Structuring The Unstructured: Deterministic AI And White Box Data Cleanliness Pharmaphorum podcast

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Across the life sciences, Regulatory Affairs (RA) teams and their colleagues in Quality and Safety are stretched beyond their limits as already impossible demands on their time are compounded by rising health authority expectations. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Sonia A. Veluchamy, CEO and co-founder of Celegence, a company dedicated to improving patient outcomes through intelligent regulatory compliance. For both pharma and medical device companies, time and bandwidth are the number one challenge RA professionals face, closely followed by costs and budgetary pressures (the latter being a more pronounced concern for medical device companies). And, as the medical device sector responds to rising demands internationally around device identification, traceability, safety, and surveillance – designed to reinforce product quality and safety – companies have a chance to expedite their preparations, by looking to the adjacent pharma industry for lessons still being learned. Veluchamy dives into the details and explains what all these endeavours ultimately mean for patients. You can listen to episode 173a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Prevention for a healthier, more productive society 15:13

for 5 dage siden15:13

15:13

In a new pharmaphorum podcast, recorded during Anthropy 2025: Rebooting Britain, web editor Nicole Raleigh spoke with David Gillen, chief medical officer at Norgine, about the role of prevention in the future of healthcare. Recorded onsite at The Eden Project in Cornwall, the conversation centred around the Adelphi Group-sponsored panel, ‘The Prevention Revolution in Your Healthcare’, exploring the key takeaways and exciting possibilities from the panel discussion. Prevention is increasingly seen as contributing to a healthier and more productive society. But, as healthcare resources are stretched and medical science is accelerating, the question remains: how do we make prevention a reality? Encouragingly, healthcare systems are increasingly seeing the health, social, and economic benefits of prevention when it is delivered in an evidence-based way. You can listen to episode 172a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Safeguarding the pharmaceutical supply chain 13:37

for 18 dage siden13:37

13:37

As we hear of the volcanic and seismic activity taking place in Iceland this week, pharmaphorum turns back to a conversation with Dean Alms, CPO of Aravo, on how extreme weather highlights the need to make adequate supply chain preparations for the seasons in which the planet pulls out all the stops with the worst of its natural disasters. Having a blueprint for supply chain resiliency is critical, as a mature and robust risk programme enables the right emergency protocols and drug reserves to be in place in the worst-case scenarios, and permits plants to return to full operation as speedily as possible. And this is where Aravo, a third-party management software solutions company, comes in, operating at three macro levels: life cycle management, the due diligence process, and providing unified visibility into all this information. Alms talks through the different scenarios and ways of approach to best safeguard the pharmaceutical supply chain, and explains what should be top of mind for chief risk officers when each extreme weather season arrives. You can listen to episode 171a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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For the continuum of mental health we need a whole system, holistic 'healthspan' 35:49

for 21 dage siden35:49

35:49

If we don’t address the mental health of young people, that mental health challenge will advance into the adult population of tomorrow. What can be done to address the issue, though? At Anthropy 2025: Rebooting Britain, web editor Nicole Raleigh sat down with Dr Sebastian Vaughn, CEO of Phytome Life Sciences, for an en plein air and explorative conversation around the topic, live onsite at The Eden Project in Cornwall, following the Adelphi sponsored panel, ‘Revolutionary Thinking for Mental Health’, also with: Charlotte Baldwin, Mental Health UK; Dr Lauren Waterman, NHS; Sarah Hughes, MIND; and Dr Sri Kalidindi CBE, klip Global Ltd; and Lloyd Morgan, Adelphi Group, as moderator. Action in the real world resultant from discussions like those held at Anthropy is what is, of course, critical. We are all agents of change. Mental health is not a binary issue, says Vaughn, but rather a continuum of a life-long management process. However, the healthcare system alone is not the only point of delivery, and community-based solutions need to be put in place, too. Indeed, it is this system shift to collaborative efforts that will be key in changing the recent high tide of mental health diagnoses, including training teachers and even parents in the skills necessary to provide support for young people with mental health issues. Also exploring the increase in diagnosis, the lessening of stigma attached to mental health, and potential reasons there – Vaughn posits that ‘healthspan’, as opposed to ‘healthcare’, should be considered. Arguing against associating addressing mental health with putting people back to work and mere consideration of productivity amelioration, instead we should be asking what helps us thrive as human beings, says Vaughn. We need, simply, to live better, and live well – such strategies currently being implemented in communities such as those in Manchester. But, of course, young people themselves need to be offered a place at the table to make the changes they need for their own mental health; systemic change of the culture around mental health. And novel, holistic approaches that can be scaled – such as those being explored at Phytome – could be part of the necessary shift. You can listen to episode 170a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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IRA updates and making sense of the chaos in Washington, with Alice Valder Curran 38:29

