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Bailey Amber

In response to the need for the next generation of skilled, inventive, critical, and creative thinkers and entrepreneurs to flourish in the future workforce, Australia’s Haileybury is launching a new entrepreneurship programme with edtech company HEX.

Students will develop the skills and knowledge required to be creative and entrepreneurial in various settings, including start-ups, technology corporations, existing businesses, the public sector, and social enterprises. They will also learn how to adapt and thrive in a virtual, competitive, innovation-led environment by merging real-world and theory-based techniques and applying them to the startup ecosystem.

Also read: New exchange program to foster Indian and Australian female tech talent

Universities such as RMIT, the University of Wollongong, and Torrens University will recognise the curriculum for ‘previous learning.’ Students in Years 10 and 11 can participate in the self-paced online curriculum. Students will have regular mentoring with the HEX team and industry experts, including Leon Belebrov, Principal Product Manager, Mobile at job search site Seek; Shoaib Iqbal, CEO & Founder of satellite technology startup Esper Satellites; and a host of technologists from tech giant Atlassian, in addition to the self-paced online learning and fortnightly check-ins with Haileybury Head of Entrepreneurship Damien Meunier.

Through “HEXcurisions,” they will also be exposed to the Melbourne startup environment and meet with founders, investors, and technologists. It’s an experience that most high school students will never have, and it could help them in their future jobs by opening up doors they didn’t know existed. Students who complete the Haileybury Enterprise Academy can receive recognition of prior learning’ in various business programmes at pre-approved universities around Australia, including RMIT University, the University of Wollongong, and others.

HEX Chief Growth Officer Chris Hoffmann, says: “We are thrilled to launch our first high school partnership program with one of Australia’s innovative and most entrepreneurial schools. We believe young people and the next generation need to be exposed to new learning pathways and future opportunities to unlock their full potential and help them design and build the world they want to live in. 

“With the world and future workforce changing at such a rapid pace and innovation being pivotal across all areas of business, it is an exciting time for us to challenge the traditional education pathways and see how we can further children’s skills and experiences sooner in life.

READ MORE: NSW launches online hub to support female entrepreneurs

“We look forward to forging partnerships with more forward-thinking schools and education providers to deliver a new kind of learning that keeps pace with the changes of tech, the workplace and the real world.”

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Sanofi’s technology for making natural killer (NK) cell therapies came from an M&A move. The pharmaceutical giant just struck a deal that adds a CRISPR-editing technology to its to toolkit for developing NK cell-based therapies for cancer.

The CRISPR technology is from Scribe Therapeutics, a startup co-founded by CRISPR technology pioneer Jennifer Doudna. Whereas CRISPR’s initial development employed the Cas9 cutting enzyme, Alameda, California-based Scribe’s platform is comprised of gene-editing and delivery tools based on CasX, a protein discovered in Doudna’s lab. CasX is a smaller protein, which makes it a better fit for the in vivo gene-editing applications that are the focus of the startup’s internal research.

Sanofi will apply the Scribe technology to ex vivo NK cell therapies. According to financial terms announced Tuesday, the pharma giant is paying $25 million up front. Development and commercialization milestone payments to Scribe could top $1 billion; Scribe would also receive royalties from sales of any approved products that stem from the collaboration.

NK cells are a type of immune cell endowed with tumor-killing enzymes. NK cells seek out cancer cells to carry out their work, and they have application across many tumor types. Two years ago, Sanofi licensed an off-the-shelf NK cell therapy from Kiadis Pharma that was in preclinical development. The stated goal was to pair that drug with Sarclisa, a Sanofi antibody drug for multiple myeloma.

Months after the licensing deal was announced, Sanofi agreed to acquire the biotech outright for €308 million cash. Sanofi said Kiadis’s NK cell therapies would be developed as standalone treatments and in combinations with the pharma giant’s drugs. Sanofi’s pipeline currently lists one clinical-stage NK program from Kiadis: SAR445419, an off-the-shelf therapy, is in Phase 1 testing for acute myeloid leukemia.

Companies conducting NK cell research are working to bring cell therapy to solid tumors. The first cell therapies, based on engineering a patient’s own T cells, have worked only on blood cancers so far. Frank Nestle, Sanofi’s global head of research and chief scientific officer, said in a statement that his company sees NK cells having applications in both solid tumors and blood cancers.

“This collaboration with Scribe complements our robust research efforts across the NK cell therapy spectrum and offers our scientists unique access to engineered CRISPR-based technologies as they strive to deliver off-the-shelf NK cell therapies and novel combination approaches that improve upon the first generation of cell therapies,” he said.

