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?

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: 
<ul>
<li><a href="https://www.fiercebiotech.com/special-reports/introducing-fierce-biotechs-2024-fierce-15">Introducing Fierce Biotech's 2024 Fierce 15</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/fierce-biotechs-gabrielle-masson-presents-fierce-15-nyse">Fierce Biotech's Gabrielle Masson presents Fierce 15 at NYSE</a></li>
<li><a href="https://www.fiercebiotech.com/biotech/fierce-15-where-are-they-now-0">Fierce 15: Where are they now?</a></li>
</ul>

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
&nbsp;

A closer look at Fierce Biotech's Fierce 15

Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation.

Bodine details how physiology strengthens biotech and pharmaceutical research by clarifying how therapies behave in complex biological systems, identifying unintended effects and supporting stronger regulatory narratives. She also examines the expanding role of physiology in wearable technology, remote patient monitoring and artificial intelligence, where biological context is essential to turning large data sets into clinically meaningful insights.

The episode also highlights the society’s campaign, “Physiology: The Science Life Depends On,” aimed at elevating awareness of foundational science amid funding uncertainty. For executives, investors and health care leaders seeking sustainable innovation and patient impact, this discussion underscores a clear message: Breakthroughs depend on physiology. Listen to the full interview.

Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation.
Bodine details how physiology strengthens biotech and pharmaceutical research by clarifying how therapies behave in complex biological systems, identifying unintended effects and supporting stronger regulatory narratives. She also examines the expanding role of physiology in wearable technology, remote patient monitoring and artificial intelligence, where biological context is essential to turning large data sets into clinically meaningful insights.
The episode also highlights the society&rsquo;s campaign, &ldquo;Physiology: The Science Life Depends On,&rdquo; aimed at elevating awareness of foundational science amid funding uncertainty. For executives, investors and health care leaders seeking sustainable innovation and patient impact, this discussion underscores a clear message: Breakthroughs depend on physiology. Listen to the full interview.

From AI to wearables, physiology turns data into discovery and drives smarter drug development.

How physiology powers biotech innovation (Sponsored)

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.

In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency.

To learn more about the topics in this episode: 


FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases 


Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout 


Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial 

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.
In this week&rsquo;s episode of "The Top Line," Fierce Pharma&rsquo;s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency&rsquo;s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency&rsquo;s "case-by-case" approach, as indicated in the article, could be similar to&mdash;and different from&mdash;CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency.
To learn more about the topics in this episode:&nbsp;
<ul>
<li>
<a href="https://www.fiercebiotech.com/biotech/fda-signals-tailored-approach-carefully-shepherd-car-t-therapy-autoimmune-diseases">FDA signals tailored approach to &lsquo;carefully shepherd&rsquo; CAR-T therapy for autoimmune diseases</a>&nbsp;
</li>
</ul>
<ul>
<li>
<a href="https://www.fiercebiotech.com/biotech/kyverna-gains-clear-view-first-car-t-approval-autoimmune-disease-after-truly-remarkable-sps">Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout</a>&nbsp;
</li>
</ul>
<ul>
<li>
<a href="https://www.fiercebiotech.com/biotech/cabalettas-car-t-therapy-wipes-out-b-cells-small-autoimmune-trial-without-preconditioning">Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial</a>&nbsp;
</li>
</ul>

Autoimmune CAR-T: Navigating the FDA’s new regulatory playbook

What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market?

In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying.

Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility.

For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.

What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market?
In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competition for specialized sterile fill expertise is intensifying.
Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility.
For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.

GRAM’s CEO on isolators, re-shoring and rising demand in sterile fill manufacturing.

A closer look at Fierce Biotech's Fierce 15

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