The Pharma Letter podcast

15:14

In this week’s podcast, we welcome Iddo Peleg, CEO and co-founder of Yonalink, who provides insights into the current and future state of the clinical trial industry. As we move headlong into 2025, a year that appears set to be characterized by global economic and political turmoil, Iddo discusses major trends in the industry, including challenges posed by the COVID-19 aftermath and the potential impacts of regulatory upheaval on clinical trials. He also outlines how Yonalink’s technology, which streams data from electronic health records to clinical trial databases, can dramatically reduce timelines and improve accuracy in clinical studies. The conversation delves into the practicalities and potentials of decentralized and distributed clinical trials, offering advice to young biotech startups on leveraging the right technology for innovation.…

The Pharma Letter Podcast

1
Japanese pharma in the UK 19:43

9 weeks ago19:43

19:43

In this episode, we’ll take a look at the role of Japanese pharmaceutical groups in the UK, with Jackie Davis, general manager at Astellas Pharma. Tokyo-headquartered Astellas (TYO: 4503) has developed a strong portfolio in urology, oncology and immunology, most recently with US FDA approval for Vyloy (zolbetuximab), a key addition to its cancer treatments. It’s one of many Japanese companies with a strong presence in the UK, represented nationally by the Japanese Pharmaceutical Group, of which Jackie is the current chair. We’ll get into the details of a recent visit from the JPG to the House of Lords, as well as her view on some of the challenges and opportunities that have arisen in the years since Brexit.…

The Pharma Letter Podcast

1
How can we use AI to program antibodies? 16:25

23 weeks ago16:25

16:25

This week, we discuss a novel AI-driven approach to drug development, and its potential to transform the treatment of cancer and autoimmune diseases. We are joined by Yanay Ofran, chief executive and founder of Israel-based Biolojic Design, a company that is working on programmable antibodies. Biolojic's platform has already yielded a first-of-its-kind computationally designed antibody, now in Phase II trials, as well as a pipeline aimed at autoimmune and inflammatory conditions. The firm has also forged collaborations with major players in the industry, including fellow Israeli firm Teva (NYSE: TEVA), as well as Eli Lilly (NYSE: LLY) and Germany’s Merck KGaA (MRK: DE).…

The Pharma Letter Podcast

1
Breakthroughs in MASH, with 89bio CEO 22:19

43 weeks ago22:19

22:19

This week we’re focusing on an area of clinical research that has been of great interest for a number of years, that is NASH, also known as MASH. It’s a high area of unmet medical need, with over 20 million diagnosed cases across Europe and the USA, and while there are more than 80 therapies currently in the pipeline, only around 5% of these are in Phase III development. One company working in this area is San Francisco-based 89bio (Nasdaq: ETNB), which has a candidate now in Phase III, pegozafermin, and in this episode we are joined by the company’s chief executive, Rohan Palekar. We are also joined by Dr Arun Sanyal, who is Professor of Medicine at VCU Health and founder of the Liver Trust.…

The Pharma Letter Podcast

1
How to develop cancer drugs faster, with Ellipses Pharma 22:50

1 year ago22:50

22:50

This week we are speaking with the chief executive of British drug development company Ellipses Pharma. Founded in 2018 to create new cancer therapies, the firm is following a unique multimodal approach to clinical development, leveraging a variety of technologies. That’s not the only way that Ellipses is rethinking drug development. The company uses a consultative model to provide an unbiased vetting process for candidates, with the goal of de-risking initial asset selection. Ellipses also wants to make sure that capital is invested in the most efficient way, pursuing a portfolio-based strategy which ensures uninterrupted development capital for each asset. Our guest on the show is Ellipses CEO and co-founder, Dr Rajan Jethwa.…

