Mike Hollan

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.

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

Author Jeremy Levin discusses how various factors are impacting the biotech industry in a negative way by pushing investment and politics over science.

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.

Trialynx’s CEO discusses the benefits of using AI for trial design and how to find the AI companies doing the most promising work.

Tris Pharma’s founder and CEO discusses his company’s history and how’s he’s adjusted his strategies over the decades.

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