Scribe emerged from stealth in 2020, backed by a $20 million Series A round of financing. Last year, Scribe closed a $100 million Series B round to finance further development of its technology platform and to advance its pipeline of CRISPR-based therapies for neurodegenerative disorders. The biotech’s neuroscience work previously led to a research partnership with Biogen focused on developing CRISPR-based therapies for amyotrophic lateral sclerosis. In May, the two companies announced that Biogen had exercised its option to expand the collaboration to an additional disease target in gene therapy. That target was not disclosed.

Photo: Nathan Laine/Bloomberg, via Getty Images

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Average monthly rents in the Greater Toronto Area surged 21 per cent on a year-over-year basis in August, according to the latest rent report by Rentals.ca and Bullpen Research & Consulting.

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Rent for all property types was up $430 to $2,528 from $2,098 in August 2021, further surpassing the pre-pandemic high of $2,461 recorded in 2019. The average is also now 28.2 per cent above the COVID low of $1,972 per month set last April.

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August rent was also up on a monthly basis, rising 2.7 per cent since July. Rental rates in the GTA have now risen by two per cent or more for the past four consecutive months, following a rise of 5.7 per cent in May, which was a multi-year high.

Rent inflation can largely be chalked up to the rising interest rate environment, “which has made owning a home more expensive and resulted in a swift decline in prices in the resale market,” the report said.

With the Bank of Canada expected to continue to hike interest rates, demand for rental properties could persist.

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In the Toronto market, apartment rents jumped 20.1 per cent. The area with the highest average across all property types was the Bay Street Corridor, at $2,779.

So far in the third quarter, average rents in Toronto have increased 13.8 per cent from the second quarter, ahead of North York (10.1 per cent), Scarborough (9.4 per cent), Etobicoke (5.7 per cent) and Mississauga (5.1 per cent).

  1. A person walking by a row of houses in Toronto.

    Investors are trying to fill the multifamily rental housing gap and that’s not a bad thing

  2. The growth in renter households has more than doubled the growth of owner households, Statistics Canada says.

    Canada’s homeownership rate is declining while renting is on the rise

  3. A for sale sign is displayed outside a home in Toronto.

    Canada’s home sales and prices are falling. Has something changed in the housing market?

“From May to August, the Greater Toronto Area rental market has experienced four significant monthly rent increases, as tenant demand has skyrocketed due to interest rate changes, a resale house price correction and the typical seasonal fall uptick,” said Ben Myers, president of Bullpen.

He noted as well that listings on TorontoRentals.com hit a multi-year high in August, doubling over the past year and up 166 per cent from August 2020.

“Prospective tenants are seeing limited vacancies due to an extreme imbalance between supply and demand, with year-to-date new housing completions down 22 per cent annually in the metro area per CMHC,” he said.

• Email: shcampbell@postmedia.com

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diabetes, diabetics, blocks

Access to quality, consistent care is imperative for patients with diabetes to maintain their health. Having an ongoing care plan is the best way for patients to avoid complications — one of the most common being diabetic foot ulcers, which can lead to the partial or whole amputation of the foot.

The Centers for Disease Control and Prevention’s most recent data on the diabetes-related amputations, from 2016, shows that there were 4.9 lower-extremity amputations per 1,000 diabetic adults in the U.S. Among diabetic people who have had a lower-extremity amputation, more than half may end up having an amputation of the opposite extremity within five years, according to the agency.

The American Diabetes Association announced an initiative last week aimed at tackling this issue. The nonprofit launched the Amputation Prevention Alliance — a three-year effort to decrease the number of diabetes-related amputations in the country — along with five partner organizations.

Those partners include diabetic foot care provider Podimetrics, wound care company Advanced Oxygen Therapy and membership-based medical society Critical Limb Ischemia Global Society, as well as medical device companies Abbott and Cardiovascular Systems.

The majority of diabetes-related amputations are preventable, according to Jon Bloom, Podimetrics’ CEO and co-founder. 

As diabetes advances within a patient, they may experience nerve damage called diabetic neuropathy, in which damaged tissue struggles to heal. Peripheral neuropathy — nerve damage that leads to sores on the feet and legs first — is the most common form of diabetic neuropathy, according to Bloom. The hands and arms can also be affected later, he said.

Patients at risk for diabetic foot ulcers might not even feel a sore forming on their foot. When this is the case, the sore continues to get worse and does not heal well due to increased blood sugar levels, Bloom pointed out. These sores often advance to require diabetic amputation — an issue Bloom said is “simply not talked about enough.”