The Pharma Letter Podcast

1
CRO sector surges in bio revolution 12:46

1 year ago12:46

12:46

In the world of outsourced clinical research, ICON is a big fish in a pond full of other increasingly big fish. In this episode of The Pharma Letter Podcast, we chat with the company’s chief commercial officer, George McMillan. Like many in the industry, the Dublin-headquartered clinical research organization (CRO) has sought to grow in size to take advantage of increasing demand for its services. A coming together of numerous advances in biotechnology over recent years has led to a new wave of innovation in the life sciences. Much of the innovation has come from smaller biotech firms, sometimes incubated by hands-on investment groups dedicated to nurturing early-stage science. But such start-ups need support to progress into clinical-stage development and beyond, with regulators keeping a close eye on the development and manufacture of new technologies. This is one area in which CROs and CDMOs have picked up the slack. Another trend is the increasing desire on the part of large pharmaceutical players to divest non-core parts of the business and focus on their key strengths - providing an opportunity for a company like ICON to pick up new partnerships and development opportunities. As new biologics and cell and gene therapies start to have a real impact on people’s lives and health, the degree of specialism required has enabled some companies to establish themselves as leading experts in certain areas. The future looks bright, and as the impact of artificial intelligence is increasingly felt in this sector, there is surely plenty more to come.…

The Pharma Letter Podcast

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Lilly looks to lead in Alzheimer's 17:20

2 years ago17:20

17:20

With an Accelerated nod for Aduhelm (aducanumab) and now full approval for Leqembi (lecanemab) in the USA, Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have overturned decades of failure in Alzheimer’s. But at the annual meeting of the Alzheimer’s Association (AAIC), it’s another neurology heavyweight taking center stage, as Eli Lilly (NYSE: LLY) makes clear its intention to remain a leader in the treatment of this challenging disease. At the AAIC in Amsterdam, we’re speaking with two key figures from the development program for donanemab, a candidate which could slow cognitive decline for millions of people with early Alzheimer’s, while generating billions in annual revenues. Lilly is presenting full results from a key Phase III trial of its antibody, which like Leqmebi, clears aberrant proteins from the brain with the goal of combatting neurodegeneration. There are important differences between the way the two molecules work, however, and Lilly is confident its approach, which includes limited duration dosing, offers the best chance of success. The new data, which form part of a regulatory submission for approval in the USA, seem to bear this out. As with other therapies in this class, all eyes will be on safety, and Lilly hopes that “treating to clear,” and then holding off on dosing, could help avoid side effects. Like Eisai , Lilly is also interested in developing a subcutaneous treatment in future, with early data for another molecule, remternetug, showing strong potential in this regard. We discuss all of this and more, in Episode 24 of The Pharma Letter Podcast.…

The Pharma Letter Podcast

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AAIC preview with Eisai deputy CCO Michael Irizarry 22:43

2 years ago22:43

22:43

In the runup to the annual meeting of the Alzheimer’s Association, this week we are speaking with Michael Irizarry, deputy chief clinical officer at Eisai US. At the event in July, there will be plenty to discuss, with recent new data from Eli Lilly (NYSE: LLY) suggesting its anti-amyloid candidate, donanemab, is likely to provide healthy competition for Eisai's (TYO: 4523) own Alzheimer’s product, lecanemab - marketed in the USA as Leqembi. Like Lilly, Eisai has been a pioneer in neurology, sticking with its Alzheimer’s research even when times were tough and it looked like a clinical breakthrough would never come. That we are now talking about potentially three approved products for early Alzheimer’s shows how quickly development has advanced - as both Lilly and Eisai look ahead to the possibility of offering more beneficial subcutaneous treatments in future. In the podcast this week, we will discuss Eisai’s upcoming presentations at AAIC and consider what the future might hold for the treatment of Alzheimer’s.…

The Pharma Letter Podcast

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A new way to innovate, from Flagship Pioneering 23:37

