Dr. Curt Bilby, Dr. Elizabeth Leffel, Monday, 10-22-12 October 23, 2012Posted by The Space Show in Uncategorized.
Tags: 1st responder, Acute Radiation Syndrome Disease, animal experimentation, astronaut radiation protection, biologic medical product, Biomedical Advanced Research and Development Authority (BARDA), chemical countermeasures, CMEs, cosmic radiation, Dr. Curt Bilby, Dr. Elizabeth Leffel, environmental radiation, FDA Animal Rule., FDA Approval Track, FDA Fast Track, human pharmaceutical trials, human spaceflight radiation risks, NASA, nuclear radiation, Oncology radiation, One way Mars trips, oxidative stress pathway, pharmaceutical venture capital financing, post exposure treatment, prophylactic treatment, radiation countermeasures, radiomitgants, RLIP76 protein, space scalable businesses, Terapio, terrorist attacks
Dr. Curt Bilby, Dr. Elizabeth Leffel, Monday, 10-22-12
Guests: Dr. Curt Bilby, Dr. Elizabeth Leffel. Topics: The RLIP76 protein by Terapio for radiation toxicity mitigation from multiple causes. You are invited to comment, ask questions, and discuss the Space Show program/guest(s) on the Space Show blog, https://thespaceshow.wordpress.com. Comments, questions, and any discussion must be relevant and applicable to Space Show programming. Written Transcripts of Space Show programs are not permitted without prior written consent from The Space Show (even if for personal use) & are a violation of the Space Show copyright. We do not permit the commercial use of any Space Show program or part thereof, nor do we permit Space Show programs to be edited, placed on YouTube, or other private channels & websites. Space Show programs can be quoted in news articles, papers, academic & research work, but must be cited or referenced using the proper citation format. Contact Dr. Livingston for questions about our copyright and trademark policies. We welcomed Drs. Curt Bilby & Elizabeth Leffel to the program to discuss the use of the RLIP76 protein for radiation damage mitigation using this biologic medical product. You can learn much more about RLIP76 at the Terapio website, www.terapio.com. Terapio won Honorable Mention at this year’s NewSpace Business Plan Competition where I met Dr. Leffel as she presented for the company at the competition. You can see Dr. Leffel’s presentation at www.spacevidcast.com/2012/07/27/newspace-2012-business-plan-competition-part-2. Dr. Leffel starts her presentation at 26 minutes 25 seconds into the video. In starting today’s discussion, our guests explained RIP76 and how it works through the oxidative stress pathway. We learned about the FDA Animal Rule being used given human radiation experiments are not allowed. We also talked about FDA fast tracking RLIP76 approval in case of an emergency, plus how RLIP76 would probably be used for acute radiation syndrome as compared to a chronic radiation exposure as the treatment models differ. Near the end of the first segment, NYC 1st responder Daniel called us with several questions applicable to his being an emergency 1st responder & likely to be closely involved in any nuclear terrorist event. We don’t often get a view of this world on The Space Show so I urge you to pay attention to Daniel’s questions & the discussion with our guests.
In our second segment, I asked Dr. Bilby questions about the venture capital model for pharmaceutical R&D, pricing, & national healthcare systems plus insurance companies blocking access to many of these cutting edge drugs due to their high cost. Curt took us through the risks associated with the different stages of pharmaceutical R&D, clinical trials, & product distribution. We talked about the very high failure rate for new drug research & we were introduced to the term “valley of death” as applied to this process. We talked more about the actual RLIP76 process, potential pricing of the product & public health policy that might control its use. We had a caller ask about using RLIP76 on a one way Mars trip as a trial, wondering if the FDA would approve such an “experiment.” Dr. Bilby explained why it was unlikely this would happen, then we talked about getting RLIP76 for a space use by going outside the U.S. Listen to why that won’t work. We also talked about space radiation issues, the possible role of RLIP76 regarding these issues, plus NASA’s interest in working with Terapio in their research. Doug called to cite Terapio as a perfect example of a space scalable business, a topic we talk often of on The Space Show. As the segment ended, I asked Dr. Bilby if Terapio was public or if it had plans to do an IPO anytime in the near future. He explained the mixture of government & private sector equity partners but no plans for an IPO at this time.
Please post your comments/questions on The Space Show blog. You can email our guests through me.