Former Cognoa executive Andy Molnar has been appointed chief executive of the Digital Therapeutics Alliance, a global trade association for companies developing evidence-based DTx products.
Molnar, who served as vice president of market access and government affairs at Cognoa, joins the four-year-old trade association at a time when the potential of using DTx to deliver remote healthcare has been thrust into the spotlight by the coronavirus pandemic.
Membership in the DTA has risen sharply since the start of COVID-19 and now consists of more than 50 companies and other organisations from around the world, including drugmakers like Roche, Novartis, Bayer, Astellas and Boehringer Ingelheim and DTx specialists such as Akili, Cognoa, Orexo, and Pear Therapeutics.
The role of DTx remains in flux however, particularly in light of regulatory changes in the US that allowed for emergency use authorisations of medical devices during the pandemic, doing away with the need for premarket approvals via the 510(k) process. That included some low-risk (Class IIa) digital health apps under the software as a medical device (SaMD) category.
The Department of Health and Human Services (HHS) issued proposals (HHS 86 FR 4088) in January to make that regulatory flexibility permanent, for example, but the DTA has said it cannot support those as there is a need for more appropriately tailored regulatory pathways for DTx to be introduced once the crisis abates.
Molnar takes the helm for the DTA as those regulatory changes play out in the US and other areas of the world that have adopted new procedures for DTx during the pandemic. In the US, the organisation is pushing for new regulatory pathways that deliver a balance between patient access and appropriate oversight DTx clinical indications, product claims, safety, and efficacy.
“Andy’s deep knowledge of the digital therapeutics industry, his expertise in market access for DTx products, and his vision for DTA make him the ideal CEO to lead us into the future,” commented Debra Reisenthel, chair of the DTA board of directors and founding CEO of member company Freespira.
Molnar’s predecessor at the head of the DTA – executive director Megan Coder – is taking on a new leadership role within the organisation based in Europe.
In that role she will “expand the DTA’s efforts related to international policy, lead the development of new content and resources, and grow cross-industry collaborative partnerships in support of DTA member goals,” according to the trade body.
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How can the pharma industry help build a greener NHS? Feedzy
NHS England has set its sights on becoming the world’s first net zero health system by 2045 – so what is industry doing to help achieve this goal, and what more needs to be done?
Sustainable healthcare systems can help create a healthier world and improve outcomes, meaning it is everyone’s responsibility to make it happen.
Pharma has made huge strides in helping NHS England achieve its net zero by 2045 target, but there is still much more work to be done, said the members of a panel discussion, held during the NHS Confederation Conference and facilitated by the Association of the British Pharmaceutical Industry (ABPI).
Exploring next steps, they talked about the value of sharing knowledge and how the “COVID effect” could accelerate progress.
Creating a healthier world
There is a huge crossover between the purpose of the health service and that of the green agenda, NHS England’s chief sustainability officer Dr Nick Watts told session moderator, Channel 4 News’ Victoria Donald.
“We exist to provide high-quality care for all, now and for future generations…if we let climate change go unmitigated… delivering that care is going to be very, very difficult in the future,” he said, adding that the interventions needed to create a greener NHS would also create a healthier society.
“A lot of what you do to respond to climate change is good for diet, good for physical activity, good for air quality, and good for running a common sense, efficient healthcare system. That is what the greener NHS programme is all about.”
Pinder Sahota, general manager at Novo Nordisk in the UK and vice president of the ABPI, said many of the association’s member organisations had already committed to significantly reducing their carbon footprint.
“We do not work in a bubble: we are part of society. We listen to politicians, the general public, the media. We listen to our families, and what our kids are saying. Organisations like ours and others have listened very carefully, and chosen to do something about it,” he said.
Top down and bottom up
The pressure to make a change was on all sides, added Anna Murphy, consultant respiratory pharmacist at University Hospitals of Leicester NHS Trust.
“There is a lot more awareness around the environment and how important it is to think about our carbon footprint. Patients are beginning to ask more about choices: could I have something more environmentally friendly or how do I dispose of it?” she said.
Explaining that even changes at trust level could make a big difference, Murphy said she was working with fellow panellist, managing director of Chiesi Limited, Tom Delahoyde, on a pilot inhaler recycling scheme.
Delahoyde, whose company is also working on a low carbon inhaler, noted that 77% of patients surveyed said they would use the programme if it was available.
“Patients want to play their part,” he said, adding that used inhalers often ended up in landfill. “It’s about giving patients what they want while also working with the NHS on sustainability.”
Delahoyde also spoke about the importance of transparency across the industry. “Words are easy. It is important that we open ourselves up for scrutiny. It’s almost trendy to talk about sustainability and every company wants its sustainability tick,” he said, explaining that all of Chiesi’s targets were validated and approved by the Science Based Targets initiative.
All three panellists agreed that collaboration, rather than competition, was the best way to achieve net zero.
“Many pharmaceutical companies have great initiatives in play to tackle this problem,” Sahota said, adding that the ABPI had an important role to play in helping the sector bring these individual programmes together.
“Now that we’ve got initiatives underway, we can come together and learn,” he said.
“Can we look at our supply chains and learn from one another? And how do we collaborate with the NHS to progress not only our individual company initiatives, but also support the NHS agenda?”
