The Fierce Biotech team published a four-part series this week exploring cell therapy, a modality that has faced clinical challenges, manufacturing constraints and multiple practice-changing events.  

In today’s episode, Fierce’s Annalee Armstrong and Gabrielle Masson discuss the series of special reports and key insights from their interviews with multiple experts.  

To learn more about the topics in this episode: 

• Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from cancer to immunology
• Cell therapy reckoning: Pivot to autoimmune leaves unmet need in oncology
• Biotech faces a reckoning: 'We've lost our luster in cell therapies'
• Fulfilling the promise of cell & gene therapies through manufacturing (Part I)
• From cell collection to commercial contracting: Advancements in cell & gene therapy manufacturing (Part II)
• Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)

 

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This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing. 

In this episode, Fierce Pharma’s Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He’s also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProthera.  

They dive into novel production approaches discussed earlier in this series, with a special focus on CAR-T therapies.  

To learn more about the topics in this episode:

• CAR-T hype faces infrastructure reality check
• CAR-T boxed warnings: What comes next?

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In the fast-paced field of life sciences, digital pathology is poised to be a game-changer.

In this episode, we sit down with Grace Lee and Douglas Clark of Agilent Technologies to explore the opportunities and challenges associated with companion diagnostics (CDx).

Clark kicks off, shedding light on the current levels of digital pathology adoption in both clinical trials and practice. Thereafter, Lee outlines several opportunities and the associated regulatory hurdles, looking at areas such as the utilization of whole slide images for companion diagnostic interpretation.

Pointing to the amplified scrutiny on Laboratory Developed Tests (LDTs) and the emerging CDx guidelines in the EU and China, she emphasizes the importance of aligning with agencies: “Oftentimes we are trying to manage changes in the CDx world by providing regulators with evidence that assay performance has not changed.”

Clark echoes these sentiments, first highlighting the challenges posed by image variability and the resultant disparities in CDx interpretation and scoring, and then offering an optimistic outlook on the transformative potential of AI in the realm of multiplexing assays.

For a deep dive into the opportunities presented by digital pathology and CDx development, tune into the full episode.

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What is the transformative potential of digital health technologies in advancing health equity? Rabin Martin, a global health consulting firm, explores those possibilities in this engaging episode.

The conversation highlights the excitement surrounding digital tools and advanced analytics in achieving deeper insights, consistent care delivery, workforce support, and addressing social determinants of health.

Listen in now.

Host: Heath Clendenning, Fierce Life Sciences

Producers: Matt Rickman and Samantha Mazzotta

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This week’s episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing.

In this episode, Fierce Pharma’s Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree.

The conversation covers cell collection, the critical first step in advanced therapy manufacturing. They also discuss the importance of locking in process decisions early and how to effectively scale projects from the lab to the clinic and eventually to the market. Additionally, they talk about Germfree’s recent asset acquisition from Orgenesis, which will allow the company to expand its mission of decentralized manufacturing.

To learn more about the topics in this episode:

• Fulfilling the promise of cell & gene therapies through manufacturing (Part I)
• With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide
• Catalent opens cell therapy production site at Belgian 'center of excellence'
• After recent troubles, Catalent expands its biologics services platform

 

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This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. 

In this episode, Fierce Pharma’s Fraiser Kansteiner sits down with Ori Biotech CEO Jason Foster and the Cell Therapy Manufacturing Center's CEO, Jason Bock. They delve into the current state of cell and gene therapy manufacturing and consider if the existing production methods can keep up with the potential of personalized medicines.

They also dive into past hurdles in the space and highlight the varied approaches—including their own—that a new generation of cell and gene therapy manufacturing companies have been pioneering. 

To learn more about the topics in this episode: 

• Ori Biotech taps MD Anderson, National Resilience joint venture to put its automated cell and gene therapy manufacturing tech to the test

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This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year.

Fierce Pharma Senior Writer Kevin Dunleavy sits down with Cody Powers, a consultant who advises companies on business development and franchise growth strategy, to discuss the reasons behind the numerous high-value deals in 2023, which companies are primed to make major moves this year, and whether the trend of acquiring ADCs and obesity treatments will continue. 

To learn more about the topics in this episode: 

• The top 10 biopharma M&A deals of 2023
• 2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue
• For biopharma M&A, the best returns come from small deals: analysts

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Fierce Pharma publishes a yearly special report highlighting the top 20 pharmas based on their revenue. The most recent edition, published this month, ranks each pharma based on their total revenues for 2023.  

This week on "The Top Line," Fierce Pharma Senior Editor Eric Sagonowsky and Senior Writer Kevin Dunleavy break down the numbers, highlight key trends and share some of the biggest changes at the top and bottom of the rankings year over year.  

To learn more about the topics in this episode:  

• The top 20 pharma companies by 2023 revenue
• The top 20 pharma companies by 2022 revenue

 

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This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. We're diving into our recent spin on March Madness at Fierce.

This time around, Fierce Biotech kicked off its inaugural Best Biotech Name tournament, while over at Fierce Pharma Marketing, we held our biannual Drug Names tournament.

The editors discuss what makes a company or drug name tick, what to steer clear of, and how the entire competition played out. 

To learn more about the topics in this episode: 

• #FierceMadness: AstraZeneca and Ionis cruise to victory as Wainua trounces Lilly's Mounjaro for the tournament win
• #FierceMadness: The Best Biotech Name Tournament—A champion is CROWNED

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Jeff Beck of BioCare is in the hotseat for this edition of The Top Line.

Beck is the Chief Development Officer at the company, which stands tall as a pioneer in specialty product distribution with over 40 years of experience dating back to hemophilia therapies.

During the conversation, Beck provides an inside look at the rapidly evolving specialty distribution landscape. He outlines how the patient-centric model is working well and is supported by efficient supply chains. However, the future will demand increasing personalization to handle a wider range of complex product archetypes like cell and gene therapies. This, Beck says, calls for expanded data capabilities around inventory visibility, site analytics and dissecting the patient journey.

Beck also goes on to explain how new regulations like the Inflation Reduction Act will impact specialty distribution, and why emerging manufacturers will increasingly rely on experienced partners like BioCare.

Don't miss this insightful discussion on meeting today's specialty distribution needs while paving the way for tomorrow's innovations.

Tune in now.

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