Editorial Videos

Silvia Taylor of Novavax explains how major biotechs like Eli Lilly and Sanofi are developing vaccine strategies for the coming years.

Silvia Taylor of Novavax details how the company leverages its expertise in vaccine development to build partnerships across the industry.

Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, notes how scale is a starting point, not a finish line, and until clinicians measure what's happening inside the body, obesity treatment will keep falling short of its promise.

Silvia Taylor of Novavax discusses the role that regulatory agencies play in vaccine usage, who can receive vaccines, how they’re administered, and under what conditions.

Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, argues the field must evolve beyond the scale, measuring success not just in pounds lost, but in visceral fat reduction, liver health, and preserved muscle mass.

Polaryx’ chief medical officer Lisa Bollinger explains the struggles finding ways to reduce patient costs for gene therapies for rare diseases.

Lisa Bollinger, chief medical officer at Polaryx, explains how treatments for lysosomal disorders struggle due to the fact that these diseases each have a unique mutation.

Silvia Taylor of Novavax discusses how new vaccine technologies are reducing side effects, lowering costs, and enhancing immune response.

Polaryx’s chief medical officer Lisa Bollinger explains how basket-trials are uniquely beneficial to rare disease therapy development.

With recent leadership shakeups, many are wondering how FDA will change its approach to regulating DTC pharma advertisements.

Former chief counsel for FDA Dan Troy explains why there is no firm timeline for regulatory reform or update at FDA for DTC pharma advertisements.

Dan Troy, former FDA chief counsel, explains limits on what regulations FDA can put on DTC advertisements.

Former FDA chief counsel Dan Troy discusses the motivation behind potential DTC pharma ad bans.

Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.

Harpreet Singh, MD, touches on how the Commissioner’s National Priority Voucher program is accelerating regulatory review timelines without fundamentally changing how pivotal trials are designed.

Kevin Dondarskit of Deloitte Consulting discusses the risks that drug makers face if they decide to put too much focus on an area where they may lack expertise, such as the emerging GLP-1 market.

Kevin Dondarskit of Deloitte Consulting discusses how pharma companies are focusing on high-value assets that serve large patient populations.

Harpreet Singh, MD, notes that the FDA’s broader shift toward accepting single pivotal trials reflects an evolution in regulatory thinking, while noting the agency still weighs disease severity, unmet need, trial design, and long-term safety

Kevin Dondarski from Deloitte Consulting discusses how changes in industry trends are causing pharma companies to explore new market opportunities provided by the rise of GLP-1 medications.

Harpreet Singh, MD, says understanding regulatory precedent, division-level dynamics, and the agency’s data-driven culture is critical for biopharma sponsors navigating today’s oncology approval landscape.

David Crean, chief business officer at MedicNova, highlights bifurcation in regulatory processes at FDA.

Sandra Coufal, MD, CEO of Toragen, says the company is positioning its HPV E5 inhibitor TGN-S15 not as a competitor to Merck’s Keytruda, but as a combination partner designed to enhance checkpoint inhibition.

MedicNova’s chief business officer David Crean explains how well-intentioned but poorly executed programs at FDA are causing tension between the agency and the industry.

Dr. Richard Graham discusses the distinction between real-time data and real-time oversite and how one option may present better results than the other.

Sandra Coufal, MD, CEO of Toragen, explains how the company’s Scientific Advisory Board was built to provide highly specialized expertise around HPV biology, immuno-oncology, and clinical development as TGN-S15 advances through trials.

Dr. Richard Graham details how real-time data review may reduce timelines but also allow for bad data or outcomes.

Investors seeking predictability are adjusting their strategies in the current regulatory environment.

Toragen’s partnership with the Bill & Melinda Gates Foundation highlights how global health priorities and commercial biotech strategy can align around one of the world’s deadliest HPV-driven cancers.