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

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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.

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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 

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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

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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

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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

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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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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 agencies
• The Supreme Court just limited federal power. Healthcare is feeling the shock waves
• How Chevron's demise could impact employers, purchasers and health payers

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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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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 analysis
• Fierce Biotech Layoff Tracker 2024

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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 disease
• Johnson & Johnson 'Save Legs. Change Lives.' campaign brings PAD amputation awareness to Black community
• Bayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery

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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 2023
• Fierce Biotech Fundraising Tracker 2024
• Fierce Biotech Fundraising Tracker 2023

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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

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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 finds
• ASCO, ACCC become latest to call for clinical trial diversity with 6 strategies for improving inclusion in cancer studies
• Digital Medicine Society rolls out initiative to improve diversity in clinical trials
• FDA's Richard Pazdur, sector leaders push for private-public partnership to boost DEI in cancer drug development

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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 2023

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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 field
• ASCO: 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 3

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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.

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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 probe
• Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

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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 table
• Setting sights on suppliers: How biopharma is tackling the environment in its ESG commitments
• Seeing green, AstraZeneca lays down £100M for 15-year renewable gas project in UK
• Gilead receives awards, pledges commitment to COVID, the environment and inclusion in 2023

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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 cholesterol
• Lilly beams up Verve gene therapy programs for $600M from deal-hungry Beam
• Verve shows base editing works in humans in first clinical data—and is punished by investors
• Verve's base editing hold lifted, starting a thaw on a regulatory blockade that sent peers ex-US

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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 2024
• BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OK
• Bristol Myers Squibb has targeted launch plan for ‘multi-billion-dollar opportunity’ in Karuna schizophrenia drug
• Meet Madrigal Pharmaceuticals, which wants to be your liver's No. 1 fan

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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.

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In this episode, Dr. Beate Mueller-Tiemann, Chief Technology Officer at Cytiva, joins Fierce Life Sciences’s Stephanie Butler.

Having spent almost all of her career working within large pharmaceutical enterprises such as Sanofi and Bayer, Beate made the switch to Cytiva in the early part 2023.

Her role at Cytiva involves overseeing teams which create and bring high-quality products and innovative manufacturing and R&D processes closer to patients. Beate also keenly supports female talents through participation in mentoring programs. Additionally, she is a member of FiDAR, an association which seeks to increase the representation of women on German corporate boards.

During the conversation, Beate discusses her passion for technology and how her career has been defined by working with technology to bring innovation and treatments to patients and improve health outcomes. She also touches on the ongoing work Cytiva is engaged in, as well as the importance of collaboration in driving R&D progress.

Tune in to the podcast to learn more. Check out this year's Fierce 50 honorees: https://fierce50.fiercelifesciences.com/

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While generative AI has dominated the spotlight in the past year, machine learning programs have already been significantly impacting patients and physicians for several years. The question now arises: how will the emergence of programs like ChatGPT, coupled with increasing calls to scrutinize their safety, influence the adoption of new AI programs and diagnostics in healthcare?  

This week on “The Top Line,” Fierce’s Conor Hale interviews Peter Shen, the North American head of digital health at Siemens Healthineers, to explore what developers and regulators can do to ensure transparency in medical AI. He also dives into how the field could potentially benefit from a 21st-century update to the Hippocratic Oath. 

To learn more about the topics in this episode: 

• 2024 forecast: Will generative AI find what it needs to deliver for patients? 
• FDA to form advisory committee for digital health and AI 
• US government to launch AI Safety Institute, develop standards for biotech R&D 
• Biden to sign sweeping executive order pursuing 'safe, secure and trustworthy' AI development 

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While it’s a known fact that women, on average, live longer than men, a recent report unveils a nuanced reality—women also spend more of their lives grappling with poor health. 

This week on “The Top Line,” Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, explores the root causes behind this disparity and the multifacted nature of the women’s health gap. She's joined by one of the lead authors of the report, Valentina Sartori, Ph.D., and a contributor to the report, Kelle Moley, M.D.  

The report highlights that addressing the women’s health gap and investing in women’s health could inject $1 trillion into the economy annually by 2040, and Dr. Sartori explains why that number could be a significant underestimation. 

While the report provides a clear understanding of the challenges, it also sheds light on viable pathways to close the women’s health gap and create a future where women not only live longer but lead healthier lives. 

