Sabrina Cohen Foundation Thanks Stem Cell Researchers

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I'm proud to use every available resource at our disposal, including this blog, to highlight the efforts of the charity we support - especially during this holiday season.  


I would be so delighted to have you join me in supporting Sabrina Cohen and her efforts.  You can start by buying next year's calendar!





The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   




--Lee


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On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.

Commercializing Cell-based Regenerative Medicines

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When introducing a regenerative medicine cell based product to a commercial setting, there are a number of things to take into consideration to ensure a commercially viable and safe product for patient use.

In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives a few insights into the commercial manufacturing scale‐up process of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ: Can you give some advice on the best way for a company to develop standards for commercialization to improve safety?

W Fodor: As with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and CBER. Cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division. So, it’s not that you need to develop standards for commercialization you just need to follow the regulations by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process. Purity and potency are all assays that need to be developed within the manufacturing process for your particular cellular product.

Pharma IQ: And what are some approval processes and pitfalls to be aware of within the scale-up process?

W Fodor: As you are scaling up your process to meet clinical trial requirements and eventually commercialization, you absolutely need to maintain current good manufacturing practices, cGMP.  Typically, during a phase one, you can get away with certain reagents that may not be fully GMPs. Or in other words, if you use a growth factor or a certain media that doesn’t have or isn’t manufactured under full GMPs, as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process. But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under cGMP.

Pharma IQ: What are some technology transfer and patent protection concerns to be cognizant of?

W Fodor: With any cellular-based product, if there’s a technology that is out there that a company wishes to pursue, to improve yield, or the manufacturing process, you need to demonstrate that that technology fits within your manufacturing process. So typically, what is done is you’ll do validation runs to ensure that that new technology satisfies the regulatory process for your manufactured product.

With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ: And do you have any tips for ensuring quality and consistency no matter how little or how much one is producing?

W Fodor: Yes, when you manufacture a cell-based product, it’s not that much different than any other biologic product. And so, during your  manufacturing runs, whatever scale it is, you have to ensure safety, such as sterility tests for microplasma, or other adventitious agents; as well as bioburden and endotoxin.  These are all tests that  need to be performed.

You need to have an identity test to make sure that your cell product, at whatever scale you are manufacturing, that at the end of that manufacturing run, the product hasn’t changed. Again, no matter what scale you’re at, you need to make sure the identity of the product is consistent from batch to batch.

For identity, you can do a number of things for a cell-based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process. And typically, what you like to do is keep it relatively simple. You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred tings to change. So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent. You can also run PCR tests to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantify the purity of your active cell type or your tissue type. And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.

And then typically, what you do is you archive. You archive samples from your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.

To contact Bill for any follow-up or other questions related to cell therapies, see his contact information on the Cell Therapy Group website.

For a PDF copy of this interview, click here to download.