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Clinical decision-making insights for haematologists and oncologists

Clinical decision-making insights for haematologists and oncologists

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Clinical trial readouts continue to emerge despite countries’ lockdown policies, providing several decision-making challenges for healthcare professionals such as haematologists and oncologists – also known as haem/oncs.

pharmaphorum’s Behavioural insights into haem/onc clinical decision making webinar, in association with Medscape, showed that this can negatively impact physicians’ confidence as they try and keep on top of information about an array of treatment options.

The webinar discussed findings of exclusive surveys showing the continuing medical education (CME) needs of doctors and shone a light on where physicians are going for their learning needs amid the COVID-19 pandemic.

The webinar also showed the enormous task facing haem/oncs, who have to keep abreast of complicated developments as a plethora of new treatments become approved.

While these new treatments have the potential to change standards in care for many patients, there can be challenging side-effects, which haem/oncs must be aware of to make the best prescribing decisions for individual patients.

Challenges for community-based haem/oncs

The considerable progress made in the field poses its own challenges as there is a vast amount of clinical trial data to navigate and learn from.

A seemingly constant flow of new medicines, as well as new insights into established therapies, mean that haem/oncs have their work cut out to keep up with the latest developments.

“The Medscape survey showed that a sizeable minority of haem/oncs (21%) were misinformed about the correct treatment choice for a case study”

Professor Mohamad Mohty, head of haematology and cellular therapy at Saint-Antoine Hospital, told the webinar audience: “It is really amazing to see the number of haematology indications, whether for new molecular entities or for biosimilars.”

He noted that the progress with new medicines has also translated into improved survival rates, with an improvement in five-year survival for leukaemia.

Data from the US cited during the webinar showed a five-year survival rate of 34.2% for leukaemia in the period 1970-77, increasing to a rate of 60.6% for the period from 2007-2013.

Diving deeper into data from Germany, the largest improvements have been seen in multiple myeloma and non-Hodgkin lymphoma, Mohty noted in his presentation.

He added: “The availability of a novel drug or several novel drugs in a given cancer, in a given disease is the key driver for the improved outcomes.”

But progress is creating its own challenges, together with the obvious impact of COVID-19.

Aside from the pandemic, haem/oncs face pressure on several fronts: from making optimal treatment decisions, from patients and from the limited time they have for balancing their clinical practice and ongoing study.

Community-based haem/oncs see a variety of patients with different tumours in this increasingly complex treatment landscape, while also having to deal with the changes to practice caused by COVID-19.

Complexities of care

The increasing number of approved therapies has led to a potentially overwhelming choice of combinations in blood cancer, each with their own advantages and disadvantages.

Katie Lucero, director of outcomes and insights at Medscape Education, outlined eight different therapy combinations that could be applied to one multiple myeloma case study.

The findings of a Medscape survey of 119 treating haem/oncs in Europe revealed that the multitude of different choices are causing physicians to lack confidence, she explained.

In the best case, 43% of those questioned were confident with a particular treatment choice, but in the worst case only 6% were confident with one of the options available.

Further analysis from the survey showed that a sizeable minority of haem/oncs (21%) were misinformed about the correct treatment choice for another case study, which involved a multiple myeloma patient presenting with severe peripheral neuropathy.

Lucero pointed out that this group of haem/oncs were confident about keeping patients on a treatment, even though it was likely causing the side-effect.

She argued that the survey shows that there is a need to increase the number of haem/oncs who have achieved mastery in making treatment choices.

Only 15% of the haem/oncs surveyed were found to have achieved mastery, a figure she said is “quite low”.

She added: “What’s concerning is the 21% who are misinformed, feeling confident but keeping the patient on a treatment that is linked to the adverse event they are experiencing.”

How to improve levels of mastery

Victoria Harvey-Jones, associate director of clinical strategy, medical education at Medscape Oncology, gave insights into the educational strategies that can be used to attain mastery.

She said: “It’s important to build foundational knowledge first, whether that be awareness of the different modes of action of novel therapies or the multitude of clinical data. Then we move on to understanding the clinical implications.”

It is also essential to understand what motivates haem/oncs to consume education, she added, so that materials meet their needs.

Half of 74 haem/oncs surveyed by Medscape said that they were motivated by a need to learn about the latest developments on a topic.

Of those questioned, 23% listed a personal interest in a topic as a motivation, while only 13% were motivated to learn when they were looking for an answer to a specific question.

Commenting on the findings, Mohty stressed the importance of continuous education as a way of encouraging haem/oncs to attain mastery, so as many haem/oncs as possible maximise their prescribing skills.

“I think we need to put everybody on track moving in the same direction,” he said.

Building knowledge and confidence with digital education

All this comes at a time when COVID-19 has made attending medical conferences and seminars in person impractical because of social distancing regulations.

A CE Outcomes survey showed that 49% of physicians do not expect to attend live meetings for at least six months, although 66% expect to attend an online version of a national meeting.

The survey showed that 65% of physicians expect to shift participation from live to online education. A separate study by McKinsey conducted in April this year also revealed that 90% expect to engage more with remote learning tools after the COVID-19 crisis.

Mohty argued that this has implications for pharma companies who are producing the research data on behalf of the medical community, in terms of the educational strategies they adopt to keep physicians up to speed with the latest developments.

He said: “They do have a responsibility towards educating healthcare professionals on the correct use of their drugs.”

Industry has recognised the need to shift to digital education, according to Harvey-Jones, who showed that leading pharma companies expect more digital activity because of the pandemic.

This was backed with additional research by Medscape, which showed digital education could reduce inappropriate use of fluoroquinolones in acute bacterial sinusitis, acute bronchitis in COPD, and uncomplicated urinary tract infections.

That study, conducted in partnership with the FDA, concluded that digital CME and targeted short form messages reduced prescription of the drug, positively impacting clinical behaviour and public health.

Mohty said: “I think the Medscape FDA results are a wonderful example of how you can positively impact a given field, and I think we should really move in this direction.”

Digital education is here to stay

During these difficult and unusual times, physicians must be prepared to adapt and change, something that is particularly true of haem/oncs where the need for CME support is immense because of the high level of innovation.

The new set of tools provided by digital education can build on the foundational information from medical journals and give doctors an insight into the latest practice-changing developments as they arise.

This will allow patients and society to feel the influence of the revolutionary new treatments that are available, despite the disruption caused by the pandemic.

As nearly all major conferences are being held online because of social distancing rules physicians have had to quickly get used to getting the latest medical education remotely.

Almost overnight virtual networking has become the norm, and for practical tasks doctors can improve their skills through digital simulations.

The increasing use of digital information will help to inform doctors who can’t attend medical conferences because of a hectic work schedule, or perhaps can’t afford the substantial travel and accommodation expenses.

As Mohty said: “Even if COVID disappears, which hopefully will happen very soon, we are going to restructure our lives. I simply think that digital CME is now here to stay, and it will continue to grow.”

Watch the Behavioural insights into haem/onc clinical decision making webinar in full.

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

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With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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