The introduction of a new medicinal product to the US market follows a complex process that may extend many years from the initial discovery through to the US Food and Drug Administration (FDA) approval and market launch. There are many factors during the product development that impact the success of drug approval and launch, a thorough understanding of the regulations and requirements is often underrated. The drug development process is becoming increasingly specialized and the regulatory pathway that works for one program may not work or be applied to another program for the same indication. 
In this webinar, we talk about: 

  • What does it mean to “Begin with the End Goal in Mind?” 
  • What information should an Investigational New Drug (IND) Application contain? 
  • How to communicate with FDA as your partner 
  • What are the FDA’s expedited programs? 
Michael Day

Michael Day, Director Regulatory Science Co-Head Complex Biologics

As a Director Regulatory Science and Co-Head Complex Biologics at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.

Susan Carter

Susan Carter, Director Regulatory Science

As a Director, Regulatory Science, Susan provides scientific and regulatory advice to clients for the development of small molecules and biologics particularly with regards to rare diseases. The projects she manages are in various stages of development, from nonclinical through to marketing application.

Regulatory Expert Mark Gautier

Mark Gauthier, Senior Director Regulatory Science Drugs & Biologics

Mark has a proven history of building and maintaining good relationships with FDA personnel to facilitate development and commercialization of new products (Orphan Products, PDUFA meetings, CBER and CDER Review Divisions including OTAT).  He has managed post-approval submissions of all types, including advertising and promotional materials, drug product listings, CMC and labeling supplements.

Expertise: Regulatory

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