2 years ago23:37

23:37

Set against a backdrop of foundering confidence in biotech stocks, the success of some companies incubated by Massachusetts-based Flagship Pioneering has been remarkable. Flagship has invested billions of dollars getting startups off the ground, many of which, such as Foghorn Therapeutics (Nasdaq: FHTX), Codiak Biosciences (Nasdaq: CDAK) and Rubius (Nasdaq: RUBY), have gone on to become publicly-traded companies. Moderna Therapeutics (Nasdaq: MRNA), the poster child for the firm’s strategy, has generated tens of billions of dollars while saving millions of lives with its mRNA-based coronavirus vaccine. Not content to propagate life-changing technologies at over 40 new startups, Flagship now hopes to reinvent the way commercial drugmakers engage with biotech platforms, launching Pioneering Medicines in 2020. The idea is to build a portfolio of cutting edge medicines by identifying novel therapeutic approaches within Flagship’s fleet of companies. Led by former Bristol Myers Squibb (NYSE: BMY) veteran Paul Biondi, executive partner at Flagship since 2019, the firm’s new venture has already scored a major partnership with Danish diabetes giant Novo Nordisk (NOV: N). The aim is to link with big players in the industry to carry forward emerging candidates into late-stage development. On this week’s episode of The Pharma Letter Podcast, we speak with Mr Biondi to understand more about his work at Pioneering Medicines, and gain an insight into broader industry trends.…

The Pharma Letter Podcast

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Will radical new EU regs hobble industry? 22:56

2 years ago22:56

22:56

A draft of the European Commission’s ongoing review of pharmaceutical legislation has leaked, prompting a bitterly-worded reaction from drugmakers, which accuse legislators of “sabotaging” the industry. There is no doubt that the proposals represent serious change. Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin, describes them as the most far-reaching for decades. On this week’s episode of The Pharma Letter Podcast, Mr Meulenbelt will walk us through the leaked draft and outline the most significant impacts, good and bad. Some of the measures to be considered include: generally shorter periods of exclusivity for novel medicines; a requirement that new drugs must launch region–wide within two years; and the introduction of a voucher system to encourage the development of new antibiotics. The European Commission is also apparently proposing to simplify the drug application process, increase obligations on drugmakers to report shortages and bring in more foreign inspections. Of course, whatever the final proposals turn out to be when they are published at the end of April, they will likely change again, with the European Parliament and the EU Council next in line to debate and revise the document. No doubt, there will be plenty of chances for the industry to have its say before then.…

The Pharma Letter Podcast

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Galapagos update—with CEO Paul Stoffels 20:15

2 years ago20:15

20:15

This week on The Pharma Letter Podcast, we are joined by Galapagos (Euronext: GLPG) chief executive Paul Stoffels. After an illustrious career as chief scientific officer at Johnson & Johnson (NYSE: JNJ), Dr Stoffels is ready for a new chapter in his home country of Belgium. His instalment as Galapagos CEO is also a kind of homecoming. Founded in 1999, the firm emerged from a joint venture between Crucell and Tibotec, an infectious disease specialist for which Dr Stoffels served as chair, before the company was acquired by J&J in 2002. While the company has a strong balance sheet and a promising pipeline, Galapagos has had its share of ups and downs in recent years, including late-stage failures and a rebuff from the US regulator for a JAK inhibitor partnered with Gilead Sciences (Nasdaq: GILD). With his feet barely under the desk, Dr Stoffels has been busy moving on from disappointments connected with the Gilead partnership, with a series of M&A moves. The acquisition of CellPoint and AboundBio will boost access to next-generation cell therapies and help the firm in its stated aim of bringing three differentiated CAR-T candidates into clinical development within three years. In this week’s episode of the podcast, we’ll ask Dr Stoffels about what motivated him to leave J&J, and what he has planned for Galapagos in the coming year.…

The Pharma Letter Podcast

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US midterms and beyond: the outlook for pharma 18:06

