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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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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