Innumerable factors can come into play, but 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 >50 marketing submissions, we will demonstrate how, through thorough planning, you can improve and shorten your speed to submission. We will focus on identifying, and planning for, the critical path for your submission. Using case studies to highlight specific risks and strategies to overcome these challenges, we’ll discuss each stage of the submission, variations such as size of the development program, type of submission, and dealing with governance bodies. The goal of the session is to help you identify how to make this activity as rapid as possible for your own team and, hopefully, to arm you with examples and strategies to make your next submission achievable in as little as three months from final database lock.
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
- Know when and how to plan for a marketing submission
- Identify key risks to submission timing
- Apply proven techniques for reducing, and sticking to, critical path timelines
Who Should Attend?
- Global Regulatory Leads
- Regulatory Project Managers
- Project Managers/Leads
- Medical/Regulatory Writers
- Regulatory Operations/Publishers
- Clinical Leads/MDs
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 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.
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.