Planning and Preparing Regulatory Submissions Using Top-down Messaging
Vice President of Global Submissions | Certara
With a career spanning more than 30 years in the pharmaceutical industry, Steve Sibley provides regulatory writing consulting services and leads the global submissions service line within Certara Drug Development Solutions (CDDS). He has led global submission teams and authored critical documentation on more than 45 marketing applications and more than 30 investigational drug applications. Sibley has particular expertise in briefing documents, regulatory defense, and submission planning. Sibley’s work has covered the full range of therapeutic areas and program types, with a particularly strong background in oncology, cardiology, and rare diseases, including participation in health authority meetings and advisory committee meetings. His experience is truly global, having worked in project teams encompassing the United States, the European Union, Australia, and Asia. Sibley draws on his substantial industry knowledge and leadership skills to mentor and train other submission leads.
Director of Global Submissions | Certara
Brenda Taylor is a Director of Global Submissions at Certara. She has over 20 years of experience in the biotechnology and pharmaceutical industry. She has led regulatory strategy and submission management activities to support pharmaceutical development and manufacturing, with an emphasis on Initial New Drug (IND) applications and marketing applications. Brenda’s research background in microbiology and immunology includes design and performance of nonclinical studies. Her therapeutic areas of expertise include oncology, cardiovascular, and anti-infective agents, spanning both small-molecule drugs and biologics.
Senior Director Global Submissions | Certara
Dr. Bowlby has over 25 years of experience in the clinical research and drug development industry. During the last 10 years, he has led many New Drug Applications, Biologics License Applications, and Investigational New Drug (IND) submissions to the Food and Drug Administration and European Medicines Agency. Dr. Bowlby has led the authoring of Investigator’s Brochures (IBs), clinical study reports (CSRs), clinical summaries and overviews, briefing packages, and other regulatory documents. Earlier in his career, Dr. Bowlby planned and wrote numerous biomedical manuscripts, posters, and slides regarding his scientific research and postdoctoral work at Harvard Medical School. His therapeutic areas of expertise include ophthalmology, neurology, psychiatry, and chronic pain. Dr. Bowlby has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.
