The Top Line

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.

This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode. They also discuss the details of the special report and share some of the stories behind the numbers. To learn more about the topics in this episode: Biotech's top money raisers of 2023Fierce Biotech Fundraising Tracker 2024Fierce Biotech Fundraising Tracker 2023 See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we explore the European biotech investment landscape. Fierce Biotech’s James Waldron sits down with Maina Bhaman, a Partner at Sofinnova Capital Strategy, who provides insights into how investors are approaching the European biotech sector. To learn more about the topics in this episode: 'The fundamentals are really strong': Why investors are staying loyal to European biotech in 2023'Optimism' at Jefferies conference, but don't expect biotech IPO boost soon, says Sofinnova chair See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we’re diving into the topic of diversity in clinical trials, examining both the progress made and the ongoing work needed to ensure inclusivity. In this episode, Fierce Biotech Senior Editor Annalee Armstrong engages in a conversation with Karen Correa, Ph.D., Head of Global Clinical Operations at Takeda and Executive Sponsor of Trial Diversity. Correa shares her insights into why it's imperative for pharmaceutical companies to adapt and prioritize diversity in their clinical trials, while also discussing the initiatives Takeda has undertaken in this area. To learn more about the topics in this episode: Clinical trial diversity craters out to lowest level in 10 years, IQVIA findsASCO, ACCC become latest to call for clinical trial diversity with 6 strategies for improving inclusion in cancer studiesDigital Medicine Society rolls out initiative to improve diversity in clinical trialsFDA's Richard Pazdur, sector leaders push for private-public partnership to boost DEI in cancer drug development See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," join Conor Hale, Senior Editor of Fierce Medtech, and Andrea Park, Deputy Editor of Fierce Life Sciences, as they share the highlights of this year's Fierce Medtech Fierce 15. To learn more about the topics in this episode: Fierce Medtech's Fierce 15 of 2023See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we’re speaking with Jared Baeten, MD, Ph.D., Vice President, HIV Clinical Development, Gilead Sciences about how advancements in HIV treatment research have enabled individuals to lead longer and healthier lives by taking and staying on medication. Nevertheless, HIV persists as a significant public health challenge. To end the HIV epidemic, it is crucial to go beyond a biomedical approach and fully integrate social determinants of health into the collective response. Not everyone is achieving long-term success. Long-term success involves meeting more than the United Nations’ goals of ending the epidemic by 2030. Treatment selection can help prioritize long-term outcomes from the very beginning. There are several other key factors for people with HIV and their healthcare providers to consider when assessing treatment choices, such as the resistance and safety profile of a treatment, drug-to-drug interaction potential, and comorbid conditions. This podcast is brought to you by Gilead Sciences. Visit gileadhivtogether.com to learn more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. See omnystudio.com/listener for privacy information.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials. In today’s episode, Fierce Pharma’s Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line. To learn more about the topics in this episode: FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probeAmid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry. Fraiser Kansteiner of Fierce Pharma engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights. Greffet makes a compelling business case for integrating ESG into the core of drugmakers' DNA. He also discusses Eli Lilly’s specific ESG initiatives, illustrating how these strategies connect to the company’s extensive history. To learn more about the topics in this episode: Patient groups want pharma to improve on ESG—and are pushing for a seat at the tableSetting sights on suppliers: How biopharma is tackling the environment in its ESG commitmentsSeeing green, AstraZeneca lays down £100M for 15-year renewable gas project in UKGilead receives awards, pledges commitment to COVID, the environment and inclusion in 2023 See omnystudio.com/listener for privacy information.

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. In the wake of these developments, new biotech companies are springing up spurred by advancements that redefine what conditions might soon become treatable. One contender in this rapidly changing landscape is Verve Therapeutics. This week on "The Top Line," Fierce Biotech’s Max Bayer sits down with the company’s CEO Sekar Kathiresan, M.D., to discuss how Verve intends to distinguish itself. They also chat about what drove Dr. Kathiresan to biotech after more than 20 years as a cardiologist and geneticist. To learn more about the topics in this episode: Verve Therapeutics unveils its lead program—a one-and-done treatment for genetic high cholesterolLilly beams up Verve gene therapy programs for $600M from deal-hungry BeamVerve shows base editing works in humans in first clinical data—and is punished by investorsVerve's base editing hold lifted, starting a thaw on a regulatory blockade that sent peers ex-US See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we explore the most anticipated drug launches of 2024. Editor-in-Chief Ayla Ellison engages in a conversation with Fierce Pharma Marketing Senior Editor Ben Adams about the drugs likely to launch this year with the most significant sales potential by 2028. To learn more about the topics in this episode: Top 10 most anticipated drug launches of 2024BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OKBristol Myers Squibb has targeted launch plan for ‘multi-billion-dollar opportunity’ in Karuna schizophrenia drugMeet Madrigal Pharmaceuticals, which wants to be your liver's No. 1 fan See omnystudio.com/listener for privacy information.

Should physicians consider the psychological status of patients more when developing and delivering treatment plans? What knowledge barriers are there to this? And how can these barriers be overcome? These questions lie at the heart of what John Kane has been pursuing as a healthcare communications and education expert for more than 30 years. As Managing Director of MedThink Communications, having run his own agency for 17 years, he works with the simple mission to "turn information into outcomes." In this episode of The Top Line podcast, John explores the link between a proper understanding of psychological factors and likely success of treatments. The conversation then moves on to discussing some of the key challenges faced by the medical industry in leveling the playing field between biological and psychological knowledge. Effective education and communication, he says, are a fundamental part of any solution. Want to hear more from John? Listen to the podcast today. See omnystudio.com/listener for privacy information.