To combat the public health issue of preventable diabetes-related amputations, the alliance will prioritize patient education about the signs and symptoms associated with diabetic foot ulcers and diabetic neuropathy. It will also work with providers to ensure their patients with complex diabetes have regular check-ups, including appointments with a podiatrist that are focused primarily on foot health, Bloom said.

The Amputation Prevention Alliance plans to advocate for needed policy changes, one example of important legislation being the The Amputation Reduction and Compassion Act. The bill, which was introduced in Congress last year, would provide coverage of peripheral artery disease (PAD) screening for at-risk beneficiaries under the Medicare and Medicaid programs without cost-sharing requirements.

“By expanding coverage for PAD screening, the bill would help prevent vulnerable individuals from developing serious complications from PAD, which can lead to amputation,” Bloom said. “The ARC Act would also prohibit the use of amputation without the completion of testing to determine if alternative options could be utilized to benefit the patient and establish a PAD education program.”

The alliance has also formed a clinical advisory working group to produce recommendations mapping to policy change, clinician education programs and improved patient engagement, according to Bloom. 

The initiative will focus on reaching providers and patients in communities facing disproportionately high rates of amputations and amputated-related mortality, such as the Black and Latino communities. Black people in the U.S. face amputation rates up to four times higher than White Americans, and Latino people are 50% more likely to have an amputation, according to the announcement.

To Bloom, the alliance’s success will be determined by one metric: whether or not it can reduce the more than 154,000 amputations that occur every year in the U.S.

Photo: gustavofrazao, Getty Images

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There is no question that the future of enterprises is in the cloud, with Australian businesses forecast to invest more than $20 billion in cloud computing technology by 2025.

In a pandemic-hastened move towards digital, the past two years have witnessed businesses jumping on the cloud services bandwagon in pursuit of greater efficiency, agility in reducing the time-to-market of business services, streamlined operational costs, and overall resource optimisation. 

The lure of the cloud 

Innovative uses of the cloud have enabled businesses and organisations to leverage emerging technologies like artificial intelligence and machine learning (AI/ML) to develop and launch industry-disruptive solutions at scale. For instance, cloud computing plays a critical role in digital twin technology by facilitating the storage and transmission of massive troves of data. Aside from storage alone, it opens the doors for the use of AI/ML technologies at the edge in virtualised environments that can be scaled as required. 

The use of digital twins across sectors ranging from urban planning, healthcare, and hospitality, to the energy and mining sector is anticipated to help save millions of dollars in resources while unlocking new frontiers. For example, the NSW Government recently announced the expansion of its Spatial Digital Twin to provide a 4D model for the entire state in an effort to boost productivity and create ease when planning and developing key infrastructure projects.

Nascent cloud adopters, too – particularly start-ups that lack resource capital or the technical know-how for complex applications of cloud technology – can reap significant cost savings in the long term with the right strategy in place. After all, with as-a-service offerings in the cloud, businesses have been promised a pay-only-what-you-consume model that leverages economies of scale to provision services at lower prices. Infrastructure maintenance fees are also eliminated, while businesses have the flexibility to scale up as required.

Yet, for all that cloud evangelists have banged on the cloud adoption drum – something appears to be running awry. In spite of the burgeoning investments being channelled into cloud solutions, Australian businesses are lagging behind in realising the full value of their investments in the cloud. 

Detecting and swerving common pitfalls

In a rush to realise all the benefits of the cloud, businesses have jumped in headfirst without formulating a holistic and thoughtful cloud strategy that looks beyond migration alone. While cloud migration is a great first step toward digital transformation, businesses must not neglect the reality that the cloud is a delivery model, not an end. Without adequate preparation, businesses may face bill shock – making cost savings with cloud adoption seem like a fallacy.

Businesses must understand that transitioning into the cloud is still a long-term investment and should mandate a rigorous decision-making process that considers future implications. For instance, complex pricing structures offered by some cloud vendors and varying terminologies make deciphering final costs more challenging. In particular, ingress and egress costs from data migration into and outside the cloud have been notorious for raising unforeseen expenses. Businesses would need to be prudent in selecting cloud providers that prioritise price predictability and transparency and offer pay-per-use pricing models.  

Businesses that go into cloud migration unprepared may also find themselves uncovering new, more complex and costly potholes, like security lapses from a lack of visibility across all IT environments. The Australian Cyber Security Centre reported a 13 per cent increase in cybercrime reports in the 2020-2021 financial year, compared to the previous year, equating to one attack every eight minutes. 

And perhaps most detrimental to the business is how its agility may be compromised with vendor lock-in that comes with integrating applications too tightly in the cloud within one vendor ecosystem alone, causing businesses to lose control over their IT stack and making it challenging to scale rapidly or diversify their use of the cloud. However, such scenarios can be easily averted by working with cloud providers that champion open standards and ensure reversibility and interoperability between multi-cloud environments. After all, cloud strategies should be crafted around businesses’ needs – not the reverse.