for 4 weeks siden38:29

38:29

Last year, Alice Valder Curran, a partner at Hogan Lovells and a healthcare policy expert in Washington, D.C. joined host Jonah Comstock on the pharmaphorum podcast to talk about the intended and unintended consequences of the drug pricing negotiation provisions in the Inflation Reduction Act. On today’s episode, Curran joins us once again for an update on the IRA, looking at the second batch of drugs announced in January, recent messaging from the Centers for Medicare and Medicaid Services and what it might communicate about their thinking, and more analysis of IRA’s consequences, including a recent study on the impact of the IRA on early stage investment. She also talks about the possibility that, because of perverse incentives for pharmacy benefit managers, patient access to medications negotiated under the IRA could actually get worse. And she looks ahead to the third round of negotiations, which will see Part D drugs, including Keytruda, become eligible. While the IRA was the main focus of discussion, Curran and Comstock discuss a lot more about the current chaotic environment in DC, including the potential impact of layoffs on the functioning of agencies like CMS and FDA, the outlook for the possibility of IRA reform under the Trump administration, and the recent dispatch from Secretary of Health and Human Services Robert F. Kennedy indicating a change in policy around notice and comment rulemaking. Things are happening fast in the United States government and the ripples could have big effects for the pharma industry. Tune in for the low-down from an expert insider.…

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GenAI and the revolution of drug development 11:05

for 7 weeks siden11:05

11:05

It takes around seven years to develop a new drug and bring it to market. With the advent of GenAI, businesses in the life sciences sector can speed up the process, wiping months or even years off that average. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Bryan Hill, life sciences chief technology officer at Cognizant, in a conversation on how generative AI is revolutionising life sciences and drug development. Though it might seem an obvious path, not all life sciences companies are jumping on the bandwagon to adopt GenAI. Instead, many are taking a wait-and-see approach, staying put until the course forward is clearer to incorporate the technology. You can listen to episode 169a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Patient-focused manufacturing models for personalised therapies 22:44

for 7 weeks siden22:44

22:44

Unique, patient-focused manufacturing models are needed to scale up innovative cell therapies for cancer and one company, CTMC, is challenging the status quo to achieve this and get them to patients. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Jason Bock, co-founder and CEO of CTMC, a first-of-its-kind cell therapy engine aiming to advance novel scientific breakthroughs into medicines developed rapidly and robustly to - ultimately - end cancer. Taking learnings from the monoclonal antibody field to come up with a fit-for-purpose solution, Bock discusses his work in the joint venture between the MD Anderson Cancer Center and biopharmaceutical manufacturer Resilience – combining industrial manufacturing and development capabilities with the work of an academic medical centre. CTMC’s is a “patient adjacent” manufacturing model – crucial when it comes to developing personalised therapies (especially when dealing with living cells), and Bock explains how patient-centric approaches streamline manufacturing processes, improve efficacy, and allow for that personalised treatment approach, particularly when the supply chain is local. You can listen to episode 168a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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On specialty pharmacies and prior authorisations 18:13

for 8 weeks siden18:13

18:13

Prior authorisations (or PAs) have long put a burden on pharmacy and medical practices, ultimately causing delays for patients. In a new podcast, web editor Nicole Raleigh speaks with Andrew Burns, chief revenue officer at DrFirst, about the ramifications of delayed patient care when it comes to specialty medications. Exploring the current PA landscape, the conversation touches upon specialty pharmacy services and medications, helping to treat rare and complex medical conditions like cancer, rheumatoid arthritis, and multiple sclerosis. Mentioned also are the place of advanced AI and automation technologies, and patient-supportive education, in such services. It is, after all, about better health outcomes for patients. You can listen to episode 167a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Paediatric rare diseases: Children are not small adults 16:56

for 8 weeks siden16:56

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Around 75% of rare diseases are diagnosed in childhood, with most before the age of two. With 30% of rare disease patients dying before the age of five, the need for different treatment methods for children is clear. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Dr Helen Thackray, chief R&D officer at biotech company BioCryst, as well as an alumnus of the Children’s National Medical Center. The conversation touches upon incentivisation for manufacturers to develop drugs to treat rare diseases, addressing age-appropriate formulations and recognising the metabolic differences between children and adults, and looks also at clinical trial design. It’s clear that the time for action is now, and serving the paediatric patient population through every stage of the drug delivery process will lead to better adherence and more effective disease management. You can listen to episode 166a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Defining, building, and implementing in the next wave of biopharma R&D 25:27

