Regulation & Business

We heard great presentations this week from Dr. Moore, who works with the Institutional Review Board at Virginia Tech, and from Dr. Van Dyke, who works between science and entrepreneurship. They both talked about different legs of moving your research from “bench to bedside” or from the lab into animal and human subjects and to market.

Was there anything that you found surprising about the IRB process from Dr. Moore’s presentation?

Did you find anything curious or unusual in thinking through the larger picture – funding, production, patenting, and research – that Dr. Van Dyke described?

What things hadn’t you considered before?

8 comments:

  1. I found it really surprising that animal trials have such strict regulations and that it is actually easier to regulate human trials. I’m not sure how it came to be that way, but I’d suppose it’s likely because humans can voice their own concerns/consent while animals cannot. And, also why we provide stricter regulations for those who might have more difficulty making their voices heard or have extra risks, such as the elderly, children, and pregnant women.

    Dr. Van Dyke’s presentation was what I expected and have been hearing about every week in the biomedical engineering seminar. The level of detail required for these grants is incredible, but given the amount of money many of them are worth, I think it’s fair for them to try to access how to get the most for their money. It’s steep learning curve though and a lot of work when you will likely not be funded the first couple times until you learn the system.

  2. Prior to Dr Moore’s presentation I knew little about the IRB. I thought that it was interesting that the IRB meetings couldn’t start if the non-scientist member was not present. This essentially makes them the most valued member on the IRB council. I think when we are in a group of people with similar scientific education it is easy to forget that our ethical viewpoints have probably been molded similarly. It made me wonder if I would we would be better scientists by going and spending time with people from lots of different educational and moral backgrounds.

    Thinking of the larger economic or practical nature of our research prior to writing grants or actually conducting research makes complete sense. I think that it is important as we go through our research careers to take a step back and ask ourselves if what we are doing is worth investing in. Making sure that what we are doing could be economically viable, or that we have the necessary patents and protection of intellectual property will help to ensure that our science will reach others. This is because researchers in regenerative medicine rely so much on outside investment to advance to the next stage of scientific discovery.

  3. I have had lectures on the IRB and translational research several times in the past, so nothing really suprised me regarding this week’s topics. I would be very interested to hear in the future how someone can be on the IRB council, and more about the types of people who make up the council at Virginia Tech.

    As far as Dr. Van Dyke’s lecture is concerned, I think translational research is something we should all keep in mind regardless of where you fall on the translational spectrum. I have heard Van Dyke lecture on this topic before, as well as on the FDA regulations, and I was happy to hear him mention the difficulties regarding RM and FDA regulations, as this is one of the topics I chose for the position paper.

  4. I am familiar with how to file an IRB application for working with human tissues in the lab, and was interested in the new rule that recently came into effect regarding materials dissected from human bodies and how biological materials such as tissues are classified as “person origin” and require IRB approval in order to use them for research purposes, whereas materials of non-biological nature such as devices don’t come under the same category and their dissection and use for research is not regulated. I find this interesting because technically, a device installed or incorporated in your body becomes essential to your core functionality and becomes a part of your body, so surgical removal of said device should also be regulated. Thank you Dr.Van Dyke for clarifying the differences between what constitutes an IRB and what doesn’t!

  5. This was my first time hearing of the IRB, but am greatful that such a board exists to regulate the practice of animal and human research.

    I am curious as to how the IRB regulates research in prosthetics that are not inside the body. It seems that everyday you hear of new 3D printed prosthetic arms and legs being made for humans, but there does not seem to be much regulation in them.

  6. I was surprised that the regulations on animal subject experiments may be stricter than human subject research when Dr. Moore mentioned that he was working on animal subjects research and then transferred to human subject IRB, especially when he said “if you are familiar with the regulations of animal subjects, you will know that if you can deal with animal protocols, you can handle human IRB.” I think these requirements of animal subject experiments come from the arguments of animal rights but actually follow the argument that animals can be used for experiments and we just have to be kind for them. I read some materials about the debate of animal rights recently. Some philosophers, such as Carl Cohen, support this idea. Cohen believes that only humans can have rights because we can operate our free will, and we need to be kind to animals even though they do not have rights. Some other philosophers, such as Peter Singer, argues that making moral judgement is not the definition of being respect; animals can suffer so that animal should be respect. Thus, this is a controversy about our relationship with animals. Dr. Moore’s presentation leads me to uncover this interesting topic.

  7. I had not considered the difficulties that TE/RM therapies had with respect to their production. The single-batch model that autologous cell therapies by definition require make it very expensive per dose because of the inability to automate and assembly-line the process. This, combined with the high failure rate of clinical trials in TE/RM makes for a very risky investment for anyone who wants to support TE/RM. This poses significant challenges for researchers, as private funding for research can be difficult to secure. The massive cost of bringing a therapy from bench to bedside is not generally covered through grants alone, so this is a genuine concern for TE/RM folks.

    I appreciated his suggestion to build the bench experiments to be better able to anticipate clinical failure, but acknowledge that the culture of the lab is not terribly accepting of experiments that “fail” or that point toward eventual failure. One wonders how we might be able to shift the culture’s expectation of pre-clinical experimentation to be more accepting of results that are not immediately translatable to the clinical stage. “Making it work” is certainly attractive, and gives a lab a lot of gravitas when it comes to being considered for future grants, but a more forward-thinking goal of more-successful clinical trials might be a better gauge of good laboratory science. How might we shift the narrative toward this goal?

  8. Dr. Van Dyke earlier on in his talk talked about the pushing of translational medicine especially by NIH and thus the phrase ‘from bench to benside’. In fact, this has encouraged more interdisciplinary research collaboration. thus, on that part, I agree with the community being created by this policy. But I think it is a huge disservice to basic research, which has been the foundation of a lot scientific findings. i do not think the policy allows for an in-dept investigation of basic research. in addition, Dr. Dahlgren raised an important question in our previous class session, in that, how do we assess the importance of research considered basic and its importance in the future of science?

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