Charting the way forward for success

In the future, cloud reliance is anticipated to grow, spurred by the rise of the metaverse and Web 3.0. Businesses looking to grow must turn towards the cloud and formulate a holistic and resilient cloud strategy that accommodates market drivers and overall landscape and supports business goals. 

Aside from market drivers, selecting cloud providers that encourage an open ecosystem will also enable businesses to diversify and repatriate workloads to on-premise environments as needed. Ensuring successful cloud adoption in the long term will require foresight, and businesses will need to clearly understand how they expect the cloud to augment their services.

Ultimately, the bottom line remains central to successful cloud strategies. Without predictability of costs to be incurred, alongside the flexibility to scale as required, businesses may find themselves unable to optimise their cloud operations to get the highest return and truly enjoy the cost savings they were lured by. 

As the adage goes, cloud adoption is not a silver bullet to digital transformation. The cloud is ubiquitous and here to stay, but success will only be within reach for businesses with the right strategies. 

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“It is with great disappointment that I’m writing to let you know that Optus has been a victim of a cyberattack that has resulted in the disclosure of some of your personal information,” this is the email notification of the data breach that was sent to millions of Australians and signed by Telecom CEO Kelly Bayer Rosmarin last week.

Optus, Australia’s second-largest telco, suffered a major data breach on Wednesday, Sept 21, with potentially millions of customers’ personal information leaked by a malicious cyber-attack. Customers’ names, dates of birth, phone numbers, and email addresses may have been compromised, according to Optus. 

Ms Rosmarin said at a video conference that she felt “terrible.” “I’m very sorry and apologetic. It should not have happened. I’m angry that people out there want to do this to our customers,” she said.

Some clients’ street addresses, driving licence information, and passport numbers were also obtained. Then, over the weekend, a user claimed to have the information gained from the attack and demanded $1 million in Monero cryptocurrency on a data market.

The user claimed to have obtained the information using an application programming interface (API) that did not require authentication, which is software that enables two different systems to communicate with one another. Due to Optus’s obligation to retain identity verification records for six years, the cyberattack may have impacted customers as far back as 2017. 

The telco has previously issued privacy guideline amendments allowing consumers to request the deletion of their data. In the aftermath of the hack, Australia intends to change its privacy regulations so that banks can swiftly receive alerts.

Was the Optus data encrypted?

According to Andrew Wilson, CEO of Senetas, the major concern Optus must solve is if the data is secure. Encryption maintains the security of common digital transactions such as online banking and shopping.

“If this is strongly encrypted sensitive data, as it should be, then Optus customers do not need to be alarmed. They likely have years to change their passports and other identity documents before the attackers can read and use what they’ve stolen. If it isn’t, customers need to get onto that process today. That’s quite a difference!”

“Further statements from Optus that this was a very “sophisticated” attack are unsatisfactory. Very sophisticated and increasingly malicious attacks are common. That’s why ‘data protection’ is essential today – and that’s encryption. It is the last line of defence. Whether the stolen data is encrypted or not should be in the first communication about a successful breach. It is concerning that this vital bit of information is missing so far.

“Many have questioned whether the prevention systems like those used by Optus are sufficient, or if the company under-invested in its cybersecurity, and this is the inevitable result. This is unlikely. No cyber-attack prevention system is bulletproof.

“The focus should instead be on regulation – we need comprehensive federal cybersecurity legislation that punishes companies and government agencies that fail to encrypt sensitive data. Not every company can afford the type of prevention systems Optus has, but the lesson must not be that they shouldn’t try or have a last line of defence in place should a breach occur.”

Major overhaul underway

Australia plans changes to its privacy rules so that banks can be alerted faster-following cyber-attacks at companies. According to media reports, the federal government is considering legislation obliging businesses to notify banks if client data is hacked, allowing lenders to monitor impacted accounts for suspicious behaviour.

Over the weekend, Cybersecurity Minister Clare O’Neill stated that the government would announce additional details about the reforms “in the coming days.” Australia has been working to strengthen its cyber defences and, in 2020, planned to invest A$1.66 billion ($1.1 billion) over a decade to protect company and household network infrastructure.

Ajay Unni, CEO and Founder of StickmanCyber, emphasises the need to educate and train business users because they are the weakest link in cybersecurity.

“While having technical defences is a step forward in terms of cybersecurity maturity, I cannot emphasise the importance of training and educating business users as people are always the weakest link regarding cybersecurity. 