2 years ago18:06

18:06

The outcome of the recent midterm elections in the USA surprised many by returning a Democrat-led Senate, preventing Republicans from gaining control of the next Congress. Analysts, having expected a stronger showing for Republicans, put some of the blame on former president Donald Trump, whose endorsements and active involvement in campaigning were said to frighten off moderates. In this week’s episode of The Pharma Letter Podcast, we are joined by Stephanie Kennan, senior VP for federal public affairs at McGuireWoods Consulting, for a discussion on the possible implications. We’ll consider the likely course of future life sciences legislation, in particular the additional provisions which were omitted from the pared back, so-called “skinny” user fee reauthorization in September. We'll also take a quick look ahead to 2024. As Florida’s Ron DeSantis basks in the triumph of his gubernatorial campaign, a run at the presidency now looks inevitable, and bookmakers are putting him above Mr Trump as favorite to win power - albeit with a long way to go until polling day. We’ll discuss what a DeSantis White House might look like for the life sciences industry.…

The Pharma Letter Podcast

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Focus on rare liver diseases, with Albireo CEO Ron Cooper 16:56

3 years ago16:56

16:56

*Partnered content In Boston, Massachusetts, one company is now making significant headway in the development of an innovative treatment for rare pediatric liver diseases. Led by president and chief executive officer Ron Cooper, Albireo (Nasdaq: ALBO) has since 2021 boasted both US and EU approval for the novel bile acid modulator Bylvay (odevixibat). The oral medicine addresses an unmet need by providing the first non-surgical treatment option for people with progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder affecting young children that causes progressive, life threatening liver disease. Bylvay is approved for the treatment of pruritus in PFIC in the USA, and for PFIC in Europe. The company has also recently announced positive top-line results from the Phase III ASSERT study, which is testing Bylvay in Alagille syndrome (ALGS), another rare genetic disorder. Approval in ALGS would open up another source of revenue for the product, and offer hope for families impacted by this serious condition, which affects multiple organ systems including the liver and heart. Estimates vary for the therapy’s peak revenue potential, but most analysts suggest the product will be able to generate hundreds of millions in annual sales, should all go according to plan. As well as transforming the treatment of rare conditions with a high disease burden, such an outcome would enable the company to more fully explore the science of IBAT inhibition, an approach which it believes has great potential in a wide range of cholestatic liver diseases. In this week’s episode of The Pharma Letter Podcast, I’m pleased to be joined by Ron Cooper, for a discussion of his company’s clinical goals and strategic focus.…

The Pharma Letter Podcast

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Inflation Reduction Act: quick take 12:19

3 years ago12:19

12:19

As President Joe Biden signs the Inflation Reduction Act into law, drugmakers in the USA are poring over the likely impact on drug prices, and how best to respond to its enactment. The legislation passed in the US Congress with Vice President Kamala Harris casting the decisive vote in an otherwise deadlocked Senate. That evident lack of bipartisanship put the kibosh on Democrats’ more ambitious plans, with the new law representing a greatly watered down version of the original $3.5 trillion Build Back Better plan. Democrats have had to scrap limits on certain drug price increases above inflation, for example, with this provision applying only to drugs paid for by the federal insurance fund Medicare. Nonetheless, the Inflation Reduction Act is a very significant piece of legislation, unlocking subsidies for so-called Obamacare recipients in order to reduce annual premiums by $800 for around 13 million people. The new law also finally realizes a long-held ambition for Democrats, empowering Medicare’s administrators to negotiate certain drug prices directly, up to a point. In this week's episode of The Pharma Letter Podcast, we take a quick look at the Act’s provisions and the likely impact on drugmakers with Stephanie Kennan, a senior member of the Federal Public Affairs group at McGuireWoods Consulting.…

The Pharma Letter Podcast

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EQRx plots radical disruption on pricing 32:06

