The Top Line – Details, episodes & analysis

In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond. 

Fierce Pharma’s Zoey Becker chats with Gregg Sylvester, M.D., Chief Health Officer at CSL Seqirus, to get insight on what we might expect to see from this upcoming flu season. He also explains efforts to increase vaccine uptake through awareness and education campaigns.  

To learn more about the topics in this episode: 

• Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season
• CDC starts 'Wild to Mild' campaign to reverse falling flu vaccine use in key groups
• American Lung Association, Sanofi urge high-risk communities to grab their flu shots in 'United Against Flu' campaign

See omnystudio.com/listener for privacy information.

Biotherapeutics are transforming healthcare for over 350 million patients globally, tackling everything from cancer and diabetes to rare diseases.

Human embryonic kidney (HEK) 293 cells play a key role in the manufacturing of many of these life-changing products. However, they are not without their challenges.

In this episode of The Top Line, sponsored by Bio-Rad, Dipika Gurnani, Global Product Manager at Digital Biology Group, discusses the critical need to accurately quantify HEK293 DNA in biotherapeutics to ensure patient safety and regulatory compliance.

Gurnani highlights the risks of residual DNA integrating into a patient's genome, potentially causing cancer or genetic abnormalities. She also addresses the limitations of traditional quantification methods like qPCR, which can be time-consuming and prone to errors.

We also look at some key innovations in the field, such as Bio-Rad’s Vericheck ddPCR HEK293 Residual DNA Quantification Kit that can minimize false positives by specifically targeting HEK293 DNA.

For deeper insights into these challenges and innovations, listen to the full episode.

See omnystudio.com/listener for privacy information.

At Fierce Biotech, we love a big M&A deal, but valuation does not always equal the most exciting.  

In this week's episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest acquisitions in recent years.  

From obesity to radiopharmaceuticals, they give you the Fierce Biotech team’s thoughts on who got the best deal. 

To learn more about the topics in this episode:  

• Top 10 smartest deals in biopharma 

See omnystudio.com/listener for privacy information.

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.

"Friend-shoring" involves conducting manufacturing processes in countries considered friendly or allied. Sheng discusses the criteria for deeming a country “friendly” and explores whether this strategy could help address drug supply shortages.

To learn more about the topics in this episode:

• Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith
• Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M

See omnystudio.com/listener for privacy information.

Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more. 

The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Angus Liu covered the event. 

In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride. 

To learn more about the topics in this episode: 

• Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think?
• ASCO: After Keytruda, Merck builds 3-pronged cancer strategy starring Moderna-partnered vaccine
• ASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapy

See omnystudio.com/listener for privacy information.

The Fierce Pharma Marketing team publishes a special report each year on the top pharmaceutical drug ad spenders. This year’s report, which includes numbers for 2023, was published on Monday.  

AbbVie was the standout in this edition, having spent heavily on ads for Skyrizi and Rinvoq. Overall spending on the top 10 ads also experienced a sizable increase compared to the previous year. 

In this week’s episode of “The Top Line,” Fierce Pharma Marketing Senior Editor Ben Adams and Deputy Editor Andrea Park discuss the report, providing key insights and takeaways.  

To learn more about the topics in this episode:  

The top 10 pharma drug ad spenders for 2023

See omnystudio.com/listener for privacy information.

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)

See omnystudio.com/listener for privacy information.

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?

See omnystudio.com/listener for privacy information.

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.

See omnystudio.com/listener for privacy information.

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

See omnystudio.com/listener for privacy information.