FDA CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) Online Courses

Here is where the utility of the internet begins to shine and FDA is taking advantage of what it has to offer.

The following multimedia courses are currently offered online from CBER's Office of Cellual, Tissue and Gene Therapies (OCTGT). You may submit suggestions for future courses to OCTGTLearn@fda.hhs.gov. 
    

Course List

• Introduction and Scope of OCTGT  
  Presenter: Patrick Riggins. Patrick Riggins introduces the Office of Cellular, Tissue and Gene Therapies and provides a scope of what the office does.
• IND Basics in OCTGT  
  Presenter: Patrick Riggins. This presentation looks at the basics of IND submission in OCTGT.
• Sponsor Meetings with OCTGT  
  Presenter: Lori Tull. Lori Tull describes various sponsor meetings with OCTGT.
• “361” Human Cells, Tissues, & Cellular and Tissue Based Products  
  Presenter: Samuel Barone. In this presentation, Samuel Barone describes what HCT/Ps are and how they are regulated.
• The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND  
  Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.
• Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products  
  Presenter: Denise Gavin. Denise Gavin aims to guide manufacturers toward successful development of quality cell and gene therapy products, in this presentation.
• Cellular Therapy Products  
  Presenter: Keith Wonnacott. Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.
• Preclinical Considerations for Products Regulated in OCTGT  
  Presenter: Allen Wensky. Allen Wensky provides a basic overview of preclinical considerations that make up one of the three key elements of an IND submission.

US FDA CDRH 2011 Strategic Priorities

Recently FDA published its 2011 Strategic Poriorities document for CDRH.  A PDF version of the document is at

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHVisionandMission/UCM240367.pdf.

Among the identified goas was one set for January 31, 2011 (tomorrow).  FDA indicated its goal was:

By January 31, 2011, finalize a framework for validation and review of array CGH applications.

A Public Meeting was held on June 30, 2010 and a public docket was established which can be viewed at http://www.regulations.gov/#!searchResults;rpp=10;so=DESC;sb=postedDate;po=0;s=FDA-2010-N-0259

It will be interesting to see if tomorrow brings the announcement of the promised framework for validation and review of these tests.  I'm sure it will be virewed with great interest by the medical device industry as well as the the laboratory and academic communities.  It will surely give our first glimpse  into the direction FDA will take concerning the regulatory of laboratory developed tests (LDTs).  Will FDA meeting its stated goal?

Slides from January 20, 2011 FDA-Industry IVD Roundtable Meeting

The meeting presentations are available on the AdvaMed public website at http://www.advamed.org/MemberPortal/Issues/FDA/FDA+Industry.htm

Meeting held onThursday, January 20, 2011 9:00 AM - 4:00 PM
Meeting held at AdvaMed Offices, 701 Pennsylvania Avenue, NW, Suite 800, Washington DC 20004

Agenda
Presentations:

OIVD Update - Gutierrez

CBER Update -  Nedjar

UDI - Naples

UDI - Crowley

Troponin - Calleja

IDEs and Clinical Trials - Mansfield

XMRV and Blood Safety - Hewlett

Industry Feedback  - Calleja

CLIA Waiver Submissions - Di Tullio

The RAinfoBlog begins

Today I start this blog as a place to share information of interest to regulatory affairs professionals.  I'm not sure where it will go, but initially I will post information that I hear about, items that I become aware of, and items that I find on the internet during my daily travels there.  Hopefully these may be of interest to some of you.  If I post something, it will at least have been interesting to me in some way.  The only criteria I have at this point is that an item relates to the US or xUS regulation of a product in one or more of the following areas:

   pharmaceutical products (Rx and OTC)
   biological products
   medical devices
   in vitro diagnositc products
   clinical laboratory testing
   pharmacogenomics
   personalized medicine
   companion diagnostics
   combination products
   genetic testing (including direct to consumer)
   foods
   recomibinant materials
   cosmetics
   tobacco products
   holistic medicine

As a regulatory professional myself (I have been doing this in the US since 1976), I find the area interesting, at times challenging, even sometimes a little bit absurd where all I can do is shake my head and carry on.  It is never dull. 

There is a plethora of information readily available on the internet with more added each day, new laws, new regulatons, confusing and conflicting requirements, guidance and advice that do not specify expectations that can be relied upon to not change next month. 

To try to make sense of this area and capture it in some way, in 1996 I started several activities to try to spread the gospel concerning available electronic information.  In those early days, it was dial up electronic telephone bulletin boards (I ran one) and "fax back" systems including some early efforts by the US Food and Drug administration with these tools, which now seem quaint and somewhat primitive.  It has now developed from simple internet websites (the remnants of mine is at http://www.rainfo.com/).  I hope to revive it and give it new life soon.  Websites have grown more sophisticated as time went by and many nice and useful "web portals" still exist.  (How many regulatory professionals do you know that still have a subscription the US Federal Register paper edition?  Mine whent by the wayside a long time ago.)  Now we are in the area of social media with RSS, Facebook, Twitter, Flickr, and blogs galore.  (Apologies to you all for any of the many social media tools I left out.) 

I will leave the option turned on for you to post comments to this blog.  I hope you will do so in the spirit of sharing things you too find or have found useful.

So here goes.  I'm sure it will be an INTERESTING EXPERIENCE.  I hope you find it so as well.

Don Kafader

donkafader2@gmail.com

Cary, North Carolina, United States