Approaching the regulatory world with passion: CERs and EU MDR processes

Virtual wards (also known as hospital at home) allow patients to get the care they need at home safely and conveniently, rather than being in hospital. The NHS is increasingly introducing virtual wards to support people at the place they call home, including care homes. In today’s podcast, web editor Nicole Raleigh speaks with Dr Samuel Ewing, global head of pharma partnerships at Doccla, about the next generation of digital tools such as wearable medical devices, as well as remote patient monitoring and digital healthcare generally. Although wearables go back decades, the true benefit for patients and healthcare systems allows home monitoring. Explaining a current COPD example, it’s about reducing hospital admissions, says Ewing, thereby reducing burden, and its also about more individualised care, on which point Ewing explores the current physician grading scale of Parkinson’s symptoms compared to remote and daily patient monitoring. In short, technology is transforming healthcare today, but there’s still a lot of work to do. Yet, Ewing caveats against ‘hysteria’ around data management and posits that there is perhaps too much concern over data privacy.

Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ultrasound. Focus ultrasound (FUS) has the potential to revolutionise therapy to the same degree that magnetic resonance imaging (MRI) scanning revolutionised diagnosis, says Kassell. The effect of the treatment can be observed as it is being administered in real time by using such imaging; it is image-guided therapy. Of the 180 indications in various stages of development using FUS, the number of regulatory approvals and reimbursements is increasing. Dialogue has shifted from ‘if’ to ‘when’ and the Focused Ultrasound Foundation works to make that when ‘now’. And it all begins with evidence, evidence come from research.

A digital health passport is an app, or online certification, that displays a traveller’s health or vaccination record. It can save lives, on both private and public levels. In today’s pharmaphorum podcast, web editor Nicole Raleigh speaks with Matt Hollingsworth, co-founder and CEO of Carta Healthcare, a company seeking to support the healthcare data registry market by transforming a previously manual clinical data abstraction process. Hollingsworth discusses his own, very personal experiences that led to Carta Healthcare’s foundation and progressed its work, as well as the comfort that can be provided patients with chronic diseases – including congenital heart defects – with digital health passports, offering an information safety net for them whilst travelling, circumventing the need to carry veritable folders full of printed health records. Diving into the what’s what of EHRs, AI’s role in digital health passports, and the pros and cons of a generally digital future, technology is nevertheless very much in our health futures, explains Hollingsworth.

The pandemic served as a catalyst for a revolution in genomic surveillance for tracking pathogens. The technology proved vital in aiding understanding of the evolution of and spread of virus in real time to inform public health measures, ultimately accelerating drug and vaccine development. In today’s podcast, web editor Nicole Raleigh speaks with Dr Evan Floden, CEO and co-founder of Seqera, a data orchestration and genomics analysis company, about barriers of entry to genomic surveillance in public health labs and how these can be lowered to support future bioinformaticians, aiding acceleration and quality and accuracy in R&D.

Precision medicine is oft spoken about these days, as it is finally addressing the elephant in the room: one size – or, more appropriately, one dose – does not fit all. Precision medicine hones in on treatment of the individual, rather than just the disease, focusing on the reality that each patient is biologically different. Personalisation is very much key. In a new pharmaphorum podcast, web editor Nicole Raleigh spoke with Hakim Yadi, PhD, OBE, and CEO and co-founder of Closed Loop Medicine, ahead of his appearance at Frontiers Health next week, 17th-18th October. Closed Loop Medicine is a TechBio company developing prescription combination drug plus software products, with the aim of bring forward the promise of precision medicine. From personalised dosing to the applicability of this approach to the GLP-1 trend in obesity treatment, the conversation covers recent collaborations and harks back to discussions at the Galien Forum earlier in 2024, honing in on the importance of workflow and cost considerations, also.

