Whether this is your first product launch or just the latest of many, obtaining timely FDA approval and considering key commercialization factors early in the development cycle are imperative to the continued success of your business. This webcast will help you navigate the complex US regulatory approval process for new molecular entities and understand the roles of regulatory, clinical, nonclinical and CMC stakeholders, including a discussion of the success factors for appropriate FDA interactions.
You will learn key considerations for outsourcing aspects of product development and regulatory approval. Topics covered also will include critical labeling decisions and other commercial considerations for product success, such as licensing, channel and distribution strategies and reimbursement.
Learning Levels: Intermediate & Advanced
Upon the webcast's conclusion, you will be able to:
- Understand the most critical aspects of development for a new molecular entity
- Efficiently communicate and interact with FDA to help reduce development timelines
- Identify the right regulatory outsourcing partner for your product development program
Who Should Attend?
- Pharmaceutical, biotechnology and medical device companies
- Companies with a product in any phase of the development continuum as well as approved products
- Small companies starting development for their first biopharmaceutical product
William (Trey) C. Putnam, PhD, RAC, vice president and general manager, Cardinal Health Specialty Solutions
Trey Putnam, PhD, RAC, is vice president and general manager of the Regulatory Sciences business of Cardinal Health Specialty Solutions. He is responsible for business strategy and managerial oversight of a diverse team of regulatory scientists and project managers. Previously, as managing director, Putnam provided scientific and regulatory consulting for activities associated with biopharmaceutical development, managed multidisciplinary drug development teams and directed the preparation of investigational and marketing applications. Prior to Cardinal Health, Putnam served as assistant professor at the Texas Tech University Health Sciences Center and as laboratory director of Texas Tech’s Pediatric Pharmacology Research Development Center. He also served as principal investigator on several federal grants with the National Institutes of Health and the US Department of Defense. Putnam has more than 15 years of industry experience, has presented dozens of lectures and is the author of many publications on drug discovery and development.