Vice President of Global Submissions | Certara
Steve Sibley 在制药行业拥有逾 30 年经验，目前为 Certara 药物开发解决方案（CDDS）提供法规撰写咨询服务，并领导全球申报服务线。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
Bowlby 博士在临床研究和药物开发行业拥有超过 25 年的经验。在过去的 10 年中，他领导了许多新药申请、生物制品许可申请和向美国食品药品监督管理局和欧洲药品管理局提交的研究性新药 (IND) 申请。Bowlby 博士领导了研究者手册 (IB)、临床研究报告 (CSR)、临床总结和概述、简报和其他监管文件的编写。在他职业生涯的早期，Bowlby 博士有计划地撰写了大量关于他在哈佛医学院的科学研究和博士后工作的生物医学手稿、海报和幻灯片。他的专业治疗领域包括眼科、神经病学、精神病学和慢性疼痛。Bowlby 博士对当前生物制药环境中使用的药物发现和开发方法有着专业的认识。