“Third-party risk is another area that requires close attention as larger organisations are often infiltrated through their partnerships with external suppliers.

“As the complexity and frequency of cyber threats increase exponentially, it is extremely sad to see Australia under attack from cybercriminals who are finding success in exploiting vulnerabilities to gain unauthorised access to businesses and critical infrastructure.

“Telcos like Optus carry large amounts of information about their customers such as call patterns, incoming/outgoing phone numbers, data/internet usage and other forms of personal information that can be easily exploited.

“The data exposed can now be maliciously used to create fake identities or as a launchpad to further target users individually through spear-phishing campaigns. These campaigns will now be even more effective as cybercriminals have access to more information than just an email address.

“The findings of the Australian Cyber Security Centre’s investigation into Optus’s data breach will reveal the true nature of the attack – whether it was the work of cybercriminals or a state-sponsored attack.

“Optus users need to remain vigilant of any email offering support due to this breach, even if the email appears to be from an authoritative or legitimate source. Optus customers need to do their due diligence regarding cyber hygiene and avoid clicking on any links in emails unless their legitimacy has been validated.”

According to Thales’ global research, – Cyber Threats to Critical Infrastructure 2022, critical infrastructure industries worldwide continue to face severe challenges and gaps in their approach to protection and risk management. 

A lack of protection for cloud-hosted data and apps, along with an increase in the extent and severity of attacks during the last 24 months, has raised the threat level posed by hacktivists and nation-state actors. Security techniques that are no longer appropriate for today’s dynamic threat landscape are increasingly endangering nations, organisations, and people’s lives.

Businesses warned to watch out for scams

Following the Optus data breach, ACCC Scamwatch is urging customers to protect their accounts and be on the lookout for fraud. 

As per ACCC, steps you can take to protect your personal information include:

  • Secure your devices and monitor for unusual activity
  • Change your online account passwords and enable multi-factor authentication for banking
  • Check your accounts for unusual activity, such as items you haven’t purchased
  • Place limits on your accounts or ask your bank how you can secure your money

If you suspect fraud, you can request a ban on your credit report.

More information about how to protect yourself is available on the OAIC website.

Check the Optus website(link is external) for information and contact Optus via the My Optus App or call 133 937.

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Healthcare is an industry designed to provide essential services and care for patients to improve their health and well-being. Over generations, the expertise of medical professionals has allowed the industry to continuously innovate and meet the ever-changing demands and needs of patients — ranging from spikes in mental health to safety concerns regarding an in-person doctor’s visit during a global pandemic. Most recently, the Covid-19 pandemic has shown the agility of the healthcare industry to innovate, as we have experienced a surge of medical startups emerging to accommodate new demands and gaps in the industry with digital innovations. There are a number of digital-first methods that improve the healthcare experience for patients, from remote patient monitoring to tech-enabled patient care, virtual reality in the operating room, and more.

As digital health companies solidify their services and technologies as a preference for many, and innovations continue to be developed, it’s critical for healthcare startups to understand the needs of patients and physicians. Companies can hear those important perspectives during innovation development for a successful product or treatment that ultimately propels the healthcare industry.

Improving R&D with the voice of patients and physicians

Many new medical tools and technologies being developed ultimately end up in a doctor’s office, prompting the need for startups to collaborate with physicians during the research and development phase. By engaging physicians in this critical stage, startups can ensure physicians feel confident in adopting and implementing the new innovations within their own practice.

Beyond verifying medical accuracy, physicians can provide exclusive insights to help navigate any number of strategic issues or healthcare challenges that may be unseen to a startup, as well as inform any gaps in a new tool or technology — such as a potential feature or add-on recommendation — based on what they are seeing in the field.

Complementing their medical expertise, physicians also serve as the voice of the patient; with a growing emphasis on tools and technologies being developed specifically for patient use and improved health outcomes, physicians are a valuable asset in informing startups with unique patient perspectives during the R&D phase. Physicians are in constant communication with patients, which provides them with a front row seat to their evolving healthcare needs and desires, as well as feedback or concerns regarding industry innovations at large. With an inside look into what patients need, and the ability to identify consistent trends among patient groups, physicians can share invaluable insights to startups that reflect today’s patient and help optimize new tools or technologies.

Maximizing go-to-market strategies

While the healthcare landscape is known for constant change, these transformations have created a new type of patient. Increasingly, patients are much savvier and more engaged with their personal healthcare journeys; and they are investing the time to become better informed about any health product, tool or treatment. As such, startups should approach their innovations and market strategy with the understanding that patients will do their own research and read the fine print before buying into a new product or technology.

