Is There A Data Capture Crisis In Biotech? The Pharma Letter podcast

18:53

This week on The Pharma Letter Podcast, we’re joined by Quin Wills, co-founder and chief scientific officer of UK biotech Ochre Bio. A physician-scientist with a background in genomics and computational biology, Quin has spent much of his career focused on the biology of liver disease — a path that has shaped Ochre’s approach to RNA-based therapies and human-based validation models. Founded in 2019, the Oxford-based biotech is developing a pipeline of RNA medicines for chronic liver conditions, using live human donor livers to test therapies in real time. With a focus on regenerative biology and fibrosis, the company’s platform has drawn interest from heavyweights in the industry. In 2024, Ochre landed a regenerative medicine partnership with Boehringer Ingelheim targeting advanced MASH cirrhosis, and signed a multi-year data licensing deal with GSK to deepen AI models of liver disease. Backed by Khosla Ventures, the firm raised a $30 million Series A in late 22 and is now progressing its first programs toward IND-enabling studies. In this week’s episode, we ask Quin about the scientific vision behind Ochre Bio, the state of innovation in liver disease, and where AI is beginning to shift the needle in drug development.…

The Pharma Letter Podcast

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ICON's AI strategy: faster, smarter trials 15:59

20 days ago15:59

15:59

This week on The Pharma Letter Podcast, we are joined by Tony Clarke, senior VP of IT digital operations at ICON (Nasdaq: ICLR). As a leader in digital transformation within clinical research, Tony has been at the forefront of implementing AI-driven solutions to enhance drug development. A global contract research organization (CRO), ICON has been tracking industry attitudes toward digital innovation. In 2019, the company conducted a survey to gauge investment trends in new technologies, and now, five years later, a new study reveals how perceptions and adoption have evolved. While the rise of AI, particularly generative AI, has dominated the debate across industries, we consider how it is truly shaping clinical research, including potential barriers to adoption. We’ll also talk about how digital tools are driving efficiencies in drug development, and what the future holds for technology in clinical trials. Partnered content.…

The Pharma Letter Podcast

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How real-time data could transform clinical trials 15:14

11 weeks ago15:14

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

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Japanese pharma in the UK 19:43

15 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

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

28 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

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Breakthroughs in MASH, with 89bio CEO 22:19

48 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

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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

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CRO sector surges in bio revolution 12:46

2 years 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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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