The Top Line

In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines. Fierce Pharma’s Zoey Becker chats with Stefan Merlo, vice president of commercial operations, North America at CSL Seqirus. He discusses the company's differentiated flu vaccine portfolio and how its manufacturing process has evolved over the decades to create and distribute vaccines offering targeted protection each year. To learn more about the topics in this episode: Driving flu vaccine uptake in the post-pandemic eraFlu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming seasonSee omnystudio.com/listener for privacy information.

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 seasonCDC starts 'Wild to Mild' campaign to reverse falling flu vaccine use in key groupsAmerican Lung Association, Sanofi urge high-risk communities to grab their flu shots in 'United Against Flu' campaignSee 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.

For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of agencies. This stipulation, called the Chevron deference, gave agencies room to advance their regulatory priorities. The Supreme Court overturned the doctrine in June, bringing significant implications for the healthcare industry and federal regulators like the FDA. In this week's episode of "The Top Line," Fierce Pharma’s Kevin Dunleavy chats with Project Farma President Anshul Mangal about the potential impact on the biopharma industry. To learn more about the topics in this episode: Supreme Court overrules Chevron deference, dealing blow to federal healthcare agenciesThe Supreme Court just limited federal power. Healthcare is feeling the shock wavesHow Chevron's demise could impact employers, purchasers and health payersSee omnystudio.com/listener for privacy information.

The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gilead Sciences, AstraZeneca and Merck. Fierce Pharma’s Angus Liu recently took a deep dive into the three TROP2 front-runners. In a feature article, he examined the strengths and potential challenges facing each candidate, as well as the considerations behind their extensive phase 3 programs and their various development strategies. In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Liu about his feature story on the three TROP2 front-runners. To learn more about the topics in this episode: 3 Big Pharma companies, 33 phase 3 trials: The race for supremacy in an ADC fieldASCO: Gilead looks for silver lining in Trodelvy’s failed lung cancer trial. But will the FDA play ball?AstraZeneca-Daiichi's Enhertu follow-up Dato-DXd unable to prove overall survival benefit in phase 3See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we’re diving into Fierce Biotech’s annual Fierce 15 special report. Fierce Biotech's Annalee Armstrong and Gabrielle Masson take you behind the scenes to explore the meticulous selection process and share interesting highlights from this year’s honorees. To learn more about the topics in this episode: Introducing Fierce Biotech's 2024 Fierce 15Fierce Biotech's Gabrielle Masson presents Fierce 15 at NYSEFierce 15: Where are they now?See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS Conference in Germany. One of them is the report of a 7th person who has likely been cured of HIV. And there’s something unique about this case that has sparked excitement among scientists. The other one is the report of a long-acting injection that showed 100% efficacy in preventing HIV infection in a phase 3 trial. Some experts have hailed the PrEP candidate as a game-changer. To dive deeper into these studies, Fierce Pharma’s Angus Liu interviews Jared Baeten, M.D., Ph.D., senior vice president and head of clinical development of the virology therapeutic area at Gilead Sciences. To learn more about the topics in this episode: With seventh person seemingly cured of HIV, signs of hope for a broader cure Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014. A decade later, she revisits these trailblazers to see how they’ve navigated the biotech landscape. To learn more about the topics in this episode: Fierce Biotech's Fierce 15 of 2014See omnystudio.com/listener for privacy information.

Back in February, Novo Holdings laid out a $16.5 billion deal to snap up contract manufacturing giant Catalent. In this week's episode of "The Top Line," we dive into the current state and implications of the proposed buyout. Fierce Pharma’s Fraiser Kansteiner is joined by former FTC policy director David Balto. They discuss the likelihood of the deal going through, potential regulatory hurdles and what the transaction could mean for the greater CDMO landscape. To learn more about the topics in this episode: Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surgeSee omnystudio.com/listener for privacy information.

In this episode of The Top Line, sponsored by the Parenteral Drug Association (PDA), we explore the upcoming PDA/FDA Joint Regulatory Conference, happening September 9-11 in Washington, D.C. Our guest, Janeen Skutnik-Wilkinson, Director of Global Quality Regulatory Surveillance and External Engagement for Moderna and Co-Chair of the 33rd annual event, shares why this conference is the essential annual CGMP event to attend. Janeen notes the direct access to federal regulators and the unique insights from FDA colleagues as standout features. The FDA co-sponsored conference is known for fostering collaboration among scientific minds to create practical solutions and best practices, with this year's focus on improving quality culture, shifting to proactive approaches, and evolving quality maturity. Key sessions will cover de-risking quality control environments by utilizing case studies on OOS and OOT results, and enhancing lab systems with QRM. The conference's focus on Current Good Manufacturing Practices (CGMP) makes it a must attend for quality assurance and operations professionals. Additionally, discussions will delve into the role of AI in manufacturing and data integrity. For a comprehensive look at this year's PDA/FDA Joint Regulatory Conference, listen to the full episode and register at pda.org/PDAFDA2024. See omnystudio.com/listener for privacy information.

Pharmaceutical CEOs often earn pay packages worth tens of millions of dollars for leading the top drugmaking companies in the industry. Every year, some new faces enter the rankings while others leave. In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss Fierce’s annual special report, “Big Pharma's 10 highest-paid CEOs.” Aside from digging into the specific numbers surrounding CEO pay packages, the discussion also touches on CEO-to-worker pay ratios for 2023 and more. To learn more about the topics in this episode: Big Pharma's 10 highest-paid CEOs of 2023See 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 biopharmaSee 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-SmithEmergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30MSee 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 vaccineASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapySee 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 immunologyCell therapy reckoning: Pivot to autoimmune leaves unmet need in oncologyBiotech 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 checkCAR-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.

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 nationwideCatalent opens cell therapy production site at Belgian 'center of excellence'After recent troubles, Catalent expands its biologics services platform See omnystudio.com/listener for privacy information.