Mike Hollan

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.

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.

Reports also claim that Kyle Diamantas will serve as acting head of FDA.

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.

Radiopharmaceutical logistics is fundamentally different from traditional pharmaceutical supply chains.

Natalie de Graaf, from the API Innovation Center, discusses a recent whitepaper detailing areas where the generic drugs pipeline is under stress.

Charlie Lyon, VP of manufacturing, procurement, and logistics at the API Innovation Center, discusses the complicated web of global manufacturing.

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.

Aradigm CEO Will Shrank discusses the significant challenge payers face in predicting and managing the costs of cell and gene therapies due to their volatility and unpredictability.

Innomar’s VP of commercial strategy and innovation discusses the shifting global landscape and building relationships with pharma manufacturers.