The Investigational New Drug (IND) Submission - Tips to Win the First Time

Date: January 25, 2017
Time: RECORDED SESSION
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts and Job Aids!

Course Description:

An Investigational New Drug (IND) submission is the first major effort in a long line of regulatory product filings to receive FDA marketing approval.  A high-quality IND submission is imperative as this will be your first real impression with FDA, and a substandard effort will stall the process and lead to costly regulatory delays.  It is important to obtain the cooperation of several disciplines either within the organization or outside consultants when writing and assembling an IND, which include staff in non-clinical, clinical, CMC/manufacturing, and regulatory affairs.  These disciplines will play pivotal roles in guaranteeing the submission is complete and on-time for filing.   Most importantly, an understanding of what it takes to assemble the various components of a successful IND – a step-by-step procedure – will give you an opportunity to stand out in the eyes of FDA.

This course will enable the you to have an appreciation/understanding of the IND process that includes:

  • Project planning – managing timelines, mitigating risk
  • Work teams – getting the right people working on the right parts of the submission
  • Introduction to FDA interactions – What to say, what not to say
  • Structured review process across disciplines – building organization and accountability
  • Working in an electronic environment

Additionally, this course will cover some of the following challenges:

  1. The pre-IND meeting with FDA (ensuring your initial success with the Agency)
  2. Preparing a high quality and comprehensive IND…step-by-step
  3. Investigator’s Brochure
  4. Clinical Protocol
  5. CMC information – how much is enough
  6. Pharm/Tox Information
  7. Previous Human Experience
  8. Versioning and preparing to publish your IND
  9. Submitting and Maintaining the IND – keeping the Agency informed

This course will benefit anyone in regulatory affairs, CMC/manufacturing, clinical, document management, and project planning.  Additionally, anyone who needs a working knowledge of the IND process should attend.

Albert Yehaskel is an independent consultant who has over 45 years of experience in the Pharmaceutical industry.  He is an experienced and accomplished pharmaceutical professional with a distinguished record of achievement and success in the management of regulatory affairs.

He has worked for Lederle Laboratories (American Cyanamid) as an international CMC regulator and, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO Pharmaceuticals from pre-IND to post-NDA holding high level regulatory positons from senior director to VP positions.  In 2010, Albert began to consult, where his expertise encompasses drugs, biologics and medical devices. His early career was devoted to medicinal pharmaceutical research and development in the areas of antibiotics and CNS agents.

During his regulatory career he authored, managed and directed all types of domestic and international regulatory submissions. Albert has filed and obtained approval of two electronic NDAs whose products are currently on the market. He is also well versed in the area of eCTD, having written many CMC sections in Modules 2 and 3. He has also filed numerous IND applications, amendments, supplements, Special Protocol Amendments, Labeling and other Regulatory documents with FDA.

Albert has had direct experience with over 14 different divisions at FDA (CDER, CBER, CDRH), preparing briefing documents, engaging in preparatory rehearsals and subsequently orchestrating key FDA meeting. He has successfully negotiated with FDA in the areas of stability, labeling and the Carcinogenicity Assessment Committee (CAC).

Albert has built, managed and mentored regulatory teams as well as creating regulatory and quality infrastructures in companies that did not have any. He has written many SOPs and provided in-house training.

Albert earned two Master degrees; a Master of Business degree in Economics and Finance from Fairleigh Dickinson University and a Master of Science degree in Organic Chemistry from Queens College, City University of New York.  His Bachelor of Science degree in Chemistry was earned at the Polytechnic Institute of Brooklyn. He also served as an undergraduate instructor while pursuing his Master of Science degree, most recently taught several Regulatory Affairs modules at Stony Brook and teaches a CMC course for DIA on an annual basis.