Every year, Fierce’s pharma, biotech, and medtech teams come together to spotlight some of the fiercest women in life sciences—leaders who are transforming the industry with their innovation and impact. This year, our special report celebrates 10 women driving change in clinical research, business development, venture capital, and beyond.

In this week's episode of "The Top Line," Fierce’s Andrea Park and Gabrielle Masson share the stories that stood out, the breakthroughs these women are championing, and why recognizing their achievements is more crucial than ever. 

To learn more about the topics in this episode: 

• 2024's Fiercest Women in Life Sciences
• Big Pharma's 10 highest-paid CEOs of 2023

See omnystudio.com/listener for privacy information.

 Last month, the NIH announced that it had found evidence of research misconduct by Eliezer Masliah, M.D., the head of the neuroscience division at the National Institute on Aging. The NIH announcement coincided with the Sept. 26 publication of an investigation by Science, finding that 132 papers published by Masliah appear to contain manipulated images. 

In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia dives into this issue with Matthew Schrag, M.D., Ph.D., a neuroscientist who contributed to the dossier outlining Masliah’s misconduct.

To learn more about the topics in this episode:  

NIH neuroscience leader committed research misconduct, agency investigation finds

See omnystudio.com/listener for privacy information.

Each year, we dive into the world of biotech closures and layoffs, tracking the industry’s pulse as companies navigate high risks and harsh realities. 

In this week's episode of "The Top Line," Fierce editors Gabrielle Masson and Andrea Park take a closer look at this year’s biotech graveyard, which tracks biotechs that have shuttered or are in the process of winding down.  
 
They also discuss how we identify these closures, the trends we’re seeing and what might be in store as the year wraps up.  

To learn more about the topics in this episode: 

• The 2024 Biotech Graveyard
• Fierce Biotech Layoff Tracker 2024

See omnystudio.com/listener for privacy information.

As the 2024 U.S. presidential election nears, the choice between Democratic nominee Vice President Kamala Harris and Republican nominee former President Donald Trump will shape the future of drug pricing policy.  

While both candidates have pledged to reduce drug costs, their approaches are likely to differ significantly.  

In this week's episode of "The Top Line," Fierce Pharma's Zoey Becker chats with John Barkett, managing director of BRG’s healthcare transactions and strategy practice and former senior policy advisor for healthcare delivery system reform on the White House Domestic Policy Council, about what we can expect from each candidate's potential presidency and how the Inflation Reduction Act could play a pivotal role.  

To learn more about the topics in this episode: 

• With election nearing, BMO analysts don't expect major pharma shake-ups from either candidate
• Biden touts drug pricing achievements as he steps down from reelection campaign
• 2024 forecast: Biden admin efforts show there's no pricing relief on the horizon for pharma

See omnystudio.com/listener for privacy information.

Discover how Turbine Simulated Cell Technologies is transforming drug development by addressing biases in training data. Guests Bence Szalai, MD, PhD, and Istvan Taisz, MD, PhD, share insights on the challenges of biased AI models in biology and introduce their groundbreaking framework, EFFECT (Evaluation Framework for Predicting Efficacy of Cancer Treatment).

Learn how Turbine's innovative bias detector ensures meaningful predictions, enhancing the accuracy of drug response models. Explore their tailored in silico biomarker discovery process, including a collaboration with Cancer Research Horizons to identify the right patient populations for new cancer drugs.

By integrating recent patient samples, Turbine achieves remarkable predictive capabilities, significantly improving model accuracy. This episode is essential for anyone interested in the future of biotechnology and precision medicine. Don’t miss this opportunity to understand how Turbine is shaping the landscape of drug development.

Listen now and be part of the conversation that’s paving the way for more effective cancer treatments.

See omnystudio.com/listener for privacy information.

EY recently published their 18th annual Pulse of the MedTech Industry report, highlighting how—despite steadily rising profits year-over-year—devicemakers large and small are still being squeezed by the cost of doing business and waning investor enthusiasm.  

During AdvaMed’s MedTech Conference this month in Toronto, John Babbitt, partner on the life sciences team at EY, chatted with Fierce Medtech’s Conor Hale about the team's findings and shared what he heard from other executive attendees on the pace of M&A, venture capital funding and recent IPOs.  

Babbitt also discussed how the industry is expanding over-the-counter, to stock shelves with consumer-focused products—as well as how a record number of AI approvals from the FDA may be counted on to help address the ever-growing demand for healthcare, amid provider burnout and staff shortages. 