To learn more about the topics in this episode:  

• Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies
• White House launches new initiative aimed at investing in women's health research
• Organon finally offers a larger pharma model for women's health. But 'one company can't do it by itself'
• CMS unveils new model to support Medicaid agencies in offering whole-person maternal health
• Menopause care is still a largely untapped market. Here's why investors and startups should dive in

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At Fierce Pharma, the arrival of a new year is synonymous with the release of our annual special report on drug approvals. This week on “The Top Line,” Fierce Pharma’s Eric Sagonowsky and Kevin Dunleavy, both instrumental in creating the special report, are breaking down the numbers and sharing key insights into the landscape of drug approvals in 2023. 

To learn more about the topics in this episode: 

• 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
• 2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37
• 2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs

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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 15
• Fierce Biotech's Gabrielle Masson presents Fierce 15 at NYSE
• Fierce 15: Where are they now?

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This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her. 

To learn more about the topics in this episode: 

• Biotechs end year 'trading for nothing' as investors mull 'what is IPO-able today?'
• Fierce Biotech Layoff Tracker 2023
• Editor's Corner—When ASCO dueled with the world's biggest pop star, Swift Biotech was ready for it
• Alzheimer's meds are here. But for the Down syndrome community, it's still the 1980s

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Paul Beresford and Lou Welebob of Agilent Technologies discuss how partnerships are vital in addressing the evolving needs of pharma for complex diagnostics and CDx development.

Discussions center around the importance of working with pharmaceutical companies to drive medical innovation and improve patient outcomes, helping to speed up the process of bringing the right treatments to the right patients at the right time.

Topics discussed include the importance of broadening technological focus on immunohistochemistry, such as bridging into digital biology and imaging as well as multiplexing. Spatial biology is touched upon, specifically looking at how spatial profiling can be used to determine cell proximity within the tumor microenvironment, potentially correlated to drug efficacy.

Looking ahead, both speakers point to the potential to use machine learning in key areas such as the development of assays for use across laboratories globally.

To discover the full range of insights from life sciences, diagnostics and applied chemical markets specialist Agilent Technologies, listen to the full podcast.

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Earlier this year, Fierce Healthcare, Fierce Pharma and Fierce Biotech recognized 50 individuals and companies that are pushing the industry forward. The Fierce 50 honorees range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "The Top Line," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees in more detail. 

To learn more about the topics in this episode: 

• The Fierce 50 of 2023

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The antifungal agent Amphotericin B is highly effective against a wide range of deadly fungi and resistance is rare, even after decades of use. But it comes with a virtual guarantee of kidney damage, earning it the nickname “Ampho-terrible.”   

Now, a better alternative might be on the way. Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., a chemistry professor and researcher at the University of Illinois and the founder of antifungal startup Sfunga Therapeutics, to get the story behind the new drug’s design, its path to the clinic and how it could influence the next generation of antimicrobials.

To learn more about the topics in this episode: 

• Potent new drug has all the power of nature's strongest antibiotic, without the toxicity

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In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech. Join Deputy Editor Andrea Park and Senior Editor Annalee Armstrong as they reflect on the inspiring stories of the women who made this year’s list.

To learn more about the topics in this episode: 

• 2023's Fiercest Women in Life Sciences
• The Fierce 50 of 2023 
• Fierce 50 Awards Gala 

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This episode of "The Top Line" is dedicated to Alzheimer’s disease, exploring the latest treatments and what lies ahead.

In the first segment, Fierce Pharma’s Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients. 

Next, Fierce Biotech’s Annalee Armstrong interviews Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. They explore the pioneering work being done in Alzheimer's research and discuss the latest breakthroughs. 

In the third segment, Fierce Pharma’s Eric Sagonowsky talks with Reisa Sperling, M.D., who is leading a research team investigating whether Leqembi holds promise in preventing disease progression before any Alzheimer’s symptoms are evident. 

To learn more about the topics in this episode: 

• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
• After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
• Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
• Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients
• Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?
• Experimental Alzheimer's molecule improves cognition in mice by tamping down on inflammation
• Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline
• Acumen's stock surges as early Alzheimer's data suggest next-gen Leqembi rival is active

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In this episode of “The Top Line,” we explore the next potential wave of mental health therapy: psychedelics. 

Fierce Biotech's Max Bayer sits down with Scott Aaronson, M.D., a seasoned clinician and psychiatrist with over 30 years of experience in the field. They discuss how psychedelics might be used in the treatment of conditions such as depression, substance addiction, PTSD, anorexia, and more. They also examine the obstacles developers face as they advance their studies.  

