My 2008 Presentations & Articles Relevant to Regenerative Medicine

2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the ‘better late than never” category, I thought I would share some of the presentations and relevant articles I have written over the past year.

Links are provided for most of the presentations and articles I have generated over the past year.

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13 Tips for Successful FDA Meetings

There are many reasons for meeting with the FDA during development of a regenerative medicine product. Some regenerative medicine products are more novel than others, meaning they are so unique they have never been studied in human clinical trials. Others may not be first of its kind, but may be used in novel clinical applications or be manufactured in new ways in comparison to competitor products. The nuts and bolts of preparing to meet with the FDA will be covered in a separate posting.

There are a number of opportunities for informal and formal communications with the FDA. For the purpose of this post, I am assuming you have requested a formal meeting with the FDA, perhaps to discuss the filing of an investigational new drug (IND) application to initiate human clinical studies.

Usually, to reach this point you will have expended a significant amounts of time and money. Therefore you don’t want to blow it by not being prepared to meet effectively with the FDA. Below is my list of tips to help the process go more smoothly:

  1. Remember, The FDA Wants You to Succeed
  2. Leave the “Dog & Pony” Show at Home
  3. Safety is the FDA’s Primary Focus
  4. Provide Clarification for FDA Identified Issues
  5. The FDA Will Have Questions, Lots of Them
  6. Designate a Spokesperson to Lead the Discussion
  7. Unity is a Virtue
  8. Take Time to Summarize
  9. Call in Early
  10. Call a “Time Out” if Needed
  11. Identify yourself
  12. You May Get the FDA’s Comments Early
  13. Overall, Remain Calm, Be Factual and Enjoy the Experience.

Read on, for my thoughts on how each of these tips can be used to ensure a smooth meeting with the FDA.

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