threats in the mining and manufacturing industries. The document focuses on emerging cyber threats affecting these sectors, with a focus on South African and other Africa-based organisations.

Although there are considerable benefits in the convergence of these advanced technological systems and the operational technology that makes up the backbone of the sectors, it is important to note that the reliance on such connected and internet-dependent systems is not without its own risks, PwC pointed out.

Junaid Amra, PwC Forensics Technology Solutions Leader said: Organisations in the manufacturing and mining sectors face a myriad of different cyber threats. A number of organisations have not been paying enough attention to these threats. They are also not prioritising the implementation of the appropriate mitigation strategies, whilst threat actors are starting to take an interest in organisations operating in this space.

Due to the increasing level of technology adoption, the consequences of attacks on organisations in these sectors can be far-reaching and potentially devastating. It is therefore important for businesses to understand key risk areas, attack vectors and vulnerabilities to ensure that they employ the correct controls to improve security and protect their assets.

The technologies most targeted by attackers within these sectors are Industrial Control Systems (ICS). ICS are embedded computing devices that are responsible for a myriad of automated process controls in industries (e.g., measuring instruments, packaging machinery and all other components of an assembly line that make parts of any production process.

The Covid-19 pandemic has further exacerbated the problem of cyber-attacks. According to international research, there was an uptake in intrusion activity in the manufacturing sector in 2020, as well as several cybersecurity incidents in some countrys mining and resources sectors, said Amra.

PwCs paper highlights the different threats to ICS technologies and the profiles of the actors perpetrating these attacks. It also focuses on notable incidents to help demonstrate the complexity and subsequent impact of ICS attacks.

Attacker tactics, techniques and procedures

PwCs global Threat Intelligence practice recognises four types of motivations driving attackers, namely espionage, hacktivism, terrorism/sabotage and organised crime. There are also a range of different tactics, techniques and procedures used by each attacker.

This not only determines the impact of each attack but also the means by which organisations get targeted and subsequently compromised. It is also notable that insiders can be part of any threat group, PwC said.

Organisations who are mindful that a security breach can take several different forms and originate from several different places are in a better position to imagine ways of implementing the correct defences.

It is important to note that local regulator stipulations and disclosure laws play a major role in the number of incidents that are reported and, as a by-product, known to the public.

Motivation

Espionage has been growing as one of the driving forces behind cyber-attacks in the manufacturing industry. Cyber-criminals gain access to the networks of businesses in the sectors with the aim of stealing trade secrets and intellectual property.

However, our research revealed that although in 2020 there was a notable uptick of espionage-motivated incidents as compared to the same period last year, most of the attacks have predominantly been financially motivated (63-95%).

We have also drawn on our experience conducting cyber-security assessments and penetration tests from across our global network to identify the most common security vulnerabilities in OT/ICS networks.

The most common attacks identified by PwCs incident response teams over 2019 and 2020 were: infiltration of insecure email platforms following cloud adoption; phishing; and insecure remote access platforms (VPN, remote login), PwC said.

Ransomware

Once attackers have a foothold in an organisation, the tools and tactics used by them are usually designed to monetise their attacks by the simplest means possible. An example is ransomware, which is a type of malicious software (malware) that holds your systems or data to ransom.

Globally, PwC has tracked ransomware attacks across various industries for 2020. Of these, 17% affected the manufacturing sector but no data appears to have been advertised from the mining sector.

Based on our experience, the nature of attacks in the mining sector have largely been focused on electronic payment fraud, industrial espionage and sabotage. Data available for the African continent is limited, however, we believe this to be a representation of how susceptible African organisations in the sectors are to these types of attacks, PwC said.

Potential impact

Cyber-attacks are becoming more pronounced as technology is embedded in operational processes. Apart from the loss of data and intellectual property, the risk to the core business operations becomes heightened and could lead to severe disruption through cyber-attacks.

In addition, safety, health, environmental and quality (SHEQ) systems could also be affected as there is a growing dependence on smart devices to support these processes and functions.

Organisations in the mining and manufacturing sectors need to embed a safety culture against potential cyber-attacks organisations should have plans and processes in place to prevent, respond and recover from a potential cyber-attack. The likelihood and consequences of a cyber-attack should not be downplayed, said Amra.

Read: What 2021 holds for cybersecurity in South Africa

Read more from the original source:

Cyber threats on the rise in these industries in South Africa - BusinessTech