While physicians can ensure medical accuracy during the R&D phase, moving forward these experts can help maximize startups’ go-to-market strategy. Particularly in healthcare, it can be challenging to simplify a new product or technology into layman’s terms without removing any critical medical information pertaining to use. Physicians can help startups identify key messages to include in communication and product materials, as well as common questions or concerns that may arise from patients to include in an FAQ. A physician’s — and startup’s — goal is to help patients, and by enlisting the support of physician expertise, startups can ensure easy-to-understand, transparent, and factual language within their go-to-market strategy to best reach patients.

Fuel startups with leading experts

Often, companies are challenged in sourcing the right expertise for a new project. And as the healthcare digital innovation market continues to grow at a rapid pace, time is of essence — however, startups cannot compromise real science. Thankfully, a national network of expert physicians can be found in one location.

By applying a gig economy model to healthcare innovation, flipMD from GoodRx is lowering the barrier for physicians and businesses to connect and collaborate through an easy-to-use online platform. Whether the latest innovation is in the research and development phase or ready to go to market, the on-demand marketplace for physicians allows startups to remain at the forefront of medicine and conserve their time in identifying the right expertise by posting a job with unique parameters to recruit experts from a broad range of specialties.

In today’s evolving healthcare industry and amid rising consumer demand, it’s important for startups to collaborate with physicians to successfully innovate while staying on track. Discover how to fuel your startups’ momentum by collaborating with expert physicians.

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An independent committee that advises the FDA on cancer drugs has weighed in on medicines from Spectrum Pharmaceuticals and Oncopeptides, issuing negative votes on both.

First up was Spectrum’s poziotinib, which was developed to treat advanced non-small cell lung cancer (NSCLC) characterized by HER2 exon 20 insertion mutations, a rare genetic signature that drives an estimated 2% to 4% of NSCLC cases.

FDA staff flagged safety concerns at the proposed dose 16 mg dose. In clinical testing, 57% of patients experienced dose reductions and 85% of patients had grade 3 or grade 4 adverse events. They also noted that Boston-based Spectrum is seeking accelerated approval at that once-daily 16 mg dose, but the planned confirmatory study will be at 8 mg twice daily. Last Thursday, the committee voted 9 to 4 that the therapy’s benefits do not outweigh its risks. An FDA decision for the drug is due by Nov. 24.

Following Spectrum, Oncopeptides faced the advisory committee regarding its multiple myeloma drug, Pepaxto. The FDA awarded Pepaxto accelerated approval last year, but months later issued an alert that noted a clinical trial found an increased risk of death associated with the drug. Oncopeptides then stopped marketing the drug in the U.S.

FDA staff pointed to results in a confirmatory trial for Pepaxto, which did not meet the goal of progression-free survival, a measure of how long patients live without their cancer worsening. Staff also added that overall survival was worse in the Pepaxto group. Results showed a higher total number and percentage of deaths in the Pepaxto arm compared to the group given a standard multiple myeloma treatment. Regulators in Europe reached different conclusions about the drug, approving it last month. It is marketed there as Pepaxti. But the FDA advisory committee remained unconvinced by the company’s analyses and the European approval. On the question of whether the drug’s benefits outweigh its risks, the committee answered “no” by a 14 to 2 vote.

The standard qualifier for every FDA advisory committee meeting is that the regulator is not required to abide by the committee vote, but it usually does. If that holds true for Spectrum and Pepaxto, the chances don’t look good for a favorable decision from the FDA.

Here’s a look at other recent regulatory news.

—An experimental gut microbiome therapy from Ferring Pharmaceutical won the backing of an FDA advisory committee, which voted 13 to 4 that the treatment’s data are adequate to support its efficacy. Switzerland-based Ferring designed its therapy, RBX2660, to reduce the recurrence of C. difficile infection (CDI). The committee also voted 12 to 1 with one abstention on the question of whether the data are adequate to support the safety of the Ferring therapy in those 18 and older following antibiotic treatment for recurrent CDI.

—Children have been excluded from many clinical trials due to what the FDA now says was a “misperception that excluding them from research was in fact protecting them.” That thinking is changing and the FDA has issued draft guidance setting out an ethical framework for including and protecting children in clinical trials. The draft is open to public comment for the next three months before the FDA finalizes the guidance.

—The FDA placed a partial clinical hold on a pivotal study testing Viaskin, a peanut allergy patch in development by DBV Technologies. That study has not yet started but France-based DBV said the agency has asked for adjustments to the statistical analysis of the patch’s adhesion, among other changes. According to DBV, the FDA said these modifications are needed for the study to support a future biologics license application.