3 years ago32:06

32:06

For years, commentators have observed that drug prices in the USA are significantly higher than elsewhere in the world. Pointing to the high levels of innovation in the USA, a country where new drugs and biologics tend to get launched first, argue that market-based pricing funds essential research and development. As the US Congress debates more government intervention to improve access, including the potential for the federal insurance fund Medicare to actively negotiate drug prices, one company is looking to work with the system to achieve the same result. Launched in 2019 , EQRx (Nasdaq: EQRX) aims to create patent-protected medicines at drastically lower prices by leveraging new technologies and reforming the drug discovery and patient delivery process. While it may sound radical, the company is by no means on the fringes of industry, with biotech heavyweights behind it, including founder Alexis Borisy, a co-founder at Foundation Medicine and Blueprint Medicines. In this week’s episode of The Pharma Letter Podcast, I’m joined by the company’s chief executive, Melanie Nallicheri. We’ll discuss EQRx’ extraordinary success in fundraising, its work with Chinese biotech firm CStone Pharmaceuticals on a novel checkpoint blocker, and more.…

The Pharma Letter Podcast

1
Can AI find new drugs for metabolic diseases? 41:29

3 years ago41:29

41:29

Interest in the potential for artificial intelligence to transform different aspects of the drug discovery and development process is at an all-time high. According to industry analyst GlobalData, the number of AI deals in pharma has doubled in the last three years, reaching 85 in 2021, and more pharmaceutical companies are hiring for AI roles than ever before. Another way of gauging interest is to look at the number of AI-based patents granted over time, with analysts recording a three-fold increase since 2015. While the broad picture is clear, a detailed look at where this activity is focused reveals that not all therapy areas have received the same level of attention, with oncology attracting much of the interest. One UK-based company is looking to transform the way metabolic disorders are treated, leveraging many of the same AI-based techniques used to great effect elsewhere. MultiOmic Health is targeting a huge area of unmet medical need and a panoply of conditions including diabetes, heart disease, liver disease and kidney disease. Together, such metabolic disorders account for the largest proportion of the world’s healthcare spend, nearly $2 trillion, with that amount set to rise as global populations age. In this week's episode of The Pharma Letter Podcast, MultiOmic chief executive Robert Thong discusses his firm’s progress and ambitions for the future.…

The Pharma Letter Podcast

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A vaccine for Alzheimer's? 40:42

3 years ago40:42

40:42

With the approval of Aduhelm (aducanumab), the first new Alzheimer’s treatment in decades, people affected by dementia were given new hope that a breakthrough had finally arrived. A year later, the product is yet to gain traction in the USA, the only country to have approved it, and developers Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have been forced to rely on confirmatory trials to open up reimbursement - results from which are not expected for some time. Despite the setbacks, the US Food and Drug Administration's accelerated approval for the amyloid beta-targeting antibody has reignited interest in a therapy area which major drug developers have stepped back from in recent years. One company, Prothena (Nasdaq: PRTX), is developing antibodies targeting both Abeta as well as the tau protein, and has an intriguing Alzheimer’s vaccine, dubbed PRX123, which is yet to enter the clinic but which scientists believe could stop the development of both of these proteins in the brain. Discussing the firm’s progress in episode 14 of The Pharma Letter Podcast is chief executive Gene Kinney.…

The Pharma Letter Podcast

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Is there a data capture crisis in biotech? 19:34

3 years ago19:34

19:34

In recent years there has been an explosion of digital tools and platforms in the life sciences industry, designed to improve processes ranging from drug discovery and development, through to registration and commercialization. As with everything in pharma and biotech, the value of these tools hinges on the strength of the underlying data, making it essential to capture research in a robust and reliable way. One UK-based company, Labstep, is helping researchers to accomplish this with a fully automated, cloud-based digital data capture tool. While digital tools to assist medical research already exist, Labstep says that many scientists still resort to documenting experiments with pen and paper, an approach which it believes could be costing the industry billions in lost opportunities. Founded in 2016, the startup is already working with over 40 global scientific and health organisations, including GlaxoSmithKline (LSE: GSK) and the UK Dementia Research Institute, as well as The Francis Crick Institute. The company has raised around $3 million to date and is looking to exceed this amount with a fresh funding round, planned for the near future. In Episode 13 of The Pharma Letter Podcast, we discuss Labstep's technology and future ambitions with the company's chief executive, Jake Schofield.…

