Editorial Videos

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.

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.

Dr. Richard Graham explains how FDA’s new program allows for the usage of real-time data during clinical trials.

David Crean, chief business officer at MedicNova, discusses changes at FDA causing variability and unpredictability in regulatory approvals.

Dr. Jeremy Levin discusses the mismatch between capital markets and biotech and how the industry doesn’t provide the results that investors are often looking for.

Toragen CEO, Sandra Coufal, MD, says women’s health remains structurally underfunded, arguing that outdated market assumptions continue to undervalue the true commercial opportunity in HPV-driven cancers.

Dr. Jeremy Levin explains how the current media environment allows for misinformation spread, and the impact it has on trust in medicine.

Toragen CEO Sandra Coufal, MD, explains why the overlooked HPV E5 protein may represent a breakthrough therapeutic target after decades of failed attempts against traditional viral pathways.

Ketan Mehta provides examples of how he’s developed new therapies that address both regulatory concerns and patient needs.

Dr. Jeremy Levin discusses the importance of relying on scientific fact to make decisions in biotech research.

Tris Pharma CEO Ketan Mehta explains how addressing a drug’s impact can improve patient experience.

Ketan Mehta, CEO of Tris Pharma, explains how the company expanded its pipeline over the past two decades.

Aradigm Health’s CEO discusses how payers and other entities in the healthcare ecosystem are developing strategies to ensure cell & gene therapy costs don’t prevent patients from accessing them.

Aradigm Health CEO Will Shrank discusses the shift in value-based care models for cell and gene therapies.

Will Shrank, Aradigm Health’s CEO, discusses the importance of transparency in healthcare payments to build trust and reduce waste.