—Eli Lilly cancer drug Retevmo received FDA approval for treating advanced solid tumors characterized by a RET gene fusion. The accelerated approval covers the treatment of cancers that have progressed following at least one prior treatment. Retevmo won its initial accelerated approval in 2020 for the treatment of three RET-driven cancers: non-small cell lung cancer (NSCLC), thyroid cancer, and medullary thyroid cancer. With the latest tumor agnostic approval, the 2020 accelerated approval in NSCLC has been converted to a traditional one.

Clinical trials of a Merck HIV drug that were paused by the FDA last year can now resume, but at a lower dose. Merck also said it will no longer pursue development of the HIV drug, islatravir, for HIV prevention. The FDA placed multiple tests of the drug on full or partial holds after the observation that some patients treated with islatravir developed lower levels of two types of immune cells.

—Larimar Therapeutics was also able to resolve a clinical hold. Last year, the regulator paused a dose-ranging clinical trial evaluating the biotech’s treatment for Friedreich’s ataxia, a rare neuromuscular disorder, after deaths were reported in a monkey study. Those deaths all happened in monkeys given the highest dose of the drug.

The lift of the full clinical hold comes with the imposition of a partial hold. The planned Phase 2 trial now has a requirement that the FDA review data from a lower 25 mg dose group before the study escalates to a higher dose in the second cohort. Larimar said it expects to begin this study in the fourth quarter of this year; data are expected in the second half of 2023.

Photo by FDA

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Businesses will need to actively monitor their income and expenses to maintain positive cash flow since economic headwinds, ranging from inflation and supply chain delays to higher interest rates and decreased consumer spending, are expected to persist throughout FY24. 

According to an unsettling new report, three-quarters of SMEs expect reduced cash flow before July of next year. Small Business Loans Australia, an Australian comparison website that assists Australian business owners in selecting the best financing and loan options in Australia, performed the research, which included 253 Australian SME owners and decision-makers.

There were 68 per cent micro businesses (1-10 employees), 18 per cent small businesses (11-50 employees), and 14% medium-sized businesses among the respondents (51–200 employees).

SMEs are expecting a cash-flow crisis

Three-quarters (76 per cent) of respondents said rising interest rates and inflation would impact their cash flow before FY24. Specifically, 30 per cent feel their cash flow would be damaged because it will be more difficult to recover consumer payments, while 26 per cent believe it will be more difficult to generate customers. Another 20 per cent stated that both issues would impact their cash flow. According to the survey, 44 per cent of respondents do not have a strategy in place to maintain cash flow during difficult times. 

How much cash flow do small businesses require to stay afloat? Small Business Loans Australia also inquired about the amount of cash flow needed each month to cover business expenses. Although 68 per cent of all respondents are tiny enterprises, more than a third (39 per cent) claimed they need more than $50,000.

Will fewer small businesses invest in themselves?

Small Business Loans Australia wanted to know if the ability and incentive of small businesses to invest in themselves would be impacted by rapidly rising interest rates and inflation. More specifically, more than a quarter (29 per cent) of respondents saidthey had no plans to invest in their firms at all this fiscal year.

Forty per cent (40 per cent) will postpone planned investments until conditions improve, demonstrating that many small businesses’ motivation to grow is closely related to excellent economic conditions. Fifteen per cent will stop or have already terminated investment in their company, while only 17 per cent would continue to invest.

Among the businesses who had planned to invest in themselves before July 2024 (including those who are cancelling their investments), half (56 per cent) planned to invest more than $50,000, and a quarter (27 per cent) planned to invest more than $70,000.

The recent ABS Business Conditions and Sentiments survey found that in the first three months of 2023, 30 per cent of employing businesses had planned to increase wages and salaries, and 27 per cent would increase employee numbers. However, small businesses are less likely to action these investments to the same extent as larger businesses.

Alon Rajic, the founder of Small Business Loans Australia, says: “As Australian businesses continue to face the repercussions of the last two years, a significant proportion will have challenges, particularly without a savings buffer or strategy to help meet their expenses.

“One of the most effective ways to invest in and protect a business is to grow customers and sales – especially acquiring customers who have healthy incomes and good cash flow. This could be a good time for small businesses to develop a strategy to not only survive but grow. Businesses often reduce costs when external conditions impact them but then de-prioritise, driving new sales. However, there are opportunities even in tough conditions. 

“Growth often requires investment. Improving your product or service offering, getting in front of new customers, and customer loyalty will be important for many businesses that want to succeed in these times. For most, it will require financing.”