The Pharma Letter Podcast

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Mastering the microbiome 28:59

3 years ago28:59

28:59

Companies developing microbiome-based treatments have garnered a lot of interest recently, following many years of uncertainty over the therapeutic potential of the approach. This has led to more money from venture capitalists, and increased valuations for publicly-listed companies. Life sciences investor Flagship Pioneering, for example, has helped found several new microbiome startups, including Kaleido Biosciences (Nasdaq: KLDO) and Seres Therapeutics (Nasdaq: MCRB), which is developing SER-109 as an option to reduce recurrence of C. difficile infection. Phase III success for Seres in this indication, followed by more positive results for candidates developed by Rebiotix and by Finch Therapeutics (Nasdaq: FNCH), have really stirred enthusiasm from the investment community. Big pharma is also starting to pay attention, with money coming from companies including Gilead Sciences (Nasdaq: GILD), Johnson & Johnson (NYSE: JNJ) and Merck & Co (NYSE: MRK). Japanese gastroenterology giant Takeda (TYO: 4502) has started new collaborations with an array of biotech startups, including Finch, Debiopharm and Enterome. In the UK, Glasgow-based startup EnteroBiotix is looking to expand quickly, with a particular focus on developing a high quality donor program as part of an end-to-end supply chain for microbiome-based therapeutics. The company’s founder and CEO, Dr James Mcllroy, spoke with The Pharma Letter about his development strategy, as well as the broader potential for this therapy area.…

The Pharma Letter Podcast

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Should US states control drug prices? 16:57

3 years ago16:57

16:57

At the national level, drug pricing continues to be a hot button issue for lawmakers, drugmakers and patients in the USA. For many years, successive administrations have proposed a range of regulatory reforms designed to contain what some regard as excessive drug prices, with Congress typically unable to agree on a way forward. Meanwhile, at the state level, regulators have sometimes taken matters into their own hands, with the concept of the Prescription Drug Affordability Board (PDAB) gaining traction in some cases. These may take different forms, with members of the board typically being appointed from a range of stakeholders. The board is then tasked with reviewing the cost of higher priced products and proposing a suitable reimbursement scheme for review by the state legislature or governor. In Maine, for example, the PDAB reviews medicines that are difficult to afford, costing more than $30,000 per year, or $3,000 for generic medicines, when they increase in price by a certain amount. But many in the industry point out that research and development is expensive, arguing that low levels of reimbursement could threaten to cut off the engine of innovation. And the fact that most new medicines originate in the USA, and are approved there first, suggests that something about the model is working well. Discussing these issues in episode 11 of The Pharma Letter Podcast is Debbie Hart, chief executive of BioNJ, a group representing the biotech industry in New Jersey.…

The Pharma Letter Podcast

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Will decentralized clinical trials become the new standard? 19:17

3 years ago19:17

19:17

This week, we look at the potential impact of decentralized clinical trials. During the The COVID-19 pandemic, we have seen increased adoption of this kind of study, as part of a general movement towards greater use of innovative digital platforms for collecting and distributing clinical data. As well as improving the experience for patients and doctors, the approach could enable researchers to collect data in a faster and more efficient manner. It is perhaps no surprise then that the number of drug trials with a virtual or decentralized component exceeded 1,000 in 2021, a 50% jump from the previous year. According to analysts, 2022 will be another record year, with around 1,300 such trials expected to initiate. However, given the tightly regulated nature of the industry, how far can we expect this kind of research to replace trials conducted within a more controlled clinical setting? With me to discuss these issues is Francesca Rinaldo, director of clinical quality and innovation at Sharecare.…

The Pharma Letter Podcast

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The rise of AI in drug discovery 20:31