Investment and strategic partnerships are the lifeblood of innovation in healthcare, driving groundbreaking discoveries and accelerating the development of life-changing therapies. And so, it was no surprise that the 2024 LSX USA Congress in Boston attracted life sciences innovators and decision-makers from around the world, eager to explore the latest trends shaping the industry. Among those attendees was pharmaphorum’s editor-in-chief, Jonah Comstock, who took to the floor to uncover the trends and talking points set to influence investment decisions in the coming months. In this special episode of the pharmaphorum podcast, Jonah sat down with Deep Dive editor Eloise McLennan to discuss key takeaways from the LSX conference. From evolving investment trends like AI in biotech and digital to emerging areas such as precision psychiatry, they explore the cautiously optimistic investment landscape, the delicate balance between early- and late-stage investments, and the importance of building honest, productive relationships across the healthcare ecosystem. Tune in to hear their in-depth analysis of the latest investment and partnership trends shaping the future of healthcare innovation.

The ESMO congress always disseminates the latest results of cancer research, a vibrant gathering and sharing of the latest data, communicating the next promising steps in oncological scientific development, ever seeking to address unmet patient needs. So it was that pharmaphorum Web Editor Nicole Raleigh found a quiet spot onsite in Barcelona this year to catch with experts from EVERSANA and discuss their takeaways from the 2024 conference. Tune in to hear more from: Ann Marie Robertson, Chief Commercial Officer, EVP, EVERSANA COMPLETE Oncology, EVERSANA; Barry Vucsko, Senior Vice President, Client Services and Business Development Leader, EVERSANA INTOUCH; Vanitha Sankaran, VP, Medical Strategy, EVERSANA INTOUCH; and Gurdip Daffu, PhD, VP, Medical Strategy (Oncology), EVERSANA INTOUCH. From the unique to the specifics of antibody-drug conjugates (ADCs) and advancements in women’s cancers, to the proliferation of AI and where it’s all going, and from diagnostics to excitement and hope at what’s on the cusp and what’s yet to come – the sense of bated breath potential is palpable.

Last month, the US Centers for Medicare and Medicaid Services released the negotiated prices for the first 10 drugs subject to the drug negotiation provisions in the Inflation Reduction Act. The industry has been waiting with bated breath to see these prices, as they give the first real indication of how impactful this unprecedented legislation will be for pharma’s bottom line. But this latest release of information raises as many questions as it answers, and on today’s podcast host Jonah Comstock is joined by Alice Valder Curran, a partner at Hogan Lovells and a healthcare policy expert, for a broad ranging discussion of some of the next steps and consequences – intended or otherwise – of this legislation. They talk about the many challenges CMS is likely to face in operationalising these prices and how much of the savings is likely to find its way to patients when the dust settles. They also discuss the prices themselves, why they aren’t lower, and just how low they really are, contextually. Additionally, they discuss some of the downstream consequences still to come from the IRA, including possible effects on oncolytics and the generics market. For the pharma industry, the IRA drug pricing negotiation provision is shaping up to be one of the most consequential political stories of the decade. Tune in for a lively and in-depth discussion of what those consequences might look like.

The Life Sciences Generative AI Council aims to bring together the best minds in pharma, academia, and technology to advance the use of GenAI in life sciences R&D, seeking through pinpointing and showcasing repeatable use cases to shape the targeted use of next-generation artificial intelligence and machine learning (AI-ML) innovation, particularly in the form of GenAI. In today’s pharmaphorum podcast, web editor Nicole Raleigh speaks with Manny Belabe, senior VP of customer success at ArisGlobal, about the Council and the role it seeks to play in furthering the success of GenAI in life sciences R&D. Discussing also ArisGlobal’s LifeSphere NavaX GenAI features and functionality, Belabe notes too that a platform-centric development approach, based on common modules, can be leveraged to reduce data redundancy and general maintenance of that data. At the present moment, however, there is also the pressing concern of sustainability in all sectors, and Belabe addresses practical issues around cooling infrastructure and space requirements for these technologies, as well.

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Brian Fiske, chief scientific officer of Mythic Therapeutics, about minimising side effects for patients and the notion of patient-centred science.