The Top Line

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.

Join Zoey Becker from Fierce Pharma and Dr. Gregg Sylvester, Chief Health Officer at CSL Seqirus, as they tackle the decline in flu vaccination rates post-pandemic. They discuss how COVID-19 has impacted public trust in vaccines and the efforts needed to rebuild that confidence. The conversation highlights alarming trends in flu vaccination, particularly among vulnerable populations, and innovative strategies to increase uptake. Discover the critical role of education and proactive health advocacy in reversing vaccine hesitancy.

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.