The Top Line

 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 findsSee 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.

At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate.  In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts.    To learn more about the topic in this episode:  iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we’re recapping and discussing the major trends from Digitial Pharma East, which took place in Philadelphia last week. The event brought together marketing experts from across the life sciences industry.  Fierce Pharma Marketing's Andrea Park and Ben Adams talk about major trends from the event that came up in conversations, including the complicated current attitudes toward artificial intelligence in this space.  They also highlight some winners of the annual Fierce Pharma Marketing Awards, held on the final night of Digital Pharma East.   To learn more about the topics in this episode:  Navigating the AI 'hype cycle': Bayer, Daiichi Sankyo and argenx leaders on implementing AI in biopharma marketing Pfizer, Sanofi, GSK among the winners of the 2024 Fierce Pharma Marketing Awards Two-thirds of top 20 pharmas have banned ChatGPT—and many in life sci call AI 'overrated,' survey finds See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report.  We share the stories of a select few 2024 Fierce 50 honorees and interesting highlights from this year's special report.  To learn more about the topics in this episode:  Fierce 50 of 2024  Innovation Honorees Health Equity Honorees Social Impact Honorees Breakthroughs Honorees Patient Advocacy Honorees See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines.  Fierce Pharma’s Zoey Becker chats with Stefan Merlo, vice president of commercial operations, North America at CSL Seqirus. He discusses the company's differentiated flu vaccine portfolio and how its manufacturing process has evolved over the decades to create and distribute vaccines offering targeted protection each year. To learn more about the topics in this episode:  Driving flu vaccine uptake in the post-pandemic era Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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.See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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? 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  See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014.  A decade later, she revisits these trailblazers to see how they’ve navigated the biotech landscape.   To learn more about the topics in this episode:  Fierce Biotech's Fierce 15 of 2014 See omnystudio.com/listener for privacy information.