3 years ago20:31

20:31

In this podcast, we discuss an exciting new collaboration between pharmaceutical majors in the field of AI. Around the world, ever increasing investments are being made in artificial intelligence, as drugmakers spy an opportunity to drive efficiencies and spur innovation. One estimate puts the total amount of venture capital funding in AI-led biotech startups at around $2 billion in 2020, an increase of around a quarter from the year before, and more than the previous three years combined. Governments are getting in on the act too. In the UK, the government recently announced a National AI Strategy, described as a ten-year plan to make Britain a global AI superpower. Overseen by a new Office for Artificial Intelligence, the strategy will include active engagement with the life sciences sector to promote the use of AI in drug development. Elsewhere, the Israel Biotech Fund, which seeks to invest in the country’s life sciences sector, has helped establish an innovation alliance, dubbed AION Labs to help spearhead the adoption of these technologies. The company is working with four major pharmaceutical companies - AstraZeneca, Pfizer, German Merck, and Teva – as well as tech giant Amazon Web Services. With funding from the Israel Biotech Fund, the group aims to transform the discovery and development of new therapies. To find out more, we spoke with Mati Gill, chief executive at AION Labs, and Christian Tidona, chief executive of the group’s strategic partner, BioMed X.…

The Pharma Letter Podcast

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Why hasn't the world embraced Sputnik V? 27:21

3 years ago27:21

27:21

In August 2020, Russia approved its homegrown coronavirus vaccine Sputnik V, months ahead of rival programs in the west. But despite the bleak pandemic outlook, there was no clamour in Europe or the USA to place orders, as scientists criticized a lack of transparency over the development process and the available clinical data. Many seemed to regard the seemingly premature approval as an attempt to bolster national prestige, an impression confirmed by the release of a slickly-designed promotional website. The political context of the program is echoed by the involvement of the Russian Direct Investment Fund, or RDIF, the country’s sovereign wealth fund. RDIF is currently under US sanctions as part of an Obama-era executive order punishing Russia for its activities in Ukraine. While the group has dismissed the idea of so-called vaccine diplomacy, RDIF has engaged global PR agencies to enthusiastically chart the product’s successes. And success there has been, with subsequent large-scale trials demonstrating a high level of safety and efficacy, underscoring the scientific bona fides of researchers at Moscow’s Gamaleya institute. Many smaller countries around the world have since placed orders. Despite this, and despite supply issues in Europe and elsewhere, no country in the west has shown an interest, again underscoring the political aspect of coronavirus vaccine development. Discussing these issues in Episode 8 of The Pharma Letter Podcast is the chief executive of RDIF, Kirill Dmitriev.…

The Pharma Letter Podcast

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Better pharma supply chains 27:22

3 years ago27:22

27:22

In the early days of the coronavirus pandemic, many drugmakers saw major share price declines as investors got to grips with the likely impact on prescribing, developing medicines, and supply chain interruptions. The second half of 2020 pointed to a more positive outlook, with stocks recovering, but economic and supply chain volatility have continued to hamper the sector, as well as the broader economy. To help respond to changing market conditions and improve output, companies could try what is known as a postponement strategy in supply chain management. Amid growing pressure to meet a backlog of demand for healthcare treatment, this could help companies prevent shortages and head off delays to clinical research. With us today to help make clear the benefits of a postponement strategy, and to outline key business considerations in implementing the approach, are Lee Feander and Jan Diederichsen of professional services firm Alvarez & Marsal.…

The Pharma Letter Podcast

1
The importance of patient empowerment in multiple sclerosis care 9:50

3 years ago9:50

9:50

Patient empowerment is a hot topic in many areas of medicine. Particularly so for diseases that are more complex to manage, and present with symptoms that aren’t immediately obvious and which vary greatly among individuals. Multiple sclerosis (MS) is one such disease. An estimated 2,500,000 people in the world have MS, a condition which can cause a broad range of symptoms and affect multiple parts of the body. Given that each person with the condition is affected in a different way, patient empowerment is a key aspect of delivering a high quality of care to patients, a fact which was clear from research presented at the recent European Committee for Treatment and Research in Multiple Sclerosis congress - ECTRIMS for short. In Episode 6 of The Pharma Letter Podcast, we are joined by Nidia Afonso, EMEA compound market access lead at Janssen, and part of a team which presented significant new data on patient empowerment at the event.…

