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.
講演者
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
Dr. Bowlbyは臨床研究および医薬品開発業界において25年余の経験を有しています。直近の10年間は、米国食品医薬品局および欧州医薬品庁への数多くの新薬申請、生物製剤承認申請、治験薬（IND）申請をリードしてきました。また、治験薬概要書（IB）、 治験総括報告書（CSR）、臨床試験の要約および概要、対面説明資料（briefing package）、およびその他の規制文書のオーサリングも指揮してきました。それ以前の職務では、ハーバード・メディカル・スクールにおける自身の科学的研究と博士課程修了後の研究に関して、多数の生物医学的な原稿、ポスター、スライドを計画・執筆しました。彼の専門の治療領域には、眼科、神経内科、精神科、慢性疼痛管理分野が含まれます。最新の生物医薬品環境で使用されている創薬および医薬品開発アプローチについての専門的知識を有しています。
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.
