The Top Line

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.

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 testSee omnystudio.com/listener for privacy information.

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 20232024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continueFor biopharma M&A, the best returns come from small deals: analystsSee omnystudio.com/listener for privacy information.

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 revenueThe top 20 pharma companies by 2022 revenue See omnystudio.com/listener for privacy information.

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 CROWNEDSee omnystudio.com/listener for privacy information.

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. See omnystudio.com/listener for privacy information.

This week on "The Top Line," we explore biopharma layoffs in the first quarter of 2024. Using data from Fierce Biotech's layoff tracker, Gabrielle Masson and Max Bayer analyze the trends of layoffs in the first quarter of 2024, comparing them to previous years. With a notable number of layoff rounds marking the start of the year, they examine the factors behind this ongoing challenge while also highlighting positive industry developments. To learn more about the topics in this episode: No reprieve for biopharma layoffs in Q1: Fierce Biotech analysisFierce Biotech Layoff Tracker 2024See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we explore peripheral arterial disease, a serious health issue that is often overlooked and undermanaged. Join Editor-in-Chief of Fierce Life Sciences and Healthcare Ayla Ellison as she sits down with Kumar Madassery, M.D., Director of the Peripheral Vascular Intervention & CLI Program at Rush University Medical Center. They discuss the hidden dangers of PAD, and Dr. Madassery emphasizes the importance of early detection. He also discusses the launch of the PAD Pulse Alliance, a collaborative effort among vascular health experts aimed at raising awareness, improving early detection and reducing amputation rates. To learn more about the topics in this episode: Philips-supported campaign wants Americans to 'get a pulse on PAD' amid ignorance of the diseaseJohnson & Johnson 'Save Legs. Change Lives.' campaign brings PAD amputation awareness to Black communityBayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery See omnystudio.com/listener for privacy information.