There are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across more than 50 marketing submissions, Synchrogenix regulatory science experts will demonstrate how, through thorough planning, you can improve and shorten your speed to drug submission.
演讲嘉宾
Anjana Bose, PhD, Director, Global Submissions, Synchrogenix, a Certara Company
A statistician and economist by training, Dr. Bose has over 30 years of experience in the pharmaceutical industry, including leadership roles in clinical development, data analytics, and regulatory submissions. During the last 15 years, she has led numerous small molecule and biologics marketing applications and contributed to many successful regulatory submissions (initial and supplemental) with concentration in psychiatry, neurology, multiple sclerosis, and oncology. Dr. Bose has collaborated with multiple partner companies in Europe in preparation of protocols, statistical analysis plans, study reports, briefing books, and integrated summary documents. She has also participated in many meetings with regulatory agencies in and outside of the US, and has worked on preparation of responses to questions from reviewers of applications. Dr. Bose has led data review, database integration, data interpretation, and analyses, and collaborated with Medical Affairs in preparation of posters, presentations, and manuscripts.
Mark Bowlby, PhD, Director, Global Submissions, Synchrogenix, a Certara Company
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。
Steve Sibley, MS, Vice President, Global Submissions and Submission Leadership, Synchrogenix, a Certara Company
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management. These include significant roles in more than 75 submissions and, in several cases, leading the entire submission team overseeing all documentation from Modules 1 through 5. Mr. Sibley drives the expansion of the company’s global submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.
