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.

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.

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.

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.

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.

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.

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.

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.