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What regulatory challenges are facing the life sciences sector?

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William Fry’s Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the line.

Click here to view the full Life Sciences Week series.

The last year has seen a massive acceleration when it comes to digital transformation and the life sciences industry is not immune.

From game-changing technologies within the healthcare sector to the increased demand for telemedicine, there are plenty of ways digitisation is improving the industry as a whole.

Charleen O’Keeffe, a partner in William Fry’s life sciences group, spoke to Siliconrepublic.com about some of these trends in more detail. She said along with digitisation, there is also a move towards non-pharmacological intervention, the use of devices to screen for diseases and changes to the medicines themselves.

“We are seeing a shift away from the one-size-fits-all approach to personalised, individualised medicines. We’re seeing development of advanced therapy medicinal products, particularly gene and cell therapies.”

While the advancements herald positive moves for the sector, O’Keeffe warned about regulations and policies that are likely to affect the world of life sciences.

“The industry’s future is likely to be shaped in some form by the European Commission’s recently published pharmaceutical strategy,” she said.

“One of the key drivers of the strategy is to ensure access for affordable medicines for all patients and also to address unmet medical needs, particularly in the areas of antimicrobial resistance and rare diseases.”

O’Keeffe also said that life sciences companies are facing the full implementation of clinical trials regulation as well as compliance with GDPR against the backdrop of “an increased appetite from European regulators to enforce the GDPR”.

She added that, as with many other industries, the life sciences sector must contend with changing consumer behaviour, accelerated technologies and cyberattacks.

Medtech challenges

More specifically to the medtech sector, O’Keeffe highlighted the imminent Medical Device Regulation (MDR), which is due to become fully applicable from next month, and the In-vitro Diagnostic Medical Devices Regulation (IVDR), which will come into effect in 2022.

There’s two big changes under the MDR. Firstly it brings all economic operators in the supply chain within its scope and it broadens the range of devices under its remit,” she said.

“From our clients’ perspective, one of the key challenges is that it has mandated a full review of their intra-group agreements and also their upstream and downstream third-party agreements. They’ve also had to do a full review of their product portfolio to ensure compliance with the MDR.”

On a broader scale, the increased number of medical devices that will require mandatory conformity assessment along with the low rate of approval of notified bodies may result in “bottleneck and a shortage of supply of products onto the market”.

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Agtech start-up tackling emissions gets backing from Bill Gates’ fund

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Iron Ox aims to reduce the carbon footprint of farming using robotics and AI.

Silicon Valley agtech start-up Iron Ox has secured $53m in Series C funding led by Breakthrough Energy Ventures.

Founded in 2015, Iron Ox has now raised $98m to date for its autonomous farming technologies.

The ultimate goal for Iron Ox is to rebuild the agricultural model so that fruit and veg can be produced locally and sustainably with a lower carbon footprint. Using robotics and AI to support a data-driven approach to farming, Iron Ox claims to create 30 times more produce per acre using 90pc less water than conventional field farms.

Food from its farms in northern California can be purchased in stores across the San Francisco Bay area, and the company expects to further its reach later this year after breaking ground on a new 535,000 sq ft indoor farm in Texas.

Existing investors in Iron Ox include Crosslink Capital, R7 Partners, Amplify Partners and Y Combinator. This is a first round of investment from Breakthrough Energy Ventures, a fund established by Bill Gates and a coalition of private investors in 2015.

With more than $2bn in committed capital, Breakthrough Energy targets its investments at companies and innovations that can help reach a goal of net-zero carbon emissions by 2050. This week, it was announced that the fund had secured investments from Microsoft, BlackRock, General Motors, American Airlines, Boston Consulting Group, Bank of America and ArcelorMittal.

Emissions from agriculture have been shown to be a significant contributor to the climate crisis. According to global research non-profit World Resources Institute, without intervention, greenhouse gas emissions from agricultural production could increase by 58pc by 2050.

The recent report from the Intergovernmental Panel on Climate Change warned that unless there are immediate and large-scale reductions in greenhouse gas emissions, limiting global heating to 1.5 degrees Celsius above pre-industrial levels, as outlined in the 2015 Paris Agreement, will be “beyond reach”.

“World-class investors know that humanity’s most important pursuit is to reverse climate change,” said Iron Ox CEO and co-founder Brandon Alexander. “To get there, we can’t settle for incrementally more sustainable crops – and we can’t ask consumers to compromise on taste, convenience or value.”

Iron Ox’s technology sets out to minimise the amount of land, water and energy needed for everyday produce. “The team at Iron Ox will not stop until we achieve our long-term mission of making the produce sector carbon negative,” said Alexander.