Alon adds: “Businesses seeking financing to help them will have a plethora of loan products to wade through. Research and loan comparisons will be important to finding the most suitable and lowest-risk loan. This may include flexibility in repayments and lower fixed interest rates. Many loans may have hidden costs and fees that should be factored into decision-making.

“However, ultimately, it is important for SMEs to seek advice from a licensed financial adviser before committing to a loan to ensure they can meet repayments and higher interest rates during periods of reduced cash flow. Using a comparison service can also assist in finding an appropriate loan option with lower interest rates.”

The full survey results can be found here.

Source: Small Business Loans.

ABS, June 2022 data: abs.gov.au/statistics/economy/business-indicators/business-conditions-and-sentiments/jun-2022

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Joining the online marketplace movement can help your enterprise expand its presence in the commercial arena.

Are you looking to increase your sales and profits and grow your footprint in new market segments? For most business owners, it’s a rhetorical question but making it happen via conventional business development activities is very often a slow burn.

Investing in a larger inventory is capital intensive. Hiring additional personnel to woo and win new accounts will increase your overheads and operating costs well before you begin to turn the desired profit. 

The rise of the marketplace

A growing number of consumer-focused businesses have circumvented these hurdles by implementing online marketplace technology that enables them to sell products and services that are owned and shipped by third-party sellers, a la Amazon and eBay.

Here in Australia, we’ve seen a string of household name players, including supermarket giant Woolworths and outdoor entertaining specialist Barbeques Galore, create their own destination sites. The next year, many others will follow suit.

Gartner highlighted the opportunity in late 2020, opining that enterprise marketplaces represented not only a new set of technologies for driving digital commerce but a fundamental business model change for commerce organisations. 

It predicted organisations that had operated enterprise marketplaces for more than a year could expect to record an increase in digital revenue of at least 10 per cent.

B2B businesses have been slower to embrace the online marketplace trend but that’s likely to change as more enterprises become cognisant of the advantages that can accrue from putting themselves at the heart of an eco-system of sellers.

Embracing B2B eCommerce

While, historically, B2B selling was heavily focused on face-to-face interactions, the Covid pandemic has upended that paradigm for what appears to be good and all. The protracted lockdowns of 2020 and 2021 put paid to industry roadshows, trade fairs and in-person sales and ushered in an era of online demonstrations and electronic interactions.

Research suggests business customers haven’t been unhappy with the change. Only 20 per cent of buyers were looking forward to the return of the rep, according to 2020 research published by McKinsey. Almost three-quarters of US businesses surveyed stated digital selling was working for them, and there’s little reason to suppose their counterparts Down Under see things any differently.  

Bottom line? Businesses are relaxed and comfortable about spending money online for everything from office supplies to high-priced plants and equipment. That means there’s a significant revenue opportunity for B2B businesses willing to invest in creating specialist destination hubs that digitally bring sellers and buyers together. 

Driving sales and growth

If you don’t know too many businesses that have succeeded in getting a B2B marketplace up and running, don’t worry – you will. Sceptics on this score may find it instructive to take a look at what’s been happening in other countries. 

Germany, for example, where Saitow, a company you’ve likely never heard of, runs Tyre24, an online marketplace where some 40,000 commercial customers go to buy tyres, wheels and automotive parts. It handles an impressive 100,000 transactions a day and clips the ticket on each and every one of them.

Steps to success: To get the wheels turning and emulate the Saitow online marketplace success story? At Spryker, we’ve seen a growing number of B2B businesses getting it right, not a few that have failed to launch. 

Those in the former category have used best-of-breed, composable software to develop a robust yet agile technical framework for their e-commerce operations.

Just as importantly, they’ve offered compelling value propositions to their seller eco-systems: clearly defined service level agreements and acceptable commission structures to all parties. 

Getting those relationships right matters far more so for B2B marketplace owners than their commercial counterparts because the former will typically deal with fewer sellers. Fail to keep them on board and on the side, and your B2B marketplace will struggle to gain traction.

Harnessing the power of marketing

And you’ll gain that traction much faster if you make marketing part of the mix from the outset. Establish your online marketplace as a go-to destination in the minds of the business buyers in your target market, and you’ll make it difficult for other suppliers in your sector to emulate your efforts.  

Smart operators will draw on the power of data to generate tailored campaigns and secure seller support to ensure those campaigns hit the mark and result in sales and growth.

Setting your B2B business up for success

The Covid crisis forced Australian businesses to abandon traditional means of doing business. Online marketplaces have emerged as an effective vehicle for bringing B2B sellers and buyers together and facilitating efficient, streamlined transactions. If increasing your revenue and profitability is important to you in 2023 and beyond, putting your enterprise at the centre of a specialist e-commerce network may prove a smart growth strategy.

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