Leadership – Talk Bio

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

4 days ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis

Eli Lilly Hires Denali Therapeutics Executive Carole Ho to Lead Neuroscience Division

6 days ago talkbio0Tagged Biological Factors, Carole Ho, Changing, Denali, eli lilly, executive leadership, Leadership, neuroscience division

Eli Lilly; Denali Therapeutics; Carole Ho; neuroscience division; executive leadership; biopharmaceuticals; leadership changes

FluoGuide Strengthens Leadership to Drive Clinical and Regulatory Advancements

1 week ago talkbio0Tagged board of directors, Camilla Harder Hartvig, Changing, Chief Operating Officer, Clinical Development, Donna Haire, FluoGuide, Leadership, precision cancer, regulatory approval

FluoGuide; leadership changes; Donna Haire; Chief Operating Officer; Camilla Harder Hartvig; Board of Directors; FG001; clinical development; regulatory approval; precision cancer surgery

‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil

2 weeks ago talkbio0Tagged agency turmoil, Center for Drug Evaluation, Center for Drug Evaluation and Research, George Tidmarsh, Kevin Tang, Leadership, personal conduct probe, Regulatory Authority, research, resignation, United States Food and Drug Administration

FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority

Inspira Technologies Appoints Former Johnson & Johnson Executive as VP of Global Sales

4 weeks ago talkbio0Tagged Appointments, Arginine Vasopressin-Neurophysin II Preproprotein, board of directors, commercialization, global sales, Health care facility, Inspira Technologies, Johnson & Johnson, Leadership, Mike Hershkovitz

Inspira Technologies; Mike Hershkovitz; Johnson & Johnson; VP of Global Sales; leadership appointment; healthcare; commercialization; board of directors

Solventum Appoints Heather Knight as Chief Commercial Officer

4 weeks ago talkbio0Tagged Appointments, Chief Commercial Officer, Chris Barry, Dental Solutions, Global commercial operations, Health Information Systems, Heather Knight, Leadership, MedSurg, medtech, R&D, Solventum

Solventum; Heather Knight; Chief Commercial Officer; MedTech; Leadership appointment; Chris Barry; MedSurg; Dental Solutions; Health Information Systems; Global commercial operations; R&D

Clarametyx Biosciences Strengthens Leadership Team to Accelerate Pipeline and Corporate Development Progress

4 weeks ago talkbio0Tagged biofilm-driven chronic respiratory disease, Brendan Doran, Clarametyx Biosciences, corporate development, executive promotions, Leadership, pipeline development, Steve St. Onge, Team

Clarametyx Biosciences; leadership team; executive promotions; pipeline development; corporate development; Steve St. Onge; Brendan Doran; immune-enabling therapies; biofilm-driven chronic respiratory disease

Accuray Accelerates Transformation Efforts with Appointments of Experienced Executive Leaders

4 weeks ago talkbio0Tagged Accuray, cell transformation, CEO, Change, Organizational, executive appointments, Leadership, med-tech, operational transformation, Steve La Neve, Suzanne Winter, Transition Mutation

Accuray; transformation; executive appointments; Steve La Neve; CEO; Suzanne Winter; organizational change; operational transformation; med-tech; leadership transition

Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction

1 month ago talkbio0Tagged Biological Science Disciplines, Canal Row Advisors, innovation, Leadership, Michael Rogers, Policy, public health medicine (field), reform, regulatory consulting, regulatory strategy, United States Food and Drug Administration

Canal Row Advisors; FDA leadership; regulatory consulting; Michael Rogers; Hilary Marston; life sciences; regulatory strategy; public health; FDA reform; innovation policy

Bicycle Health Grows Leadership Team to Expand Access for Justice-Involved Populations

1 month ago talkbio0Tagged Andy Thomas, Bicycle Health, Business Development, Criminal Justice, executive team, Leadership, Opioid Use Disorder, Steve Tomlin, virtual care

Bicycle Health; Leadership team; Executive team; Steve Tomlin; Business development; Criminal justice; Opioid use disorder; Virtual care; Manu Kuppalli; Andy Thomas