The start-up will use this Series C round to expand its retail presence and accelerate hiring. In particular, it’s seeking plant scientists, engineers, roboticists and greenhouse operators to join the team. The company also plans to boost its R&D programmes, accelerate its manufacturing scale-up and expand its operations across the US.

Carmichael Roberts from Breakthrough Energy Ventures said that this investment aligns with the fund’s aim to accelerate innovations that can reduce global greenhouse gas emissions.

“Iron Ox is uniquely positioned to accelerate the shift towards climate-friendly agriculture, while increasing the accessibility and quality of fresh produce,” he said.

“It’s the type of solution that’s designed to scale quickly and has the potential to get us one big step closer to net zero.”

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Henry Stone: the 10 funniest things I have ever seen (on the internet) | Comedy

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I write comedy and I direct comedy, and all of the money I make is from making comedy. However not all of the comedy I make is for making money. I like making things that are borne of nothing other than my fancy being tickled. I’m biased because I’m me and me is a perfect boy, but I’m pretty sure that this is the exactly correct way to approach your craft; one for you, one for them.

Ira Glass likes to talk about the taste gap and I like to talk about Ira Glass talking about the taste gap. It’s the mental chasm you find yourself in when you’re really into your chosen creative pursuit but you haven’t flexed your own muscle enough yet and you KNOW IT and it hurts cos you know you suck. I want to half-hijack my own funniest things list to celebrate the taste-gap-closing creative phase because I feel like its necessity is slowly being ignored.

This is a list of the funniest things on the internet that I know have been made only for the love of the process. No budgets or institutional support – simply really funny ideas explored to what appears to be the limit of the creators’ resources and abilities at the time. Has anyone laboured the ideology behind a selection criteria for a funny videos listicle as much as this? Probably not, but I’m trying to close up my opinion-piece-writing taste gap cos I’m thinking about starting a locky-d newsletter so like, forgive me?

1. Tiny Fuppets

Wow the Tiny Fuppets are AMAZE! I STAN TINY FUPPETS! If you don’t know about the Tiny Fuppets well they are simply just some Fuppets who are tiny teehee. This series started in 2011 and not too long after the creators became Conan writers.

2. Aunty Donna – GPS tries to kill man

Feels like you’re legally required to have an Aunty Donna video in your Guardian 10 funniest things list – they themselves had a list populated almost entirely with their own videos (due to the law I guess). Here we find the Donnas in 2012 being very funny and dumb and now we find them everywhere being funny and dumb cos they closed up their gap noice and toight.

3. F the Internet

A public-access-aping sketch that breaks out of the confines of its well-trodden framing with a confidently silly central performance and a clear willingness in the film-making to find the comedy on the day. This is 2015. Three years later star/writer/director Elizabeth Zephyrine McDonough started working for Full Frontal with Samantha Bee.

4. The New Pet Detectives

2013, my best friends Sam and Greg form the dream team of them, Tom Ward and Jonathan Schuster, to make a sketch for our shared YouTube. They’re in Melbourne and I’ve only just moved to Sydney so I wasn’t involved at all and therefore don’t feel grotty about putting it on my list. Eight years later, The New Pet Detectives makes me laugh every time and even though it ends with literally an apology for how shit they thought it was, all of them have closed up their gaps enough to continue to make comedy on bigger and crazier world stages.

5. Redfern Electrical

This one’s some red-hot 2021 business. John Cruckshank, beyond being a man of the people, is achingly funny and along with his film-making collaborator Luke Smith has the storytelling prowess to make this work of autofiction both hilarious moment-to-moment as well as structurally watertight. Together they’ve got more chops than Sam Kekovich and when viewed as a local sitcom it’s hard to argue that there’s anything better being made on Australia TV by people getting paid to do it. Off the back of this the Shank got tapped to be in the Big Lez Show as well as some other upcoming US animation stuff. If you’re sleeping on him, cut it out.

6. Just 2 Guyz

I don’t think it’s that necessary to go deep into why the Lonely Island are good. Just 2 Guyz was a standalone 2004 video that wound up in their failed 2005 sketch show pilot. Later that year they were all hired into Saturday Night Live. Two years after that, Hot Rod, my favourite comedy movie, comes out. I did toy with including the Stolen Footage: Jorm Dances video series in this list but those were made during SNL which disqualified them from being “for free” in my staunch opinion.

7. Laura’s Shock Attack

Sam (see: The New Pet Detectives) showed this to me and I commend its makers for at once nodding to the past with their use of French New Wave jump cuts while also being forward thinking by experimenting with unusual aspect ratios before your A24 johnny-come-lately’s like Jonah Hill and Robert Eggers ever did. Though it’s rudimentary you gotta crawl before you can walk oddly down steps (see: 40s mark).

