Mike Hollan

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

5 Prime Sciences CEO discusses how simply building a massive data set can cause more problems than it solves during clinical trials.

Polaryx’s chief medical officer discusses the regulatory environment for rare, pediatric treatments and how it’s directly impacting clinical trials.

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

The two executives discuss joining Persica Pharmaceuticals and how they’re driving the company forward with non-opioid pain medication.

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.

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.

Lisa Bollinger, chief medical officer at Polaryx, discusses signs that regulatory agencies are taking the issues related to rare disease therapy development seriously.

Between 2026 and 2030, billions of dollars in revenue will be at risk due to expiring patents and periods of exclusivity.

The former lead counsel discusses FDA’s efforts to bring about strict oversight on DTC drug ads and the difficulties the agency faces in doing so.

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.

The Lupus Research Alliance’s CEO and president discusses how recent treatment breakthroughs are changing the patient experience in Lupus treatment.

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

The Deloitte Consulting partner discusses how GLP-1s are becoming key value drivers and driving R&D focus during a period of market concentration.

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.

Jeffrey Taubenberger’s departure was announced by Senator Baldwin during a congressional hearing.

MedicNova’s chief business officer details how changes at FDA are causing tension with the industry and investors, who are finding themselves less confident in the regulatory process.

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

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.

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.

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.