Regulatory Open Forum

Hi everyone,

My group is developing a novel cell therapy at NIH in preparation for clinical trials, and we will need some help with the IND.  Can any of you recommend a CRO or consultant in the Washington, DC area with expertise and good outcome in these matters?  

The therapeutic is an autologous, iPS cell-based retinal pigmented epithelial patch for treating severe age-related (dry) macular degeneration.  

Right now, we need some help in IND strategy.  For example, is there an advantage in preparing for eCTD vs. paper-based submission?  What programs at FDA/CBER, and which of their pet issues, should be considered during product development and IND preparation?  Because this therapeutic is biologic but contains matrix and surgical device components, how can we structure the submission?  Etc.

Thank you, -Matt

Dear David,

Hi everyone,

My group is developing a novel cell therapy at NIH in preparation for clinical trials, and we will need some help with the IND.  Can any of you recommend a CRO or consultant in the Washington, DC area with expertise and good outcome in these matters?  

The therapeutic is an autologous, iPS cell-based retinal pigmented epithelial patch for treating severe age-related (dry) macular degeneration.  

Right now, we need some help in IND strategy.  For example, is there an advantage in preparing for eCTD vs. paper-based submission?  What programs at FDA/CBER, and which of their pet issues, should be considered during product development and IND preparation?  Because this therapeutic is biologic but contains matrix and surgical device components, how can we structure the submission?  Etc.

Thank you, -Matt

Good morning,

Nowadays, eCTD is so much better than paper submission and so even it is not mandatory I always do my submission electronically. For the fact that your drug product has a device associated with, this is pretty standard with cell therapy and so some company used already marked device (i.e. catheter) or they built their own in which case both the new drug investigation and the new device move together on the product development path. The FAD are used to this approach.

Good luck.

Catherine

eCTD without any doubt at all.

We want to discuss the IND strategy in some depth with an expert consultant or CRO as mentioned above, if you have any recommendation of someone in the DC area.  But thank you Sorin and Catherine for your answers on the eCTD issue!

-Matt

Good morning,

Nowadays, eCTD is so much better than paper submission and so even it is not mandatory I always do my submission electronically. For the fact that your drug product has a device associated with, this is pretty standard with cell therapy and so some company used already marked device (i.e. catheter) or they built their own in which case both the new drug investigation and the new device move together on the product development path. The FAD are used to this approach.

Good luck.

Catherine

Hi everyone,

My group is developing a novel cell therapy at NIH in preparation for clinical trials, and we will need some help with the IND.  Can any of you recommend a CRO or consultant in the Washington, DC area with expertise and good outcome in these matters?  

The therapeutic is an autologous, iPS cell-based retinal pigmented epithelial patch for treating severe age-related (dry) macular degeneration.  

Right now, we need some help in IND strategy.  For example, is there an advantage in preparing for eCTD vs. paper-based submission?  What programs at FDA/CBER, and which of their pet issues, should be considered during product development and IND preparation?  Because this therapeutic is biologic but contains matrix and surgical device components, how can we structure the submission?  Etc.

Thank you, -Matt