To learn more about the topics in this episode: 

• MDMA approval filing nears after drug hits again in phase 3, showing consistent PTSD improvements
• Early clinical data on psilocybin in anorexia point Compass to potential new opportunity
• Otsuka adopts new Mindset, dropping $59M to buy Canadian psychedelic biotech

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While the new Alzheimer’s disease medicine Leqembi has generated lots of buzz since its debut this year, one research team is investigating whether the medicine holds promise in preventing disease progression before any Alzheimer’s symptoms are evident.

In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky talks with the study lead, Reisa Sperling, M.D., to learn more. 

To learn more about the topics in this episode: 

• Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?
• 'The Top Line': Leqembi's full approval and the future of Alzheimer's treatment
• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

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In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.  

Genevieve Kanter, Ph.D., a professor at the USC Sol Price School of Public Policy, joins Fierce's Kevin Dunleavy to discuss the implications of a study published in July in JAMA Health Forum, which found the FDA's propensity to favor positive panel recommendations. They explore the impact of this potential bias on drug development and public health. 

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In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients.

To learn more about the topics in this episode: 

• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest
• After winning full FDA nod for Leqembi, Eisai touts 'promising' study on subcutaneous version
• Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug
• Eisai launches 'digital business' Theoria to build out a dementia ecosystem for patients

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 

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In this episode of "The Top Line," Fierce Biotech's Annalee Armstrong engages in a conversation with Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation.

They delve into the pioneering work being done in Alzheimer's research, discuss the latest breakthroughs, and explore the ongoing efforts to combat this complex disease.

To learn more about the topics in this episode: 

• With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

• Eisai, Biogen's Leqembi may face rollout hurdles now, but experts still like the Alzheimer's drug

• Experimental Alzheimer's molecule improves cognition in mice by tamping down on inflammation

• Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline

• Acumen's stock surges as early Alzheimer's data suggest next-gen Leqembi rival is active

See omnystudio.com/listener for privacy information.

“Essentially, this allows our clinical researchers to improve the chances of success for the trial leading to faster, more efficient drug development… Ultimately, this is going to benefit patients.”

Greg Lever is speaking about the use of flexible modeling to allow real-time changes to be made to clinical trial design and processes. 

As a Director within the IQVIA Applied Data Science Center, and with over a dozen years of experience in the field, Greg knows the importance of data and advanced analytics in generating accurate patient insights to underpin key trial decision-making.

By making clinical trials more patient friendly, he states, the more likely it is that research organizations will be able to attract and retain the participants they need to bring life-saving treatments to patients.

In this podcast, Greg outlines how modeling can be used to enhance the entire patient journey, from the initial giving of informed consent right through to the trial’s close.

Host: Julia Douthart

Producer: Matt Rickman

Sponsored by IQVIA

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In this episode of "The Top Line," we delve into the uncharted territory that pharma marketers face, from harnessing AI's potential to navigating the Inflation Reduction Act. Ayla Ellison, editor-in-chief of Fierce Life Sciences and Healthcare, engages with three industry experts to unravel the opportunities and challenges that lie ahead.

In the first segment, Robert Allen, the leader behind engagement and channel planning for U.S. Oncology at Bristol Myers Squibb, shares his insights into strategic planning for customer engagement and channel strategies. Next, Terry Terifay, the Chief Commercial Officer at Azurity Pharmaceuticals, offers a glimpse into what the future holds for the industry. In the third segment, Dorothy Gemmel, the Chief Commercial Officer of GoodRx, shares the projects she's excited about and her biggest piece of advice for others in the industry."

To learn more about the topics in this episode: 

• Will Big Pharma engage in Medicare price negotiations? Merck, AZ and BMS say they will

• Providers can now see patients' insurance coverage in GoodRx's cost comparison tool

• Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

• GoodRx, Walgreens team to lower prices for 200 drugs

• Fierce Pharma unveils the winners of the 5th annual creativity contest for outstanding marketing campaigns

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AstraZeneca has made several news headlines for its environmental sustainability pledges, including deals for renewable natural gas and a commitment to plant hundreds of millions of trees.

In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions.

To learn more about the topics in this episode: 

• Fellowship of the green: AstraZeneca, Samsung, GSK and more unite to slash greenhouse gas emissions

• AstraZeneca sows $400M investment in push to plant 200M trees by 2030

• From farm to pharma: AstraZeneca inks renewable natural gas pact to shrink environmental footprint

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