Sign in Subscribe
Drugs

Gliatech Inc. Announces Interim Report on External Investigation

Strategic Insights

— 2 min read

Gliatech Inc.'s Board of Directors has announced the receipt of an interim report on the results of its external investigation, which revealed concerns regarding the Company's post-approval U.S. clinical study of ADCON(R)-L. While the investigation is ongoing, the Board has concluded that certain aspects of the study were not conducted in accordance with good clinical practices, resulting in observations by the FDA. To address these issues, the Board has implemented measures to enhance the quality of the Company's clinical research, including hiring additional personnel in quality control and assurance and strengthening internal operating procedures. The Company is also working closely with the FDA to resolve the issues raised in the Form FDA 483.

Key Takeaways:

  • Gliatech Inc.'s Board of Directors has received an interim report on the results of its external investigation, which revealed concerns regarding the Company's post-approval U.S. clinical study of ADCON(R)-L.
  • The investigation is ongoing, but the Board has concluded that certain aspects of the study were not conducted in accordance with good clinical practices, resulting in observations by the FDA.
  • The Board has implemented measures to enhance the quality of the Company's clinical research, including:

+ Hiring additional personnel in quality control and assurance

+ Strengthening internal operating procedures

+ Working closely with the FDA to resolve the issues raised in the Form FDA 483.

  • The resignation of three executives, including President and CEO Thomas O. Oesterling, Ph.D., Executive Vice President of Research and Development Michael A. Zupon, Ph.D., and Vice President of Regulatory Affairs Raymond P. Silkaitis, Ph.D., has been accepted.
  • Rodney E. Dausch has been appointed as Chief Operating Officer, and Clark E. Tedford, Ph.D., has been promoted to Vice President of Research and Development to assume additional responsibilities for regulatory matters.
  • A search firm has been engaged to conduct an executive search for a new Chief Executive Officer and President.
  • Robert P. Pinkas, Chairman of the Board, will assume the position of Acting Chief Executive Officer and President until a replacement is named.

Statistics:

  • The clinical study of ADCON(R)-L involved observations by the FDA.
  • 3 executives resigned from their positions: Thomas O. Oesterling, Ph.D., Michael A. Zupon, Ph.D., and Raymond P. Silkaitis, Ph.D.
  • 2 executive appointments were made: Rodney E. Dausch as Chief Operating Officer and Clark E. Tedford, Ph.D., as Vice President of Research and Development.
  • The Company has hired additional personnel in quality control and assurance.

Sources:

  • Gliatech Inc. Press Release, September 25, 2023.

Read more