8. This @jjjhack tweet

Half a decade late admin reveal: @jjjhack was run by Sophie Braham, Tom Cashman and myself. When we started it, Crikey wrote an article about the account’s follower rise without ever checking to see whether the followers were all eggs, which they were because I paid $60 to get 70,000 fake ones so that we aesthetically mirrored the real @triplejhack Twitter account as closely as possible. We made a pact with ourselves to only ever reply to any emails or tweets with a photo of George Rose from the Dragons which we just kind of plucked from the ether for no real reason. Highlights of the @jjjhack era were sending George Rose to Tom Tilley when he thanked us for the lols and duping Malcolm Turnbull into tagging us instead of the real account.

Again, I don’t feel grimy about sharing something I was involved in because this specific tweet was written by Tom or Soph as I quit writing on it long before they did. The three of us now do other things for fun I guess because we actually did age out of parodying the national youth broadcaster.

9. Side of Smooth

Nathan Fielder and Chris Locke in 2008, five years prior to Nathan For You.

10. Obedience

Fine, I’ll include my own proper one. I made this with Aaron Chen in 2017, it has very little sheen because the entire budget was me paying for lunch. It was knocked back by Tropfest – though I think that’s reasonable because I made it before the year’s theme of “Pineapple” was announced and then I pretended like having pine cones at the start and an apple at the end was an intentionally bookended approach to that theme, but they’d been duped one too many times.

To conclude this list in full earnestness, I wrote this sketch during one of my first ever bouts of depression, a time when I was deeply uncertain of my craft and incredibly distrustful of the local industry and the alleged experts working within it. Aaron, being the perpetually supportive friend he is, agreed to do the role and we got our friend Toby to bring his dog for Aaron to spit on. I think the sketch is pretty funny and is certainly helped to its feet through Chen being one of the most daftly captivating and to-the-core hilarious people this side of the River Murray. Through some twists and turns that reinvigorated my trust in the industry it fell into the laps of the people at Adult Swim and helped get our foot (feet?) in the door to make our short film for them last year. So yeah, it’s in the list because of how clearly it epitomises the cause-and-effect power of making your own stuff.

Remember to try to close up your gap, appreciate it when other people try to close up theirs and always revel in creating for creation’s sake!

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New X.Org Server release candidate appears after long delay • The Register

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More than three years after X.Org Server 1.20, released in May 2018, a release candidate for 21.1.0 has been posted.

The Linux display server remains widely used despite the introduction of Wayland, first released in 2012 and intended to replace X.

The future of the software, in terms of significant new releases, was in doubt when project owner Adam Jackson declared the project “abandoned” last year, but Lithuanian developer Povilas Kanapickas (who formerly worked on the Unity game engine) stepped up and said:

“There are new features in the Xorg DDX that I would like to see released, so I’m volunteering to do the releasing work.”

XWayland, a compatibility piece that enabled X clients for Wayland display servers, is part of the X.Org project but in December maintainer Michel Dänzer proposed that “there are new Xwayland features that we’d like to ship to users. Since there’s currently no clear plan for a new major release of xserver as a whole, I’m volunteering to make releases of Xwayland only instead.”

This was met with approval, and in March there was a standalone release of XWayland 21.1.0. Kanapickas considered this separation “good practice” and therefore the new release candidate is X.Org-only.

Work is proceeding on the 21.1 release of X.Org Server

Work is proceeding on the 21.1 release of X.Org Server

Wayland use is increasing and it is the default in popular distributions including Fedora, Red Hat Enterprise Linux, and Debian. Ubuntu switched to Wayland as the default in version 21.04, a second attempt since it was default in 17.10 but reverted to X.Org for 18.04, which means that the current LTS edition, 20.04, remains on X for most users.

The same applies to distributions such as Linux Mint, based on Ubuntu LTS. Even where Wayland is the default, some users prefer to run X for compatibility or performance reasons.

The new release candidate includes variable refresh rate support, support for AMD GLAMOR acceleration in the Xvfb (X virtual framebuffer), touchpad gesture support, and correct reporting of display DPI “in more cases that may affect rendering of client applications on hi-DPI screens.” There is also full support for the Meson build system and the older autotools support will be dropped in future releases. Kanapickas has also helpfully listed all the fixes since version 1.20.0 which is a long list.

While many users will welcome a new X Server release, Jackson observed last year: “I’m of the opinion that keeping xfree86 alive as a viable alternative since Wayland started getting real traction in 2010ish is part of the reason those are still issues.” ®

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