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

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.

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Jane Reed, director of life sciences at Linguamatics, an IQVIA company, to discuss some of the major barriers preventing researchers from accessing the data they need to advance drug discovery and development and address safety concerns – and just how AI technologies can assist.

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

Chronic cough impacts up to 10% of the adult population and has a physical, psychological, and social impact on patients’ lives. Farrell Simon, chief commercial officer at Trevi Therapeutics, joins web editor Nicole Raleigh on the pharmaphorum podcast to discuss prioritising patients in clinical and commercial development, with an especial focus on chronic cough. There are currently no approved therapies in either the US or the UK for what is a highly disruptive affliction, accompanied by a wide range of complications, which causes a significant burden on patients, caregivers, and healthcare systems. Also discussing Trevi’s own work in the field, in particular a potential treatment for idiopathic pulmonary fibrosis (IPF), the conversation explores how to work more closely and holistically with patients in clinical development. Integrating the patient voice is, as Simon says, critical in clinical trial design. After all, the patient is the utmost stakeholder.

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Ethan Drower, co-founder and CEO of Cite Medical Solutions, a company providing full Clinical Evaluation Report (CER) services and industry literature review for European Union Medical Device Regulation (or EU MDR) processes.  

One of the things that makes patient engagement for pharma companies so challenging is that it's not something that can be added to one step of a process and then checked off the list. Real patient engagement needs to be integrated into processes every step of the way. In today's podcast, brought to you by Reverba, Reverba CEO Cheryl Lubbert joins host Jonah Comstock to walk through the steps of the product lifestyle and explore the role of the patient at each of those stages: from preclinical through commercialisation and beyond. Lubbert discusses the relationship between patient engagement, patient activation, patient centricity, and patient co-creation. She gives a wealth of examples from her experience as a long-time leader in the pharma industry to give context to the many ways to incorporate patients and their feedback into product discovery, clinical trials, product development, launch, and post-launch. Finally, at the end of the podcast Lubbert gets into a few other hot-button issues including diversity and representation, as well as AI and how it will affect patient engagement. Tune in for interesting and actionable tips about patient engagement in pharma.

In today’s podcast, web editor Nicole Raleigh speaks with Carolyn Ward, director of clinical strategy at Particle Health Inc, a data transformation platform for healthcare, enabling organisations across the care continuum to turn medical records into actionable insights.