The Pharma Letter Podcast

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Innovation in preleukemia 22:17

4 years ago22:17

22:17

High-risk MDS, often referred to as preleukemia, is a chronic form of blood cancer with a significant level of unmet medical need. MDS is a complicated disease, presenting several obstacles to drug developers, and no new therapies have been approved for the condition in over a decade. But that may be about to change, with multiple drugmakers, including some large pharmaceutical companies, including Takeda Pharmaceutical (TYO: 4502), Gilead Sciences (Nasdaq: GILD0, AbbVie (NYSE: ABBV) and Novartis (NOVN: VX) making significant progress. In the last few years, at least half a dozen Phase II or Phase III trials have been initiated globally, with a variety of approaches under investigation. Three such trials have started this year alone, including a pivotal study of Syros Pharmaceuticals’ (Nasdaq: SYRS) candidate tamibarotene - an oral RARa agonist which could become the first in a new class of treatment option. In this episode we discuss the treatment landscape in preleukemia, as well as the company’s plans for tamibarotene, with Syros chief executive Nancy Simonian and chief medical officer David Roth.…

The Pharma Letter Podcast

1
The state of biotech investing 21:21

4 years ago21:21

21:21

With all signs pointing to an M&A boom in late 2021 and throughout 2022, our guest will provide valuable insight into current and emerging trends in the biotech investing landscape. In this episode of The Pharma Letter Podcast, we speak with Lance Minor, principal and national co-leader of the life sciences practice at BDO, a global business intelligence firm. With the coronavirus pandemic continuing to cast its shadow across the life sciences, we look at how external factors - such as supply chain disruption and clinical trial delays - could help explain a recent slowdown in research spending. We also discuss the likely impact of record high valuations for drug development startups, including what that might mean for future spending on research and development. Co-author of BDO’s Summer 2021 Biotech Brief , Lance explains how more cash on hand and increased debt will shape the sector in the coming period.…

The Pharma Letter Podcast

1
Psychedelics in medicine 18:27

4 years ago18:27

18:27

For many years, industry commentators have observed that there could be huge untapped therapeutic potential for psychedelics, should the correct development pathways be found. Investment in this area is now at an all-time high, with waves of neurological research yielding encouraging results, including in depression, where data have shown that people with depressive disorders can react positively to psilocybin-assisted therapy. In this week's podcast, we speak with Sean McLintock and Clara Burtenshaw, partners at London-based psychedelic healthcare investment fund Neo Kuma Ventures. With multiple early stage psychedelics firms in its portfolio, Neo Kuma is at the forefront of clinical research into illnesses including depression, PTSD, addiction, inflammation and chronic pain.…

The Pharma Letter Podcast

1
Non-opioid analgesics 28:30

4 years ago28:30

28:30

The USA continues to wrestle with the legacy of an epidemic of opioid abuse, believed to have cost the lives of over half a million people through overdose. Until the pandemic struck, it looked as though the tide had turned, thanks to remedial actions on the part of drugmakers - prompted no doubt by a raft of lawsuits - as well as changes to prescribing practices. Now, opioid abuse is on the rise again, leading a broad swathe of society, from patients and drugmakers to lawmakers and regulators, to consider the best course of action. For several years, the US Food and Drug Administration has committed to a number of measures designed to encourage the development of non-addictive analgesic alternatives. These changes have created a positive regulatory framework for stem cell specialist Mesoblast (ASX: MSB), a Melbourne-based biotech developing an off-the-shelf cell therapy targeting chronic low back pain (CLBP) - an indication which absorbs half of US opioid prescriptions at present. In Episode 2 of The Pharma Letter Podcast, we discuss this option, as well as the broader therapeutic landscape, with the company's chief executive, Silviu Itescu.…

The Pharma Letter Podcast

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Belong.Life 28:24

4 years ago28:24