Michael Werner

Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions

Michael-Werner-Pic

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much …

Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions Read More »

Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited

Alliance-for-Regenerative-Medicine

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for …

Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited Read More »

Proposed Moratorium on Genetic Modification of Human Germ Cells

sperm-and-egg

One of the hottest topics in the biomedical world in 2015 is heritable human genetic modification including via germ cells. There is an unsettling sense that genetically modified human germ cells and eventually GMO human beings are likely coming even if science and society are not ready for it. There are a hodgepodge of laws against human …

Proposed Moratorium on Genetic Modification of Human Germ Cells Read More »

ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation

Alliance-for-Regenerative-Medicine

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances  (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has …

ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation Read More »

Flash stem cell contest: free passes to see Yamanaka & more at WAFSF meeting in SFO

World-Alliance-Forum-San-Francisco

One of the best stem cell meetings each year is the World Alliance Form San Francisco (WAFSF) stem cell conference. It brings together in San Francisco many of the very best stem cell researchers from around the world doing the most cutting edge translational research. You should go! The speakers include Shinya Yamanaka, Masayo Takahashi, …

Flash stem cell contest: free passes to see Yamanaka & more at WAFSF meeting in SFO Read More »

World Alliance Forum “Future of Stem Cells” features Shinya Yamanaka

If there was one stem cell meeting I would absolutely not want to miss next month in November if at all possible, it is the 2013 World Alliance Forum “Future of Stem Cells” in San Francisco. Are you going? Win free tickets to this meeting here! Unfortunately I have a conflict so I will this …

World Alliance Forum “Future of Stem Cells” features Shinya Yamanaka Read More »

Stem Cell Field Shocker: Coalition for Advancement of Medical Research (CAMR) to Dissolve

The Board of Directors of the Coalition for the Advancement of Medical Research (CAMR) announced today that they have voted to dissolve the organization. CAMR is effectively at an end. The CAMR Board has decided, as described in an email, to “transfer its mission and its resources to an outstanding colleague organization, the Alliance for Regenerative …

Stem Cell Field Shocker: Coalition for Advancement of Medical Research (CAMR) to Dissolve Read More »