To learn more about the topics in this episode: 

• Ceribell CEO Jane Chao explains why now was the time for its upsized IPO
• Stryker strikes again, acquiring brain surgery device maker Nico
• How will regulators adapt to adaptive AI?
• Medtech VC investment held steady in Q2 with $3.3B of deal value: PitchBook
• EY's Pulse of the MedTech Industry report 2024

See omnystudio.com/listener for privacy information.

At this year’s Fierce Biotech Summit in Boston, we caught up with leaders in the biotech industry who have been recognized as past Fierce 15 honorees. 

These private biotechs have made significant contributions to their field, and their groundbreaking work is shaping the industry's future.

Fierce Biotech’s Gabrielle Masson sat down with Liang Schweizer, Ph.D. founder, chairperson and CEO of HiFiBiO Therapeutics; Adam Friedman, M.D., Ph.D., CEO of Scorpion Therapeutics; and Debanjan Ray CEO of Synthekine. 

In this week’s episode of “The Top Line,” these leaders share their insights, experiences, and visions for the evolving biotech landscape.

To learn more about the topics in this episode: 

• Introducing Fierce Biotech's 2024 Fierce 15

• Scorpion snaps up $150M in series C funds to widen clinical plans for cancer pipeline

• Synthekine hopes new IL-2 will be the high-alpha in a beta class 

See omnystudio.com/listener for privacy information.

In this episode, we dive into the world of gene therapy logistics with Cryoport Systems' innovative Elite Ultra Cold shipping system. Mike Dybicz and Khoa Tran are in the hotseat to discuss how their solution addresses critical challenges in transporting temperature-sensitive gene therapies.

The pair explain how Cryoport Elite offers extended hold times, exceeding industry standards to ensure therapy viability during unexpected delays. Here, its unique payload holding system provides consistent cooling without direct dry ice contact, maintaining product integrity throughout transit.

Security is paramount for these high-value therapies. The system allows for re-icing without accessing the payload, reducing tampering risks. Meanwhile, real-time monitoring tracks key metrics such as temperature, pressure and humidity, providing comprehensive visibility during shipping.

Dybicz and Tran also emphasize their collaborative product development approach, working with clients to meet current needs and anticipate future challenges. In addition, they discuss their commitment to sustainability and share insights on upcoming innovations, including the SafePak system and plans to expand the Elite product line.

Catch the full episode for more insights!

See omnystudio.com/listener for privacy information.

The neuroscience sector has seen a surge in investment over the past year, leading to breakthroughs and high-stakes deals, especially in the closing months of 2023. This momentum shows no signs of slowing, as companies continue to push boundaries in neuroscience and psychiatric disease research.

At this year's Fierce Biotech Summit on Oct. 1, pharma staff writer, Fraiser Kansteiner, sat down with a panel of industry leaders to explore the latest trends, groundbreaking discoveries and the next big targets in neuropharmaceuticals.

Joining the conversation were Camille Bendrosian, M.D., chief medical officer at Amylyx; Craig Thompson, CEO of Cerevance; Sara Kenkare-Mitra, Ph.D., president and head of R&D at Alector; and Blake Mandell, co-founder and CEO of Transcend Therapeutics. 

To learn more about the topics in this episode: 

• Bristol Myers Squibb's Karuna buyout pays off with FDA approval for novel schizophrenia med Cobenfy
• PTSD treatment is on the cusp of a paradigm shift. This biotech hopes to Transcend the competition
• After 'clearing the decks,' Alkermes ready to roll as pure-play neuroscience company
• Merck is back in Alzheimer's saddle with $1B-plus Cerevance pact, years after dropping the BACE

See omnystudio.com/listener for privacy information.

Since the introduction of the BIOSECURE Act in January, named companies and U.S.-based biopharmas alike have speculated on what the legislation could mean for the life sciences industry. 

In this week's episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner sits down with Arnold & Porter’s Life Sciences practice chair Dan Kracov to discuss the broader implications of the bill, and what the likely next steps are for the legislation to become law. 

Kracov also breaks down what measures life sciences companies are already taking in light of the bill and concessions that may need to be made to appease lawmakers on both sides of the aisle.  

To learn more about the topics in this episode: 

• After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned
• Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects
• Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

See omnystudio.com/listener for privacy information.