for 9 weeks siden25:27

25:27

In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with two PharmaLex experts about navigating complex R&D processes to unleash the next wave of biopharma breakthroughs. PharmaLex’s Dr Christian Schneider, VP & Chief Medical Officer, Clinical Development Services, together with Dr Christelle Boileau, Director of Regulatory Development Strategy and IPD solution lead at PharmaLex, which is part of Cencora, explore the many challenges faced across the clinical trial landscape when it comes to new therapies, including ATMP development. From preclinical to market access and regulatory considerations, Dr Boileau warns that development is not a linear process, and for both an early-as-possible strategy is paramount. Comparing classical paradigms with the new, traditional endpoints need to be reassessed – for example, when defining dosage – says Dr Schneider. You can listen to episode 165a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Insights from JP Morgan Healthcare 2025: Key trends shaping the pharma industry 1:04:49

for 10 weeks siden1:04:49

1:04:49

The JP Morgan Healthcare Conference remains one of the most influential events for the life sciences sector, setting the stage for major deal-making, investment trends, and strategic shifts that will define the year ahead. Keen to capture all the key trends and talking points from this year’s event, pharmaphorum editor-in-chief, Jonah Comstock, hit the ground running in Philadelphia, live blogging key sessions and interviewing experts to find out what industry insiders foresee for 2025. In this special extended episode of the pharmaphorum podcast, Jonah sits down with Deep Dive editor, Eloise McLennan, to break down the key themes and takeaways from this year’s event. From the impact of the new Trump Administration on research and development to advancements in brain health, PBM reform, and the evolving role of GenAI in clinical trials, they explore the discussions and developments set to shape pharma’s trajectory in 2025 and beyond. Plus, hear exclusive interviews from experts, including: Catherine Owen Adams from Acadia Pharmaceuticals on trends and innovations in brain health NKarta’s Paul Hastings discusses natural killer cells and developments in cell and gene therapies Evidation’s Phil Johnson on the role of real world data in drug development Grove AI’s Tran Le and Sohit Gatiganti on the immense potential of AI in audio for clinical trials You can listen to this episode, as well as previous episodes of the pharmaphorum podcast , in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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‘Show me the molecule’ – On synthetic biology and cutting through AI hype 15:01

for 11 weeks siden15:01

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Therapeutic antibodies are a vital weapon in combating diseases such as cancer, but developing these treatments through conventional methods is slow and unreliable. In a new pharmaphorum podcast, web editor Nicole Raleigh spoke with Dr James Field, founder and CEO of LabGenius, a drug discovery company pioneering the discovery of next-generation therapeutic antibodies in order to solve this predicament. Dr Field speaks to how can industry cut through the hype that surrounds AI and optimally assess the technical underpinnings of an AI proposition in medicine. He describes how LabGenius overcomes the so-called “cognition barrier” by using mathematical models to understand how molecules will respond to disease, and then designs novel therapeutics with the right collection of properties. You can listen to episode 164a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Simulated clinical trial populations and AI scalability 29:03

for 11 weeks siden29:03

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AI might still be in the modish buzzword stage, but discussions exploring the potential for its scaling within life sciences are critical. In a new pharmaphorum podcast with ZS Associates’ Sharon Karlsberg, principal and leader of oncology solutions, and Brandi Davis-Dusenbery, principal and partner, web editor Nicole Raleigh explores the potential for scaling advanced technologies in the biopharmaceutical industry. From digital twins and insilico modelling and the potential to reduce experimentation in human populations with simulated populations and differently designed trials, to document authoring and automation for time-saving purposes – the conversation on leveraging AI turns also to the global regulatory landscape. You can listen to episode 163a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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Rare disease and the women's health gap 15:43

for 12 weeks siden15:43

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For women with rare diseases, they often face a double jeopardy, where many of the symptoms they experience can be confused with and misdiagnosed as menopause. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Jennifer Schranz, head of rare diseases at Ipsen, for a conversation focused on rare liver disease primary biliary cholangitis (PBC), which affects nine women for every one man, and the women’s health gap more generally. Schranz explains the importance of developing a more individualised approach to management and treatment of PBC for each patient and discusses Ipsen’s PBC therapy Iqirvo (elafibranor). You can listen to episode 162a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes , Spotify , Amazon Music , Podbean , and pretty much wherever you get your other podcasts!…

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From science fiction to reality: AI in drug development 21:32

for 14 weeks siden21:32