He used the example of Novo Nordisk’s project to reduce waste from its production sites.
“When we first looked at taking waste out of our manufacturing plant, and converting it to biogas, it didn’t happen straight away. We had to learn how to do it. I think it would be useful for other organisations to learn how can they jump to that solution quicker,” he said.
“It’s about trying things and improving processes, but then there should be a conversation that enables others to build on that knowledge.”
Creating a sustainable health service is a mammoth task – but the sector’s response to COVID-19 has demonstrated just how much the sector can achieve.
“It has been a very difficult 12 months,” said Murphy, “but we have had to work smarter, differently, more efficiently, and with perhaps colleagues who normally would have been behind a barrier… Some of the bureaucracy has been reduced.
“We’ve got this opportunity now to build on what we’ve learned.”
Sahota agreed, pointing to the success of the vaccination programme as proof of what can be achieved when the sector unites behind a common purpose.
“The collaboration that’s taken place, with multiple partners from the NHS, industry, and diagnostics companies, shows that when you have a great singular goal, when everyone is behind and you collaborating, you could achieve great things.
“If we could bring that mentality and momentum to sustainability, I think we can smash our targets.”
About the author
Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.
Source Here: pharmaphorum.com
US aims $80m of its rescue plan funding at public health IT Feedzy
President Joe Biden’s $3 billion pandemic rescue package includes $80 million in funding for to strengthen the US’s public health IT and data science capabilities.
The top-line objective is to make sure that the US health care system is “better equipped for the next public health emergency,” according to the Department of Health and Human Services.
The HHS also wants to improve data collection and reporting around infection, hospitalisation, and mortality rates and to “root out pervasive health and socioeconomic inequities that have been exacerbated by the pandemic”.
The pandemic disproportionately affected minority and underserved communities, and also exposed gaps in public health reporting and data analysis, particularly around race and ethnicity-specific data. The HHS attributes that at least in part to a shortage of staff and underfunding of public health IT at state and local levels.
The cash injection will go towards training more than 4,000 people over a four-year period in public health informatics and technology to create a steady flow through of public health IT specialists.
The hope is that bolstering the public health IT workforce will help tackle underlying health and social vulnerabilities.
A shortage of public health professionals trained in informatics and technology “was one of the key challenges the nation experienced during the COVID-19 pandemic,” according to Micky Tripathi, national coordinator for health information technology for the federal government.
In conjunction with the new funding, the Office of the National Coordinator for Health Information Technology (ONC) is asking colleges and universities to apply for funding through the programme.
The ONC particularly wants to get applications from colleges and universities which have strong links to black, Hispanic, tribal, Asian American and native American/Pacific Islander groups as well as other minority-serving institutions.
A consortium will develop the curriculum, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies, public health-focused non-profits or public health-focused private sector or clinical settings.
“Representation is important – particularly when we are deploying technology to tackle our most pressing health care challenges,” said HHS Secretary Xavier Becerra.
“With this funding, we will be able to train and create new opportunities for thousands of minorities long underrepresented in our public health informatics and technology fields,” he added.
Source Here: pharmaphorum.com
Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly’s Jardiance Feedzy
AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance.
The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.
Jardiance, Farxiga (dapagliflozin) and other SGLT2 drugs are already widely used to treat type 2 diabetes, and their developers have long had aspirations to expand their use into other cardiometabolic disorders, including heart failure and chronic kidney disease (CKD).
AZ stole a march on its rivals after it claimed approval for Farxiga as a treatment for HFrEF in the US in May 2020 and in Europe the following November. That helped drive sales of the drug up 30% to almost $2 billion last year, and more than 50% to $624 million in the first three months of this year.
That was followed by another first-in-class FDA approval for Farxiga in CKD in April, leaving Boehringer/Lilly playing catch-up with Jardiance once again.
Now, the approval of Jardiance for HFrEF in Europe – with an FDA decision due in the coming weeks – gives them a chance to reset the playing field. A readout in CKD from the EMPA-Kidney is expected next year.
The approval is based on the results of the EMPEROR-Reduced trial, which showed that Jardiance cut the risk of cardiovascular death or hospitalisation for HFrEF by 25% compared to placebo in patients, regardless of whether they had diabetes.
Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs, reporting sales of nearly $1 billion and $3 billion respectively, helped by data showing it could reduce cardiovascular complications in diabetic patients.
Both Jardiance and Farxiga have also benefited from side-effect problems – specifically amputation risks – that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson. The FDA removed the boxed warning for those risks last year but the product hasn’t recovered commercially.
As the marketing tussle between AZ and Boehringer/Lilly moves into the heart failure category, all eyes are now on upcoming data readouts in heart failure with preserved ejection fraction (HFpEF), a much more challenging indication.
Boehringer/Lilly are running the EMPEROR-Preserved trial while AZ has the DELIVER study on the go in HFpEF, which are due to generate results this year and in early 2022, respectively.
GlobalData has said that the lead in heart failure could push sales of Farxiga head of Jardiance in 2028, at $9 billion and $4.6 billion respectively, assuming they also get approved for the HFpEF indication.
Original Post: pharmaphorum.com
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